Jun 13, 2002 (CIDRAP News) – President George W. Bush yesterday signed a far-reaching bioterrorism bill designed to strengthen the public health system, tighten controls on dangerous pathogens, and protect the nation’s food and water supplies.
Proposed after the anthrax attacks last fall, the law authorizes the spending of billions of dollars to improve state, local, and hospital preparedness, expand the National Pharmaceutical Stockpile, increase inspections of imported foods, assess the security of drinking-water systems, and upgrade facilities at the Centers for Disease Control and Prevention (CDC).
"Biological weapons are potentially the most dangerous weapons in the world," Bush said before signing the bill. "Last fall’s anthrax attacks were an incredible tragedy to a lot of people in America, and it sent a warning that we needed and have heeded. We must begetter prepared to prevent, identify and respond. And this bill I'm signing today will help a lot in this regard."
Congress sent the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 to the president three weeks ago. The measure is a compromise between somewhat different versions that were passed by the Senate and House last December. The original bills were sponsored by Bill Frist, R-Tenn., and Edward Kennedy, D-Mass., in the Senate and by Billy Tauzin, R-La., and John Dingell, D-Mich., in the House.
The lengthy act has three titles addressing, respectively, general bioterrorism preparedness, regulation of biological agents and toxins, and protection of the food and drug supply. A fourth title extends the Prescription Drug User Fee program, in which drug manufacturers pay the Food and Drug Administration (FDA) for faster review of new drug applications.
The general preparedness title of the bill authorizes more than $1.5 billion in grants to develop new drugs and vaccines and to help state and local governments and hospitals improve their planning, enhance laboratory capacity, and train personnel, according to a statement issued by Tauzin when the bill was passed. The measure also authorizes $1.15 billion for expansion of the pharmaceutical stockpile and $300 million for improving CDC facilities.
A summary of the new law is available on the Library of Congress' Thomas Web site (see link below). Among other noteworthy provisions, the general preparedness title of the law:
- Establishes the position of assistant secretary of the Department of Health and Human Services (HHS) for public health emergency preparedness
- Calls for establishing temporary advisory committees to make recommendations on protecting children and on emergency public information and communications
- Recommends the establishment of a federal Internet site on bioterrorism
- Requires HHS to develop and disseminate training materials on responding to bioterrorism
- Authorizes loans, grants, and other funding mechanisms to help train healthcare professionals in bioterrorism-response skills that are in short supply
- Directs the HHS secretary to designate "priority countermeasures" against bioterrorism as fast-track products under the Federal Food, Drug, and Cosmetic Act (FFDCA).
- Directs the Department of Energy and the National Nuclear Security Administration to increase research on the rapid detection of pathogens likely to be used in bioterrorist attacks
The second section of the law requires HHS to establish and maintain a list of biological agents and toxins that could threaten the public health. Further, HHS must regulate transfers of such agents and toxins; set standards and procedures regarding their possession and use; require registration of possession, use, and transfer; and set security requirements for people who possess or use the agents. Clinical laboratories that may possess listed agents in diagnostic specimens are exempt from the requirements, but they must report any agents identified.
The law provides similar requirements, to be administered by the US Department of Agriculture (USDA), concerning agents and toxins that could threaten animal or plant health or animal or plant products.
The act authorizes $545 million for expanded FDA and USDA programs to protect the food supply, according to Tauzin's statement. The food-security title of the bill:
- Provides for more inspectors for imported food
- Provides for research to develop methods for quickly detecting adulterants in food
- Authorizes the FDA to detain food items when there is "credible evidence" that they pose a serious health risk to people or animals
- Provides for halting food imports by businesses that commit repeated or serious violations
- Requires food importers to give prior notice of shipments so they can be inspected
- Gives inspectors access to records regarding food suspected of being contaminated
- Calls for expanding the capacity of the USDA's Animal and Plant Health Inspection Service and the Food Safety and Inspection Service.
Concerning drinking-water security, the new law requires each water system serving more than 3,300 people to assess the system’s vulnerability to sabotage and to prepare or revise an emergency response plan. The measure also calls for a review of methods for preventing, detecting, and responding to contamination of water systems.
Deadlines for completing vulnerability assessments depend on the size of the water system, according to a statement issued yesterday by the American Water Works Association (AWWA), based in Denver. Systems serving 100,000 people or more have until March 31, 2003; those serving 50,000 to100,000 have until the end of 2003; and those serving 3,300 to 50,000 have until June 30, 2004.
The AWWA estimated it will cost $450 million to do the assessments in all 8,000 affected systems and at least $1.6 billion for needed security upgrades. The act authorizes $160 million this year and "such sums as may be necessary" in the following 3 years for these activities, the AWWA said.
The National Food Processors Association (NFPA) in Washington, DC, yesterday praised the food-security portions of the new law but said implementing them by the end of 2003 will be a major challenge for the FDA. The law is "the largest expansion of food-related enforcement authorities in the history of the Federal Food Drug, and Cosmetic Act," said Kelly Johnston, NFPA executive vice president for government affairs and communications.
Summary of the new law
President Bush's statement on signing the bill