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requirements. However, many farms had a difficult time determining whether they
needed to register based on the amount of handling or processing they performed.
Registration documents are protected from public disclosure under the Freedom
of Information Act. The registry provides, for the first time, a complete list of com-
panies subject to FDA authority, and will enhance the agency's capability to trace
contaminated food. Critics argued that registration created a record keeping bur-
den without proof that facilities will be able to respond in an emergency.
Prior Notice of Imports
As of December 12, 2003, importers are required to give advance notice to FDA
before importing food. Electronic notice must be provided by the importer within
a specified period before arrival at the border (within two hours by road, four hours
by air or rail, and eight hours by water). With prior notice, FDA can assess whether
a shipment meets criteria that can trigger an inspection. If notice is not given, the
food will be refused entry and held at the port or in secure storage. Some critics
are concerned that the administrative cost of compliance may raise the price of
food. Others have argued that perishable imports are subject to increased spoilage
if delays arise, or that certain perishables (especially from Mexico) are not harvested
or loaded onto trucks before the two-hour notification period. However, imple-
mentation of the new system generally has not caused delays and most shippers
have been accommodated.
To facilitate compliance, FDA and the Department of Homeland Security
(DHS) Bureau of Customs and Border Protection (CBP) integrated their informa-
tion systems to allow food importers to provide the required information using
CBP's existing system for imports. In December 2003, the two agencies agreed to
allow CBP officers to inspect imported foods on FDA's behalf, particularly at ports
where FDA has no inspectors.
Security for Biological Agents and Toxins
In December 2002, the USDA APHIS issued regulations to reduce the threat that
certain biological agents and toxins could be used in domestic or international ter-
rorism. APHIS determined that the “select agents” on the list have the potential to
pose a severe threat to agricultural production or food products.
The select agent regulations (9 CFR 121 for animals, 7 CFR 331 for plants)
establish the requirements for possession, use, and transfer of the listed pathogens.
The rules affect many research institutions, including federal, state, university, and
private laboratories, as well as firms that transport such materials. The laboratories
have had to assess security vulnerabilities and upgrade physical security, often with-
out additional financial resources. Some have been concerned that certain research
programs may be discontinued or avoided because of regulatory difficulties in
handling the select agents.
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