To: Seafood Mailing List
Fr: Pamela Tom, University of California - Sea Grant Extension Program
On December 6, 2004 the U.S. FDA issued final regulations on the
establishment and maintenance of records to protect the U.S. human food
and animal feed supply in the event of credible threats of serious adverse
health consequences or death to humans or animals.
http://www.fda.gov/OHRMS/DOCKETS/98fr/02n-0277-nfr0001.pdf (344 pages)
FDA also issued draft guidance to FDA staff and industry, which details
the internal procedures the agency will follow before requesting access to
records.
http://www.cfsan.fda.gov/~dms/secgui12.html
This is the fourth and final regulation designed to increase the safety
and security of the U.S. human and animal food supply under the authority
of the "Public Health Security and Bioterrorism Preparedness and Response
Act of 2002" (the Bioterrorism Act).
The record retention period for human foods ranges from six months to two
years depending on the shelf life of the food. Records for animal food,
including pet food, must be retained for one year. The maximum record
retention requirement for transporters of all types of food is one year.
Records must be retained at the establishment where the activities covered
in the records occurred or at a reasonable accessible location. To
minimize the burden on food companies affected by the final rule,
companies may keep the required information in any format, paper or
electronic. All businesses covered by this rule must comply within 12
months from the date the rule is published in the Federal Register, except
small and very small businesses. Small businesses (11-499 full-time
equivalent employees (FTEs)) must comply within 18 months from this date,
and very small businesses (10 or fewer FTEs) have to comply within 24
months from this date.
When FDA 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, any records or other information to which FDA has
access must be available for inspection and copying as soon as possible,
not to exceed 24 hours from time of receipt of the official request. The
records access authority applies both to records required to be
established and maintained by the final rule, or any other records a
covered entity may keep to comply with federal, state, or local law or as
a matter of business practice.
FDA has already issued three other final regulations under the
Bioterrorism Act, which are in effect. They cover:
- Registration foreign and domestic food facilities;
- Prior notice of food shipments imported or offered for import into the
U.S.; and
-Administrative detention, so that food products that might pose a threat
of serious adverse health consequences or death may be detained.
FDA will be holding seven public meetings across the U.S. in January and
February 2005 to explain the requirements of the final rule to interested
parties and answer questions.
http://www.cfsan.fda.gov/~dms/fsbtac24.html
A fact sheet on FDA's New Food Terrorism Regulation: Establishment and
Maintenance of Records is available on line at:
http://www.cfsan.fda.gov/~dms/fsbtac23.html
Source: FDA News, December 6, 2004
http://www.fda.gov/bbs/topics/news/2004/NEW01143.html
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