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HHS/FDA RIN: 0910-AG68 Publication ID: Spring 2011 
Title: ●Suspension of Food Facility Registration 
Abstract: The FDA Food Safety Modernization Act (FSMA) amends the Federal Food, Drug, and Cosmetic (the FD&C Act) with respect to the safety of the food supply. This law (Pub. L. 111-353), in section 102, authorizes the Secretary, or as delegated, the FDA Commissioner, to suspend the registration of a facility registered under section 415 of the FD&C Act if he or she determines that food manufactured, processed, packed, received, or held by that facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, if the facility created, caused, or was otherwise responsible for such a reasonable probability; or knew of, or had reason to know of, such reasonable probability and packed, received or held such food. Section 102 of the FSMA further includes provisions relating to opportunities for informal hearings on registration suspension, FDA's authority to require submission of a corrective action plan, and vacation or modification of suspension orders and reinstatement of registration. Section 102 of the FSMA directs FDA to implement these provisions by promulgating regulations, which may be done on an interim final basis. If the registration of a facility is suspended under the authority provided by section 102 FSMA, no person shall import or export food into the United States from such a facility, offer to import or export food into the United States from such facility, or otherwise introduce food from such facility into interstate or intrastate commerce in the United Sates. Anticipated cost to registrants involve their inability to legally conduct such business operations if their food facility registration is suspended. 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: Not Yet Determined     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: PL 111-353, sec 102 and secs 415 and 701(a) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 350d and 371(a)).   
Legal Deadline:  None
Action Date FR Cite
Interim Final Rule  07/00/2011    
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Small Entities Affected: Businesses  Federalism: Undetermined 
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:
William A. Correll, Jr.
Supervisory Consumer Safety Officer
Department of Health and Human Services
Food and Drug Administration
Room 3C-019, CPK1, HFS-607, 5100 Paint Branch Parkway,
College Park, MD 20740
Phone:240 402-1611
Fax:301 436-2716