- Regulation for bioengineered food animals would move from the purview of the FDA to the USDA under a proposal announced Monday. USDA put an advanced notice of proposed rulemaking in the Federal Register to solicit input on the plan.
- Under this plan, USDA would consult with FDA on regulation, but USDA would become the agency that both determines whether the genetically modified animals are safe to eat and monitors their meat as part of the food supply. USDA would become responsible for reviewing the safety and efficacy of genetic modification in the animals, their impact on the environment and overall food safety for the bioengineered products. USDA would not regulate genetically modified seafood, which falls under FDA's jurisdiction, and it would not regulate animals that have been bioengineered for medical reasons.
- The proposal is the result of President Donald Trump's directive last year to eliminate regulatory hurdles that stood in the way of barriers to the biotech industry, Agriculture Secretary Sonny Perdue said in a written statement.
Researchers around the world have been working to genetically modify animals to make them better for food. They've aimed to make them grow faster, have more muscle, resist disease or be devoid of allergens. These sound like great advances, but who's eating these animals? The answer: almost nobody.
At the moment, the process of approving genetically modified animals for food in the U.S. is mostly theoretical. Two have been approved — AquAdvantage salmon in 2015 and GalSafe pork earlier this month. But neither of those are on store shelves or restaurant menus yet. As seafood, AquAdvantage salmon falls under the regulatory purview of FDA, so this new regulation would not have impacted it. GalSafe pork was primarily developed for medical purposes, so the regulatory approval pathway for it might have been the same.
Regardless how few GMO food animals have been approved, regulation here has been a bit of a political football. Days before President Barack Obama left office in 2017, proposed regulations were published that required all animals genetically modified for food to be regulated by FDA with the same scrutiny as new drugs. Scientists had mixed responses to the move. Those who worked in the gene editing field were afraid it would squash interest in new research and progress, while others in the social science field applauded taking a more careful approach to a controversial issue.
Farm groups, led by the National Pork Producers Council, started lobbying the Trump administration in 2019 to change the regulatory approach to animals used for meat, right after the president's directive to eliminate hurdles in biotech regulation. The groups wanted to move regulation of bioengineered animals to the purview of USDA. Politico reported that at the time, FDA defended its place in the regulatory framework.
This week's rulemaking seems to reverse that course and would give pork producers and other farm groups exactly what they wanted. A statement on the proposed rulemaking from the NPPC points out that U.S. agriculture has been in a holding pattern for several years. Countries that have been more progressive with biotech regulations — including Canada, China and Brazil — have moved ahead of the U.S. in this area during the last few years, the statement said.
"FDA regulation of gene editing will result in an impractical, lengthy and expensive approval process. Thankfully, that is not the administration’s intended plan," NPPC President Howard "A.V." Roth said in the statement. "This announcement represents a critical milestone to ensuring American agriculture maintains its global competitive edge."
The rulemaking gives 60 days for comments before any regulations change. However, by that time, President-elect Joe Biden will have taken office, and his administration will have say over what happens in terms of biotech regulation. It's not clear if Biden's administration would support making this change in regulatory approval. Since Biden was Obama's vice president, the new administration could withdraw this rulemaking and stop the changes in their tracks.
However, technology in food has come a long way in four years. Today, there is a GMO labeling framework in place — which has been a big part of the delay in getting AquAdvantage salmon to market. Food manufacturers and consumers alike are more aware of the environmental impact of the industry.
As Biden makes slowing climate change a main policy focus, he may look more favorably at changes in food production that could make the same animals produce more meat or grow faster. And cell-based meat, once a wild scientific idea, is now a menu item at a Singapore restaurant. The U.S. has been working to develop its own regulatory framework, and some in the space are hopeful they can gain U.S. approval next year. Regulatory and consumer attitudes have shifted, and this regulation could help this technology move forward.