USDA - APHIS - Biotechnology

BRS News and Information

Genetically Engineered Animals

USDA and the Food and Drug Administration (FDA) have important roles and authorities relevant to the oversight of genetically engineered (GE) animals. USDA, Animal and Plant Health Inspection Service (APHIS) is authorized under the Animal Health Protection Act (AHPA) to protect the health of U.S. livestock. Based on that authority, APHIS may broadly consider the potential effects of animals with GE traits on the health of the U.S. livestock population. FDA has oversight over new animal drugs under the Federal Food, Drug, and Cosmetics Act (FFDCA). FDA has indicated that a recombinant DNA construct intended to affect the structure or function of an animal meets the definition of a new animal drug.

One of APHIS' responsibilities is to evaluate how changes in technologies used in the livestock industry–such as genetic engineering–could impact the agency's ability to prevent the introduction and spread of diseases and pests.

On Sept. 19, 2008, APHIS published a Request for Information (RFI) inviting public comment on the agency's role in the regulation of GE animals. FDA concurrently issued draft guidance for public comment on its requirements and recommendations for developers of GE animals.

In the RFI, APHIS requested the following information:

What research on GE animals is currently being conducted or planned for the future?
What, if any, implications would activities such as the importation and interstate movement of such animals have for the health of the U.S. livestock population?
What, if any, activities should APHIS consider with respect to U.S. livestock health under the AHPA that would complement the requirements and recommendations described in FDA's draft guidance?

APHIS accepted comments through November 18, 2008. APHIS received a total of 670 comments on the RFI.

While most comments were focused on issues outside of APHIS' authority under the AHPA, APHIS received several comments and recommendations on activities and actions that the agency should consider as its examines its role in the oversight of GE animals. FDA issued its final guidance for developers of GE animals on January 15, 2009.

APHIS will continue to work closely with FDA to determine its role in the comprehensive oversight over GE animals. Further information on FDA’s regulation of GE animals can be found on the FDA website.

September 19, 2008 Request for Information Federal Register Notice

September 18, 2008 Request for Information Press Release

Request for Information on Genetically Engineered Animals Q&A