EPA, FDA, and USDA release plan to improve biotech regulation

biotech regulation

Several federal agencies on May 8 announced a plan to coordinate and streamline regulation of plants, animals, and microorganisms modified through biotechnology.

The plan is part of an effort to enable faster commercialization of biotech innovations that can increase food security and combat climate change.

Promised in President Biden’s September 2022 Executive Order 14081, the plan describes better coordination of regulatory oversight by the Environmental Protection Agency (EPA), Food and Drug Administration (FDA), and U.S. Department of Agriculture (USDA).

“The plan incorporates processes and timelines to implement regulatory reform, such as identifying guidance and regulations to update, streamline, or clarify, and identifying the potential need for new guidance or regulations. The plan supports a whole-of-government approach to the regulation of biotechnology products,” according to a USDA press release.

Arriving nearly a year after it was anticipated in Biden’s Executive Order, the document has been welcomed as an important, if delayed, step forward by the Biotechnology Innovation Organization (BIO).

“We need a regulatory process that works at the speed of today’s innovation. The agencies lay out in this report a plan to update existing guidance, develop new guidance and streamline processes,” says a BIO statement.

Why this report

While biotech innovation in plants, animals, and microorganisms are revolutionizing sustainable agriculture, bringing these innovations to market is a cumbersome process.

It now takes an average of 16.5 years to bring a novel trait to market, and more than half the cost of trait development and commercialization is attributed to the regulatory process, according to an AgbioInvestor report. The new plan for federal regulatory reform seeks to address this problem.

“This plan provides a roadmap for actions the agencies will take, individually and collaboratively, to improve regulatory clarity, streamline regulatory oversight, reduce regulatory redundancies and gaps, and increase regulatory coordination for specific product categories and across the Coordinated Framework,” according to the document’s introduction.

The plan explains how the EPA, FDA, and USDA will develop better coordination, says Leah Buchman, Ph.D., BIO’s Senior Manager, Agriculture & Environment Regulatory Policy.

“This report is not itself guidance, but it does lay out lots of opportunities for the agencies to develop new guidance or update guidance or come out with requests for information,” Buchman says. “It gives industry and stakeholders the ability to see what’s coming and also prepare for comments and engagement with the agencies.”

Potential for improvement

The report describes improvements that can have a major impact, according to Buchman. For example, it envisions developing much more robust regulation for genetically engineered microbes.

“As regulation currently stands, there’s no pathway to commercialization for genetically modified microorganisms,” Buchman says. “These GE microbes have the ability to increase nutrient uptake for plants and help plants with mitigating those abiotic stressors that come with climate change—increased heat, drought and so on.”

To this end, the report describes efforts to clarify and harmonize EPA and USDA roles in regulatory approval. It explains plans to move the process forward through actions like requests for information on microorganisms.

“A pathway to commercialization to get these products into the hands of growers and producers is necessary, so that consumers like you and me have access to food, domestically and internationally,” says Buchman. “We need to get these products into the hands of the users to combat issues like climate change.”

Overall, the efforts at coordination and harmonization described in the document are encouraging for Buchman.

“I think the main takeaway is that the agencies are working together at various levels, and it’s evident in this document. They really took this holistic approach,” she says. “And that’s really exciting for innovation. Innovation is stymied without the ability to reach consumers who it can help, to reach growers planting in the field. A pathway forward to streamline this work to meet the needs of today is really important. And I think that this plan lays that out.”

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