Required Notification of Possession/Non-Possession of Select Agents Deadline

BIO members should immediately become familiar with provisions of the Public Health Security and Bioterrorism Response Act of 2002 (Pub. L. No. 107-188) that require facilities in possession of select agents or high consequence livestock pathogens and toxins to notify HHS or USDA (or both agencies) of that fact by September 10, 2002. In accordance with the statutory mandate, on July 12, 2002, CDC and USDA published in the Federal Register "Preliminary Guidance for Notification of Possession of Select Agents", which included a draft information collection form. (67 Fed. Reg. 46364.) This Preliminary Guidance followed a July 2, 2002 Register Notice (67 Fed. Reg. 44464), addressing the same topic and inviting public comment. On August 6, 2002, CDC published a "Notice of Approval of Data Collection" (506 KB PDF) that acknowledges the receipt of "a number of comments" to the Federal Register Notice, but makes few changes in the collection form in response to comments. The details of the July 12 and August 6 notices are as follows:

• Responsible Facility Officer. The information collection form will be mailed to approximately 190,000 "facilities", including research, clinical, and diagnostic laboratories. It will be available on the CDC web site http://www.cdc.gov/od/ohs/Irsat.htm and the APHIS web site http://www.aphis.usda.gov/vs/ncie/bta.html. "Facilities" will be required to designate a Responsible Facility Official (RFO) who will be charged with completing the form by September 10, 2002, for reporting possession of select agents or overlap agents and by October 8 for reporting high consequence livestock pathogens and toxins. The RFO must be a "safety officer", and/or "senior management official", but "whenever possible" should not be an individual who actually uses, transfers or possesses select agents.
• Facility. All facilities that may possess a select agent, including research, clinical and diagnostic laboratories must complete the form. The only facilities exempt from the filing are those that possess products that are, bear, or contain select agents or toxins that have been "cleared, approved, licensed, or registered under the Federal Food, Drug, and Cosmetic Act, Section 351 of the Public Health Service Act, the Virus-Serum-Toxin Act, and the Federal Insecticide, Fungicide, and Rodenticide Act." A "facility" is "any individual or government agency, university, corporation, company, partnership, society, association, firm, or other legal entity located at a single geographic site".
• Declaration of Non-Possession. The data collection form includes a "Declaration of Non-Possession", requiring the RFO to certify that the reporting facility does not possess select agents or high consequence livestock pathogens and toxins.

• Description of Agents. For each agent or toxin used or possessed by the reporting facility, one of the following descriptive categories must be noted on the form:

   

  1. Viable
  2. Recombinant organism, Nucleic acid, Genetic elements from agent:
     • Nonviable agents
     • Full-length nucleic acid from any of the viruses on the list. For Variola major virus (Smallpox), any segment that exceed 100 nucleotides in length.
     • Natural or synthetic nucleic acids from bacteria, fungi, or viruses on the list that encode for either a functional toxin or virulence factor sufficient to cause disease, or natural or synthetic nucleic acid that encodes for a functional toxin of any of the toxins listed, if: (1) expressed in vivo; (2) in an expression vector or host chromosome; or (3) in a carrier plasmid.

   

• Inventory. The data collection form clearly requires facilities to conduct a thorough inventory. It would therefore be prudent to begin that process immediately so as to be able to meet the deadline.
• Submission of Form. The form must be submitted to Analytical Sciences, Inc. of Bethesda, Md. Several members have requested more information regarding the security of proprietary information required by the data form. We are looking into this and will keep you informed.

  The form and guidelines are attached and these links may be useful:

  • 67 Fed. Reg. 44464, Tuesday July 2, 2002 (PDF)
  • 67 Fed. Reg. 46364, Friday, July 12, 2002 (PDF)
  • 67 Fed. Reg. 51057, Tuesday, August 6, 2002 (506 KB PDF)

If you have questions, please contact Steve Lawton, Vice President and General Counsel at BIO at 202.962.9215 or by email at SLawton@bio.org.