DHHS Interim Final Rule on Possession, Use and Transfer of Select Agents and Toxins, 68 Fed. Reg. 62245, Nov. 3, 2003 amends Dec. 13, 2002 interim final rule.

This rule amends the applicability requirements to allow for the issuance of provisional registration certificates for all entities, and provisional grants of access for all individuals, from whom, prior to November 12, 2003, the Attorney General has received all of the information required by the Attorney General to conduct a security risk assessment if those entities and individuals otherwise meet all of the requirements of Part 73. This amendment is to ensure that both ongoing and new research and educational efforts important to the national defense are not disrupted. This interim final rule is effective Nov. 3, 2003. See also the parallel Animal Plant and Inspection Service interim final rule at 68 Fed. Reg. 62218 (Nov. 3, 2003).

FDA Interim Final Rule on Registration of Food Facilities  68 Fed. Reg. 58893, Oct. 10, 2003

This interim final rule requires domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States to register with FDA by December 12, 2003.

The interim final rule implements the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. The effective date is December 12, 2003. Schools that have central storehouses that simply supply food on campus need not register, but schools may need to register if they import food directly not bought from a vendor or  if they sell food supplies or seed for edible crops or to feed animals intended for human or animal consumption.  While most colleges and universities will not be required to register, schools may want to ask their food suppliers if they are  registered, and what their registration number is. For more on this interim rule see the FDA Food Supply Web Page on the rule.  See also the February 2004 Q and A on Registration of Food Facilities. This is a revision of the second edition issued in January 2004.

Department of Health and Human Services Interim Final Rule on Possession, Use, and Transfer of Select Agents and Toxins, 67 Fed. Reg. 76885, Dec. 13, 2002.

This document establishes requirements regarding possession and use in the United States, receipt from outside the United States, and transfer within the United States, of select agents and toxins.
This includes requirements concerning registration, security risk assessments, safety plans, security plans, emergency response plans, training, transfers, record keeping, inspections, and notifications.
This document also contains delegations of authority to the Office of Inspector General concerning civil money penalties. The interim final rule implements provisions of the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002 and is designed to provide protection against misuse of select agents and toxins whether inadvertent or the result of terrorist acts against the United States homeland (such as the recent terrorist acts involving anthrax) or other criminal acts.  This interim final rule is effective Feb. 7, 2003. The interim rule refers to the aggregate amount of a select agent under the control of a principal investigator, ( as opposed to counting aggregate held by institution.)  Select Agent transfers must have prior approval by the CDC to ensure that both the sender and recipient are registered. The Dept. of Justice will create a web-based database where Responsible Officers and individuals required to access Select Agents may input their information.  Approval at one facility does not transfer to another facility if a PI moves from one institution to another; i.e., each institution must verify the need of the PI to have access to SAs.

See also 67 Fed. Reg. 76907 (Dec. 13, 2002) Department of Agriculture interim final rule (under the Agriculture Bioterrorism Protection Act) establishing  standards and procedures governing the possession, use, and transfer of biological agents and toxins that have been determined to have the potential to pose a severe threat to both human and animal health, to animal health, to plant health, or to animal and plant products.

42 CFR § 73.9 contains detailed information on the institution's obligation to identify a Responsible Official if the insititution possesses select agents. A Responsible Official must be approved for access to biological agents and toxins; be familiar with the requirements of the part 73 regulations, and have authority and responsibility to ensure that the requirements of the part 73 are met.  The interim final rule also provides for the designation of Alternate Responsible Officials to conduct the duties of the Responsible Official. The Responsible Official may identify one or more individuals, any of whom may serve as the Alternate Responsible Official when the Responsible Official is unavailable. The Responsible Official and all individuals identified to serve as the Alternate Responsible Official must meet all of the qualifications for a Responsible Official. HSS recommends that the Responsible Official and Alternate Responsible Officials be either biosafety officers or senior management officials of the entity, or both, and strongly recommends where feasible that the Responsible Official should not be an individual actually using, working with, or transferring or receiving the select agents and toxins.

An entity in possession of select agents must also develop and implement a safety plan. See 42 CFR § 73.10 for the elements of a safety plan.

Office of Inspector General Report on Select Agent Regulations compliance
This June 30, 2006 report published by the OIG, Department of Health and Human Services summarizes the OIG review of 15 colleges and universities, and their level of compliance with respect to select agent rules.

Further Resources:

CDC FAQ for New Select Agent Regulations. (42 CFR 73)

List of HHS agents and toxins, USDA list, plant agents and overlap list

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;
• physical security;
• data and electronic technology systems;
• security policies for personnel;
• policies regarding accessing the laboratory and animal areas;
• specimen accountability;
• 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.