PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF

2002

 

SEC. 414. <<NOTE: 21 USC 350c.>>  MAINTENANCE AND INSPECTION OF RECORDS.

 

    ``(a) Records Inspection.--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, each person

(excluding farms and restaurants) who manufactures, processes, packs, distributes, receives, holds, or imports such article shall, at the request of an officer or employee duly designated by the Secretary, permit such officer or employee, upon presentation of appropriate credentials and a written notice to such person, at reasonable times and within reasonable limits and in a reasonable manner, to have access to and copy all records relating to such article that are needed to assist the Secretary in determining whether the food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals. <<NOTE: Applicability.>>  The requirement under the preceding sentence applies to all records relating to the manufacture, processing, packing, distribution, receipt, holding, or importation of such article maintained by or on behalf of such person in any format (including paper and electronic formats) and at any location.

 

Food and Drug Administration

 

21 CFR Parts 1 and 11

 

[Docket No. 2002N-0277]

RIN 0910-AC39

 

Establishment and Maintenance of Records Under the Public Health

Security and Bioterrorism Preparedness and Response Act of 2002

 

AGENCY: Food and Drug Administration, HHS.

 

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final regulation that requires the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States. Such records are to allow for the identification of the immediate previous sources and immediate subsequent recipients of food. The final rule implements the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), and is necessary to help address credible threats of serious adverse health consequences or death to humans or animals.

 

DATES: Effective Date: This final rule is effective February 7, 2005.

Compliance Dates: The compliance date is December 9, 2005; except that for small businesses employing fewer than 500, but more than 10 full-time equivalent employees, the compliance date is June 9, 2005; and except that for very small businesses that employ 10 or fewer full-time equivalent employees, the compliance date is December 11, 2006.

 

Persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States are subject to the regulations in part 1 (21 CFR part 1) subpart J of this final rule (i.e., record keeping and access requirements);

 

Records must be made available as soon as possible, not to exceed 24 hours from the time of receipt of the official request.

    • Failure to establish or maintain records or refusal to permit access to or verification or copying of any record is a prohibited act under section 301 of the FD&C Act.

 

 

 

Source:

http://www.cfsan.fda.gov