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USDA Proposes New Biotech Regulatory Review Policies

NGFA emphasizes importance of engaging with trading partners

In response to today's release of proposals regarding the U.S. government's pre-market regulatory oversight of genetically engineered plants, the National Grain and Feed Association (NGFA) emphasized the importance of working to achieve consistent regulatory policies globally for products of the latest plant breeding methods to avoid costly disruptions in international trade.

The U.S. Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA) published several documents related to the pre-market regulatory oversight of genetically engineered plants and plants and animals derived from certain newer precision breeding techniques, commonly known as genome editing. The NGFA still is reviewing in detail the USDA's pre-published proposed rule on the "Importation, Interstate Movement, and Release into the Environment of Certain Genetically Engineered Organisms," as well as a companion proposal and guidance document issued by FDA.

The NGFA said given the global nature of agriculture and the importance of trade to the economic well-being of farmers, ranchers and the nation as a whole, consistent regulatory policies among governments for products of the latest plant breeding methods, such as gene editing, are needed so that trade in U.S. commodities, research collaborations and global seed movement are not hindered or disrupted.

"It is critical that the U.S. government actively engage with our trading partners around the world, and secure alignment in regulatory approaches with U.S. trading partners before these regulations are finalized and take effect," the NGFA noted.

USDA's proposal recognizes that some applications of gene editing result in plant varieties that are essentially equivalent to varieties developed through more traditional breeding methods, and proposes to exclude such traits from pre-market regulatory review.

The NGFA also noted that consumer education about the safety of these products should be a top priority.

"It will be imperative that the U.S. government and the seed industry, technology providers and the value chain explain the scientific basis and rationale for this regulatory approach to consumers to facilitate understanding and acceptance of these technologies and their commercial application in the marketplace," the NGFA stated.

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