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US ag groups push for modern regulatory structure for gene editing

19 April 2022

Gene editing, they say, holds tremendous promise

In a letter to US Department of Agriculture (USDA) secretary Tom Vilsack, a group of 11 agricultural organisations expressed their supper for the development of a "modern regulatory structure related to gene editing in livestock." 

In the letter, US livestock groups said producers face many urgent challenges, such as zoonotic disease, climate change, and a growing global population, which could be addressed by new solutions that protect food supply and sustainably meet demand.

"Gene editing is one technology that holds tremendous promise to help America’s food and agricultural producers address these challenges," said the letter. "Producers need these tools to continue to sustainably produce an abundant, affordable food supply for America and the world."

The organisations feel the existing system is not conducive to the timely adoption of these sorts of innovations.

"The FDA’s current regulatory approach – an approach that producers, other stakeholders, and Congress have repeatedly expressed concern with – will only stifle US producers’ access to much-needed innovations," the letter continued.

Under the current approach, FDA regulators make case-by-case decisions on innovations to determine their regulatory pathway, data requirements, and ultimate market opportunities. "The decades-long approval process for these technologies is based on FDA exercising enforcement discretion under agency guidance rather than through rule making," the letter stated. "This is an untenable way to regulate."

The organisations expressed concern that academics, developers and investors are unlikely to make the investments needed to develop these innovations if the criteria needed to develop reasonable market access are not clear and predictable.

"We support USDA’s ongoing efforts to modernise regulations governing these technologies, as proposed under the advanced notice of proposed rule making (ANPR) for the Regulation of Movement of Animals Modified or Developed by Genetic Engineering (APHIS-2020-0079)," said the letter. "We strongly urge USDA to continue this rule making process to ensure US agriculture is sufficiently equipped with the tools needed to address our food production challenges in the future."

The letter was signed by 11 agricultural groups, including the American Farm Bureau Federation, the National Cattlemen’s Beef Association, the National Milk Producers Federation, the National Pork Producers Council, and the National Turkey Federation.



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