Appendix A of 42 CFR 72

Section 511 of The Antiterrorism and Effective Death Penalty Act of 1996 (PL 104-132)

Section 175b of title 18 of the US Code

Congress Passes Public Health Security and Bioterrorism Preparedness Act/Expands Controls over Select Agents 

On May 23, Congress gave final approval to the Public Health Security and Bioterrorism Preparedness Act, HR 3448, which the President has indicated he will sign into law. In the wake of the September 11 terrorist attack and the deliberate release of anthrax spores in the mail last October, this legislation provides new programs and authorities to increase the preparedness and response capability of the US public health system for a bioterrorist attack and public health emergency. The bill is intended to improve the health system’s ability to respond to bioterrorism, protect the nation’s food supply and drinking water from bioterrorist attacks, speed the development and production of new drug treatments and vaccines, address shortages of specific types of health professionals, improve coordination of federal antibioterrorism activities, increase investment in federal, state and local preparedness and expand controls over the most dangerous biological agents and toxins.   

Expanded Controls of Select Agents 

Important new provisions for the possession, use and transfer of select agents, the 42 biological agents and toxins listed in Appendix A of 42 CFR Part 72, are included in Title II of HR 3448, Enhancing Controls on Dangerous Biological Agents and Toxins.  Title II includes the following provisions:

• Requires facilities which possess, use or transfer select agents to register with the Secretary of Health and Human Services (HHS) and be subject to reasonable safety and security requirements, including access controls, screening of personnel determined by the facility to have a legitimate need to handle or use select agents, and inspections to ensure compliance with the requirements. Current law implementing Section 511 of The Antiterrorism and Effective Death Penalty Act of 1996 (PL 104-132) requires registration only of those facilities transferring select agents. HR 3448 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. Registered facilities are subject to penalties provided for violation of the regulations;
• Requires that registration include, if available to the person registering, information regarding the characterization of the select agent to facilitate its identification, including its source.  Establishes a national database of the names and locations of registered facilities, the select agents they possess, use or transfer and information about the characterization of the select agents to assist public health and law enforcement officials to identify the origin or source of a select agent used to cause harm to the public.  No identifying or site specific information can be disclosed by the government.
• Requires registered facilities to provide access to select agents to only those determined by the registered facility to have a legitimate need to handle or use select agents and to promptly submit the names of such individuals to the HHS and the Attorney General who shall promptly use criminal, immigration, national security and other electronic databases available to the federal government to check if the individual is a restricted person as defined in section 175b of title 18 of the US Code or is reasonably suspected by any federal law enforcement or intelligence agency of committing a crime, knowing involvement with domestic or international terrorism or crime or being an agent of a foreign power.  Section 175b was enacted on 26 October 2001 in the Patriot Act (PL 107-56) and prohibits restricted persons from possessing, using or transferring select agents and includes individuals with criminal felony records, fugitives from justice, aliens illegally in the United States, foreign nationals from terrorism-sponsoring nations, individuals dishonorably discharged from the Armed Services, and individuals adjudicated as mentally defective. The Attorney General shall promptly notify the HHS Secretary who shall promptly notify the registered facility about whether an individual is granted or denied access. 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 or contain select agents and are approved under specific federal laws unless the Secretary determines that additional regulation is necessary for a specific product to ensure protection to 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 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 possessing select agents within 90 days of enactment of the bill based on guidance issued by the Secretary within 30 days of enactment and the issuance of a final rule with requirements for registration of facilities in 180 days of enactment. The final rule will take effect after 60 days of the final rule. The legislation provides that the interim final rule shall include time frames for applicability of 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 and the Managers expect the Secretary will ensure the timely registration and screening of such grantees so as not to delay this important research.
• The legislation provides comparable regulatory authorities to the US Department of Agriculture (USDA) as to the DHHS for the possession, use or transfer of listed biological agents and toxins that present a severe threat to plant or animal health or animal or plant products. In an effort to minimize regulatory duplication and burden, the legislation seeks to ensure uniformity in the statutory authority that the two departments will administer. The Secretary of Agriculture will develop a list of agriculturally significant biological agents and toxins within 60 days of enactment of the bill and within 60 days of the publishing of the list facilities must notify the USDA of possession. The legislation includes provisions to facilitate coordination and cooperation between USDA and HHS with respect to overlap agents or toxins that are regulated by both agencies. In the case of zoonotic agents that appear on both the HHS and USDA lists of select agents, Congress intends that the two agencies work cooperatively to develop a streamlined, joint registration system whereby the registrant shall be permitted to submit a single registration document to either USDA or HHS.
• The legislation amends the biological weapons statute Chapter 10 in Title l8 of the criminal code with respect to new criminal penalties and provides that any person who transfers a select agent to any person one knows or has reasonable cause to believe has not registered could be fined or imprisoned up to five years or both and whoever knowingly possesses a select agent for which the person has not obtained a registration shall be fined or imprisoned for up to five years;

In this new age of terrorism, the ASM has testified before Congress on issues surrounding biosecurity and has worked closely with Congress in the last eight months during the drafting of Title II to balance public concern over safety and security with the need to protect legitimate scientific research and diagnostic testing. The ASM will continue to work with federal agencies to ensure the best possible regulations to implement these legislative provisions. The ASM will notify members of the opportunity to comment on these regulatory proposals as they are written in the next six months. Information will also be posted on the ASM web page.