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USDA/FSIS RIN: 0583-AD89 Publication ID: Fall 2024 
Title: Labeling of Meat and Poultry Products Made Using Animal Cell Culture Technology 
Abstract:

The Food Safety and Inspection Service (FSIS) intends to establish new requirements for the labeling of meat or poultry food products intended for human consumption that are made using animal cell-culture technology. FSIS is currently considering all comments submitted on the proposed rule to inform any agency final action.

 
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 381    9 CFR 412   
Legal Authority: 21 U.S.C. 451 et seq.    21 U.S.C. 601 et seq.   
Legal Deadline:  None

Statement of Need:

FSIS has determined that new regulatory requirements for labeling are necessary to ensure that meat or poultry food products intended for human consumption that contain or are comprised of cultured animal cells are truthfully and accurately labeled. Because the nature, source, and underlying characteristics of meat or poultry food products derived from animal cell-culture technology are expected to differ from conventionally produced meat or poultry, FSIS is proposing new labeling requirements to help consumers differentiate meat or poultry food products made using animal cell-culture technology from conventional meat or poultry products and better understand what they are buying and consuming.

Summary of the Legal Basis:

The FMIA and PPIA require that meat and poultry products be truthfully and accurately labeled and that their labels be pre-approved by FSIS (21 U.S.C. 607(d) and 457(c), respectively), prior to movement in commerce. FSIS issues labeling regulations and reviews and approves meat and poultry product labels pursuant to these statutory labeling requirements. Food products made using animal cell culture technology and derived from the cells of species amenable to the FMIA or PPIA are subject to the labeling (and other applicable) requirements of these Acts and the regulations issued thereunder.

Alternatives:

In addition to the option proposed, the Agency would consider the following alternatives: 1.) Taking no action, 2.) Adopting different terms in the product name than those in the proposed rule, and 3.) Allowing generic approval for product labeling.

Anticipated Costs and Benefits:

FSIS’ proposed regulations would help consumers to better understand the nature and source of meat or poultry food products intended for human consumption that contain or are comprised of cultured animal cells and differentiate such foods from their conventionally produced counterparts. The rule is intended to benefit industry because all producers will have consistent labels for their products made using animal cell-culture technology. The rule is also intended to allow producers to design labels that adhere to FSIS regulations as these products become commercially available, reducing potential label modification costs.

FSIS expects costs to industry to be minimal for label submission.

FSIS expects the Agency costs to be minimal and that current staffing would meet approval needs.

 

Risks:

None.

Timetable:
Action Date FR Cite
ANPRM  09/03/2021  86 FR 49491   
ANPRM Comment Period End  12/02/2021 
NPRM  12/00/2024 
Final Action  11/00/2025 
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:
Melissa Hammar
Director, Regulations Development Staff
Department of Agriculture
Food Safety and Inspection Service
1400 Independence Avenue SW,
Washington, DC 20250-3700
Phone:202 286-2255
Email: melissa.hammar@usda.gov