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HHS/FDA | RIN: 0910-AC39 | Publication ID: Spring 2005 |
Title: Establishment and Maintenance of Records Pursuant to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002(Completion of a Section 610 Review) | |
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 are 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: Completed Actions |
Major: Yes | Unfunded Mandates: Private Sector |
RFA Section 610 Review: Completion of a Section 610 Review | |
CFR Citation: 21 CFR 1 | |
Legal Authority: PL 107-188, sec 306 |
Legal Deadline:
None |
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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: No | |
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 |