Letter
Dear Chair Thompson, Chair Stabenow, Ranking Member Scott, and Ranking Member Boozman,
We write to express our great concern with a rule recently finalized by EPA regarding plant-incorporated protectants (PIP) derived from gene editing. The rule as finalized will suppress access to agricultural innovations greatly needed to reduce inputs, adapt to a changing climate and, respond to increased pest and disease challenges while maintaining a safe, reliable, and affordable food system for a growing global population. This rule will disproportionally stifle innovation by publicly supported federal and academic plant breeders and smaller plant breeding companies, inhibiting their development of new varieties, particularly of specialty and other smaller acreage crops.
PIPs are a broad class of substances that plants produce to protect themselves from pests and pathogens, much like the human immune system. These characteristics have been sought after by plant breeders for centuries. Under longstanding rules, EPA exempts conventionally bred PIPs from regulation under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) due to the history of safe use and the fact that they are inherently low-risk substances to humans and the environment.
In the final rule, EPA recognizes that PIPs created through gene editing from a sexually compatible plant and loss-of-function modifications, “pose no greater risk than the PIPs created through conventional breeding that have been exempt [from FIFRA] since 2001.” The Agency claims the new exemptions are “reducing the regulatory burden for the regulated community,” and will “result in increased research and development activities, commercialization of new pest control options for farmers, particularly in minor crops, and increase the diversity of options for pest and disease management, which could provide environmental benefits.”
However, we find EPA’s claims inaccurate since the rule applies different compliance requirements between conventionally bred PIP and equivalent PIP developed using gene editing. Developers of PIPs created through gene editing from a sexually compatible plant are required to undertake a mandatory premarket process to confirm “eligibility” for the exemption and are subject to a recordkeeping requirement not imposed on conventionally bred PIPs. Further, any PIPs created through gene editing from a sexually compatible plant that do not qualify for the exemptions would be subject to full EPA registration. This is not “reducing the regulatory burden” and will hinder, not incentivize, research and development in crops that most need innovation and can less afford scientifically unjustified regulatory hurdles. These crops are disproportionately specialty and small acreage crops that have historically relied on public sector, academic institutions, and smaller companies for new improved varieties.
EPA’s newly published regulation creating “PIPs created through genetic engineering from a sexually compatible plant” and “loss-of-function PIPs” is not risk-based, science-based and focuses on process of development rather than product. We ask that Congress take the necessary steps to ensure that U.S. agriculture can continue to innovate and respond to the environmental and crop production challenges we face. The undersigned request that Congress direct EPA to withdraw the current rule and replace it with one that appropriately considers risk and benefits of PIPs created through gene editing from a sexually compatible plant and loss-of-function PIPs and treats them as equivalent to conventionally bred plant characteristics.
Thank you, and we stand ready to assist you in cultivating a risk-appropriate, science-based regulatory system for these vital innovations.
Sincerely,
Agricultural Retailers Association
American Farm Bureau Federation
American Seed Trade Association
American Society of Plant Biologists
American Soybean Association
American Sugarbeet Growers
Association Arkansas Rice Growers Association
Biotechnology Innovation Organization
California Avocado Commission
California Citrus Mutual
California Fresh Fruit Association
California Seed Association
California Specialty Crops Council
California Walnut Commission
Cherry Marketing Institute
Controlled Environment Agriculture Alliance
CropLife America
Crop Science Society of America
Florida Citrus Mutual
Florida Fruit and Vegetable Association
Florida Tomato Exchange
Georgia Fruit and Vegetable Growers Association
Global Banana Sustainability Alliance Hop
Growers of America
Idaho-Oregon Fruit and Vegetable Association
Illinois Soybean Association
Independent Professional Seed Association
International Fresh Produce Association
Michigan Agri-Business Association
Michigan Asparagus Association
Michigan Apple Association
Michigan Farm Bureau
Michigan Soybean Association
Michigan Vegetable Council
National Alliance of Independent Crop Consultants
National Association of Plant Breeders
National Association of State Departments of Agriculture
National Association of Wheat Growers
National Corn Growers Association
National Cotton Council
National Council of Farmer Cooperatives
National Onion Association
National Potato Council
National Sorghum Producers
National Watermelon Association
Ohio AgriBusiness Association
Pacific Seed Association
Pennsylvania Vegetable Growers Association
Society of American Florists
South Dakota Agri-Business Association
Southern Crop Production Association
Synergistic Hawaii Agriculture Council
Texas Citrus Mutual
Texas Seed Trade Association
Texas International Produce Association
The Fertilizer Institute
USA Rice
U.S. Apple Association
U.S. Canola Association Western Growers
