This document summarizes the US Food and Drug Administration's (FDA) regulatory approach and activities related to agricultural biotechnology products. It discusses the FDA's 1992 policy on genetically engineered plant-derived foods, which states that foods will be regulated based on their characteristics rather than the method used to develop them. The document also summarizes the FDA's guidance and requests for comment on the regulation of genome edited plants and animals. It outlines the FDA's commitment to facilitating innovation while ensuring safety and maintaining public confidence.

1. Innovation and US Regulation of the
Products of Agricultural Biotechnology
Ongoing FDA Activities Related to Agricultural
Biotechnology Products
Kathleen M. Jones, Ph.D.
U.S. Food and Drug Administration
June, 2018

2. Regulation of GE Plant-derived Foods
1992 Policy Statement – “Statement of Policy: Foods Derived from
New Plant Varieties”
• Clarifies interpretation of legal provisions for foods derived from
new plant varieties, including those developed through genetic
engineering.
• The regulatory status of a food, irrespective of the method by which
it is developed, is dependent upon objective characteristics of the
food.
• Describes how certain safety provisions in the FD&C Act can be
applied to foods from new plant varieties.
– Section 402- Adulterated Food
– Section 409- Food Additives
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3. 1992 Policy Statement
Section 409- Food Additives
• New components of food will be regulated as food additives if they
are not generally recognized as safe (GRAS), subject to certain
exceptions.
• Food additives require premarket review and approval before they
can be lawfully marketed. The safety standard for use of a food
additive is reasonable certainty of no harm under the conditions of
intended use in food.
• In order for use of a substance to be GRAS:
– there must be reasonable certainty of no harm under the conditions of
intended use and general recognition of that fact
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4. Genome Editing – Plant-Derived Foods
Request for Comments (RFC) seeking public input to help inform
FDA’s regulatory approach to genome editing plant-derived foods
(82 FR 6564-6566; January 19, 2017)
• How is FDA’s knowledge of and experience with current plant
varieties relevant to the safety assessment and regulatory status of
food from genome edited plant varieties?
• Are there categories of genome edited plant varieties that are
unlikely to present food safety risks different from or greater than
those for traditional plant breeding?
• Are there categories that are more likely to present food safety
risks relative to traditionally-bred plants ?
• How can FDA help small firms engage with the agency about
genome edited plant varieties?
Comment period ended in June, 2017
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5. Regulation of GE Animals
Federal Food, Drug, and Cosmetic Act (FD&C Act)
• Products are regulated; not processes
National Environmental Policy Act (NEPA)
• Procedural; agencies must evaluate impacts of “agency actions”
2009 FDA Guidance for Industry (GFI) #187: the subject of the New
Animal Drug Application is “the rDNA construct at a specific site in the
genome”
• Safe for the animal
• Safe for food
• Effective
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6. 2017 Draft Revised GFI #187
Updated 2009 guidance for GE animals; Scope expanded to animals
whose genomes have been intentionally altered
Questions for public comment:
• Terminology: How do we refer to these animals?
• Is there any existing empirical evidence demonstrating that certain
types of genome editing may pose minimal risk?
– Categories with no significant target animal, user safety, food safety,
environmental risk?
– Categories where evidence shows durability?
– Degrees of introduced changes with less risk?
We intend to modify our proposed regulatory approach based on
comments, submission of evidence of low risk
We intend to be as flexible as possible under the law, based on risk
Comment period ended in June, 2017
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Genome Editing – Animals

7. FDA Voice Blog - June 6, 2018
FDA is committed to helping ensure the
safety of biotechnology products, while also
facilitating innovation by applying a risk-
based regulatory approach that provides
developers with regulatory clarity and
predictability and maintains public
confidence in our regulatory system.
Action Plan (under development)
• Advance and protect public and animal
health by promoting innovation
• Strengthen public outreach and
communication
• Increase engagement with domestic and
international partners
www.fda.gov
New Efforts to Advance Biotechnology Innovation
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8. Key Messages
• FDA’s work with regard to genome editing is ongoing – taking
steps to clarify science-based policies to advance agricultural
innovation, help ensure safety of products
• USDA/APHIS’ statement does not impact regulation of food safety
in the United States. While some plant products may not be
regulated by APHIS, developers may still be subject to regulation by
FDA, which oversees food safety (and EPA, which has
responsibility for pesticides)
• FDA will continue to coordinate with EPA and USDA under the
Coordinated Framework, and engage with domestic and
international partners
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9. For Information on Agricultural
Biotechnology at FDA
Regulation of GE Plants
https://www.fda.gov/Food/IngredientsPackagingLabeling/GEPlants/default.
htm
Regulation of GE Animals
http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/Genet
icEngineering/GeneticallyEngineeredAnimals/default.htm
FDA’s New Efforts to Advance Biotechnology Innovation
https://blogs.fda.gov/fdavoice/index.php/2018/06/fdas-new-efforts-to-
advance-biotechnology-innovation/
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