Regulatory Alert – Request for Comment on New Regulations for Select Agents and Toxins

On December 13, 2002, the Department of Health and Human Services (DHHS)/Centers for Disease Control and Prevention (CDC) and the U.S. Department of Agriculture (USDA) published in the Federal Register the interim final rules which establish new stricter regulations for the possession, use and transfer of select biological agents and toxins that could pose a threat to human, animal and plant health and safety.  The new regulations have important implications for microbiology laboratories and research with select agents and toxins and require careful attention.  The HHS and USDA regulations are complementary and implement Title II of Public Law 107-188, the Public Health Security and Bioterrorism Preparedness Response Act of 2002, signed into law on June 12.  The new rules (42 CFR 73 for HHS, 7 CFR 331 and 9 CFR 121 for USDA) establish the registration process for facilities possessing select agents and toxins, timeline dates for compliance, safety and physical security compliance requirements, exemptions, and procedures for approving entities and individuals with access to a select agent or toxin in accordance with the restricted person prohibition in Section 175b of the USA Patriot Act.  The HHS rule, information that explains the rule, CDC FAQ for Select Agent Regulation, laboratory security and emergency response guidance and the USDA rule, can be obtained at the links in the scholar's column to the left of this page.  An updated listing of the covered select agents and toxins is included as part of the HHS (73.4 and 73.5) and USDA (331.3 and 121.3) regulations.  The new rules will take effect on February 7, 2003.  Although phase-in dates are provided for facilities currently registered under the existing transfer regulation 42 CFR 72.6, all facilities possessing, using and transferring select agents and toxins must be in full compliance with the new regulations by November 12, 2003.  HHS and USDA are accepting public comments on the interim final rule for 60 days.  

The new regulations are complex and each institution and principal investigator should carefully review them and prepare constructive comments to HHS and USDA.  The ASM participated in a HHS/USDA public forum to discuss the regulations on December 16 and presented preliminary comments on several key issues, including the lack of details for the applications for clearance for entities and individuals with the Department of Justice, the inclusion of provisions to proscribe certain experiments, and the potential impact of biosecurity requirements and the deadlines for compliance requirements on institutions and research.  The ASM has urged the HHS, USDA and Department of Justice to provide as much detail as soon as possible to assure an efficient process that does not delay or interfere with research.  The ASM is preparing formal detailed comments to submit to HHS and USDA within the 60 day comment period.  Please forward copies of your comments to ASM at publicaffairs@asmusa.org. 

The ASM recognizes that some individuals and institutions currently in possession of select agents may wish to destroy those agents. Given the potential value of microbial cultures for future biomedical research and biodefense efforts, it would be prudent to transfer select agents, whose identity as a select agent is documented, in accordance with the CDC regulations to other registered facilities willing to receive them. As indicated in a New York Times article that appeared on December 17, 2002, the Office of Science and Technology Policy (OSTP) has requested the assistance of the ASM in notifying the research community of its interest in attempting to preserve the biodiversity of select agents either by the lawful retention in accordance with the regulations by those possessing such agents or through the lawful transfer in accordance with the regulation of those agents to registered facilities.  The requirements for retention and/or transfer of select agents are available from the CDC or USDA. 

The ASM has compiled a list of applicable regulations and laws which is available on the ASM web page.  Any updated information about the select agent regulations and registered government laboratories that would serve as repositories for select agents will be posted on the ASM Public Affairs web page.

Sincerely,

Ronald M. Atlas, Ph.D., President, ASM
Kenneth I. Berns, M.D., Ph.D., Chair, ASM Task Force on Biological Weapons Defense
Gail H. Cassell, Ph.D., Chair, Public and Scientific Affairs Board
Janet Shoemaker, Director, Public and Scientific Affairs