Loomis/CBC Joint Symposium and Workshop Genome Editing Putting Together the Pieces Innovation and USDA Regulation of the Products of Biotechnology

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1 Loomis/CBC Joint Symposium and Workshop Genome Editing Putting Together the Pieces Innovation and USDA Regulation of the Products of Biotechnology May 9, 2018 Sally L. McCammon Science Advisor Biotechnology Regulatory Services

2 The Plant Protection Act APHIS-BRS conducts its regulatory activities under the authority of the Plant Protection Act of 2000 The Plant Protection Act provides two provisions that could be used in regulating GE organisms: Plant Pest provisions Basis of current APHIS regulations (7 CFR part 340) Noxious Weed provisions Proposed by APHIS in the 2008 draft rule; remains under consideration for revised regulations

3 USDA- APHIS Regulated Activities If a GE organism is regulated (plant pest used in development), a Permit or Notification is required for the following activities: Importation Interstate movement Field test (confined release)

4 GE Plant Development LABORATORY / GREENHOUSE (mostly/not regulated by APHIS) FIELD TESTING (regulated by APHIS) COMMERCIALIZATION (not regulated by APHIS) 4

5 Cumulative Number of APHIS-Authorized Permits/Notifications CRISPR TALEN ZFN * * 2017 data collected through September 2017.

6 APHIS Issuance of Authorizations: Products of Genome Editing Number of Permits and Notifications Year CRISPR+ CRISPR TALEN ZFN TALEN TOTAL

7 USDA-APHIS Regulatory Oversight Determinations under Current 7CFR 340 Regulated Article Genetically engineered + plant pest component Permits and Notifications Non-Regulatory Status PPRA and EA Plant Pest Risk Assessment & Environmental Ass Petitions-PPRA+EA Extensions-PPRA Am I regulated

8 Plant Pest Risk Assessment Development of Modified Plant Description of Inserted Genetic Material, Inheritance and Expression of gene product etc. Disease & Pest Impacts Impacts on Weediness of the GE crop Impacts on the Weediness of Other Plants through Interbreeding

9 Plant Pest Risk Assessment Impacts on Nontarget Organisms Beneficial to Agriculture Changes to Agriculture or Cultivation Practices Impacts from Transfer of Genetic Information to Organisms with which Modified Plant Cannot Interbreed (HGT)

10 GE Plants with Nonregulated Status under 7 CFR part 340 (127) Alfalfa HT, PQ Canola HT, AP, PQ Corn HT, IR, AP, PQ Cotton HT, IR Papaya VR Soybean HT, IR, AP, PQ Sugar Beet HT Rose PQ Squash VR Tobacco PQ Apple PQ Chicory AP Flax HT Plum VR Potato IR, VR, PQ, FR Rice HT Tomato PQ Creeping Bentgrass-HT HT Herbicide Tolerant IR Insect Resistant VR Virus Resistant AP Agronomic Properties PQ Product Quality FR Fungal Resistant

11 Technique and Risk Assessment Risk assessment principles apply to any new plant variety, regardless of techniques used in development There are many tools for plant breeding dynamic and expanding rapidly individual techniques will be used in combination Technique may be useful in product characterization Assessment for safe use focuses on: characteristics of the plant phenotype and intended use 11

12 Am I Regulated (AIR) Process Am I Regulated by USDA/APHIS? Developers submit Letter of Inquiry to APHIS 61 Letters and responses (July, March 30, 2018) ology/am_i_reg.shtml

13 APHIS Regulatory Triggers Plant Pest Is a plant pest used in development of the organism? Agrobacterium, CaMV Is the organism a plant pest? Is the organism to be released into the environment? Is the organism genetically engineered? Not all GE organisms have a plant pest nexus may not be regulated.

14 Plants Ornamental plants Baby s breath Tobacco Corn Apple Grapevine Pineapple Plum Potato Soybean Arabidopsis Loblolly pine Grasses Kentucky Blue Grass Switchgrass St. Augustine Grass Tall Fescue Bahia Grass Setaria Wheat Rice Sorghum Camelina Moss

15 Genome Edited Organisms Not Regulated through AIR Waxy Corn Anti Browning Mushroom High Oleic Acid Soy CRISPR Cas9 Wx1 deletion 15 CRISPR Cas9 Ppo deletion TALEN - (fad2) deletion

16 Plants with Targeted Deletions Plant is not a plant pest or noxious weed Naturally occurring DNA repair after targeted break No genetic material inserted into genome Or inserted genetic material/plant pest sequences segregated away No plausible harm Not regulated by APHIS under 7CFR

17 Case-by-Case Genetic Modification Plant Pest Component Deletion Substitution Insertion Donor Vector Agrobacterium Vector Agent TALENS

18 Genome Editing Am I Regulated Requests Site Directed Nuclease Number of Inquires Number Pending Number of Responses * Meganuclease Zinc Finger TALEN CRISPR TOTAL * All are SDN-1, All Responses = Not Regulated

19 Genome Editing Am I Regulated Requests Site Directed Nuclease Number of Inquires Plant Pest Donor Plant Pest AGRO Plant Pest TALEN Meganucleas e Zinc Finger TALEN CRISPR TOTAL

20 Insertions (39) Camelina Corn Rice Moss PPQ, EPA, FDA

21 Revisions to 7 CFR 340 (I) Regulations promulgated in 1987 Efforts to revise CFR340 ongoing since January 2004 Proposed rule published in 2008 Withdrawn in 2015

22 Revisions to 7 CFR 340 (II) Proposed Rule published January 19, Comments Received Withdrawn November 7,

23 Need for Change Bring regulation into alignment with the U.S. Coordinated Framework for the Regulation of Biotechnology Prepare U.S. regulation for emerging technologies of tomorrow Focus on GE organisms that pose a risk to Plant Health Regulatory Relief Regulatory Experience

24 Secretary Perdue Issues USDA Statement on Plant Breeding Innovation Washington, D.C., March 28, 2018 Clarification of USDA s oversight of plants produced through innovative new breeding techniques, including techniques called genome editing.

25 Secretary Perdue Statement on Plant Breeding Innovation Regulation of plants indistinguishable to those developed by traditional techniques As long as no plant pest Currently do not regulate No intent to regulate as modernize regulations No regulation when no risk to plant health Facilitate innovation New traits introduced quickly and precisely

26 Approach to Plant Breeding Innovation: Organisms that are created using techniques that could otherwise have been produced using: Traditional breeding techniques Chemical based mutagenesis Radiation based mutagenesis

27 What does this mean in practice? Organisms with the following alterations would not be considered regulated under the USDA proposed approach: Deletions Single base pair substitution Introduction of sequences from sexually compatible plant relatives Null segregants

28 Rationale: Such organisms are essentially identical despite the method of creation Changes occur naturally in all organisms Selection of desirable phenotypes has been used since the beginning of modern agriculture Chemical and radiation based mutagenesis has already created thousands of mutations in single organisms Impractical and unnecessary to regulate plants created through means similar to traditional breeding

29 Benefits: Efforts by plant breeders to eliminate unwanted traits can otherwise take years to complete Generations of plant crossing may otherwise be necessary to introduce the desired trait Using plant breeding innovation can be administered more quickly, more efficiently than traditional techniques

30 Bottom line: U.S. Coordinated Framework states regulation based upon risks not process used to create it No scientific evidence of unique risk to plant health compared to traditionally bred plants Same Risk = Same Treatment under regulatory approach

31 Why issue the clarification statement now? Clarity about regulatory treatment of plant breeding innovations is important:...to help promote international regulatory compatibility, which is important to minimize trade disruption and because other countries are already forming policies on plant breeding innovations such as genome editing

32 Global Regulatory Status Canada: Not regulated unless product is novel Norway: Proposed; foreign DNA insertion regulated; otherwise case by case Europe: Awaiting summer 2018 European Court of Justice ruling United States: Am I Regulated? inquiries Israel: Foreign DNA insertions regulated China, Japan, Korea: Issue still being debated; no formal guidance Argentina, Brazil, Chile: Case by case approaches; foreign DNA insertions generally regulated Countries with regulation Countries with pending policies, regulations, or legal rulings Australia: Under review; likely regulated whenever foreign DNA involved; otherwise case by case

33 Plant Breeding Innovation (Genome Editing) and Regulation Issues Compatible approaches Trade disruptions Product Regulated? Yes? A GMO? Novel insertion Foreign DNA inserted Gene Drive No? Not a GMO? Deletion Product similar or indistinguishable from traditional breeding Risk Presented?

34 International Discussions on Breeding Innovation International Seed Federation (ISF) Inter American Institute for Cooperation in Agriculture (IICA) Asia Pacific Economic Cooperation (APEC) Organization for Economic Cooperation and Development (OECD) (35) Like Minded Group (7)

35 Like-Minded Group for Innovative Agricultural Biotechnologies LMG Countries Issues Support discussions of PBIs Promote Science-based Regulatory Approaches, Ag innovation Objective Share information and work collaboratively Work together on trade challenges

36 THANK YOU! USDA-APHIS-BRS: in.shtml