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USDA/FSIS RIN: 0583-AD78 Publication ID: Fall 2021 
Title: Prior Label Approval System: Expansion of Generic Label Approval 

The Food Safety and Inspection Service (FSIS) is amending its labeling regulations to expand the categories of meat and poultry product labels that it will deem generically approved and thus not required to be submitted to FSIS. These reforms will reduce the regulatory burden on producers seeking to bring products to market, as well as the Agency costs expended to evaluate the labels.

Agency: Department of Agriculture(USDA)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 9 CFR 412.2 (a) (1)    9 CFR 317.7    9 CFR 381.128    9 CFR 412.2 (b)   
Legal Authority: 21 U.S.C. 601 et seq.    21 U.S.C. 451 et seq.   
Legal Deadline:  None

Statement of Need:

This action is needed to reduce the regulatory burden on producers seeking to bring products to market, as well as the Agency costs expended to evaluate the labels. Based on FSIS experience evaluating the labels in question and the ability of inspection personnel to verify labeling in the field, FSIS anticipates this action will have no impact on food safety or the accuracy of meat and poultry product labeling.

Summary of the Legal Basis:

The Acts direct the Secretary of Agriculture to maintain meat and poultry inspection programs designed to assure consumers that these products are safe, wholesome, not adulterated, and properly marked, labeled, and packaged. Section 7(d) of the Federal Meat Inspection Act (21 U.S.C. 607(d)) states: No article subject to this title shall be sold or offered for sale by any person, firm, or corporation, in commerce, under any name or other marking or labeling which is false or misleading, or in any container of a misleading form or size, but established trade names and other marking and labeling and containers which are not false or misleading and which are approved by the Secretary are permitted. The Poultry Products Inspection Act contains similar language in section 21 U.S.C. 457(c).


FSIS considered three alternatives to the proposed rule: taking no action, adopting the current proposal except with continued evaluation of labels that would otherwise be generically approved, and allowing all labels to be generically approved.

Anticipated Costs and Benefits:

There are no additional costs to industry, or the Agency associated with this rule. FSIS will continue to verify that product labels, including those that are generically approved, are truthful and not misleading and otherwise comply with FSIS’s requirements.

This rule is expected to reduce the number of labels industry is required to submit to FSIS for evaluation by approximately 35 percent. Establishments will realize a cost savings because they will no longer need to incur costs for submitting certain types of labels to FSIS for evaluation (e.g., preparing a printer’s proof). In addition, streamlining the evaluation process for specific types of labels would allow a faster introduction of products into the marketplace by reducing wait times for label approvals.

FSIS will also benefit from a reduction in the number of labels submitted to it for review. FSIS will be able to reallocate staff hours from evaluating labels towards the development of labeling policy.


Action Date FR Cite
NPRM  09/14/2020  85 FR 56538   
NPRM Comment Period End  11/13/2020 
Final Rule  04/00/2022 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: No 
Agency Contact:
Matthew Michael
Director, Regulations Development Staff
Department of Agriculture
Food Safety and Inspection Service
Office of Policy and Program Development, 1400 Independence Avenue SW,
Washington, DC 20250-3700
Phone:202 720-0345
Fax:202 690-0486