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USDA/FSIS RIN: 0583-AC59 Publication ID: Fall 2009 
Title: Prior Labeling Approval System: Generic Label Approval 
Abstract: This rulemaking will continue an effort initiated several years ago by amending FSIS' regulations to expand the types of labeling that are generically approved. FSIS plans to propose that the submission of labeling for approval prior to use be limited to certain types of labeling, as specified in the regulations. In addition, FSIS plans to reorganize and amend the regulations by consolidating the nutrition labeling rules that currently are stated separately for meat and poultry products (in part 317, subpart B, and part 381, subpart Y, respectively) and by amending their provisions to set out clearly various circumstances under which these products are misbranded. 
Agency: Department of Agriculture(USDA)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 9 CFR 317; 9 CFR 327; 9 CFR 381; 9 CFR 412 
Legal Authority: 21 USC 451 to 470; 21 USC 601 to 695 
Legal Deadline:  None

Statement of Need: Expanding the types of labeling that are generically approved would permit Agency personnel to focus their resources on evaluating only those claims or special statements that have health and safety or economic implications. This would essentially eliminate the time needed for FSIS personnel to evaluate labeling features and allocate more time for staff to work on other duties and responsibilities. A major advantage of this proposal is that it is consistent with FSIS’ current regulatory approach, which separates industry and Agency responsibilities.

Summary of the Legal Basis: This action is authorized under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.) and the Poultry Products Inspection Act (21 U.S.C. 451 et seq.).

Alternatives: FSIS considered several options. The first was to expand the types of labeling that would be generically approved and consolidate into one part, all of the labeling regulations applicable to products regulated under the FMIA and PPIA and the policies currently contained in FSIS Directive 7220.1, Revision 3. The second option FSIS considered was to consolidate only the meat and poultry regulations that are similar and to expand the types of generically approved labeling that can be applied by Federal and certified foreign establishments. The third option and the one favored by FSIS was to amend the prior labeling approval system in an incremental three-phase approach.

Anticipated Costs and Benefits: The proposed rule would permit the Agency to realize an estimated cost savings of $670,000 over 10 years. The proposed rule would be beneficial because it would streamline the generic labeling process, while imposing no additional cost burden on establishments. Consumers would benefit because industry would have the ability to introduce products into the marketplace more quickly.

Risks: None

Timetable:
Action Date FR Cite
NPRM  08/00/2010   
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Undetermined 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: No 
Agency Contact:
Jeff Canavan
Deputy Director, Labeling and Program Delivery Staff (LPDS)
Department of Agriculture
Food Safety and Inspection Service
Office of Policy and Program Development, Patriots Plaza 3, 1400 Independence Avenue SW., Room 8-146, Mailstop 5273,
Washington, DC 20250-5273
Phone:301 504-0879
Fax:202 245-4792
Email: jeff.canavan@fsis.usda.gov

 
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