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Proposed US rules have global implications for gene editing

By Joan Conrow

Graduate student Lindsay Upperman (left), and animal geneticist Alison Van Eenennaam at UC Davis with gene-edited hornless dairy calves. Photo by Karin Higgins/UC Davis

US regulatory agencies have proposed guidelines and draft regulations that suggest they may subject gene-edited crops and livestock to the same prolonged review now imposed on transgenic plants and animals.

Some university researchers have expressed concern over the proposals, saying there is no scientific justification for such an approach, which would impose impediments to agricultural innovations that address animal welfare, environmental sustainability and climate change concerns.

Though the guidelines would affect decision-making only in the United States, they likely would have a much broader impact, given America’s influence on the international regulatory sphere. The agencies will be accepting comments from the global public only through June 19.

Specifically, the US Food and Drug Administration (FDA) has released guidelines that call for regulating gene-edited livestock under the same stringent rules that currently apply to animal drugs. That onerous and expensive process is now used to review transgenic animals.

Similarly, the US Department of Agriculture (USDA) has indicated it plans to treat at least some gene-edited plants as “regulated articles,” requiring their developers to prove they pose no plant pest risk. That review, now required of transgenic crops, requires years of highly regulated field trials.

Gene editing involves using a technique, such as CRISPR, to alter the genome to achieve a desired result, such as silencing the gene that causes dairy cows to grow horns that farmers must later remove. Transgenic means a gene has been added from another organism to obtain a specific outcome, such as transferring a gene from the ringspot virus to a papaya to inoculate it against that disease.

Some researchers have objected to the proposed guidelines, saying they’re scientifically unsound and excessively burdensome, especially since genetically engineered crops have been safely cultivated and consumed since 1994. Indeed, USDA’s proposal summarizes an impressive record of transgenic crop safety confirmed by its own regulatory experience spanning nearly three decades.

The rationale for the strict review is questionable, given the USDA’s own finding: “The Agency's evaluations to date have provided evidence that most genetic engineering techniques, even those that use a plant pest as a vector, vector agent, or donor, do not result in a GE organism that presents a plant pest risk. Additionally, genetic engineering techniques, such as genome editing and synthetic genomics, have been developed that do not employ plant pests as donor organisms, recipient organisms, vectors, or vector agents; such techniques could be used to produce GE organisms with plant pest risks without falling within the scope of regulated article.”

Other scientists say the proposed rules presume hazards despite a lack of supporting evidence and fail to accurately assess risks. As Dr. Alison Van Eenennaam, a University of California at Davis livestock cooperative extension specialist, noted: “It is not the intent or method behind the alteration that is important, but rather the phenotype that results from the alteration that is associated with any potential risks.”

The current regulatory process for genetically engineered animals, which the FDA proposes extending to those produced through gene-edited, has been so onerous that only one animal — a fast-growing salmon — has been approved in 28 years, at a cost of more than $80 million.

“Such high costs to achieve regulatory approval have limited the development of improved GE plant and animal varieties by public sector scientists and small companies,” Van Eenennaam wrote in her comment to the FDA. “As a result, social and environmentally valuable GE animals, as well as specialty (i.e., non-commodity) GE crops, are noticeably absent from the market, with the exception of disease-resistant papaya.”

In terms of international impacts, “[t]he most profound implications of the high cost of regulation triggered by the use of GE in the development of new varieties include delays in the global diffusion of proven technologies, which has resulted in a lower rate of growth in the global food supply and higher food prices, and disincentives for investing in further research and development using GE as a breeding method,” Van Eenennaam wrote.

Details on the FDA’s proposed guidelines can be found here. Comments can be submitted here.

More information on the USDA proposal is available here. Comments can be submitted here

The FDA also is seeking scientific evidence and other factual information to help inform its thinking on human and animal foods derived from new plant varieties produced using genome editing.

All comments are due by June 19.

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