On June 12, 2002, a new law on bioterrorism, The Public Health Security and Bioterrorism Preparedness and Response Act (H.R. 3448) was signed by President Bush. The federal government enacted the new legislation to enhance the country's preparedness in dealing with bioterrorist attacks. The law amends the Biological Agents Provisions of the Antiterrorism and Effective Death Penalty Act of 1996 and includes several provisions that are of interest and have the potential impact to research at Harvard University. Relevant provisions include:

List of Biological Agents

• The Secretary of Health and Human Services (HHS) will establish and maintain a list of biological agents and toxins that has a potential to pose a severe threat to public health and safety. The list of biological agents and toxins will be reviewed and republished biennially or more often as needed.

Transfer of Listed Biological Agents and Toxins

• The Secretary of HHS will provide through regulations, the establishment and enforcement of safety procedures for the transfer of listed biological agents and toxins, that include:
  • Proper training and appropriate skills to handle such agents and toxins;
  • Proper laboratory facilities to contain and dispose of such agents and toxins;
  • Safeguards and security measure to prevent access to such agents and toxins for use in domestic or international terrorism or for any other criminal purpose;
  • Appropriate availability of biological agents and toxins for research, education, and other legitimate purposes.

Registration, Identification, Database

• The regulation requires the registration with the Secretary of HHS for the possession, use, and transfer of listed agents and tox-ins. It must include the information regarding the characterization of the listed agents and toxins to facilitate their identification, including their source.
• Registered persons including laboratories, institutions, Federal, State, and local entities, will only allow access to individuals whom the registered person involved determines have legitimate need to handle or use listed agents or toxins.
• Registered persons must submit the names and other identifying information for such individuals to the Secretary of HHS and the Attorney General, once the need for access is determined, as well as periodically (at least once every five years) thereafter while the individual has access to the listed agent or toxin.
• Registered persons must deny access to individuals that have been identified as restricted persons by the Attorney General. Re-stricted persons is defined as any of the following (section 175b of Title 18 USC):

  1. Under indictment for a crime punishable by imprisonment for a term exceeding 1 year.
  2. Has been convicted in any court of a crime punishable by imprisonment for a term exceeding 1 year.
  3. Is a fugitive from justice.
  4. Is an unlawful user of any controlled substance.
  5. Is an alien illegally or unlawfully in the United States.
  6. Has been adjudicated as a mental defective or has been committed to any mental institution.
  7. Is an alien who is a national of a country that has repeatedly provided support for acts of international terrorism. The countries currently on the list are Cuba, Libya, Iran, Iraq, North Korea, Sudan, and Syria.
  8. Has been dishonorably discharged from the Armed Services.

• Access must also be denied to an individual that is reasonably suspected by any Federal law enforcement or intelligence agency of committing a federal a federal crime of terrorism; knowing involvement with an organization that engages in domestic or inter-national terrorism; or being an agent of foreign power, as determined by the Secretary in consultation with the Attorney General.
• The Attorney General will use criminal, immigration, national security, and other electronic database, to determine an individual's restricted status.
• The Secretary will establish procedures to allow possible expedited reviews. A registered person can only request expedited re-view when submitting an individual's name and identifying information, and when good cause can be demonstrated.
• In order to register, the Secretary will submit the person's name to the Attorney General. The Attorney General will determine the person's eligibility and restriction status through government databases. In addition, the individual who owns or controls the person may also be required to meet the conditions of the registration.
• An individual whose registration is rejected or revoked, can request additional review by the Secretary. Forthcoming regulations will determine the review procedures. The final review is considered final agency action on the matter.

Notifications Regarding Theft or Loss of Agents or Toxins

• It is required that the prompt notification of the Secretary and appropriate Federal, State, and local law enforcement agencies be made for theft or loss of listed agents or toxins.

Inspections

• The Secretary shall have the authority to inspect persons subject to the regulation to ensure compliance, including prohibitions on restricted persons.

Exemptions

• Clinical or diagnostic laboratories are exempted, as well as individuals who handle, use, or transfer listed agents or toxins that are contained in specimens presented for diagnostic, verification, or proficiency testing. The agent should be reported to the Secretary once the agent is identified or when required by federal, State and local authorities.
• Exemptions may also be granted for an investigational product that is, bears, or contains a listed agent, when it is being used in an investigation authorized under the Federal Act, and not determined to be a threat to public safety.

Penalty

• Any person who violates any provision of the regulation will be subject to civil money penalty up to $250,000.

Implementation Dates

• Those in possession of listed agents or toxins have 90 days after the enactment of the legislation to notify the Secretary of the possession.
• The Secretary will prepare written guidance on how to provide the notification no later than 30 days after the enactment of the legislation.
• The final regulation, promulgated no later than 180 days, will include time frames for the applicability of the rule that minimize disruption of research or education projects that involve agents that were underway as of the effective date of the rule (60 days after promulgation).

Current List of Biological Agents and Toxins

Places to get more information

For more information, please contact the Environmental Health and Safety department at 617-495-2060 (Cambridge/Allston) or 617-432-1720 (Longwood/Southborough). Additional resources may also be found at the following web sites: