An EPA rule regulating plant-incorporated protectants received swift criticism Thursday from groups representing the seed industry and soybean growers, who said it would hamper innovation.
The agency’s rule will regulate PIPs created using genetic engineering to confer pesticidal traits to plants, allowing exemptions from the Federal Insecticide, Fungicide, and Rodenticide Act and the Federal Food, Drug, and Cosmetic Act when the modifications could have been made through conventional breeding and pose no greater risk than PIPs the agency already approved, the agency says in a final rule.
In a departure from the original proposal, EPA has narrowed the option for crop developers to “self-determine” whether they've met the exemption criteria. The exemption will be limited to “loss-of-function” PIPs, where the genetically engineered modification “reduces or eliminates the activity of a gene, which then helps makes the plant resistant to pests,” the agency says.
EPA said there would be no such option for PIPs created through genetic engineering from a sexually compatible plant.
The rule also finalizes the documentation needed for the exemptions. Since EPA removed “loss-of-function” PIPs as a subcategory in federal regulations and made them their own category, the agency said “establishment of documentation requirements … (was) necessary.”
The rule also requires EPA “confirmation” that the exemption criteria have been met.
The American Seed Trade Association, in a statement from President & CEO Andy LaVigne, called the rule “a disappointing blow to plant breeders, public and private, working to bring innovative plant varieties to U.S. farmers and producers.”
“Rather than improving and modernizing the U.S. biotechnology regulatory system, as called for by multiple administrations, EPA’s new rule adds bureaucratic layers of red tape for the development of improved plant varieties created using innovative plant breeding techniques, like genome editing -- even though the agency views those products as posing no greater risk than their conventional counterparts,” LaVIgne said.
He added, “The cost of EPA’s new regulatory burden will ensure that only the largest of companies can afford to develop future innovations, resulting in the unintended consequence of driving additional industry consolidation.”
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Similarly, Alan Meadows, a director of the American Soybean Association and soy farmer in Tennessee, said the rule requires “costly, unscientific requirements for PIPs that EPA admits are low risk and ‘indistinguishable’ from conventionally bred PIPs, which are not subject to the same requirements."
In a release, EPA says, “PIPs are one of the safest methods to control pests because of their narrow activity spectrum, and their use can greatly reduce the need for conventional pesticides. Advances in science and technology now enable the modification of plants’ genomes such that PIPs created using genetic engineering can be indistinguishable from those found in conventionally bred plants.”
“Why would EPA want to impose unnecessary burdens on something it acknowledges as ‘low risk?’” Meadows asked rhetorically. “This decision in no way advances the administration’s goal of using these tools to tackle food security and environmental challenges, and the decision will limit farmer access to important innovations.”
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