Ag Alert September 9, 2020

New EPA rule would speed approval for biotech plants

pest-resistant cultivars to be developed more quickly and efficiently.” For example, it could be particularly useful for moving disease-resistance genes fromwild relatives into elite culti- vars, he added, although noting the EPA proposal seems to focus more on exam- ples where a specific chemical or protein is produced. Under the proposed exemption, EPA would require developers of biotech pes- ticides incorporated into plants to sub- mit either a self-determination letter or a request for EPA confirmation that their

productmeets the criteria for exemption; a developer could also submit both. EPA listed several benefits it said may result from the proposed exemptions, including lower costs from reduced regulatory burden; increased research, development and commercialization of pest-control options for farmers, partic- ularly in “minor” crops; and reduced use of conventional pesticides that couldpro- vide environmental benefits. EPA estimated the new rule would re-

ByChing Lee In an effort to streamline regulations of certain pesticides derived through biotechnology, the U.S. Environmental Protection Agency has proposed a new rule it says would speed development of new, genetically engineered plant varieties that could help farmers fight pest and disease pressure, potentially in more crops. Specifically, EPA has proposed ex- emptions under the Federal Insecticide, Fungicide and Rodenticide Act and the Federal Food, Drug andCosmetic Act for certain biotech pesticides incorporated into plants “that pose no risks of con- cern to humans or the environment,” the agency said. Under the proposed rule, announced last week, regulatory exemptions for such biotech pesticides would be allowed “as long as their pesticidal substances are found in plants that are sexually compat- iblewith the recipient plant andmeet the proposed exemption criteria, ensuring their safety.”Once the rule is published in the Federal Register , the public will have 60 days to comment. The agency said the proposed ex- emptions “seek to facilitate the de- velopment of new tools for American farmers to protect their crops and con- trol agricultural pests.” By “reducing antiquated regulations that restrict access to the market for biotechnolo- gy products,” EPA said, farmers would have more access to science-based innovations that could potentially in- crease the nation’s food supply. “This new rulewill provide critical new tools for America’s farmers as they work to increase agricultural productivity, im- prove the nutritional value and quality of crops, fight pests and diseases, and boost food safety,” EPA Administrator Andrew Wheeler said. “Embracing this technolo- gy through a transparent, consistent and science-based process is long overdue, and will secure benefits to American ag- riculture well into the future.” Kent Bradford, director of the Seed Biotechnology Center at the University of California, Davis, said the EPApropos- al appears similar to a recent proposal by the U.S. Department of Agriculture to allow changes to a plant using biotech- nology if those changes could have been achieved throughconventional breeding. The rule would allow sexually com- patible plants with desirable traits such as possession of pesticidal substances to be crossed, and it would be possible to recover viable progeny from them, he explained. Most crops are sexually com- patible with some wild species to which they are closely related, such as among pepper or tomato species, he added. The advantage to this part of the rule, Bradford said, is that “the gene encoding the enzyme that makes a chemical pesti- cide or the pesticidal protein itself could be introduced into amodern cultivar and confer resistance to the pest without hav-

ing to actually make the cross to the wild species and then backcross repeatedly,” sometimes over six to 10 generations, to get back to the “elite variety.” “It is often difficult to keep all of the advantageous traits of the elite variety, and undesirable traits can also come along from the wild parent,” he said. “So theoretically, this change could enable

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September 9, 2020 Ag Alert 5

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