This section contains information
on the four sets of regulations issued by the U.S. Food and Drug
Administration to implement the requirements of the Bioterrorism
Act enacted by Congress in 2002.
Click on the hyperlinks on this page
to access information on what’s required by each of these
regulations.
Facility Registration
Recordkeeping
Prior Notice for Food and Feed Imports
Administrative Detention of Food, Feed
Imports
Current Status of U.S. Food Defense
Facility Registration
Summary
FDA on Oct. 10, 2003 issued interim
final regulations implementing the section of the Bioterrorism
Act that requires domestic and foreign facilities to register
with FDA by Dec. 12, 2003 if they store, manufacture, process
or pack food for human or animal consumption in the United States.
Facilities are defined as any establishment, structure or structures
under one ownership at one general physical location –
or, in the case of mobile facilities, one that travels to multiple
destinations.
Among the types of facilities covered
by the registration requirement are grain elevators, feed mills,
flour mills, corn and oilseed processors, pet food manufacturers,
feed ingredient manufacturers, renderers and others.
(More
- Click Here to View Complete Summary)
Access to
More Information
Click on the hyperlinks below for:
1) compliance guidance from FDA; 2) the text of FDA’s
interim final rule on facility registration; 3) information
on how to register; and 4) NGFA/GEAPS compliance guidance.
Recordkeeping Requirements
Summary
FDA on Dec. 9, 2004
issued final regulations implementing the section of the Bioterrorism
Act that requires entities to maintain and provide access to records.
FDA’s regulations require that firms maintain records sufficient
to identify the immediate previous source of incoming agricultural
commodities and the immediate subsequent recipient of outbound
products – in effect, one-step-forward and one-step back
recordkeeping.
Covered by the recordkeeping requirements
are U.S. firms and persons that manufacture, process, store, pack,
transport, distribute, receive or import food, feed or feed ingredients.
This includes country, terminal and export grain elevators; commercial
feed mills; corn and soy processing plants; pet food manufacturers;
feed ingredient manufacturers; and transporters (including railroads,
barges and commercial truckers).
(More - Click Here to View Complete Summary)
Access to
More Information
Click on the hyperlinks below for:
1) compliance guidance from FDA; 2) the text of FDA’s
final rule on recordkeeping; and 3) NGFA/GEAPS compliance guidance.
Prior Notice for Food, Feed Imports
Summary
FDA on Oct. 10, 2003 issued interim
final regulations implementing the section of the Bioterrorism
Act that requires importers of food for humans or animals for
consumption in the United States to notify FDA in advance of
the shipment’s arrival. The “prior-notice”
regulations took effect on Dec. 12, 2003.
Who’s
Covered
The prior notice requirement applies
to importers of agricultural commodities intended for use in
humans or animals in the United States. (More
- Click Here to View Complete Summary)
Access
to More Information
Click on the hyperlinks below for:
1) compliance guidance from FDA; 2) the text of FDA’s
final rule on prior notice; and 3) NGFA/GEAPS compliance guidance.
Administrative Detention of Food, Feed Imports
Summary
The Bioterrorism Act also gives
FDA the authority to take control of an imported food or feed
product if FDA “has credible evidence or information indicating
such article presents a threat of serious adverse health consequences
or death to humans or animals.” FDA issued final rules
implementing this “administrative detention” authority
on June 4, 2004.
This so-called “administrative-detention
authority” is different from FDA’s right to refuse
entry of product. FDA can exercise its authority to refuse entry
of an imported product into the United States when it determines
that the product was not properly or safely produced, packed,
or held. FDA intends to use its right for administrative detention
when it believes the product could be part of a terrorism incident.
The administrative detention provisions
took effect immediately upon enactment of the Bioterrorism Act
in 2002.
Access to
More Information
Click on the hyperlinks below for:
1) compliance guidance from FDA; 2) the text of FDA’s
final rule on prior notice; and 3) NGFA/GEAPS compliance guidance.
