SUMMARY OF HR 3448: "Bioterrorism Preparedness Act of 2001"
David Drooz, North Carolina State University
June 2002

HR 3448 is the final bill of Congress, combining aspects of House and Senate bills on bioterrorism preparedness. This bill was cleared for the White House on May 23, 2002, but has not yet been signed into law by the President (as of June 6, 2002).

Full information on the bill can be found on the Congressional website at: http://www.loc.gov/index.html
The American Society for Microbiology has information at http://www.asm.org , Legal analysis at http://www.nacua.org/ and http://www.nacua.org/documents/H.R.%203448%20Memo%20(5).pdf

The bill appropriates about $4.6 billion for bioterrorism preparedness. There is emphasis on using university researchers to develop bioterrorism preparedness. The bill also requires greater federal oversight of biological agents, including a new registration process with US Dept. of Agriculture and US Dept. of Health and Human Services (HHS), and federal screening of persons who work with biological agents.

Here is a capsule summary of the bill:

Title I is a statement of the public health and security goals of the legislation.

Title II A requires the Secretary of HHS to develop measures of national, state, and local bioterrorism preparedness. It requires HHS to maintain a stockpile of vaccines and other medical supplies for use in emergencies (FY 2002 appropriation of $640 million for this). It requires enhancement of Centers for Disease Control ($60 million in FY 2002), and establishment of a network of public health labs ($59.5 million FY 2002).

Title II B creates a federal administrative structure for emergency management, including emergency powers, working groups, and task forces. It provides for a bioterrorism website. It adds $420 million in FY 2002 appropriations for grants to improve public health agencies.

Of special note to research universities, Title II B requires more extensive federal regulation of biological agents. HHS is to create a list of biological agents and toxins that pose severe threats to public health (there is an exemption for inactive samples used in biomedical research). HHS must promulgate strict regulations on the transfer, possession, use, and access to biological agents and toxins. There is to be a federal registration system to enable identification and tracing of the agents and toxins. Access to biological agents and toxins will be limited to persons who (a) need to use them for legitimate purposes, and (b) have registered and been screened by the U.S. Attorney General. Note that this will cover more substances than just "select agents." Persons (including institutions) who violate the new regs on transfer and possession of biological agents and toxins may be fined up to $500,000 (per violation). Possession or transfer of "select agents" by unregistered persons may be penalized by up to 5 years in prison.

Title III establishes a State Bioterrorism Preparedness and Response Block Grant Program. For FY 2002, HHS this program gets $667 million in funding, with a minimum of $5 million to go to every state. The monies are to help states develop plans for detecting and responding to biological attacks, create training programs, and upgrade hospitals' and other health providers' ability to serve victims of a biological attack. "Bioterrorism response medical centers" are to receive additional grant funding. Another $370 million is appropriated to fund existing Public Health Service programs. Title III specifically recognizes the importance of university programs related to biodefense, and encourages grant-funding for such programs.

Title IV creates a limited antitrust exemption for meetings and agreements on the development, purchase, manufacture, or distribution of bioterrorism countermeasures, where there is HHS oversight. This is aimed at drugs, medical devices, diagnostic tests, etc. Title IV also appropriates $509 million in FY 2002 for stockpiling of smallpox vaccine and other vaccines. It adds "the sequencing of the genomes of priority pathogens" to the items that NIH is to prioritize. It directs HHS to award grants for studies on the epidemiology and parthenogenesis of biological agents and toxins, for development of new vaccines, and for development of diagnostic tests for biological agents and toxins. It allows HHS to designate "priority countermeasures" for fast-track federal regulatory approval, and allows animal trials.

Title V instructs the President's Council on Food Safety to devise a communications and education strategy for bioterrorist threats to food supply. Likewise, USDA is instructed to bolster the capabilities of the Animal and Plant Health Inspection Service (APHIS). USDA is to implement a system of electronic monitoring for biological threats to plants and animals, and to award grants to states to expand the system ($30 million for FY 2002). The capabilities of the Food Safety Inspection Service and the Food and Drug Administration are to be expanded. Four ARS stations are designated for major biosecurity upgrades, as well as HHS labs.

Title V directs the USDA to grant up to $50,000 per land grant university for purposes of assessing security of facilities that store biohazards, and to assess communication networks for relating information on biological agents and toxins. The grants are to be awarded within 45 days of the enactment of this bill. USDA shall establish minimum security standards for the land grant universities. USDA shall also create a national inventory of biological agents and toxins at agricultural research facilities. USDA shall also establish a national protocol for screening persons who have access to agricultural research facilities. USDA shall sponsor a biosecurity education program for farm and livestock operations (topics: disease prevention, quarantine, crop handling procedures). Similarly, HHS is to promote safety education programs in the food industry.

Title V authorizes the FDA to detain food for safety reasons. FDA may debar food importers for certain felonies and for patterns of importing unhealthy food. Title V expands the authority of HHS to inspect food-related records, require the registration of food manufacturing, processing and handling facilities. Among several new provisions relating to food imports, there is a requirement that at least 4 hours before food arrives in the U.S., the importer must provide information about the food to HHS. Port shopping is prohibited. HHS receives FY 2002 funding of $10 million to award as grants to states for purposes of food inspections and investigations. Title V notes that USDA retains all its existing authority over meat, poultry, and egg products (as opposed to FDA/HHS).

Finally, Title V appropriates $19.5 million for grants to states participating in Pulsenet, the Foodborne Diseases Active Surveillance Network, and other food safety networks. It directs HHS to develop a plan for surveillance of zoonotic and human diseases. It appropriates $190 million for FY 2002 to expand ARS and Extension Service programs to protect food supply and respond to bioterrorism.

New federal regulations will flow from this bill after it's signed into law. The regulations will be most important in terms of university compliance - we cannot respond to the new requirements for registration of biological agents, registration of persons who access them, and lab security until we see the implementing regulations.