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The
Bioterrorism Act and FDA’s New Powers
On June 2002, in response to September 11 and to safeguard
the nation from attacks to its food supply, drug supply or water supply,
sweeping changes in the powers of a number of federal agencies, including
the FDA and USDA. The new law, the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002, is commonly called the
Bioterrorism Act of 2002.
The FDA and the Fight Against
Terrorism, by Michelle Meadows, FDA Consumer
magazine, January-February 2004 Issue:
http://www.fda.gov/fdac/features/2004/104_terror.html
FDA Bioterrorism Act website
FDA Counterterrorism information
Bioterrorism: A
Threat to Agriculture and the Food Supply. GAO-04-259T
(November 19, 2003)
Highlights
Abstract
Food Facility Registration
The new regulations require registration with FDA of all
domestic and foreign food facilities that manufacture/process, pack, or hold
food for human or animal consumption in the United States. The key features
of the interim final registration regulations are that any domestic or
foreign facility that manufactures, processes, packs, or holds food for
human or animal consumption in the United States is required to register the
facility with the FDA by December 12, 2003, unless the facility is exempt.
Facilities exempt
from registration include farms; retail food establishments whose principal
business is selling food directly to consumers; restaurants; private
residences; transport vehicles that hold food only in the usual course of
business; nonprofit food establishments; fishing vessels not engaged in
processing; and facilities regulated exclusively throughout the entire
facility by the USDA. Foreign facilities are exempt from registration if
food from the facilities undergoes further manufacturing, processing or
packaging (of more than a de minimis nature) at another foreign facility
before it is exported to the U.S. Essentially, the last foreign facility
that manufactures, processes, or packages the food, and any subsequent
foreign facility that packs or holds the food, must register. Other
key provisions include:
v
Foreign facilities required to register must also designate a U.S. agent who is
physically present in the United States.
v
The owner, operator, or agent of a covered facility must submit the registration
to FDA.
v
The new registration requirement requires registration of covered facilities,
not companies. A single company may be required to register multiple
facilities.
v
If
any of the required information listed above changes, the registrant must submit
an updated Form 3537 to FDA within 60 days of the change.
v
If
a facility is required to register, it is a violation of United States federal
law to fail to register. If a foreign facility required to register fails to do
so and food from that facility is offered for import into the U.S., the
Bioterrorism Act requires that the food be held at the port of entry.
Interim Final Rule -- Registration of Food Facilities
Press Release
(October 16, 2003);
Press Release (October
9, 2003)
Federal
Register notices:
Registration of Food Facilities (PDF
2.0 MB)
Fact sheet
on FDA'S New Regulation: Interim Final Rule - Registration of Food
Facilities
Booklet,
What You
Need to Know About Registration of Food Facilities
FDA Issues Final Rule on the Establishment and Maintenance of Records to
Enhance the Security of the U.S. Food Supply Under the Bioterrorism Act.
FDA also
issues draft guidance regarding records access. FDA (December 6, 2001)
http://www.fda.gov/bbs/topics/news/2004/NEW01143.html
FDA releases final rule on administrative detention
FDA on May 27
announced it has completed the final rule for administrative detention of
suspect food, one of the four main food-related provisions of the 2002
Bioterrorism Act. The rule allows FDA to seize and detain food for which
the agency has "credible evidence or information that it presents a threat
of serious adverse health consequences or death to humans or animals." In
the past, FDA only had the authority to work jointly with state government
to seize and detain suspect foodstuffs. Now, under the final rule, FDA may
single-handedly detain and sequester suspect foods in a secure location for
up to 30 days. The May 27 FDA news release:
http://www.fda.gov/bbs/topics/news/2004/NEW01073.html
Food Safety Guidance
in Emergency Situations
The Food and Agriculture Organization (FAO) has developed a Guidance
document to assist those responsible for planning and overseeing food
operations, especially in emergency situations, to recognize aspects of
their function that influence food safety and to guide them in minimizing
risk of foodborne illness. http://www.fao.org/es/esn/food/foodquality_en.stm
FDA and Customs Revise Enforcement Strategy on Prior Notice for Imported
Foods
FDA Talk Paper, August 12, 2004. FDA and the U.S. Customs and Border
Protection (CBP) have revised a compliance policy guide (CPG) that describes
how the agencies will enforce requirements for companies to give FDA prior
notice of foods being imported into the United States. The revisions include
clarification of how the agencies will handle violations of the prior notice
rule. FDA receives about 160,000 prior notice submissions a week.
“The prior notice provision in the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) gives
FDA advance information of imported food shipments. This allows FDA to
target inspections more effectively and helps to ensure the safety of
imported food products before they enter domestic commerce.”
FDA and CBP also are announcing a corresponding three month
delay in their projected date for issuing the prior notice final rule from
March 2005 to June 2005. Revised Compliance Policy Guide:
http://www.cfsan.fda.gov/~pn/cpgpn3.html
Other Resources
Domestic WMD Incident
Management Legal Deskbook - the U.S. Defense Department’s Defense Threat
Reduction Agency (DTRA) has published the first-ever legal guidebook for dealing
with mass emergencies. The 529-page guidebook, entitled is designed as a
research tool for lawyers responding to weapons of mass destruction accidents or
incidents of terrorism. “We needed to get our hands around this in some kind of
deskbook fashion,” said Gregory Huckabee, a former judge advocate who helped
write the book. “Lawyers aren’t going to have expertise in this - they don’t
teach this in law schools.” The handbook covers statutes -- from quarantine to
Posse Comitatus -- that would come into play during an emergency. Officials
from nine federal agencies, including CDC, helped write the book. “The most
important thing about it is the comprehensive nature of all the sources that
have been pulled together involved with emergency response,” said Raymond
Heddings, the associate general counsel at DTRA, who coordinated the work. The
manual may be the most comprehensive record of federal and state emergency laws
written to date. The guidebook is available online at
http://www.dtra.mil/news/deskbook/index.html.
The Food Institute's bioterrorism
resource page:
http://www.foodinstitute.com/bioterrorresources.cfm
Livestock Biosecurity/Agrisecurity
from Michigan State University
http://cvm.msu.edu/extension/Biosecurity/BiosecurityMenu.htm
Agrisecurity resources from Michigan State University
http://www.lib.msu.edu/harris23/crimjust/agrosec.htm
BIOTERRORISM plan sparks food feud
Bradenton Herald - Bradenton, FL, USA. The value of new FDA regulations to
address bioterrorism are questioned. "Anybody who was following the law was
not the problem anyway." Several food industry experts counter that the
regulations give the FDA a foundation of laws to work with.
http://www.bradenton.com/mld/bradenton/news/local/8623755.htm
Shared Nightmare Over the Food Supply
Elizabeth
Becker, New York Times (December 11, 2004)
http://www.nytimes.com/2004/12/11/politics/11food.html. When Tommy G.
Thompson, the departing secretary of health and human services, used his
farewell news conference last week to warn that terrorists could easily
poison the nation's food supply, he was, according to this story, saying out
loud what he and other experts have been warning since the attacks of Sept.
11. Other Washingtonians who spend sleepless nights worrying about tainted
food can expand on Mr. Thompson's nightmare with the chilling precision of
the author Stephen King, and with the knowledge that terrorists can strike
the food supply without anyone's noticing.
FDA gets new tools to trace attacks on food supply
Laura Meckler,
Chicago Sun Times (December 7, 2004)
http://www.suntimes.com/output/news/cst-nws-food07.html
Rules announced Monday will make it easier to investigate a bioterror attack
on the U.S. food supply, though they won't change the vulnerability of the
nation's food. The regulations will allow the agency to track foods
implicated in emergencies such as intentional contamination. The regulations
require food manufacturers and other food handlers to maintain records that
identify the immediate previous source of all food received and the
immediate recipient of all food released. The recordkeeping requirement is
the fourth final regulation designed to increase the security of the U.S.
food supply issued under the authority of 2002 bioterrorism legislation.
-- Press release:
http://www.fda.gov/bbs/topics/news/2004/NEW01143.html
-- Fact sheet:
http://www.cfsan.fda.gov/~dms/fsbtac23.html
Farmlands seen as fertile for terrorism
Charles Piller, The Los Angeles Times (08/22/04). Much has changed
for the nation’s farmlands since the terrorist attacks of 2001. Armed
guards now patrol poultry plants, and slaughterhouses conduct preparedness
drills. Dairy farmers have installed video cameras to watch over their
milking operations. The potential for agroterrorism – the use of microbes
and poisons to attack the U.S. food supply, has led to a new protocol for
the nation’s $201 billion farm industry. No specific intelligence links
terrorists to attempts to compromise the food supply, federal officials
said, but investigators did discover that the 9-11 hijackers had explored
the use of crop dusters. Al Queda militants were also found to be in
possession of hundreds of pages of U.S. agricultural documents, according to
Sen. Susan Collins (R-Maine), chairwoman of the Senate Governmental Affairs
Committee. The U.S. Department of Agriculture (USDA) has responded to the
potential threat by building or modernizing two dozen laboratories that can
quickly screen disease samples from across the country. The agency has also
created rapid response teams of plant and animal pathologists in each region
who can respond to outbreaks. “We’re looking at what changes are needed.
We may need to harden targets,” said Jeremy Stump, the USDA’s domestic
security director.
http://www.latimes.com/news/printedition/la-na-agroterror22aug22,1,4165952.story
“Debate over how to protect farmland from terror”
Bryn Nelson, Newsday (07/26/04). A quiet debate is simmering in government
and farming circles about the best way to protect America’s agriculture
industry from terrorism. An attack on farms and ranches would not kill many
people immediately, but the eventual economic impact could be devastating.
But protecting agricultural facilities is problematic, in part because they
are so big. One feedlot, for example, may contain 10,000 cattle, and the
current security arrangements for such facilities are nearly nonexistent. A
2002 report by the National Research Council said American agriculture is
particularly vulnerable to attack, in part because of the huge scale of
farms and feedlots in some regions of the country. The outbreak of the
highly contagious foot and mouth disease last year in the United Kingdom
illustrates how devastating agricultural outbreaks can be on a nation’s
economy. During that outbreak, an estimated 4.2 million sheep and cows had
to be destroyed. Academic and government experts are debating another
related issue -- how much censorship should be placed on reports of
agricultural risks. If provided in enough detail, some reports might be
useful to terrorists bent on doing damage. “On the one hand, you want to
disseminate as much information as possible. On the other hand, you do not
want to put out so much information that you enable people who want to do
harm,” says James Stack, director of the Great Plains Diagnostic Center at
Kansas State University. The USDA is putting money into new information
networks that might provide early warning of attacks. USDA has also advised
farmers to take common sense precautions, such as locking up pesticides at
night, being aware of who has access to the farm during the day, and
establishing contacts with local law enforcement officials.
http://www.newsday.com/news/health/ny-hsagro0726,0,1699208.story
“Biowar: Balancing rights and needs legally”
Dee Ann Divis, United Press International (07/23/04). During a
bioterrorism emergency, doctors would spring into action and local health
departments would activate disaster plans. The response might include
strict measures designed to protect the population from the spread of
disease, such as vaccination and forced quarantine. These are traditional
public health measures used to control infectious disease outbreaks. During
last year’s SARS emergency, for example, one uncooperative patient was
detained to stop him from transmitting the infection. But it is unclear
whether all such measures would be legal to the same degree everywhere in
the United States, because the laws that govern the measures are based in
the states, not in the federal government, and they vary widely from state
to state. After September 11, 2001, the federal Centers for Disease Control
and Prevention sponsored the drafting of a model public health response law,
called the Model State Emergency Health Powers Act. The Model Act, written
by experts at the Center for Law and the Public’s Health (at
Georgetown/Johns Hopkins), is a template intended to help the states revamp
their own emergency public health response laws. Not surprisingly, the
Model Act came down strongly on the side of the powers needed to protect the
public health during emergencies. The Model Act clarifies the states’ power
to take control of medical supplies, seize or destroy property, place people
in quarantine, or do other things needed to stop the spread of disease. The
Model Act also contains safeguards to preserve individual rights. Some
observers view the Model Act as controversial, but many states have adopted
parts of it, including some measures that are even broader than the Model
Act provides. Some states are now studying whether persons in quarantine
should be entitled to compensation for lost wages, childcare, food
deliveries, and other services.
http://www.washingtontimes.com/upi-breaking/20040721-101902-3555r.htm
[For more information on the Model State Emergency Powers Act, see
http://www.publichealthlaw.net/]
NFPA
to FDA: Prior notice still not perfect
The National Food Processors Association (NFPA) offered several critiques of
the Bioterrorism Act's prior notice provision before the comment period
closed July 13. "Certain provisions in these prior notice requirements will
have adverse implications for trade and business operations, if not
resolved," said John Cady, NFPA President and CEO. Specifically, NFPA
said prior notice should not be required for small food imports that are
designated for research and development. "NFPA strongly believes that a
solution must be identified to allow U.S. companies to import samples from
unregistered foreign companies for product research and development," Cady
said. "Lacking such a solution, food companies will be forced to discontinue
certain aspects of research or relocate R&D facilities to other countries,
putting U.S. food companies at a competitive disadvantage globally."
The group also urged FDA to extend the discretionary enforcement period
until Dec. 12, 2004, to give industry some time to evaluate how the system
is working.
NFPA urges FDA to 'address remaining key issues on Bioterrorism Act'
NFPA Press Release (June 25, 2004) In testimony delivered before a U.S.
House of Representatives Subcommittee today, John R. Cady, President and CEO
of the National Food Processors Association (NFPA), urged the Food and Drug
Administration (FDA) to address remaining key issues for the food industry
in the Bioterrorism Act that still need attention. "The major problem
posed by FDA's interim final rule for prior notice of imported food
shipments concerns the inability of industry to import research and
development samples," said Cady. "FDA and Customs and Border Protection (CBP)
prior notice requirements are not the same, however, there are efforts
currently underway to determine if these requirements can be more closely
aligned," said Cady. While FDA has not yet issued a final rule for the
establishment and maintenance of records, Cady highlighted key issues raised
in NFPA's comments on the proposed rule and recommended the following: In
identifying sources and recipients of food ingredients to address a
terrorism incident, FDA should rely on the most readily available
information from the companies involved, which may include information from
knowledgeable company staff. Rapid response to an incident should not depend
on FDA's review of records.
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