EPA decision to tighten oversight of gene-edited crops draws mixed response | Science

When the CRISPR gene editor landed in U.S. plant science labs a decade ago, allowing researchers to tweak a crop’s own DNA instead of pasting in foreign genes, hopes rose that it would pave the way for looser regulation of genetically modified crops. Last year, the U.S. Department of Agriculture (USDA) gave plant scientists much of their wish, exempting certain gene-edited changes to plants. But the Environmental Protection Agency (EPA) is taking a tougher stance.

In a final rule published last week, EPA said that like USDA, it will exempt gene-edited plants from an in-depth review process if the change could have been achieved with conventional breeding. But under its mandate to ensure safety for humans and wildlife, EPA will still require developers to submit data showing that plants that have been gene edited to resist pests—for example, by producing more of a naturally occurring toxic protein—won’t harm other components of the plant’s ecosystem or sicken people.

The move clarifies the regulatory requirements for industry and provides valuable oversight, says Jennifer Kuzma of North Carolina State University, an expert on biotechnology and public policy. But an industry group says the new rule will stifle innovation.

Three federal agencies regulate genetically modified crops in the United States. USDA evaluates whether a biotech crop might harm agriculture by becoming a noxious weed, for example. EPA checks whether a “plant-incorporated protectant” might harm farmworkers or wildlife. And the Food and Drug Administration is responsible for food safety.

For more than 20 years, all three bodies have reviewed crops engineered to contain DNA from other species, an appraisal process that can take years and cost industry millions of dollars in testing. The extent of agency oversight has been unclear for gene-edited crops, in which DNA is modified but not moved between species.

Last year, USDA’s finalized rule limited its oversight. For example, researchers won’t need to ask for agency approval if they give a crop a trait that already exists naturally in a sexually compatible plant.

EPA announced on 25 May that it, too, will use the conventional breeding exemption for many gene-edited crops. But unlike USDA, the agency will require companies to submit confirmatory safety data, such as evidence that the changes don’t increase pesticide levels beyond those found in food from conventional crops.

The agency says regulatory review will still be faster and cheaper for gene-edited crops compared with transgenic plants. But the American Seed Trade Association (ASTA) worries that researchers who use conventional breeding—and have not previously needed to ask EPA for a regulatory review—will be dissuaded from adopting gene editing.

“EPA’s new rule adds bureaucratic layers of red tape,” ASTA Director Andy LaVigne said in a statement. “The ramifications of EPA’s policy for U.S. innovation are potentially widespread and significant, especially when it comes to impacts on small and medium-sized entities in the U.S.—particularly in fruits, vegetables and other small acreage crops. … The cost[s] will ensure that only the largest of companies can afford to develop future innovations.”

Kuzma says EPA has struck a reasonable balance. “We need some sort of outside check to make sure that that the industry is thinking about risks to nontarget organisms and humans when it comes to pesticidal compounds. I feel better with the EPA looking at this.”

When the CRISPR gene editor landed in U.S. plant science labs a decade ago, allowing researchers to tweak a crop’s own DNA instead of pasting in foreign genes, hopes rose that it would pave the way for looser regulation of genetically modified crops. Last year, the U.S. Department of Agriculture (USDA) gave plant scientists much of their wish, exempting certain gene-edited changes to plants. But the Environmental Protection Agency (EPA) is taking a tougher stance.

In a final rule published last week, EPA said that like USDA, it will exempt gene-edited plants from an in-depth review process if the change could have been achieved with conventional breeding. But under its mandate to ensure safety for humans and wildlife, EPA will still require developers to submit data showing that plants that have been gene edited to resist pests—for example, by producing more of a naturally occurring toxic protein—won’t harm other components of the plant’s ecosystem or sicken people.

The move clarifies the regulatory requirements for industry and provides valuable oversight, says Jennifer Kuzma of North Carolina State University, an expert on biotechnology and public policy. But an industry group says the new rule will stifle innovation.

Three federal agencies regulate genetically modified crops in the United States. USDA evaluates whether a biotech crop might harm agriculture by becoming a noxious weed, for example. EPA checks whether a “plant-incorporated protectant” might harm farmworkers or wildlife. And the Food and Drug Administration is responsible for food safety.

For more than 20 years, all three bodies have reviewed crops engineered to contain DNA from other species, an appraisal process that can take years and cost industry millions of dollars in testing. The extent of agency oversight has been unclear for gene-edited crops, in which DNA is modified but not moved between species.

Last year, USDA’s finalized rule limited its oversight. For example, researchers won’t need to ask for agency approval if they give a crop a trait that already exists naturally in a sexually compatible plant.

EPA announced on 25 May that it, too, will use the conventional breeding exemption for many gene-edited crops. But unlike USDA, the agency will require companies to submit confirmatory safety data, such as evidence that the changes don’t increase pesticide levels beyond those found in food from conventional crops.

The agency says regulatory review will still be faster and cheaper for gene-edited crops compared with transgenic plants. But the American Seed Trade Association (ASTA) worries that researchers who use conventional breeding—and have not previously needed to ask EPA for a regulatory review—will be dissuaded from adopting gene editing.

“EPA’s new rule adds bureaucratic layers of red tape,” ASTA Director Andy LaVigne said in a statement. “The ramifications of EPA’s policy for U.S. innovation are potentially widespread and significant, especially when it comes to impacts on small and medium-sized entities in the U.S.—particularly in fruits, vegetables and other small acreage crops. … The cost[s] will ensure that only the largest of companies can afford to develop future innovations.”

Kuzma says EPA has struck a reasonable balance. “We need some sort of outside check to make sure that that the industry is thinking about risks to nontarget organisms and humans when it comes to pesticidal compounds. I feel better with the EPA looking at this.”