3 federal agencies ponder the new biotech regulatory regime

On June 11, President Donald Trump signed an executive order that would set in motion a review by three federal agencies the United States agricultural biotechnology regulation process.

“They were to streamline the system that is in place, and the executive order directs them to modernize the regulatory framework for agricultural biotechnology products,” explained Megan Provost, vice president of policy programs for Farm Foundation. The executive order directed the U.S. Department of Agriculture, the Environmental Protection Agency and the Food and Drug Administration to streamline regulations and create guidance documents in six months. And, those changes must be science-based; consistent with legal and economic factors; and involve the public in the guidance and regulation development.

To review the progress of the agencies so far, and to discuss what this process must entail, the Farm Foundation hosted the “New Biotechnolgoy Regulatory Regime” forum, July 23, at the National Press Club in Washington, D.C.

Stan Abramson, a counsel at the Arent Fox law firm in Washington, D.C., where he co-chairs the Life Sciences Group, and his practice is focused on biotechnology and other emerging technologies. He remembered working on the original Coordinated Framework for Regulation of Biotechnology in 1986. He said that policy was based that it would only focus on the product of genetic modification techniques, not the processes themselves. And that it would line out the turfs for FDA, EPA and USDA in regulating these events. But that was at the very early stages of the leaps in scientific knowledge surrounding biotechnology tools. That revolution kicked off an economic growth across the globe.

“In the 21 years, from 1996 to 2017, nearly 6 billion acres of biotech crops were planted worldwide,” Abramson said. “Biotech crops provided nearly $186 billion in economic gains to 17 million farmers, 95% of which are in developing countries.” Biotechnology is a tool in the farmers’ toolbox that isn’t going away any time soon. And in the decades since the framework was approved, there’s not been any evidence of these products causing any adverse risks to health, safety or environment, he added.

“Still, we can’t be complacent,” he said. “There are dozens of new plant and animal products in development using genome editing. We can make plants and animals that are disease resistant and climate hardy.” New gene editing could make microbial products for application on fields and animals with useful sustainability traits for both animal welfare and the environment, Abramson added. But, the regulatory process can hold up valuable biotechnology tools.

Consider, for example, the case of the Aqua Advantage Salmon, a salmon that was genetically engineered to express one single trait for faster growth than wild salmon cousins.

“That salmon sat around for 20 years in the new animal drug review process,” Abramson said. “We can’t afford to wait that long for new animal products to get approved.” Considering that research today is trying to develop disease resistance, and traits that will answer environmental challengers along with improving profitability, ranchers just can’t wait.

“It’s not a question if these agencies have the authority to regulate,” Abramson said. “The question is if they can cooperate here without their jurisdictions overlapping.”

EPA’s look

Mike Mendelsohn is chief of the EPA’s Emerging Technologies Branch in the Biopesticides and Pollution Prevention Division of the Office of Pesticide Programs. That’s a long title to explain that he manages plant-incorporated protectants and biopesticides like Bt corn and others.

EPA is approaching this executive order with the intent that regulatory decisions be based on risks assessments and using existing statutory authority as approval to remove undue regulations to getting products to the marketplace in a timely fashion.

“We have an important and critical role in the Office of Pesticide Programs in the EPA to evaluate current approaches to streamline and get them on the market efficiently,” he said. To that point, he stressed that EPA will be using consistent, science-based reviews in its regulatory system for PIPs. 

FDA’s role

Laura Epstein, senior policy advisor in the Office of the Center Director at FDA’s Center for Veterinary Medicine, provides poly advice on animal drugs and foods.

“The FDA looks at food safety of the products derived from these new varieties of plants and animals,” she explained. Now, at question are animals that are engineered for some specific trait.

“If it’s a new drug or animal drug, it has to be approved by the FDA prior to entering our marketplace,” she explained. “Well, how can an animal be a drug? The answer is the animal isn’t the drug. The regulated article is the intentional genomic alteration.” To that end, FDA’s duty is to make sure that these genomic alterations in question are safe to the animal and safe to people who may consume food from that animal and that the genomic alteration does what it claims to do so that farmers aren’t being defrauded.

In 2009, FDA issued a guidance document on genetically engineered animals, before many people had heard of genome editing, CRISPR or the like. In 2018, that guidance document was updated, and clarified to include other technologies.

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The executive order’s demand for streamlining the process means that FDA is being more flexible on their data requirements without compromising safety and effectiveness standards. On such way is considering those animals that are “low risk.”

“Lab mice can be genetically engineered,” Epstein explained. “We don’t regulate those, mostly because there’s just too many out there.” But, if a post-market problem arises, then the FDA will get involved.

“Requiring data from multiple generations of animals, well in fish that’s not so hard to produce,” she said. “But in cattle and swine that can be more difficult so we try to be flexible in data requirements.” This not only clears a path to market quicker, but it frees up valuable agency resources for use elsewhere.

Confusing aspects

In all of this, Epstein said there’s been confusion. For example the FDA isn’t going to start regulating all farms as “drug manufcacturers,” she said.

“We don’t expect them to register with the FDA or require them to report adverse events,” Epstein said. “But, if they are raising an animal to be, say, disease-resistant, and they come down with a disease, we ask that they contact us.” But if a farmers is considering breeding his genetically engineered livestock to other animals, they wouldn’t have to go to the agency first and every single time.

Fan-Li Chou, is biology coordinator in the USDA Office of Pest Management Policy, and comes from a “bench scientist” background.

“Our job at USDA is to provide farmers with access to the tools that they can use,” she said. “It’s up to them what tools they want to use. But we also work to ensure market access for the tools that they use.” U.S. farmers are in the global marketplace and so the department considers the implications for trade in any regulatory review.

“I thought as a bench scientist the speed of discovery was slow,” she said. “The speed of regulation is even slower than the science.” Today the science is CRISPR, but tomorrow it may be base editing, and the day after something else that we have yet to discover, Chou said. So any regulatory process that the USDA develops has to be flexible for future technology.

But also stewarding limited research dollars is critical in the regulatory review process.

“In 30 years, we have looked at every single glyphosate resistant soybean that’s been put on the market, and not one has ever shown a single risk,” she said. “Is it a good use of our scientists? Of our taxpayer money to keep doing this? We think not.”

USDA believes that regulations should be based on the best available scientific evidence and flexible to take in new knowledge, Chou said. “It must be flexible to new science, new evidence, new learning and we must justify the cost. It must promote innovation.”

To listen to the full discussion, visit www.farmfoundation.org/forums and scroll through their archives of this and other webinars.

Jennifer M. Latzke can be reached at 620-227-1807 or [email protected].