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Innovation and US Regulation of the
Products of Agricultural Biotechnology
Ongoing FDA Activities Related to Agricultural
...
Regulation of GE Plant-derived Foods
1992 Policy Statement – “Statement of Policy: Foods Derived from
New Plant Varieties”...
1992 Policy Statement
Section 409- Food Additives
• New components of food will be regulated as food additives if they
are...
Genome Editing – Plant-Derived Foods
Request for Comments (RFC) seeking public input to help inform
FDA’s regulatory appro...
Regulation of GE Animals
Federal Food, Drug, and Cosmetic Act (FD&C Act)
• Products are regulated; not processes
National ...
2017 Draft Revised GFI #187
Updated 2009 guidance for GE animals; Scope expanded to animals
whose genomes have been intent...
FDA Voice Blog - June 6, 2018
FDA is committed to helping ensure the
safety of biotechnology products, while also
facilita...
Key Messages
• FDA’s work with regard to genome editing is ongoing – taking
steps to clarify science-based policies to adv...
For Information on Agricultural
Biotechnology at FDA
Regulation of GE Plants
https://www.fda.gov/Food/IngredientsPackaging...
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Ongoing FDA Activities Related to Agricultural Biotechnology Products in the US - Kathleen Jones

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Ongoing FDA Activities Related to Agricultural Biotechnology Products in the US - Kathleen Jones

  1. 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. 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 2
  3. 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 3
  4. 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 4
  5. 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 5 5
  6. 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 6 6 Genome Editing – Animals
  7. 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 7
  8. 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 8
  9. 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/ 9

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