Security & Bioterrorism

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.

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

Food Facility Registration Questions and Answers

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.

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.