Animal Biotechnology

CVM is committed to using a science- and risk-based regulatory framework to further the advancement of emerging technologies for the development of safe and effective products, while ensuring consumer confidence. CVM regulates the following types of animal biotechnology products:

• Intentional genomic alterations (IGAs) in animals;
• Animal cells, tissues, and cell- and tissue-based products (ACTPs); and
• Animal food derived from plants produced with biotechnology.

CVM encourages and supports the development and research of innovative animal products, such as IGAs in animals and ACTPs. To facilitate advancements in development of innovative animal products, CVM instituted the Veterinary Innovation Program (VIP), which provides greater certainty in the regulatory process, encourages development and research, and supports an efficient and predictable pathway to approval for ACTPs and IGAs in animals. Additionally, to assist developers of animal biotechnology products in understanding the regulatory process, CVM offers the Animal Biotechnology Products Resource Center.

IGAs in Animals

Intentionally altering genomic DNA is a process that includes, but is not necessarily limited to, the use of molecular technologies such as genome editing (e.g., CRISPR) or use of recombinant DNA constructs to introduce desirable traits into organisms.

ACTPs

ACTPs are articles containing, consisting of, or derived from cells or tissues that are intended for implantation, transplantation, infusion, transfer, or other means of administration to an animal recipient. 

Related Resources

• FDA’s Regulation of Plant and Animal Biotechnology Products
• The Coordinated Framework for Regulation of Biotechnology
• Federal Register Notice: Office of Science and Technology Policy. Coordinated Framework for Regulation of Biotechnology; Announcement of Policy and Notice for Public Comment. June 26, 1986
• Federal Register Notice: Science and Technology Policy Office. Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology. Sept 22, 2016  
• The Unified Website for Biotechnology Regulation
• FDA’s Plant and Animal Biotechnology Innovation Action Plan
• Agricultural Biotechnology: Feed Your Mind
• Veterinary Innovation Program
• Development & Approval Process
• Animal Biotechnology Information Rounds
• FDA-Track: CVM - Emerging Technologies

Guidances for Industry (GFIs)

• Draft CVM GFI #187 Regulation of Intentionally Altered Genomic DNA in Animals
• CVM GFI #218 Cell-Based Products for Animal Use
• CVM GFI #253 Current Good Manufacturing Practice for Animal Cells, Tissues, and Cell- and Tissue-Based Products
• CVM GFI #254 Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products

Plant biotechnology for animal food

FDA has provided the following additional resources:

• Food from New Plant Varieties
• Understanding New Plant Varieties
• Voluntary Labeling of Foods Derived from Genetically Engineered Plants