This script search US Code. View Rule
Menu Item - Home
Menu Item - Agenda Main page
Menu Item - Historical Agenda
Menu Item - Historical Agenda
Menu Item - Agenda Search
Menu Item - EO Dashboard
Menu Item - Reg Review
Menu Item - EO Agency lists
Menu Item - EO Search
Menu Item - EO Historical Reports
Menu Item - Review Counts
Menu Item - OIRA Letters
Menu Item - EOM 12866 Search
Menu Item - EO XML Reports
Menu Item - ICR Dashboard page
Menu Item - ICR Main page
Menu Item - ICR Search
Menu Item - ICR XML Reports
Menu Item - FAQ
Menu Item - Additional Resources
Menu Item - Contact Us
Search: Agenda Reg Review ICR
       Search

View Rule

View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML

HHS/FDA RIN: 0910-AC39 Publication ID: Fall 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

Statement of Need: The events of September 11, 2001, highlighted the need to enhance the security of the U.S. 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 regulations will implement section 306 of the Bioterrorism Act.

Summary of the Legal Basis: Section 306 of the Bioterrorism Act amended the FFDCA 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.

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 recordkeeping provisions would impose a substantial cost on industry. A first estimate is that the proposed provisions will cost the food industry approximately $235 million in the first year, approximately $510 million in the second year, and approximately $220 million every year there after. 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 and Prevention (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. While 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, FDA uses data collected by the agency on past outbreaks to estimate the benefit of the recordkeeping provisions on standard traceback investigations. Specifically, we estimate the number of illnesses averted from faster tracebacks and higher traceback completion rates that will result from improved recordkeeping practices.

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  05/09/2003  68 FR 25188 
NPRM Comment Period End  07/08/2003   
Final Action  12/00/2004   
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: Yes 
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

 
About Us   Vertical Spacer Spacer Related Resources   Vertical Spacer Spacer Disclosure   Vertical Spacer Spacer Accessibility   Vertical Spacer Spacer Privacy Policy   Vertical Spacer Spacer Contact Us