On October 30, 2018, the U.S. Food and Drug Administration “announced the Plant and Animal Biotechnology Innovation Action Plan to outline the key priorities the agency will pursue to support innovation in plant and animal biotechnology while advancing the agency’s public health mission. The overall goal of the action plan is to ensure the safety of plant and animal products of biotechnology while avoiding unnecessary barriers to future innovation.” See https://www.fda.gov/animal-veterinary/cvm-updates/fda-announces-plant-and-animal-biotechnology-innovation-action-plan.
Both Acting FDA Commissioner Sharpless and FDA Chief Counsel Amin both emphasized the importance of this plan in their remarks at the Annual Conference of the Food and Drug Law Institute held in Washington, D.C. on May 2-3, 2019.
As explained in the action plan, sister agencies—FDA, USDA and EPA—each federal governmental agencies with regulatory authority over animal biotechnology (the plant issues are important but excluded for purposes of this blog) have worked in a coordinated fashion to “began to modernize the regulatory framework for biotechnology products to ensure the preparedness of federal regulatory agencies for future products of biotechnology.”
Among other initiatives, FDA has begun the process of “review[ing] the science behind genome editing in animals, the promising uses of this technology in animals, the potential risks, and information about CVM’s risk-based approach to the oversight of intentional genomic alterations to animals.”
the Veterinary Innovation Program (VIP), to provide intensive assistance, both technical and programmatic, for developers seeking FDA approval of intentionally altered genomic DNA in animals and animal cells, tissues, and cell- or tissue-based products that provide a benefit to human health, animal health, animal well-being (e.g. husbandry improvements), or food production.
USDA explains its role in biotechnology by first defining the term “biotechnology to mean the use of recombinant DNA technology, or genetic engineering (GE) to modify living organisms. APHIS regulates certain GE organisms that may pose a risk to plant or animal health. In addition, APHIS participates in programs that use biotechnology to identify and control plant and animal pests.”
USDA regulates: 1) the importation and exportation of genetically engineered animals and animal products; 2) veterinary biologic that are developed using genetically engineered organisms; and 3) research facilities used for certain vertebrate animals, including vertebrate animals that are genetically engineered.
States may also regulate these evolving industries.
As always, it will be important that laws are based on sound scientific principles that advance and protect the health and well-being of animals, people and the environment in which we live.