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HHS/FDA | RIN: 0910-AC39 | Publication ID: Fall 2002 |
Title: ●Establishment and Maintenance of Records to Identify Immediate Previous Source and Immediate Subsequent Recipient of Foods | |
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, authorizes the Secretary, through FDA, to promulgate final regulations by December 12, 2003. The regulations will 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. This section does not extend to recipes for food, financial data, pricing data, personnel data, research data, and sales data (other than shipment data regarding sales). 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. In addition, the Secretary is directed to take appropriate measures to ensure that effective procedures are in place to prevent the unauthorized disclosure of any trade secret or confidential information that is obtained by FDA pursuant to these regulations. | |
Agency: Department of Health and Human Services(HHS) | Priority: Economically Significant |
RIN Status: First time 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:
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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. |
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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. |
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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. 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, as required by the new regulations, a prohibited act. |
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Alternatives: None, based on clear statutory authority to establish regulations. |
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Anticipated Costs and Benefits: The records provisions will impose a substantial cost on industry. Using the 1999 Country Business Patterns (CBP) database from the U.S. Census and recordkeeping cost estimates based on other FDA regulations (and assuming no small establishment exemptions), a rough first estimate is that the current provisions will affect approximately 500,000-600,000 establishments and will cost the food industry approximately $400 million in the first year and approximately $150 million every year thereafter. 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 production history 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. |
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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. |
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Timetable:
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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 |