February 01, 2003

 

 Regulations amended for select biologic agents - February 1, 2003

Posted on January 15, 2003
 

On Aug. 12, 2002, the Department of Health and Human Services and the Department of Agriculture announced that they had developed lists of select agents and livestock pathogens, and that facilities possessing these agents must register with the departments.

The agencies established the new safeguards for the possession, use, and transfer of select biologic agents and toxins that could pose a threat to public, animal, and plant health safety. They specified who should be restricted from working with select agents, and they outlined the safety and security requirements for possessing certain agents and toxins.

The two departments have now announced that they have made several revisions to the interim rules, including amending the list of biologic agents and toxins and changing the reporting system. Since some of the select agents subject to the regulations appear on both the HHS and USDA select agents lists, the two agencies, working together to reduce the burden on facilities, have established a single reporting system that will be used by both agencies.

The two interim final rules were published in the Dec. 13, 2002, Federal Register, www.access.gpo.gov/su_docs/fedreg/a021213c.html. Each department will accept public comments on the new rules for 60 days, and those comments could result in regulatory changes in the future. The rule will take effect on Feb. 7, 2003.