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HHS/FDA RIN: 0910-AC39 Publication ID: Spring 2004 
Title: Establishment and Maintenance of Records Pursuant to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 
Abstract: This rulemaking is one of a number of actions being taken to improve FDA's ability to respond to threats of bioterrorism. Section 414(b) of the Federal Food, Drug and Cosmetic Act (FFDCA), which was added by section 306 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Act), authorizes the Secretary, through FDA, to promulgate final regulations by December 12, 2003. The Act authorizes regulations that require the establishment and maintenance of records, for not longer than two years, that would allow the Secretary to identify the immediate previous sources and the immediate subsequent recipients of food, including its packaging. The required records would be those that are needed by FDA in order to address credible threats of serious adverse health consequences or death to humans or animals. Specific covered entities are those that manufacture, process, pack, transport, distribute, receive, hold, or import food. Farms and restaurants are excluded. The Secretary is directed to take into account the size of a business in promulgating these regulations. Section 306 of the Act also added section 414(a) and amended section 704(a) of FFDCA to permit FDA to inspect these records and other information if the Secretary has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals. 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Yes  Unfunded Mandates: Private Sector 
CFR Citation: 21 CFR 1   
Legal Authority: PL 107-188, sec 306   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  05/09/2003  68 FR 25188   
NPRM Comment Period End  07/08/2003    
Final Action  07/00/2004    
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: Yes 
RIN Information URL: www.fda.gov/oc/bioterrorism/bioact.html   Public Comment URL: www.fda.gov/ohrms/dockets/02N0277/02n0277.htm  
Agency Contact:
Nega Beru
Supervisory Chemist, Office of Plant, Dairy Foods
Department of Health and Human Services
Food and Drug Administration
HFS-305, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway,
College Park, MD 20740
Phone:301 436-1400
Fax:301 436-2651
Email: nberu@cfsan.fda.gov