Biotech crop developers are calling on the Biden administration to reform U.S. regulatory oversight of gene-edited plant products to compete with other countries that have streamlined approval processes.

Biotech crop approvals in Brazil, for example, “are now consistently much faster than U.S. approvals,” Jerry Hjelle of Hjelle Advisors in Missouri, which advises small and medium-sized biotech companies, told the Office of Science and Technology Policy at a recent listening session.

“Inconsistencies and delays at USDA for gene-edited products are threatened to hamper U.S. competitiveness even at the field trial testing stage.”

Gene editing “is simply an advanced method of breeding, with no insertion of DNA from non-sexually compatible species, and in most cases no change in the amino acid composition,” said Rachel Gast, senior director of regulatory at Inari in West Lafayette, Indiana. “There is no science-based reason to treat the resulting product any differently than those of conventional breeding methods.”

Further, she said, “the improvements we are able to achieve through gene editing are more precise and are created in less time. As we accelerate climate-smart agriculture, these advancements should be championed and supported.” Instead, “many aspects of gene editing technology are being burdened by regulations established for the evaluation of products that included the presence of new transgenic traits.”

USDA’s SECURE rule, issued in 2020, exempts from regulation modifications that could be achieved through conventional breeding, specifically single modifications where “1) the genetic modification is a change resulting from cellular repair of a targeted DNA break in the absence of an externally provided repair template; or 2) the genetic modification is a targeted single base pair substitution; or 3) the genetic modification introduces a gene known to occur in the plant’s gene pool or makes changes in a targeted sequence to correspond to a known allele of such a gene or to a known structural variation present in the gene pool.”  

Gast said regulatory reviews are taking longer than USDA initially estimated — 390 days compared to the 180-day timeline in the rule. Speaking for the American Seed Trade Association, Jim Radtke, Cibus vice president of product development said “developers are experiencing growing delays in APHIS’s permitting process and there are overly burdensome permitting conditions for low-risk crops.”

Jerry_Hjelle.jpgJerry Hjelle, Hjelle Advisors

“The pace of innovation today is amazing,” Hjelle said. But he worries that USDA, FDA and EPA may not be able to keep up with the swiftly evolving science.

“The underlying framework of regulations … generally permits the agencies to provide updated guidance to assist developers, and now is the time to make incremental improvements and clarifications,” Hjelle said, especially for products and technologies that have a low probability of harm.

OSTP is accepting comments until Feb. 3 on biotech regulatory gaps and inefficiencies, and until this Friday on an executive order issued by President Joe Biden establishing the National Biotechnology and Biomanufacturing Initiative.

In particular, USDA should treat multiplex gene editing — where multiple edits are made in a plant’s genome all at once — the same as it treats single edits, Hjelle and others said,

Dan Jenkins, head of regulatory for Pairwise, which has been working to genetically engineer fruits and vegetables, said at the session that “applications for genetic technologies, including genome editing, should be regulated based on the phenotype and product characteristics rather than on the process used to create them.”

“Regulating genetic technology on the basis of whether the outcome could or could not have been achieved using traditional breeding techniques perpetuates the false assumption that risk and benefits are determined by the technology used to make a change,” he said.

“The technique shouldn't matter,” Jenkins said in an interview. “And I do believe that USDA understands this.”

The regulatory issue is particularly important for companies such as Pairwise that work with specialty crops, he said, because “their genomes can be more complicated.”

“Most of the things that we're trying to do are not going to fall into those exemptions,” Jenkins said. “We're going to have more than a single edit.” 

USDA should have enough research now, nearly three years after the SECURE rule was published, to move forward on easing regulations for gene editing, Hjelle said.

“Over the last three to five years, USDA has now reviewed data and is familiar with several multiplex gene-edited products,” he said.

At the listening session, Hjelle called for a new category of field trial permits to allow “critical experiments on trait combinations to identify plant trait mechanism of actions of interest.”

“The U.S. currently permits the testing, trait combination and sale of plants combined by breeding, whereas the same exact genetic changes produced simultaneously by multiplexing are prohibited,” he said.

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Gast also pointed to issues with the FDA's process, noting the “lack of FDA guidelines for gene-edited products, including those already considered exempt under USDA regulations, has greatly increased regulatory uncertainty and may stifle farmers from accessing this new technology.” 

Cibus's Radtke said FDA needs to “follow through” on pledges in the 2018 Plant and Animal Biotechnology Innovation Action Plan, when the agency said it would take public comment on draft guidance for foods derived from “new plant varieties developed through genome editing.” The current biotechnology consultation process, he said, needs “immediate process improvements.”

The former voluntary premarket consultation typically took less than a year, but Radtke said the new process “can take up to five years in some instances.”

Nathan Pumplin, CEO of Norfolk Healthy Produce in Davis, California, said his company is currently working with FDA on a food safety review of its purple tomato, the first gene-edited product to make it through USDA’s new regulatory review process when it received approval for cultivation in September.

Pumplin said Norfolk has been engaged with FDA since March 2020, but despite ample communication with the agency, “we have no ability to assess when, or if, we'll receive notice that FDA has no additional concerns about the product.”

Pumplin_Open_Mic_Thumb.jpgNathan Pumplin, Norfolk Healthy Produce

“This lingering ambiguity materially adversely impacts our small company to generate revenue to attract partners and investors, and in the worst case could cause our company to go out of business,” he said, urging FDA to provide a clear timeline for its reviews.

The purple tomato has been engineered to have high levels of antioxidants called anthocyanins and also has been shown to have an extended shelf life.

EPA also got some advice from speakers at the listening session.

Radtke said the agency needs to “develop and clearly articulate a risk-proportionate, progressive regulatory approach to exempt most plant incorporated protectants (PIPs) based on sexually compatible plants, including those developed using plant breeding innovation such as gene editing.”

He urged the agency to finalize its 2020 proposed rule to exempt PIPs developed using biotechnology, “consistent with the scope of existing requirements for conventionally bred PIPs.” The agency issued a proposal in October 2020; its latest regulatory agenda estimates a final rule will be issued in April.    

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