Spending bill should require FDA to clarify genome editing policy

Spending bill should require FDA to clarify genome editing policy, lawmakers say

The 2023 appropriations legislation currently under debate in Congress should require the U.S. Food and Drug Administration (FDA) to clarify its policy on genome editing in food, says a bipartisan letter sent last week by 11 Members of Congress to their colleagues in the House and Senate.

Ahead of the December 16 deadline, the House passed a one-week budget extension on Wednesday. Now, lawmakers have until December 23 to pass the 2023 budget in 0rder to avoid a government shutdown. Democrats want to pass that legislation by year’s end, while Republicans are divided on the benefits of quick passage, reports The Hill.

The House and Senate must include the agriculture appropriation in the final legislation. And several bipartisan Members of Congress, led by U.S. Reps. Jimmy Panetta (D-CA) and James Baird (R-IN), say the final agriculture appropriation should include provisions supporting biotech innovation, which were passed by the House in July.

Genome editing needs a clear path to market

Under the House-passed plan, modernized FDA regulations on genome editing would need to be submitted for public comment.

This would give biotech companies a much-needed clear path to market, say proponents. (And it’s something BIO has sought for years).

“FDA’s longstanding delay on issuing draft guidance for industry on novel genetic technologies and reviewing and modernizing the agency’s plant consultation has greatly increased regulatory uncertainty,” says the congressional letter. Without change, “we will stifle American farmers from accessing these new, innovative technologies.”

Clear and science-based regulation is crucial

The letter states that in order to facilitate the development and commercialization of critical agricultural biotechnology products and to enable growers’ access to cutting-edge tools for addressing the challenges facing farmers today and in the future, clear, science-based, and timely regulation of agricultural biotech traits is fundamental.

Agricultural biotech innovations are needed “to urgently address crop resiliency, sustainable cultivation, and the growing threat of food insecurity,” the letter says—and regulatory agencies need to deal with them.

The Biotechnology Innovation Organization (BIO) previously applauded the House-passed bill and its agricultural provisions. “The task before us is feeding and fueling a growing world in an increasingly sustainable way. The House-passed agricultural appropriations bill will help biotech developers and their farmer and rancher partners meet the 21st-century challenges we face through innovation. We urge the Senate also to support these provisions,” said BIO’s Chief Policy Officer, John Murphy.

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