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Animals and Animal Products
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2020-01-01
2020-01-01
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POULTRY PRODUCTS INSPECTION REGULATIONS
381

PART 381
Animals and Animal Products
FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE
AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND POULTRY PRODUCTS INSPECTION AND VOLUNTARY INSPECTION AND CERTIFICATION
Pt. 381

PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS

Subpart A—Definitions
Sec.
381.1
Definitions.

Subpart B—Administration; Application of Inspection and Other Requirements
381.3
Administration.
381.4
Inspection in accordance with methods prescribed or approved.
381.5
Publications.
381.6
Establishments requiring inspection.
381.7
Coverage of all poultry and poultry products processed in official establishments.

Subpart C—Exemptions
381.10
Exemptions for specified operations.
381.11
Exemptions based on religious dietary laws.
381.12
Effect of religious dietary laws exemptions on other persons.
381.13
Suspension or termination of exemptions.
381.14
Inspection concerning purportedly exempted operations.
381.15
Exemption from definition of “poultry product” of certain human food products containing poultry.

Subpart D—Application for Inspection; Grant or Refusal of Inspection
381.16
How application shall be made.
381.17
Filing of application.
381.18
Authority of applicant.
381.20
Survey and grant of inspection.
381.21
Refusal of inspection.
381.22
Conditions for receiving inspection.

Subpart E—Inauguration of Inspection; Official Establishment Numbers; Separation of Establishments and Other Requirements; Withdrawal of Inspection
381.25
Official establishment numbers.
381.26
Separation of establishments.
381.27
Inauguration of service; notification concerning regulations; status of uninspected poultry products.
381.28
Report of violations.

Subpart F—Assignment and Authorities of Program Employees; Appeals
381.30-381.31
[Reserved]
381.32
Access to establishments.
381.33
Identification.
381.34
Financial interest of inspectors.
381.35
Appeal inspections; how made.

Subpart G—Facilities for Inspection; Overtime and Holiday Service; Billing Establishments
381.36
Facilities required.
381.37
Schedule of operations.
381.38
Overtime and holiday inspection service.
381.39
Basis of billing for overtime and holiday services.

Subpart H—Attestation on Work-Related Conditions
381.45
Attestation requirements.
381.46
Severability.

Subpart I—Operating Procedures
381.65
Operations and procedures, generally.
381.66
Temperatures and chilling and freezing procedures.
381.67
Young chicken and squab slaughter inspection rate maximums under traditional inspection procedure.
381.68
Maximum inspection rates—New turkey inspection system.
381.69
Maximum line speed rates under the New Poultry Inspection System.

Subpart J—Ante Mortem Inspection
381.70
Ante mortem inspection; when required; extent.
381.71
Condemnation on ante mortem inspection.
381.72
Segregation of suspects on ante mortem inspection.
381.73
Quarantine of diseased poultry.
381.74
Poultry suspected of having biological residues.
381.75
Poultry used for research.

Subpart K—Post Mortem Inspection; Disposition of Carcasses and Parts
381.76
Post-mortem inspection under Traditional Inspection, the Streamlined Inspection System (SIS), the New Line Speed (NELS) Inspection System, the New Poultry Inspection System (NPIS), the New Turkey Inspection System (NTI), and Ratite Inspection.
381.77
Carcasses held for further examination.
381.78
Condemnation of carcasses and parts: separation of poultry suspected of containing biological residues.
381.79
Passing of carcasses and parts.
381.80
General; biological residues.
381.81
Tuberculosis.
381.82
Diseases of the leukosis complex.
381.83
Septicemia or toxemia.
381.84
Airsacculitis.
381.85
Special diseases.
381.86
Inflammatory processes.
381.87
Tumors.
381.88
Parasites.
381.89
Bruises.
381.90
Cadavers.
381.91
Contamination.
381.92
Overscald.
381.93
Decomposition.
381.94
Contamination with microorganisms; process control verification criteria and testing; pathogen reduction standards for establishments that slaughter ratites.

Subpart L—Handling and Disposal of Condemned or Other Inedible Products at Official Establishments
381.95
Disposal of condemned poultry products.

Subpart M—Official Marks, Devices and Certificates; Export Certificates; Certification Procedures
381.96
Wording and form of the official inspection legend.
381.97
[Reserved]
381.98
Official seal.
381.99
Official retention and rejection tags.
381.100
Official detention tag.
381.101
Official U.S. Condemned mark.
381.102
[Reserved]
381.103
Official poultry condemnation certificates; issuance and form.
381.104
Export inspection marks.
381.105
Marking products for export.
381.106
Export certification.
381.107
Special procedures as to certification of poultry products for export to certain countries.
381.108
Official poultry inspection certificates; issuance and disposition.
381.109
Form of official poultry inspection certificate.
381.110
Erasures or alterations made on certificates.
381.111
Data to be entered in proper spaces.
381.112
Official mark for maintaining the identity and integrity of samples.

Subpart N—Labeling and Containers
381.115
Containers of inspected and passed poultry products required to be labeled.
381.116
Wording on labels of immediate containers.
381.117
Name of product and other labeling.
381.118
Ingredients statement.
381.119
Declaration of artificial flavoring or coloring.
381.120
Antioxidants; chemical preservatives; and other additives.
381.121
Quantity of contents.
381.121a-381.121e
[Reserved]
381.122
Identification of manufacturer, packer or distributor.
381.123
Official inspection mark; official establishment number.
381.124
Dietary food claims.
381.125
Special handling label requirements.
381.126
Date of packing and date of processing; contents of cans.
381.127
Wording on labels of shipping containers.
381.128
Labels in foreign languages.
381.129
False or misleading labeling or containers.
381.130
False or misleading labeling or containers; orders to withhold from use.
381.131
Preparation of labeling or other devices bearing official inspection marks without advance approval prohibited; exceptions.
381.132-381.133
[Reserved]
381.134
Requirement of formulas.
381.136
Affixing of official identification.
381.137
Evidence of labeling and devices approval.
381.138
Unauthorized use or disposition of approved labeling or devices.
381.139
Removal of official identifications.
381.140
Relabeling poultry products.
381.141-381.143
[Reserved]
381.144
Packaging materials.

Subpart O—Entry of Articles Into Official Establishments; Processing Inspection and Other Reinspections; Processing Requirements
381.146
Sampling at official establishments.
381.148
Processing and handling requirements for frozen poultry products.
381.150
Requirements for the production of fully cooked poultry products and partially cooked poultry breakfast strips.
381.151
Adulteration of product by polluted water; procedure for handling.
381.152
Manufacture of uninspected, inedible products at official establishments.
381.153
[Reserved]

Subpart P—Definitions and Standards of Identity or Composition
381.155
General.
381.156
Poultry meat content standards for certain poultry products.
381.157
Canned boned poultry and baby or geriatric food.
381.158
Poultry dinners (frozen) and pies.
381.159
Poultry rolls.
381.160
(Kind) burgers; (Kind) patties.
381.161
“(Kind) A La Kiev.”
381.162
“(Kind) steak or fillet.”
381.163
“(Kind) baked” or “(Kind) roasted.”
381.164
“(Kind) barbecued.”
381.165
“(Kind) barbecued prepared with moist heat.”
381.166
Breaded products.
381.167
Other poultry dishes and specialty items.
381.168
Maximum percent of skin in certain poultry products.
381.169
[Reserved]
381.170
Standards for kinds and classes, and for cuts of raw poultry.
381.171
Definition and standard for “Turkey Ham.”
381.172
Requirements for substitute standardized poultry products named by use of an expressed nutrient content claim and a standardized term.
381.173
Mechanically Separated (Kind of Poultry).
381.174
Limitations with respect to use of Mechanically Separated (Kind of Poultry).

Subpart Q—Records, Registration, and Reports
381.175
Records required to be kept.
381.176
Place of maintenance of records.
381.177
Record retention period.
381.178
Access to and inspection of records, facilities and inventory; copying and sampling.
381.179
Registration.
381.180
Information and reports required from official establishment operators.
381.181
Reports by consignees of allegedly adulterated or misbranded products; sale or transportation as violations.
381.182
Reports of inspection work.

Subpart R—Cooperation With States and Territories; Certification of State and Territorial Programs as at Least Equal to Federal Program
381.185
Assistance to State and Territorial programs.
381.186
Cooperation of States and other jurisdictions in Federal programs.
381.187
Cooperation of States for the interstate shipment of poultry products.

Subpart S—Transportation; Exportation; or Sale of Poultry or Poultry Products
381.189
Provisions inapplicable to specimens for laboratory examination, etc., or to naturally inedible articles.
381.190
Transactions in slaughtered poultry and other poultry products restricted; vehicle sanitation requirements.
381.191
Distribution of inspected products to small lot buyers.
381.192
Penalties inapplicable to carriers.
381.193
Poultry carcasses, etc., not intended for human food.
381.194
Transportation and other transactions concerning dead, dying, disabled, or diseased poultry, and parts of carcasses of poultry that died otherwise than by slaughter.

Subpart T—Imported Poultry Products
381.195
Definitions; requirements for importation into the United States.
381.196
Eligibility of foreign countries for importation of poultry products into the United States.
381.197
Foreign inspection certificate requirements.
381.198
Import inspection application.
381.199
Inspection of poultry products offered for entry.
381.200
Poultry products offered for entry, retention in customs custody; delivery under bond; movement prior to inspection; handling; facilities and assistance.
381.201
Means of conveyance and equipment used in handling poultry products offered for entry to be maintained in sanitary condition.
381.202
Poultry products offered for entry; reporting of findings to customs; handling of articles refused entry; appeals, how made; denaturing procedures.
381.203
Products offered for entry; charges for storage, cartage, and labor with respect to products which are refused entry.
381.204
Marking of poultry products offered for entry; official import inspection marks and devices.
381.205
Labeling of immediate containers of poultry products offered for entry.
381.206
Labeling of shipping containers of poultry products offered for entry.
381.207
Small importations for consignee's personal use, display, or laboratory analysis.
381.208
Poultry products offered for entry and entered to be handled and transported as domestic; entry into official establishments; transportation.
381.209
Returned United States inspected and marked poultry products: exemption.

Subpart U—Detention; Seizure and Condemnation; Criminal Offenses
381.210
Poultry and other articles subject to administrative detention.
381.211
Method of detention; form of detention tag.
381.212
Notification of detention to the owner of the poultry or other article, or the owner's agent, and person having custody.
381.213
Notification of governmental authorities having jurisdiction over article detained; form of written notification.
381.214
Movement of poultry or other article detained; removal of official marks.
381.215
Poultry or other articles subject to judicial seizure and condemnation.
381.216
Procedure for judicial seizure, condemnation, and disposition.
381.217
Authority for condemnation or seizure under other provisions of law.
381.218
Criminal offenses.

Subpart V—Special Provisions for Designated States and Territories; Criteria and Procedure for Designating Establishments With Operations Which Would Clearly Endanger the Public Health; Disposition of Poultry Products Therein
381.220
Definition of “State”.
381.221
Designation of States under paragraph 5(c) of the Act.
381.222
States designated under paragraph 5(c) of the Act; application of regulations.
381.223
Control and disposition of nonfederally inspected poultry products in States designated under paragraph 5(c) of the Act.
381.224
Designation of States under section 11 of the Act; application of sections of the Act and the regulations.
381.225
Criteria and procedure for designating establishments with operations which would clearly endanger the public health; disposition of poultry products therein.
Subpart X [Reserved]

Subpart Y—Nutrition Labeling
381.400
Nutrition labeling of poultry products.
381.401
Required nutrition labeling of ground or chopped poultry products.
381.402
Location of nutrition information.
381.403-381.407
[Reserved]
381.408
Labeling of poultry products with number of servings.
381.409
Nutrition label content.
381.410-381.411
[Reserved]
381.412
Reference amounts customarily consumed per eating occasion.
381.413
Nutrient content claims; general principles.
381.414-381.443
[Reserved]
381.444
Identification of major cuts of poultry products.
381.445
Nutrition labeling of single-ingredient, raw poultry products that are not ground or chopped products described in § 381.401.
381.446-381.453
[Reserved]
381.454
Nutrient content claims for “good source,” “high,” and “more”.
381.455
[Reserved]
381.456
Nutrient content claims for “light” or “lite”.
381.457-381.459
[Reserved]
381.460
Nutrient content claims for calorie content.
381.461
Nutrient content claims for the sodium content.
381.462
Nutrient content claims for fat, fatty acids, and cholesterol content.
381.463
Nutrient content claims for “healthy.”
381.464-381.468
[Reserved]
381.469
Labeling applications for nutrient content claims.
381.470-381.479
[Reserved]
381.480
Label statements relating to usefulness in reducing or maintaining body weight.
381.481-381.499
[Reserved]
381.500
Exemption from nutrition labeling.

Subpart Z—Selected Establishments; Cooperative Program for Interstate Shipment of Poultry Products
381.511
Definitions.
381.512
Purpose.
381.513
Requirements for establishments; ineligible establishments.
381.514
State request for cooperative agreement.
381.515
Establishment selection; official number for selected establishments.
381.516
Commencement of a cooperative interstate shipment program; inspection by designated personnel and official mark.
381.517
Federal oversight of a cooperative interstate shipment program.
381.518
Quarterly reports.
381.519
Enforcement authority.
381.520
Deselection of ineligible establishments.
381.521
Transition to official establishment.
381.522
Transition grants.
381.523
Separation of operations.
381.524
Voluntary withdrawal.

Authority:
7 U.S.C. 1633, 1901-1906; 21 U.S.C. 451-472; 7 CFR 2.18, 2.53.

Source:
37 FR 9706, May 16, 1972, unless otherwise noted.

Subpart A—Definitions
§ 381.1
Definitions.
(a) For the purposes of the regulations in this part, unless otherwise required by the context, the singular form shall also import the plural and the masculine form shall also import the feminine, and vice versa.
(b) For the purposes of such regulations, unless otherwise required by the context, the following terms shall be construed, respectively, to mean:
Acceptable. “Acceptable” means suitable for the purpose intended and acceptable to the Administrator.
Act. “Act” means the Poultry Products Inspection Act (71 Stat. 441, as amended by the Wholesome Poultry Products Act, 82 Stat. 791; 21 U.S.C. 451 et seq.).
Adulterated. “Adulterated” applies to any poultry product under one or more of the following circumstances:
(i) If it bears or contains any 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;
(ii)(a) If it bears or contains (by reason of administration of any substance to the live poultry or otherwise) any added poisonous or added deleterious substance (other than one which is a pesticide chemical in or on a raw agricultural commodity; a food additive; or a color additive) which may, in the judgment of the Administrator, make such article unfit for human food;
(b) If it is, in whole or 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;
(c) 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;
(d) 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 otherwise deemed adulterated under paragraphs (b)(4)(ii) (b), (c), or (d) 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 part in official establishments;
(iii) 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;
(iv) If it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health;
(v) If it is, in whole or in part, the product of any poultry which has died otherwise than by slaughter;
(vi) If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health;
(vii) 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; or
(viii) 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.
Animal food. Any article intended for use as food for dogs, cats, or other animals, derived wholly, or in part, from carcasses or parts or products of the carcass of poultry, except that the term animal food as used herein does not include (i) processed dry animal food or (ii) livestock or poultry feeds manufactured from processed poultry byproducts (such as poultry byproduct meal, hydrolyzed poultry feathers, and hydrolyzed poultry byproducts aggregate).
Animal food manufacturer. “Animal Food Manufacturer” means any person engaged in the business of manufacturing or processing animal food.
Applicant. “Applicant” means any person who requests inspection service, exemption, or other authorization under the regulations.
Biological residue. “Biological Residue” means any substance, including metabolites, remaining in poultry at the time of slaughter or in any of its tissues after slaughter, as the result of treatment or exposure of the live poultry to a pesticide, organic compound, metallic or other inorganic compound, hormone, hormone-like substance, growth promoter, antibiotic, anthelmintic, tranquilizer, or other agent that leaves a residue.
Capable of use as human food. The term “capable of use as human food” applies to any carcass, or part or product of a carcass of any poultry, unless it is denatured or otherwise identified as required by the regulations, or it is naturally inedible by humans.
Carcass. This term means all parts, including viscera, of any slaughtered poultry.
Commerce. “Commerce” means 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.
Consumer package. “Consumer package” means any container in which a poultry product is enclosed for the purpose of display and sale to household consumers.
Container. The term “container” includes any box, can, tin, cloth, plastic, or any other receptacle, wrapper, or cover.
Edible. This term means that an article is intended for use as human food.
Egg Products Inspection Act. “Egg Products Inspection Act” means the Act so entitled, approved December 29, 1970 (84 Stat. 1620, 21 U.S.C. 1031 et seq.).
Federal Food, Drug, and Cosmetic Act. “Federal Food, Drug, and Cosmetic Act” means the Act so entitled, approved June 25, 1938 (52 Stat. 1040), and acts amendatory thereof or supplementary thereto (21 U.S.C. 301 et seq.).
Federal Meat Inspection Act. “Federal Meat Inspection Act” means the Act so entitled, approved March 4, 1907, 34 Stat. 1260, as amended by the Wholesome Meat Act, 81 Stat. 584 (21 U.S.C. 601 et seq.).
Free from protruding pinfeathers. “Free from protruding pinfeathers” means that the carcass is free from protruding pinfeathers which are visible to an inspector during an examination of the carcass at normal operating speeds. However, a carcass may be considered as being free from protruding pinfeathers if it has a generally clean appearance (especially on the breast), and if not more than an occasional protruding pinfeather is in evidence during a more careful examination of the carcass.
Giblets. “Giblets” means the liver from which the bile sac has been removed, the heart from which the pericardial sac has been removed, and the gizzard from which the lining and contents have been removed: Provided, That each such organ has been properly trimmed and washed.
Immediate container. “Immediate container” includes any consumer package; or any other container in which poultry products, not consumer packaged, are packed.
Inedible. This term means any carcass or any part of a carcass that is either naturally inedible by humans or is rendered unfit for human food by reason of adulteration or denaturing.
Inspected for wholesomeness. This term means that the poultry product so identified has been inspected and was found at the time of such inspection to be not adulterated.
Inspection. “Inspection” means any inspection required by the regulations to determine whether any poultry or poultry products comply with the requirements of the Act and the regulations.
Label. This term applies to any display of written, printed, or graphic matter upon any article or the immediate container (not including package liners) of any article.
Labeling. This term applies to all labels and other written, printed, or graphic matter (i) upon any article or any of its containers or wrappers, or (ii) accompanying such article.
Misbranded. This term applies to any poultry product under one or more of the following circumstances:
(i) If its labeling is false or misleading in any particular;
(ii) If it is offered for sale under the name of another food;
(iii) 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;
(iv) If its container is so made, formed, or filled as to be misleading;
(v) If in a package or other container, unless it bears a label showing:
(a) The name and place of business of the manufacturer, packer, or distributor; and
(b) An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; except as otherwise provided in § 381.121(a) with respect to the quantity of contents;
(vi) 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;
(vii) If it purports to be or is represented as a food for which a definition and standard of identity or composition is prescribed by the regulations in subpart P of this part unless:
(a) It conforms to such definition and standard, and
(b) 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.
(viii) 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 regulations of the Secretary, ^2 and 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;
^2 No such standards are currently in effect. However, § 381.129 prohibits the use of false or misleading containers.
(ix) If it is not subject to the provisions of paragraph (b)(vii) of this section, unless its label bears:
(a) The common or usual name of the food, if any there be, and
(b) In case it is fabricated from two or more ingredients, the common or usual name of each ingredient, except as otherwise provided in § 381.118(c);
(x) If it purports to be or is represented for special dietary uses, unless the label bears such information concerning its vitamin, mineral, and other dietary properties as is required by § 381.124;
(xi) 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 in § 381.119, or
(xii) If it fails to bear, directly thereon or on its containers, when required by § 381.123, the official inspection legend and the official establishment number of the establishment where the product was processed; and unrestricted by any of the foregoing; such other information as the Administrator may require in the 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 compounds. 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 poultry or poultry products, excluding labeling and packaging materials as covered in subpart N of this part.
Official certificate. This term means any certificate prescribed in subpart M of this part relating to poultry or poultry products.
Official device. This term means any label or other device prescribed in subpart M of this part for use in applying any official mark.
Official establishment. “Official establishment” means any establishment as determined by the Administrator at which inspection of the slaughter of poultry, or the processing of poultry products, is maintained pursuant to the regulations.
Official import inspection establishment. This term means any establishment, other than an official establishment as defined in this definition where inspections are authorized to be conducted as prescribed in § 381.199.
Official inspection legend. This term means the official inspection mark prescribed in § 381.96 or the official poultry identification mark prescribed in § 381.97, showing that an article was inspected for wholesomeness and passed in accordance with the Act.
Official mark. This term means any symbol prescribed in subpart M of this part to identify the status of any article or poultry under the Act.
Packaging material. Any cloth, paper, plastic, metal, or other material used to form a container, wrapper, label, or cover for poultry products.
Pesticide chemical, food additive, color additive, raw agricultural commodity. These terms shall have the same meanings for the purposes of the Act and the regulations as under the Federal Food, Drug, and Cosmetic Act.
Poultry. “Poultry” means any domesticated bird (chickens, turkeys, ducks, geese, guineas, ratites, or squabs, also termed young pigeons from one to about thirty days of age), whether live or dead.
Poultry product. (i) This term means any poultry carcass or part thereof; or any product which is made wholly or in part from any poultry carcass or part thereof, excepting those exempted from definition as a poultry product in § 381.15. Except where the context requires otherwise (e.g., in paragraph (b)(42) of this section), this term is limited to articles capable of use as human food.
(ii) Poultry food product. This term means any product capable of use as human food which is made in part from any poultry carcass or part thereof, excepting those exempted from definition as a poultry product in § 381.15.
Poultry products broker. “Poultry products broker” means any person engaged in the business of buying or selling poultry products on commission, or otherwise negotiating purchases or sales of such articles other than for his own account or as an employee of another person.
Process. Process used as a verb means to conduct any operation or combination of operations, whereby poultry is slaughtered, eviscerated, canned, salted, stuffed, rendered, boned, cut up, or otherwise manufactured or processed. The term “process” does not refer to freezing of poultry products, except when freezing is incidental to operations otherwise classed as “processing” under this paragraph.
Process authority. A person or organization with expert knowledge in poultry production process control and relevant regulations.
Process schedule. A written description of processing procedures, consisting of any number of specific, distinct, and ordered operations directly under 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.
Ready-to-cook poultry. “Ready-to-cook poultry” means any slaughtered poultry free from protruding pinfeathers and vestigial feathers (hair or down), from which the head, feet, crop, oil gland, trachea, esophagus, entrails, and lungs have been removed, and from which the mature reproductive organs and kidneys may have been removed, and with or without the giblets, and which is suitable for cooking without need of further processing. Ready-to-cook poultry also means any cut-up or disjointed portion of poultry or other parts of poultry, such as reproductive organs, head, or feet that are suitable for cooking without need of further processing.
Regulations. “Regulations” means the provisions of this entire part.
Renderer. “Renderer” means any person engaged in the business of rendering carcasses, or parts or products of the carcasses, of poultry, except rendering conducted under inspection or exemption pursuant to the regulations.
Shipping container. “Shipping container” means any container used or intended for use in packaging the product packed in an immediate container.
Slaughter. “Slaughter” means the act of killing poultry for human food.
State. Except as otherwise provided in § 381.220 “State” means any State of the United States and the Commonwealth of Puerto Rico.
Supervision. This term means the controls, as prescribed in instructions to Inspection Service 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 part.
Territory. The term “territory” means Guam, the Virgin Islands of the United States, American Samoa, and any other territory or possession of the United States, excluding the Canal Zone.
United States. This term means the States, the District of Columbia, and the territories of the United States.
U.S. Condemned. This term means that the poultry carcass, or part or product of a poultry carcass, so identified was inspected and found to be adulterated and is condemned.
U.S. Detained. This term is applicable to poultry, poultry products, and other articles which are held in official custody in accordance with section 19 of the Act and § 381.210, pending disposal as provided in said section 19.
U.S. Refused Entry. This term means that the slaughtered poultry or other poultry product so identified was presented for inspection for entry into the United States and was found not to comply with the requirements of the Act.
U.S. Rejected. This term means that the equipment or facility so identified is prohibited from being used in the processing of any poultry or poultry product until such equipment or facility is found by an inspector to be sanitary and otherwise eligible for use under the regulations.
U.S. Retained. This term means that the poultry or carcass, or part or product of a carcass, of poultry so identified is held at an official establishment by the inspection service for further determination as to its disposal.
(c) For the purposes of the standard for cooked, smoked sausage (§ 319.180 of this chapter), the term “poultry byproduct” means the skin, fat, gizzard, heart, or liver, or any combination thereof, of any poultry.
[37 FR 9706; May 16, 1972, as amended at 39 FR 4568, Feb. 5, 1974; 40 FR 42338, Sept. 12, 1975; 48 FR 6091, Feb. 10, 1983; 49 FR 2236, Jan. 19, 1984; 49 FR 3643, Jan. 30, 1984; 49 FR 47478, Dec. 5, 1984; 51 FR 37709, Oct. 24, 1986; 64 FR 745, Jan. 6, 1999; 64 FR 56416, Oct. 20, 1999; 66 FR 1770, Jan. 9, 2001; 66 FR 22905, May 7, 2001; 67 FR 13258, Mar. 22, 2002; 69 FR 255, Jan. 5, 2004; 79 FR 56233, Sept. 19, 2014]

Subpart B—Administration; Application of Inspection and Other Requirements
§ 381.3
Administration.
(a) [Reserved]
(b) The Administrator may in specific classes of cases waive for limited periods any provisions of the regulations 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 processing techniques may be tested to facilitate definite improvements: Provided, That such waivers of the provisions of the regulations are not in conflict with the purposes or provisions of the Act.
(c) Pursuant to section 6 of the Act, the Administrator believes that, in establishments processing poultry products at which inspection under the Act and regulations is required, the frequency with which and the manner in which poultry products made from poultry previously slaughtered and eviscerated in official establishments are reinspected by Inspection Service employees should be based on considerations relevant to effective regulation of poultry 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, if so, to what extent the intensity of inspection coverage exceeds that which should be deemed necessary pursuant to section 6 of the Act, 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 Inspection Service employees shall be determined on the basis of the results of those reviews and be otherwise in accordance with this section.
(d) The determinations referred to in paragraph (c) of this section shall be made by the Inspection Service and shall reflect evaluations of the performance and the characteristics of 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 operating such establishment or by anyone responsibly connected with the business operating such establishment, as “responsibly connected” is defined in section 18(a) of the Act,
(ii) The competence of the person operating 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 Inspection Service 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 and evisceration operations also are conducted at such establishment,
(v) What, if any, food products not regulated under this Act or the Federal Meat Inspection Act also are processed at such establishment, and
(vi) The size of such establishment.
(e)(1) For the period of experimentation described in paragraph (c) of this section, the frequency of inspection by Inspection Service employees of operations other than slaughter and evisceration 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 (d)(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 (d)(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
(C) The availability of Inspection Service employees.
(ii) To the extent that frequency of inspection or other conditions and methods of inspection coverage are identified as conflicting with provisions of the regulations in this part, the Administrator will waive such provisions for the period of experimentation, in accordance with paragraph (b) of this section.
[37 FR 9706, May 16, 1972, as amended at 52 FR 10033, Mar. 30, 1987; 69 FR 255, Jan. 5, 2004]
§ 381.4
Inspection in accordance with methods prescribed or approved.
Inspection of poultry products shall be rendered pursuant to the regulations and under such conditions and in accordance with such methods as may be prescribed or approved by the Administrator.
§ 381.5
Publications.
Publications under the Act and the regulations shall be made in the Federal Register and in such other media as the Administrator may designate.
§ 381.6
Establishments requiring inspection.
Inspection under the regulations is required at:
(a) Every establishment, except as provided in § 381.10 (a) and (b) or § 381.11, in which any poultry is slaughtered for transportation or sale in commerce, or in which any poultry products are wholly or in part, processed for transportation or sale in commerce, as articles intended for use as human food;
(b) Every establishment, except as provided in § 381.10 (a) and (b), (c), or (d), or § 381.11, within any State or organized territory which is designated in § 381.221 pursuant to section 5(c) of the Act, at which any poultry is slaughtered or any poultry products are processed, for use as human food solely for distribution within such jurisdiction; and
(c) Except as provided in § 381.10 (a) and (b), or (c), or § 381.11, every establishment designated by the Administrator pursuant to section 5(c) of the Act as one producing adulterated poultry products which would clearly endanger the public health.
§ 381.7
Coverage of all poultry and poultry products processed in official establishments.
All poultry and poultry products processed in an official establishment shall be inspected, handled, processed, marked, and labeled as required by the regulations.

Subpart C—Exemptions
§ 381.10
Exemptions for specified operations.
(a) The requirements of the Act and the regulations for inspection of the processing of poultry and poultry products shall not apply to:
(1) Any retail dealer with respect to poultry products sold in commerce directly to consumers in an individual retail store, if the only processing operation performed by such retail dealer is the cutting up of poultry products on the premises where such sales to consumers are made: Provided, That such operation is conducted under such sanitary standards, practices, and procedures as result in the preparation of poultry products that are not adulterated: And provided further, That the poultry products sold in commerce are derived from poultry inspected and passed under the Act and such poultry products are not adulterated or misbranded at the time of sale (except that the official inspection legend shall not be used). (For the purposes of this subparagraph, a retail dealer is any person who sells poultry products directly to consumers as defined in paragraph (d)(2)(vi) of this section and whose sales of poultry products to household consumers constitute, in terms of dollar value, at least 75 percent of his total sales of poultry products.)
(2) The slaughter of poultry, and the processing of poultry products, by any person in any territory not organized with a legislative body, solely for distribution within such territory: Provided, That such poultry is sound and healthy and is slaughtered under such sanitary standards, practices, and procedures as result in the preparation of poultry products that are not adulterated: And provided further, That the poultry products are not adulterated or misbranded when so distributed (except that the official inspection legend shall not be used).
(3) The slaughtering by any person of poultry of his own raising, and the processing by him and transportation in commerce of the poultry products exclusively for use by him and members of his household and his nonpaying guests and employees: Provided, That in lieu of complying with all the adulteration and misbranding provisions of the Act, such poultry is healthy and is slaughtered and processed under such sanitary standards, practices, and procedures as result in the preparation of poultry products that are sound, clean, and fit for human food, and the shipping containers of such poultry products bear the producer's name and address and the statement “Exempted—P.L. 90-492.”
(4) The custom slaughter by any person of poultry delivered by the owner thereof for such slaughter, and the processing by such slaughterer and transportation in commerce of the poultry products exclusively for use, in the household of such owner, by him and members of his household and his nonpaying guests and the employees: Provided, That such custom slaughterer does not engage in the business of buying or selling any poultry products capable of use as human food: And provided further, That in lieu of complying with all the adulteration and misbranding provisions of the Act, such poultry is healthy and is slaughtered and processed under such sanitary standards, practices, and procedures as result in the preparation of poultry products that are sound, clean and fit for human food, and the shipping containers of such poultry products bear the owner's name and address and the statement “Exempted—P.L. 90-492.”
(5) The slaughtering of sound and healthy poultry and processing of poultry products therefrom in any State or territory or the District of Columbia by any poultry producer on his own premises with respect to poultry raised on his premises, and the distribution by any person solely within such jurisdiction of the poultry products derived from such operations: Provided, That (i) in lieu of complying with all the adulteration provisions of the Act, such poultry is slaughtered and otherwise processed and handled under such sanitary standards, practices, and procedures as result in the preparation of poultry products that are sound, clean, and fit for human food when so distributed; (ii) such poultry products when so distributed, bear (in lieu of labeling that would otherwise be required) the producer's name and address and the statement “Exempted—P.L. 90-492” and such poultry products are not otherwise misbranded; (iii) such producer and distributor do not engage in the current calendar year in the business of buying or selling any poultry or poultry products other than as specified in this paragraph (a) (5) or (6) of this section; and (iv) neither such producer or distributor slaughters or processes the products of more poultry than allowed by paragraph (b) of this section.
(6) The slaughtering of sound and healthy poultry or the processing of poultry products of such poultry in any State or territory or the District of Columbia by any poultry producer or other person for distribution by him solely within such jurisdiction directly to household consumers, restaurants, hotels, and boardinghouses, for use in their own dining rooms, or in the preparation of meals for sales direct to consumers: Provided, That (i) in lieu of complying with all the adulteration provisions of the Act, such poultry is slaughtered and otherwise processed and handled under such sanitary standards, practices, and procedures as result in the preparation of poultry products that are sound, clean, and fit for human food when distributed by such processor; (ii) such poultry products when so distributed bear (in lieu of labeling that would otherwise be required) the processor's name and address and the statement “Exempted—P.L. 90-492” and such poultry products are not otherwise misbranded; (iii) such processor does not engage in the current calendar year in the business of buying or selling any poultry or poultry products other than as specified in this paragraph (a) (6) or (5) of this section; and (iv) such processor does not exceed the volume limitation prescribed in paragraph (b) of this section.
(7) The operations and products of small enterprises (including poultry producers) not exempted under paragraphs (a) (1) through (6) of this section that are engaged in any State or territory or the District of Columbia in slaughtering and/or cutting up poultry for distribution as carcasses or parts thereof solely for distribution within such jurisdiction; Provided, That (i) such poultry is sound and healthy when slaughtered and is slaughtered and/or cut up and handled under such sanitary standards, practices and procedures as result in the preparation of poultry products that are not adulterated when so distributed; and (ii) when so distributed, such poultry products are not misbranded (except that the official inspection legend shall not be used).
(b) No person qualifies for any exemption specified in paragraph (a)(5), (6), or (7) of this section if, in the current calendar year, such person:
(1) Slaughters or processes the products of more than 20,000 poultry, or
(2) Slaughters or processes poultry products at a facility used for slaughtering or processing poultry products by any other person, except when the Administrator grants such exemption after determining, upon review of a person's application, that such an exemption will not impair effectuating the purposes of the Act.
(c) The provisions of the Act and the regulations do not apply to any poultry producer with respect to poultry, of his own raising on his own farm, which he slaughters if:
(1) Such producer slaughters not more than 1,000 poultry during the calendar year for which this exemption is being determined;
(2) Such poultry producer does not engage in buying or selling poultry products other than those produced from poultry raised on his own farm; and
(3) None of such poultry moves in “commerce” (as defined in § 381.1).
(d)(1) The requirements of the Act and the regulations for inspection of the processing of poultry and poultry 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 the purposes of paragraph (d)(1) of this section:
(i) Operations of types traditionally and usually conducted at retail stores and restaurants include any processing of poultry products except canning of poultry products and except slaughtering of poultry unless such slaughtering is conducted at a retail store with respect to live poultry purchased by the consumer at the retail store and processed by the retail store operator in accordance with the consumer's instructions.
(ii) A normal retail quantity is any quantity of a poultry product purchased by a household consumer from a retail supplier that in the aggregate does not exceed 75 pounds. A normal retail quantity sold by a retail supplier to other than a household consumer is any quantity that in the aggregate does not exceed 150 pounds.
(iii) A retail store is any place of business where:
(a) The sales of poultry products 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 Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250 (202) 447-3219.
(c) Only federally or State inspected and passed, or exempted (or, as provided in § 381.223, State or local agency inspected and passed or exempted) poultry products are handled or used in the preparation of any poultry products;
(d) No sale of poultry products is made in excess of a normal retail quantity as defined in paragraph (d)(2)(ii) of this section; and
(e) The processing of poultry products for sale is limited to traditional and usual operations as defined in paragraph (d)(2)(i) of this section.
(iv) Restaurants. (a) A restaurant is any establishment where:
(1) Poultry products are processed only for sale or service in meals or as entrees directly to individual consumers at such establishments;
(2) Only federally inspected and passed, or exempted (or, as provided in § 381.223, State or local agency inspected and passed or exempted) poultry products are handled or used in the preparation of any poultry products;
(3) No sale of poultry products is made in excess of a normal retail quantity as defined in paragraph (d)(2)(ii) of this section; and
(4) The processing of poultry products 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 as a restaurant central kitchen facility shall be considered as being conducted at a restaurant if the restaurant central kitchen prepares poultry 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 requirement of this paragraph: Provided, That the requirements of §§ 381.175 through 381.178 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 poultry 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) A similar retail-type establishment is 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 paragraph (d)(2) (iii) or (iv) of this section; or other establishment as determined by the Administrator in specific cases.
(vi) A consumer is any household consumer, hotel, or 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 establishment or restaurant claiming exemption under this paragraph (d) in any designated State or organized territory listed in § 381.221 that is also identified in § 381.224 as a jurisdiction 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 paragraph (d) for such 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 establishment or restaurant and afford him reasonable opportunity to present his views informally with respect to the matter. Thereafter, if the Administrator determines that such a violation has occurred, and that a requirement that the operator keep records concerning the operations of the retail establishment or restaurant would effectuate the purposes of the Act, the Administrator shall order the operator to maintain complete, accurate, and legible records of his total monthly purchases and of his total monthly sales of poultry and poultry products. 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 § 381.177. 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.
(4) The adulteration and misbranding provisions of the Act and the regulations other than the requirement of the official inspection legend, apply to articles which are exempted from inspection under this paragraph (d).
(e)(1) The requirements of the Act and the regulations in this subchapter for inspection of the preparation of products do not apply to poultry pizzas containing poultry 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 poultry pizzas are to be served in public or private nonprofit institutions, provided that the poultry 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 upstream 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 § 381.10(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 pending the completion of the proceeding and any judicial review thereof, unless otherwise ordered by the Administrator.
(6) The adulteration and misbranding provisions of the Act and the regulations apply to articles which are exempted from inspection under § 381.10(e).
[37 FR 9706, May 16, 1972, as amended at 38 FR 16991, June 28, 1973; 45 FR 27922, Apr. 25, 1980; 46 FR 46288, Sept. 16, 1981; 48 FR 2959, Jan. 24, 1983; 51 FR 29909, Aug. 21, 1986; 53 FR 24679, June 30, 1988; 57 FR 34184, Aug. 3, 1992]
§ 381.11
Exemptions based on religious dietary laws.
(a) Any person who slaughters, processes, or otherwise handles poultry or poultry products which have been or are to be processed as required by recognized religious dietary laws may apply for exemption from specific provisions of the Act or regulations which are in conflict with such religious dietary laws. Any person desiring such an exemption shall apply in writing to the Meat and Poultry Inspection Program, Food Safety and Inspection Service, Department of Agriculture, Washington, DC 20250, setting forth the specific provisions of the Act and the regulations from which exemption is sought and setting forth the provisions of the religious dietary laws in support of the requested exemption. In addition, the applicant for such an exemption shall submit a statement from the clerical official having jurisdiction over the enforcement of the religious dietary laws with respect to the poultry or poultry products involved, which identifies the requirements of such laws pertaining to the slaughter of the poultry and the processing or other handling of the poultry products involved, and certifies that such requirements are in conflict with specific provisions of the Act and regulations from which the exemption is sought.
(b) The Administrator, upon a determination that an exemption should be granted, will grant such exemption to the extent necessary to avoid conflict with the religious requirements while still effectuating the purposes of the Act. He may impose such conditions as to sanitary standards, practices, and procedures in granting such exemption as he deems necessary to effectuate the purposes of the Act. Any person who processes poultry or poultry products under exemption from certain requirements as provided in this section shall be subject to all of the other applicable provisions of the Act and the regulations. Processing plants shall meet the sanitary requirements set forth in this part and unless exempted from inspection under the provisions of this subpart, shall be required to qualify for inspection and operate as official establishments. Slaughtered poultry which is prepared under an exemption authorizing the sale of noneviscerated poultry in commerce shall be individually identified with a label approved by the Administrator which identifies the clerical official under whose supervision the poultry was slaughtered.
§ 381.12
Effect of religious dietary laws exemptions on other persons.
Whenever a slaughterer or processor is granted an exemption under § 381.11 with respect to the slaughtering or processing of any poultry or poultry products under this part, under specified conditions, the sale, offer for sale, transportation and other handling in commerce by any person of such poultry and poultry products in accordance with such conditions is hereby authorized, except as restricted by the Act.
§ 381.13
Suspension or termination of exemptions.
(a) The Administrator may, by order, in accordance with the applicable rules of practice suspend or terminate any exemption under § 381.10(a) with respect to any person whenever he finds that such action will aid in effectuating the purposes of the Act. Failure to comply with the conditions of the exemption, including, but not limited to, failure to process poultry and poultry products under clean and sanitary conditions may result in termination of an exemption, in addition to any other penalties provided by law.
(b) Except as provided in § 381.10(c), the Administrator may extend the requirements of the Act to any establishment in any State or organized territory at which poultry products are processed for distribution solely within such jurisdiction if he determines in accordance with the provisions of subparagraph 5(c)(1) of the Act that the establishment is producing adulterated poultry products which would clearly endanger the public health.
§ 381.14
Inspection concerning purportedly exempted operations.
Inspectors of the Inspection Service are authorized to make inspections in accordance with law to ascertain whether any of the provisions of the Act or the regulations applying to producers, retailers, or other persons purporting to be exempted from any requirements under this subpart have been violated.
§ 381.15
Exemption from definition of “poultry product” of certain human food products containing poultry.
The following articles contain poultry ingredients only in a relatively small proportion or historically have not been considered by consumers as products of the poultry food industry. Therefore said articles are exempted from the definition of “poultry product” and the requirements of the Act and the regulations applicable to poultry products, if they comply with the conditions specified in this section.
(a) Any human food product (in a consumer package) not provided for in paragraph (c) of this section, if:
(1) It contains less than 2 percent cooked poultry meat (deboned white or dark poultry meat, or both) and/or “Mechanically Separated (Kind of Poultry)” as defined in § 381.173;
(2) It contains less than 10 percent of cooked poultry skins, giblets, or fat, separately, and less than 10 percent of cooked poultry skins, giblets, fat, and meat (as meat is limited in paragraph (a)(1) of this section) or “Mechanically Separated (Kind of Poultry)” as defined in § 381.173, in any combination;
(3) The poultry ingredients used in the product were prepared under inspection as defined in § 381.1, or were inspected under a foreign inspection system approved under § 381.196(b) and imported in compliance with the Act and the regulations;
(4) The immediate container of the product bears a label which shows the name of the product in accordance with this section; and
(5) The product is not represented as a poultry product. The aforesaid percentages of ingredients shall be computed on the basis of the moist, deboned, cooked poultry in the ready-to-serve product when prepared according to the serving directions on the consumer package.
(b) Any human food product (in an institutional pack), not provided for in paragraph (c) of this section, if:
(1) It is prepared for sale only to institutional users, such as hotels, restaurants, and boardinghouses, for use as a soup base or flavoring;
(2) It contains less than 15 percent cooked poultry meat (deboned white or dark poultry meat or both) and/or “Mechanically Separated (Kind of Poultry)” as defined in § 381.173, computed on the basis of the moist deboned, cooked poultry meat and/or “Mechanically Separated (Kind of Poultry)” in such product; and
(3) It complies with the provisions of paragraphs (a)(3), (4), and (5) of this section in all respects.
(c) Bouillon cubes, poultry broths, gravies, sauces, seasonings, and flavorings if:
(1) They contain poultry meat and/or “Mechanically Separated (Kind of Poultry)” as defined in § 381.173 or poultry fat only in condimental quantities;
(2) They comply with the provisions of paragraphs (a)(3), (4), and (5) of this section in all respects; and
(3) In the case of poultry broth, it will not be used in the processing of any poultry product in any official establishment.
(d) Fat capsules and sandwiches containing poultry products if they comply with the provisions of paragraphs (a)(3), (4), and (5) of this section in all respects.
(e) Products of the types specified in this section except those specified in paragraphs (c) and (d) of this section will be deemed to be represented as poultry products if the kind name of the poultry (chicken, turkey, etc.) is used in the product name of the product without appropriate qualification. For example, a consumer-packaged noodle soup product containing less than 2 percent chicken meat on a ready-to-serve basis may not be labeled “Chicken Noodle Soup” but, when appropriate, could be labeled as “Chicken Flavored Noodle Soup.” Products exempted under this section are subject to the requirements of the Federal Food, Drug, and Cosmetic Act.
[37 FR 9706, May 16, 1972, as amended at 60 FR 55982, Nov. 3, 1995]

Subpart D—Application for Inspection; Grant or Refusal of Inspection
§ 381.16
How application shall be made.
The operator of each establishment of the kind required by § 381.6 to have inspection shall make application to the Administrator for inspection service. In cases of change of name, ownership, or location, a new application shall be made.
§ 381.17
Filing of application.
Every application for inspection at any establishment shall be made by the operator on a form furnished by the Meat and Poultry Inspection Program, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250, and shall include all information called for by that form, including the name of any subsidiary corporation that will prepare any poultry product or conduct any other operation at the establishment for which inspection is requested. The applicant for inspection will be held responsible for compliance by all its subsidiaries with the requirements of the regulations at such establishments if inspection is granted. Processing of poultry products and other operations at the establishment for which inspection is granted may be conducted only by the applicant, except that such a subsidiary of the grantee, may conduct such operations at such establishment.
§ 381.18
Authority of applicant.
Any person applying for inspection service may be required at the discretion of the Administrator to demonstrate that the operator of the establishment authorized him to do so.
§ 381.20
Survey and grant of inspection.
(a) Before inspection is granted, FSIS shall survey the establishment to determine if the construction and facilities of the establishment are in accordance with the regulations. FSIS will grant inspection, subject to § 381.21, when these requirements are met.
(b) 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.
[62 FR 45026, Aug. 25, 1997]
§ 381.21
Refusal of inspection.
(a) Any application for inspection in accordance with this part may be denied or refused in accordance with the rules of practice in part 500 of this chapter.
(b)(1) Any applicant for inspection at an establishment where the operations thereof may result in any discharge into the navigable waters of the United States is required by subsection 21(b) of the Federal Water Pollution Control Act, as amended, 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 Administrator of the Environmental Protection Agency to act on a request for certification within 1 year after receipt of such request. Further, upon receipt of an application for inspection and a certification as required by subsection 21(b) of the Federal Water Pollution Control Act, the Administrator (as defined in § 381.1) is required by paragraph (2) of said subsection to notify the Administrator of the Environmental Protection Agency for proceedings in accordance with that paragraph. No grant of inspection can be made until the requirements of said paragraph (2) have been met.
(2) However, certification under subsection 21(b) of the Federal Water Pollution Control Act 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 or to 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.
(3) 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.
(4) In the case of any activity which will affect water quality but for which there are no applicable water quality standards, no certification is required prior to the grant of inspection but such grant will be conditioned upon a requirement of compliance with the purpose of the Federal Water Pollution Control Act as provided in paragraph 21(b)(9) of said Act.
[37 FR 9706, May 16, 1972, as amended at 64 FR 66545, Nov. 29, 1999]
§ 381.22
Conditions for receiving inspection.
(a) Before being granted Federal inspection, an official establishment or an official import inspection establishment, must have developed written Sanitation Standard Operating Procedures, as required by part 416 of this chapter, and written recall procedures as required by part 418 of this chapter.
(b) Before being granted Federal inspection, an establishment shall have conducted a hazard analysis and developed and validated a HACCP plan, in accordance with §§ 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 38866, July 25, 1996, as amended at 77 FR 26936, May 8, 2012; 79 FR 56233, Sept. 19, 2014]

Subpart E—Inauguration of Inspection; Official Establishment Numbers; Separation of Establishments and Other Requirements; Withdrawal of Inspection
§ 381.25
Official establishment numbers.
An official establishment number shall be assigned to each establishment granted inspection service. Such number shall be used to identify all containers of inspected poultry products prepared in the establishment. An establishment shall not have more than one establishment number.
§ 381.26
Separation of establishments.
Each official establishment shall be separate and distinct from any other official establishment and from any unofficial establishment except an establishment preparing meat products under the Federal Meat Inspection Act or under State meat inspection. Further, doorways, or other openings, may be permitted between establishments at the discretion of the Administrator and under such conditions as he may prescribe.
§ 381.27
Inauguration of service; notification concerning regulations; status of uninspected poultry products.
The inspector in charge or his supervisor shall, upon or prior to the inauguration of service, inform the operator of the establishment of the requirements of the regulations. If the establishment at the time service is inaugurated contains any poultry product which has not been inspected and marked in compliance with the regulations, its identity shall be maintained, and it shall not be represented or dealt with as a product which has been inspected. Such products may not be shipped in commerce unless such products are eligible for such shipment under an exemption from inspection under subpart C and comply with all requirements of said subpart.
§ 381.28
Report of violations.
Each inspector, agent, representative, or employee of the Inspection Service shall report, in the manner prescribed by the Administrator, all violations of the Act and noncompliance with the regulations of which he has knowledge.

Subpart F—Assignment and Authorities of Program Employees; Appeals
§§ 381.30-381.31
[Reserved]
§ 381.32
Access to establishments.
[See § 300.6 of this chapter regarding access to establishments and other places of business.]
[69 FR 255, Jan. 5, 2004]
§ 381.33
Identification.
Each inspector will be furnished with a numbered official inspection badge, which shall remain in his or her possession at all times, and which shall be worn in such manner and at such times as the Administrator may prescribe.
[59 FR 42156, Aug. 17, 1994, as amended at 69 FR 255, Jan. 5, 2004]
§ 381.34
Financial interest of inspectors.
(a) No inspector shall inspect any poultry or poultry product in which he, his spouse, minor child, partner, organization in which he is serving as officer, director, trustee, partner, or employee, or any person with whom he is negotiating or has any arrangement concerning prospective employment, is financially interested.
(b) All inspectors are subject to statutory restrictions with respect to political activities; e.g., 5 U.S.C. 7324 and 1502.
(c) Violation of the provisions of paragraph (a) of this section or the provisions of applicable statutes referenced in paragraph (b) of this section will constitute grounds for dismissal in the case of appointees and for revocation of licenses in the case of licensees.
(d) Inspectors are subject to all applicable provisions of law and regulations and instructions of the Department and the Food Safety and Inspection Service and other authority concerning employee responsibilities and conduct. The setting forth of certain prohibitions in this part in no way limits the applicability of such general or other regulations or instructions.
§ 381.35
Appeal inspections; how made.
Any person receiving inspection service may, if dissatisfied with any decision of an inspector relating to any inspection, file an appeal from such decision: Provided, That such appeal is filed within 48 hours from the time the decision was made. Any such appeal from a decision of an inspector shall be made to his immediate superior having jurisdiction over the subject matter of the appeal, and such superior shall determine whether the inspector's decision was correct. Review of such appeal determination, when requested, shall be made by the immediate superior of the employee of the Department making the appeal determination. The cost of any such appeal shall be borne by the appellant if the Administrator determines that the appeal is frivolous. The charges for such frivolous appeal shall be at the rate of $9.28 per hour for the time required to make the appeal inspection. The poultry or poultry products involved in any appeal shall be identified by U.S. retained tags and segregated in a manner approved by the inspector pending completion of an appeal inspection.
[48 FR 11419, Mar. 18, 1983, as amended at 60 FR 67456, Dec. 29, 1995]

Subpart G—Facilities for Inspection; Overtime and Holiday Service; Billing Establishments
§ 381.36
Facilities required.
(a) Inspector's Office. Office space, including, but not being limited to furnishings, light, heat, and janitor service, shall be provided rent free in the official establishment, for the use of Government personnel for official purposes. The room or space set apart for this purpose must meet the approval of the Inspection Service and be conveniently located, properly ventilated, and provided with lockers or file cabinets suitable for the protection and storage of supplies and with facilities suitable for inspectors to change clothing. 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. Each official establishment shall provide commercial laundry service for inspectors' outer work clothing, or disposable outer work garments designed for one-time use, or uniform rental service garments which are laundered by the rental service.
(b) Facilities for ante mortem inspection. A suspect pen is required for adequate ratite inspection.
(c) Facilities for the Streamlined Inspection System (SIS). The following requirements for lines operating under SIS are in addition to the normal requirements to obtain a grant of inspection. The requirements for SIS in § 381.76(b) also apply.
(1) The following provisions shall apply to every inspection station:
(i) The conveyor line shall be level for the entire length of the inspection station. The vertical distance from the bottom of the shackles to the top of the adjustable platform (paragraph (c)(1)(iv) of this section) in its lowest position shall not be less than 60 inches.
(ii) Floor space shall consist of 4 feet along the conveyor line for the inspector, and 4 feet for the establishment helper. A total of at least 8 feet along the conveyor line shall be supplied for one inspection station and 16 feet for two-inspection stations.
(iii) Selectors or “kickouts” shall be installed in establishments with two inspection stations on a line so each inspector will receive birds on 12-inch centers with no intervening birds to impede inspection. The selector must move the bird to the edge of the trough for the inspector and establishment helper. The selectors must be smooth, steady, and consistent in moving the birds parallel and through the inspection station. Birds shall be selected and released smoothly to avoid swinging when entering the inspection station.
(iv) Each inspector's station shall have a platform that is slip-resistant and can be safely accessed by the inspector. The platform shall be designed so that it can be easily and rapidly adjusted for a minimum of 14 inches vertically while standing on the platform. The platform shall be a minimum length of 4 feet and have a minimum width of 2 feet; the platform shall be designed with a 42-inch high rail on the back side and with 1/2-inch foot bumpers on both sides and front to allow safe working conditions. The platform must have a safe lift mechanism and be large enough for the inspector to sit on a stool and to change stations during breaks or station rotation.
(v) Conveyor line stop/start switches shall be located within easy reach of each inspector.
(vi) A trough or other facilities shall extend beneath the conveyor at all places where processing operations are conducted from the point where the carcass is opened to the point where the trimming has been performed. The trough must be of sufficient width to preclude trimmings, drippage, and debris from accumulating on the floor or platforms. The clearance between the suspended carcasses and the trough must be sufficient to preclude contamination of carcasses by splash.
(vii) A minimum of 200-footcandles of shadow-free lighting with a minimum color rendering index value of 85 where the birds are inspected to facilitate inspection.
(viii) Online handrinsing facilities with a continuous flow of water must be provided for and within easy reach of each inspector and each establishment helper. The hand-contact element must be rinsed automatically with a sufficient volume of water to remove all fat, tissue, debris, and other extraneous material from the hand contact element after each use. Both hot and cold running water shall be available at each inspection station on the eviscerating line and shall be delivered through a suitable mixing device controlled by the inspector. Alternatively, water for hand washing shall be delivered to such inspection stations at a minimum temperature of 65 degrees F.
(ix) Hangback racks shall be provided for and positioned within easy reach of the establishment helpers.
(x) Each inspection station shall be provided with receptacles for condemned carcasses and parts. Such receptacles shall comply with the performance standards in § 416.3(c) of this chapter.
(2) The following provisions shall apply only to prechill and postchill reinspection stations:
(i) Floor space shall consist of a minimum of 3 feet along each conveyor line and after each chiller to allow carcasses to be removed for evaluation. The space shall be level and protected from all traffic and overhead obstructions.
(ii) The vertical distance from the bottom of the shackles to the floor shall not be less than 48 inches.
(iii) A table, at least 2 feet wide, 2 feet deep, and 3 feet high designed to be readily cleanable and drainable shall be provided for reinspecting the sampled birds.
(iv) A minimum of 200-footcandles of shadow-free lighting with a minimum color rendering index of 85 on the table surface shall be provided.
(v) A separate clip board holder shall be provided for holding the recording sheets.
(vi) Handwashing facilities shall be provided for and shall be within easy access of persons working at the stations.
(vii) Hangback racks designed to hold 10 carcasses shall be provided for and positioned within easy reach of the person at the station.
(d) Facilities for the New Line Speed (NELS) inspection system. The following requirements for lines operating under the NELS inspection system are in addition to the normal requirements to obtain a grant of inspection and to the requirements for NELS in § 381.76 (b) and (c).
(1) The following provisions shall apply to every inspection station:
(i) The conveyor line shall be level for the entire length of the inspection station. The vertical distance from the bottom of the shackles to the top of the adjustable platform (paragraph (d)(1)(iv) of this section) in its lowest position shall not be less than 60 inches.
(ii) Floor space shall consist of 6 feet along the conveyor line for the establishment employee presenting the birds, 4 feet for the inspector, and 4 feet for the establishment helper. A total of at least 42 feet along the conveyor line shall be supplied for three inspection stations.
(iii) Selectors or “kickouts” shall be installed so the three inspection stations will receive birds on 18-inch centers with no intervening birds to impede inspection. The selector must move the bird to the end of the trough for the presenter, inspector, and establishment helper. The selectors must be smooth, steady, and consistent in moving the birds parallel and through the inspection station. Birds shall be selected and released smoothly to avoid splashing the mirror (paragraph (d)(1)(vii) of this section) and swinging when entering the inspection station. Guide bars shall not extend in front of the inspection station mirror to avoid obstructing the inspector's view.
(iv) Each inspector's station shall have an easily and rapidly adjustable platform, with a minimum of 14 inches of vertical adjustment, which covers the entire length of the station (4 feet) and has a minimum width of 2 feet. The platform shall be designed with a 42-inch high rail on the back side and with 1/2-inch foot bumpers on both sides and front to allow safe working conditions.
(v) Conveyor line stop/start switches shall be located within easy reach of each inspector.
(vi) A trough shall extend beneath the conveyor at all places where processing operations are conducted from the point where the carcass is opened to the point where the trimming has been performed. The trough must be of sufficient width to preclude trimmings, drippage, and debris from accumulating on the floor or platforms. The clearance between the suspended carcasses and the trough must be sufficient to preclude contamination of carcasses by splash.
(vii) A distortion-free mirror, at least 3 feet wide and 2 feet high, shall be mounted at each inspection station so that it can be adjusted between 5 and 15 inches behind the shackles, tilt up and down, tilt from side to side, and be raised and lowered. The mirror shall be positioned in relation to the inspection platform so that the inspector can position himself/herself opposite it 8 to 12 inches from the downstream edge. The mirror must be maintained abrasion free.
(viii) A minimum of 200-footcandles of shadow-free lighting with minimum color rendering index value of 85 ^1 where the birds are inspected to facilitate inspection. A light shall also be positioned above and slightly in front of the mirror to facilitate the illumination of the bird and mirror surfaces.
^1 This requirement may be met by deluxe cool white type of fluorescent lighting.
(ix) “One-line” handrinsing facilities with a continuous flow of water shall be provided for and within easy reach of each inspector and each establishment presenter and helper.
(x) Hangback racks shall be provided for and positioned within easy reach of the establishment helpers.
(xi) Each inspection station shall be provided with receptacle for condemned carcasses and parts. Such receptacles shall comply with the performance standards in § 416.3(c) of this chapter.
(2) The following provisions shall apply only to the reinspection station:
(i) Floor space shall consist of 6 feet along the conveyor line. The space shall be level and protected from all traffic and overhead obstructions.
(ii) The vertical distance from the bottom of the shackles to the floor shall not be less than 48 inches.
(iii) A table, at least 3 feet wide and 2 feet deep, shall be provided for reinspecting the sample birds.
(iv) A minimum of 200-footcandles of shows free lighting with a minimum color rendering index of 85 ^1 on the table surface.
(v) A separate clip board holder shall be provided for holding the recording sheets.
(vi) Handwashing facilities shall be provided for and shall be within easy reach of persons working at the station.
(vii) Hangback racks designed to hold 10 carcasses shall be provided for and positioned within easy reach of the person at the station.
(e) Facilities for the New Turkey Inspection (NTI) System. The following requirements for lines operating under the NTI System are in addition to the normal requirements to obtain a grant of inspection and to the requirements for the NTI System in § 381.76 (b) and (c).
(1) The following provisions apply to every inspection station:
(i) The conveyor line must be level for the entire length of the inspection station. The vertical distance from the bottom of the shackles to the top of the adjustable platform (paragraph (e)(1)(iii) of this section) in its lowest position shall not be less than 60 inches.
(ii) Floor space shall consist of 8 feet along the conveyor line; at least 4 feet for the inspector, and at least 4 feet for the establishment helper.
(iii) The inspector's station shall have an easily and rapidly adjustable platform with a minimum width of 2 feet which covers the entire length of the station (4 feet). The platform must adjust vertically a minimum of 14 inches, and must have a 42-inch rail on the back side and 1/2-inch foot bumpers on the sides and the front to allow safe working conditions.
(iv) Conveyor line stop/start switches shall be located within easy reach of each inspector.
(v) A trough or other facilities shall extend beneath the conveyor at all places where processing operations are conducted from the point where the carcass is opened to the point where the trimming has been performed. The trough must be wide enough to prevent trimmings, drippage, and debris from accumulation on the floor or platforms. The clearance between suspended carcasses and the trough must be sufficient to prevent contamination of carcasses by splash.
(vi) A minimum of 200 foot-candles of shadow-free lighting with a minimum color rendering index value of 85 ^1 where the birds are inspected to facilitate inspection is required. The minimum lighting requirement for inspection stations in § 381.52(b) shall not apply.
^1 This requirement may be met by deluxe cool white fluorescent lighting.
(vii) On-line handrinsing facilities with a continuous flow of water shall be provided for and within easy reach of each inspector and each establishment helper.
(viii) Hangback racks shall be provided for and within easy reach of the establishment helper.
(ix) Each inspection station shall be provided with receptacles for condemned carcasses and parts. Such receptacles shall comply with the performance standards in § 416.3(c) of this chapter.
(2) The following provisions shall apply only to the reinspection station:
(i) Floor space shall consist of a minimum of 3 feet along the conveyor line so carcasses can be removed from each line for evaluation. The space shall be level and protected from all traffic and overhead obstructions.
(ii) The vertical distance from the bottom of the shackles to the floor must not be less than 48 inches.
(iii) A table at least 3 feet wide and 2 feet deep designed to be readily cleanable and drainable shall be provided for reinspecting the sampled birds.
(iv) A minimum of 200 foot-candles of shadow-free lighting with a minimum color rendering index of 85 ^1 at the table surface is required.
(v) A clipboard holder shall be provided for holding the recording sheets.
(vi) Handwashing facilities shall be provided for and within easy reach of persons working at the station.
(vii) Hangback racks designed to hold 10 carcasses shall be provided for and positioned within easy reach of the person at this station.
(f) Facilities for post-mortem inspection under the New Poultry Inspection System. The following facilities requirements apply to establishments operating under the New Poultry Inspection System and are in addition to the requirements for obtaining a grant of inspection.
(1) The following provisions apply to the online carcass inspection station:
(i) On each production line, at a point before the chiller and after the establishment has completed all sorting, trimming, and reprocessing activities necessary to comply with § 381.76(b)(6)(ii), at least 4 feet of floor space along the conveyor line must be provided for one online carcass inspection station.
(ii) The conveyor line must be level for the entire length of the online carcass inspection station. The vertical distance from the bottom of the shackles to the top of the platform (paragraph (f)(1)(iii) of this section) must not be less than 60 inches.
(iii) Each online carcass inspection station must have a platform that is slip-resistant and can be safely accessed by the inspector. The platform must be designed so that it can be easily and rapidly adjusted for a minimum of 14 inches vertically while standing on the platform. The platform must be a minimum length of 4 feet and have a minimum width of 2 feet. The platform must be designed with a 42-inch high rail on the back side and with 1/2-inch foot bumpers on both sides and front to allow safe working conditions. The platform must have a safe lift mechanism and be large enough for the inspector to sit on a stool and to change stations during breaks or station rotation.
(iv) Conveyor line stop/start switches must be located within easy reach of the online carcass inspector.
(v) A minimum of 200 foot-candles of shadow-free lighting with a minimum color rendering index value of 85 must be provided where the birds are inspected to facilitate online carcass inspection.
(vi) Hand rinsing facilities must be provided for use by and within easy reach of the online carcass inspector. The hand rinsing facilities must have a continuous flow of water or be capable of being immediately activated and deactivated in a hands-free manner, must minimize any splash effect, and must otherwise operate in a sanitary manner that prevents contamination of carcasses and inspector clothing. The hand rinsing facilities must provide water at a temperature between 65 and 120 degrees Fahrenheit.
(vii) A separate clipboard holder for holding recording sheets must be provided for and within easy reach of the online carcass inspector.
(viii) Receptacles for condemned carcasses and parts that comply with the performance standards in § 416.3(c) of this chapter must be provided at each online carcass inspection station.
(ix) Hangback racks designed to hold at least 10 carcasses must be provided and positioned within easy reach of the online carcass inspector.
(x) A buzzer shall be located within easy reach of the online carcass inspector to be used by the carcass inspector to alert the inspector-in-charge, offline inspectors, or establishment management of conditions that require their attention.
(2) The following provisions apply to pre-chill and post-chill offline verification inspection stations:
(i) One or more offline verification inspection stations must be located at the end of the line or lines prior to the chiller. One or more offline verification inspection stations must also be located after the chiller or chillers. The Agency will determine the total number of offline verification inspection stations needed in establishments having more than one processing line or more than one chiller.
(ii) Floor space for all offline verification inspection stations must consist of a minimum of 3 feet along each conveyor line and after each chiller, as applicable, to allow carcasses to be removed for evaluation by the verification inspector. The space must be level and protected from all traffic and overhead obstructions.
(iii) At the pre-chill location, the vertical distance from the bottom of the shackles to the floor must not be less than 48 inches.
(iv) At each offline verification inspection station, a table designed to be readily cleanable and drainable must be provided for offline verification inspectors to conduct offline verification activities. At turkey slaughter establishments, the table must be at least 3 feet wide, 2 feet deep, and 3 feet high. At all other poultry slaughter establishments, the table must be at least 2 feet wide, 2 feet deep, and 3 feet high
(v) A minimum of 200 foot-candles of shadow-free lighting with a minimum color rendering index of 85 on the table surface must be provided.
(vi) The establishment must provide a separate clipboard holder for holding recording sheets; or alternatively, the establishment may provide electronic means for the offline verification inspector to record inspection results.
(vii) Hangback racks designed to hold at least 10 carcasses must be provided and positioned within easy reach of the offline verification inspector.
(viii) Hand washing facilities must be provided within easy access of all offline verification inspection stations.
(3) Each young chicken establishment operating under the New Poultry Inspection System must provide a location at a point along the production line after the carcasses are eviscerated at which an inspector may safely and properly inspect for leukosis the first 300 carcasses of each flock together with associated viscera either uniformly trailing or leading, or otherwise identified with the corresponding carcass. The leukosis inspection area must provide a minimum of 200 foot-candles of shadow-free lighting on the surface where the viscera are inspected.
(4) A trough or other similar drainage facility must extend beneath the conveyor at all places where processing operations are conducted from the point where the carcass is opened to the point where trimming has been performed. The trough must be of sufficient width to preclude trimmings, drippage, and debris from accumulating on the floor or platforms. The clearance between suspended carcasses and the trough must be sufficient to preclude contamination of carcasses by splashing.
[37 FR 9706, May 16, 1972, as amended at 38 FR 9794, Apr. 20, 1973; 47 FR 23434, May 28, 1982; 49 FR 42554, Oct. 23, 1984; 50 FR 37512, Sept. 16, 1985; 52 FR 39209, Oct. 21, 1987; 64 FR 56416, Oct. 20, 1999; 66 FR 22905, May 7, 2001; 79 FR 49633, Aug. 21, 2014]
§ 381.37
Schedule of operations.
(a) No operations requiring inspection shall be conducted except under the supervision of an Inspection Service employee. All eviscerating of poultry and further processing 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 hours per shift during the basic workweek subject to the provisions of § 381.38: 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, except that, when possible, the Department shall schedule the basic workweek so as to consist of 5 consecutive 8-hour days Monday through Friday. The 8-hour day excludes the lunch period but shall include activities deemed necessary by the Agency to fully carry out an inspection program, including the time for FSIS inspection program personnel to put on required gear, pick up required forms and walk to a work station; and the time for FSIS inspection program personnel to return from a work station, drop off required forms, and remove required gear; and to conduct duties scheduled by FSIS, including administrative duties. 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 functions. These provisions are applicable to all official establishments except in certain cases as provided in § 381.145(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 in account the efficient and effective use of inspection personnel. The work schedule must specify the workweek, 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 changes in the workweek or 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) Requests 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 the completion of his daily tour of duty under the provisions of § 381.39(b).
[40 FR 45800, 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; 76 FR 33980, June 10, 2011; 77 FR 59294, Sept. 27, 2012]
§ 381.38
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 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 be the holiday.
[40 FR 45801, Oct. 3, 1975, as amended at 43 FR 51754, Nov. 7, 1978; 50 FR 51513, Dec. 18, 1985; 52 FR 5, Jan. 2, 1987; 53 FR 13398, Apr. 22, 1988; 54 FR 6390, Feb. 10, 1989]
§ 381.39
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 § 381.38(a) and at the rate 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 Inspection Service employee.
(b) Official establishments, importers, or exporters requesting and receiving the services of an Inspection Service 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 45801, Oct. 3, 1975, as amended at 54 FR 6390, Feb. 10, 1989]

Subpart H—Attestation on Work-Related Conditions

Source:
79 FR 49634, Aug. 21, 2014, unless otherwise noted.
§ 381.45
Attestation requirements.
Each establishment that participates in the New Poultry Inspection System (NPIS) shall submit on an annual basis an attestation to the management member of the local FSIS circuit safety committee stating that it maintains a program to monitor and document any work-related conditions of establishment workers, and that the program includes the following elements:
(a) Policies to encourage early reporting of symptoms of injuries and illnesses, and assurance that it has no policies or programs in place that would discourage the reporting of injuries and illnesses.
(b) Notification to employees of the nature and early symptoms of occupational illnesses and injuries, in a manner and language that workers can understand, including by posting in a conspicuous place or places where notices to employees are customarily posted, a copy of the FSIS/OSHA poster encouraging reporting and describing reportable signs and symptoms.
(c) Monitoring on a regular and routine basis of injury and illness logs, as well as nurse or medical office logs, workers' compensation data, and any other injury or illness information available.
§ 381.46
Severability.
Should a court of competent jurisdiction hold any provision of this part 381, subpart H to be invalid, such action shall not affect any other provision of this part 381.

Subpart I—Operating Procedures
§ 381.65
Operations and procedures, generally.
(a) Operations and procedures involving the processing, other handling, or storing of any poultry product must be strictly in accord with clean and sanitary practices and must be conducted in a manner that will result in sanitary processing, proper inspection, and the production of poultry and poultry products that are not adulterated.
(b) Poultry must be slaughtered in accordance with good commercial practices in a manner that will result in thorough bleeding of the carcasses and ensure that breathing has stopped prior to scalding. Blood from the killing operation must be confined to a relatively small area.
(c) When thawing frozen ready-to-cook poultry in water, the establishment must use methods that prevent adulteration of, or net weight gain by, the poultry.
(d) The water used in washing the poultry must be permitted to drain freely from the body cavity.
(e) Detached ova may be collected for human food and handled only in accordance with 9 CFR 590.44 and may leave the establishment only to be moved to an official egg product processing plant for processing. Ova from condemned carcasses must be condemned and treated as required in § 381.95.
(f) Procedures for controlling visible fecal contamination. Official poultry slaughter establishments must develop, implement, and maintain written procedures to ensure that poultry carcasses contaminated with visible fecal material do not enter the chiller. Establishments must incorporate these procedures into their HACCP plans, or sanitation SOPs, or other prerequisite programs.
(g) Procedures for controlling contamination throughout the slaughter and dressing operation. Official poultry slaughter establishments must develop, implement, and maintain written procedures to prevent contamination of carcasses and parts by enteric pathogens and fecal contamination throughout the entire slaughter and dressing operation. Establishments must incorporate these procedures into their HACCP plans, or sanitation SOPs, or other prerequisite programs. At a minimum, these procedures must include sampling and analysis for microbial organisms in accordance with the sampling location and frequency requirements in paragraphs (g)(1) and (2) of this section to monitor their ability to maintain process control.
(1) Sampling locations. Establishments, except for very small establishments operating under Traditional Inspection or very low volume establishments operating under Traditional Inspection must collect and analyze samples for microbial organisms at the pre-chill and post-chill points in the process. Very small establishments operating under Traditional Inspection and very low volume establishments operating under Traditional Inspection must collect and analyze samples for microbial organisms at the post-chill point in the process.
(i) Very small establishments are establishments with fewer than 10 employees or annual sales of less than $2.5 million.
(ii) Very low volume establishments annually slaughter no more than 440,000 chickens, 60,000 turkeys, 60,000 ducks, 60,000 geese, 60,000 guineas, or 60,000 squabs.
(2) Sampling frequency. (i) Establishments, except for very low volume establishments as defined in paragraph (g)(1)(ii) of this section, must, at a minimum, collect and analyze samples at a frequency proportional to the establishment's volume of production at the following rates:
(A) Chickens. Once per 22,000 carcasses, but a minimum of once during each week of operation.
(B) Turkeys, ducks, geese, guineas, and squabs. Once per 3,000 carcasses, but at a minimum once each week of operation.
(ii) Very low volume establishments as defined in paragraph (g)(1)(ii) of this section must collect and analyze samples at least once during each week of operation starting June 1 of every year. If, after consecutively collecting 13 weekly samples, a very low volume establishment can demonstrate that it is effectively maintaining process control, it may modify its sampling plan.
(iii) Establishments must sample at a frequency that is adequate to monitor their ability to maintain process control for enteric pathogens. Establishments must maintain accurate records of all test results and retain these records as provided in paragraph (h) of this section.
(h) Recordkeeping requirements. Official poultry slaughter establishments must maintain daily records sufficient to document the implementation and monitoring of the procedures required under paragraph (g) of this section. Records required by this section may be maintained on computers if the establishment implements appropriate controls to ensure the integrity of the electronic data. Records required by this section must be maintained for at least one year and must be accessible to FSIS.
[66 FR 1771, Jan. 9, 2001; 66 FR 19714, Apr. 17, 2001, as amended at 79 FR 49634, Aug. 21, 2014]
§ 381.66
Temperatures and chilling and freezing procedures.
(a) General. Temperatures and procedures that are necessary for chilling and freezing ready-to-cook poultry, including all edible portions thereof, must be in accordance with operating procedures that ensure the prompt removal of the animal heat, preserve the condition and wholesomeness of the poultry, and assure that the products are not adulterated.
(b) Chilling performance standards, except for ratites. (1)(i) Each official poultry slaughter establishment must ensure that all poultry carcasses, parts, and giblets are chilled immediately after slaughter operations so that there is no outgrowth of pathogens, unless such poultry is to be frozen or cooked immediately at the official establishment.
(ii) Previously chilled poultry carcasses and major portions must be kept chilled so that there is no outgrowth of the pathogens, unless such poultry is to be packed and frozen immediately at the official establishment.
(2) After product has been chilled, the establishment must prevent the outgrowth of pathogens on the product as long as the product remains at the establishment.
(3) The establishment must develop, implement, and maintain written procedures for chilling that address, at a minimum, the potential for pathogen outgrowth, the conditions affecting carcass chilling, and when its chilling process is completed. The establishment must incorporate these procedures into its HACCP plan, or sanitation SOP, or other prerequisite program.
(c) Ice and water chilling. (1) Only ice produced from potable water may be used for ice and water chilling, except that water and ice used for chilling may be reused in accordance with § 416.2(g). The ice must be handled and stored in a sanitary manner.
(2)(i) Poultry chilling equipment must be operated in a manner consistent with meeting the applicable pathogen reduction performance standards for raw poultry products as set forth in § 381.94 and the provisions of the establishment's HACCP plan.
(ii) Major portions of poultry carcasses, as defined in § 381.170(b)(22), may be chilled in water and ice.
(d) Water absorption and retention. (1) Poultry washing, chilling, and draining practices and procedures must be such as will minimize water absorption and retention at time of packaging.
(2) The establishment must provide scales, weights, identification devices, and other supplies necessary to conduct water tests.
(e) Air chilling. Air chilling is the method of chilling raw poultry carcasses and parts predominately with air. An antimicrobial intervention may be applied with water at the beginning of the chilling process, provided that its use does not result in any net pick-up of water or moisture during the chilling process. The initial antimicrobial intervention may result in some temperature reduction of the product, provided that the majority of temperature removal is accomplished exclusively by chilled air.
(f) Freezing. (1) Ready-to-cook poultry which is to be or is labeled with descriptive terms such as “fresh frozen,” “quick frozen” or “frozen fresh” or any other term implying a rapid change from a fresh state to a frozen state shall be placed into a freezer within 48 hours after initial chilling in accordance with paragraph (b) of this section. During this period, if such poultry is not immediately placed into a freezer after chilling and packaging, it shall be held at 36 °F. or lower.
(2) Ready-to-cook poultry shall be frozen in a manner so as to bring the internal temperature of the birds at the center of the package to 0 °F. or below within 72 hours from the time of entering the freezer. Such procedures shall not apply to raw poultry product described in § 381.129(b)(6)(i) of this subchapter.
(3) Upon written request, and under such conditions as may be prescribed by the Administrator, in specific cases, ready-to-cook poultry which is to be frozen immediately may be moved from the official establishment prior to freezing: Provided, That the plant and freezer are so located and such necessary arrangements are made that the Inspection Service will have access to the freezing room and adequate opportunity to determine compliance with the time and temperature requirements specified in paragraph (f)(2) of this section.
(4) Warm packaged ready-to-cook poultry which is to be chilled by immediate entry into a freezer within the official establishment shall within 2 hours from time of slaughter be placed in a plate freezer or a freezer with a functioning circulating air system where a temperature of −10 °F. or lower is maintained.
(5) Frozen poultry shall be held under conditions which will maintain the product in a solidly frozen state with temperature maintained as constant as possible under good commercial practice.
[37 FR 9706, May 16, 1972, as amended at 39 FR 4568, 4569, Feb. 5, 1974; 40 FR 42338, Sept. 12, 1975; 49 FR 9411, Mar. 13, 1984; 60 FR 44412, Aug. 25, 1995; 63 FR 48960, Sept. 11, 1998; 66 FR 1771, Jan. 9, 2001; 66 FR 19714, Apr. 17, 2001; 66 FR 22905, May 7, 2001; 79 FR 49634, Aug. 21, 2014]
§ 381.67
Young chicken and squab slaughter inspection rate maximums under traditional inspection procedure.
The maximum number of birds to be inspected by each inspector per minute under the traditional inspection procedure for the different young chicken and squab slaughter line configurations are specified in the following table. These maximum rates will not be exceeded. The inspector in charge will be responsible for reducing production line rates where in the inspector's judgment the prescribed inspection procedure cannot be adequately performed within the time available, either because the birds are not presented by the official establishment in such a manner that the carcasses, including both internal and external surfaces and all organs, are readily accessible for inspection, or because the health conditions of a particular flock dictate a need for a more extended inspection procedure. The standards in 381.170(a) of this part specify which classes of birds constitute young chickens and squabs. Section 381.76(b) specifies when either the traditional inspection procedure or the modified traditional inspection procedure can or must be used.
Maximum Production Line Rates—Chickens and Squabs-Traditional Inspection Procedures
Line configuration ^1 | Number of inspection stations | Birds per inspector per minute
6-1 | 1 | 25
12-1 | 2 | 23
12-2 | 2 | 21
18-1 | 3 | 19
18-2 | 3 | 19
18-3 | 3 | 18
24-1 | 4 | 161/2
24-2 | 4 | 16
24-4 | 4 | 151/2
^1 Birds are suspended on the slaughter line at 6-inch intervals. The first number indicates the interval in inches between the birds that each inspector examines. The second number indicates how many of the birds presented, the inspector is to inspect, i.e., “1” means inspect every bird. “4” means inspect every fourth bird, etc.
[47 FR 23435, May 28, 1982, as amended at 66 FR 22905, May 7, 2001]
§ 381.68
Maximum inspection rates—New turkey inspection system.
(a) The maximum inspection rates for one inspector New Turkey Inspection (NTI-1 and NTI-1 Modified) and two inspectors New Turkey Inspection (NTI-2 and NTI-2 Modified) are listed in the table below. The line speeds for NTI-1 and NTI-2 are for lines using standard 9-inch shackles on 12-inch centers with birds hung on every shackle and opened with J-type or Bar-type opening cuts. The line speeds for NTI-1 Modified and NTI-2 Modified are for Bar-type cut turkey lines using a shackle with a 4-inch by 4-inch selector (or kickout), a 45 degree bend of the lower 2 inches, an extended central loop portion of the shackle that lowers the abdominal cavity opening of the carcasses to an angle of 30 degrees from the vertical in direct alignment with the inspector's view, and a width of 10.5 inches. Maximum rates for those establishments having varying configurations will be established by the Administrator but will not exceed those in the table. Neither the rates in the table nor those established for establishments with varying configurations shall be exceeded under any circumstances.
(b) There are two categories of turkeys for determining inspection rates, “light turkeys” and “heavy turkeys”. Light turkeys are all turkeys weighing less than 16 pounds. Heavy turkeys are all turkeys weighing 16 pounds or more. The weights refer to the bird at the point of post-mortem inspection, with blood, feathers and feet removed.
(c) The inspector in charge may reduce inspection line rates when in his/her judgment the prescribed inspection procedure cannot be adequately performed within the time available because the health conditions of a particular flock or other factors, including the manner in which birds are being presented to the inspector for inspection and the level of contamination among the birds on the line, dictate a need for a more extended inspection.
Maximum Turkey Inspection Rates
Inspection system | Line configuration | Number of inspectors | Birds/minute | J-Type | (<16#) light | (>16#) ^1 heavy | Bar-Type | (<16#) light | (>16#) ^1 heavy
NTI-1 | 12-1 | 1 | 32 | 30 | 25 | 21
NTI-2 | ^2 24-2 | 2 | 51 | 41 | 45 | 35
NTI-1 Modified | 12-1 | 1 | — | — | 32 | 30
NTI-2 Modified | ^2 24-2 | 2 | — | — | 51 | 41
^1 This weight refers to the bird at the point of post-mortem inspection without blood or feet.
^2 The turkeys are suspended on the slaughter line at 12-inch intervals with two inspectors each looking at alternating birds at 24-inch intervals.
[50 FR 37512, Sept. 16, 1985, as amended at 73 FR 51902, Sept. 8, 2008]

Editorial Note:
At 75 FR 27926, May 19, 2010, § 381.68(a) was amended in the second sentence by removing “10.5” and adding in its place “10”; however, the amendment could not be incorporated because “10.5” does not exist in that sentence.
§ 381.69
Maximum line speed rates under the New Poultry Inspection System.
(a) The maximum line speed for young chicken slaughter establishments that operate under the New Poultry Inspection System is 140 birds per minute.
(b) The maximum line speed for turkey slaughter establishments that operate under the New Poultry Inspection System is 55 birds per minute.
(c) Notwithstanding paragraphs (a) and (b) of this section, establishments that operate under the New Poultry Inspection System must reduce their line speed as directed by inspectors-in-charge. Inspectors-in-charge are authorized to direct establishments to operate at a reduced line speed when in their judgment a carcass-by-carcass inspection cannot be adequately performed within the time available due to the manner in which the birds are presented to the online carcass inspector, the health conditions of a particular flock, or factors that may indicate a loss of process control.
(d) Establishments operating under the line speed limits authorized in this section shall comply with all other applicable requirements of the laws, including, but not limited to, 29 U.S.C. 654(a).
[79 FR 49635, Aug. 21, 2014]

Subpart J—Ante Mortem Inspection
§ 381.70
Ante mortem inspection; when required; extent.
(a) An ante mortem inspection of poultry shall, where and to the extent considered necessary by the Administrator and under such instructions as he may issue from time to time, be made of poultry on the day of slaughter in any official establishment.
(b) The examination and inspection of ratites will be on the day of slaughter, except:
(1) When it is necessary for humane reasons to slaughter an injured animal at night or on a Sunday or holiday, and the FSIS veterinary medical officer cannot be obtained; or
(2) In low volume establishments, when ante mortem inspection cannot be done on the day of slaughter, and the birds to be slaughtered have received ante mortem inspection in the last 24 hours, provided the establishment has an identification and control system over birds that have received ante mortem inspection.
[37 FR 9706, May 16, 1972, as amended at 66 FR 22906, May 7, 2001]
§ 381.71
Condemnation on ante mortem inspection.
(a) Birds plainly showing on ante mortem inspection any disease or condition, that under §§ 381.80 to 381.93, inclusive, would cause condemnation of their carcasses on post mortem inspection, shall be condemned. Birds which on ante mortem inspection are condemned shall not be dressed, nor shall they be conveyed into any department of the official establishment where poultry products are prepared or held. Poultry which has been condemned on ante mortem inspection and has been killed or died otherwise shall under the supervision of an inspector of the Inspection Service, be disposed of as provided in § 381.95.
(b) Dead-on-arrival ratites and ratites condemned on ante mortem inspection will be tagged “U.S. Condemned” by an establishment employee under FSIS supervision and disposed of by one of the methods prescribed in § 381.95.
(c) All seriously crippled ratites and non-ambulatory ratites, commonly termed “downers,” shall be identified as “U.S. Suspects.”
(d) Ratites exhibiting signs of drug or chemical poisoning shall be withheld from slaughter.
(e) Ratites identified as “U.S. Suspects” or “U.S. Condemned” may be set aside for treatment. The “U.S. Suspect” or “U.S. Condemned” identification device will be removed by an establishment employee under FSIS supervision following treatment if the bird is found to be free of disease. Such a bird found to have recovered from the condition for which it was treated may be released for slaughter or for purposes other than slaughter, provided that in the latter instance permission is first obtained from the local, State, or Federal sanitary official having jurisdiction over movement of such birds.
(f) When it is necessary for humane reasons to slaughter an injured ratite at night or Sunday or a holiday, and the Agency veterinary medical officer cannot be obtained, the carcass and all parts shall be kept for inspection, with the head and all viscera except the gastrointestinal tract held by the natural attachment. 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 bird 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 that rendered emergency slaughter necessary, the carcass shall be condemned. Ratites that are sick, dying, or that have been treated with a drug or chemical and presented for slaughter before the required withdrawal period, are not covered by emergency slaughter provisions.
[37 FR 9706, May 16, 1972, as amended at 66 FR 22906, May 7, 2001; 67 FR 13258, Mar. 22, 2002]
§ 381.72
Segregation of suspects on ante mortem inspection.
(a) All birds, except ratites, that on ante mortem inspection do not plainly show, but are suspected of being affected with, any disease or condition that under §§ 381.80 to 381.93 of this Part may cause condemnation in whole or in part on post mortem inspection, shall be segregated from the other poultry and held for separate slaughter, evisceration, and post mortem inspection. The inspector shall be notified when such segregated lots are presented for post mortem inspection, and inspection of such birds shall be conducted separately. Such procedure for the correlation of ante mortem and post mortem findings by the inspector, as may be prescribed or approved by the Administrator, shall be carried out.
(b) All ratites showing symptoms of disease will be segregated, individually tagged as “U.S. Suspects” by establishment personnel under FSIS supervision with a serially numbered metal or plastic leg band or tag bearing the term “U.S. Suspect,” and held for further examination by an FSIS veterinarian. Depending upon the findings of the veterinarian's examination, these birds will either be passed for regular slaughter, slaughtered as suspects, withheld from slaughter, or condemned on ante mortem. Those ratites affected with conditions that 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 ratites are segregated and otherwise handled as “U.S. Suspects.” All ratites identified as “U.S. Condemned” shall be tagged by establishment personnel, under FSIS supervision, with a serially numbered metal or plastic leg band or tag bearing the term “U.S. Condemned.”
[66 FR 22906, May 7, 2001]
§ 381.73
Quarantine of diseased poultry.
If live poultry, which is affected by any contagious disease which is transmissible to man, is brought into an official establishment, such poultry shall be segregated. The slaughtering of such poultry shall be deferred and the poultry shall be dealt with in one of the following ways:
(a) If it is determined by a veterinary inspector that further handling of the poultry will not create a health hazard, the lot shall be slaughtered separately, subject to ante mortem and post mortem inspection pursuant to the regulations.
(b) If it is determined by a veterinary inspector that further handling of the poultry will create a health hazard, such poultry may be released for treatment under the control of an appropriate State or Federal agency. If the circumstances are such that release for treatment is impracticable, a careful bird-by-bird ante mortem inspection shall be made, and all birds found to be, or which are suspected of being, affected with a contagious disease transmissible to man shall be condemned.
§ 381.74
Poultry suspected of having biological residues.
When any poultry at an official establishment is suspected of having been treated with or exposed to any substance that may impart a biological residue that would make their edible tissues adulterated, they shall, at the option of the operator of the establishment, be processed at the establishment and the carcasses and all parts thereof retained under U.S. Retained tags, pending final disposition in accordance with § 381.80, of this part, and other provisions in subpart K; or they shall be slaughtered at the establishment and buried or incinerated in a manner satisfactory to the inspector. Alternatively, such poultry may be returned to the grower, if further holding is likely to result in their not being adulterated by reason of any residue. The Inspection Service will notify the other Federal and State agencies concerned of such action. To aid in determining the amount of residue present in the poultry, officials of the Inspection Service may permit the slaughter of any such poultry for the purpose of collecting tissues for analysis of the residue. Such analysis may include the use of inplant screening procedures designed to detect the presence of antimicrobial residues in any species of poultry.
[47 FR 41336, Sept. 20, 1982]
§ 381.75
Poultry used for research.
(a) No poultry used in any research investigation involving an experimental biological product, drug, or chemical shall be eligible for slaughter at an official establishment unless the operator of such establishment, the sponsor of the investigation, or the investigator has submitted to the Inspection Service, or the Veterinary Biologics unit of Veterinary Services, Animal and Plant Health Inspection Service of the Department or the Environmental Protection Agency, or 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 poultry being adulterated, and the Administrator has approved such slaughter.
[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974]

Subpart K—Post Mortem Inspection; Disposition of Carcasses and Parts
§ 381.76
Post-mortem inspection under Traditional Inspection, the Streamlined Inspection System (SIS), the New Line Speed (NELS) Inspection System, the New Poultry Inspection System (NPIS), the New Turkey Inspection System (NTI), and Ratite Inspection.
(a) A post-mortem inspection shall be made on a bird-by-bird basis on all poultry eviscerated in every official establishment. Each carcass, or all parts comprising such carcass, must be examined by an inspector, except for parts that are not needed for inspection purposes and are not intended for human food and are condemned. Each carcass eviscerated shall be prepared as ready-to-cook poultry.
(b)(1) There are six systems of post-mortem inspection: the New Poultry Inspection System (NPIS), which may be used for young chickens and turkeys; the Streamlined Inspection System (SIS) and the New Line Speed Inspection System (NELS), both of which may be used only for broilers and cornish game hens; the New Turkey Inspection (NTI) System, which may be used only for turkeys; Traditional Inspection, which may be used for all poultry, except for ratites; and Ratite Inspection.
(i) The SIS shall be used only for broilers and cornish game hens if:
(a) The Administrator determines that SIS will increase inspector efficiency; or
(b) The operator requests SIS and the Administrator determines that the system will result in no loss of inspection efficiency.
(ii) The NELS Inspection System shall be used only for broilers and cornish game hens if:
(a) The operator requests the NELS Inspection System, and
(b) The Administrator determines that the establishment has the intent and capability to operate at line speeds greater than 70 birds per minute, and meets all the facility requirements in § 381.36(d).
(iii) The NTI System shall be used only for turkeys if:
(a) The operator requests it, and
(b) The Administrator determines that the establishment meets all the facility requirements in § 381.36(e).
(iv) The NPIS may be used for young chickens and turkeys if the official establishment requests to use it and meets or agrees to meet the requirements of paragraph (b)(6) of this section and the Administrator approves the establishment's request. The Administrator may permit establishments that slaughter classes of poultry other than young chickens and turkeys to operate under the New Poultry Inspection System under a waiver from the provisions of the regulations as provided in § 381.3(b).
(v) Traditional Inspection shall be used for turkeys when neither the NTI System nor the NPIS is used. For other classes of poultry, Traditional Inspection shall be used when SIS, NELS, and the NPIS are not used.
(2) Official establishments that operate under Traditional Inspection, SIS, NELS, NTI, or Ratite Inspection must meet the following requirements:
(i) No viscera or any part thereof may be removed from any poultry processed in any official establishment, except at the time of post-mortem inspection, unless its identity with the rest of the carcass is maintained in a manner satisfactory to the inspector until such inspection is made.
(ii) Each carcass to be eviscerated must be opened so as to expose the organs and the body cavity for proper examination by the inspector.
(iii) If a carcass is frozen, it must be thoroughly thawed before being opened for examination by an inspector.
(3) The following requirements are applicable to SIS:
(i) Definitions. For purposes of this paragraph, the following definitions shall apply:
(a) Cumulative sum (CUSUM). A statistical concept used by the establishment and monitored by the inspector whereby compliance is determined based on sample results collected over a period of time. For purposes of determining compliance with the finished product standards, the CUSUM is equal to the sum of prior test results plus the weighted result of the current test minus the tolerance, with the condition that the resulting CUSUM cannot go below zero.
(b) Tolerance number. A weighted measure that equates to product being produced at a national product quality level. See Table 2.
(c) Action number. A level reached by the CUSUM where the process is out of control and product action is required by the establishment or the inspector. See Table 2.
(d) “Start number”. A value halfway between zero and the action number. The start number is used to determine the starting CUSUM for the first subgroup of a shift and to reset the CUSUM value if the CUSUM is equal to or greater than the action number. See Table 2.
(e) Subgroup. A 10-bird sample collected before product enters the chiller and after product leaves the chiller.
(f) Subgroup absolute limit. The tolerance number plus 5. See Table 2.
(g) Prechill testing. Testing conducted by the establishment to determine the CUSUM on consecutive 10-bird subgroup samples collected prior to product entering the chilling system.
(h) Postchill testing. Testing conducted by the establishment to determine the CUSUM on consecutive 10-bird subgroup samples collected as the product leaves the chilling system.
(i) Rework. Reprocessing the product to correct the condition or conditions causing the nonconformances listed in Table 1.
(ii) General. (a) Under SIS, one inspector inspects the outside, inside, and viscera of each bird. There may be two inspectors on one processing line, each inspecting every other bird. For the establishment to run its processing line(s) at maximum speed, optimal conditions must be maintained so that inspection may be conducted efficiently. The inspector in charge determines the speed at which each processing line may be operated to permit inspection. A variety of conditions may affect this determination including the health of each flock and the manner in which birds are being presented to the inspector for inspection.
(b) SIS may be performed by one inspector (SIS-1) or two inspectors (SIS-2). SIS-1 requires that the establishment provide one inspection station for each line and adequate reinspection facilities so carcasses can be removed from each line for evaluation. The maximum line speed for SIS-1 is 35 birds per minute. SIS-2 requires that the establishment provide two inspection stations for each line and adequate reinspection facilities so carcasses can be removed from each line for evaluation. The maximum line speed for SIS-2 is 70 birds per minute.
(c) Under all inspection systems, including SIS, inspectors conduct post-mortem inspection and look for a number of conditions, as specified elsewhere in this subpart, which may indicate adulteration. Adulterated product is condemned and destroyed, except that carcasses and parts which may be made unadulterated by reprocessing (reworking) may be so reprocessed under the supervision of an inspector and reinspected. Under SIS, inspectors also reinspect product by sampling finished birds (both before and after chilling) for nonconformances with finished product standards (see Table 1). If such nonconformances are present at certain statistical levels, it may indicate process difficulties requiring corrective action by the establishment. If the establishment does not take adequate corrective action, the inspector shall initiate corrective actions such as conducting closer post-mortem inspections and requiring reprocessing and reinspection of previously processed carcasses and parts. Thus, SIS is conducted in two phases—a post-mortem inspection phase and a reinspection phase. The following paragraphs describe the inspection requirements (not addressed elsewhere in this subpart) under each.
(iii) Post-mortem inspection. (a) Facilities: Each inspection station must comply with the facility requirements in § 381.36(c).
(b) Presentation: Each inspector shall be flanked by an establishment employee assigned to be the inspector's helper. The one inspector on the SIS-1 line shall be presented every bird. Each inspector on the SIS-2 line shall be presented every other bird on the line. An establishment employee shall present each bird to the inspector properly eviscerated with the back side toward the inspector and the viscera uniformly trailing or leading. Each inspector shall inspect the inside, viscera, and outside of all birds presented.
(c) Disposition: The inspector shall determine which birds shall be salvaged, reprocessed, condemned, retained for disposition by the veterinarian, or allowed to proceed down the line as a passed bird subject to trim and reinspection. Carcasses with certain defects not requiring condemnation of the entire carcass shall be passed by the inspector, but shall be subject to reinspection to ensure the physical removal of the defects. The helper, under the supervision of the inspector, shall mark such carcasses for trim when the defects are not readily observable. Trimming of birds passed subject to reinspection shall be performed by:
(1) The helper, time permitting, and
(2) One or more plant trimmers positioned after all giblets are harvested and prior to reinspection.
(iv) Reinspection. (a) Facilities: Reinspection stations are required at both the prechill and postchill locations. The Agency will determine the number of stations needed in those establishments having more than one processing line or more than one chiller. One or more prechill reinspection stations shall be conveniently located at the end of the line or lines prior to chilling. One or more postchill stations must be conveniently located at the end of the chiller or chillers. The prechill and postchill reinspection stations must meet the following provisions:
(1) Floor space shall consist of 3 feet along each conveyor line. The space shall be level and protected from all traffic and overhead obstructions.
(2) A table at least 2 feet wide and 2 feet deep and 3 feet in height designed to be readily cleanable and drainable shall be provided for reinspecting the sampled birds.
(3) A minimum of 200 foot-candles of shadow-free lighting with a minimum color rendering index of 85 on the table surface.
(4) A separate clip board holder shall be provided for holding the recording sheets.
(5) Hangback racks designed to hold 10 carcasses shall be provided for and positioned within easy reach of the person at the station.
(b) Disposition: An inspector shall monitor the establishment's application of the Finished Product Standards program and shall take corrective action including retaining product to prevent adulterated product from leaving the establishment when the inspector determines that the establishment has failed to apply the program as prescribed in paragraph (b)(3)(iv)(c) of this section).
(c) Finished Product Standards: Finished Product Standards (FPS) are criteria applied to processed birds before and after chill to ensure that the product being produced is consistently wholesome and unadulterated. These criteria consist of nonconformances (listed in Table 1), the incidence of which is determined from 10 bird subgroup samples, reduced to a CUSUM number, and measured against the standards (Table 2). The standards are applied to permit the Agency to estimate when the production process is in control and when it is out of control. The establishment is responsible for maintaining FPS which, in turn, is monitored by the inspector. FPS is applied in two separate parts. The first is called prechill testing. It is designed to ensure that the slaughter and evisceration procedures are in control. Compliance is measured by determining the CUSUM on consecutive 10-bird subgroup samples collected prior to product entering the chilling system. The second part of the FPS is called postchill testing. It is designed to monitor the production through the chill system to ensure that it meets the postchill FPS. This test is independent of the prechill test. Compliance is measured by determining the CUSUM on consecutive 10-bird subgroup samples as they exit the chilling system. When the system is operating within compliance, the establishment applies the FPS to product samples at the prechill reinspection station. Testing time and time between tests are such that birds represented by the test are still within the chiller. If an out-of-compliance condition is found, the product leaving the chiller is segregated for rework and retested before it may proceed into commerce. A second 10 bird subgroup sample of the birds is taken after they leave the chiller to ensure that the product meets the postchill FPS. Since the product is closer to the end of processing, the controls on releasing reworked product are stricter than controls under prechill testing, again to ensure that no adulterated product enters into commerce.
(d) Prechill testing. The prechill FPS have been divided into processing and trim categories. The processing category is designed to monitor the output of the dressing and evisceration procedures. The trim category monitors the establishment's ability to remove unwholesome lesions and conditions from inspected and passed carcasses. Each category is monitored independently of the other category using a separate CUSUM for each category.
(1) Actions to be taken when the process is in control. If the CUSUM is less than the action number and the subgroup absolute limit is not exceeded, the process is judged to be in control.
(i) Establishment Actions. The establishment shall:
(A) Randomly select and record subgroup sampling times for each production unit of time before product reaches the prechill reinspection station on the production line. In no case shall the time between tests exceed 1 hour of production time.
(B) Conduct a 10-bird subgroup test at a random time on each poultry slaughter line. These times are preselected by the establishment and available to the inspector prior to the start of the shift/day's operations. All 10 samples of the subgroup shall be collected at the random time.
(C) Obtain the weighted value of each nonconformance by multiplying the number recorded for each nonconformance by the “factor” in Table 1, sum the total of all the nonconformances, and calculate the CUSUM value for that test.
(ii) Inspector Actions. The inspector shall:
(A) Select random times for monitoring subgroup tests for each half-shift on the evisceration line. In establishments that have multiple evisceration lines on a production shift, monitor all lines of product at the random times.
(B) Collect the subgroup samples to be monitored at preselected times. All 10 samples of the subgroup shall be collected at the random time selected in paragraph (b)(3)(iv)(d)(1)(ii)(A) of this section.
(C) Conduct the 10-bird monitoring subgroup test.
(2) Actions to be taken when the subgroup absolute limit is exceeded. If either an inspector or establishment subgroup test exceeds the subgroup absolute limit of tolerance plus 5 (T + 5), the establishment shall determine if any of the immediate past 5 plant prechill subgroups for that category (processing or trim) resulted in a CUSUM above the start number.
(i) If all of the past 5 plant prechill subgroups are at or below the start number, the establishment shall immediately conduct a retest subgroup on that category of prechill to determine sample validity. If retest subgroup total equals tolerance or less, the establishment resumes random time testing. If the retest subgroup total exceeds tolerance, the establishment shall proceed as if CUSUM reaches the action number and shall begin process actions as set forth in paragraph (b)(3)(iv)(d)(4) of this section. In either case, the prechill retest results will be used to calculate CUSUM.
(ii) If any of the past 5 plant prechill subgroups resulted in a CUSUM above the start number, the establishment shall proceed as if CUSUM reaches the action number and shall begin process actions as set forth in paragraph (b)(3)(iv)(d)(4) of this section.
(3) Actions to be taken when a trimmable lesion/condition is found. If either inspection or plant monitoring finds any trimmable lesion or condition as specified in item B(7) of Table 1 during a prechill subgroup test, the establishment shall immediately conduct an additional prechill subgroup test for the same trimmable lesion/condition category. This is a requirement on the subgroup testing for the prechill trim nonconformance that is in addition to the CUSUM test described in paragraph (b)(3)(iv)(d)(1) of this section.
(i) If no additional item in the same category is found on retest, the establishment shall resume random time sampling.
(ii) If an additional item in the same category is found on retest, the establishment shall proceed as if CUSUM reaches the action number and shall initiate corrective action set forth in paragraph (b)(3)(iv)(d)(4) of this section for this category only.
(4) Actions to be taken when the CUSUM reaches the action number. Once CUSUM reaches the action number, the process is judged to be not in control.
(i) Establishment Actions. The establishment shall:
(A) Immediately notify the inspector in charge and the production supervisor responsible for the affected evisceration line.
(B) Suspend random time prechill testing of the affected nonconformance category (processing or trim). Suspend random time postchill subgroup testing when the processing category is the affected nonconformance category.
(C) Conduct subgroup retests on carcasses leaving the chill system. Apply the prechill criteria in Table 1 (A) or (B), depending upon which category caused the action, and apply prechill Finished Product Standards as listed in Table 2 to determine product compliance. In no case shall the time between retests exceed 30 minutes of production time. Apply prechill standard criteria at the postchill location after notifying the establishment's production supervisor. If any of these subgroup retests on product leaving the chill system result in a subgroup total exceeding tolerance, identify for rework subsequent product at the postchill location. All noncomplying product will be brought into compliance prior to release into commerce. Product from the chiller will continue accumulating for rework until a subsequent subgroup test results in a subgroup total equal to or less than tolerance.
(D) Conduct additional subgroup tests at the prechill reinspection station to determine the adequacy of production corrective action. If the prechill tests results in a subgroup total exceeding the tolerance, notify the production supervisor. The number of additional tests at the postchill reinspection station using prechill standards is increased as required to include the product in the chiller represented by this additional prechill test.
(E) After two consecutive additional prechill subgroup tests result in subgroup totals equal to or less than tolerance:
—Resume random time prechill subgroup testing as set forth in actions to be taken when the process is in control at paragraph (b)(3)(iv)(d)(1) of this section.
—Identify product entering the chill system that will mark the end of the retest action upon arrival at the postchill sampling location. Such identification may include tagging or empty space in chillers, depending upon the establishment's identification method.
—Once all product identified as needing retesting has arrived at the postchill sampling location, random time postchill FPS testing resumes.
—If two consecutive additional prechill subgroup tests demonstrate process control with subgroup totals equal to or less than tolerance, but they do not cause CUSUM to fall to the start line or below, reset CUSUM at the start number.
(ii) Inspector Actions. The inspector shall monitor product and process actions by making spot-check observations to ensure that all program requirements are met.
(e) Postchill testing. Postchill subgroups shall be collected after the product leaves the chiller but before the product is divided into separate processes. Each bird sampled shall be observed and its conformance measured against the postchill criteria. The subgroup nonconformance weights shall be totaled and the CUSUM calculated by subtracting the tolerance from the sum of the subgroup total and the starting CUSUM.
(1) Actions to be taken when the process is in control. If the CUSUM is less than the action number and the subgroup absolute limit is not exceeded, the process is judged to be in control.
(i) Establishment Actions. The establishment shall conduct a 10-bird subgroup test for each chiller system at a randomly selected time of production. In no case shall the time between tests exceed 2 hours of production time.
(ii) Inspector Actions. The inspector shall:
(A) Select random times for postchill monitoring.
(B) Monitor each chill system twice per shift.
(C) Conduct subgroup tests at preselected random times.
(2) Actions to be taken when the subgroup absolute limit is exceeded. If either an inspector or establishment subgroup test exceeds the subgroup absolute limit of tolerance plus 5(T + 5), the establishment shall determine if any of the last 5 postchill monitoring subgroups resulted in a CUSUM above the start number.
(i) If all of the past 5 postchill monitoring subgroups resulted in a CUSUM at or below the start number, the establishment shall immediately retest a subgroup to determine sample validity. If this retest subgroup total exceeds tolerance, the establishment shall proceed as if CUSUM reaches the action number and shall begin process actions as set forth in paragraph (b)(3)(iv)(e)(3) of this section.
(ii) If any of the past 5 postchill monitoring subgroups resulted in a CUSUM above the start number, the establishment shall proceed as if CUSUM reaches the action number and shall begin process actions as set forth in paragraph (b)(3)(iv)(e)(3) of this section.
(3) Actions to be taken when the CUSUM reaches the action number. Once CUSUM reaches the action number, the process is judged to be not in control.
(i) Establishment Actions. The establishment shall:
(A) Notify the inspector in charge and the production supervisor responsible for product in the chiller.
(B) Suspend random time postchill subgroup testing.
(C) Immediately conduct an additional postchill subgroup test. If the retest subgroup total exceeds tolerance, the establishment shall identify subsequent product for rework. Product will continue accumulating for rework until a subsequent subgroup test results in a subgroup total equal to or less than tolerance.
(D) After two consecutive additional postchill subgroup tests results in subgroup totals equal to or less than tolerance:
—Resume random time postchill subgroup testing as set forth in actions to be taken when the process is in control at paragraph (b)(3)(iv)(e)(1) of this section.
—If the two consecutive additional postchill subgroup totals equal to or less than tolerance do not cause CUSUM to fall to the start number or below, reset CUSUM at the start number.
(ii) Inspector Actions. The inspector shall monitor product and process actions to ensure that program requirements are met.
(v) When the prechill or postchill product has been identified as having been produced when the process was not in control, additional online subgroup testing by the establishment is required to determine its conformance to the standard. If any of the additional plant subgroup testing results in a subgroup total exceeding tolerance, offline product corrective actions must take place. The responsibilities of the establishment and the inspector change depending on the CUSUM.
All corrective actions such as identifying affected product, segregating product, and maintaining control through rework actions are the establishment's responsibility. Corrective actions by the inspector depends upon the establishment's ability to control rework of affected product. If the establishment fails in its responsibilities, the inspector will identify, segregate, and retain affected product to prevent adulterated product from reaching consumers.
(a) Offline product. The establishment shall identify the affected product so that it may be segregated and accumulated offline for rework. The inspector shall spot check the establishment's identification, segregation, and control of reworked product to ensure that program requirements are met.
(b) Reworked product. Reworked product must be tested by the establishment with a randomly selected subgroup test of the accumulated reworked lot. Before product is released, the random subgroup test must result in a subgroup total equal to or less than tolerance. If the subgroup test of a reworked lot results in a subgroup total exceeding tolerance, the lot must be reworked again before another subgroup is selected. The following actions are required.
(1) Establishment Actions. The establishment shall:
(i) Select the random subgroup from throughout the lot only after the total lot has been reworked.
(ii) Conduct the subgroup test using the same criteria (prechill or postchill) that resulted in the rework action.
(iii) Release the lot if the reworked subgroup test resulted in a subgroup total equal to or less than tolerance.
(iv) Identify and control the lot to be reworked if the reworked subgroup total again exceeds tolerance.
(2) Inspector Actions: The inspector shall spot check the rework procedure to ensure that plant monitoring and production meet the requirements of the program.
(vi) After the 10 bird subgroup tests are completed, the prechill and postchill processing nonconformances shall be corrected on all bird samples prior to returning the samples to the product flow. Samples with trim nonconformances shall be returned to the trim station for correction prior to their return to the product flow.
Table 1—Definitions of Nonconformances
A Processing Nonconformances
1 Extraneous material ≤1/16″
—Include any specks, tiny smears, or stains of material that measure 1/16″ or less in the greatest dimension.
Examples: Ingesta, unattached feathers, grease, bile remnants, and/or whole gall bladder or spleen, embryonic yolk, etc.
—Factor is one.
—1 to 5 = 1 defect: 6 to 10 = 2 defects; 11 or more = 3 defects. A maximum of three incidents per carcass.
2 Extraneous material >1/16″ to 1″
—The same material as line 1, but measuring >1/16″ to 1″ in the longest dimension.
—Factor is one.
—A maximum of three incidents per carcass.
3 Extraneous material >1″
—The same material as lines 1 to 2, but measuring greater than one inch.
—Factor is two.
—A maximum of two incidents per carcass.
4 Oil glands remnant—less than two whole glands
—Recognizable fragment(s) of one or both oil glands equals one incident.
—Factor is one.
—Maximum of one incident per carcass.
5 Oil glands—two whole glands
—Both whole oil glands with no missing fragments equals one incident. If the oil glands are cut, but no fragment is removed, consider them to be whole. But if even a small fragment is removed, use line 4.
—Factor is two.
—A maximum of one incident per carcass.
6 Lung ≥1/4″ whole
—Any portion less than a whole lung, and equal to or greater than 1/4″ at the greatest dimension, equals one incident.
—Factor is one.
—A maximum of two incidents per carcass.
7 Lung—whole
—Each whole lung equals one incident.
—Factor is two.
—A maximum of two incidents per carcass.
8 Intestine
—Any identifiable portion of the terminal portion of the intestinal tract with a lumen (closed circle) present, or split piece of intestine large enough to be closed to form a lumen.
—Factor is five.
—A maximum of one incident per carcass.
9 Cloaca
—Any identifiable portion of the terminal portion of the intestinal tract with mucosal lining.
—Factor is five.
—A maximum of one incident per carcass.
10 Bursa of Fabricius
—A whole rosebud, or identifiable portion with two or more mucosal folds.
—Factor is two.
—A maximum of one incident per carcass.
| 11 Esophagus
—Any portion of the esophagus with identifiable mocosal lining.
—Factor is two.
—A maximum of one incident per carcass.
12 Crop—partial—with mucosa
—Any portion of the crop that includes the mucosal lining.
—Factor is two.
—A maximum of one incident per carcass.
13 Crop—whole
—Any complete crop.
—Factor is five.
—A maximum of one incident per carcass.
14 Trachea ≤1″
—Identifiable portion of trachea less than or equal to one inch long.
—Factor is one.
—A maximum of one incident per carcass.
15 Trachea >1″
—Identifiable portion of trachea greater than one inch.
—Factor is two.
—A maximum of one incident per carcass.
16 Hair ≥1/4″ 26 or more.
—Hair which is one-fourth inch long or longer measured from the top of the follicle to the end of the hair. 26 or more hairs equal one incident.
—Factor is one.
—A maximum of one incident per carcass.
17 Feather and/or Pinfeathers ≤1″
—Attached feathers or protruding pinfeathers less than or equal to one inch long. Scored 5 to 10 per carcass as one incident, 11 to 15 per carcass as two incidents, and 16 or more as three incidents.
—Factor is one.
—A maximum of three incidents per carcass.
18 Feathers >1″
—Attached feathers longer than one inch. Scored 1 to 3 per carcass as one incident 4 to 6 per carcass as two incidents, and 7 or more as three incidents.
—Factor is one.
—A maximum of three incidents per carcass.
19 Long Shank—both condyles covered
—If the complete tibiotarsal joint is covered, it equals one incident.
—Factor is two.
—A maximum of two incidents per carcass.
B Trim nonconformances
1 Breast blister
—Inflammatory tissue, fluid, or pus between the skin and keel must be trimmed if membrane “slips” or if firm nodule is greater than 1/2″ in diameter (dime size).
—Factor is two.
—A maximum of one incident per carcass.
2 Breast blister—partially trimmed
—All inflammatory tissue, including that which adheres tightly to the keel bone, must be removed.
—Factor is two.
—A maximum of one incident per carcass.
3 Bruise 1/2″ to 1″
—Blood clumps or clots in the superficial layers of tissue, skin, muscle or loose subcutaneous tissue may be slit and the blood completely washed out. When the bruise extends into the deeper layers of muscle, the affected tissue must be removed. Very small bruises less than 1/2″ (dime size) and areas showing only slight reddening need not be counted as defects.
—Factor is one.
—A maximum of five incidents per carcass.
4 Bruise >1″
—Same criteria as in line three, but greater than one inch in greatest dimension.
—Factor is two.
—A maximum of three incidents per carcass.
5 Bruise black/green 1/4″ to 1″
—Bruises 1/4″ to 1″ that have changed from red to a black/blue or green color due to age.
—Factor is two.
—A maximum of three incidents per carcass.
6 Bruise Black/green >1″
—Same as line 5, but measuring greater that 1″ in greatest dimension.
—Factor is five.
—A maximum of two incidents per carcass.
7 Trimmable lesions/Condition
—A trimmable tumor or identifiable portion of a tumor on any part of the carcass.
—Trimmable Synovitis/airsacculitis (saddle/frog) lesions that have not been removed.
| —Lesion/condition subject to removal following an approved cleanout process. Examples: airsacculitis, salpingitis, nephritis, spleen, or liver conditions requiring removal of the kidneys.
Note: All establishments shall develop and maintain a permanent marking system that identifies carcasses with removable lesions/conditions on the inside surfaces. When removable lesions/conditions are identified inside the carcass by the inspector, the helper will be notified to apply the permanent mark. When removable inside lesions/conditions are found on a subgroup sample without the permanent mark, the error is not recorded in line 7. The affected carcass(s) will be hungback for IIC disposition and corrective action.
—Factor is five.
—A maximum of one incident per carcass.
8 Failure to complete task as indicated by marking system.
Example: Synovitis, airsacculitis, inflammatory process, contamination, etc.
—The helper, under the inspector's direction, will apply a mark to the carcass, indicating to the trimmer(s) that specific action must be taken on that carcass. When airsac and kidney cleanout, or synovitis part removal, or carcass removal from the line is not completed, or only partially completed, this occurrence is recorded as one defect.
—Factor is five. It will also be recorded as a line 7 defect for a total factor of 10.
—A maximum of one incident per carcass.
9 Compound fracture
—Any bone fracture (i.e., leg or wing) that has caused an opening through the skin. May be accompanied with a bruise, but not always. Do not count the bruise in line 3 or 4 if it is associated with the compound fracture.
—Factor is two.
—A maximum of three incidents per carcass.
10 Wingtip compound fracture
—Same criteria as line 9, but only for wingtips.
Note: Bruises not associated with the fracture should be recorded in the appropriate lines.
—Factor is one.
—A maximum of two incidents per carcass.
11 Untrimmed short hock
—When no cartilage of the hock surface is present and no tendons are attached to the bone.
—Factor is two.
—A maximum of two incidents per carcass.
12 Sores, scabs, inflammatory process, etc. ≤1/2″
—Any defects such as sores, abscesses, scabs, wounds, dermatitis, inflammatory process, that measure less than or equal to 1/2″ in the greatest dimension.
—Factor is two.
—A maximum of two incidents per carcass.
13 Sores, scabs, inflammatory process, etc. >1/2″
—Same as line 12, but greatest dimension is greater than 1/2″, or a cluster of smaller lesions in close proximity >1/2″, this category also includes turkey leg edema.
—Factor is five.
—A maximum of one incident per carcass.
14 External mutilation
—Mutilation to the skin and/or muscle that is caused by the slaughter, dressing or eviscerating processes. Skinned elbows (bucked wings) do not trim require unless affected wing joint capsule is also opened.
—Factor is one.
—A maximum of three incidents per carcass.
C Postchill nonconformances—(Designed to monitor those nonconformances added to product during the chilling process)
1 Extraneous material ≤1/16″
—Include specks, grease, or unidentifiable foreign material that measure 1/16″ or less in the greatest dimension.
—Example: Ingesta, grease, or unidentifiable foreign material.
—Factor is one.
—3 to 7 = 1 defect; 8 to 12 = 2 defects; 13 or more = 3 defects. A maximum of three incidents per carcass.
2 Extraneous material >1/16″ to 1″
—This includes ingesta, grease, or unidentifiable foreign material measureing >1/16″ to 1″ longest dimension.
—Factor is one.
—A maximum of three incidents per carcass.
3 Extraneous material >1″
—The same material as line 2, but measuring greater than one inch.
—Factor is two.
| —A maximum of two incidents per carcass.
Table 2—Finished Product Standards
| SIS
Prechill Processing Nonconformance
Tolerance number (T) | 25
Subgroup Absolute Limit (T + 5) | 30
Action number | 22
Start number | 11
Prechill Trim Nonconformance
Tolerance number (T) | 12
Subgroup Absolute Limit (T + 5) | 17
Action number | 15
Start number | 8
Postchill Nonconformance
Tolerance number (T) | 5
Subgroup Absolute Limit (T + 5) | 10
Action number | 10
Start number | 5
(4) The following requirements are also applicable to NELS inspection:
(i) Inspection under NELS is conducted in two phases, as post-mortem inspection phase and a reinspection phase.
(a) Post-mortem inspection. The establishment shall provide three inspection stations on each eviscerating line in compliance with the facility requirements § 381.36(d)(1). The three inspectors shall inspect the inside, viscera, and outside of all birds presented. Each inspector shall be flanked by two establishment employees—the presenter and the helper. The presenter shall ensure that the bird is properly eviscerated and presented for inspection and the viscera uniformly trailing or leading. The inspector shall determine which birds shall be salvaged, reprocessed, condemned, retained for disposition by the veterinarian, or allowed to proceed down the line as a passed bird subject to reinspection. Poultry carcasses with certain defects not requiring condemnation of the entire carcass shall be passed by the inspector, but shall be subject to reinspection to ensure the physical removal of the specified defects. The helper, under the supervision of the inspector, shall mark such carcasses for trim when the defects are not readily observable. Trimming or birds passed subject to reinspection shall be performed by:
(1) The helper, time permitting, and
(2) One or more plant trimmers positioned after giblet harvest and prior to reinspection.
(b) A reinspection station shall be located at the end of each line. This station shall comply with the facility requirements in § 381.36(d)(2). The inspector shall ensure that the establishment has performed the indicated trimming of carcasses passed subject to reinspection by visually monitoring, checking data, or gathering samples at the station or at other critical points on the line.
(ii)-(iii) [Reserved]
(iv) The maximum inspection rate for NELS shall be 91 birds per minute per eviscerating line.
(5) The following requirements are also applicable to the NTI System:
(i) Inspection under the NTI System is conducted in two phases, a post-mortem inspection phase and a reinspection phase. The NTI-1 Inspection System requires that the establishment provide one inspection station for each line and adequate reinspection facilitiates so carcasses can be removed from each line for evaluation. The NTI-2 Inspection System requires that the establishment provide two inspection stations for each line and adequate reinspection facilities so carcasses can be removed from each line for evaluation.
(a) Post-mortem inspection. Each inspection station must comply with the facility requirements in § 381.36(e)(1). Each inspector shall be flanked by and establishment employee assigned to be the inspector's helper. The one inspector on an NTI-1 Inspection System shall be presented every bird. Each inspector on an NTI-2 Inspection System line shall be presented every other bird on the line. An establishment employee shall present each bird to the inspector properly eviscerated with the back side toward the inspector and the viscera uniformly trailing or leading. Each inspector shall inspect the inside, viscera, and outside of all birds presented. The inspector shall determine which bird shall be salvaged, reprocessed, condemned, retained for disposition by a veterinarian, or allowed to proceed down the line as a passed bird subject to reinspection. Turkey carcasses with certain defects not requiring condemnation of the entire carcass shall be passed by the inspector, but shall be subject to reinspection to ensure the physical removal of the specified defects. The helper, under the supervision of the inspector, shall mark such carcasses for trim when the defects of birds passed subject to reinspection shall be performed by:
(1) The helper, time permitting, and
(2) One or more plant trimmers positioned after the giblet harvest and prior to reinspection.
(b) Reinspection. A reinspection station shall be located at the end of the lines. This station shall comply with the facility requirements in § 381.36(e)(2). The inspector shall ensure that establishments have performed the indicated trimming of each carcass passed subject to reinspection by visually monitoring, checking data, and/or sampling product at the reinspection station and, if necessary, at other points, critical to the wholesomeness of product, on the eviscerating line.
(ii)-(iii) [Reserved]
(6) The following requirements are applicable to the NPIS:
(i) Facilities. The establishment must comply with the facilities requirements in § 381.36(f).
(ii) Carcass sorting and disposition. (A) The establishment must conduct carcass with associated viscera sorting activities, dispose of carcasses and parts exhibiting condemnable conditions, and conduct appropriate trimming and reprocessing activities before carcasses are presented to the online carcass inspector.
(B) Any carcasses removed from the line for reprocessing activities or salvage must be returned to the line before the online carcass inspection station. The establishment must include in its written HACCP plan, or sanitation SOP, or other prerequisite program a process by which parts, other than parts identified as “major portions” as defined in § 381.170(b)(22), are available for inspection offline after reprocessing or salvage.
(C) The establishment must develop, implement, and maintain written procedures to ensure that poultry carcasses contaminated with septicemic and toxemic conditions do not enter the chiller. The establishment must incorporate these procedures into its HACCP plan, or sanitation SOP, or other prerequisite program. These procedures must cover, at a minimum, establishment sorting activities required under paragraph (b)(6)(ii) of this section.
(D) The establishment must maintain records to document that the products resulting from its slaughter operation meet the definition of ready-to-cook poultry in § 381.1. These records are subject to review and evaluation by FSIS personnel.
(iii) Presentation for online carcass inspection. To ensure the online carcass inspector may properly inspect every carcass, the establishment must present carcasses as follows:
(A) Each carcass, except carcasses and parts identified as “major portions” under 9 CFR 381.179(b)(22), must be held by a single shackle;
(B) Both hocks of each carcass must be held by the shackle;
(C) The back side of the carcass must be faced toward the inspector;
(D) There must be minimal carcass swinging motion;
(E) The establishment must ensure that it can sufficiently identify viscera and parts corresponding with each carcass inspected by the online carcass inspector so that if the carcass inspector condemns a carcass all corresponding viscera and parts are also condemned.
(iv) Inspection for Avian Visceral Leukosis. (A) Establishments that slaughter young chickens must notify the inspector-in-charge prior to the slaughter of each new flock to allow the inspection of viscera as provided in § 381.36(f)(3).
(B) If there is evidence that a flock may be affected by avian visceral leukosis, the inspector-in-charge is authorized to adjust inspection procedures as needed to ensure adequate inspection of each carcass and viscera for that condition. The inspector-in-charge is also authorized to require the establishment to adjust its processing operations as needed to accommodate the adjusted inspection procedures.
(Recordkeeping requirements approved by the Office of Management and Budget under control number 0583-0008)
[47 FR 23435, May 28, 1982, as amended at 49 FR 42555, Oct. 23, 1984; 50 FR 37513, Sept. 16, 1985; 50 FR 38097, Sept. 20, 1985; 51 FR 3574, Jan. 29, 1986; 53 FR 46861, Nov. 21, 1988; 62 FR 5143, Feb. 4, 1997; 65 FR 34390, May 30, 2000; 66 FR 22906, May 7, 2001; 79 FR 49635, Aug. 21, 2014]
§ 381.77
Carcasses held for further examination.
Each carcass, including all parts thereof, in which there is any lesion of disease, or other condition which might render such carcass or any part thereof adulterated and with respect to which a final decision cannot be made on first examination by the inspector, shall be held for further examination. The identity of each such carcass, including all parts thereof, shall be maintained until a final examination has been completed.
§ 381.78
Condemnation of carcasses and parts: separation of poultry suspected of containing biological residues.
(a) At the time of any inspection under this subpart each carcass, or any part thereof, which is found to be adulterated shall be condemned, except that any such articles which may be made not adulterated by reprocessing, need not be so condemned if so reprocessed under the supervision of an inspector and thereafter found to be not adulterated.
(b) When a lot of poultry suspected of containing biological residues is inspected in an official establishment, all carcasses and any parts of carcasses in such lot which are condemned shall be kept separate from all other condemned carcasses or parts.
[37 FR 9706, May 16, 1972, as amended at 48 FR 22899, May 23, 1983; 48 FR 23807, May 27, 1983]
§ 381.79
Passing of carcasses and parts.
Each carcass and all organs and other parts of carcasses which are found to be not adulterated shall be passed for human food.
§ 381.80
General; biological residues.
(a) The carcasses or parts of carcasses of all poultry inspected at an official establishment and found at the time of post mortem inspection, or at any subsequent inspection, to be affected with any of the diseases or conditions named in other sections in this subpart, shall be disposed of in accordance with the section pertaining to the disease or condition. Owing to the fact that it is impracticable to formulate rules for each specific disease or conditions and to designate at just what stage a disease process results in an adulterated article, the decision as to the disposal of all carcasses, organs or other parts not specifically covered by the regulations, or by instructions of the Administrator issued pursuant thereto, shall be left to the inspector in charge, and if the inspector in charge is in doubt concerning the disposition to be made, specimens from such carcasses shall be forwarded to the Inspection Service laboratory for diagnosis.
(b) All carcasses, organs, or other parts of carcasses of poultry shall be condemned if it is determined on the basis of a sound statistical sample that they are adulterated because of the presence of any biological residues.
§ 381.81
Tuberculosis.
Carcasses of poultry affected with tuberculosis shall be condemned.
§ 381.82
Diseases of the leukosis complex.
Carcasses of poultry affected with any one or more of the several forms of the avian leukosis complex shall be condemned.
§ 381.83
Septicemia or toxemia.
Carcasses of poultry showing evidence of any septicemic or toxemic disease, or showing evidence of an abnormal physiologic state, shall be condemned.
§ 381.84
Airsacculitis.
Carcasses of poultry with evidence of extensive involvement of the air sacs with airsacculitis or those showing airsacculitis along with systemic changes shall be condemned. Less affected carcasses may be passed for food after complete removal and condemnation of all affected tissues including the exudate.
[40 FR 14297, Mar. 31, 1975]
§ 381.85
Special diseases.
Carcasses of poultry showing evidence of any disease which is characterized by the presence, in the meat or other edible parts of the carcass, or organisms or toxins dangerous to the consumer, shall be condemned.
§ 381.86
Inflammatory processes.
Any organ or other part of a carcass which is affected by an inflammatory process shall be condemned and, if there is evidence of general systemic disturbance, the whole carcass shall be condemned.
§ 381.87
Tumors.
Any organ or other part of a carcass which is affected by a tumor shall be condemned and when there is evidence of metastasis or that the general condition of the bird has been affected by the size, position, or nature of the tumor, the whole carcass shall be condemned.
§ 381.88
Parasites.
Organs or other parts of carcasses which are found to be infested with parasites, or which show lesions of such infestation shall be condemned and, if the whole carcass is affected, the whole carcass shall be condemned.
§ 381.89
Bruises.
Any part of a carcass which is badly bruised shall be condemned and, if the whole carcass is affected as a result of the bruise, the whole carcass shall be condemned. Parts of a carcass which show only slight reddening from a bruise may be passed for food.
§ 381.90
Cadavers.
Carcasses of poultry showing evidence of having died from causes other than slaughter shall be condemned.
§ 381.91
Contamination.
(a) Carcasses of poultry contaminated by volatile oils, paints, poisons, gases, scald vat water in the air sac system, or other substances which render the carcasses adulterated shall be condemned. Any organ or other part of a carcass which has been accidentally multilated in the course of processing shall be condemned, and if the whole carcass is affected, the whole carcass shall be condemned.
(b) Any carcass of poultry accidentally contaminated during slaughter with digestive tract contents need not be condemned if promptly reprocessed under the supervision of an inspector and thereafter found not to be adulterated. Contaminated surfaces that are cut must be removed only by trimming. Contaminated inner surfaces that are not cut may be cleaned by trimming alone or may be re-processed as provided in subparagraph (b)(1) or (2) of this section.
(1) Online reprocessing. Poultry carcasses accidentally contaminated with digestive tract contents may be cleaned by applying an online reprocessing antimicrobial intervention to all carcasses after evisceration and before the carcasses enter the chiller if the parameters for use of the antimicrobial intervention system have been approved by the Administrator. Establishments must incorporate procedures for the use of any online reprocessing antimicrobial intervention system into their HACCP plans, or sanitation SOPs, or other prerequisite programs.
(2) Offline reprocessing. Contaminated inner surfaces that are not cut may be cleaned at an approved reprocessing station away from the main processing line by any method that will remove the contamination, such as vacuuming, washing, and trimming, singly or in combination. All visible specks of contamination must be removed, and if the inner surfaces are reprocessed other than solely by trimming, all surfaces of the carcass must be treated with chlorinated water containing 20 ppm to 50 ppm available chlorine or another approved antimicrobial substance in accordance with the parameters approved by the Administrator. Establishments must incorporate procedures for the use of any offline reprocessing into their HACCP plans, or sanitation SOPs, or other prerequisite programs.
[37 FR 9706, May 16, 1972, as amended at 43 FR 12847, Mar. 28, 1978; 79 FR 49636, Aug. 21, 2014]
§ 381.92
Overscald.
Carcasses of poultry which have been overscalded, resulting in a cooked appearance of the flesh, shall be condemned.
§ 381.93
Decomposition.
Carcasses of poultry deleteriously affected by post mortem changes shall be disposed of as follows:
(a) Carcasses which have reached a state of putrefaction or stinking fermentation shall be condemned.
(b) Any part of a carcass which is green struck shall be condemned and, if the carcass is so extensively affected that removal of affected parts is impracticable, the whole carcass shall be condemned.
(c) Carcasses affected by types of post mortem change which are superficial in nature may be passed for human food after removal and condemnation of the affected parts.
§ 381.94
Contamination with microorganisms; process control verification criteria and testing; pathogen reduction standards for establishments that slaughter ratites.
(a) Criteria for verifying process control; E. coli testing. (1) Each official establishment that slaughters ratites shall test for Escherichia coli Biotype I (E. coli). Establishments that slaughter ratites and livestock, shall test the type of ratites or livestock 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 that slaughters ratites 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 whole ratites at the end of the chilling process. Samples from ratites may be collected by sponging the carcass on the back and thigh or samples can be collected by rinsing the whole carcass in an amount of buffer appropriate for that type of bird.
(iii) Sampling frequency. Establishments that slaughter ratites, except very low volume ratite establishments as defined in paragraph (a)(2)(v) of this section, must take samples at a frequency proportional to the establishment's volume of production at the following rate: 1 sample per 3,000 carcasses, but at a minimum one sample 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 ratite establishments. (A) Very low volume ratite establishments annually slaughter no more than 6,000 ratites. Very low volume ratite establishments that slaughter ratites in the largest number must collect at least one sample during each week of operation after June 1 of each year, and continue sampling at a minimum of once each week the establishment operates until June of the following year or until 13 samples have been collected, whichever comes first.
(B) Upon the establishment's meeting the 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 by 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) 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.
(4) Recording of test results. The establishment shall maintain accurate records of all test results, in terms of colony forming units (CFU)/ml of rinse fluid. Results shall be recorded onto a process control chart or table showing at least the most recent 13 test results. Records shall be retained at the establishment for a period of 12 months and shall be made available to FSIS upon request.
(5) Establishments 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 will be suspended in accordance with rules of practice that will be adopted for such proceeding, upon a finding by FSIS that one or more provisions of paragraphs (a) (1) through (4) of this section have not been complied with and written notice of same has been provided to the establishment.
(b) [Reserved]
[61 FR 38866, July 25, 1996, as amended at 62 FR 26218, May 13, 1997; 62 FR 61009, Nov. 14, 1997; 64 FR 66553, Nov. 29, 1999; 67 FR 13258, Mar. 22, 2002; 79 FR 49636, Aug. 21, 2014]

Subpart L—Handling and Disposal of Condemned or Other Inedible Products at Official Establishments
§ 381.95
Disposal of condemned poultry products.
All condemned carcasses, or condemned parts of carcasses, or other condemned poultry products, except those condemned for biological residues shall be disposed of by one of the following methods, under the supervision of an inspector of the Inspection Service. (Facilities and materials for carrying out the requirements in this section shall be furnished by the official establishment.)
(a) Steam treatment (which shall be accomplished by processing the condemned product in a pressure tank under at least 40 pounds of steam pressure) or thorough cooking in a kettle or vat, for a sufficient time to effectively destroy the product for human food purposes and preclude dissemination of disease through consumption by animals. (Tanks and equipment used for this purpose or for rendering or preparing inedible products shall be in rooms or compartments separate from those used for the preparation of edible products. There shall be no direct connection by means of pipes, or otherwise, between tanks containing inedible products and those containing edible products.)
(b) Incineration or complete destruction by burning.
(c) Chemical denaturing, which shall be accomplished by the liberal application to all carcasses and parts thereof, of:
(1) Crude carbolic acid,
(2) Kerosene, fuel oil, or used crankcase oil, or
(3) Any phenolic disinfectant conforming to commercial standards CS 70-41 or CS 71-41 which shall be used in at least 2 percent emulsion or solution.
(d) Any other substance or method that the Administrator approves in specific cases, which will denature the poultry product to the extent necessary to accomplish the purposes of this section.
(e) Carcasses and parts of carcasses condemned for biological residue shall be disposed of in accordance with paragraph (b) of this section or by burying under the supervision of an inspector.

Subpart M—Official Marks, Devices, and Certificates; Export Certificates; Certification Procedures
§ 381.96
Wording and form of the official inspection legend.
Except as otherwise provided in this subpart, the official inspection legend required to be used with respect to inspected and passed poultry products shall include wording as follows: “Inspected for wholesomeness by U.S. Department of Agriculture.” This wording shall be contained within a circle. The form and arrangement of such wording shall be exactly as indicated in the example in Figure 1, except that the appropriate official establishment number shall be shown, and if the establishment number appears elsewhere on the labeling material in the manner prescribed in § 381.123(b), it may be omitted from the inspection mark. The administrator may approve the use of abbreviations of such inspection mark; and such approved abbreviations shall have the same force and effect as the inspection mark. The official inspection legend, or the approved abbreviation thereof, shall be printed on consumer packages and other immediate containers of inspected and passed poultry products, or on labels to be securely affixed to such containers of such products and may be printed or stenciled thereon, but shall not be applied by rubber stamping. When applied by a stencil, the legend shall not be less than 4 inches in diameter. An official brand must be applied to inspected and passed carcasses and parts of ratites that are shipped unpacked.
[66 FR 22906, May 7, 2001]
§ 381.97
[Reserved]
§ 381.98
Official seal.
The official mark for use in sealing means of conveyance used in transporting poultry products under any requirement in this part shall be the inscription and a serial number as shown below, and any seals approved by the Administrator for applying such mark shall be an official device.
§ 381.99
Official retention and rejection tags.
The official marks for use in post-mortem inspection and identification of adulterated products, insanitary equipment and facilities are:
(a) A paper tag (a portion of Form MP-35) bearing the legend “U.S. Retained” for use on poultry or poultry products under this section.
(b) A paper tag (another portion of Form C&MS 510) bearing the legend “U.S. Rejected” for use on equipment, utensils, rooms and compartments under this section.
[64 FR 56417, Oct. 20, 1999]
§ 381.100
Official detention tag.
The detention tag prescribed in § 381.211 is an official device.
§ 381.101
Official U.S. Condemned mark.
The term “U.S. Condemned” as shown below is an official mark and the devices used by the Department for applying such mark are official devices.
§ 381.102
[Reserved]
§ 381.103
Official poultry condemnation certificates; issuance and form.
Upon request by the operator of the establishment, the inspector in charge shall issue a poultry condemnation certificate (Form MP-514-1), showing the total number of poultry in the lot and the numbers condemned and the reasons for such condemnations.
The official poultry condemnation certificate authorized by this subpart is a paper certificate (Form MP-514-1), for signature by an inspector, bearing the legend

U.S. Department of Agriculture Animal and Plant Health Inspection Service

poultry condemnation certificate
and the seal of the United States Department of Agriculture, with a certification that the poultry enumerated on the form were inspected and condemned for the listed causes in compliance with the regulations of the Department. A statement to the effect that certain figures on the certificate were derived from information supplied by plant management, and a signature line for an authorized plant official is also shown.
§ 381.104
Export inspection marks.
The export inspection mark required in § 381.105 must be either a mark that contains a unique identifier that links the consignment to the export certificate or an official mark with the following form: ^1
^1 The number “1234567” is given as an example only. The number on the mark will correspond to the printed number on the export certificate.
[81 FR 42234, June 29, 2016]
§ 381.105
Marking products for export.
When authorized by inspection personnel, establishments must mark the outside container of any inspected and passed product for export, the securely enclosed pallet within the consignment, or closed means of conveyance transporting the consignment, with a mark that contains a unique identifier that links the consignment to the export certificate or an official mark as described in § 381.104. Ship stores, small quantities exclusively for the personal use of the consignee and not for sale or distribution, and shipments by and for the U.S. Armed Forces, are exempt from the requirements of this section.
[81 FR 42234, June 29, 2016]
§ 381.106
Export certification.
(a) Exporters must apply for export certification of inspected and passed products to any foreign country. Exporters may apply for an export certificate using a paper or electronic application. FSIS will assess exporters that submit an electronic application the charge in § 362.5(e) of this chapter.
(b) FSIS will issue only one certificate for each consignment, except in the case of error in the certificate or loss of the certificate originally issued. A request for a replacement certificate, except in the case of a lost certificate, must be accompanied by the original certificate. The new certificate will carry the following statement: “Issued in replacement of ___”, with the numbers of the certificates that have been superseded.
(c) FSIS will deliver a copy of the certificate to the person who requested such certificate or his agent. Such persons may duplicate the certificate as required in connection with the exportation of the product.
(d) FSIS will retain a copy of the certificate.
(e) Exporters may request inspection personnel to issue certificates for export consignments of product of official establishments not under their supervision, provided the consignments are first identified as having been “U.S. inspected and passed,” are found to be neither adulterated nor misbranded, and are marked as required by § 381.105.
[81 FR 42234, June 29, 2016]
§ 381.107
Special procedures as to certification of poultry products for export to certain countries.
When export certificates are required by any foreign country for poultry products exported to such country, the Administrator shall in specific cases prescribe or approve the form of export certificate to be used and the methods and procedures he deems appropriate with respect to the processing of such products, in order to comply with requirements specified by the foreign country regarding the export products. Inspectors shall satisfy themselves that all such requirements are met before issuing such an export certificate. It shall be the responsibility of the exporter to provide any unofficial documentation needed to meet the foreign requirements, before the export certificate will be issued. Such certificates may also cover articles exempted from definition as a poultry product under § 381.15 if they have been inspected and are certified under the regulations in part 362 of this chapter.
[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974; 41 FR 23702, June 11, 1976]
§ 381.108
Official poultry inspection certificates; issuance and disposition.
(a) Upon the request of an interested party, any veterinary inspector is authorized to issue an official poultry inspection certificate with respect to any lot of slaughtered poultry inspected by him. At any official establishment each such certificate shall be signed by the inspector who made the inspection covered by the certificate, and if more than one inspector participated in the inspection of the lot of poultry, each such inspector shall sign the certificate with respect to such lot. If the inspection of a lot covered by a certificate was made by a food inspector, such certificate shall also be signed by the inspector in charge when such inspection was made. Any inspector is authorized to issue a poultry inspection certificate with respect to any other poultry product inspected by him.
(b) The original and one copy of each poultry inspection certificate shall be issued to the applicant who requested such certificate, and one copy shall be retained by the inspector for filing. The inspector who issues any inspection certificate is authorized to furnish an additional copy of such certificate upon the request of an interested party. The person who sold the live poultry involved to the official establishment is an interested party for purposes of this section.
[37 FR 9706, May 16, 1972, as amended at 39 FR 36000, Oct. 7, 1974]
§ 381.109
Form of official poultry inspection certificate.
(a) The official poultry inspection certificate authorized by this subpart is a paper certificate (Form MP-505) for signature by an inspector, bearing the legend

U.S. Department of Agriculture Animal and Plant Health Inspection Service Meat and Poultry Inspection Program

poultry inspection certificate
and the seal of the U.S. Department of Agriculture, with a certification that the poultry described therein had been inspected in compliance with the Regulations of the Secretary of Agriculture Governing the Inspection of Poultry and Poultry Products.
(b) The certificate also bears a serial number such as “B 3208” and shows the respective name and address of the applicant, the shipper or seller and the receiver or buyer and the net weight in pounds of amount passed, amount rejected or condemned, type of poultry, lot number and class, and such other information as the Administrator may prescribe or approve in specific cases.
§ 381.110
Erasures or alterations made on certificates.
Erasures or alterations not initialed by the issuing inspector shall not be permitted on any official certificate or any copy thereof. All certificates rendered useless through clerical error or otherwise and all certificates canceled for whatever cause shall be voided and initialed, and one copy shall be retained in the inspector's file; and the original and all other copies shall be forwarded to the appropriate program supervisor.
§ 381.111
Data to be entered in proper spaces.
All certificates shall be so executed that the data entered thereon will appear in the proper spaces on each copy of the certificate.
§ 381.112
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 part and section 11(b) of the Poultry Products 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.
[52 FR 41958, Nov. 2, 1987]

Subpart N—Labeling and Containers
§ 381.115
Containers of inspected and passed poultry products required to be labeled.
Except as may be authorized in specific cases by the Administrator with respect to shipment of poultry products between official establishments, each shipping container and each immediate container of any inspected and passed poultry product shall at the time it leaves the official establishment bear a label which contains information, and has been approved, in accordance with this subpart.
§ 381.116
Wording on labels of immediate containers.
(a) Each label for use on immediate containers for inspected and passed poultry products shall bear on the principal display panel (except as otherwise permitted in the regulations), the items of information required by this subpart. Such items of information shall be in distinctly legible form. Except as provided in § 381.128, 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.
(b) 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. The principal display panel shall be large enough to accommodate all the mandatory label information required to be placed thereon by the regulations with clarity and conspicuousness and without being obscured by design or vignettes, or crowding. 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 area that is to bear the principal display panel shall be:
(1) In the case of a rectangular package, one entire side, the area of which is 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 on the side of the container that is 40 percent of the product of the height of the container times the circumference, 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 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 §§ 381.118, 381.122, and 381.123. 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 as provided in this § 381.116.
(3) In the case of a container of any other shape, 40 percent of the total surface of the container.
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.
(c) (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.
[37 FR 9706, May 16, 1972, as amended at 40 FR 11347, Mar. 11, 1975; 59 FR 40214, Aug. 8, 1994]
§ 381.117
Name of product and other labeling.
(a) The label shall show the name of the product, which, in the case of a poultry product which purports to be or is represented as a product for which a definition and standard of identity or composition is prescribed in subpart P, shall be the name of the food specified in the standard, and in the case of any other poultry product shall be the common or usual name of the food, if any there be, and if there is none, a truthful descriptive designation.
(b) The name of the product required to be shown on labels for fresh or frozen raw whole carcasses of poultry shall be in either of the following forms: The name of the kind (such as chicken, turkey, or duck) preceded by the qualifying term “young” or “mature” or “old”, whichever is appropriate; or the appropriate class name as described in § 381.170(a). The name of the kind may be used in addition to the class name, but the name of the kind alone without the qualifying age or class term is not acceptable as the name of the product, except that the name “chicken” may be used without such qualification with respect to a ready-to-cook pack of fresh or frozen cut-up young chickens, or a half of a young chicken, and the name “duckling” may be used without such qualification with respect to a ready-to-cook pack of fresh or frozen young ducks. The class name may be appropriately modified by changing the word form, such as using the term “roasting chicken”, rather than “roaster.” The appropriate names for cut-up parts are set forth in § 381.170(b). When naming parts cut from young poultry, the identity of both the kind of poultry and the name of the part shall be included in the product name. The product name for parts or portions cut from mature poultry shall include, along with the part or portion name, the class name or the qualifying term “mature.” The name of the product for cooked or heat processed poultry products shall include the kind name of the poultry from which the product was prepared but need not include the class name or the qualifying term “mature.”
(c) Poultry products containing light and dark chicken or turkey meat in quantities other than the natural proportions, as indicated in Table 1 in this paragraph, must have a qualifying statement in conjunction with the name of the product indicating, as shown in Table 1, the types of meat actually used, except that when the product contains less than 10 percent cooked deboned poultry meat or is processed in such a manner that the character of the light and dark meat is not distinguishable, the qualifying statement will not be required, unless the product bears a label referring to the light or dark meat content. In the latter case, the qualifying statement is required if the light and dark meat are not present in natural proportions. The qualifying statement must be in type at least one-half the size and of equal boldness as the name of the product; e.g., Boned Turkey (Dark Meat).
Table 1
Label terminology | Percent light meat | Percent dark meat
Natural proportions | 50-65 | 50-35
Light or white meat | 100 | 0
Dark meat | 0 | 100
Light and dark meat | 51-65 | 49-35
Dark and light meat | 35-49 | 65-51
Mostly white meat | 66 or more | 34 or less
Mostly dark meat | 34 or less | 66 or more
(d) Boneless poultry products shall be labeled in a manner that accurately describes their actual form and composition. The product name shall specify the form of the product (e.g., emulsified, finely chopped, etc.), and the kind name of the poultry, and if the product does not consist of natural proportions of skin and fat, as they occur in the whole carcass, shall also include terminology that describes the actual composition. If the product is cooked, it shall be so labeled. For the purpose of this paragraph, natural proportions of skin, as found on a whole chicken or turkey carcass, will be considered to be as follows:
| Percent | Raw | Cooked
Chicken | 20 | 25
Turkey | 15 | 20
Boneless poultry product shall not have a bone solids content of more than 1 percent, calculated on a weight basis.
(e) On the label of any “Mechanically Separated (Kind of Poultry) “ described in § 381.173, the name of such product shall be followed immediately by the phrase: “with excess skin” unless such product is made from poultry product that does not include skin in excess of the natural proportion of skin present on the whole carcass, as specified in paragraph (d) of this section. Appropriate terminology on the label shall indicate if heat treatment has been used in the preparation of the product. The labeling information described in this paragraph shall be identified on the label before the product leaves the establishment at which it is manufactured.
(f) 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 subpart Q of this part.
(g) 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.
(h) The product name for a raw poultry product that contains added solution and does not meet a standard of identity in this part must contain a descriptive designation that includes:
(1) The percentage of added solution (total weight of the solution ingredients divided by the weight of the raw poultry without solution or any other added ingredients multiplied by 100). The percentage of added solution must appear as a number (such as, 15, 20, 30) and the percent symbol (%). The percentage of added solution may be declared by the words “containing” or “contains” (such as, “contains 15% added solution of water and salt,” or “containing 15% added solution of water and teriyaki sauce”).
(2) The common or usual name of all individual ingredients or multi-ingredient components in the solution listed in descending order of predominance by weight.
(3) When the descriptive designation includes all ingredients in the solution, a separate ingredients statement is not required on the label. When the descriptive designation includes multi-ingredient components and the ingredients of the component are not declared in the product name, all ingredients in the product must be declared in a separate ingredients statement on the label as required in § 381.118.
(4) The product name and the descriptive designation must be printed in a single easy-to-read type style and color and must appear on a single-color contrasting background. The print may appear in upper and lower case letters, with the lower case letters not smaller than one-third (1/3) the size of the largest letter.
(5) The word “enhanced” cannot be used in the product name.
[37 FR 9706, May 16, 1972, as amended at 60 FR 55983, Nov. 3, 1995; 66 FR 40845, Aug. 6, 2001; 79 FR 79061, Dec. 31, 2014]
§ 381.118
Ingredients statement.
(a)(1) The label shall show a statement of the ingredients in the poultry product if the product is fabricated from two or more ingredients. Such ingredients shall be listed by their common or usual names in the order of their descending proportions, except as prescribed in paragraph (a)(2) of this section.
(2)(i) 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 or less of _____ ,” or “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.
(ii) 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 subpart P of this part and § 424.21(c) of subchapter E, 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.
(b) For the purpose of this paragraph, the term “chicken meat,” unless modified by an appropriate adjective, is construed to mean deboned white and dark meat; whereas the term “chicken” may include other edible parts such as skin and fat not in excess of their natural proportions, in addition to the chicken meat. If the term “chicken meat” is listed and the product also contains skin, giblets, or fat, it is necessary to list each such ingredient. Similar principles shall be followed in listing ingredients of poultry products processed from other kinds of poultry.
(c) The terms spice, natural flavor, natural flavoring, flavor or flavoring may be used in the following manner:
(1) 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.
(2) The term “natural flavor,” “natural flavoring,” “flavor” or “flavoring” means the essential oil, oleoresin, essence or extractive, protein hydrolysate, distillate, or any product of 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 portions 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, powdered onion, powdered garlic, and powdered celery.
(i) Natural flavor, natural flavoring, flavor or flavoring as described in paragraph (c)(1) and (2) of this section, which are also colors shall be designated as “natural flavor and coloring,” “natural flavoring and coloring,” “flavor and coloring” or “flavoring and coloring” unless designated by their common or usual name.
(ii) Any ingredient not designated in paragraphs (c) (1) and (2) of this section 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 or poultry origin must be designated by names that include the species and livestock and poultry tissues from which the ingredients are derived.
(d) On containers of frozen dinners, entrees, and pizzas, and similarly 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 pointing to the front riser panel, are placed on the principal display panel immediately above the location of such statement, without intervening printing or designs.
(e) The ingredients statement may be placed on the information panel, except as otherwise permitted in this subchapter.
(f) Establishments may interchange the identity of two kinds of poultry (e.g., chicken and turkey, chicken meat and turkey meat) used in a product formulation without changing the product's ingredient statement or product name under the following conditions:
(1)(i) The two kinds of poultry used must comprise at least 70 percent by weight of the poultry and the poultry ingredients [e.g. giblets, skin or fat in excess of natural proportions, or mechanically separated (kind)] used; and,
(ii) Neither of the two kinds of poultry used can be less than 30 percent by weight of the total poultry and poultry ingredients used;
(2) The word “and” in lieu of a comma must be shown between the declaration of the two kinds of poultry in the ingredients statement and in the product name.
[37 FR 9706, May 16, 1972, as amended at 55 FR 7294, Mar. 1, 1990; 55 FR 26422, June 28, 1990; 58 FR 38049, July 15, 1993; 59 FR 40215, Aug. 8, 1994; 63 FR 11360, Mar. 9, 1998; 76 FR 82078, Dec. 30, 2011]
§ 381.119
Declaration of artificial flavoring or coloring.
(a) When an artificial smoke flavoring or a smoke flavoring is added as an ingredient in the formula of any poultry product, 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 applicable, and the ingredient statement shall identify any artificial smoke flavoring or smoke flavoring added as an ingredient in the formula of the poultry product.
(b) Any poultry product which bears or contains any artificial flavoring other than an artificial smoke flavoring or a smoke flavoring, or bears or contains any artificial coloring shall bear a statement stating that fact on the immediate container or, if there is none, on the product.
§ 381.120
Antioxidants; chemical preservatives; and other additives.
When an antioxidant is added to a poultry product, there shall appear on the label in prominent letters and contiguous to the name of the product, a statement showing the name of the antioxidant and the purpose for which it is added, such as “BHA added to help protect the flavor.” Immediate containers of poultry products packed in, bearing, or containing any chemical preservative shall bear a label stating that fact and naming the additive and the purpose of its use. Immediate containers of poultry products packed in, bearing or containing any other chemical additive shall bear a label naming the additive and the purpose of its use when required by the Administrator in specific cases. When approved proteolytic enzymes as permitted in a regulation permitting that use in this subchapter or 9 CFR Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B of this subchapter are used in mature poultry muscle tissue, 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 a regulation permitting that use in this subchapter or 9 CFR Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B of this subchapter are used in mature poultry muscle tissue, there shall appear on the label, in a prominent manner, contiguous to the product name, the statement, “Tenderized with (name of approved inorganic chloride(s))” to indicate the use of such inorganic chlorides. Any other approved substance which may be used in the solution shall also be included in the statement.
[37 FR 9706, May 16, 1972, as amended at 45 FR 58820, Sept. 5, 1980; 49 FR 18999, May 4, 1984; 64 FR 72175, Dec. 23, 1999]
§ 381.121
Quantity of contents.
(a) The label shall bear a statement of the quantity of contents in terms of weight or measures as provided in paragraph (c)(5) of this section. However, the Administrator may approve the use of labels for certain types of consumer packages which do not bear a statement of the net weight that would otherwise be required under this subparagraph: Provided, That the shipping container bears a statement “Net weight to be marked on consumer packages prior to display and sale”: And provided further, That the total net weight of the contents of the shipping container is marked on such container: And provided further, That the shipping container bears a statement “Tare weight of consumer package” and in close proximity thereto, the actual tare weight (weight of packaging material), weighed to the nearest one-eighth ounce or less, of the individual consumer package in the shipping container. The above-specified statements may be added to approved shipping container labels upon approval by the inspector in charge.
(b) When a poultry product and a nonpoultry product are separately wrapped and are placed in a single immediate container bearing the same name of both products, the net weight on such immediate container may be the total net weight of the products, or such immediate container may show the net weights of the poultry product and the nonpoultry product separately. Notwithstanding the other provisions of this paragraph, the label on consumer size retail packages of stuffed poultry and other stuffed poultry products must show the total net weight of the poultry product, and in close proximity thereto, a statement specifying the minimum weight of the poultry in the product.
(c)(1) The statement of net quantity of contents shall appear (except as otherwise permitted under this paragraph (c)), 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 (c). An unused tare weight, as defined in section 381.121b of this subchapter, may be printed adjacent to the statement of net quantity of contents when the product is packaged totally with impervious packaging material and is packed with a usable medium.
(2) 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. The declaration may appear in more than one line.
(3) 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 for all packages of substantially the same size by complying with the following type specifications:
(i) Not less than one-sixteenth inch in height on containers, 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 containers, 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-sixteenth inch in height on containers, 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 containers, 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 containers, the principal display panel of which has an area of more than 400 square inches.
(vi) 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). This height standard pertains 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.
(4) The statement shall appear as a distinct item on the principal display panel and shall be separated, from other label information appearing to the left or right of the statement, by a space at least equal in width to twice the width of the letter “N” of the style of type used in the quantity of contents statement and shall be separated from other label information appearing above or below the statement by a space at least equal in height to the height of the lettering used in the statement.
(5) 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 “contents” when stating the net quantity of contents in terms of fluid measure. Except as provided in § 381.128, 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. On packages containing less than 1 pound or 1 pint, the statement shall be expressed in ounces or fractions of a pint, respectively. On packages containing 1 pound or 1 pint or more, and less than 4 pounds or 1 gallon, the statement shall be expressed as a dual declaration both in ounces and (immediately thereafter in parenthesis) 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 fraction of the pint or quart. For example, a declaration of three-fourths pound avoirdupois weight shall be expressed as “Net Wt. 12 oz.”; 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.).” However, 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. The numbers may be written in provided the unit designation is printed. Paragraphs (c) (8) and (9) of this section permit certain exceptions to this paragraph for multi-unit packages, and random weight consumer size and small packages (less than 1/2 ounce), respectively.
(6) 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 section 381.121b of this subchapter. 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 except as provided in paragraph (b) of this section.
(7) 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.
(8) On a multiunit retail package, a statement of the 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 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 otherwise required by this paragraph (c). “A multiunit retail package” is 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 sold individually. Open multiunit retail packages that do not obscure the number of units and the labeling thereon are not subject to this paragraph (c) (8) if the labeling of each individual unit complies with the requirements of this paragraph (c).
(9) The following exemptions from the requirements contained in this section are hereby established:
(i) Individually wrapped, random weight consumer size packages of poultry products (as specified in paragraph (c)(10) of this section) and poultry products that are subject to shrinkage through moisture loss during good distribution practices and are designated as gray area type of products as defined in NBS handbook 133, section 3.18.2, need not bear a net weight statement when shipped from an official establishment provided a net weight shipping statement which meets the requirements of paragraph (c)(6) of this section is applied to the 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 of 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 (c)(6) 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.
(10) As used in this section a “random weight consumer size package” is one of a lot, shipment or delivery of packages of the same product, with varying weights and with no fixed weight pattern.
[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974; 53 FR 28635, July 29, 1988; 55 FR 49835, Nov. 30, 1990]
§§ 381.121a-381.121e
[Reserved]
§ 381.122
Identification of manufacturer, packer or distributor.
The name and address, including zip code, of the manufacturer, packer, or distributor shall be shown on the label and if only the name and address of the distributor is shown, it shall be qualified by such term as “packed for,” “distributed by,” or “distributors.” The name and place of business of the manufacturer, packer, or distributor may be shown on the principal display panel, on the 20-percent panel of the principal display panel reserved for required information, on the front riser panel of frozen food cartons, or on the information panel.
[37 FR 9706, May 16, 1972, as amended at 59 FR 40215, Aug. 8, 1994]
§ 381.123
Official inspection mark; official establishment number.
The immediate container of every inspected and passed poultry product shall bear:
(a) The official inspection legend; and
(b) The official establishment number of the official establishment in which the product was processed under inspection and placed as follows:
(1) Within the official inspection legend in the form required by subpart M of this part; 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 “P”; 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 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 “Plant No. on Package Closure” or “Plant No. on Pan”, if shown in a prominent and legible manner in a size sufficient to ensure 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 “P”.
[47 FR 29515, July 7, 1982]
§ 381.124
Dietary food claims.
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).
§ 381.125
Special handling label requirements.
(a) 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,” “Keep Refrigerated or Frozen,” “Perishable—Keep Under Refrigeration,” or such similar statement as the Administrator may approve in specific cases. The immediate containers for products that are frozen during distribution and intended to be thawed prior to or during display for sale shall bear the statement “Shipped/Stored and Handled Frozen for Your Protection, Keep Refrigerated or Freeze.” For all canned perishable 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 shown in letters one-half inch in height.
(b) Safe handling instructions shall be provided for all poultry products not processed in accordance with the provisions of § 381.150(a) or that have not undergone other processing that would render them ready-to-eat, except as exempted under paragraph (b)(4) of this section.
(1) (i) Safe handling instructions shall accompany the poultry products, specified in this paragraph (b), 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 (b)(2) and (b)(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) (i) The labels of the poultry products, specified in this paragraph (b) and prepared from inspected and passed poultry, 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.
(ii) The labels of the poultry products, specified in this paragraph (b) and prepared pursuant to § 381.10(a) (2), (5), (6), and (7), shall include the following rationale statement as part of the safe handling instructions, “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) Poultry products, specified in this paragraph (b), 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) Poultry products intended for further processing at another official establishment are exempt from the requirements prescribed in paragraphs (b)(1) through (b)(3) of this section.
[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974; 59 FR 14540, Mar. 28, 1994; 64 FR 746, Jan. 6, 1999]
§ 381.126
Date of packing and date of processing; contents of cans.
(a) Either the immediate container or the shipping container of all poultry food products shall be plainly and permanently marked by code or otherwise with the date of packing. If calendar dating is used, it must be accompanied by an explanatory statement, as provided in § 381.129(c)(2).
(b) The immediate container for dressed poultry shall be marked with a lot number which shall be the number of the day of the year on which the poultry was slaughtered or a coded number.
(c) All canned products shall be plainly and permanently marked, by code or otherwise, on the containers, with the identity of the contents and date of canning, except that canned products packed in glass containers are not required to be marked with the date of canning if such information appears on the shipping container. If calendar dating is used, it must be accompanied by an explanatory statement, as provided in § 381.129(c)(2).
(d) If any marking is by code, the inspector in charge shall be informed as to its meaning.
[37 FR 9706, May 16, 1972, as amended at 39 FR 28516, Aug. 8, 1974; 39 FR 35784, Oct. 4, 1974]
§ 381.127
Wording on labels of shipping containers.
(a) Each label for use on a shipping container for inspected and passed poultry products shall bear, in distinctly legible form, the following information:
(1) The official inspection legend.
(2) The official establishment number of the official establishment in which the poultry product was inspected, either within the official inspection mark, or elsewhere on the container clearly visible and in proximity to the official inspection mark.
§ 381.128
Labels in foreign languages.
Any label to be affixed to a container of any dressed poultry or other poultry product for foreign commerce may be printed in a foreign language. However, the official inspection legend and establishment number shall appear on the label in English, but in addition, may be literally translated into such foreign language. Each such label shall be subject to the applicable provisions of §§ 381.115 to 381.141, inclusive. Deviations from the form of labeling required under the regulations may be approved by the Administrator in specific cases and such modified labeling may be used for poultry products to be exported: Provided, (a) That the proposed labeling accords to the specifications of the foreign purchaser, (b) that it is not in conflict with the Act or the laws of the country to which it is intended for export, and (c) that the outside of the shipping 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 the regulations shall apply.
§ 381.129
False or misleading labeling or containers.
(a) No poultry product subject to the Act shall have any false or misleading labeling or any container that is so made, formed, or filled as to be misleading. However, established trade names and other labeling and containers which are not false or misleading and which are approved by the Administrator in the regulations or in specific cases are permitted.
(b) No statement, word, picture, design, or device which is false or misleading in any particular or conveys any false impression or gives any false indication of origin, identity, or quality, shall appear on any label. For example:
(1) Official grade designations such as the letter grades A, B, and C may be used in labeling individual carcasses of poultry or containers of poultry products only if such articles have been graded by a licensed grader of the Federal or Federal-State poultry grading service and found to qualify for the indicated grade.
(2) Terms having geographical significance with reference to a particular locality may be used only when the product was produced in that locality.
(3) “Fresh frozen”, “quick frozen”, “frozen fresh”, and terms of similar import apply only to ready-to-cook poultry processed in accordance with § 381.66(f)(1). Ready-to-cook poultry handled in any other manner and dressed poultry may be labeled “frozen” only if it is frozen in accordance with § 381.66(f)(2) under Department supervision and is in fact in a frozen state. “Individually quick frozen (Kind)” and terms of similar import are applicable only to poultry products that are frozen as stated on the label and whose component parts can be easily separated at time of packing.
(4) Poultry products labeled with a term quoted in any paragraph of § 381.170(b) shall comply with the specifications in the applicable paragraph. However, parts of poultry may be cut in any manner the processor desires as long as the labeling appropriately reflects the contents of the container of such poultry.
(5) 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.
(6)(i) A raw poultry product whose internal temperature has ever been below 26 °F may not bear a label declaration of “fresh.” A raw poultry product bearing a label declaration of “fresh” but whose internal temperature has ever been below 26 °F is mislabeled. The temperature of individual packages of raw poultry product within an official establishment may deviate below the 26 °F standard by 1 degree (i.e., have a temperature of 25 °F) and still be labeled “fresh.” The temperature of individual packages of raw poultry product outside an official establishment may deviate below the 26 °F standard by 2 degrees (i.e., have a temperature of 24 °F) and still be labeled “fresh.” The average temperature of poultry product lots of each specific product type must be 26 °F. Product described in this paragraph is not subject to the freezing procedures required in § 381.66(f)(2) of this subchapter.
(ii) Raw poultry product whose internal temperature has ever been at or below 0°F must be labeled with the descriptive term “frozen,” except when such labeling duplicates or conflicts with the labeling requirements in § 381.125 of this subchapter. The word “previously” may be placed next to the term “frozen” on an optional basis. The descriptive term must be prominently displayed on the principal display panel of the label. If additional labeling containing the descriptive term is affixed to the label, it must be prominently affixed to the label. The additional labeling must be so conspicuous (as compared with other words, statements, designs, or devices in the labeling) that it is likely to be read and understood by the ordinary individual under customary conditions of purchase and use. Product described in this paragraph is subject to the freezing procedures required in § 381.66(f)(2) of this subchapter.
(iii) Raw poultry product whose internal temperature has ever been below 26 °F, but is above 0 °F, is not required to bear any specific descriptive term. Raw poultry product whose internal temperature has ever been below 26 °F, but is above 0 °F, may bear labeling with an optional, descriptive term, provided the optional, descriptive term does not cause the raw poultry product to become misbranded. If used, an optional, descriptive term must be prominently displayed on the principal display panel of the label. If additional labeling containing the optional, descriptive term is affixed to the label, it must be prominently affixed on the label. The additional labeling must be so conspicuous (as compared with other words, statements, designs, or devices in the labeling) that it is likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
(iv) Handling and relabeling of products. (A) Except as provided under paragraph (b)(6)(iii)(C) of this section, when any inspected and passed product has become misbranded under this subpart after it has been transported from an official establishment, such product may be transported in commerce to an official establishment after oral permission is obtained from the Area Supervisor of the area in which that official establishment is located. The transportation of the product may be to the official establishment from which it had been transported or to another official establishment designated by the person desiring to handle the product. The transportation shall be authorized only for the purpose of the relabeling of the product. The Area Supervisor shall record the authorization and other information necessary to identify the product and shall provide a copy of the record to the inspector at the establishment receiving the product. The shipper shall be furnished a copy of the authorization record upon request.
(B) Upon the arrival of the shipment at the official establishment, a careful inspection shall be made of the product by the inspector, and if it is found that the product is not adulterated, it may be received into the establishment; but if the product is found to be adulterated, it shall at once be condemned and disposed of in accordance with § 381.95 of this subchapter. Wholesome product will be relabeled in accordance with paragraph (b)(6) (i) or (ii) of this section, as appropriate.
(C) When any inspected and passed product has become misbranded under this subpart after it has been transported from an official establishment, the owner may transport the product in commerce to a retail entity for relabeling in accordance with paragraph (b)(6) (i) or (ii) of this section, as appropriate, or to other end users, such as hotels, restaurants or similar institutions; or, relabel the product in accordance with paragraph (b)(6) (i) or (ii) of this section, as appropriate if the product is already at a retail entity. A hotel, restaurant or similar institution is not required to relabel product misbranded under this subpart; Provided, That the product is prepared in meals or as entrees only for sale or service directly to individual consumers at such institutions, and that the mark of inspection is removed or obliterated. Oral permission shall be obtained from the Area Officer-in-Charge of the Compliance Program for the area in which the product is located prior to such transportation or relabeling. The Area Officer-in-Charge shall record the authorization and other information necessary to identify the product, and shall furnish a copy of the authorization record upon request. Before being offered for sale at a retail entity, such product shall be relabeled.
(v) Ready-to-cook chicken may bear the claim “air chilled” or “air chilling” on its label only if the product was chilled under a process that meets the definition of air chilling in § 381.66(e).
(c) A calendar date may be shown on labeling when declared in accordance with the provisions of this paragraph:
(1) 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.
(2) Immediately adjacent to the calendar date will 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.”
(d) When sodium alginate, calcium carbonate, lactic acid, and calcium lactate are used together in a dry binding matrix in ground or formed poultry products, as permitted in § 424.21(c) of subchapter E, there shall appear on the label contiguous to the product name a statement to indicate the use of sodium alginate, calcium carbonate, lactic acid, and calcium lactate.
(e) When transglutaminase enzyme is used to bind pieces of poultry to form a cut of poultry, or to reform a piece of poultry from a multiple cuts of poultry, 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 Turkey Thigh Roast” or “Reformed and Shaped Chicken Breast.”
(f) A country of origin statement on the label of any poultry product “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.
[37 FR 9706, May 16, 1972, as amended at 39 FR 28516, Aug. 8, 1974; 39 FR 42339, Dec. 5, 1974; 55 FR 5977, Feb. 21, 1990; 60 FR 44412, Aug. 25, 1995; 61 FR 66200, Dec. 17, 1996; 61 FR 68821, Dec. 30, 1996; 66 FR 54916, Oct. 31, 2001; 73 FR 50703, Aug. 28, 2008; 76 FR 82078, Dec. 30, 2011; 78 FR 66838, Nov. 7, 2013; 79 FR 49637, Aug. 21, 2014]
§ 381.130
False or misleading labeling or containers; orders to withhold from use.
If the Administrator has reason to believe that any marking or other labeling or the size or form of any container in use or proposed for use with respect to any article subject to the Act is false or misleading in any particular, he may direct that the use of the article be withheld unless it is modified in such manner as the Administrator may prescribe so that it will not be false or misleading. If the person using or proposing to use the labeling or container does not accept the determination of the Administrator, he may request a hearing, but the use of the labeling or container shall, if the Administrator so directs, be withheld pending hearing and final determination by the Secretary in accordance with applicable rules of practice. Any such determination with respect to the matter by the Secretary shall be conclusive unless, within 30 days after the receipt of notice of such final determination, the person adversely affected thereby appeals to the U.S. Court of Appeals for the Circuit in which he has his principal place of business, or to the U.S. Court of Appeals for the District of Columbia Circuit. The provisions of section 204 of the Packers and Stockyards Act of 1921, as amended, shall be applicable to appeals taken under this section.
§ 381.131
Preparation of labeling or other devices bearing official inspection marks without advance approval prohibited; exceptions.
(a) 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 do not apply to marking devices containing the official inspection legend shown in Figure 5 of § 381.102.
(b) No brand manufacturer or other person shall cast or otherwise make, without an official certificate issued in quadruplicate by a Program employee, a marking device containing the official inspection legend shown in Figure 5 of § 381.102 or any simulation of that legend.
(1) The certificate is a Food Safety and Inspection Service form for signature by a Program employee and the official establishment ordering the 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 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 marking device manufacturer.
(3) The manufacturer of the marking devices shall engrave or otherwise mark each 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 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 marking devices to the Program employee whose name and address are given on the certificate as the recipient.
(4) In order that all such marking devices bear identifying numbers, within one year after June 24, 1985, an establishment shall either replace each such marking device that does not bear an identifying number, or, under the direction of the inspector-in-charge, mark such marking device with a permanent identifying number.
(Recordkeeping requirements approved by the Office of Management and Budget under control number 0583-0015)
[50 FR 21423, May 24, 1985]
§§ 381.132-381.133
[Reserved]
§ 381.134
Requirement of formulas.
Copies of each label submitted for approval, shall when the Administrator requires in any specific case, be accompanied by a statement showing, by their common or usual names, the kinds and percentages of the ingredients comprising the poultry product and by a statement indicating the method or preparation of the product with respect to which the label is to be used. Approximate percentages may be given in cases where the percentages of ingredients may vary from time to time, if the limits of variation are stated.
[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974; 59 FR 45196, Sept. 1, 1994. Redesignated at 60 FR 67457, Dec. 29, 1995]
§ 381.136
Affixing of official identification.
(a) No official inspection legend or any abbreviation or other simulation thereof may be affixed to or placed on or caused to be affixed to or placed on any poultry product or container thereof, except by an inspector or under the supervision of an inspector or other person authorized by the Administrator, and no container bearing any such legend shall be filled except under such supervision.
(b) No official inspection legend shall be used on any poultry product or other article which does not qualify for such mark under the regulations.
§ 381.137
Evidence of labeling and devices approval.
No inspector shall authorize the use of any device bearing any official inspection legend unless he or she has on file evidence that such device has been approved in accordance with the provisions of this subpart.
[60 FR 67458, Dec. 29, 1995]
§ 381.138
Unauthorized use or disposition of approved labeling or devices.
(a) Labeling and devices approved for use pursuant to § 381.115 shall be used only for the purpose for which approved, and shall not be disposed of from the official establishment for which approved except with written approval of the Administrator. Any unauthorized use or disposition of approved labeling or devices bearing official inspection marks is prohibited and may result in cancellation of the approval.
(b) Labeling and containers bearing any official inspection marks, with or without the official establishment number, may be transported from one official establishment to any other official establishment, only if 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. Approved labeling and containers may be moved without restriction under this part between official establishments operated by the same person if such labeling and containers are approved for use at all such establishments. No such material shall be used at the establishment to which it is shipped unless such use conforms with the requirements of this subpart.
§ 381.139
Removal of official identifications.
(a) Every person who receives any poultry product in containers which bear any official inspection legend shall remove or deface such legend or destroy the containers upon removal of such articles from the containers.
(b) No person shall alter, detach, deface, or destroy any official identifications prescribed in subpart M that were applied pursuant to the regulations, unless he is authorized to do so by an inspector or this section; and no person shall fail to use any such official identification when required by this part.
§ 381.140
Relabeling poultry products.
When it is claimed by the operator of an official establishment that some of its labeled poultry product, which has been transported to a location other than an official establishment, is in need of relabeling because the labeling has become mutilated or damaged, or for some other reason needs relabeling, the requests for relabeling the poultry product shall be sent to the Administrator and accompanied with a statement of the reasons therefor and the quantity of labeling required. 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 official labels shall be done under the supervision of an inspector pursuant to the regulations in part 362 of this chapter. The establishment shall reimburse the Inspection Service for any cost involved in supervising the relabeling of such product as provided in said regulations.
§§ 381.141-381.143
[Reserved]
§ 381.144
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 the 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 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 materials 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 to 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 the 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 2236, Jan. 19, 1984]

Subpart O—Entry of Articles Into Official Establishments; Processing Inspection and Other Reinspections; Processing Requirements
§ 381.145
Poultry products and other articles entering or at official establishments; examination and other requirements.
(a) No poultry product (including poultry broth for use in any poultry product in any official establishment) may be brought into any official establishment unless it has been processed in the United States only in an official establishment or imported from a foreign country eligible to export such poultry and poultry products to the United States under § 381.196(b), and inspected and passed, in accordance with the regulations; and unless the container of such product is marked so as to identify the product as so inspected and passed, in accordance with § 381.115 or § 381.205, except that poultry products inspected and passed and identified as such under the laws of an “at least equal” State or territory listed in § 381.187 may be brought into any official establishment solely for storage and distribution therefrom without repackaging, relabeling, or processing in such establishment. No carcass, part thereof, meat or meat food product of cattle, sheep, swine, goats, or equines may be brought into an official establishment unless it has been prepared in the United States only in an official meat packing establishment, or imported, and inspected and passed, in accordance with the Federal Meat Inspection Act, and the regulations under such Act (Subchapter A of this chapter) and is properly marked as so inspected and passed; or has been inspected and passed and is identified as such in accordance with the requirements of the law and regulations of a State not designated in § 331.2 of this chapter; or is present in the official establishment by reason of an exemption allowed in the Federal Meat Inspection Act and the regulations under such Act (Subchapter A of this chapter) or the law and regulations of a State not so designated. However, such exempted articles may enter only under conditions approved by the Administrator in specific cases, including but not limited to, complete separation of inspected poultry products and processing and other operations with respect thereto from the exempted articles and operations with respect thereto, complete cleanup of facilities and equipment between processing of inspected poultry products and the exempted articles and no commingling of inspected and exempted articles in receiving, holding or storage areas.
(b) All poultry products and all carcasses, parts thereof, meat and meat food products of cattle, sheep, swine, goats, or equines which enter any official establishment shall be identified by the operator of the official establishment at the time of receipt at the official establishment. All poultry products, and all carcasses, parts thereof, meat and meat food products of such animals, which are processed or otherwise handled at any official establishment shall be subject to examination by an inspector at the official establishment in such manner and at such times as may be deemed necessary by the inspector in charge to assure compliance with the regulations. Upon such examination, if any such article or portion thereof is found to be adulterated, such article or portion shall, in the case of poultry products, be condemned and disposed of as prescribed in § 381.95, unless by reprocessing they may be made not adulterated, and shall, in the case of such other articles be disposed of according to applicable law.
Such examination may be accomplished through use of statistically sound sampling plans that assure a high level of confidence. The inspector in charge 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 Supervisor. 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.
(c) Applying for Total Plant Quality Control. Any owner or operator of an official establishment preparing poultry product who has a total plant quality control system or plan for controlling such products, 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 or 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 systems require 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 a small establishment which does not have full-time quality control personnel, information indicating the nature of the duties and responsibilities of the person who will also be responsible for the quality control system.
(3) A list identifying those subparts and sections of the poultry products 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 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 of limits which will be used and the points at which corrective action will occur, and the nature of such corrective action—ranging from the 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)-(e) [Reserved]
(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 label, the following logo.
(g) Termination of Quality Control Systems. (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 or a quality control system for irradiation facilities may be terminated upon the establishment's receipt of a written notice from the Administrator under the following conditions:
(i) If adulterated or misbranded poultry product is found by the Adminstrator 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 a conflict of facts, a hearing, under applicable Rules of Practice, will be afforded to the establishment owner or operator, if requested, 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 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 afforded to the establishment owner or operator, if requested, 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 modified total establishment quality control system will not be evaluated by the Administrator for at least 6 months from the termination date.
(4) If approval of a quality control system for irradiation facilities, as specified in section 381.149 of this subpart, has been terminated in accordance with the provisions of this section, a request for approval of the same or a modified quality control system will be evaluated by the Administrator upon receipt.
(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. Permissions 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 § 381.145(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 inspectiom services at the discretion of the circuit supervisor and charged for such services.
(i) To ensure the safe use of preparations used in poultry scald water, 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.
(Recordkeeping requirements approved by the Office of Management and Budget under control number 0583-0015)
[37 FR 9706, May 16, 1972, as amended at 45 FR 54323, Aug. 15, 1980; 46 FR 48904, Oct. 5, 1981; 50 FR 6, Jan. 2, 1985; 51 FR 32304, Sept. 11, 1986; 57 FR 43598, Sept. 21, 1992; 62 FR 45026, Aug. 25, 1997; 62 FR 54759, Oct. 22, 1997; 64 FR 72175, Dec. 23, 1999; 65 FR 34390, May 30, 2000; 78 FR 66838, Nov. 7, 2013; 84 FR 65268, Nov. 27, 2019]
§ 381.146
Sampling at official establishments.
Inspectors may take, without cost to the Department, such samples as are necessary of any poultry product, or other article for use as an ingredient of any poultry product, at any official establishment to determine whether it complies with the requirements of the regulations.
§ 381.148
Processing and handling requirements for frozen poultry products.
Procedures with respect to processing of frozen ready-to-heat-and-eat poultry products or stuffed ready-to-roast poultry shall be in accordance with sound operating practices and carried out in a manner which will assure freedom from adulteration of the products. Products to be frozen shall be moved into the freezer promptly under such supervision by an inspector as is necessary to assure preservation of the products by prompt and efficient freezing. Adequate freezing facilities shall be provided within the official establishment where products to be frozen are prepared, except that, upon written request, and under such conditions as may be prescribed by the Administrator in specific cases, such products may be moved from the official establishment prior to freezing: Provided, That the official establishment and freezer are so located and the necessary arrangements are made so that the Inspection Service will have access to the freezing room and adequate opportunity to determine that the products are being properly handled and frozen.
§ 381.150
Requirements for the production of fully cooked poultry products and partially cooked poultry breakfast strips.
(a) Fully cooked poultry products must be produced using processes ensuring that the products meet the following performance standards:
(1) Lethality. A 7-log 10 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 a 1 log 10 multiplication of Clostridium perfringens within the product.
(b) Partially cooked poultry breakfast strips must be produced using processes ensuring that the products meet the performance standard listed in paragraph (a)(2) of this section. Labeling for these products must comply with § 381.125. In addition, the statement “Partially Cooked: For Safety, Cook Until Well Done” must appear on the principal display panel in letters no smaller than 1/2 the size of the largest letter in the product name. Detailed cooking instructions shall be provided on the immediate container of the products.
(c) 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, available to FSIS, a process schedule, as defined in § 381.1(b). 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.
(d) 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 746, Jan. 6, 1999]
§ 381.151
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 poultry 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.
^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.
(c) Hermetically sealed containers of poultry 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 poultry products 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
(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 poultry product shall be maintained throughout all stages of the rehandling operations, to insure correct labeling of containers.
[38 FR 34456, Dec. 14, 1973]
§ 381.152
Manufacture of uninspected, inedible products at official establishments.
(a) Official establishments may manufacture pet food or similar uninspected, inedible products in areas where edible products also are produced, provided that the manufacture of uninspected, inedible products does not:
(1) Adulterate edible products;
(2) Create insanitary conditions in the official establishment whereby edible products may be adulterated; or
(3) Prevent or interfere with inspection or other program tasks performed by FSIS personnel in the official establishment.
(b) The immediate container of uninspected, inedible products manufactured in an official establishment shall be conspicuously labeled so as to distinguish them from human food in accordance with § 381.193 of this subchapter.
[84 FR 40227, Aug. 14, 2019]
§ 381.153
[Reserved]

Subpart P—Definitions and Standards of Identity or Composition
§ 381.155
General.
(a) Authorization to establish specifications. (1) The Administrator is authorized to establish specifications or definitions and standards of identity or composition, covering the principal constituents of any poultry product with respect to which a specified name of the product or other labeling terminology may be used, whenever he determines such action is necessary to prevent sale of the product under false or misleading labeling. Further, the Administrator is authorized to prescribe definitions and standards of identity or composition for poultry products whenever he determines such action is otherwise necessary for the protection of the public. The requirements of this subpart are hereby found to be necessary for these purposes and standards are hereby established as set forth in this subpart.
(2) Where cooked poultry meat is specified in this subpart as an ingredient of poultry products, this means poultry meat derived from poultry processed, cooked, and cooled in a manner approved by the Administrator in specific cases without use of liquid or moisture in direct contact with the poultry meat following the cooking and cooling of the poultry.
(3) If, following cooking and cooling of poultry meat to be used in poultry products, liquid or moisture is used in direct contact with such poultry meat and the percentage of solids, excluding salt, in the poultry meat is found to be below 34 percent when such poultry meat is tested by acceptable methods, the percentage of poultry meat required by this section for any poultry product shall be increased in proportion to the deficiency, or the meat shall be so processed as to raise the solids content, excluding salt, to 34 percent. The official establishment shall furnish adequate facilities for such testing.
(b) Any binder or antimicrobial agent that has been found to be safe and suitable by the Food and Drug Administration and the Food Safety and Inspection Service may be used in the production of poultry products with standards of identity in this part, where the product standards and applicable Federal regulations already permit the use of these types of ingredients.
[37 FR 9706, May 16, 1972, as amended at 68 FR 22578, Apr. 29, 2003]
§ 381.156
Poultry meat content standards for certain poultry products.
Poultry products with labeling terminology as set forth in Table I shall comply with the specifications for percent light meat and percent dark meat set forth in said table.
Table I
Label terminology | Percent light meat | Percent dark meat
Natural proportions | 50-65 | 50-35.
Light or white meat | 100 | 0.
Dark meat | 0 | 100.
Light and dark meat | 51-65 | 49-35.
Dark and light meat | 35-49 | 65-51.
Mostly white meat | 66 or more | 34 or less.
Mostly dark meat | 34 or less | 66 or more.
[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974]
§ 381.157
Canned boned poultry and baby or geriatric food.
(a) Canned boned poultry shall, unless otherwise specified in this section, be prepared from cooked deboned poultry meat and may contain skin and fat not in excess of natural whole carcass proportions. Gelatin, stabilizers, or similar solidifying or emulsifying agents shall not be added to product labeled “Boned (Kind)—Solid Pack,” but may be added in quantities not in excess of a total of 0.5 percent of the total ingredients in the preparation of other canned boned poultry products and in such cases the common name of the substance shall be included in the name of the product, e.g., “Boned Chicken with Broth—Gelatin Added.”
(b) Canned boned poultry, except poultry within paragraph (c) of this section, shall meet the requirements set forth in Table II. The percentages in Table II shall be calculated on the basis of the total ingredients used in the preparation of the product.
(c) Canned boned poultry with natural juices (Boned (Kind) with natural juices) shall be prepared from either raw boned poultry or a mixture of raw boned poultry and cooked boned poultry and shall have no liquid added during the preparation of the product.
(d) Canned shredded poultry (Shredded Kind), consists of poultry meat reduced to a shredded appearance, from the kind of poultry indicated, with meat, skin, and fat not in excess of the natural whole carcass proportions. Canned shredded poultry from specific parts may include skin or fat in excess of the proportions normally found on a whole carcass, but not in excess of the proportions of skin and fat normal to the particular part or parts; and such product shall be labeled in accordance with § 381.117(d).
(e) Canned boned poultry shall be prepared as set forth in Table II, items 1, 2, 3, or 4, whichever is applicable.
Table II
Product name | Minimum percent cooked, deboned poultry meat of kind indicated, with skin, fat, and seasoning | Maximum percent liquid that may be added ^1
1. Boned (Kind)—solid pack | 95 | 5
2. Boned (Kind) | 90 | 10
3. Boned (Kind) with broth ^2 | 80 | 20
4. Boned (Kind) (__) percent broth ^{2 3} | 50 | 50
^1 Liquid may be in the form of, but is not limited to, broth or extractives.
^2 Alternatively, product may be prepared from raw boned poultry in combination with cooked boned poultry so long as the product complies with the specified standard.
^3 Total amount of liquid added shall be included in the name of the product; e.g., “Boned Chicken with 25 percent broth.”
(f) Poultry products intended for infant or geriatric use and represented as having a “high meat” content shall contain not less than 18.75 percent cooked, deboned poultry meat of the kind indicated, with seasoning.
Table IIa
Product name | Minimum percent cooked, deboned, poultry meat of kind indicated, with seasoning | Maximum percent liquid that may be added ^1
1. Strained or chopped (Kind) with broth ^{2 3} | 43 | 57
2. High meat dinner ^3 | 18.75
^1 Liquid may be in the form of, but not limited to, broth or extractives.
^2 Alternatively, product may be prepared from raw boned poultry meat in combination with cooked bone poultry meat so long as the product complies with the specified standard.
^3 Label must indicate in some manner that product is for infant or geriatric servings.
[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974]
§ 381.158
Poultry dinners (frozen) and pies.
Poultry dinners (frozen) and pies shall meet the requirements set forth in Table III of this section and the percentage or weight specified therein shall be calculated on the basis of total ingredients used in the preparation of the poultry product.
Table III
| Minimum cooked deboned poultry meat of kind indicated | Percent | Weight | Minimum raw deboned poultry meat of kind indicated | Percent | Weight
(Kind) Pies | 14 | or 11/8 oz. per 8-oz. pie ^1 | 25 | or 2 oz. per 8-oz. pie. ^1
(Kind) Dinners | 18 | or 2 oz. ^{2 3}
^1 14 percent or 11/8 oz., whichever is greater; or 25 percent or 2 oz., whichever is greater.
^2 Excluding weight of appetizers, desserts, etc.
^3 18 percent or 2 oz., whichever is greater. A minimum of 45 percent, or 5 ounces per dinner, whichever is greater, of cooked poultry including bone and breading may be used in lieu of minimum 18 percent or 2 ounces of cooked deboned poultry meat and the cooked poultry including bone and breading shall not contain more than 30 percent breading.
§ 381.159
Poultry rolls.
(a) Binders or extenders may be added in accordance with a regulation in this subchapter, in 9 CFR Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B. In addition to the binders referred to in the preceding sentence, the following substances are permitted for use as binders in poultry rolls: transglutaminase enzyme at up to 65 ppm. When binding agents are added in excess of 3 percent for cooked rolls and 2 percent for raw rolls, the common name of the agent or the term “Binders Added” shall be included in the name of the product; e.g., “Turkey Roll-Gelatin Added.”
(b) With respect to heat processed rolls, 2 percent or less liquid based on the weight of the finished product without liquid may remain with or be returned to product labeled as “(Kind) Roll.”
(c) Heat processed rolls which have more than 2 percent liquid remaining with or returned to the product shall be labeled as “(Kind) Roll with Natural Juices.” If more than 2 percent of any liquid other than natural cookout juices is added, the product must be labeled to indicate that fact; e.g., “Turkey Roll with Broth.” Liquid shall not be returned or added to product within this paragraph graph in excess of the amount normally cooked out during preparation.
[37 FR 9706, May 16, 1972, as amended at 55 FR 34684, Aug. 24, 1990; 66 FR 54916, Oct. 31, 2001]
§ 381.160
(Kind) burgers; (Kind) patties.
Such product consists of 100 percent poultry of the kind indicated, with skin and fat not in excess of natural proportions. Product containing fillers or binders shall be named “(Kind) Patties.”
§ 381.161
“(Kind) A La Kiev.”
Such product consists of poultry meat of the kind indicated, stuffed with butter which may be seasoned and the product may be wrapped in sufficient skin to cover the meat. It may be dipped in batter, fried, and frozen.
§ 381.162
“(Kind) steak or fillet.”
Such product consists of a boneless slice or strip of poultry meat of the kind indicated.
§ 381.163
“(Kind) baked” or “(Kind) roasted.”
Such product consists of ready-to-cook poultry of the kind indicated, that has been cooked in dry source heat, e.g., oven roasted or oven baked.
§ 381.164
“(Kind) barbecued.”
Such product consists of ready-to-cook poultry of the kind indicated, that has been cooked in dry heat and basted with a seasoned sauce.
§ 381.165
“(Kind) barbecued prepared with moist heat.”
Such product consists of ready-to-cook poultry of the kind indicated that has been cooked by the action of moist heat in a barbecue sauce.
§ 381.166
Breaded products.
“Breaded” is a term applicable to any poultry product which is coated with breading or a batter and breading in an amount not to exceed 30 percent of the weight of the finished breaded product.
§ 381.167
Other poultry dishes and specialty items.
Poultry dishes and specialty items listed in Table IV of this paragraph shall meet the requirements set forth in said table, irrespective of the type of packaging, and the percentages in Table IV shall be calculated on a ready-to-serve basis, except that soup bases in institutional packs which are prepared for sale to institutional users shall have a minimum of 15 percent cooked deboned poultry meat based on the weight of the soup base product.
Table IV
Product name ^1 | Minimum percent cooked deboned poultry meat of kind indicated | Minimum percent cooked poultry of kind indicated, indicating bone
(Kind) Ravioli | 2
(Kind) Soup | 2
Chop Suey with (Kind) | 2
(Kind) Chop Suey | 4
(Kind) Chow Mein without noodles | 4
(Kind) Tamales | 6
Noodles or Dumplings with (Kind) ^2 | 6
(Kind) Stew | 12
(Kind) Fricassee of Wings | | 40
(Kind) Noodles or Dumplings ^2 | 15 | 30
(Kind) with Vegetables | 15
Gravy with sliced (Kind) | 15
(Kind) Tetrazzini | 15
(Kind) chili with beans | 17
Creamed (Kind) | 20
(Kind) Cacciatore | 20 | 40
(Kind) Fricassee | 20 | 40
(Kind) A-La-King | 20
(Kind) croquettes | 25
Slice (Kind) with Gravy and Dressing | 25
(Kind) Salad ^3 | 25
(Kind) chili | 28
(Kind) Hash | 30
Sliced (Kind) with Gravy | 35
Minced (Kind) Barbecue | 40
^1 The product name may contain other appropriate descriptive terms such as “noodle”; e.g., “Chicken Noodle Soup.”
^2 This standard also applies to products named (Kind) with rice or similar starches.
^3 The 25 percent-standard listed includes poultry meat plus proportions of skin and fat natural to the poultry used.
[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974]
§ 381.168
Maximum percent of skin in certain poultry products.
The poultry products listed in Table V shall have not more than the percent of skin specified in the table, when raw and when cooked.
Table V
Product name | Percent skin | Raw | Cooked
Boneless Turkey Breast
or
Boneless Turkey Breast Roll | 14
Boneless Turkey Thigh
or
Boneless Turkey Thigh Roll | 8
Boneless Turkey
or
Turkey Roll | 15
Boneless Chicken Breast
or
Boneless Chicken Breast Roll | 18 | 20
Boneless Chicken
or
Chicken Roll | 20 | 25
§ 381.169
[Reserved]
§ 381.170
Standards for kinds and classes, and for cuts of raw poultry.
(a) The following standards specify the various classes of the specified kinds of poultry and the requirements for each class:
(1) Chickens—(i) Rock Cornish game hen or Cornish game hen. A “Rock Cornish game hen” or “Cornish game hen” is a young, immature chicken (less than 5 weeks of age), of either sex, with a ready-to-cook carcass weight of not more than 2 pounds.
(ii) Broiler or fryer. A “broiler” or “fryer” is a young chicken (less than 10 weeks of age), of either sex, that is tender-meated with soft, pliable, smooth-textured skin and flexible breastbone cartilage.
(iii) Roaster or roasting chicken. A “roaster” or “roasting chicken” is a young chicken (less than 12 weeks of age), of either sex, with a ready-to-cook carcass weight of 5.5 pounds or more, that is tender-meated with soft, pliable, smooth-textured skin and breastbone cartilage that is somewhat less flexible than that of a broiler or fryer.
(iv) Capon. A “capon” is a surgically neutered male chicken (less than 4 months of age) that is tender-meated with soft, pliable, smooth-textured skin.
(v) Hen, fowl, baking chicken, or stewing chicken. A “hen,” “fowl,” “baking chicken,” or “stewing chicken” is an adult female chicken (more than 10 months of age) with meat less tender than that of a roaster or roasting chicken and a nonflexible breastbone tip.
(vi) Cock or rooster. A “cock” or “rooster” is an adult male chicken with coarse skin, toughened and darkened meat, and a nonflexible breastbone tip.
(2) Turkeys—(i) Fryer-roaster turkey. A “fryer-roaster turkey” is an immature turkey (less than 12 weeks of age), of either sex, that is tender-meated with soft, pliable, smooth-textured skin, and flexible breastbone cartilage.
(ii) Young turkey. A “young turkey” is a turkey (less than 8 months of age), of either sex, that is tender-meated with soft, pliable, smooth-textured skin and breastbone cartilage that is less flexible than that of a fryer-roaster turkey.
(iii) Yearling turkey. A “yearling turkey” is a turkey (less than 15 months of age), of either sex, that is reasonably tender-meated with reasonably smooth-textured skin.
(iv) Mature or old (hen or tom) turkey. A “mature turkey” or “old turkey” is an adult turkey (more than 15 months of age), of either sex, with coarse skin and toughened flesh. Sex designation is optional.
(3) Ducks—(i) Duckling. A “duckling” is a young duck (less than 8 weeks of age), of either sex, that is tender-meated and has a soft bill and soft windpipe.
(ii) Roaster duck. A “roaster duck” is a young duck (less than 16 weeks of age), of either sex, that is tender-meated and has a bill that is not completely hardened and a windpipe that is easily dented.
(iii) Mature duck or old duck. A “mature duck” or an “old duck” is an adult duck (more than 6 months of age), of either sex, with toughened flesh, a hardened bill, and a hardened windpipe.
(4) Geese—(i) Young goose. A “young goose” is an immature goose, of either sex, that is tender-meated and has a windpipe that is easily dented.
(ii) Mature goose or old goose. A “mature goose” or “old goose” is an adult goose, of either sex, that has toughened flesh and a hardened windpipe.
(5) Guineas—(i) Young guinea. A “young guinea” is an immature guinea, of either sex, that is tender-meated and has a flexible breastbone cartilage.
(ii) Mature guinea or old guinea. A “mature guinea” or “old guinea” is an adult guinea, of either sex, that has toughened flesh and a non-flexible breastbone.
(b) The following standards specify the requirements for the specified cuts of poultry:
(1) “Breasts” shall be separated from the back at the shoulder joint and by a cut running backward and downward from that point along the junction of the vertebral and sternal ribs. The ribs may be removed from the breasts, and the breasts may be cut along the breastbone to make two approximately equal halves; or the wishbone portion, as described in paragraph (b)(3) of this section, may be removed before cutting the remainder along the breastbone to make three parts. Pieces cut in this manner may be substituted for lighter or heavier pieces for exact weight-making purposes and the package may contain two or more of such parts without affecting the appropriateness of the labeling as e.g., “chicken breasts.” Neck skin shall not be included with the breasts, except that “turkey breasts” may include neck skin up to the whisker.
(2) “Breasts with ribs” shall be separated from the back at the junction of the vertebral ribs and back. Breasts with ribs may be cut along the breastbone to make two approximately equal halves; or the wishbone portion, as described in paragraph (b)(3) of this section, may be removed before cutting the remainder along the breastbone to make three parts. Pieces cut in this manner may be substituted for lighter or heavier pieces for exact weight-making purposes and the package may contain two or more of such parts without affecting the appropriateness of the labeling as “breasts with ribs.” Neck skin shall not be included, except that “turkey breasts with ribs” may include neck skin up to the whisker.
(3) “Wishbones” (Pulley Bones), with covering muscle and skin tissue, shall be severed from the breast approximately halfway between the end of the wishbone (hypocledium) and front point of the breastbone (cranial process of the sternal crest) to a point where the wishbone joins the shoulder. Neck skin shall not be included with the wishbone.
(4) “Drumsticks” shall be separated from the thigh by a cut through the knee joint (femorotibial and patellar joint) and from the hock joint (tarsal joint).
(5) “Thighs” shall be disjointed at the hip joint and may include the pelvic meat, but shall not include the pelvic bones. Back skin shall not be included.
(6) “(Kind) legs” shall be the poultry product which includes the thigh and the drumstick, i.e., the whole leg, and may include the pelvic meat, but shall not include the pelvic bones. Back skin shall not be included.
(7) “Wings” shall include the entire wing with all muscle and skin tissue intact, except that the wingtip may be removed.
(8) “Backs” shall include the pelvic bones and all the vertebrae posterior to the shoulder joint. The meat shall not be peeled from the pelvic bones. The vertebral ribs and/or scapula may be removed or included without affecting the appropriateness of the name. Skin shall be substantially intact.
(9) “Stripped backs” shall include the vertebrae from the shoulder joint to the tail, and include the pelvic bones. The meat may be stripped off of the pelvic bones.
(10) “Necks”, with or without neck skin, shall be separated from the carcass at the shoulder joint.
(11) “Halves” are prepared by making a full-length back and breast split of an eviscerated poultry carcass so as to produce approximately equal right and left sides.
(12) “Quarters” consist of the entire eviscerated poultry carcass, which has been cut into four equal parts, but excluding the neck.
(13) “Breast quarter” consists of half a breast with the wing and a portion of the back attached.
(14) “Breast quarter without wing” consists of a front quarter of a poultry carcass, from which the wing has been removed.
(15) “Leg quarter” consists of a poultry thigh and drumstick, with a portion of the back attached.
(16) “Thigh with back portion” consists of a poultry thigh with back portion attached.
(17) “Legs with pelvic bone” consists of a poultry leg with adhering meat and skin and pelvic bone.
(18) “Wing drummette” consists of the humerus of a poultry wing with adhering skin and meat attached.
(19) “Wing portion” consists of a poultry wing except that the drummette has been removed.
(20) “Cut-up Poultry” is any cut-up or disjointed portion of poultry or any edible part thereof, as described in this section.
(21) “Giblets” consist of approximately equal numbers of hearts, gizzards, and livers, as determined on a count basis.
(22) “Major portions” of eviscerated poultry carcasses are either carcasses from which parts may be missing, or the front or rear portions of transversely-split carcasses.
[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974; 63 FR 48960, Sept. 11, 1998; 76 FR 68064, Nov. 3, 2011; 81 FR 21709, Apr. 13, 2016]
§ 381.171
Definition and standard for “Turkey Ham.”
(a) “Turkey Ham” shall be fabricated from boneless, turkey thigh meat with skin and the surface fat attached to the skin removed. The thighs shall be that cut of poultry described in § 381.170(b)(5) of this part.
(b) The product may or may not be smoked, and shall be cured using one or more of the approved curing agents as provided in a regulation permitting that use in this subchapter or 9 CFR Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B. The product may also contain cure accelerators, phosphates, and flavoring agents as provided in a regulation permitting that use in this subchapter or 9 CFR Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B; common salt, sugars, spices, spice extractives, dehydrated garlic, and dehydrated onions; and water for purpose of dissolving and dispersing the substances specified above.
(c) The cooked finished product weight shall be no more than the original weight of the turkey thigh meat used prior to curing.
(d) The product name on the label shall show the word “Turkey” in the same size, style, color, and with the same background as the word “Ham” and shall precede and be adjacent to it.
(e) The product name shall be qualified with the statement “Cured Turkey Thigh Meat.” The qualifying statement shall be contiguous to the product name, without intervening type or designs, shall be not less than one-half the size of the product name but not less than one-eighth inch in height, and shall be in the same style and color and with the same background as the product name.
(f) If the product is fabricated from pieces of turkey thigh meat that result from the cutting through the muscle (as opposed the whole thighs intact or whole thighs with some incidental separation of muscle tissue during removal of the bone), the product name shall be further qualified by a descriptive statement. The product name of product fabricated from such pieces of turkey thigh meat equivalent in size to a one-half inch cube or greater shall be further qualified to specify that the product is “Chunked and Formed.” The product name of product fabricated from such pieces of turkey thigh meat smaller than the equivalent of a one-half inch cube shall be further qualified to specify that the product is “Ground and Formed” or “Chopped and Formed” as appropriate. The qualifying statement shall immediately follow and be contiguous to the statement required in paragraph (e) of this section, and shall be not less than one-half the size of the product name but not less than one-eighth inch in height, and shall be in the same style and color and with the same background as the product name.
[44 FR 51190, Aug. 31, 1979; 64 FR 72175, Dec. 23, 1999]
§ 381.172
Requirements for substitute standardized poultry products named by use of an expressed nutrient content claim and a standardized term.
(a) Description. The poultry products prescribed by this general definition and standard of identity are those products that substitute, in accordance with § 381.413(d), for a standardized product defined in this subpart and use the name of that standardized product in their statements of identity, but that do not comply with the established standard because of a compositional deviation that results from reduction of a constituent that is described by an expressed nutrient content claim that has been defined by regulation in this subpart. The expressed nutrient content claim shall comply with the requirements of § 381.413 and with the requirements in subpart Y of this part which define the particular nutrient content claim that is used. The poultry product shall comply with the relevant standard in this part in all other respects, except as provided in paragraphs (b) and (c) of this section.
(b) Performance characteristics. The performance characteristics, such as physical properties, functional properties, and shelf-life, of the poultry product shall be similar to those of the standardized poultry product produced under subpart P of this part. If there is a significant difference in a performance characteristic that materially limits the use of the product compared to the use of the standardized product defined in subpart P of this part, the label shall include a statement in accordance with § 381.413(d)(1) and (2) of this part, that informs the consumer of such differences (e.g., if appropriate, “not recommended for frozen storage” or “not suitable for roller grilling”). Deviations from the ingredient provisions of the standard must be the minimum necessary to qualify for the nutrient content claim, while maintaining similar performance characteristics.
(c) Ingredients used in substitute products. (1) Ingredients used in the product shall be those ingredients provided for in the standard as defined in subpart P of this part, except that safe and suitable ingredients permitted for use in poultry products as provided in a regulation permitting that use in this subchapter or in 9 CFR Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B, may be used at the minimum level necessary to improve texture and prevent syneresis, so that the substitute product is not inferior in performance characteristics from the standardized product defined in subpart P of this part for which it is a substitute.
(2) An ingredient that is specifically required by the standard prescribed in subpart P of this part shall not be replaced or exchanged with a similar ingredient from another source, for example, extruded turnips shall not replace noodles in poultry with noodles.
(3) An ingredient that is specifically prohibited from use in any poultry product by subpart P of this part shall not be added to the substitute poultry product under this section.
(4) Unless otherwise specified in this part, a substitute poultry product must meet all other requirements of the applicable standards of identity or composition.
(5) Water and fat-replacers (e.g., binders), in combination, may be added to replace fat in accordance with paragraph (c) of this section.
(6) Textured vegetable protein may be used by itself or in combination with other binders and water as a fat replacer in accordance with paragraph (c) of this section.
(d) Nomenclature. The name of a substitute poultry product that complies with this section is the appropriate expressed nutrient content claim and the applicable standardized term.
(e) Label declaration. (1) Each of the ingredients used in the substitute poultry product shall be declared on the label as required by this section and subpart N of this part.
(2) Ingredients not provided for, and ingredients used in excess of those levels provided for, by the standard as defined in subpart P of this part, shall be identified as such with an asterisk in the ingredients statement. The statement “*Ingredients not in regular _____” (the blank shall be filled in with the name of the traditional standardized product) or “**Ingredients in excess of amounts permitted in regular _____” (the blank shall be filled in with the name of the traditional standardized product), or both, as appropriate, shall immediately follow the ingredients statement in the same type and size.
[70 FR 33818, June 10, 2005]
§ 381.173
Mechanically Separated (Kind of Poultry).
(a) “Mechanically Separated (Kind of Poultry)” is any product resulting from the mechanical separation and removal of most of the bone from attached skeletal muscle and other tissue of poultry carcasses and parts of carcasses that has a paste-like form and consistency, that may or may not contain skin with attached fat and meeting the other provisions of this section. Examples of such product are “Mechanically Separated Chicken” and “Mechanically Separated Turkey.”
(b) “Mechanically Separated (Kind of Poultry)” shall not have a bone solids content of more than 1 percent. At least 98 percent of the bone particles present in “Mechanically Separated (Kind of Poultry) “ shall have a maximum size no greater than 1.5 mm (millimeter) in their greatest dimension and there shall be no bone particles larger than 2.0 mm in their greatest dimension.
(c) “Mechanically Separated (Kind of Poultry)” shall not have a calcium content exceeding 0.235 percent when made from mature chickens or from turkeys as defined in § 381.170(a)(l)(vi) and (vii) and (a)(2), respectively, or 0.175 percent when made from other poultry, based on the weight of product that has not been heat treated, as a measure of a bone solids content of not more than 1 percent.
(d) “Mechanically Separated (Kind of Poultry)” may be used in the formulation of poultry products in accordance with § 381.174 and meat food products in accordance with subchapter A of this chapter.
(e) Product resulting from the mechanical separation process that fails to meet the bone particle size or calcium content requirements for “Mechanically Separated (Kind of Poultry)” shall be used only in producing poultry extractives, including fats, stocks, and broths and labeled as “Mechanically Separated (Kind of Poultry) for Further Processing.”
[60 FR 55983, Nov. 3, 1995]
§ 381.174
Limitations with respect to use of Mechanically Separated (Kind of Poultry).
(a) A poultry product required to be prepared from a particular kind of poultry (e.g., chicken) shall not contain “Mechanically Separated (Kind of Poultry)” described in § 381.173, that is made from any other kind of poultry (e.g., Mechanically Separated Turkey).
(b) “Mechanically Separated (Kind of Poultry)” described in § 381.173 may be used in the formulation of any poultry or meat food product, provided such use conforms with any applicable requirements of the definitions and standards of identity or composition in this subchapter or part 319 of this chapter, and provided that it is identified as “Mechanically Separated (Kind of Poultry).”
[60 FR 55983, Nov. 3, 1995]

Subpart Q—Records, Registration, and Reports
§ 381.175
Records required to be kept.
(a) Every person within any of the classes specified in paragraph (a) (1), (2), or (3) of this section is required by the Act to keep such records as are properly necessary for the effective enforcement of the Act:
(1) Any person that engages in the business of slaughtering any poultry or processing, freezing, packaging, or labeling any carcasses, or parts or products of carcasses, of any poultry, for commerce, for use as human food or animal food;
(2) Any person that engages in the business of buying or selling (as a poultry products broker, wholesaler, or otherwise) or transporting, in commerce, or storing in or for commerce, or importing, any carcasses, or parts or products of carcasses, of any poultry;
(3) Any person that engages in business, in or for commerce, as a renderer, or engages in the business of buying, selling, or transporting in commerce, or importing, any dead, dying, disabled, or diseased poultry or parts of the carcasses of any poultry that died otherwise than by slaughter.
(b) The required records are:
(1) Records, such as bills of sale, invoices, bills of lading, and receiving and shipping papers, giving the following information with respect to each transaction in which any poultry or poultry carcass, or part or product of a poultry carcass, is purchased, sold, shipped, received, transported, or otherwise handled by said person in connection with any business subject to the Act.
(i) The name or description of the poultry or other articles;
(ii) The net weight of the poultry or other articles;
(iii) The number of outside containers;
(iv) The name and address of the buyer of the poultry or other articles sold by such person, and the name and address of the seller of the poultry or other articles purchased by such person;
(v) The name and address of the consignee or receiver (if other than the buyer);
(vi) The method of shipment;
(vii) The date of shipment; and
(viii) The name and address of the carrier.
(2) Guaranties provided by suppliers of packaging materials under § 381.144.
(3) Records of canning as required by part 431 of this chapter.
(4) Records of irradiation as required by sections 381.149 of this part.
(5) Records of nutrition labeling as required by subpart Y of this part.
(6) Records of all labeling, along with the product formula, processing procedures, and any additional documentation needed to support that the labels are consistent with the Federal meat and poultry regulations and policies on labeling, as prescribed in § 412.1 of this chapter.
(Approved by the Office of Management and Budget under control number 0583-0015)
[37 FR 9706, May 16, 1972, as amended at 47 FR 746, Jan. 7, 1982; 49 FR 2236, Jan. 19, 1984; 51 FR 45633, Dec. 19, 1986; 57 FR 43600, Sept. 21, 1992; 58 FR 675, Jan. 6, 1993; 60 FR 67458, Dec. 29, 1995; 78 FR 66838, Nov. 7, 2013; 83 FR 25308, May 31, 2018]
§ 381.176
Place of maintenance of records.
Every person engaged in any business described in § 381.175(a) shall maintain the records required by § 381.175 at the place of business where such business is conducted, except that, if such person conducts such business at multiple locations, he may maintain such records at his headquarters' office. When not in actual use, all such records shall be kept in a safe place at the prescribed location in accordance with good commercial practices.
§ 381.177
Record retention period.
(a) Every record required to be maintained under this subpart shall be retained for a period not to exceed 2 years after December 31 of the year in which the transaction to which the record relates has occurred, and for such further period as the Administrator may require for purposes of any investigation or litigation under the Act, by written notice to the person required to keep such record under this subpart.
(b) Records of canning as required by subpart X of this part 381, subchapter C, 9 CFR chapter III, shall be retained as required in § 381.307; except that records required by § 381.302 (b) and (c) shall be retained as required by those sections.
[37 FR 9706, May 16, 1972, as amended at 51 FR 45633, Dec. 19, 1986]
§ 381.178
Access to and inspection of records, facilities and inventory; copying and sampling.
Representatives of the Secretary afforded access to a business specified in § 381.175 of this part (see § 300.6(b)(2) of this chapter) also must be afforded any necessary facilities (other than reproduction equipment) for the examination and copying of records and the examination and sampling of inventory.
[69 FR 255, Jan. 5, 2004]
§ 381.179
Registration.
(a) Except as provided in paragraph (c) of this section, every person that engages in business, in or for commerce, as a poultry products broker, renderer, or animal food manufacturer, or engages in business in commerce as a wholesaler of any carcasses, or parts or products of the carcasses, of any poultry, whether intended for human food or other purposes, or engages in the business as a public warehouseman storing any such articles in or for commerce, or engages in the business of buying, selling, or transporting in commerce, or importing, any dead, dying, disabled, or diseased poultry, or parts of the carcasses of any poultry that died otherwise than by slaughter, shall register with the Administrator, giving such information as is required, including his name, and the address of each place of business at which, and all trade names under which he conducts such business. Such persons shall register under this section by filing with the Administrator, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250, a form containing such information, within 90 days after the effective date hereof or after such later date as he begins to engage in such business if not engaged therein upon said effective date. All information submitted shall be current and correct. The registration form shall be obtained from District Enforcement Operations, Field Operations, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250 or by calling the District Office.
(b) Whenever any change is made in the name of, or address of any place of business at which, or any trade name under which a registrant conducts his business, he shall report such change in writing to the Administrator within 15 days after making the change.
(c) The registration requirements prescribed in this section shall not apply to persons conducting any of the businesses specified in this section only at an official establishment.
[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974; 57 FR 53982, Nov. 16, 1992; 69 FR 255, Jan. 5, 2004]
§ 381.180
Information and reports required from official establishment operators.
(a) The operator of each official establishment shall furnish to Program employees accurate information as to all matters needed by them for making their daily reports of the amount of products prepared or handled in the departments of the establishment to which they are assigned and such reports concerning sanitation, mandatory microbiological testing, and other aspects of the operations of the establishment and the conduct of inspection thereat, as may be required by the Administrator in special cases.
(b) The operator of each official establishment shall also make such other reports as the Administrator may from time to time require under the Act.
[37 FR 9706, May 16, 1972, as amended at 61 FR 38868, July 25, 1996]
§ 381.181
Reports by consignees of allegedly adulterated or misbranded products; sale or transportation as violations.
Whenever the consignee of any poultry product which bears an official inspection legend refuses to accept delivery of such product on the grounds that it is adulterated or misbranded, the consignee shall notify the appropriate program supervisor, Meat and Poultry Inspection Program, Food Safety and Inspection Service, U.S. Department of Agriculture, of the kind, quantity, source and present location of the product and the respects in which it is alleged to be adulterated or misbranded, and it will be a violation of the Act for any person to sell or transport, or offer for sale or transportation or receive for transportation, in commerce, any such product which is capable of use as human food and is in fact adulterated or misbranded at the time of such sale, transportation, offer, or receipt: Provided, That any such allegedly adulterated or misbranded product may be transported to any official establishment for reinspection.
§ 381.182
Reports of inspection work.
Reports of the inspection work carried on within official establishments shall be forwarded to the Administrator by the inspector in charge in such a manner as may be specified by the Administrator.

Subpart R—Cooperation With States and Territories; Certification of State and Territorial Programs as at Least Equal to Federal Program
§ 381.185
Assistance to State and Territorial programs.
(a) The Administrator is authorized, under paragraph (a) of section 5 of the Act, when he determines it would effectuate the purposes of the Act, to cooperate with any State (including Puerto Rico) or any organized territory in developing and administering the poultry product inspection program of such jurisdiction, with a view to assuring that it imposes and enforces requirements at least equal to those under sections 2 through 4, 6 through 10, and 12 through 22 of the Act, with respect to establishments at which poultry are slaughtered or poultry products are processed for use as human food, solely for distribution within such jurisdiction, and with respect to the poultry products of such establishments. Such cooperation is authorized if the jurisdiction has enacted a mandatory law imposing ante mortem and post mortem inspection, reinspection, and sanitation requirements (at least equal to those under the Federal Act), with respect to all or certain classes of persons engaged in slaughtering poultry or otherwise processing poultry products for use as human food solely for distribution within such jurisdiction.
(b) The Administrator is also authorized under paragraph (a) of section 5 of the Act, to cooperate with any State (including Puerto Rico) or any organized territory in developing and administering programs under the laws of such jurisdiction containing authorities at least equal to those provided in section 11 of the Act (relating to records; registration of specified classes of operators; dead, dying, disabled, or diseased poultry; and products not intended for human food) when he determines that such cooperation would effectuate the purposes of the Act.
(c) Such cooperation may include advisory assistance, technical and laboratory assistance and training, and financial aid. The Federal contribution to any State (or territory) for any year shall not exceed 50 percent of the estimated total cost of the cooperative State (or territorial) program. A cooperative program under this section is called a State-Federal program.
§ 381.186
Cooperation of States and other jurisdictions in Federal programs.
Under the “Talmadge-Aiken Act” of September 28, 1962 (7 U.S.C. 450), the Administrator is authorized under stated conditions to utilize employees and facilities of any State in carrying out Federal functions under the Poultry Products Inspection Act. A cooperative program for this purpose is called a Federal-State program. Under paragraph (a) of section 5 of the Poultry Products Inspection Act, the Administrator is also authorized to conduct examinations, investigations, and inspections under the Act through any officer or employee of any State or territory or the District of Columbia commissioned by him for such purpose.
§ 381.187
Cooperation of States for the interstate shipment of poultry products.
(a) The Administrator is authorized under 21 U.S.C. 472(b) to coordinate with States that have poultry products inspection programs as provided in § 381.185 of this subpart to select certain establishments operating under these programs to participate in a cooperative program to ship poultry products in interstate commerce. A cooperative program for this purpose is called a “cooperative interstate shipment program.”
(b) Establishments selected to participate in a cooperative interstate shipment program described in this section must receive inspection services from designated State personnel that have been trained in the enforcement of the Act. If the designated personnel determine that the poultry products prepared in establishments selected to participate in the cooperative interstate shipment program comply with all requirements under the Act, these items will bear an official Federal mark of inspection and may be shipped in interstate commerce. The Administrator will assign an FSIS “selected establishment coordinator,” who will be an FSIS employee, to each State that participates in a cooperative interstate shipment program to provide Federal oversight of the program and enforcement of the program's requirements. The Federal contribution for inspection services provided by States that enter into a cooperative interstate shipment program under this section will be at least 60 percent of eligible State costs. Eligible State costs are those costs that a State has justified and FSIS has approved as necessary for the State to provide inspection services to selected establishments in the State.
(c) Subpart Z, of this part 381 prescribes conditions under which States and establishments may participate in the cooperative interstate shipment program.
(d) The Administrator will terminate a cooperative interstate shipment agreement with a State if the Administrator determines that the State is not conducting inspection at selected establishments in a manner that complies with the Act and the implementing regulations in this chapter.
[76 FR 24756, May 2, 2011]

Subpart S—Transportation; Exportation; or Sale of Poultry or Poultry Products
§ 381.189
Provisions inapplicable to specimens for laboratory examination, etc., or to naturally inedible articles.
The provisions of this subpart do not apply:
(a) To dead, dying, disabled or diseased poultry and specimens of undenatured, uninspected or adulterated carcasses, parts, or products of poultry sent to or by the Department of Agriculture or divisions thereof in Washington, DC, or elsewhere, for laboratory examination, exhibition purposes, or other official use;
(b) To dead, dying, disabled or diseased poultry and specimens of undenatured, uninspected or adulterated carcasses, parts, or products of poultry thereof for educational, research, or other nonfood purposes shipped under permit issued by the inspector in charge upon his determination that collection and movement thereof will not interfere with inspection or sanitary conditions at the establishment, and the specimens are for nonfood purposes. The person desiring such specimens shall make a written application to the inspector in charge for such permit on Form MP-112 and shall obtain permission from the operator of the official establishment to obtain the specimens. Permits shall be issued for a period not longer than one year. The permit may be revoked by the inspector in charge if he determines after notice and opportunity to present views is afforded to the permittee that any such specimens were 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. The specimens referred to in this paragraph 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.
(c) To parts of poultry carcasses that are naturally inedible by humans, such as entrails and feathers in their natural state.
[40 FR 55310, Nov. 28, 1975]
§ 381.190
Transactions in slaughtered poultry and other poultry products restricted; vehicle sanitation requirements.
(a) No person shall sell, transport, offer for sale or transportation, or receive for transportation, in commerce or from any official establishment, any slaughtered poultry from which the blood, feathers, feet, head, or viscera have not been removed in accordance with the regulations.
(b)(1) No person shall sell, transport, offer for sale or transportation, or receive for transportation, in commerce, any slaughtered poultry or other poultry product which is capable of use as human food and is adulterated or fails to bear an official inspection legend or is otherwise misbranded at the time of such sale, transportation, offer or receipt, except as otherwise provided in this paragraph (b) and subpart C or T.
(2)(i) Poultry heads and feet that are collected and handled at an official establishment in an acceptable manner may be shipped from the official establishment directly for export as human food, if they have been examined and found to be suitable for such purpose, by an inspector and are labeled as prescribed in this paragraph.
(ii) The containers of all such products shall bear a label showing: (A) The name of the products; (B) the name and address of the packer or distributor, and, when the name of the distributor is shown, it shall be qualified by such terms as “packed for,” “distributed by,” or “distributors”; and (C) the official establishment number of the establishment where packed.
(iii) Such products shall not bear the official inspection legend.
(3)(i) Poultry heads and feet that are collected and handled at an official establishment in an acceptable manner may be shipped from the official establishment and in commerce directly to another official establishment for processing before export, provided the receiving establishment maintains records that:
(A) Identify the source of the incoming undenatured poultry product;
(B) Identify the location of the product at all times during processing and preparation for export; and
(C) Contain a written certification from an official of the receiving establishment that the undenatured poultry product intended for export has not been, and will not be, commingled with any product intended for consumption in the United States.
(ii) The receiving establishment may only ship the undenatured poultry product intended for export in accordance with the inspection and labeling requirements of paragraph (b)(2) of this section.
(c) No person, engaged in the business of buying, selling, freezing, storing, or transporting, in or for commerce, poultry products capable of use as human food, or importing such articles, shall transport, offer for transportation, or receive for transportation, in commerce or in any State designated under § 381.221, any poultry product which is capable of use as human food and is not wrapped, packaged, or otherwise enclosed to prevent adulteration by airborne contaminants, unless the railroad car, truck, or other means of conveyance in which the product is contained or transported is completely enclosed with tight fitting doors or other covers for all openings. In all cases, the means of conveyance shall be reasonably free of foreign matter (such as dust, dirt, rust, or other articles or residues), and free of chemical residues, so that product placed therein will not become adulterated. Any cleaning compound, lye, soda solution, or other chemical used in cleaning the means of conveyance must be thoroughly removed from the means of conveyance prior to its use. Such means of conveyance onto which product is loaded, being loaded, or intended to be loaded, shall be subject to inspection by an inspector at any official establishment. The decision whether or not to inspect a means of conveyance in a specific case, and the type and extent of such inspection shall be at the Inspection Service's discretion and shall be adequate to determine if poultry product in such conveyance is, or when moved could become, adulterated.
Circumstances of transport that can be reasonably anticipated shall be considered in making said determination. These include, but are not limited to, weather conditions, duration and distance of trip, nature of product covering, and effect of restowage at stops en route. Any means of conveyance found upon such inspection to be in such condition that poultry product placed therein could become adulterated shall not be used until such condition which could cause adulteration is corrected. Poultry product placed in any means of conveyance that is found by the inspector to be in such condition that the poultry product may have become adulterated shall be removed from the means of conveyance and handled in accordance with § 381.145(b).
[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974; 40 FR 42338, Sept. 12, 1975; 41 FR 23700, June 11, 1976; 60 FR 43358, Aug. 21, 1995]
§ 381.191
Distribution of inspected products to small lot buyers.
For the purpose of facilitating the distribution in commerce of inspected poultry products to small lot buyers (such as small restaurants), distributors or jobbers may remove inspected and passed non-consumer-packaged poultry carcasses or consumer-packaged poultry products from shipping containers or immediate containers, other than consumer packages, and place them into other containers which do not bear an official inspection mark: Provided, That the individual non-consumer-packaged carcasses bear the official inspection legend and the official establishment number of the establishment that processed the articles; and the consumer-packaged articles are fully labeled in accordance with subpart N: And provided further, That the other container is marked with the name and address of the distributor or jobber and bears the statement “The poultry product contained herein was inspected by the U.S.D.A.” in the case of poultry products processed in the United States, or the statement “The poultry products contained herein have been approved for importation under P.P.I.A.” in the case of imported poultry products.
§ 381.192
Penalties inapplicable to carriers.
No carrier shall be subject to the penalties of the Act, other than the penalties for violation of section 11, by reason of his receipt, carriage, holding, or delivery, in the usual course of business, as a carrier, of poultry or poultry products, owned by another person, unless the carrier has knowledge, or is in possession of facts which would cause a reasonable person to believe that such poultry or poultry products were not inspected or marked in accordance with the provisions of the Act or where otherwise not eligible for transportation under the Act, or unless the carrier refuses to furnish on request of a representative of the Secretary, the name and address of the person from whom he received such poultry or poultry products, and copies of all documents, if any there be, pertaining to the delivery of the poultry or poultry products to such carrier.
§ 381.193
Poultry carcasses, etc., not intended for human food.
(a) Except as provided in paragraph (b) of this section, poultry carcasses, and parts and products thereof, that are not intended for use as human food may, after they have been denatured as prescribed in § 381.95, be bought, sold, transported, offered for sale or transportation, or received for transportation, in commerce, or imported, even though they do not comply with all the provisions of the regulations, provided they are marked “Not fit for human food.” These requirements do not apply to parts of poultry carcasses that are naturally inedible by humans, such as entrails.
(b)(1) Except as provided in paragraphs (b) (2), (3), and (4) of this section, no animal food processed, in whole or in part, from materials derived from the carcasses of poultry in an official establishment or elsewhere, shall be bought, sold, transported, offered for sale or transportation, or received for transportation in commerce, or imported, unless:
(i) It is properly identified as animal food;
(ii) It is not represented as being a human food; and
(iii) It has been denatured as prescribed in § 381.95 so as to be readily distinguishable from an article of human food.
(2) Notwithstanding the provisions of paragraph (b)(1) of this section, an animal food that consists of less than 5 percent of parts or products of the carcasses of poultry and that is not represented by labeling or appearance or otherwise as being a human food or as a product of the poultry industry need not be denatured in accordance with § 381.95.
(3) Notwithstanding the provisions of paragraph (b)(1) of this section, animal food packed in hermetically sealed, retort processed, conventional retail-size containers, and retail-size packages of semi-moist animal food need not be denatured in accordance with § 381.95 if the name of the article clearly conveys the article's intended use for animal food and appears on the label in a conspicuous manner.
(i) Except as provided in paragraph (ii) of paragraph (b)(3) of this section, the name of the article must be stated on the label as “Animal Food,” “Pet Food,” or “(name of species) Food” (e.g., “Dog Food” or “Cat Food”). To be considered conspicuous, the name of the article, wherever it appears on the label, must be stated in letters at least twice as high, wide, and thick as the letters indicating the presence in the article of any ingredients derived from carcasses of poultry.
(ii) Notwithstanding the provisions of paragraph (i) of paragraph (b)(3) of this section, the article's name may be stated on the label to show that it is or contains poultry carcass-source material and that the article is for animals; e.g., “Chicken for Pets” or “Turkey Dinner for Cats”: Provided, That the entire name of the article is stated, wherever it appears on the label, as an individual, contiguous unit, whether stated on a single line or more than one line, and the letters denoting the article's intended use for animal food are at least as high, wide, and thick as the letters indicating the presence of material derived from any poultry carcass. However, when the label bears on its principal display panel a vignette which pictures, in clearly recognizable form and size, one or more animals of the species for which the article's name indicates the article is intended, the letters used to state the article's intended use shall be at least one-half as high, wide, and thick as the letters used in the article's name or other letters indicating the presence of material derived from any poultry carcass, but shall not be less than 1/8 inch high. The letters used to state the article's intended use may be separated from the article's name by the vignette.
(iii) Letters used to denote the intended use of the article must contrast as markedly with their background as the letters indicating the presence in the article of poultry carcass-source material contrast with their background.
(4) The requirements of this part do not apply to livestock or poultry feed manufactured from processed poultry byproducts (such as poultry byproduct meal, hydrolyzed poultry feathers, and hydrolyzed poultry byproducts aggregate), or to processed dry animal food.
[49 FR 47479, Dec. 5, 1984]
§ 381.194
Transportation and other transactions concerning dead, dying, disabled, or diseased poultry, and parts of carcasses of poultry that died otherwise than by slaughter.
No person engaged in the business of buying, selling, or transporting in commerce, or importing any dead, dying, disabled, or diseased poultry or parts of the carcasses of any poultry that died otherwise than by slaughter shall:
(a) Sell, transport, offer for sale or transportation or receive for transportation, in commerce, any dead, dying, disabled, or diseased poultry, or parts of the carcasses of any poultry that died otherwise than by slaughter, unless such poultry and parts are consigned and delivered, without avoidable delay, to establishments of animal food manufacturers, renderers, or collection stations that are registered as required by § 381.179, or to official establishments that operate under Federal inspection, or to establishments that operate under a State or Territorial inspection system approved by the Secretary as one that imposes requirements at least equal to the Federal requirements for purposes of section 5(c) of the Act.
(b) Buy in commerce or import any dead, dying, disabled, or diseased poultry or parts of the carcasses of any poultry that died otherwise than by slaughter, unless he is an animal food manufacturer or renderer and is registered as required by § 381.179, or is the operator of an establishment inspected as required by paragraph (a) of this section and such poultry or parts of carcasses are to be delivered to establishments eligible to receive them under paragraph (a) of this section.
(c) Unload en route to any establishment eligible to receive them under paragraph (a) of this section, any dead, dying, disabled, or diseased poultry or parts of the carcasses of any poultry that died otherwise than by slaughter, which are transported in commerce or imported by any such person: Provided, That any such dead, dying, disabled, or diseased poultry, or parts of carcasses may be unloaded from a means of conveyance en route where necessary in case of a wreck or otherwise extraordinary emergency, and may be reloaded into another means of conveyance; but in all such cases, the carrier shall immediately report the facts by telegraph or telephone to the Director, Compliance Staff, Meat and Poultry Inspection Program, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250.
[40 FR 55310, Nov. 28, 1975]

Subpart T—Imported Poultry Products
§ 381.195
Definitions; requirements for importation into the United States.
(a) When used in this part, the following terms are defined to mean:
(1) Import (imported). To bring within the territorial limits of the United States whether that arrival is accomplished by land, air, or water.
(2) Offer(ed) for entry. The point at which the importer presents the imported product for reinspection.
(3) Entry (entered). The point at which imported product offered for entry receives reinspection and is marked with the official mark of inspection, as required by § 381.204.
(b) No slaughtered poultry, or parts or products thereof, shall be imported into the United States unless they are healthful, wholesome, fit for human food, not adulterated, and contain no dye, chemical, preservative, or ingredient which renders them unhealthful, unwholesome, adulterated, or unfit for human food and they also comply with the regulations prescribed in this subpart to assure that they comply with the standards provided for in the Act: Provided, That the provisions of this subpart apply to such articles only if they are capable of use as human food.
(c) Except as provided in § 381.207, slaughtered poultry and other poultry products may be imported only if they were processed solely in countries found eligible to export poultry products to the United States under § 381.196(b). Slaughtered poultry may be imported only if it qualifies as ready-to-cook poultry.
[37 FR 9706, May 16, 1972, as amended at 40 FR 42338, Sept. 12, 1975; 54 FR 41049, Oct. 5, 1989; 79 FR 56233, Sept. 19, 2014; 84 FR 65268, Nov. 27, 2019]
§ 381.196
Eligibility of foreign countries for importation of poultry products into the United States.
(a)(1) Whenever it shall be determined by the Administrator that the system of poultry inspection maintained by any foreign country, with respect to establishments preparing products in such country for export to the United States, insures compliance of such establishments and their poultry products, with requirements equivalent to all the provisions of the Act and the regulations in this part which are applied to official establishments in the United States, and their poultry products, and that reliance can be placed upon certificates required under this subpart from authorities of such foreign country, notice of that fact will be given in accordance with paragraph (b) of this section. Thereafter, poultry products processed in such establishments which are certified and approved in accordance with paragraph (a)(3) of this section shall be eligible, so far as the regulations in this part are concerned, for importation into the United States from such foreign country after applicable requirements of this part have been met.
(2) The determination of acceptability of a foreign poultry inspection system for purposes of this section shall be based on an evaluation of the foreign program in accordance with the following requirements and procedures:
(i) The system shall have a program organized and administered by the national government of the foreign country. The system as implemented must provide standards equivalent to those of the Federal system of poultry inspection in the United States with respect to:
(A) Organizational structure and staffing, so as to insure uniform enforcement of the requisite laws and regulations in all establishments throughout the system at which poultry products are processed for export to the United States;
(B) Ultimate control and supervision by the national government over the official activities of all employees or licensees of the system;
(C) The assignment of competent, qualified inspectors;
(D) Authority and responsibility of national inspection officials to enforce the requisite laws and regulations governing poultry inspection and to certify or refuse to certify poultry products intended for export;
(E) Adequate administrative and technical support;
(F) The inspection, sanitation, quality, species verification, and residue standards applied to products produced in the United States.
(G) Other requirements of adequate inspection service as required by the regulations.
(ii) The legal authority for the system and the regulations thereunder shall impose requirements equivalent to those governing the system of poultry inspection organized and maintained in the United States with respect to:
(A) Ante mortem inspection of poultry for slaughter, which shall be performed by veterinarians or by other employees or licensees of the system under the direct supervision of veterinarians;
(B) Post mortem inspection of carcasses and parts thereof at time of slaughter, performed by veterinarians or other employees or licensees of the system under the direct supervision of veterinarians;
(C) Official controls by the national government over establishment construction, facilities, and equipment;
(D) Direct and continuous official supervision of slaughtering of poultry and processing of poultry products, by the assignment of inspectors to establishments certified under paragraph (a)(3) of this section to assure that adulterated or misbranded poultry products are not processed for export to the United States;
(E) Complete separation of establishments certified under subparagraph (3) of this paragraph from establishments not certified, and the maintenance of a single standard of inspection and sanitation throughout all certified establishments;
(F) Requirements for sanitation at certified establishments and for sanitary handling of poultry products;
(G) Official controls over condemned material until destroyed or removed and thereafter excluded from the establishment;
(H) A Hazard Analysis and Critical Control Point (HACCP) system, as set forth in part 417 of this chapter.
(I) Other matters for which requirements are contained in the Act or the regulations in this part.
(iii) Countries desiring to establish eligibility for importation of poultry products into the United States may request a determination of eligibility by presenting copies of the laws and regulations on which the foreign poultry inspection system is based and such other information as the Administrator may require with respect to matters enumerated in paragraphs (a)(2) (i) and (ii). Determination of eligibility is based on a study of the documents and other information presented and an initial review of the system in operation by a representative of the Department using the criteria listed in paragraphs (a)(2) (i) and (ii) of this section. Maintenance of eligibility of a country for importation of poultry products into the United States depends on the results of periodic reviews of the foreign poultry inspection system in operation by a representative of the Department, and the timely submission of such documents and other information related to the conduct of the foreign inspection system as the Administrator may find pertinent to and necessary for the determinations required by this section.
(iv) The foreign inspection system must maintain a program to assure that the requirements referred to in this section, equivalent to those applicable to the Federal system in the United States, are being met. The program as implemented must provide for the following:
(A) Periodic supervisory visits by a representative of the foreign inspection system to each establishment certified in accordance with paragraph (a)(3) of this section to ensure that requirements referred to in paragraphs (a)(2)(ii)(A) through (H) of this section are being met: Provided, That such visits are not required with respect to any establishment during a period when the establishment is not operating or is not engaged in producing products for exportation to the United States;
(B) Written reports prepared by the representative of the foreign inspection system who has conducted a supervisory visit, documenting his or her findings with respect to the requirements referred to in paragraphs (a)(2)(ii)(A) through (a)(2)(ii)(H) of this section, copies of which shall be made available to the representative of the Department at the time of the representative's review upon request by that representative to a responsible foreign inspection official: Provided, that such reports are not required during a period when the establishment is not operating or not engaged in producing products for exportation to the United States.
(C) Random sampling and testing at the point of slaughter of carcasses, including internal organs and fat, for residues identified by the exporting country's inspection authorities or by this Agency as potential contaminants, in accordance with sampling and analytical techniques approved by the Administrator: Provided, that such testing is required only on samples taken of carcasses from which poultry or poultry products intended for importation into the United States are produced.
(3) Only those establishments that are determined and certified to the Agency by a responsible official of the foreign meat inspection system as fully meeting the requirements of paragraphs (a)(2)(i) and (ii) of this section are eligible to have their products imported into the United States. Establishment eligibility is subject to review by the Agency (including observations of the establishments by Program representatives at times prearranged with the foreign meat inspection system officials). Foreign establishment certifications must be renewed annually. Notwithstanding certification by a foreign official, the Administrator may terminate the eligibility of any foreign establishment for the importation of its products into the United States if it does not comply with the requirements listed in paragraphs (a)(2)(i) and (ii) of this section, or if current establishment information cannot be obtained. The Administrator will provide reasonable notice to the foreign government of the proposed termination of any foreign establishment, unless a delay in terminating its eligibility could result in the importation of adulterated or misbranded product.
(i) For a new establishment or any establishment for which information from last year's electronic certification or paper certificate has changed, the certification or certificate must contain: The date; the foreign country; the foreign establishment's name, address, and foreign establishment number; the foreign official's title; the foreign official's signature (for paper certificates only); the type of operation(s) conducted at the establishment (e.g., slaughter, processing, storage, exporting warehouse); and the establishment's eligibility status (e.g., new or relisted (if previously delisted)). Slaughter and processing establishment certifications must address the species and type of products produced at the establishment (e.g., the process category).
(ii) If the establishment information provided on the preceding year's electronic foreign establishment certification or paper certificate, as required in paragraph (a)(3)(i) of this section, has not changed, the certification or certificate must contain: The date, the foreign country, the foreign establishment's name, the foreign official's title and signature (for paper certificates only).
(4) Poultry products from foreign countries not deemed eligible in accordance with paragraph (b) of this section may not be imported into the United States, except as provided by §§ 381.207 and 381.209. Eligibility of any foreign country under this section may be withdrawn whenever the Administrator determines that the system of poultry inspection maintained by such foreign country does not assure compliance with requirements equivalent to all the requirements of the Act and the regulations as applied to official establishments in the United States; or that reliance cannot be placed upon certificates required under this subpart from authorities of such foreign country; or that, for lack of current information concerning the system of poultry inspection being maintained by such foreign country, such foreign country should be required to reestablish its eligibility.
(b) A list of countries eligible to export specific process categories of poultry products to the United States is maintained at http://www.fsis.usda.gov/importlibrary. Such products from listed countries must be accompanied by inspection certificates of the country of origin, as required by § 381.197, and are eligible under the regulations in this subpart for entry into the United States, after inspection and marking as required by the applicable provisions of this subpart.
[37 FR 9706, May 16, 1972, as amended at 43 FR 8117, Feb. 28, 1978; 52 FR 23021, June 17, 1987; 54 FR 41049, Oct. 5, 1989; 54 FR 43951, Oct. 30, 1989; 60 FR 38668, July 28, 1995; 61 FR 38868, July 25, 1996; 64 FR 49645, Sept. 14, 1999; 68 FR 37071, June 23, 2003; 71 FR 20871, Apr. 24, 2006; 71 FR 43961, Aug. 3, 2006; 72 FR 61796, Nov. 1, 2007; 79 FR 16661, Mar. 26, 2014; 79 FR 56234, Sept. 19, 2014; 84 FR 13520, Apr. 5, 2019; 84 FR 60324, Nov. 8, 2019; 84 FR 65268, Nov. 27, 2019]
§ 381.197
Foreign inspection certificate requirements.
(a) Except as provided in §§ 381.207 and 381.209, each consignment imported into the United States must have an electronic foreign inspection certification or a paper foreign inspection certificate issued by an official of the foreign government agency responsible for the inspection and certification of the product.
(b) An official of the foreign government must certify that any product described on any official certificate was produced in accordance with the regulatory requirements in § 381.196.
(c) The electronic foreign inspection certification must be in English, be transmitted directly to FSIS before the product's arrival at the official import inspection establishment, and be available to import inspection personnel.
(d) The paper foreign inspection certificate must accompany each consignment; be submitted to import inspection personnel at the official import inspection establishment; be in English; and bear the official seal of the foreign government responsible for the inspection of the product, and the name, title, and signature of the official authorized to issue inspection certificates for products imported to the United States.
(e) The electronic foreign inspection certification and paper foreign inspection certificate must contain:
(1) The date;
(2) The foreign country of export and the producing foreign establishment number;
(3) The species used to produce the product and the source country and foreign establishment number, if the source materials originate from a country other than the exporting country;
(4) The product's description, including the process category, the product category, and the product group;
(5) The name and address of the importer or consignee;
(6) The name and address of the exporter or consignor;
(7) The number of units (pieces or containers) and the shipping or identification mark on the units;
(8) The net weight of each lot; and
(9) Any additional information the Administrator requests to determine whether the product is eligible to be imported into the United States.
[79 FR 56234, Sept. 19, 2014]
§ 381.198
Import inspection application.
(a) Applicants must submit an import inspection application to apply for the inspection of any product offered for entry. Applicants may apply for inspection using a paper or electronic application form.
(b) Import inspection applications for each consignment must be submitted (electronically or on paper) to FSIS in advance of the shipment's arrival at the official import establishment where the product will be reinspected, but no later than when the entry is filed with U.S. Customs and Border Protection.
(c) The provisions of this section do not apply to products that are exempted from inspection by §§ 381.207 and 381.209.
[79 FR 56234, Sept. 19, 2014]
§ 381.199
Inspection of poultry products offered for entry.
(a)(1) Except as provided in § 381.209 and paragraph (c) of this section, all slaughtered poultry and poultry products offered for entry from any foreign country shall be reinspected by a Program import inspector before they shall be allowed entry into the United States.
(2) Every lot of product shall routinely be given visual inspection for appearance and condition, and checked for certification and label compliance.
(3) The electronic inspection system shall be consulted for reinspection instructions. The electronic inspection system will assign reinspection levels and procedures based on established sampling plans and established product and plant history.
(4) When the inspector deems it necessary, the inspector may sample and inspect lots not designated by the electronic inspection system.
(b) Inspectors may take, without cost to the United States, from each consignment of poultry products offered for entry, such samples of the products as are deemed necessary to determine the eligibility of the products for entry into the commerce of the United States.
(c) Poultry products imported under § 381.207 shall not be sampled and inspected under this section unless there is reason for suspecting the presence therein of a substance in violation of that section, and in such case they shall be sampled and inspected in accordance with paragraph (a) of this section.
(d) In addition to the provisions specified in paragraphs (a), (b), and (c) of this section, the following requirements apply to imported canned product.
(1) Imported canned products are required to be sound, healthful, properly labeled, wholesome, and otherwise not adulterated at the time the products are offered for importation into the United States. Provided other requirements of this part are met, the determination of the acceptability of the product and the condition of the containers shall be based on the results of an examination of a statistical sample drawn from the consignment as provided in paragraph (a) of this section. If the inspector determines, on the basis of the sample examination, that the product does not meet the requirements of the Act and regulations thereunder, the consignment shall be refused entry. However, a consignment rejected for container defects but otherwise acceptable may be reoffered for inspection under the following conditions:
(i) If the defective containers are not indicative of an unsafe or unstable product as determined by the Administrator;
(ii) If the number and kinds of container defects found in the original sample do not exceed the limits specified for this purpose in FSIS guidelines; and
(iii) If the defective containers in the consignment have been sorted out and exported or destroyed under the supervision of an inspector.
(2) Representative samples of canned product designated by the Administrator in instructions to inspectors shall be incubated under the supervision of such inspectors in accordance with § 381.309 (d)(1)(ii), (d)(1)(iii), (d)(1)(iv)(c), (d)(1)(v), (d)(1)(vii), and (d)(1)(viii) of this subchapter. The importer or his/her agent shall provide the necessary incubation facilities in accordance with § 381.309(d)(1)(i) of this subchapter.
(3) Sampling plans and acceptance levels as prescribed in paragraphs (d)(1) and (d)(2) of this section may be obtained, upon request, from International Programs, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250.
(e) All products, required by this part to be inspected, shall be inspected only at an official establishment or at an official import inspection establishment approved by the Administrator as provided in this section. Such approved official import inspection establishments will be listed in the Meat, Poultry and Egg Product Inspection Directory, published by the Food Safety and Inspection Service. The listing will categorize the kind or kinds of product which may be inspected at each official import inspection establishment, based on the adequacy of the facilities for making such inspections and handling such products in a sanitary manner.
(f) Owners or operators of establishments, other than official establishments, who want to have import inspections made at their establishments, shall apply to the Administrator for approval of their establishments for such purpose. Application shall be made on a form furnished by the Program, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC, and shall include all information called for by that form.
(g) Approval for Federal import inspection shall be in accordance with subpart D of this part.
(h) Owners or operators of establishments at which import inspections of product are to be made shall furnish adequate sanitary facilities and equipment for examination of such product. The requirements of §§ 381.21 and 381.36, and part 416 of this chapter shall apply as conditions for approval of establishments as official import inspection establishments to the same extent and in the same manner as they apply with respect to official establishments.
(i) The Administrator is authorized to approve any establishment as an official import inspection establishment provided that an application has been filed and drawings have been submitted in accordance with the requirements of paragraphs (c) and (d) of this section and he determines that such establishment meets the requirements under paragraph (e) of this section. Any application for inspection under this section may be denied or refused in accordance with the rules of practice in part 500 of this chapter.
(j) Approval of an official import inspection establishment may be withdrawn in accordance with applicable rules of practice if it is determined that the sanitary conditions are such that the product is rendered adulterated, that such action is authorized by section 21(b) of the Federal Water Pollution Control Act, as amended (84 Stat. 91), or that the requirements of paragraph (e) of this section were not complied with. Approval may also be withdrawn in accordance with section 401 of the Act and applicable rules of practice.
(k) A special official number shall be assigned to each official import inspection establishment. Such number shall be used to identify all products inspected and passed for entry at the establishment.
[37 FR 9706, May 16, 1972, as amended at 49 FR 36819, Sept. 20, 1984; 51 FR 45633, Dec. 19, 1986; 54 FR 275, Jan. 5, 1989; 54 FR 41050, Oct. 5, 1989; 79 FR 56234, Sept. 19, 2014]
§ 381.200
Poultry products offered for entry, retention in customs custody; delivery under bond; movement prior to inspection; handling; facilities and assistance.
(a) No slaughtered poultry or other poultry product required by this subpart to be inspected shall be released from customs custody prior to inspection, but such product may be delivered to the consignee, or his agent, prior to inspection, if the consignee shall furnish a bond, in form prescribed by the Secretary of the Treasury, conditioned that the product shall be returned, if demanded, to the collector of the port where the same is offered for clearance through the customs.
(b) Except as provided in paragraph (a) of this section, no product required by this subpart to be inspected shall be moved, prior to inspection, from the port of arrival where first unloaded, and if arriving by water, from the wharf where first unloaded at such port, to any place other than the place designated in accordance with this subpart as the place where the same shall be inspected; and no product shall be conveyed in any manner other than in compliance with this subpart.
(c) The consignee, or his agent, shall furnish such facilities and shall provide such assistance for handling and marking poultry products offered for entry as the inspector may require.
[37 FR 9706, May 16, 1972, as amended at 51 FR 37710, Oct. 24, 1986; 54 FR 41050, Oct. 5, 1989; 56 FR 65180, Dec. 16, 1991]
§ 381.201
Means of conveyance and equipment used in handling poultry products offered for entry to be maintained in sanitary condition.
Compartments of steamships, railroad cars, and other means of conveyance transporting any poultry product to the United States, and all chutes, platforms, racks, tables, tools, utensils, and all other devices used in moving and handling any poultry product offered for entry into the United States, shall be maintained in a sanitary condition.
§ 381.202
Poultry products offered for entry; reporting of findings to customs; handling of articles refused entry; appeals, how made; denaturing procedures.
(a)(1) Program inspectors shall report their findings as to any product which has been inspected in accordance with this part, to the Director of Customs at the original port of entry.
(2) When product has been identified as “U.S. refused entry,” the inspector shall request the Director of Customs to refuse admission to such product and to direct that it be exported by the owner or consignee within the time specified in this section, unless the owner or consignee, within the specified time, causes it to be destroyed by disposing of it under the supervision of a Program employee so that the product can no longer be used as human food, or by converting it to animal food uses, if permitted by the Food and Drug Administration. The owner or consignee of the refused entry product shall not transfer legal title to such product, except to a foreign consignee for direct and immediate exportation, or an end user, e.g., an animal food manufacturer or a renderer, for destruction for human food purposes. “Refused entry” product must be delivered to and used by the manufacturer or renderer within the 45-day time limit. Even if such title is illegally transferred, the subsequent purchaser will still be required to export the product or have it destroyed as specified in the notice under paragraph (a)(4) of this section.
(3) No lot of product which has been refused entry may be subdivided during disposition pursuant to paragraph (a)(2) of this section, except that removal and destruction of any damaged or otherwise unsound product from a lot destined for reexportation is permitted under supervision of USDA prior to exportation. Additionally, such refused entry lot may not be shipped for export from any port other than that through which the product came into the United States without the expressed consent of the Administrator, based on full information concerning the product's disposition, including the name of the vessel and the date of export. For the purposes of this paragraph, the term “lot” shall refer to that product identified on MP Form 410 in the original request for inspection for importation pursuant to § 381.198.
(4) The owner or consignee shall have 45 days after notice is given by FSIS to the Director of Customs at the original port of entry to take the action required in paragraph (a)(2) of this section for “refused entry” product. Extension beyond the 45-day period may be granted by the Administrator when extreme circumstances warrant it; e.g., a dock workers' strike or an unforeseeable vessel delay.
(5) If the owner or consignee fails to take the required action within the time specified under paragraph (a)(4) of this section, the Department will take such actions as may be necessary to effectuate its order to have the product destroyed for human food purposes. The Department shall seek court costs and fees, storage, and proper expenses in the appropriate forum.
(6) No product which has been refused entry and exported to another country pursuant to paragraph (a)(2) of this section may be returned to the United States under any circumstance. Any such product so returned to the United States shall be subject to administrative detention in accordance with section 19 of the Act, and seizure and condemnation in accordance with section 20 of the Act.
(b) Upon the request of the Director of Customs at the port where a product is offered for clearance through the customs, the consignee of the product shall, at the consignee's own expense, immediately return to the Director any product which has been delivered to consignee under this subpart and subsequently designated “U.S. Refused Entry” or found in any request not to comply with the requirements in this subpart.
(c) Except as provided in § 381.200(a) or (b), no person shall remove or cause to be removed from any place designated as the place of inspection, any poultry product which the regulations in this subpart require to be marked in any way, unless the same has been clearly and legibly marked in compliance with this subpart.
(d) Any person receiving inspection service may, if dissatisfied with any decision of an inspector relating to any inspection, file an appeal from such decision: Provided, That such appeal is filed within 48 hours from the time the decision was made. Any such appeal from a decision of an inspector shall be made to his/her immediate supervisor having jurisdiction over the subject matter of the appeal, and such supervisor shall determine whether the inspector's decision was correct. Review of such appeal determination, when requested, shall be made by the immediate supervisor of the employee of the Department making the appeal determination. The cost of any such appeal shall be borne by the appellant if the Administrator determines that the appeal is frivolous. The charges for such frivolous appeal shall be at the rate of $9.28 per hour for the time required to make the appeal inspection. The poultry or poultry products involved in any appeal shall be identified by U.S. retained tags and segregated in a manner approved by the inspector pending completion of an appeal inspection.
(e) All condemned carcasses, or condemned parts of carcasses, or other condemned poultry products, except those condemned for biological residues, shall be disposed of by one of the following methods, under the supervision of an inspector of the Inspection Service. (Facilities and materials for carrying out the requirements in this section shall be furnished by the official establishments.)
(1) Steam treatment (which shall be accomplished by processing the condemned product in a pressure tank under at least 40 pounds of steam pressure) or thorough cooking in a kettle or vat, a sufficient time to effectively destroy the product for human food purposes and preclude dissemination of disease through consumption by animals. (Tanks and equipment used for this purpose or for rendering or preparing inedible products shall be in rooms or compartments separate from those used for the preparation of edible products. There shall be no direct connection by means of pipes, or otherwise, between tanks containing inedible products and those containing edible products.)
(2) Incineration or complete destruction by burning.
(3) Chemical denaturing, which shall be accomplished by the liberal application to all carcasses and parts thereof, of:
(i) Crude carbolic acid,
(ii) Kerosene, fuel oil, or used crankcase oil, or
(iii) Any phenolic disinfectant conforming to commercial standards CS 70-41 or CS 71-41 which shall be used in at least 2 percent emulsion or solution.
(4) Any other substances or method that the Administrator approves in specific cases, which will denature the poultry product to the extent necessary to accomplish the purposes of this section.
(5) Carcasses and parts of carcasses condemned for biological residue shall be disposed of in accordance with paragraph (e)(2) of this section or by burying under the supervision of an inspector.
[37 FR 9706, May 16, 1972, as amended at 48 FR 15890, Apr. 13, 1983; 50 FR 19908, May 13, 1985; 51 FR 37709, Oct. 24, 1986; 53 FR 17015, May 13, 1988; 54 FR 50735, Dec. 11, 1989; 60 FR 67458, Dec. 29, 1995]
§ 381.203
Products offered for entry; charges for storage, cartage, and labor with respect to products which are refused entry.
All charges for storage, cartage, and labor with respect to any product offered for entry which is refused entry pursuant to the regulations shall be paid by the owner or consignee and, in default of such payment, shall constitute a lien against any other products offered for entry thereafter by or for such owner or consignee.
[54 FR 41050, Oct. 5, 1989]
§ 381.204
Marking of poultry products offered for entry; official import inspection marks and devices.
(a) Except for products offered for entry from Canada, poultry products which upon reinspection are found to be acceptable for entry into the United States shall be marked with the official inspection legend shown in paragraph (b) of this section. Such inspection legend shall be placed upon such products only after completion of official import inspection and product acceptance.
(b) The official mark for marking poultry products offered for entry as “U.S. inspected and passed” shall be in the following form, and any device approved by the Administrator for applying such mark shall be an official device. ^2
^2 The number “I-42” is given as an example only. The establishment number of the official establishment or official import inspection establishment where the product was inspected shall be shown on each stamp impression.
Figure 1
(c) When products are refused entry into the United States, the official mark to be applied to the products refused entry shall be in the following form:
Figure 2
(d) The import warning notice prescribed in § 381.200(c) is an official mark.
(e) The ordering and manufacture of brands shall be in accordance with the provisions contained in § 317.3(c) of the Federal meat inspection regulations.
(f) The inspection legend may be placed on containers of product before completion of official import inspection if the containers are being inspected by an import inspector who reports to an Import Field Office Supervisor, the product is not required to be held at the establishment pending the receipt of laboratory test results; and a written procedure for controlled stamping, submitted by the import establishment and approved by the Director, Import Inspection Division, is on file at the import inspection facility where the inspection is to be performed.
(1) The written procedure for controlled pre-stamping should be in the form of a letter and shall include the following:
(i) That stamping under this subpart will be limited to those lots of product which can be inspected on the day that certificates for the product are examined;
(ii) That all products which have been pre-stamped will be stored in the facility where the import inspection will occur;
(iii) That inspection marks applied under this part will be removed from any lot of product subsequently refused entry on the day the product is rejected; and
(iv) That the establishment will maintain a daily stamping log containing the following information for each lot of product: the date of inspection, the country of origin, the foreign establishment number, the product name, the number of units, the shipping container marks, and the MP-410 number covering the product to be inspected. The daily stamping log must be retained by the establishment in accordance with the requirements of § 381.177.
(2) An establishment's controlled pre-stamping privilege may be cancelled orally or in writing by the inspector who is supervising its enforcement whenever the inspector finds that the establishment has failed to comply with the provisions of this subpart or any conditions imposed pursuant thereto. If the cancellation is oral, the decision and the reasons therefor shall be confirmed in writing, as promptly as circumstances allow. Any person whose controlled pre-stamping privilege has been cancelled may appeal the decision to the Administrator, in writing, within ten (10) days after receiving written notification of the cancellation. The appeal shall state all of the facts and reasons upon which the person relies to show that the controlled pre-stamping was wrongfully cancelled. The Administrator shall grant or deny the appeal, in writing, stating the reasons for such decision, as promptly as circumstances allow. If there is a conflict as to any material fact, a hearing shall be held to resolve such conflict. Rules of practice concerning such a hearing will be adopted by the Administrator. The cancellation of the controlled pre-stamping privilege will be in effect until there is a final determination in the proceeding.
(Approved by the Office of Management and Budget under control number 0583-0015)
[51 FR 37710, Oct. 24, 1986, as amended at 53 FR 17015, May 13, 1988; 54 FR 41050, Oct. 5, 1989]
§ 381.205
Labeling of immediate containers of poultry products offered for entry.
(a) Immediate containers of poultry products imported into the United States shall bear a label printed in English showing in accordance with subpart N of this part all information required by that section (except that the inspection mark and establishment number assigned by the foreign poultry inspection system and certified to the Inspection Service shall be shown instead of the official dressed poultry identification mark or other official inspection legend, and official establishment number); and in addition the label shall show the name of the country of origin preceded by the words “Product of,” which statement shall appear immediately under the name of the product.
(b) The labels shall not be false or misleading in any respect.
(c) All marks and other labeling for use on or with immediate containers must be approved for use by the Food Safety and Inspection Service in accordance with part 412 of this chapter before products bearing such marks and other labeling will be permitted for entry into the United States.
[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974; 54 FR 41050, Oct. 5, 1989; 60 FR 67458, Dec. 29, 1995; 78 FR 66838, Nov. 7, 2013]
§ 381.206
Labeling of shipping containers of poultry products offered for entry.
Shipping containers of imported poultry products are required to bear in a prominent and legible manner the name of the product, the name of the country of origin, the foreign inspection system establishment number of the establishment in which the product was processed, and the inspection mark of the country of origin. Labeling on shipping containers shall be examined at the time of inspection in the United States and if found to be false or misleading, the product shall be refused entry. All labeling used with a shipping container of imported poultry products must be approved in accordance with subpart N of this part.
[37 FR 9706, May 16, 1972, as amended at 54 FR 41050, Oct. 5, 1989; 60 FR 67458, Dec. 29, 1995]
§ 381.207
Small importations for consignee's personal use, display, or laboratory analysis.
Any poultry product (other than one which is forbidden entry by other Federal law or regulation) from any country in quantities of less than 50 pounds net weight, exclusively for the personal use of the consignee, or for display or laboratory analysis by the consignee, and not for sale or distribution; which is sound, healthful, wholesome, and fit for human food, and which is not adulterated and contains no substance not permitted by the Act or regulations, may be imported into the United States without a foreign inspection certificate, and such product is not required to be inspected upon arrival in the United States and may be shipped to the consignee without further restriction under this part, except as provided in § 381.199(c): And provided, That the Department may with respect to any specific importation, require that the consignee certify that such product is exclusively for the personal use of said consignee, or for display or laboratory analysis by said consignee, and not for sale or distribution.
[37 FR 9706, May 16, 1972, as amended at 54 FR 41050, Oct. 5, 1989]
§ 381.208
Poultry products offered for entry and entered to be handled and transported as domestic; entry into official establishments; transportation.
(a) All poultry products, after entry into the United States in compliance with this subpart, shall be deemed and treated and, except as provided in § 381.207, shall be handled and transported as domestic products, and shall be subject to the applicable provisions of this part and to the provisions of the Poultry Products Inspection Act and the Federal Food, Drug, and Cosmetic Act.
(b) Poultry products entered in accordance with this subpart may, subject to the provisions of the regulations, be taken into official establishments and be mixed with or added to poultry products that are inspected and passed or exempted from inspection in such establishments.
(c) Imported poultry products which have been inspected, passed, and marked under this subpart may be transported in commerce, only upon compliance with the applicable regulations.
[37 FR 9706, May 16, 1972, as amended at 54 FR 41050, Oct. 5, 1989]
§ 381.209
Returned United States inspected and marked poultry products; exemption.
Poultry products which have been inspected and passed by the U.S. Department of Agriculture and are so marked, and are returned from foreign countries, may be imported if they are not adulterated or misbranded at the time of such return. Such products are exempted from further requirements under this part. Such returned shipments shall be reported to the Administrator by letter prior to arrival at the United States port of entry.

Subpart U—Detention; Seizure and Condemnation; Criminal Offenses
§ 381.210
Poultry and other articles subject to administrative detention.
Any poultry carcass, or part thereof; or any product made wholly or in part from any poultry carcass or part thereof; or any dead, dying, disabled, or diseased poultry is subject to detention for a period not to exceed 20 days when found by any authorized representative of the Secretary upon any premises where it is held for purposes of, or during or after distribution in commerce or otherwise subject to the Act, and there is reason to believe that any such poultry or other article is adulterated or misbranded and is capable of use as human food or has not been inspected, in violation of the provisions of the Act, any other Federal law, or the laws of any State or territory, or the District of Columbia; or that it has been or is intended to be distributed in violation of the provisions of the Act, any other Federal law, or the laws of any State or territory, or the District of Columbia.
§ 381.211
Method of detention; form of detention tag.
An authorized representative of the Secretary shall detain any poultry or other article to be detained under this subpart, by affixing an official “U.S. Detained” tag (FSIS Form 8400-2) to such article.
[55 FR 47843, Nov. 16, 1990]
§ 381.212
Notification of detention to the owner of the poultry or other article, or the owner's agent, and person having custody.
(a) When any poultry or other article is detained under this subpart, an authorized representative of the Secretary shall:
(1) Orally notify the immediate custodian of the poultry or other article detained, and
(2) Promptly furnish a copy of a completed “Notice of Detention” (FSIS Form 8080-1) to the immediate custodian of the detained poultry or other article.
(b) If the owner of the detained poultry or other article, or the owner's agent, is not the immediate custodian at the time of detention and if the owner, or owner's agent, can be ascertained and notified, an authorized representative of the Secretary shall furnish a copy of the completed “Notice of Detention” to the owner, or the owner's agent. Such copy shall be served, as soon as possible, by delivering the notification to the owner, or the owner's agent, or by certifying and mailing the notification to the owner, or the owner's agent, at his or her last known residence or principal office or place of business.
[55 FR 47843, Nov. 16, 1990]
§ 381.213
Notification of governmental authorities having jurisdiction over article detained; form of written notification.
Within 48 hours after the detention of any poultry or other article pursuant to § 381.211, an authorized representative of the Secretary shall give oral or written notification of such detention to any Federal authorities not connected with the Inspection Service, and any State or other governmental authorities, having jurisdiction over such article. In the event notification is given orally, it shall be confirmed in writing, as promptly as circumstances permit.
§ 381.214
Movement of poultry or other article detained; removal of official marks.
(a) No poultry or other article detained in accordance with the provisions in this subpart shall be moved by any person from the place at which it is located when so detained, until released by an authorized representative of the Secretary: Provided, That any such article may be moved from the place at which it is located when so detained, for refrigeration or freezing, or storage purposes if such movement has been approved by an authorized representative of the Secretary and the article so moved will be further detained by an authorized representative of the Secretary after such movement.
(b) Upon terminating the detention of such article, an authorized representative of the Secretary shall:
(1) Orally notify the immediate custodian of the released article, and
(2) Furnish copies of a completed “Notice of Termination of Detention” (FSIS Form 8400-1) to the persons notified when the article was detained. The notice shall be served by either delivering the notice to such persons or by certifying and mailing the notice to such persons at their last known residences or principal offices or places of business.
(c) All official marks may be required by such representative to be removed from such article before it is released unless it appears to the satisfaction of the representative that the article is eligible to retain such marks.
[37 FR 9706, May 16, 1972, as amended at 55 FR 47843, Nov. 16, 1990]
§ 381.215
Poultry or other articles subject to judicial seizure and condemnation.
Any poultry carcass, or part thereof, or any product made wholly or in part from any poultry carcass or part thereof; except those exempted from the definition of a poultry product in § 381.15, or any dead, dying, disabled, or diseased poultry, that is being transported in commerce or is otherwise subject to the Act, or is held for sale in the United States after such transportation, is subject to seizure and condemnation, in a judicial proceeding pursuant to section 20 of the Act if such poultry or other article:
(a) Is or has been processed, sold, transported, or otherwise distributed or offered or received for distribution in violation of the Act; or
(b) Is capable of use as human food and is adulterated or misbranded; or
(c) In any other way is in violation of the Act.
§ 381.216
Procedure for judicial seizure, condemnation, and disposition.
Any poultry or other article subject to seizure and condemnation under this subpart is liable to be proceeded against and seized and condemned, and disposed of, at any time, on an appropriate pleading in any U.S. district court, or other proper court specified in section 21 of the Act, within the jurisdiction of which the article is found.
§ 381.217
Authority for condemnation or seizure under other provisions of law.
The provisions of this subpart relating to detention, seizure, condemnation and disposition of poultry or other articles do not derogate from authority for retention, condemnation, or seizure conferred by other provisions of the Act, or other laws.
§ 381.218
Criminal offenses.
The Act contains criminal provisions with respect to numerous offenses specified in the Act, including but not limited to forcible assaults on, or other interference with, any person while engaged in, or on account of the performance of, his official duties under the Act. Criminal provisions with respect to gifts or offers of bribes to such persons and related offenses are contained in the general criminal code (18 U.S.C. 201).

Subpart V—Special Provisions for Designated States and Territories; Criteria and Procedure for Designating Establishments With Operations Which Would Clearly Endanger the Public Health; Disposition of Poultry Products Therein
§ 381.220
Definition of “State”.
For purposes of this subpart, the term “State” means any State (including the Commonwealth of Puerto Rico) or organized territory.
§ 381.221
Designation of States under paragraph 5(c) of the Act.
Each of the following States has been designated, under paragraph 5(c) of the Act, as a State in which the provisions of sections 1 through 4, 6 through 10, and 12 through 22 of the Act shall apply to operations and transactions wholly within the State. The Federal provisions apply, effective on the dates shown below:
States | Effective date of application of Federal provisions
Alaska | July 31, 1999.
Arkansas | Jan. 2, 1971.
California | Apr. 1, 1976.
Colorado | Jan. 2, 1971.
Connecticut | Oct. 1, 1975.
Florida | Dec. 2, 1997.
Georgia | Jan. 2, 1971.
Guam | Jan. 21, 1972.
Hawaii | Nov. 1, 1995.
Idaho | Jan. 2, 1971.
Kentucky | July 28, 1971.
Maryland | Mar. 31, 1991.
Massachusetts | Jan. 12, 1976.
Michigan | Jan. 2, 1971.
Nebraska | July 28, 1971.
Nevada | July 1, 1973.
New Hampshire | Aug. 6, 1978
New Jersey | Do.
New Mexico | Aug. 13, 2007.
New York | Apr. 10, 1977.
Northern Mariana Islands | Oct. 29, 1979.
Oregon | Jan. 2, 1971.
Pennsylvania | Oct. 31, 1971.
Puerto Rico | Jan. 17, 1972.
Rhode Island | Oct. 1, 1981.
South Dakota | Jan. 2, 1971.
Tennessee | Oct. 1, 1975.
Virgin Islands | Nov. 27, 1971.
Washington | June 1, 1973.
[42 FR 2949, Jan. 14, 1977]

Editorial Note:
For Federal Register citations affecting § 381.221, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.
§ 381.222
States designated under paragraph 5(c) of the Act; application of regulations.
The provisions of the regulations in this part apply to operations and transactions wholly within each State designated in § 381.221 under paragraph 5(c) of the Act, except as otherwise provided in this section. (The provisions of the regulations apply in all respects to operations and transactions in or for commerce.)
(a) Each establishment located in such a designated State, shall be granted inspection required under § 381.6(b) only if it is found, upon a combined evaluation of its premises, facilities, and operating procedures, to be capable of producing products that are not adulterated or misbranded.
(b) Section 381.26 will apply to establishments required to have inspection under § 381.6(b), except that existing interconnections between official and unofficial establishments or between official establishments will be permitted if it is determined in specific cases that the interconnections are such that transfer of inedible poultry product into the official establishment would be difficult or unusual, and any such transfers are strictly prohibited, except as permitted under other provisions of the regulations. It is essential that separation of facilities be maintained to the extent necessary to assure that inedible poultry product does not enter the official establishment contrary to the regulations.
(c) Sections 381.49 and 381.51 shall apply to such establishments, except that separate facilities for men and women workers will not be required when the majority of the workers in the establishment are related by blood or marriage, provided that this will not conflict with municipal or State requirements; and except that separation of toilet soil lines from house drainage lines to a point outside the buildings will not be required in existing construction when positive acting backflow devices are installed.
(d) Subpart N of this part shall apply to such establishments except as provided in this paragraph (d).
(1) The operator of each such establishment shall, prior to the inauguration of inspection, identify all labeling and marking devices in use, or proposed for use (upon the date of inauguration of inspection) to the Front Line Supervisor in which the establishment is located. Temporary approval, pending formal approval under § 412.1 of this chapter, will be granted by the Front Line Supervisor for labeling and marking devices that he determines are neither false nor misleading, provided the official inspection legend bearing the official establishment number is applied to the principal display panel of each label, either by a mechanical printing device or a self-destructive pressure sensitive sticker, and provided the label shows the true product name, an accurate ingredient statement, the name and address of the manufacturer, packer, or distributor, and any other features required by section 4(h) of the Act.
(2) The Front Line Supervisor will forward one copy of each item of labeling and a description of each marking device for which he has granted temporary approval to the FSIS Labeling and Program Delivery Staff and will retain one copy in a temporary approval file for the establishment.
(3) The operator of the official establishment shall promptly forward a copy of each item of labeling and a description of each marking device for which temporary approval has been granted by the Front Line Supervisor (showing any modifications required by the Front Line Supervisor) to the FSIS Labeling and Program Delivery Staff at headquarters, accompanied by the formula and details of preparation and packaging for each product. Within 90 days after inauguration of inspection, all labeling material and marking devices temporarily approved by the Front Line Supervisor must receive approval as required by § 412.1 or their use must be discontinued.
(4) The Front Line Supervisor will also review all shipping containers to ensure that they do not have any false or misleading labeling and are otherwise not misbranded. Modifications of unacceptable information on labeling material by the use of pressure sensitive tape of a type that cannot be removed without visible evidence of such removal, or by blocking out with an ink stamp will be authorized on a temporary basis to permit the maximum allowable use of all labeling materials on hand. All unacceptable labeling material which is not modified to comply with the requirements of the regulations must be destroyed or removed from the official establishment.
(e) Sections 381.175 through 381.179 apply to operations and transactions not in or for commerce in a State designated under paragraph 5(c) only if the State is also designated under section 11 of the Act and if such provisions are applicable as shown in § 381.224.
(f) Section 381.185(a) will not apply to States designated under paragraph 5(c) of the Act.
(g) Provisions of this part relating to exports and imports do not apply to operations and transactions solely in or for intrastate commerce.
[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974; 62 FR 45027, Aug. 25, 1997; 78 FR 66838, Nov. 7, 2013]
§ 381.223
Control and disposition of nonfederally inspected poultry products in States designated under paragraph 5(c) of the Act.
Upon the effective date of designation of a State under paragraph 5(c) of the Act, no poultry products can be processed within the State unless they are prepared under inspection pursuant to the regulations or are exempted from the requirement of inspection under § 381.10, and no unexempted poultry products which were processed without any inspection can lawfully be distributed within the State. For a period of 90 days from the effective date of such designation, poultry products which were processed in any State listed in § 381.187 and inspected and passed under the supervision of a responsible State or local inspection agency or exempted from State inspection can be distributed solely within the State, provided they are not adulterated or misbranded, except that the official inspection legend shall not be used. Such products may not enter official establishments. After said 90-day period, only federally inspected and passed products may be distributed within the designated State, except as provided in § 381.10.
§ 381.224
Designation of States under section 11 of the Act; application of sections of the Act and the regulations.
Each of the following States has been designated, effective on the date shown below, under section 11 of the Act, as a State in which the provisions of the sections of the Act and regulations specified below shall apply to operators engaged, other than in or for commerce, in the kinds of business indicated below:
Paragraphs of act and regulations | Classes of operators | State | Effective date
Act, 11(b): §§ 381.175-381.178 | Persons engaged (not in or for commerce) in (1) the business of slaughtering any poultry or processing, freezing, packaging, or labeling any poultry carcasses, or parts or products thereof, for use as human food or animal food; (2) the business of buying or selling (as a poultry products broker, wholesaler, or otherwise), transporting or storing any poultry carcasses, or parts or products thereof; or (3) business as a renderer or in the business of buying, selling, or transporting any dead, dying, disabled, or diseased poultry or parts of carcasses of any poultry that died otherwise than by slaughter | Alaska Arkansas California Colorado Connecticut Georgia Guam Idaho Kentucky Maryland Massachusetts Michigan Nebraska Nevada New Hampshire New Jersey New York Northern Mariana Islands Oregon Pennsylvania Puerto Rico Rhode Island South Dakota Tennessee Virgin Islands Washington | July 31, 1999. Apr. 1, 1976. July 1, 1975. Oct. 1, 1975. Nov. 12, 1976. Nov. 19, 1976. Nov. 12, 1976. Apr. 18, 1973. Nov. 12, 1976. Jan. 12, 1976. Nov. 12, 1976. Jan. 31, 1975. Jan. 31, 1975. Oct. 29, 1979. July 1, 1975. July 16, 1975. July 23, 1973. Oct. 29, 1979. Jan. 31, 1975. May 2, 1974. Nov. 19, 1976. Mar. 29, 1982. Nov. 12, 1976. Oct. 1, 1975. Nov. 19, 1976. Jan. 31, 1975. Nov. 12, 1976.
Act, 11(c); § 381.179 | Persons engaged (not in or for commerce) in business as a poultry products broker; renderer; animal food manufacturer; wholesaler or public warehouseman of poultry carcasses, or parts or products thereof; or buying, selling, or transporting dead, dying, disabled, or diseased poultry or parts of carcasses of any poultry that died otherwise than by slaughter | Alaska Arkansas California Colorado Connecticut Georgia Guam Idaho Kentucky Maryland Massachusetts Michigan Nebraska Nevada New Hampshire New Jersey New York Northern Mariana Islands Oregon Pennsylvania Puerto Rico Rhode Island South Dakota Tennessee Virgin Islands Washington | July 31, 1999. Apr. 1, 1976. July 1, 1975. Oct. 1, 1975. Nov. 12, 1976. Nov. 19, 1976. Nov. 12, 1976. Apr. 18, 1973. Nov. 12, 1976. Jan. 12, 1976. Nov. 12, 1976. Jan. 31, 1975. Jan. 31, 1975. Oct. 29, 1979. July 1, 1975. July 16, 1975. July 23, 1973. Oct. 29, 1979. Jan. 31, 1975. May 2, 1974. Nov. 19, 1976. Mar. 29, 1982. Nov. 12, 1976. Oct. 1, 1975. Nov. 19, 1976. Jan. 31, 1975. Nov. 12, 1976.
| Act, 11(d); 381.194 | Persons engaged (not in or for commerce) in the business of buying, selling or transporting any dead, dying, disabled or diseased poultry, or parts or carcasses of any poultry that died otherwise than by slaughter | Alaska Arkansas Georgia Guam Idaho Maryland Michigan New Hampshire Northern Mariana Islands Puerto Rico Rhode Island South Dakota Virgin Islands | July 31, 1999. Nov. 12, 1976. Nov. 19, 1976. Nov. 12, 1976. Nov. 12, 1976. Nov. 12, 1976. Oct. 29, 1979. Oct. 29, 1979. Nov. 19, 1976. Mar. 29, 1982. Nov. 12, 1976. Nov. 19, 1976. Nov. 12, 1976.
[37 FR 9706, May 16, 1972; 65 FR 6888, Feb. 11, 2000]

Editorial Note:
For Federal Register citations affecting § 381.224, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.
§ 381.225
Criteria and procedure for designating establishments with operations which would clearly endanger the public health; disposition of poultry products therein.
(a) An establishment in any State not listed in § 381.221 that is preparing poultry products solely for distribution within such State shall be designated as one producing adulterated products which would clearly endanger the public health, if:
(1) Any poultry product processed at the establishment is adulterated in any of the following respects:
(i) It bears or contains a pesticide chemical, food additive, or color additive, that is “unsafe” within the meaning of section 408, 409, or 706 of the Federal Food, Drug, and Cosmetic Act or was intentionally subjected to radiation in a manner not permitted under section 409 of said Act; or if it bears or contains any other added poisonous or added deleterious substance which may render it injurious to health or make it unfit for human food; or
(ii) 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 (for example, it was prepared from a poultry carcass or other ingredients exhibiting spoilage characteristics); or it is, or was prepared from, a poultry carcass which would be required to be condemned under subpart K at official establishments; or
(iii) It has been prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth or may have been rendered injurious to health (for example, if insects or vermin are not effectively controlled at the establishment, or insanitary water is used in preparing poultry products for human food); or
(iv) It is, in whole or in part, the product of poultry that died otherwise than by slaughter; or
(v) Its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; and
(2) Such adulterated articles are intended to be or are distributed from the establishment while capable of use as human food.
(b) When any such establishment is identified by an inspector as one producing adulterated poultry products which would clearly endanger public health under the criteria in paragraph (a) of this section, the following procedure will be followed:
(1) The inspector will informally advise the operator of the establishment concerning the deficiencies found by him and report his findings to the appropriate Regional Director for the Inspection Service. When it is determined by the Regional Director that any establishment preparing poultry products solely for distribution within any State is producing adulterated poultry products for distribution within such State which would clearly endanger the public health, written notification thereof will be issued to the appropriate State officials, including the Governor of the State and the appropriate Advisory Committee, for effective action under State or local law to prevent such endangering of the public health. Such written notification shall clearly specify the deficiencies deemed to result in the production of adulterated poultry products and shall specify a reasonable time for such action under State or local law.
(2) If effective action is not taken under State or local law within the specified time, written notification shall be issued by the Regional Director to the operator of the establishment, specifying the deficiencies involved and allowing him 10 days to present his views or make the necessary corrections, and notifying him that failure to correct such deficiencies may result in designation of the establishment and operator thereof as subject to the provisions of sections 1 through 4, 6 through 10, and 12 through 22 of the Act as though engaged in commerce.
(3) Thereafter the inspector shall survey the establishment and designate it if he determines, in consultation with the Regional Director, that it is producing adulterated poultry products, which would clearly endanger the public health, and formal notice of such designation will be issued to the operator of the establishment by the Regional Director.
(c) Poultry products on hand at the time of designation of an establishment under this section are subject to retention or detention, and seizure and condemnation in accordance with § 381.145 or subpart U of this part: Provided, That poultry products that have been federally inspected and so identified and that have not been further prepared at any nonfederally inspected establishment may be released for distribution if the products appear to be not adulterated or misbranded at the time of such release.
(d) No establishment designated under this section can lawfully prepare any poultry products unless it first obtains inspection or qualifies for exemption under § 381.10 of this subpart. All other provisions of the regulations shall apply to establishments designated under this section to the same extent and in the same manner as if they were engaged in commerce, except that the exceptions provided for in § 381.222 shall apply to such establishments.
Subpart X [Reserved]

Subpart Y—Nutrition Labeling

Source:
58 FR 675, Jan. 6, 1993, unless otherwise noted.
§ 381.400
Nutrition labeling of poultry products.
(a) Nutrition labeling must be provided for all poultry products intended for human consumption and offered for sale, except single-ingredient, raw poultry products that are not ground or chopped poultry products described in § 381.401 and are not major cuts of single-ingredient, raw poultry products identified in § 381.444, unless the product is exempted under § 381.500. Nutrition labeling must be provided for the major cuts of single-ingredient, raw poultry products identified in § 381.444, either in accordance with the provisions of § 381.409 for nutrition labels, or in accordance with the provisions of § 381.445 for point-of-purchase materials, except as exempted under § 381.500. For all other products that require nutrition labeling, including ground or chopped poultry products described in § 381.401, nutrition labeling must be provided in accordance with the provisions of § 381.409, except as exempted under § 381.500.
(b) Nutrition labeling may be provided for single-ingredient, raw poultry products that are not ground or chopped poultry products described in § 381.401 and that are not major cuts of single-ingredient, raw poultry products identified in § 381.444, either in accordance with the provisions of § 381.409 for nutrition labels, or in accordance with the provisions of § 381.445 for point-of-purchase materials.
[75 FR 82166, Dec. 29, 2010]
§ 381.401
Required nutrition labeling of ground or chopped poultry products.
Nutrition labels must be provided for all ground or chopped poultry (kind) with or without added seasonings (including, but not limited to, ground chicken, ground turkey, and (kind) burgers) that are intended for human consumption and offered for sale, in accordance with the provisions of § 381.409, except as exempted under § 381.500.
[75 FR 82166, Dec. 29, 2010]
§ 381.402
Location of nutrition information.
(a) Nutrition information on a label of a packaged poultry 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) Poultry 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 675, Jan. 6, 1993, as amended at 59 FR 40215, Aug. 8, 1994]
§§ 381.403-381.407
[Reserved]
§ 381.408
Labeling of poultry products with number of servings.
The label of any package of a poultry product that bears a representation as to the number of servings contained in such package shall meet the requirements of § 381.121(c)(7).
§ 381.409
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, the 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 § 381.412(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 § 381.412(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 that are not ground or chopped poultry products as described in § 381.401 may be declared on the basis of the product “as consumed.” For single-ingredient, raw products that are not ground or chopped poultry products described in § 381.401, if data are based on the product “as consumed,” the data must be presented in accordance with § 381.445(d). In addition to the required declaration on the basis of “as packaged” for products other than single-ingredient, raw products that are not ground or chopped poultry products as described in § 381.401, 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., chicken wings, 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., chicken wings 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., chicken wings 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 § 381.412(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, pan of poultry lasagna), 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 § 381.412(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 § 381.412(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 turkey, turkey breast, ground poultry), 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., turkey breast 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 § 381.412(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 12/3 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., wing, 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., chicken wings 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 § 381.412(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 chicken roll. 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, 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. The declaration of the number of servings per container need not be included in nutrition labeling of single-ingredient, raw poultry products that are not ground or chopped poultry products described in § 381.401, including those that have been previously frozen.
(11) The declaration of nutrient and food component content shall be on the basis of product as packaged or purchased with the exception of single-ingredient, raw products that are not ground or chopped poultry products described in § 381.401 and 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 § 381.413(l) and § 381.413 (m) in single-serve 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 § 381.412(b) if the product is listed in § 381.412(b). Serving size for meal-type products and main-dish products in multi-serve containers that are not listed in § 381.412(b) will be based on the reference amount according to § 381.412(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 § 381.409(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 poultry 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 poultry 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 § 381.462(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 § 381.462(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 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.
(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 § 381.409(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 B 12, 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) | 2400
Potassium | ......do | 3500
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 § 381.500(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 or on single-ingredient, raw poultry products that are not ground or chopped poultry products described in § 381.401.
(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 heading “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 § 381.500(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 | 2400 mg | 2400 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:
(13)(i) Nutrition labeling on the outer label of packages of poultry 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., poultry 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 § 381.412(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, but may be on the basis of 'as consumed' for single-ingredient, raw poultry products that are not ground or chopped poultry products described in § 381.401, and according to the label serving size based on the Reference Amount in § 381.412(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, but may be on the basis of 'as consumed' for single-ingredient, raw poultry products that are not ground or chopped poultry products described in § 381.401, and according to the label serving size based on the Reference Amount in § 381.412(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, but may be on the basis of 'as consumed' for single-ingredient, raw poultry products that are not ground or chopped poultry products described in § 381.401, 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:
(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 § 381.500(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 § 381.402(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 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 § 381.409(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 4(h) of the Poultry Products Inspection Act (21 U.S.C. 453(h)(4)) 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 4(h) of the Poultry Products Inspection Act (21 U.S.C. 453(h)(4)) 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 poultry products that are not ground or chopped poultry products described in § 381.401, 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 released form, the USDA National Nutrient Database for Standard Reference, as provided in § 381.445(e) and (f).
(Paperwork requirements were approved by the Office of Management and Budget under control number 0583-0088.)
[58 FR 675, Jan. 6, 1993; 58 FR 43788, Aug. 18, 1993, as amended at 58 FR 47628, Sept. 10, 1993; 59 FR 45196, Sept. 1, 1994; 60 FR 197, Jan. 3, 1995; 60 FR 10304, Feb. 24, 1995; 69 FR 58802, Oct. 1, 2004; 75 FR 82166, Dec. 29, 2010]
§§ 381.410-381.411
[Reserved]
§ 381.412
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 poultry), 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 poultry and poultry 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 the 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 with poultry) | 110 g | n/a
Salad and potato toppers; e.g., poultry bacon bits | 7 g | n/a
Bacon; e.g., poultry breakfast strips. | 15 g | 26 g = bacon. 18 g = breakfast strips
Dried; e.g., poultry jerky, dried poultry, poultry sausage products with a moisture/protein ratio of less than 2:1 | 30 g | n/a
Snacks; e.g., poultry snack food sticks | 30 g | n/a
Luncheon products, poultry bologna, poultry Canadian style bacon, poultry crumbles, poultry luncheon loaf, potted poultry products, poultry taco filings | 55 g | n/a
Linked poultry sausage products, poultry franks, poultry Polish sausage, smoked or pickled poultry meat, poultry smoked sausage | 55 g | n/a 69 g = uncooked sausage.
Entrees without sauce, poultry cuts, ready to cook poultry cuts, including marinated, tenderized, injected cuts of poultry, poultry corn dogs, poultry croquettes, poultry fritters, cured poultry ham products, adult pureed poultry | 85 g | 114g
Canned poultry, canned chicken, canned ^4 turkey | 55 g | n/a
Entrees with sauce, turkey and gravy | 140 g | n/a
Mixed dishes NOT measurable with a cup; ^5 e.g., poultry burrito, poultry enchiladas, poultry pizza, poultry quiche, all types of poultry sandwiches, cracker and poultry lunch-type packages, poultry gyro, poultry stromboli, poultry frank on a bun, poultry burger on a bun, poultry taco, chicken cordon bleu, poultry calzone, stuffed vegetables with poultry, poultry kabobs | 140 g (plus 55 g for products toppings) | n/a
Mixed dishes, measurables with a cup; e.g., poultry casserole, macaroni and cheese with poultry, poultry pot pie, poultry spaghetti with sauce, poultry chili, poultry chili with beans, poultry hash, creamed dried poultry, poultry ravioli in sauce, poultry a la king, poultry stew, poultry goulash, poultry lasagna, poultry-filled pasta | 1 cup | n/a
Salads—pasta or potato, potato salad with poultry, macaroni and poultry salad | 140 g | n/a
Salads—all other, poultry salads, chicken salad, turkey salad | 100 g | n/a
Soups—all varieties | 245 g | n/a
| Major main entree type sauce; e.g., spaghetti sauce with poultry | 125 g | n/a
Minor main entree sauce; e.g., pizza sauce with poultry, gravy | 1/4 cup | n/a
Seasoning mixes dry, freeze dry, dehydrated, concentrated soup mixes, bases, extracts, dried broths and stock/juice, freeze dry trail mix products with poultry
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 a 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., poultry 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 § 381.413(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 parenthesis, 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 381.412 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., turkey 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 poultry 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 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 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.
(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 675, Jan. 6, 1993; 58 FR 43789, Aug. 18, 1993, as amended at 58 FR 47628, Sept. 10, 1993; 59 FR 45198, Sept. 1, 1994; 60 FR 207, Jan. 3, 1995]
§ 381.413
Nutrient content claims; general principles.
(a) This section applies to poultry 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 § 381.409, 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 Y 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 § 381.409 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 § 381.121(c) 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 § 381.500(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 chicken 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., “chicken breast meat, a low sodium 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 §§ 381.413, 381.454, 381.456, 381.460, 381.461, 381.462, and 381.480, 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 § 381.500(d)(2).
(h) [Reserved]
(i) Except as provided in § 381.409 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 Y 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 § 381.121(c) 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 § 381.500(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 § 381.462(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 § 381.121(c) 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 § 381.500(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;
(C) A claim on the information panel; or
(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;
(C) Milk, yogurt, and cheese;
(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 entrèe. 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)Iii)(E) of this section.
(A) Bread, cereal, rice, and pasta;
(B) Fruits and vegetables;
(C) Milk, yogurt, and cheese;
(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)(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 a form commonly understood to be, a main dish (e.g., not a beverage or a dessert). Such representations may be made by statements, photographs, or vignettes.
(n) Nutrition labeling in accordance with § 381.409 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 § 381.409(h).
(p)(1) Unless otherwise specified, the reference amount customarily consumed set forth in § 381.412(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 § 381.412(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 § 381.121(c) 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 § 381.500(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 4(h) of the Act (21 U.S.C. 453(h)(4)).
(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 § 381.409 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 § 381.469.
[58 FR 675, Jan. 6, 1993; 58 FR 43789, Aug. 18, 1993, as amended at 58 FR 47628, Sept. 10, 1993; 59 FR 40215, Aug. 8, 1994; 59 FR 45198, Sept. 1, 1994; 60 FR 208, Jan. 3, 1995; 69 FR 58802, Oct. 1, 2004]
§§ 381.414-381.443
[Reserved]
§ 381.444
Identification of major cuts of poultry products.
The major cuts of single-ingredient, raw poultry products are: Whole chicken (without neck and giblets), chicken breast, chicken wing, chicken drumstick, chicken thigh, whole turkey (without necks and giblets; separate nutrient panels for white and dark meat permitted as an option), turkey breast, turkey wing, turkey drumstick, and turkey thigh.
§ 381.445
Nutrition labeling of single-ingredient, raw poultry products that are not ground or chopped products described in § 381.401.
(a)(1) Nutrition information on the major cuts of single-ingredient, raw poultry products identified in § 381.444, including those that have been previously frozen, is required, either on their label or at their point-of-purchase, unless exempted under § 381.500. If nutrition information is presented on the label, it must be provided in accordance with the provisions of § 381.409. If nutrition information is presented at the point-of-purchase, it must be provided in accordance with the provisions of this section.
(2) Nutrition information on single-ingredient, raw poultry products that are not ground or chopped poultry products described in § 381.401 and are not major cuts of single-ingredient, raw poultry products identified in § 381.444, including those that have been previously frozen, may be provided at their point-of-purchase in accordance with the provisions of this section or on their label, in accordance with the provisions of § 381.409.
(3) A retailer may provide nutrition information at the point-of-purchase by various methods, 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 format and content requirements of § 381.409 apply. However, if only nutrition information—and not a nutrition claim—is supplied on point-of-purchase materials, the requirements of § 381.409 apply, provided, however:
(i) The listing of percent of Daily Value for the nutrients (except vitamins and minerals specified in § 381.409(c)(8)) and footnote required by § 381.409(d)(9) may be omitted; and
(ii) The point-of-purchase materials are not subject to any of the format requirements.
(b) [Reserved]
(c) For the point-of-purchase materials, the declaration of nutrition information may be presented in a simplified format as specified in § 381.409(f).
(d) The nutrition label data for products covered in paragraphs (a)(1) and (a)(2) must be based on either raw or cooked edible portions of poultry cuts with skin. If data are based on cooked portions, the methods used to cook the products must be specified and for products covered in paragraphs (a)(1) and (a)(2) must 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 skinless poultry meat.
(e) Nutrient data that are the most current representative data base values contained in USDA's National Nutrient Data Bank or its released form, the USDA National Nutrient Database for Standard Reference, may be used for nutrition labeling of single-ingredient, raw poultry products, including those that have been previously frozen. These data may be composite data that reflect different classes of turkey or other variables affecting nutrient content. Alternatively, data that reflect specific classes or other variables may be used, except that if data are used on labels attached to a product which is labeled as to class of poultry 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 poultry tissues present in the package.
(f) If the nutrition information is provided in accordance with paragraph (e) of this section, a nutrition label or labeling will not be subject to the Agency compliance review under § 381.409(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 poultry products, 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 675, Jan. 6, 1993, as amended at 58 FR 47628, Sept. 10, 1993; 60 FR 209, Jan. 3, 1995; 75 FR 82166, Dec. 29, 2010]
§§ 381.446-381.453
[Reserved]
§ 381.454
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 § 381.409(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 § 381.413; and
(3) The product for which the claim is made is labeled in accordance with § 381.409.
(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 § 381.413(l) and main-dish products as defined in § 381.413(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 § 381.413(l) and main-dish product as defined in § 381.413(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 § 381.413(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 § 381.413(l) and main-dish product as defined in § 381.413(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 § 381.462(b)(2) or, in the case of a meal-type product or in a main-dish product, is not “low” in total fat as defined in § 381.462(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 § 381.413(l) and main-dish products as defined in § 381.413(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 § 381.413(j)(1); and
(ii) As required in § 381.413(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 § 381.413(l) and main-dish products as defined in § 381.413(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 § 381.413(j)(1); and
(ii) As required in § 381.413(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 per 3 ounces (oz) than does ‘reference product’ ”), and
(B) Quantitative information comparing the level of the nutrient in the meal-type product or in 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 210, Jan. 3, 1995, as amended at 69 FR 58803, Oct. 1, 2004]
§ 381.455
[Reserved]
§ 381.456
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 § 381.413; and
(3) The product for which the claim is made is labeled in accordance with § 381.409.
(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 § 381.413(l) and main-dish products as defined in § 381.413(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 § 381.413(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 § 381.413(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 § 381.413(j)(1); and
(3) As required in § 381.413(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 § 381.413(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 § 381.413(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., 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 § 381.413(l) and main-dish products as defined in § 381.413(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 § 381.413(l) and main-dish product as defined in § 381.413(m), provided that:
(i) The product meets the definition of:
(A) “Low in calories” as defined in § 381.460(b)(3); or
(B) “Low in fat” as defined in § 381.462(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 § 381.413(l) and main-dish product as defined in § 381.413(m), provided that the product meets the definition of “low in sodium” as defined in § 381.461(b)(5)(i); and
(ii) “Light” or “lite” and “in sodium” are presented in uniform type size, style, color, and prominence.
(3) The terms “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 § 381.413(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
(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) 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 § 381.413(j)(1)(i)(B) and (j)(1)(ii)(B), provided that if the product is not “low in sodium” as defined in § 381.461(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 § 381.413(j)(2).
[60 FR 210, Jan. 3, 1995, as amended at 69 FR 58803, Oct. 1, 2004]
§§ 381.457-381.459
[Reserved]
§ 381.460
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 § 381.413; and
(3) The product for which the claim is made is labeled in accordance with § 381.409.
(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 § 381.413(l) and main-dish products as defined in § 318.413(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 § 381.409(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 § 381.413(l) and main-dish product as defined in § 381.413(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 § 381.413(l) and main-dish products as defined in § 318.413(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 § 381.413(j)(1); and
(ii) As required in § 381.413(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’—“33 1/3 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 § 381.413(l) and main-dish product as defined in § 381.413(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 § 381.413(j)(1); and
(ii) As required in § 381.413(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 § 381.409(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 § 381.409(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 § 381.413(l) and main-dish products as defined in § 318.413(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 § 381.413(j)(1); and
(ii) As required in § 381.413(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 § 381.413(l) and main-dish product as defined in § 381.413(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 § 381.413(j)(1); and
(ii) As required in § 381.413(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 211, Jan. 3, 1995, as amended at 69 FR 58803, Oct. 1, 2004]
§ 381.461
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 § 381.413; and
(3) The product for which the claim is made is labeled in accordance with § 381.409.
(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 § 381.413(l) and main-dish products as defined in § 381.413(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 § 381.409(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.
(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 § 381.413(l) and main-dish product as defined in § 381.413(m), provided that:
(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 § 381.413(l) and main-dish products as defined in § 381.413(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 § 381.409(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.
(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 § 381.413(l) and main-dish product as defined in § 381.413(m), provided that:
(i) The product contains 140 mg or less sodium per 100 g of product; 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.
(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 § 381.413(l) and main-dish products as defined in § 381.413(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 § 381.413(j)(l); and
(ii) As required in § 381.413(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 § 381.413(l) and main-dish product as defined in § 381.413(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 § 381.413(j)(l); and
(ii) As required in § 381.413(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 213, Jan. 3, 1995; 60 FR 5762, Jan. 30, 1995, as amended at 69 FR 58803, Oct. 1, 2004]
§ 381.462
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 § 381.413; and
(3) The product for which the claim is made is labeled in accordance with § 381.409.
(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 § 381.413(l) and main-dish products as defined in § 381.413(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 § 381.409(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.
(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 § 381.413(l) and main-dish product as defined in § 381.413(m), provided that:
(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
(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.
(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 § 381.413(l) and main-dish products as defined in § 381.413(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 § 381.413(j)(1); and
(ii) As required in § 381.413(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.”
(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 § 381.413(l) and main-dish product as defined in § 381.413(m), provided that:
(i) The product contains at least 25 percent less fat per 100 g of product than an appropriate reference product as described in § 381.413(j)(1); and
(ii) As required in § 381.413(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 § 381.413(l) and main-dish products as defined in § 381.413(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 § 381.413(l) and main-dish product as defined in § 381.413(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 § 381.413(l) and main-dish products as defined in § 381.413(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 § 381.413(j)(1); and
(ii) As required in § 381.413(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.”
(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 § 381.413(l) and main-dish product as defined in § 381.413(m), provided that:
(i) The product contains at least 25 percent less saturated fat per 100 g of product than an appropriate reference product as described in § 381.413(j)(1); and
(ii) As required in § 381.413(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 § 381.413(l) and main-dish product as defined in § 381.413(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 § 381.413(l) and main-dish product as defined in § 381.413(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 § 381.413(j)(1) and for which it substitutes as described in § 381.413(d) that has a significant (e.g., 5 percent or more of a national or regional market) market share. As required in § 381.413(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 § 381.413(l) and main-dish products as defined in § 381.413(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 § 381.409(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 § 381.413(j)(1) and for which it substitutes as described in § 381.413(d) that has a significant (e.g., 5 percent or more of a national or regional market) market share. As required in § 381.413(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 § 381.413(l) and main-dish product as defined in § 381.413(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 § 381.413(d), excluding meal-type products as defined in § 381.413(l) and main-dish products as defined in § 381.413(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 § 381.413(j)(1) and for which it substitutes as described in § 381.413(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 § 381.413(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 § 381.413(l) and main-dish product as defined in § 381.413(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 § 381.413(j)(1) and for which it substitutes as described in § 381.413(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 100 g of product; and
(iii) As required in § 381.413(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 § 381.413(l) and main-dish products as defined in § 381.413(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 § 381.413(l) and main-dish products as defined in § 381.413(m).
(f) A statement of the lean percentage may be used on the label or in labeling of ground or chopped poultry products described in § 381.401 when the product does not meet the criteria for “low fat,” defined in § 381.462(b)(2), provided that a statement of the fat percentage is contiguous to and in lettering of the same color, size, type, and on the same color background, as the statement of the lean percentage.
[60 FR 214, Jan. 3, 1995, as amended at 69 FR 58803, Oct. 1, 2004; 75 FR 82167, Dec. 29, 2010]
§ 381.463
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 poultry product, provided that the product is labeled in accordance with § 381.409 and § 381.413.
(b)(1) The product shall meet the requirements for “low fat” and “low saturated fat,” as defined in § 381.462, except that single-ingredient, raw products may meet the total fat and saturated fat criteria for “extra lean” in § 381.462.
(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 § 381.409(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 § 381.413(m), and meal-type product, as defined in § 381.413(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 § 381.462.
(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 § 381.409(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 § 381.413(m), and meal-type product, as defined in § 381.413(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 poultry 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 § 381.409 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 § 381.413(m), and including meal-type 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 § 381.413(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 217, Jan. 3, 1995; 63 FR 7281, Feb. 13, 1998; 64 FR 72492, Dec. 28, 1999; 68 FR 463, Jan. 6, 2003; 69 FR 58803, Oct. 1, 2004; 71 FR 1686, Jan. 11, 2006]
§§ 381.464-381.468
[Reserved]
§ 381.469
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 381.469 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 381.409(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 above 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.
(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.
(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 poultry 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 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 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 381.469 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 Y of part 381).
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 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)
(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 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.
(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.
(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 381.469 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
(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 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.
(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.
(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 a 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 poultry 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 implied 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 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 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 675, Jan. 6, 1993, as amended at 59 FR 45198, Sept. 1, 1994; 60 FR 217, Jan. 3, 1995]
§§ 381.470-381.479
[Reserved]
§ 381.480
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 § 381.409 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 § 381.460.
(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 § 387.460(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 § 381.460(c).
[58 FR 675, Jan. 6, 1993; 58 FR 43789, Aug. 18, 1993, as amended at 58 FR 47628, Sept. 10, 1993; 60 FR 217, Jan. 3, 1995]
§§ 381.481-381.499
[Reserved]
§ 381.500
Exemption from nutrition labeling.
(a) The following poultry products are exempt from nutrition labeling:
(1) Food products produced by small businesses other than the major cuts of single-ingredient, raw poultry products identified in § 381.444 produced by small businesses, provided that the labels for these products bear no nutrition claims or nutrition information, and ground or chopped products described in § 381.401 produced by small businesses that bear a statement of the lean percentage and fat percentage on the label or in labeling in accordance with § 381.462(f), provided that labels or labeling for these products bear no other nutrition claims or nutrition information,
(i) A food product, for 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, including a single retail store, or multi-plant company/firm, including a multi-retail store operation 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
(C) During the third year of implementation and subsequent years thereafter, 100,000 pounds or less.
(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 claims 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, provided, however, that this exemption does not apply to ready-to-eat ground or chopped poultry products described in § 381.401 that are packaged or portioned at a retail establishment, unless the establishment qualifies for an exemption under (a)(1);
(ii) Multi-ingredient products (e.g. sausage) processed at a retail store or similar retail-type establishment, provided, however, that this exemption does not apply to multi-ingredient ground or chopped poultry products described in § 381.401 that are processed at a retail establishment, unless the establishment qualifies for an exemption under (a)(1); and
(iii) Products that are ground or chopped at an individual customer's request.
(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 § 381.409(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 § 381.409(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 except that this exemption does not apply to the major cuts of single-ingredient, raw poultry products identified in § 381.444. 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 poultry 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 675, Jan. 6, 1993, as amended at 58 FR 47628, Sept. 10, 1993; 59 FR 45198, Sept. 1, 1994; 60 FR 217, Jan. 3, 1995; 75 FR 82167, Dec. 29, 2010; 76 FR 76891, Dec. 9, 2011]

Subpart Z—Selected Establishments; Cooperative Program for Interstate Shipment of Poultry Products

Source:
76 FR 24756, May 2, 2011, unless otherwise noted.
§ 381.511
Definitions.
Cooperative interstate shipment program. A cooperative poultry products inspection program described in § 381.187 of this part.
Cooperative State poultry products inspection program. A cooperative State-Federal poultry products inspection program described in § 381.185 of this part.
Designated personnel. State inspection personnel that have been trained in the enforcement of the Act and any additional State program requirements in order to provide inspection services to selected establishments.
Interstate commerce. “Interstate commerce” has the same meaning as “commerce” under § 381.1 of this part.
Selected establishment. An establishment operating under a State cooperative poultry products inspection program that has been selected by the Administrator, in coordination with the State where the establishment is located, to participate in a cooperative interstate shipment program.
§ 381.512
Purpose.
This subpart Z prescribes the conditions under which States that administer cooperative State poultry products inspection programs and establishments that operate under such programs may participate in a cooperative interstate shipment program.
§ 381.513
Requirements for establishments; ineligible establishments.
(a) An establishment that operates under a cooperative State poultry products inspection program may apply to participate in a cooperative interstate shipment program under this subpart if:
(1) The establishment employs on average no more than 25 employees based on the standards described in paragraph (b) of this section, or
(2) The establishment employed more than 25 employees but fewer than 35 employees as of June 18, 2008. If selected to participate in a cooperative interstate shipment program, an establishment under this paragraph must employ on average no more than 25 employees as of July 1, 2014, or it must transition to become an official establishment as provided in § 381.521 of this subpart.
(b) An establishment that has 25 or fewer employees based on the following standards is considered to have 25 or fewer employees on average for purposes of this subpart.
(1) All individuals, both supervisory and non-supervisory, employed by the establishment on a full-time, part-time, or temporary basis whose duties involve handling the poultry products prepared by the establishment are counted when calculating the total number of employees.
(2) All individuals employed by the establishment from a temporary employee agency, professional employee organization, or leasing concern whose duties involve handling the poultry products prepared by the establishment are counted when calculating the total number of employees.
(3) The average number of employees is calculated for each of the pay periods for the preceding 12 calendar months.
(4) Part-time and temporary employees are counted the same as full-time employees.
(5) If the establishment has not been in business for 12 months, the average number of employees is calculated for each of the pay periods in which the establishment has been in business.
(6) Volunteers who receive no compensation are not considered employees unless their duties involve handling the poultry products prepared by the establishment.
(7) The total number of employees can never exceed 35 individuals at any given time, regardless of the average number of employees.
(c) The following establishments are ineligible to participate in a cooperative interstate shipment program:
(1) Establishments that employ more than 25 employees on average (except as provided under paragraph (a)(2) of this section);
(2) Establishments operating under a Federal-State program as provided in § 381.186 of this part as of June 18, 2008;
(3) Official establishments;
(4) Establishments that were official establishments as of June 18, 2008, but that were re-organized on a later date by the person that controlled the establishment as of June 18, 2008;
(5) Establishments operating under a cooperative State poultry products inspection program that employed more than 35 employees as of June 18, 2008, that were reorganized on a later date by the person that controlled the establishment as of June 18, 2008;
(6) Establishments that are the subject of a transition under § 381.521 of this subpart;
(7) Establishments that are in violation of the Act;
(8) Establishments located in States without a cooperative State poultry products inspection program; and
(9) Establishments located in a State whose agreement for a cooperative interstate shipment program was terminated by the Administrator as provided in § 381.187(d) of this part.
(d) An establishment that meets the conditions in paragraph (a) of this section and that is not an ineligible establishment under paragraph (c) of this section may apply for selection into a cooperative interstate shipment program through the State in which the establishment is located.
[76 FR 24756, May 2, 2011, as amended at 76 FR 81360, Dec. 28, 2011]
§ 381.514
State request for cooperative agreement.
(a) State participation in a cooperative interstate shipment program under this subpart is limited to States that have implemented cooperative State poultry products inspection programs.
(b) To request an agreement for a cooperative interstate shipment program under this subpart, a State must submit a written request to the Administrator through the FSIS District Office for the FSIS District in which the State is located. In the request the State must:
(1) Identify establishments in the State that have requested to be selected for the program that the State recommends for initial selection into the program, if any;
(2) Demonstrate that the State is able to provide the necessary inspection services to selected establishments in the State and conduct any related activities that would be required under a cooperative interstate shipment program established under this subpart; and
(3) Agree that, if the State enters into an agreement with FSIS for a cooperative interstate shipment program, the State will:
(i) Provide FSIS with access to the results of all laboratory analyses conducted on product samples from selected establishments in the State;
(ii) Notify the selected establishment coordinator for the State of the results of any laboratory analyses that indicate that a product prepared in a selected establishment may be adulterated or may otherwise present a food safety concern; and
(iii) When necessary, cooperate with FSIS to transition selected establishments in the State that have been deselected from a cooperative interstate shipment program to become official establishments.
(c) If the Administrator determines that a State that has submitted a request to participate in a cooperative interstate shipment program qualifies to enter into a cooperative agreement for such a program, the Administrator and the State will sign a cooperative agreement that sets forth the terms and conditions under which each party will cooperate to provide inspection services to selected establishments located in the State.
(d) After the Administrator and a State have signed an agreement for a cooperative interstate shipment program as provided in paragraph (c) of this section, the Administrator will:
(1) Appoint an FSIS employee as the FSIS selected establishment coordinator for the State and
(2) Coordinate with the State to select establishments to participate in the program as provided in § 381.515(b) of this subpart.
§ 381.515
Establishment selection; official number for selected establishments.
(a) An establishment operating under a cooperative State poultry products inspection program will qualify for selection into a cooperative interstate shipment program if the establishment:
(1) Has submitted a request to the State to be selected for the program;
(2) Has the appropriate number of employees under § 381.513(a) of this subpart;
(3) Is not ineligible to participate in a cooperative interstate shipment program under § 381.513(c) of this subpart;
(4) Is in compliance with all requirements under the cooperative State poultry products inspection program; and
(5) Is in compliance with all requirements under the Act and the implementing regulations in this chapter.
(b) To participate in a cooperative interstate shipment program, an establishment that meets the conditions in paragraph (a) of this section must be selected by the Administrator, in coordination with the State where the establishment is located.
(c) If an establishment is selected to participate in a cooperative interstate shipment program as provided in paragraph (b) of this section, the State is to assign the establishment an official number that reflects the establishment's participation in the cooperative interstate shipment program and advise the FSIS selected establishment coordinator for the State of the official number assigned to each selected establishment in the State. The official numbers assigned to every selected establishment must contain a suffix, e.g., “SE,” that identifies the establishment as a selected establishment; that includes the letter “P,” which identifies the establishment as a poultry establishment; and that identifies the State, e.g., “SEPND,” for “selected establishment poultry North Dakota.”
(d) Failure of a State to comply with paragraph (c) of this section will disqualify the State from participation in the cooperative interstate shipment program.
§ 381.516
Commencement of a cooperative interstate shipment program; inspection by designated personnel and official mark.
(a) A cooperative interstate shipment program will commence when the Administrator, in coordination with the State, has selected establishments in the State to participate in the program.
(b) Inspection services for selected establishments participating in a cooperative interstate shipment program must be provided by designated personnel, who will be under the direct supervision of a State employee.
(c) Poultry products processed in a selected establishment and inspected and passed by designated State personnel must bear an official Federal mark, stamp, tag, or label of inspection in the appropriate form prescribed in subpart M of this part that includes the information specified in § 381.515(c) of this subpart.
(d) Poultry products processed in a selected establishment that comply with the conditions in paragraph (c) of this section may be distributed in interstate commerce.
§ 381.517
Federal oversight of a cooperative interstate shipment program.
(a) The FSIS selected establishment coordinator for a State that has entered into an agreement for a cooperative interstate shipment program will visit each selected establishment in the State on a regular basis to verify that the establishment is operating in a manner that is consistent with the Act and the implementing regulations in this chapter. The frequency with which the SEC will visit selected establishments under the SEC's jurisdiction will be based on factors that include, but are not limited to, the complexity of the operations conducted at the selected establishment, the establishment's schedule of operations, and the establishment's performance under the cooperative interstate shipment program. If necessary, the selected establishment coordinator, in consultation with the District Manager that covers the State, may designate qualified FSIS personnel to visit a selected establishment on behalf of the selected establishment coordinator.
(b) The selected establishment coordinator, in coordination with the State, will verify that selected establishments in the State are receiving the necessary inspection services from designated personnel, and that these establishments are eligible, and remain eligible, to participate in a cooperative interstate shipment program. The selected establishment coordinator's verification activities may include:
(1) Verifying that each selected establishment employs, and continues to employ, 25 or fewer employees, on average, as required under § 381.513(a) of this part, unless the establishment is transitioning to become an official establishment;
(2) Verifying that the designated personnel are providing inspection services to selected establishments in a manner that complies with the Act and the implementing regulations in this chapter;
(3) Verifying that that the State staffing levels for each selected establishments are appropriate to carry out the required inspection activities; and
(4) Assessing each selected establishment's compliance with the Act and implementing regulations in this chapter.
(c) If the selected establishment coordinator determines that designated personnel are providing inspection services to selected establishments in the State in a manner that is inconsistent with the Acts and the implementing regulations in this chapter, the Administrator will provide an opportunity for the State to develop and implement a corrective action plan to address inspection deficiencies identified by the selected establishment coordinator. If the State fails to develop a corrective action plan, or the selected establishment coordinator for the State determines that the corrective action plan is inadequate, the Administrator will terminate the agreement for the cooperative interstate shipment program as provided in § 381.187(d) of this part.
§ 381.518
Quarterly reports.
(a) The selected establishment coordinator will prepare a report on a quarterly basis that describes the status of each selected establishment under his or her jurisdiction.
(b) The quarterly report required in paragraph (a) of this section will:
(1) Include the selected establishment coordinator's assessment of the performance of the designated personnel in conducting inspection activities at selected establishments and
(2) Identify those selected establishment that the selected establishment coordinator has verified are in compliance with the Act and implementing regulations in this chapter, those that have been deselected under § 381.520 of this subpart, and those that are transitioning to become official establishments under § 381.521 of this subpart.
(c) The selected establishment coordinator is to submit the quarterly report to the Administrator through the District Manager for the State where the selected establishments identified in the report are located.
§ 381.519
Enforcement authority.
(a) To facilitate oversight and enforcement of this subpart, selected establishments operating under a cooperative interstate shipment program must, upon request, give the FSIS selected establishment coordinator or other FSIS officials access to all establishment records required under the Act and the implementing regulations in this chapter. The Administrator may deselect any selected establishment that refuses to comply with this paragraph.
(b) Selected establishment coordinators may initiate any appropriate enforcement action provided for in part 500 of this chapter if they determine that a selected establishment under their jurisdiction is operating in manner that is inconsistent with the Act and the implementing regulations in this chapter. Selected establishments participating in a cooperative interstate shipment program are subject to the notification and appeal procedures set out in part 500 of this chapter.
(c) If inspection at a selected establishment is suspended for any of the reasons specified in § 500.3 or § 500.4 of this chapter, FSIS will:
(1) Provide an opportunity for the establishment to implement corrective actions and remain in the cooperative interstate shipment program, or
(2) Move to deselect the establishment as provided in § 381.520 of this subpart.
(d) The decision to deselect a selected establishment under a suspension will be made on a case-by-case basis. In making this decision, FSIS, in consultation with the State where the selected establishment is located, will consider, among other factors:
(1) The non-compliance that led to the suspension;
(2) The selected establishment's compliance history; and
(3) The corrective actions proposed by the selected establishment.
§ 381.520
Deselection of ineligible establishments.
(a) The Administrator will deselect a selected establishment that becomes ineligible to participate in a cooperative interstate shipment program for any reason listed under § 381.513(c) of this subpart.
(b) An establishment that has been deselected must transition to become an official establishment as provided in § 381.521 of this subpart.
§ 381.521
Transition to official establishment.
(a) If an establishment is deselected from a cooperative interstate shipment program as provided in § 381.520 of this subpart, FSIS, in coordination with the State where the establishment is located, will develop and implement a plan to transition the establishment to become an official establishment. Except that an establishment that was deselected from a cooperative interstate shipment program because it is located in a State whose agreement for such a program was terminated may either transition to become an official establishment or transition to become a State-inspected establishment under the cooperative State poultry products inspection program.
(b) An establishment that has been deselected from a cooperative interstate shipment program and successfully transitioned to become an official establishment may withdraw from the Federal inspection program and resume operations under the cooperative State poultry products inspection program after operating as an official establishment in full compliance with the Act for a year.
§ 381.522
Transition grants.
(a) Transition grants are funds that a State participating in a cooperative interstate shipment program under this subpart may apply for to reimburse selected establishments in the State for the cost to train one individual in the seven HACCP principles for meat or poultry processing as required under § 417.7 of this chapter and associated training in the development of sanitation standard operating procedures required under part 416 of this chapter.
(b) A State participating in a cooperative interstate shipment program that receives a transition grant must use grant funds to reimburse the training costs of one employee per each selected establishment in the State. Any other use of such funds is prohibited.
§ 381.523
Separation of operations.
A selected establishment may conduct operations under the cooperative State poultry products inspection program if the establishment implements and maintains written procedures for complete physical separation of product and process for each operation by time or space.
§ 381.524
Voluntary withdrawal.
A selected establishment that is in full compliance with the requirements in this part may voluntarily end its participation in a cooperative interstate shipment program and operate under the cooperative State poultry products inspection program. Establishments that voluntarily end their participation in the cooperative may re-apply for the program after operating under the cooperative State poultry products inspection program for one year.