Regulatory Brief

 FDA Draft Guidance Document 187: "Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs"

Formal title: Docket Number [FDA-2008-D-0394] Guidance for Industry: Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs; Availability

Brief Description:

In the September 19, 2008 Federal Register the Food and Drug Administration announced the availability of a draft guidance document (GFI#187) entitled "Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs." The draft guidance is intended to clarify FDA's requirements and recommendations to producers and developers of genetically engineered (GE) animals and their products. The draft guidance describes how the new animal drug provisions of the Federal Food, Drug, and Cosmetic Act apply with respect to GE animals including FDA's intent to exercise enforcement discretion regarding requirements for certain GE animals.

AVMA Response:

In its response, the AVMA applauded the effort of FDA in the development and release of draft guidance on the use of genetically engineered (GE) animals in research and food production.

The AVMA urged all stakeholders involved in GE to incorporate a thorough science-based review of related technologies and to responsibly address not only improved efficiencies, but also animal welfare concerns. AVMA enthusiastically supports the responsible use of biotechnologies, including GE animals, for improvement of animal and human health. However, the AVMA also wishes to emphasize that the welfare of animals involved in the development and delivery of these technologies must be protected.

AVMA recognizes that the need for a coordinated system in regulated all GE organisms. Therefore the association urges all federal agencies with GE oversight to work closely with USDA-APHIS Animal Care to ensure that regulations and policies used in enforcement of the Animal Welfare Act (AWA) are sufficient to protect the welfare of animals used in the development of GE technologies.

Background Documents:

View Federal Register document (PDF)

View AVMA's response to USDA-APHIS (PDF)

View AVMA's response to USDA-APHIS Animal Care (PDF)

View AVMA's response to FDA (PDF)


AVMA responded on November 18, 2008. FDA final rule (PDF)