Summary of Federal Laws
The Public Health Security and Bioterrorism Preparedness and Response Act
HR 3448 Public Law 107-188, 18 USC 175b
Under this law, all colleges and universities that possess select agents, which are certain biological agents and toxins need to register with the Secretary of the U.S. Department of Health and Human Services. The law requires Health and Human Services and the Department of Agriculture to develop new lists of biological agents and toxins that have the potential to pose a severe threat to the public's health and safety. The lists are to be reviewed at least biennially. See below for the interim final rule establishing standards and procedures governing the possession and use of the agents and toxins, which includes standards for transfer of the agents, training in handling the agents and toxins, and assurance that proper laboratory facilities exist to store the agents. Safeguards to prevent unauthorized access will be established. The Secretary of HHS will maintain a national database that includes the names and locations of registered persons, the listed agents and toxins such persons possess, use, or transfer, and information characterizing the agents and toxins. The new law also requires prompt notification of the release of a select agent outside of the biocontainment area, or of theft or loss of a select agent. Thus universities must keep comprehensive inventories of select agents if they do not already do so.
The university will be required to submit the names and other identifying information for individuals who the university determines have a legitimate need to handle or use the toxins. The university must also deny access to the agents/toxins by restricted persons. The definition of restricted includes a person who:
Is under indictment for a crime punishable by imprisonment for a term exceeding 1 year;
Has been convicted in any court of a crime punishable by imprisonment for a term exceeding 1 year;
Is a fugitive from justice;
Is an unlawful user of any controlled substance;
Is an alien illegally or unlawfully in the United States;
Has been adjudicated as a mental defective or has been committed to any mental institution;
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 or
Has been dishonorably discharged from the Armed Services.
The Attorney General must promptly use criminal, immigration, national security, and other electronic databases that are available to the Federal Government to conduct background checks on the registered individuals.See below for the The Secretary of Agriculture list of each biological agent and each toxin that the Secretary determines has the potential to pose a severe threat to animal or plant health, or to animal or plant products.
Certain exemptions exist for clinical or diagnostic laboratories and other persons who possess, use, or transfer listed agents or toxins that are contained in specimens presented for diagnosis, verification, or proficiency testing. Penalties for violation of the law include both civil and criminal penalties. Knowing possession of listed agents without proper registration, and transferring a select agent to a person who the transferor knows or has reason to believe has not obtained the required registration will be a criminal violation of the law.
President Obama Announces Significant Easing of Sanctions and Export Controls Applicable to Cuba (Hogan Lovells, Dec. 17th, 2014) Not yet fully implemented, but coming soon. Article is a good summary of changes in the works.
Notice of Proposed U.S. Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern, 78 Fed. Reg. 12369, Feb. 22, 2013
The Office of Science and Technology Policy is asking for comments on the proposed U.S. policy for Institutional Oversight of Life Sciences Dual Use Research of Concern. The purpose of the policy is to protect against misuse of certain select agents and toxins that could post a threat to public health, agriculture, the environment or national security. This is a close the gap policy to deal with "dual use" research not specifically addressed under existing federal regulations. Dual Use Research of Concern is research that can be reasonably anticipated to provide knowledge, information, products or technologies that could be misapplied to pose a significant threat to public health and other areas as referenced above. The covered agents and toxins are listed in section 6.2.1 of the Policy and are as follows:
a) Avian influenza virus (highly pathogenic) b) Bacillus anthracis c) Botulinum neurotoxin d) Burkholderia mallei e) Burkholderia pseudomallei f) Ebola virus g) Foot-and-mouth disease virus h) Francisella tularensis i) Marburg virus j) Reconstructed 1918 Influenza virus k) Rinderpest virus l) Toxin-producing strains of Clostridium botulinum m) Variola major virus n) Variola minor virus and o) Yersinia pestis.
The categories of experiments are
a) Enhances the harmful consequences of the agent or toxin;
b) Disrupts immunity or the effectiveness of an immunization against the agent or toxin without clinical and/or agricultural justification;
c) Confers to the agent or toxin resistance to clinically and/or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin or facilitates their ability to evade detection methodologies;
d) Increases the stability, transmissibility, or the ability to disseminate the agent or toxin;
e) Alters the host range or tropism of the agent or toxin;
f) Enhances the susceptibility of a host population to the agent or toxin; or
g) Generates or reconstitutes an eradicated or extinct agent or toxin listed in 6.2.1, above.
Under the proposal, if the University works with any of the agents in the manner described, the Principal Investigator has to refer any research involving those agents to an institutional dual use review entity, which will then determine if any of the listed effects might be produced, and if yes, the review entity would weigh the benefits and risks of the research and develop a risk management plan. Comments are due by April 23, 2013. For more on this topic see the Boston University Research Compliance web page on Dual Use Research of Concern.
Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review, Final Rule, 77 Fed. Reg. 61083,Oct. 5, 2012.
Effective Dates: The amendments to Sec. Sec. 73.1, 73.3 through 73.6, 73.9, 73.10, 73.13, 73.16, 73.17, and 73.20, of Title 42, Code of Federal Regulations are effective December 4, 2012.
The remaining provisions to this final rule are effective April 3, 2013.
Applicability Dates: By December 4, 2012, all entities that possess SARS, Chapare, and Lujo viruses
must provide notice to CDC regarding their possession of these viruses, and by April 3, 2013 all previously
unregistered entities must meet all of the requirements of this part. The rule requires the institutions to document security plans and information security measures, and expands the inventory audit requirements for all agents.
(March 2012) Under the policy federal departments or agencies that fund life sciences research are directed to conduct a review to identify all life sciences research projects that involve specified agents or toxins or specified categories of experiments in order to determine which projects constitute DURC, and to conduct risk assessment and develop risk mitigation plans for such projects.
CDC FAQ for New Select Agent Regulations. (42 CFR 73)
Government Issues Guidance on Lab Security
The Laboratory Security and Emergency Response Guidance for Laboraties Working with Select Agents was issued in the Dec. 6, 2002 Center for Disease Control Publication MMWR. These guidelines are presented to assist facility managers with meeting the regulatory mandate of 42 CFR 73. They are also intended for labs where select agents are used under biosafety levels 2,3, or 4. The guidance notes that Appendix F of the Biosafety in Microbiological and Biomedical Laboraties (BMBL) manual is being revised to include consideration of the following biosecurity policies and procedures:
risk and threat assessment;
facility security plans;
data and electronic technology systems;
security policies for personnel;
policies regarding accessing the laboratory and animal areas;
receipt of agents into the laboratory;
transfer or shipping of select agents from the laboratory;
emergency response plans; and
reporting of incidents, unintentional injuries, and security breaches.
updated 12/19/14 to add HL article on Cuba
*see HL article on Cuba