Genome editing is a technique that can be used to introduce useful genetic alterations into breeding programs. It involves the use of enzymes that cut DNA at a specific sequence (site-specific nucleases such as CRISPR-Cas9), thereby introducing a break into the DNA at a targeted location. Plant and animal breeders could use genome editing to introduce sustainability traits (e.g., disease resistance, drought and salt tolerance, climate adaptability, and product quality) into agricultural breeding programs.
- Selection for more productive and resilient plant and animal varieties has been an incredibly important component of improving yield while resulting in a decreased environmental footprint per unit of food production.
- Regulatory agencies do not routinely evaluate new conventionally bred plant and animal varieties and breeds before their commercial release. Rather, breeders are responsible for evaluating selection candidates and choosing only the most viable, productive, and healthy individuals to be parents of the next generation.
- The White House Office of Science and Technology Policy (OSTP) Coordinated Framework for Regulation of Biotechnology1 states that regulation should be based on the risk posed by the introduction of a new biotechnology organism “and should not turn on the fact that an organism has been modified by a particular process or technique.”
- The OSTP clarified that additional regulatory oversight of biotechnology-derived breeds and varieties should only be exercised when the risk posed is unreasonable, which was clarified to mean “when the value of the reduction in risk obtained by additional oversight is greater than the cost thereby imposed.”2
- The US National Academies of Sciences, Engineering, Medicine report3 recommended a risk-based “product not process” trigger for the regulation of genome-edited crops.
- In 2018, the US Department of Agriculture (USDA) announced that it has no plans to place additional regulations on gene-edited plants that could otherwise have been developed through traditional breeding before commercialization. Under this ruling, genetic deletions, single base-pair substitutions, and the insertion of nucleotide sequences from related plants that could have come about through crossbreeding do not trigger additional regulatory scrutiny.
- Conversely, in 2017, the US Food and Drug Administration (FDA) proposed mandatory, multigenerational premarket new animal drug regulatory evaluation for all “intentional genome alterations” in food animals, including those resulting from the use of modern molecular technologies, including genome editing techniques.4
- Regulating intentional DNA alterations in food animals as veterinary drugs, inclusive of deletions, single base-pair substitutions, and the introduction of alleles between breeds, will make US food animal genome editing research prohibitively expensive and disincentivize the incorporation of genome editing in livestock breeding programs.
FASS supports the harmonization of the US regulatory approach to genome editing in food-producing species so that both plant and animal breeders have access to genome editing innovations.
- FASS supports regulations that are risk-based and product-focused.
- FASS supports regulations that are proportionate and process-agnostic, meaning low-risk products have a lesser regulatory burden than high-risk products, and equivalent products are treated similarly, irrespective of their origin.
Adopted by the FASS Board of Directors on November 11, 2020
For more information, please contact FASSPolicyStatements@assochq.org
1 Office of Science and Technology Policy (OSTP). 1986. Coordinated framework for regulation of biotechnology. Federal Register 51, 23302-23350.
2 National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. https://doi.org/10.17226/23395.
3 Office of Science and Technology Policy (OSTP). 1992. Exercise of federal oversight within scope of statutory authority: planned introductions of biotechnology products into the environment. Federal Register 57, 6753-6762.
4 Food and Drug Administration (FDA). 2017. Guidance for industry. Regulation of intentionally altered genomic DNA in animals. https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM113903.pdf.