APHIS Announces Changes to Requirements for Research Facilities to Implement the 21st Century Cures Act

The United States Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced a final rule amending the Animal Welfare Act (AWA) regulations to reduce duplicative requirements and the administrative burden for research facilities while continuing to ensure humane animal care. The changes apply to registered facilities that use animals to conduct research, teaching, testing and experimentation.

APHIS is taking this action in response to requirements under the 21^st Century Cures Act, which directs USDA to work with the Food and Drug Administration and the National Institutes of Health to complete a review of regulations and policies for the care and use of laboratory animals. 

Specifically, the changes include:

• Eliminating the administrative requirement to update the research facility registration every 3 years, as it is a duplicative requirement.  Facilities are already required to notify APHIS of any change in the name, address, or ownership, or other change in operations affecting its status as a research facility, within 10 days after making such change. 
• Clarifying the duration of registration and conditions for termination of registration.  A research facility registration will no longer be valid or effective if a research facility voluntarily requests registration termination; fails to file an annual report of animal use to the appropriate Animal Care office for 2 consecutive years; goes out of business or ceases to function as a research facility, or changes its method of operation so that it no longer uses, handles, or transports animals, and does not plan to use, handle, or transport animals for a period of at least 2 consecutive years.
• Eliminating the requirement for a research facility that has not used, handled, or transported animals for a period of at least 2 years to request being placed on an inactive status to reduce the administrative burden associated with submitting an annual report of animal use while inactive.
• Replacing annual reviews of protocols already approved by the IACUC with a requirement to conduct a complete review of IACUC-approved protocols at 3-year intervals instead.  This will result in a protocol remaining valid for 3 years after IACUC approval and requiring a new submission to the IACUC for review and approval at the end of the 3-year term.  This harmonizes APHIS’ protocol with that of the National Institutes of Health into one timeline.
• Eliminating the requirement for facility chief executive officer or institutional official signatures on the Annual Report to guard against identity theft through signatures, while maintaining the assurance requirements regarding the content of the Annual Report and practices at the research facility.

The final rule is effective on December 27, 2021 and may be viewed in today’s Federal Register.