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HHS/FDA RIN: 0910-AC39 Publication ID: Spring 2003 
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: Proposed Rule Stage 
Major: Yes  Unfunded Mandates: Private Sector 
CFR Citation: 21 CFR 1 
Legal Authority: PL 107-188, sec 306 
Legal Deadline:
Action Source Description Date
Final  Statutory    12/12/2003 

Overall Description of Deadline: The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, section 306, directs the Secretary, through FDA, to issue final regulations establishing recordkeeping requirements by December 12, 2003.

Statement of Need: The events of September 11, 2001, highlighted the need to enhance the security of the United States food supply. Congress responded by passing the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which was signed into law on June 12, 2002. The proposed regulations would implement section 306 of the Bioterrorism Act.

Summary of the Legal Basis: Section 306 of the Bioterrorism Act amended the Federal Food, Drug and Cosmetic Act by adding section 414(b), which authorizes the Secretary to establish by regulation requirements for the creation and maintenance of records. That section of the Bioterrorism Act also added section 414(a) and amended section 704(a) of the FFDCA to permit FDA to inspect records and other information under certain circumstances. In addition, section 306 of the Bioterrorism Act also amends section 301 of the Federal Food, Drug and Cosmetic Act by making the failure to establish or maintain any record required by the new regulations, or refusal to permit access to those records or other information as required by the new regulations, a prohibited act.

Alternatives: None, based on clear statutory directive to establish regulations by December 12, 2003.

Anticipated Costs and Benefits: The records provisions will be classified as significant under Executive Order 12866 (having an annual effect on the economy of over $100 million). The provisions will improve substantially FDA's ability to respond to outbreaks from deliberate and accidental contamination of food. FDA will use data collected by the Center for Disease Control (CDC) and FDA on past outbreaks to estimate the benefit of improved documentation in standard tracing investigations. Of the 1,344 food-borne illness outbreaks CDC identified in 1999, only 368 (27 percent) had a confirmed etiology. A host of factors contribute to the inability to identify the cause of an outbreak, but many investigations are hampered by the lack of adequate records identifying the chain of custody of foods. Unfortunately, it is not possible to directly estimate the benefits of averting a terrorist attack, as we do not know what form an attack might take or the probability of an attack occurring. Instead, to get an idea of the cost of a food disaster, we will look at the costs of some severe food-borne illness outbreaks.

Risks: Regulations implementing legislation to protect the health of citizens against bioterrorism would advance the development, organization, and enhancement of public health prevention systems and tools. The magnitude of the risks addressed by such systems and tools is at least as great as the other risk reduction efforts within HHS' jurisdiction. These regulations will improve the ability to address credible threats of serious adverse health consequences or death to humans or animals.

Timetable:
Action Date FR Cite
NPRM  05/00/2003   
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: Yes 
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

 
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