public Health

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August 13, 2019

Administrator Kevin Shea Animal and Plant Health Inspection Service U.S. Department of Agriculture Attention: APHIS-2018-0034 1400 Independence Ave., S.W. Washington, DC 20250 Re: APHIS-2018-0034; Movement of Certain Genetically Engineered Organisms Dear Administrator Shea: I am pleased to submit the following comments on the proposed rule updating and modernizing the U.S. Department of Agriculture’s (USDA) approach to evaluating and assessing risks posed by genetically engineered (GE) organisms. Appropriate regulation of GE organisms is important to promoting and protecting the health of Americans. Although, the USDA has not made significant updates to the regulation of GE organisms in nearly three decades, the proposed rule would institute less regulation, permitting, and field testing for the majority of GE and gene edited plants. 1 In addition, the proposed oversight pathways for GE plants appear to be less transparent than existing regulations because they do not include Federal Register notices, or other public comment procedures. For these reasons, I write to express my concerns with the proposed rule. The Plant Protection Act (PPA) authorizes the USDA to administer a premarket program that includes the review of GE organisms (including plants) to determine whether they pose plant pest risks to domestic agriculture. 2 If the USDA concludes that they do pose such a risk, the agency requires a permit or notification to facilitate the organism’s importation, interstate movement, or environmental release. In other words, any movement of a GE organism must first be authorized by the USDA under existing regulations. 3 My major concern with the proposed rule is that it is a significant departure from the existing oversight processes, which introduces more health risks into the consumer market. Specifically, the proposed regulatory framework is likely to lead to more genetically engineered plants entering the market without undergoing a rigorous assessment and evaluation by the USDA. Moreover, GE plant developers will be able to “self-determine” whether certain GE plants should be exempted from premarket review and evaluation, rather than the USDA making that determination proactively.4 This increases the risk of potentially harmful GE plant products, or plant products that have adverse effects entering the market and being consumed by Americans. Adequate regulation of GE organisms is vital to maintaining the public health of Americans. I support the USDA’s mission to promote agriculture production that better nourishes Americans while also helping to feed others throughout the world, however, this proposed rule would increase the risk and abundance of harmful GE plants entering the market.

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I urge the USDA to revise the proposed rule to keep in place the existing regulatory framework that requires premarket approval and review of GE organisms and plants. I also urge the USDA to ensure that a process for public comment and feedback, such as posting notices in the Federal Register, is included in the final rule to ensure transparency. I appreciate the opportunity to submit these comments and welcome further discussion. Sincerely, X References

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1. Kuzma, Jennifer. Biotechnology Oversight Gets an Early Make-Over by Trump’s White House and USDA: Part 2 – The USDA-APHIS Rule. Genetic Engineering and Society Center, North Carolina State University. https://research.ncsu.edu/ges/2019/07/ag-biotech-oversight-makeover- part-2-usda-aphis-rule/ 2. 7 U.S.C. §§ 7701–7786. 3. Beaver, Nathan, et. al. Key Takeaways from USDA’s Biotech Regulation Proposal. Foley & Lardner, LLP. June 26, 2019. https://www.foley.com/en/insights/publications/2019/06/key- takeaways-usda-biotech-regulation-proposal 4. Bergeson & Campbell, P.C. APHIS Proposes Revised Regulatory Framework Regarding the Movement of Certain Genetically Engineered Organisms. June 8, 2019. https://www.natlawreview.com/article/aphis-proposes-revised-regulatory-framework-regarding- movement-certain-genetically