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"Terrorism is real, whether it's domestic or foreign, and we need
to do everything we can to be prepared."- USDA Secretary Mike Johanns,
Statement - May 3, 2005
- FDA to review the registrations of food facilities.
FDA is announcing that a proposed collection of information regarding
the registration of food facilities under the Public Health Security
and Bioterrorism Preparedness and Response Act of 2002 was submitted
to the Office of Management and Budget for review and clearance, according
to the Dec. 15, 2006 Federal Register.
Owners, operators, or agents in charge of domestic or foreign facilities
that manufacture/process, pack, or hold food for human or animal consumption
in the U.S. are responsible for registration.
FDA received 82,485 new domestic facility registrations during 2003;
32,099 during 2004; and 13,652 during 2005. Based on this experience,
FDA estimates the annual number of new domestic facility registrations
will be 13,650.
FDA received 89,990 new foreign facility registrations during 2003;
49,574 during 2004; and 29,193 during 2005. Furthermore, FDA received
131,354 updates to facility registrations during 2003; 137,384 during
2004; and 92,835 during 2005. Based on this experience, FDA estimates
that it will receive 92,850 updates annually.
In addition, FDA received 12,556 cancellations of facility registrations
during 2003; 7,467 during 2004; and 1,280 during 2005. Based on this
experience, FDA estimates the annual number of cancellations will be
1,300. Comments must be received by Jan. 16, 2007. Contact: Jonna Capezzuto
301-827-4659. Full
Notice
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Bioterrorism Act Update: Only 53% Of Food Facilities
Have Registered With FDA
Of the 420,000 food facilities worldwide that FDA estimates must
register under the Bioterrorism and Preparedness act of 2002, the
Agency received only 221,450 registrations through Sept. 17 – indicating
that 47%, or 198,550 have yet to register. The 420,000 total
is split approximately evenly between domestic and foreign facilities.
While FDA has not penalized any firms for not registering thus
far, the agency has noted that after Nov. 1, 2004 it may reject product
imported from non-registered facilities.
A total of 118,963 foreign facilities are registered, about
57% of the 210,000 anticipated, while only 49% — 102,487 — of the
domestic faculties have. Japan has registered the most overseas’ facilities,
with 15,446 or about 13% of the foreign total registered. The top
10 nations with registered facilities accounted for 59% of the total
foreign registrations received.
A number of resources are available from the Food Institute
to assist you in complying with the Bioterrorism regulations, including
The Bioterrorism Act Guide, which can be ordered by calling Sue Antista
at (201)791-5570, ext. 212, or going to www.foodinstitute.com/bioterrorism.cfm
If you need a U.S. agent for your overseas facility, USA Food Agents
is at your service. For details, call Brian Todd at (201)791-5570,
ext. 217 or visit
www.usafoodagents.com
- The final rule establishing procedures for administrative detention
of food under the authority of the Bioterrorism Act was issued by
FDA on May 28, 2004. FDA plans to issue shortly the fourth final rule
on recordkeeping shortly. Full
Story, FDA
Release, Fact
Sheet
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Now
Available!
FOOD
INDUSTRY BIOTERRORISM ACT GUIDE
This
comprehensive, reader-friendly summary of the Bioterrorism
Act and FDA's regulations and guidance documents is now
available from The Food Institute. Authored by Olsson,
Frabk & Weeda, P.C., topics include food facility
registration and prior notice of food imports. Summaries
of recordkeeping requirements and FDA's new administrative
detention authority will be published and shipped automatically
to purchasers when the rules are finalized by FDA. For
more information or to order the book, click
here.
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- Joint Venture To Aid Food Firms With Compliance
The Food Institute, the 75-year old food industry information service,
and Olsson, Frank and
Weeda, PC, the 25-year old Washington, DC based law firm specializing
in food and drug law, have formed a new joint venture under the name
U.S.A. Food Agents, LLC. The new venture will serve the needs of foreign
and domestic food, beverage, pet food, and dietary supplement firms
who will have to register each of their facilities with the Food and
Drug Administration under the new Bioterrorism Act and its implementing
regulations. To find out more about U.S.A. Food Agents, click
here.
- FDA issues a revised guidance entitled "Questions and Answers
Regarding the Interim Final Rule on Registration of Food Facilities''
Full
Notice
- View the entire
Federal Register Notice containing FDA's interim final rule on Registration
of Food Facilities Under the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002.
- HHS
Press Release on two new interim final bioterrorism rules
- Online Survey of Food Professionals
Food importers will be required to provide detailed shipping information
to FDA no later than the day before the items arrive in the U.S. as
part of FDA’s implementation of the Bioterrorism Act. However, FDA’s
proposed rule regarding the prior notice of imports is unknown to nearly
half of the thousand-plus food industry professionals surveyed by The
Food Institute via its Daily Update emails. In addition, of those respondents
aware of the new rule, more than half said they have done nothing to
prepare for it. The regulation is expected to be finalized in early
October and must be in place by Dec. 12, leaving only two months for
implementation. To read the full press release regarding this survey,
click here
- Highlights of the FDA interim final rule on registration of food facilities
and notice prior to import by Olsson, Frank & Weeda P.C. for U.S.A.
Food Agents, LLC available here.
- A proposed rule on Establishment, Maintenance, and Availability of
Records Under the Bioterrorism Act would require that persons
who manufacture, process, pack, transport, distribute, receive, hold
or import food intended for human or animal consumption in the U.S.
establish and maintain records sufficient to identify the immediate
previous source and immediate subsequent recipient of such food. The
Food Institute's counsel, Olsson, Frank & Weeda PC, has summarized
the proposed rule, click
here to view.
- FDA's proposed rule, Administrative Detention of Articles of Food
Under the Bioterrorism Act establishes procedures for FDA to detain
an article of food, if an FDA officer or qualified employee has credible
evidence or information indicating that the article presents a threat
of serious adverse health consequences or death to humans or animals.
Read an analysis of the proposed rule prepared for The Food Institute
by Olsson, Frank & Weeda PC. Click
here for analysis.
- FDA's Prior Notice of Imported Food Proposed Rule represents a dramatic
departure from current import practices. Any entity importing food
or products that come in contact with food would have to alter their
import procedures under the proposed regulations. The agency devotes
specific analyses to the economic harm likely to result to those involved
in the importation of fish, seafood and produce. The Food Institute's
counsel, Olsson, Frank & Weeda PC, has summarized the proposed rule,
click
here to view.
- Bioterrorism Act Analysis - FDA may have exceeded its statutory authority
in its proposed rule requiring registration of food facilities that
was required by The Bioterrorism Act, according to an analysis of prepared
for The Food Institute by Olsson, Frank & Weeda PC. Click
here for analysis.
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 Need
A U.S. Agent For Your Foreign Suppliers?
If you are sourcing product
overseas, your suppliers will have to register their facilities
with FDA and must appoint a U.S. Agent under FDA's new
bioterrorism regulations. U.S.A. Food Agents has been
formed to act as U.S. agent for foreign facilities and
to provide registration assistance. Click
here for details.
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Public
Health Security and Bioterrorism Preparedness and Response Act of 2002.
Prepublished
Prior Notice of Imported Food Shipments Interim Final Rule
FDA
Prior Notice of Imported Food Shipments Fact Sheet
FDA
Actions on New Bioterrorism Legislation as of January 2003
FDA
Registration of Food Facilities Fact Sheet
FDA Food Facility
Registration Form (Form 3537) and Cancellation of Food Facility
Registration (Form 3537a) (PDF)
Food Institute research resources
Food Price Outlook 2005
Publication Catalog
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