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HHS/FDA RIN: 0910-AI66 Publication ID: Spring 2022 
Title: Certifications Concerning Imported Foods 

Section 303 of the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353, sec. 303) amended section 801(a) (21 U.S.C. 381(a)) and added a new subsection 801(q) (21 U.S.C. 381(q)) to the Federal Food, Drug, and Cosmetic Act (Act) to allow the agency to require, as a condition of importation of food with known safety risk, a certification or such other assurances as the Agency determines appropriate, that imported food complies with U.S food safety requirements. This regulation, if finalized, will help prevent potentially harmful imported foods from reaching consumers and thereby improve the safety of the U.S. food supply.

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: Undetermined 
CFR Citation: 21 CFR 1   
Legal Authority: 21 U.S.C. 381    21 U.S.C. 371(b)    42 U.S.C. 243    42 U.S.C. 264    42 U.S.C. 271    ...   
Legal Deadline:  None
Action Date FR Cite
NPRM  12/00/2022 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Undetermined 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: No 
Agency Contact:
Peter Fox
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
12420 Parklawn Drive, ELEM, RM 41416,
Rockville, MD 20857
Phone:240 402-1857