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CERSA Workshops Help Inform Regulatory Reform

The Center for Excellence for Regulatory Science in Agriculture has been at the forefront of recent efforts to inform and reform the regulatory processes for agricultural biotechnology.

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With companies developing more crop-protecting treatments using techniques such as CRISPR genome editing, the time is right for reform of federal policies that govern these products, says the director of a center focused on using agricultural science to inform agricultural regulations.

NC State University’s Danesha Seth Carley, director of the Center for Excellence in Regulatory Science in Agriculture, or CERSA, says a new plan to coordinate regulations by three federal agencies should ease challenges in bringing new agricultural biotechnologies to market, without compromising safety. 

The U.S. Environmental Protection Agency, the U.S. Department of Agriculture and the U.S. Food and Drug Administration recently released their plan to update, streamline and clarify their regulations and oversight mechanisms for the products of biotechnology, including biological products for agriculture.

At issue was the Coordinated Framework for the Regulation of Biotechnology, established in 1986 and updated in 2017. Efforts to reform the policy emerged in response to U.S. President Joe Biden’s 2022 executive order for “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy.

Catching up with science changes

Seth Carley, an NC State associate professor of horticultural science and a faculty member with the N.C. Plant Sciences Initiative, said the framework hadn’t kept up with advancements in biotechnology and left many companies wondering which agency was supposed to handle regulatory oversight for new agricultural products derived from naturally occurring microorganisms and other organic material.

These products help crops grow and protect them from disease, insects, pests and competition from weeds.

Seth Carley co-led three CERSA workshops over the past two years that brought together representatives of academia, industry and the federal government to discuss concerns about regulation of genome-edited microbial products and to share concerns and recommendations with the regulatory agencies. Genome editing involves using technologies such as CRISPR to change an organism’s DNA.

One of her partners in leading the workshops, CRISPR pioneer Rodolphe Barrangou said, “Importantly, at a time of disruptive innovation with novel emerging technologies like CRISPR for genome editing, we need to update regulatory frameworks to keep up with the science, enable the industrial pursuit of next-generation products, while ensuring we meet the high regulatory standards that drive consumer acceptance and confidence.”

A new pathway

The consensus among the company representatives who attended the workshops was that “there was no transparent pathway for them to go from discovery to sale of these products because they don’t fall under the EPA, USDA or the FDA particularly well,” Seth Carley said. “The industry felt like they were being slowed down by the regulatory process. They were talking to each different regulatory body to get approval, which is not ideal.”

Another workshop co-leader, Randy Deinhammer, global head of regulatory affairs for plant biosolutions at Novonesis North America, said, “I think that it’s really been because of CERSA’s continued involvement and together with industry … that we’ve moved the topic of existing regulations around genome-edited organisms so far and so quickly.”

Participants at the first workshop in CERSA’s Genome-Edited Microbials Workshop Series met in Washington, D.C.

That’s important, because more appropriate regulatory practices will go a long way toward bringing biotech solutions to the marketplace to address climate change and the need for sustainable food for a growing world population.

“Without appropriate regulations in place that would enable these technologies to make it to the commercial space,” Deinhammer said, “we’re basically setting ourselves up for a future that isn’t what we need it to be.”

According to the new joint EPA-FDA-USDA biotechnology regulatory reform plan, released in May, the agencies intend to clarify and streamline regulatory oversight for genetically engineered plants, animals and microorganisms. They also will update and expand their information sharing through an agreement to improve and broaden communication and coordination of oversight of modified microbes.

In addition, they’re planning a pilot project to explore the feasibility and costs of developing a web-based tool to help developers determine which agency regulates a given microbial-based product.

CERSA’s core

Barrangou, NC State’s Todd R. Klaenhammer Distinguished Professor in the Department of Food, Bioprocessing and Nutrition Sciences, said the workshops provided a venue for “an invaluable open dialogue about the path forward.”

As Danesha Seth Carley said, “This is the core of what CERSA was designed to do — to foster conversations and help in a very positive way to move the needle when it comes to regulation and the regulatory process. We were on the front line from the beginning and working with those regulators, and I really feel we were instrumental in getting this new coordinated framework out into the community.”

The Center for Regulatory Science in Agriculture is an NC State University partnership with Louisiana State University that was founded in 2018 to raise awareness of regulatory challenges, increase cooperation and collaboration among stakeholders, address important challenges in an unbiased manner and educate the next generation of regulatory scientists. It falls under the umbrella of the N.C. Plant Sciences Initiative.

The N.C. Plant Sciences Initiative works to solve the grand challenges in agriculture and the environment in North Carolina and beyond through interdisciplinary team-based science, partnerships and talent development. The N.C. PSI includes includes over 60 scientists, engineers and scholars from eight NC State colleges.