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“To be clear, this does not mean that other countries need to adopt a regulatory approach to new

plant-breeding techniques that is identical to a future approach employed by APHIS. But,
emphatically, it does mean that APHIS’s regulatory approach must be recognized by, and

acceptable to, government regulatory authorities in U.S. export markets so as not to trigger

regulatory action against U.S. commodities produced using genetic engineering or plant-breeding
innovation, including gene-editing, in international commerce,” the groups said.

Bobby Frederick, director of legislative affairs and public policy for the National Grain and Feed
Association, applauded USDA’s decision to withdraw the Part 340 rule, saying it gave APHIS time to
pursue the internationally coordinated approach that the exporters have been seeking. “You can’t
guarantee seamlessness, but you can line things up where they are more clear,” he said.

The exporters are simultaneously urging the FDA to require companies to notify the agency before they

go to market with new gene edited products. Not only is that premarket notification necessary to protect
consumer confidence, it also would be “invaluable in facilitating the domestic and international

marketability of crops utilizing these new techniques, thereby benefiting agricultural producers, the
value chain, consumers and ultimately plant breeders,” the groups wrote in their joint comments.

Gene editing also has raised trade issues in the meat and dairy sectors. Industry groups are worried that
FDA will move ahead with regulating all intentionally altered genomic DNA as a new animal drugs, the
approach the agency now uses for all genetically engineered animals.

“Treating these animals as drugs also will likely have a negative impact on domestic and international
trade,” the North American Meat Institute said in comments to FDA. NAMI noted that some foreign
countries may not regulate gene-edited animals.

National Pork Producers Council President Ken Maschhoff says it would be “indefensible” for
FDA to regulate all gene-edited animals as animal drugs.

"We ask the FDA to acknowledge that not all gene editing applications to animals require approval as

new animal drugs under the Food, Drug and Cosmetic Act (FD&C Act)," Maschhoff wrote in public

comments to FDA in June 2017. "Such an interpretation of the
FD&C Act—especially as applied to many potential uses of
gene editing techniques in livestock— mischaracterizes resultant

edited genomes as an 'article,' creates potentially insurmountable

practical barriers to enforcement by the FDA and utilization by

industry, and is not in keeping with federal policy and
precedence - and indeed, global regulatory trends—concerning

the use of biotechnology in agriculture."

The Foreign Agricultural Service has been tracking Ken Maschhoff, NPPC
developments globally and there are signs of some consensus
developing on approaches to gene edited products. As with the
United States, however, countries are still in various stages of
developing or revising policies. Some countries are even ahead
of the U.S. government, according to an FAS survey obtained
by Agri-Pulse.

44 www.Agri-Pulse.com