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HHS/FDA RIN: 0910-AG67 Publication ID: Spring 2011 
Title: ●Administrative Detention of Food for Human or Animal Consumption 
Abstract: The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) with respect to the safety of the food supply. Section 207 of FSMA amends the criteria for ordering administrative detention of human or animal food in section 304(h)(1)(A) of the FD&C Act. The existing criteria allow the agency to order the detention of any article of food if during an inspection, examination, or investigation an FDA officer or qualified employee finds there is credible evidence or information indicating that the article of food presents a threat of serious adverse health consequences or death to humans or animals. Under the new criteria, FDA can order administrative detention if an FDA officer or qualified employee has reason to believe that an article of food is adulterated or misbranded. Section 207 also requires the Secretary to issue an interim final rule implementing this change no later than 120 days following the date of enactment of FSMA. The interim final rule will amend the administrative detention regulations codified at 21 CFR part 1, subpart K. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR part 1, subpart K     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: PL 111-353, sec 207 and secs 304(h) and 701(a) of the Federal Food, Drug, and Cosmetic Act (21 USC 334(h) and 371(a)).   
Legal Deadline:
Action Source Description Date
Other  Statutory  Interim Final Rule to amend 21 CFR part 1, subpart K within 120 days of the FDA FSMA.  05/00/2011 
Timetable:
Action Date FR Cite
Interim Final Rule  05/05/2011  76 FR 25538   
Interim Final Rule Effective  07/03/2011    
Interim Final Rule Comment Period End  08/03/2011    
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
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
Email: william.correll@fda.hhs.gov