Bioterrorism Act Update
Recordkeeping Rules Issued by FDA
In early December 2004, the Food and Drug Administration issued final rules regarding the establishment
and maintenance of records for compliance with provisions of the Bioterrorism Act of 2002.
The new regulation requires persons who manufacture, process, pack, transport, distribute, receive,
hold or import food to establish and maintain records as described in the newly issued rules.
The rules set forth mandatory maintenance of records that identify the immediate previous source of all food received,
the immediate subsequent recipient of all food released, as well as who must keep records,
what types of records must be kept and how long the records must be kept.
The FDA has also issued a draft guidance document detailing the internal procedures that the agency
will follow before requesting access to records. 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 employees) must comply within 18 months from this date,
and very small businesses (10 employees or fewer) have to comply within 24 months.
The FDA press release can be viewed at:
http://www.fda.gov/bbs/topics/news/2004/NEW01143.html
Information about the public meetings, contact information, submission of comments, and regularly updated information
on provisions of the Bioterrorism Act under FDA's jurisdiction can be obtained at:
http://www.fda.gov/oc/bioterrorism/bioact.html
New Rules on Registration of Food Facilities, Prior Notice of Imports
The owner, operator, agent in charge or other authorized individual of a domestic or foreign facility that manufactures, processes, packs or holds food for human consumption in the US must register that facility with FDA by December 12, 2003.
Farms are exempt and are defined as facilities in one general location devoted to growing and harvesting crops...washing, trimming leaves and cooling produce is part of harvesting, but slicing is processing. The term 'farm' also pertains to a facility that packs or holds food, if all food is grown on that farm or another under the same ownership.
Food facilities can be registered on the internet, by filling out a paper form, or by submitting a CD-ROM with relevant registration infomation to FDA. Registering online is simple, requiring general contact info. The online registration is available at www.fda.gov/furls
The rule on prior notice of imports requires an electronic submission of data, provided by brokers and importers, to the Bureau of Customs and Border Protection (CBP) when foods arrive in the US. This information will also be provided to the FDA prior to the imported food's arrival. Nearly all shipments can comply by using CBP's Automated Broker Interface of the Automated Commercial System (ABI/ACS). Prior notice begins December 12, 2003 and must be received and confirmed electronically by FDA no more than five days before arrival and specified by transportation type no fewer than:
2 hours before arrival by land or road
4 hours before arrival by air or by land by rail
8 hours before arrival by water
www.fda.gov/oc/bioterrorism/furls |
