Bioterrorism: A Federal Regulatory Response

Robert S. McLaughlin
Bond, Schoeneck & King, PLLC
Syracuse, NY

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Act) was signed into law on June 12, 2002. This statute responds to last year's anthrax attacks and potential future threats, and in Title II requires enhanced measures to safeguard biological agents and toxins that can threaten public health and the food supply when used as biological weapons (regulated agents). Colleges and universities, research, medical, and analytical laboratories, pharmaceutical and agrichemical facilities, museums, hospitals, and medical offices are most likely to be impacted by the new requirements.

The Centers for Disease Control and Prevention (CDC) and the Department of Agriculture's Animal and Plant Health Inspection Service (APHIS) share the responsibility for implementing Title II of the Act. Regulated agents include the "select agents" currently listed in CDC regulations (42 C.F.R. Part 72 Appendix A; see also proposed amendments to the CDC list at 67 Fed. Reg. 54,605 (Aug. 23, 2002)) and agents identified in APHIS regulations (7 C.F.R. § 331.2 and 9 C.F.R. § 121.2) (promulgated at 67 Fed. Reg. 52,383 (Aug. 12, 2002)).

The Act imposes three new obligations on possessors of regulated agents:

Notification. Persons who possess a CDC select agent (including "overlap agents" that are listed by both CDC and APHIS) were required to notify CDC by Sept. 10, 2002. In addition, anyone who received a notification form from CDC who did not possess a select agent was required to submit a declaration of nonpossession. Entities that received multiple notification forms were required to acknowledge and respond to each.

A second notification requirement applied to any person or organization that possesses a regulated agent included in the APHIS lists. For this notification, only persons who possessed an APHIS regulated agent were required to submit a notification form. The APHIS notice was required by Oct. 11, 2002.

Registration. Under prior law, an individual or organization that transferred or received any of the CDC select agents after April 14, 1997, was required to register with CDC. The Act extends this registration requirement to any person who possesses, transfers, or uses any quantity of one or more regulated agents. CDC and APHIS are required to promulgate regulations concerning the registration requirements by early December, and they will be effective 60 days after promulgation. The U.S. Department of Justice (DOJ) will review all registration statements to determine whether a person or organization seeking registration should be allowed to use, possess, receive, or transfer a regulated agent.

Security and Other Requirements. Registrants may only transfer a regulated agent to another registrant or to the government. They may only allow an individual to have access to a regulated agent if the registrant determines that the individual has a legitimate need to handle or use the agent and is not restricted from access by law. Once regulations are in place, before allowing an individual access, the registrant must notify DOJ and CDC or APHIS, as appropriate, of the name and identifying information of the individual. DOJ is required to review this information to assure that the individual is not included in a category of persons who are precluded from access. The Act does not require government approval before an individual is allowed access to a regulated agent. A registrant is required to consider the same factors the government will use in its screening process, however, and will be at risk if it allows access and the government ultimately disagrees.

Among other categories, a "restricted person" who must be denied access to regulated agents, include any person who is:

• indicted or convicted for a felony;
• a "fugitive from justice";
• an unlawful user of a controlled substance;
• an illegal alien;
• adjudicated as a mental defective or who has been committed to any mental institution;
• an alien who is a national of a "country [that] has repeatedly provided support for acts of international terrorism"; or
• dishonorably discharged from the U.S. military.

Access also must be denied to any individual that is "reasonably suspected" by any federal law enforcement or intelligence agency of "knowing involvement" with an organization that engages in domestic or international terrorism or international crimes of violence.

The government will notify the registrant whether the individual may have access to the regulated agent, and, if access is denied, must also notify the individual directly. Ultimately, the registrant and individual review process will result in a national database of individuals and organizations with access to regulated agents. The Act contains provisions to protect this information from public disclosure.

Registrants will also be required to assure that regulated agents are securely maintained and to promptly notify the government in the event of the theft or loss of a regulated agent or a release of regulated agents out of a biocontainment area.

The Act provides limited exemptions that apply to: 1) clinical and diagnostic laboratories; 2) "approved products" subject to federal regulation; 3) investigational products that are being used in a study authorized by federal law; and 4) public health or agricultural emergencies. These exemptions are more restrictive than those available under existing CDC regulations and only the "approved products" exemption is self-implementing.

The "approved products" exemption includes all products that are cleared, approved, licensed, or registered pursuant to: 1) the Federal Food, Drug and Cosmetic Act; 2) Section 351 of the Public Health Service Act; 3) the Virus-Serum-Toxin Act; and 4) the Federal, Insecticide, Fungicide and Rodenticide Act. Under the "approved products" exemption, the regulated agents are completely exempt, unless CDC or APHIS impose additional regulatory requirements by order. The "approved products" exemption applies only to products as approved by the applicable federal agency. The exemption does not apply to products under development or products that have been altered.

Implementation of the requirements of the Act is in its earliest stages. It is clear, however, that there will be additional significant requirements on individuals and organizations that possess any regulated agents.