9 CFR 381.133 - Generically approved labeling.

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There are 2 Updates appearing in the Federal Register for 9 CFR 381. View below or at eCFR (GPOAccess)
§ 381.133 Generically approved labeling.
(a)
(1) An official establishment or an establishment certified under a foreign inspection system, in accordance with subpart T of this part, is authorized to use generically approved labeling, as defined in paragraph (b) of this section, without such labeling being submitted for approval to the Food Safety and Inspection Service in Washington or the field, provided the labeling is in accord with this section and shows all mandatory features in a prominent manner as required in subpart N of this part, and is not otherwise false or misleading in any particular.
(2) The Food Safety and Inspection Service shall select samples of generically approved labeling from the records maintained by official establishments and establishments certified under foreign inspection systems, in accordance with subpart T of this part, as required in § 381.132, to determine compliance with labeling requirements. Any finding of false or misleading labeling shall institute the proceedings prescribed in § 381.233.
(b) Generically approved labeling is labeling which complies with the following:
(1) Labeling for a product which has a product standard as specified in subpart 381 of this subchapter or the Standards and Labeling Policy Book and which does not contain any special claims, such as quality claims, nutrient content claims, health claims, negative claims, geographical origin claims (except as provided by paragraph (b)(9)(xxviii) of this section), or guarantees, or which is not a domestic product labeled in a foreign language;
(2) Labeling for single-ingredient products (such as chicken legs or turkey breasts) which does not contain any special claims, such as quality claims, nutrient content claims, health claims, negative claims, geographical origin claims (except as provided by paragraph (b)(9)(xxviii) of this section), or guarantees, or which is not a domestic product labeled with a foreign language;
(3) Labeling for containers of products sold under contract specifications to Federal Government agencies, when such product is not offered for sale to the general public, provided that the contract specifications include specific requirements with respect to labeling, and are made available to the inspector-in-charge;
(4) Labeling for shipping containers which contain fully labeled immediate containers, provided such labeling complies with § 381.127;
(5) Labeling for products not intended for human food, provided they comply with §§ 381.152(c) and 381.193, and labeling for poultry heads and feet for export for processing as human food if they comply with § 381.190(b);
(6) Poultry inspection legends, which comply with subpart M of this part;
(7) Inserts, tags, liners, pasters, and like devices containing printed or graphic matter and for use on, or to be placed within containers, and coverings of products, provided such devices contain no reference to product and bear no misleading feature;
(8) Labeling for consumer test products not intended for sale; and
(9) Labeling which was previously approved by the Food Labeling Division as sketch labeling, and the final labeling was prepared without modification or with the following modifications:
(i) All features of the labeling are proportionately enlarged or reduced, provided that all minimum size requirements specified in applicable regulations are met and the labeling is legible;
(ii) The substitution of any unit of measurement with its abbreviation or the substitution of any abbreviation with its unit of measurement, e.g., “lb.” for “pound,” or “oz.” for “ounce,” or of the word “pound” for “lb.” or “ounce” for “oz.”;
(iii) A master or stock label has been approved from which the name and address of the distributor are omitted and such name and address are applied before being used (in such case, the words “prepared for” or similar statement must be shown together with the blank space reserved for the insertion of the name and address when such labels are offered for approval);
(iv) Wrappers or other covers bearing pictorial designs, emblematic designs or illustrations, e.g., floral arrangements, illustrations of animals, fireworks, etc. are used with approved labeling (the use of such designs will not make necessary the application of labeling not otherwise required);
(v) A change in the language or the arrangement of directions pertaining to the opening of containers or the serving of the product;
(vi) The addition, deletion, or amendment of a dated or undated coupon, a cents-off statement, cooking instructions, packer product code information, or UPC product code information;
(vii) Any change in the name or address of the packer, manufacturer or distributor that appears in the signature line;
(viii) Any change in the net weight, provided that the size of the net weight statement complies with § 381.121;
(ix) The addition, deletion, or amendment of recipe suggestions for the product;
(x) Any change in punctuation;
(xi) Newly assigned or revised establishment numbers for a particular establishment for which use of the labeling has been approved by the Food Labeling Division, Regulatory Programs;
(xii) The addition or deletion of open dating information;
(xiii) A change in the type of packaging material on which the label is printed;
(xiv) Brand name changes, provided that there are no design changes, the brand name does not use a term that connotes quality or other product characteristics, the brand name has no geographic significance, and the brand name does not affect the name of the product;
(xv) The deletion of the word “new” on new product labeling;
(xvi) The addition, deletion, or amendment of special handling statements, provided that the change is consistent with § 381.125(a);
(xvii) The addition of safe handling instructions as required by § 381.125(b);
(xviii) Changes reflecting a change in the quantity of an ingredient shown in the formula without a change in the order of predominance shown on the label, provided that the change in the quantity of ingredients complies with any minimum or maximum limits for the use of such ingredients prescribed in subpart P of this part and § 424.21(c) of subchapter E;
(xix) Changes in the color of the labeling, provided that sufficient contrast and legibility remain;
(xx) A change in the product vignette, provided that the change does not affect mandatory labeling information or misrepresent the content of the package;
(xxi) The addition, deletion, or substitution of the official USDA poultry grade shield; (xxii) A change in the establishment number by a corporation or parent company for an establishment under its ownership;
(xxiii) Changes in nutrition labeling that only involve quantitative adjustments to the nutrition labeling information, except for services sizes, provided the nutrition labeling information maintains its accuracy and consistency;
(xxiv) Deletion of any claim, and the deletion of non-mandatory features or non-mandatory information;
(xxv) The addition or deletion of a direct translation of the English language into a foreign language for products marked “for export only”; and
(xxvi) The use of the descriptive term “fresh” in accordance with § 381.129(b)(6)(i) of this subchapter.
(xxvii) The use of the descriptive Term frozen as required by § 381.129(b)(6)(ii) of this subchapter.
(xxviii) A country of origin statement on any product label described in § 381.129(f) that complies with the requirements in that paragraph.
[60 FR 67457, Dec. 29, 1995, as amended at 61 FR 66201, Dec. 17, 1996; 73 FR 50703, Aug. 28, 2008; 76 FR 82079, Dec. 30, 2011]

Title 9 published on 2014-01-01

The following are only the Rules published in the Federal Register after the published date of Title 9.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-08-21; vol. 79 # 162 - Thursday, August 21, 2014
    1. 79 FR 49566 - Modernization of Poultry Slaughter Inspection
      GPO FDSys XML | Text
      DEPARTMENT OF AGRICULTURE, Food Safety and Inspection Service
      Final rule.
      Effective Date: October 20, 2014. Notification Date: All young chicken and turkey slaughter establishments will initially have until February 23, 2015, to notify their District Office in writing of their intent to operate under the New Poultry Inspection System (NPIS). Establishments that do not notify their District Office of their intent by February 23, 2015, will be deemed to have chosen the inspection system that they are currently operating under. Young chicken and turkey slaughter establishments that decide that they would like to convert to NPIS after the initial notification date may notify FSIS of their intent at any time after that date. The Agency will implement the NPIS in the additional establishments that intend to convert on a schedule consistent with Agency resources and readiness. The Agency intends to implement the NPIS in all young chicken and turkey establishments that choose to operate under the NPIS, regardless of when the establishment notifies FSIS of its intent to transition to the NPIS. However, the initial implementation wave will only include those establishments that submitted their notifications within the initial notification period. After October 20, 2014, FSIS will begin selecting from those establishments that have notified FSIS of their intent to switch to the NPIS. The Agency will use a computerized ranking system to determine the schedule of establishments for implementation of the NPIS. This ranking system will take into consideration several factors, such as FSIS staffing needs, past performance of the establishment, the location of the establishment with respect to other federally-inspected establishments, and establishment readiness to transition to the NPIS. FSIS will implement the NPIS in phases by clusters of establishments in close geographic proximity to one another. The initial implementation wave will only include those establishments that notified FSIS of their intent to switch to the NPIS during the initial six-month notification period. FSIS expects that in subsequent years many more establishments will choose to transition to the new system. The Agency's implementation strategy for the NPIS is described in more detail in the preamble to this final rule. Applicability Dates: The regulations that prescribe procedures for controlling visible fecal contamination in 9 CFR 381.65(f), the regulations that prescribe procedures for controlling contamination throughout the slaughter and dressing process in 9 CFR 381.65(g), and the regulations that prescribe recordkeeping requirements in 9 CFR 381.65(h) will be applicable as follows: • In large establishments, defined as all establishments with 500 or more employees, on November 19, 2014; • In small establishments, defined as all establishments with 10 or more employees but fewer than 500, on December 19, 2014; • In very small establishments, defined as all establishments with fewer than 10 employees or annual sales of less than $2.5 million February 17, 2015.
      9 CFR Parts 381 and 500

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


United States Code
U.S. Code: Title 7 - AGRICULTURE
U.S. Code: Title 21 - FOOD AND DRUGS

§ 451 - Congressional statement of findings

§ 452 - Congressional declaration of policy

§ 453 - Definitions

§ 454 - Federal and State cooperation in development and administration of State poultry product inspection programs

§ 455 - Inspection in official establishments

§ 456 - Operation of premises, facilities and equipment

§ 457 - Labeling and container standards

§ 458 - Prohibited acts

§ 459 - Compliance by all establishments

§ 460 - Miscellaneous activities subject to regulation

§ 461 - Offenses and punishment

§ 462 - Reporting of violations; notice; opportunity to present views

§ 463 - Rules and regulations

§ 464 - Exemptions

§ 465 - Limitations upon entry of poultry products and other materials into official establishments

§ 466 - Imports

§ 467 - Inspection services

§ 467a - Administrative detention; duration; pending judicial proceedings; notification of government authorities; release; removal of official marks

§ 467b - Seizure and condemnation

§ 467c - Federal court jurisdiction of enforcement and injunction proceedings and other kinds of cases; limitations; United States as plaintiff; subpenas

§ 467d - Administration and enforcement; applicability of penalty provisions; conduct of inquiries; power and jurisdiction of courts

§ 467e - Non-Federal jurisdiction of federally regulated matters; prohibition of additional or different requirements for establishments...purposes of adulterated or misbranded and imported articles; other matters

§ 467f - Federal Food, Drug, and Cosmetic Act applications

§ 468 - Cost of inspection; overtime

§ 469 - Authorization of appropriations

§ 470 - Omitted

Title 9 published on 2014-01-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 9 CFR 381 after this date.

  • 2014-08-21; vol. 79 # 162 - Thursday, August 21, 2014
    1. 79 FR 49566 - Modernization of Poultry Slaughter Inspection
      GPO FDSys XML | Text
      DEPARTMENT OF AGRICULTURE, Food Safety and Inspection Service
      Final rule.
      Effective Date: October 20, 2014. Notification Date: All young chicken and turkey slaughter establishments will initially have until February 23, 2015, to notify their District Office in writing of their intent to operate under the New Poultry Inspection System (NPIS). Establishments that do not notify their District Office of their intent by February 23, 2015, will be deemed to have chosen the inspection system that they are currently operating under. Young chicken and turkey slaughter establishments that decide that they would like to convert to NPIS after the initial notification date may notify FSIS of their intent at any time after that date. The Agency will implement the NPIS in the additional establishments that intend to convert on a schedule consistent with Agency resources and readiness. The Agency intends to implement the NPIS in all young chicken and turkey establishments that choose to operate under the NPIS, regardless of when the establishment notifies FSIS of its intent to transition to the NPIS. However, the initial implementation wave will only include those establishments that submitted their notifications within the initial notification period. After October 20, 2014, FSIS will begin selecting from those establishments that have notified FSIS of their intent to switch to the NPIS. The Agency will use a computerized ranking system to determine the schedule of establishments for implementation of the NPIS. This ranking system will take into consideration several factors, such as FSIS staffing needs, past performance of the establishment, the location of the establishment with respect to other federally-inspected establishments, and establishment readiness to transition to the NPIS. FSIS will implement the NPIS in phases by clusters of establishments in close geographic proximity to one another. The initial implementation wave will only include those establishments that notified FSIS of their intent to switch to the NPIS during the initial six-month notification period. FSIS expects that in subsequent years many more establishments will choose to transition to the new system. The Agency's implementation strategy for the NPIS is described in more detail in the preamble to this final rule. Applicability Dates: The regulations that prescribe procedures for controlling visible fecal contamination in 9 CFR 381.65(f), the regulations that prescribe procedures for controlling contamination throughout the slaughter and dressing process in 9 CFR 381.65(g), and the regulations that prescribe recordkeeping requirements in 9 CFR 381.65(h) will be applicable as follows: • In large establishments, defined as all establishments with 500 or more employees, on November 19, 2014; • In small establishments, defined as all establishments with 10 or more employees but fewer than 500, on December 19, 2014; • In very small establishments, defined as all establishments with fewer than 10 employees or annual sales of less than $2.5 million February 17, 2015.
      9 CFR Parts 381 and 500