PROTECTING THE PUBLIC UNDER THE NEW BIOTERRORISM ACT
Statement of Caroline Smith DeWaal
Director of Food Safety
Center for Science in the Public Interest
At the National Food Policy Conference
May 9, 2003
My name is Caroline Smith DeWaal, and I am director of food safety for the Center for Science in the Public Interest (CSPI). CSPI is a nonproft health advocacy and education organization focused on food safety, nutrition, and alcohol issues. CSPI is supported principally by the 900,000 subscribers to its Nutrition Action Healthletter and by foundation grants. We accept no government or industry funding.
September 11, 2001 was not only a tragedy, it served a wake-up call. As Americans, we suddenly recognized that we are vulnerable to terrorist attacks. The anthrax attacks a few weeks later only heightened this sense of vulnerability. We now must worry not only about the safety of our airports, public transportation systems, and public buildings, but also about our water and our food supply.
According to the World Health Organization (WHO), "food is . . . the most vulnerable to intentional contamination by debilitating or lethal agents. The diversity of sources of foods, including the global market, makes prevention difficult, if not impossible."1 This year we learned from news reports that terrorists have developed materials to manufacture Salmonella and botulinum, and they may have intended to poison the food supply of American military troops in Afghanistan.2 Even more alarming was a recent Washington Post article on biological weapons developed by the South African government under the apartheid regime, including a biological agent created by splicing a common strain of E. coli with a toxin-producing gene from Clostridium perfringens.3
Outbreaks demonstrate that FDA-regulated foods are vulnerable
There are a number of examples of food bioterrorism, both nationally and internationally, that demonstrate the health and economic damage that could be inflicted through an attack on the food supply. Just last year in China, thirty eight people died and hundreds were sickened from baked good spiked with rat poison by a competitor. And following the World Cup race in New Zealand this year, there was a terrorist threat of food tampering that resulted in headlines all over that country warning consumers to "Watch what you eat". Domestically, there was a case of food bioterrorism in 1984, when a cult in Oregon spiked salad bars with Salmonella, causing 751 illnesses.
Many foods regulated by the Food and Drug Administration (FDA) pose a special risk. For example, a large portion of the produce and seafood we consume in this country is imported. Yet only a very small percentage — about 2% — of this imported produce and seafood gets inspected. Fruits and vegetables are particularly vulnerable to a terrorist threat since they are consumed directly with minimal processing.
Unintentionally contaminated imported produce has been associated with numerous outbreaks of illness in the United States. These outbreaks demonstrate that a hazard placed on a fruit or vegetable in a foreign field or factory can be distributed rapidly in the U.S. and cause thousands of illnesses. Other risky imported products include ingredients, like spices or additives, which, if contaminated, could enable a poison to be incorporated into a large variety of processed food products around the country.
FDA should exert full authority under the new Bioterrorism Act
In an effort to address this vulnerability, Congress passed the Public Health Security and Bioterrorism Preparedness and Response Act (Bioterrorism Act for short) in 2002. The Act gives FDA several important new tools to protect the food supply: it includes provisions for registration of food facilities, prior notice of imports, recordkeeping to trace foods, and administrative detention of suspect foods. Back in January, FDA proposed rules to implement two of the Act’s provisions relating to registration and prior notice. And just this week, FDA released proposed rules to implement two other provisions relating to recordkeeping and administrative detention.
The FDA Commissioner, Dr. Mark McClellan, recently stated in an interview with the New York Times that he was surprised that FDA did not previously have clear authority to address a bioterrorist threat.4 Well, it does now. But industry groups, importers, and others are already attacking FDA’s proposals. We cannot let industry weaken FDA’s new powers — the FDA needs to hear consumers’ voices on these issues as well. So I’m urging all of you to write to the FDA and tell the agency that you want it to assert its new authorities in the strongest possible way to protect the food supply from intentional contamination.
Let’s talk a little more about each of the provisions in the Bioterrorism Act and why they are so critical to protection of the American food supply from a bioterrorist attack.
- Registration of food plants and importers: Under the requirement for the registration of food plants and importers, for the first time, the U.S. Food and Drug Administration (FDA) will have information on all food plants and facilities (other than those that produce meat and poultry) that process food for U.S. consumers. Hundreds of thousands of food plants will register with FDA, including both foreign and domestic facilities. The registration data will help FDA identify foods that may pose a health or security threat, and will allow the agency to quickly communicate to facilities effected by an attack. It also will allow the agency to better target their scarce inspection and investigation resources.5
- Prior notice of imports: The requirement for prior notice of imports gives FDA notice of what food is entering the U.S. and where, so that the agency can ensure that there are inspectors at ports and other entry points to check food they believe is a threat. Today, food enters the U.S. at any port or border crossing without notice to the FDA. The proposed rule requires that notice be provided at least by noon of the day before the food will arrive. The food industry and many exporters to the U.S. have strongly objected to this notice requirement. However, it seems the minimum necessary to ensure that FDA can target its inspection resources devoted to imported food to the highest risk food shipments.6
- Recordkeeping: Under the recordkeeping provision, FDA will require food processors and transporters to maintain records that allow the agency to trace products up and down the chain of distribution and to inspect those records. This authority gives FDA an essential tool to trace tainted food back through the chain of distribution, to help identify the source of illness outbreaks and more effectively implement a product recall.7 According to the World Health Organization in its recent report "Terrorist Threats to Food," "tracing systems and market recalls are... critical in responding to food contamination, whether deliberate or inadvertent." Consumer anxiety in the event of a bioterrorist attack against the food supply will be minimized by good tracing mechanisms that remove tainted food from supermarket shelves as quickly as possible. CSPI has also called on FDA to require source labeling on all foods. Recently, Congress required USDA to develop a plan for country-of-origin labeling requirement for most imported foods, but more specific labeling (tracing all foods back to the processing plant or even the farm) would allow for faster recalls while minimizing the business disruption for other similar products.
- Administrative detention: Under the administrative detention provision, for the first time, FDA will have authority to detain food where it has evidence that the food could cause serious illness or death.
Many of these authorities are common sense and we share Commissioner McClellan’s surprise that it took the threat of bioterrorism to convince Congress that FDA should have such basic regulatory tools. After all, it is a basic consumer expectation that FDA, as our leading public health agency charged with food protection, actually knows what food plants it is regulating and what food imports are arriving that will require inspection.
The unfortunate reality is that through its power to influence Congress, the food industry has kept FDA barefoot and pregnant — literally hobbled under a workload that is far too vast with insufficient resources. While the food industry is now complaining about these new regulatory "burdens," FDA still lacks such essential tools as mandatory recall authority that would be critical if terrorists attacked the food supply. And when it comes to preventing bioterrorism, FDA needs authority to monitor that every country that exports food to the United States has systems in place to deter the intentional contamination of the food.
What More Needs To Be Done
I’ve focused today on the new authorities that FDA has under the Bioterrorism Act. The U.S. Department of Agriculture also plays a role in protecting our meat and poultry. They must take additional actions, such as increasing the number of inspections and product tests to assure that meat and poultry is not subject to intentional contamination.
There are also other steps that could and should be taken to assure our food supply is protected.
- Creation of a single food safety agency is the most crucial step in protecting our food supply. We need to end the current fragmented approach where the left hand frequently does not know what the right hand is doing.
- We need to continue to strengthen our disease surveillance systems and improve communication and coordination among local, state and federal agencies to heighten the ability to recognize and quickly respond to foodborne outbreaks.
- Both FDA and USDA should have mandatory recall authority. Recently, Secretary of Agriculture Anne Veneman called on Congress to give FSIS enhanced enforcement authority over meat and poultry companies. She is right, but needs to go farther, and support her predecessor’s call for mandatory recall authority for tainted meat and poultry products. With potential terrorist threats against the food supply, it is more important than ever that the federal government hold the power to order contaminated food off the market.
- We need to expand laboratory capacity to assure that we can test for a range of potential biological agents, test products quickly, and that results are communicated to relevant agencies, health care providers, and the general public as quickly as possible.
Unfortunately, we live a new era — one where we as Americans seem to be looking over our shoulders at all times. It is critical that the government is fully empowered to protect the public from potential biological, chemical and nuclear attack.
To protect the food supply, Congress has given FDA some very important new tools. The question is how FDA will use these tools — will it adopt the strongest possible requirements to protect consumers and the integrity of the food supply or will it squander them by adopting weaker rules in response to the well-oiled machinery of industry opposition.
1 World Health Organization, Food Safety Department, FOOD SAFETY ISSUES:
Terrorist Threats to Good, Guidance for Establishing and Strengthening Prevention and Response Systems (2002), at p. 5.
2 Barton Gelman, Al Queda Near Biological, Chemical Arms Production, THE WASHINGTON POST, Mar. 24, 2003, at A01. See also James Risen and Don Van Natta, Jr., Plot to Poison Food of British Troops is Suspected, THE NEW YORK TIMES, Jan. 24, 2003, at A1.
3 Joby Warrick and John Mintz, Lethal Legacy: Bioweapons for Sale, The Washington Post, April 20, 2003, at A01.
4 Gina Kolata, Scientist At Work: Mark B. McClellan, New York Times (Apr. 29, 2003), at Sec. F, page 1.
5 All domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption will now be required to register with FDA. There are exemptions for farms, retail operations, restaurants, and non-profits that prepare and serve food directly to consumers.
6 Under the proposed rule, the notice must include, among other things, information on the article of foods, the quantity, the identification of the manufacturer, and the originating country.
7 Facilities that manufacture, process, pack, transport, distribute, receive, hold or import food must also maintain certain records and make them available for inspection. Surprisingly, FDA has not, to date, had any system in place to track food products through the distribution chain where they have been and where they are going. Just last week, though, FDA announced that it is finally in the process of developing such a system to help it trace food in the event of a bioterrorist attack. Such a system would be important and should be used in tracking food in the event of unintentional contamination as well.