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Current U.S. gene editing regulatory framework lags

Pork industry warns that FDA’s current regulations on gene-edited animals could put industry at competitive disadvantage.

Livestock producers and animal researchers both are excited about the potential opportunities that exist within gene editing for animals. It offers non-transgenic solutions to diseases, animal welfare traits, heat tolerance and product quality traits and promises significant animal health benefits, including a natural immunity to disease and a reduction in the need for antibiotic use. Yet, the current regulatory framework looks to put U.S. producers at a disadvantage.

Simply put, gene editing allows for undesired traits to be blocked, which is different from the transgenic method in which foreign DNA is introduced into an organism.

Currently, Food & Drug Administration regulation classifies livestock as drugs, and farms could be classified as drug manufacturing facilities, creating significant challenges for international trade in animals and animal products. The currently lengthy and expensive approval process also requires a multigenerational examination of species, even though what is being created could occur naturally in traditional breeding.

Dr. Alison Van Eenennaam, animal biotechnology and genomics extension specialist at the University of California-Davis, said regulations are cost prohibitive for food animal research. So far, research has examined cows that were gene edited to not have horns. FDA requires those animals to be incinerated, even though the they have same genetic sequence as an Angus cow.

“Multigenerational safety testing doesn’t make much scientific sense and will preclude research in the United States,” Van Eenennaam said.

Numerous countries, most notably Argentina, Brazil and Canada, are rapidly moving ahead with a less cumbersome approval processes for the technology, giving them a head start in a highly competitive global agricultural marketplace. China and the European Union are also exploring gene editing as a way to combat major livestock diseases, including African swine fever, which U.S. producers could be hindered from adopting due to the onerous FDA regulatory regime.

"International competitors that commercialize this technology will gain as much as a 15% production efficiency advantage over U.S. pork,” said Dr. Bradley Wolter, a pork producer and president of The Maschhoffs, a company that produces more than 4 million market hogs per year. “Should this technology be approved in another country, it could be game-changing for the U.S. pork industry and render us in a non-competitive position in the global market.”

The National Pork Producers Council (NPPC) launched a campaign Tuesday seeking U.S. Department of Agriculture jurisdiction of gene-edited animals. Wolter said the USDA is better positioned as a longtime leader in the international space for genetic improvement.

“It's critical that America remains the global leader in agricultural innovation and gives regulatory oversight to the USDA, the agency that is most equipped to do so," Wolter added.

After President Donald Trump issued an executive order in mid-June, there was some hope that it would realign the priorities of animal gene-editing with USDA. However, FDA’s statement following the executive order was not in line with the President’s vision for a pro-innovation or pro-farmer regulatory scheme, according to Dan Kovich, NPPC director of science and technology.

“We need to get USDA involved as this technology moves to farm so it’s regulated appropriately and addresses the safety of animals and food products,” Kovich added. “NPPC is not asking the technology not to be regulated; we just want that right regulation to take advantage of all these benefits.”

Kovich said those in the agriculture industry have had many dialogues with the Administration and Congress on the issue. Agriculture Secretary Sonny Perdue is a “strong champion” of using a risk-based system to allow for innovation, he added.

Greg Ibach, USDA undersecretary for regulatory affairs, testified before the House Agriculture Committee in late May about his concern that other countries are offering a pathway for commercialization of gene-edited animals, which could put U.S. producers at a competitive disadvantage.

Ibach said USDA and FDA need to have a cursory conversation to identify FDA’s vision for the path ahead on gene editing. “Perhaps there’s an opportunity to work together with FDA to find a solution similar to the one we found with cellular protein, where we split that jurisdiction to work together to move it towards commercialization,” Ibach said at the May 22 hearing.

Kovich added that as NPPC and other producer groups engage with the Administration, especially as it relates to the biotechnology executive order, the hope is that it will bring FDA back to the table. NPPC is looking for leadership from the White House to reconvene these agencies so they will come up with a new way forward, Kovich stated.

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