The U.S. is in danger of losing its position as a global leader in agriculture innovation. While the Biden administration has set forth bold goals for U.S. biotechnology to drive climate adaptation and mitigation in the agriculture and food system, the EPA, with its recent final rule on Plant Incorporated Protectants (PIPs), has inexplicably chosen to handcuff U.S. agricultural innovation, especially those from small companies and public sector plant breeding programs.
Unless the agency decides to pause and reconsider, or Congress takes action to halt the rule, EPA’s policy goes into effect on July 31, enforcing the downward trajectory of U.S. leadership in agriculture innovation.
This is not a niche issue impacting only a few companies or a few crops. It is causing concern across the food and agriculture sector. Yesterday, a diverse group of food, agribusiness, and grower organizations, representing both large-acre and specialty crops, sounded the alarm in a letter to Congress, calling on EPA to withdraw and replace the rule.
Sustainable agriculture and food production require a diverse range of innovative solutions, including the latest precision plant breeding tools like gene editing. These tools allow plant breeders to develop better crops, in less time with more accuracy than older methods. For example, plant breeders are using innovative tools to develop crops that are drought tolerant and climate resilient, berries with added nutritional benefits, and produce that addresses food waste by staying fresher, longer.
EPA’s precautionary and process-based policy imposes non-risk based regulatory hurdles for certain plant characteristics created using the latest precision breeding tools, even though the agency itself has stated that they are “virtually indistinguishable from those created through conventional breeding.” It makes no sense that EPA would choose to treat these plants differently, adding costly and time-consuming regulatory barriers, when they are the same as their conventionally-counterparts and pose no additional safety risks. At a time when weshould be encouraging more innovation, not less, EPA is forcing U.S. innovators to pump the brakes, and in some cases to consider moving their research to other countries.
Under the new EPA rule, a plant breeder of a disease-resistant lettuce generated through conventional breeding will have no requirements from EPA prior to bringing the product to market. The same plant breeder could then use a more precise, efficient tool of breeding, like gene editing, to generate the exact same disease resistant characteristic in another variety of lettuce. The characteristic is the same; however, the plant breeder will have to make a submission to EPA and provide data to justify that the variety is eligible under EPA’s exemption for “PIPs created through genetic engineering from a sexually compatible plant.” The plant breeder will then have to wait for EPA to confirm their justification and maintain records for five years, while EPA requires none of the above for the conventionally bred lettuce.
The agency’s policy is not justified by science and offers no added safety benefit. Instead, it will prevent the anticipated widespread democratization of breeding tools like gene editing, and ensure that future innovation will be constrained to a limited number of large acre, row crops and a few large companies.
Domestically, EPA’s policy is out of alignment with USDA’s policy under the U.S. Coordinated Framework, in essence negating much of the regulatory streamlining enabled and envisioned under USDA’s recent revisions to its regulations around innovative plant breeding.
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Internationally, the rule is out of step with a growing list of international regulatory authorities that have used a science-based rationale to streamline their policies to support commercialization of innovative products. Notably, Canada, the U.S.’ top trading partner for seeds, as well as Argentina, Brazil and Chile.
Both the U.S. government and private sector have made substantial investments in foundational agricultural research, with much of the genetic discovery and development of innovative plant breeding tools being done by our public institutions and government research programs. This rule will unfortunately create barriers to the application of that research and discovery — and we’ll never see the return on investment.
The new and emerging challenges of tomorrow will not be solved with the tools of yesterday. This is true in agriculture as it is in every industry. Why would EPA choose to go backward?
It’s time to walk the walk. We can’t ask our farmers to do more with less, feed the world, and do it in a more sustainable way, while at the same time limiting their access to the latest innovation being embraced by our global trading partners. From organic, to conventional, to biotechnology, our farmers need access to all of the tools available to meet global demand and provide consumers with an array of options for safe, affordable and nutritious foods.
Cathy Burns is the CEO of the International Fresh Produce Association and Andy LaVigne is the president and CEO of the American Seed Trade Association.