Prudent regulation, national registry sought for gene-edited products

With gene-edited products nearing the marketplace, six major consumer and conservation groups called on Wednesday for “effective, science-based government regulation” of the sector, including a national registry of gene-edited plants and animals. By contrast, they said, the USDA has “substantially deregulated gene-edited plants and proposed a similarly minimal oversight system for gene-edited animals.”

Government risk-based oversight of gene editing and a public registry of gene-edited products in use in food, agriculture, and the environment were two of the six principles proposed by the groups for stewardship of the technology. “As representatives of nongovernmental organizations, we recognize the potential societal benefits of gene-editing technologies while acknowledging their risks,” said the groups in an article in the journal Nature Biotechnology. “However, we contend that the United States has inadequate regulatory oversight to address concerns presented by biotechnology.”

The consumer and conservation groups framed their set of six principles as an invitation to stakeholders to jointly develop a framework for governance. “Gene editing, responsibly managed by both the public and private sector, has substantial promise. The technology is advancing rapidly; governance must keep pace.”

In 2020, the USDA said it would exempt most genetically engineered plants from pre-market review if they were deemed unlikely to pose an environmental risk, nearly a year after President Trump said in an executive order that federal regulators should “exempt low-risk products of agriculture biotechnology from undue regulation.” Trump’s Agriculture Secretary, Sonny Perdue, said the new approach would streamline innovation.

The biotechnology industry says gene editing is a safe and speedier way to produce plants with traits that could have been developed through traditional breeding techniques. U.S. agricultural and trade groups supported the new framework as a way to both assure U.S. preeminence in the field and a safe food supply for a growing population.

The six groups, however, disagreed that gene editing is the equivalent of traditional plant breeding. “Unintentional non-target changes to the genome have been observed in gene-edited cattle, for example. As a result, the product, rather than the process used to develop it, should be the subject of evaluation.”

A sound public-private system for developing and regulating gene-edited products would result in public confidence in them, unlike during the years of controversy over genetically modified plants, said the groups. The letter came from the Environmental Defense Fund, the Center for Science in the Public Interest, the Nature Conservancy, the National Wildlife Federation, the Consumer Federation of America, and the World Wildlife Fund-U.S.

The six principles called for by the groups were: effective, science-based government regulation; voluntary best practices to supplement and complement regulatory oversight; risk avoidance and delivery of tangible societal benefits; robust, inclusive societal engagement; inclusive access to gene-editing technology and resources; and transparency on gene-editing products in use.

Last month, a coalition of farm, environmental, and consumer groups filed suit to overturn the 2020 USDA biotech regulation on the grounds that the USDA had “unconstitutionally delegated its own duties to protect farmers and the environment to GE crop developers.”

A position paper explaining the six principles is available here.

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