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BIOLOGICAL AGENTS - LEGISLATION October 29,
2002 - Biological, Chemical, and Radiological Weapons
Countermeasures Research Act of 2002 May 31, 2002 - Legislative Alert: Congress Passes Health Security and Bioterrorism Preparedness Act/Expands Controls over Select Agents Public Health Security and Bioterrorism
Preparedness and Response Act The House-Senate Conference Committee on the "Public Health Security and Bioterrorism Preparedness and Response Act" HR 3448 have reached agreement on legislation to improve the nation's capacity to respond to bioterrorism and other public health emergencies. Title II, Enhancing Controls on Dangerous Biological Agents and Toxins, requires persons and individuals who possess, use or transfer select agents, the 42 biological agents and toxins currently listed by the Secretary of Health and Human Services as posing "a severe threat to public health and safety, to register with the Secretary and be subject to reasonable safety and security requirements, including access controls and screening of personnel, and inspections. Current law requires registration only of those facilities transferring select agents. The legislation establishes a national database of the location and characterization of select agents and the identities of those who possess them. The legislation recognizes that some select agents pose a greater threat to public health and safety than others, and gives the Secretary the flexibility to impose different levels of security requirements on different select agents based on an evaluation of the level of threat to the public as is currently done with respect to laboratory biosafety levels. The legislation requires that registered persons promptly notify the Secretary if a select agent is lost, stolen, or released outside a biocontainment area of a facility. The legislation requires prompt action by the Attorney General and the Secretary of HHS with respect to screening of and notification of affected individuals and provides an expedited review process where good cause has been demonstrated by the registered facility. The legislation also provides for the review of denials by the Secretary based on the screening process and judicial review, with provisions that classified or sensitive law enforcement information is not compromised during those reviews. Exemptions are provided consistent with the current select agent transfer rule, for products that are approved under specific federal laws unless the Secretary determines that additional regulation is necessary for a specific product to ensure protection of public health and safety. The Secretary is given discretionary authority to exempt on a case-by-case basis investigational products when they are being used in investigational or clinical trials authorized under federal laws, with attention to the time sensitivity of such trials the legislation mandates a prompt determination by the Secretary of such an exemption within 14 days after the applicant has submitted a complete exemption request and has notified the Secretary that the investigation may proceed as authorized under federal law. The Secretary shall exempt clinical or diagnostic laboratories that may come into possession of select agents when conducting specimen diagnosis, verification or proficiency testing, but only if they report the identification of select agents to the Secretary and either promptly transfer the agent to a registered facility or destroy the agent on site. The Secretary may not exempt laboratories that possess select agents for reference purposes. The legislation creates two temporary exemption authorities to deal with public health emergencies and agricultural emergencies whether domestic or foreign. The legislation requires notification to the Secretary of HHS by facilities and individuals possessing select agents within 90 days of enactment based on guidance issued by the Secretary within 30 days of enactment and the issuance of final rule within 180 days of enactment. The legislation provides that the interim final rule shall include time frames for applicability the rule that minimize disruption of research or educational projects that involve select agents and that were underway as of the effective date of the rule. The Managers statement on the legislation notes that the interim final rule and effective date provisions will result in the new regulations going into effect at approximately the same time as the National Institutes of Health begins to award fiscal year 2003 grants for research, some of which will be in the select agent area. The Managers expect the Secretary will ensure the timely registration and screening of such grantees so as not to delay this important research. Bioterrorism
Preparedness Act of 2001 On December 20, 2001 the Senate passed by unanimous consent the Kennedy-Frist "Bioterrorism Preparedness Act, S. 1765 (formerly S. 1715). Senators William Frist (R-TN) and Edward Kennedy (D-MA) reintroduced S. 1765, the Bioterrorism Preparedness Act of 2001 on December 4, 2001. Public Health
Security and Bioterrorism Response Act of 2001 On December 12, 2001 H.R. 3448, the Public Health Security and Bioterrorism Response Act of 2001 was passed by the House of Representatives, under suspension of the rules. The bill is sponsored by Representative W. J. "Billy" Tauzin (R-LA). Department of
Defense Appropriations Bill On December 4, 2001, the Senate Appropriations Committee approved HR 3338, the DOD Appropriations Bill for FY 2002, which Senator Diane Feinstein (D-CA) and Senator Judd Gregg (R-NH) amended to include Section 8134 Regulation of Biological Agents and Toxins. Section 8134 amends the Public Health Service Act Section 351A Enhanced Control of Biological Agents and Toxins and is the same as Section 216 Regulation of Biological Agents and Toxins of S l765, the Bioterrorism Preparedness Act of 2001, which was reintroduced by Senator Frist and Senator Kennedy on December 4, 2001. Section 8134 was removed from the Senate DOD Appropriations bill on December 19. Bioterrorism
Preparedness Act of 2001 On November 16, 2001 Representative Greg Ganske (R-IA) introduced H.R. 3310, the Bioterrorism Preparedness Act of 2001. Bioterrorism
Protection Act (BioPAct) of 2001 On November 8, 2001 Representative Robert Menendez (D-NJ) introducted H.R. 3255, the Bioterrorism Protection Act (BioPAct) of 2001. Deadly
Biological Agent Control Act of 2001 On November 8, 2001 Senators Diane Feinstein (D-CA) and Jon Kyl (R-AZ) introduced S. 1661, the Deadly Biological Agent Control Act of 2001. Antiterrorism Legislation, H.R. 3162 (Entire Bill) Public Law
107-56 (Signed October 26, 2001) Bioterrorism Enforcement Act of 2001, H.R. 3160 The bill also restricts certain persons from possessing select agents. The bill, by reference incorporates the list of persons, who are forbidden to own a hand gun for reasons of criminal or pathological behavior. Aliens, not lawfully admitted for permanent residence, may not possess select agents; however, the DHHS Secretary is given waiver authority, in consultation with the Attorney General, to designate categories of aliens or particular individuals who may be admitted to the U.S. on non-immigration visas to permit them to work with select agents in order not to impede public health activities or research. Bioweapons
Control and Tracking Act of 2001 On November 15, 2001 Senator Tom Harkin (D-IA) introduced S. 1706, the Bioweapons Control and Tracking Act of 2001. Deadly
Biological Agent Control Act of 2001 On November 15, 2001 Representative Adam Schiff (D-CA) introduced H.R. 3306, the Deadly Biological Agent Control Act of 2001. Pathogen
Research, Emergency Preparedness and Response Efforts Act of 2001 On November 6, 2001, Senator Tim Hutchinson (R-AR) introduced S. 1635, the Pathogen Research, Emergency Preparedness and Response Efforts Act of 2001.
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