The Agriculture Department proposed Monday to take over the Food and Drug Administration's oversight of gene-altered animals, a potential victory for livestock groups seeking to speed approval of genetic modifications.
Whether the plan becomes a reality depends on the priorities of the incoming Biden administration, however. Any regulatory changes not finalized by the outgoing Trump administration, including this one, can easily be shelved.
In an advance notice of proposed rulemaking, USDA said that “in consultation with FDA, USDA is contemplating regulations that would establish a flexible, risk- and science-based regulatory framework for the regulation of certain animals modified or developed using genetic engineering that are intended for agricultural purposes.”
USDA's undersecretary for marketing and regulatory programs, Greg Ibach, said USDA “worked very closely with FDA figure out a path that would include us taking the lead on food animals and allow them to maintain the regulatory authority over those genetic technologies that would enhance biomedical and pharmaceutical uses.”
“USDA will consult with FDA to ensure our reviews benefit from FDA’s expertise, while providing developers with a one-stop-shop for their products at USDA,” the department said in a news release.
“USDA looks forward to FDA experts participating in the development of our review process.”
Currently, FDA regulates intentional genetic alterations, or IGAs, as new animal drugs in a process that the biotech and livestock industries have criticized as burdensome. The agency has approved two such animals: genetically engineered salmon and pigs bred for both food and potential biomedical use.
“The overall regulatory system remains opaque and cumbersome, needlessly bureaucratic, and vastly disproportionate to actual risk,” Dana O’Brien, executive vice president for food and agriculture at the Biotechnology Innovation Organization, said in an Agri-Pulse op-ed in February.
In a statement issued after the ANPR was announced, O’Brien said, “A modern U.S. regulatory system will pave the way for breakthroughs that can help prevent and respond to zoonotic diseases such as COVID-19, improve animal well-being, make our farming and food systems more sustainable, protect our environment, and bolster our resilience to climate change.”
O’Brien also cited the support of the newly formed Food and Agriculture Climate Alliance for “a risk- and science-based regulatory pathway to streamline the animal biotechnology approval process.” FACA is led by four co-chairs from the American Farm Bureau Federation, Environmental Defense Fund, National Council of Farmer Cooperatives and National Farmers Union.
The National Pork Producers Council said it was pleased. “Today’s announcement is a big step forward for America’s farmers, who have weathered significant challenges over the past few years,” NPPC President Howard “AV” Roth, a pork producer from Wauzeka, Wis., said.
“FDA regulation of gene editing will result in an impractical, lengthy and expensive approval process,” Roth said. “Thankfully, that is not the administration’s intended plan. This announcement represents a critical milestone to ensuring American agriculture maintains its global competitive edge.”
Allison Rivera, the National Cattlemen's Beef Association's Executive Director of Government Affairs, said, “Cattlemen and women applaud the recent USDA announcement of an Advanced Notice of Proposed Rulemaking (ANPR) to modernize the regulatory framework for biotechnology in certain farm animals using genetic engineering for agricultural purposes. This proposed action paves the way for increases in future innovation through a scientific, risk-based, and predictable system of oversight at USDA.”
The National Association of State Departments of Agriculture also weighed in, with CEO Barb Glenn saying NASDA is "pleased to see USDA continue steps to reform the regulatory framework for agricultural biotechnology products. Using the law as intended by Congress to bring order and efficiency to our current process welcomes innovation and enables our regulatory system to keep pace with science. The pandemic reminds us of the necessity of tools, like animal biotechnology, that bolster our food supply chain and promote healthy animals and a healthy environment."
The fate of the plan will rest with the next administration, however, raising questions about the significance of the announcement, given that USDA will now be led by former Agriculture Secretary Tom Vilsack — provided he gets confirmed by the Senate. By delaying the proposal until the final month of President Donald Trump's term, the administration effectively dropped the issue in Vilsack's lap.
Ibach could not offer a prediction on what the new administration would do, but said the issue likely would have come up in discussions between career staff and the Biden transition team.
“This is not necessarily a new issue,” he said, noting that other countries have moved forward with animal biotech products.
Under the proposed framework, the Animal and Plant Health Inspection Service would conduct a safety assessment of animals subject to the Federal Meat Inspection Act (FMIA) or Poultry Products Inspection Act (PPIA) modified using genetic engineering “that may increase the animal’s susceptibility to pests or diseases of livestock, including zoonotic diseases, or ability to transmit the same.”
The Food Safety and Inspection Service would conduct a “pre-slaughter food safety assessment to ensure that the slaughter and processing of certain animals modified or developed using genetic engineering would not result in a product that is adulterated or misbranded,” the ANPR says.
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“Under the regulatory framework being contemplated, USDA would provide regulatory oversight from pre-market reviews through post-market food safety monitoring for certain farm animals developed using genetic engineering,” the department said in the news release. USDA would issue regulations using authorities granted to the department through the Animal Health Protection Act (AHPA), the FMIA and the PPIA.
The National Pork Producers Council said, “U.S. agriculture had been in a holding pattern, as USDA and the FDA were locked in a regulatory tug of war over authority on gene editing in livestock. Meanwhile, China, Brazil, Canada and other global competitors moved ahead in the race to pursue this technology.”
Asked about staffing to implement a new framework, Ibach said, “Between APHIS, ARS, and FSIS, we definitely have the science talent at USDA. We also have a 30-year track history of APHIS regulating plant biotech, and a lot of the concepts are very similar. We feel very confident that staffing is something we can handle.”
Jaydee Hanson, policy director for the Center for Food Safety, said the ANPR is deficient in some key areas.
“The environmental section just says that they will check to see if [the National Environmental Policy Act] would apply,” he said. “They fail to specify that they would look at the Endangered Species Act. Given that many food animals can breed with their wild relatives, that is not good. They need to read Judge Chhabria’s ruling on the failure of FDA to do adequate NEPA and ESA reviews.”
U.S. District Judge Vince Chhabria in California recently ordered FDA to go back and conduct adequate environmental reviews under NEPA and the ESA of its approval of Aquabounty’s genetically engineered salmon.
Hanson also said the department “should require tracking of these animals from the laboratory to the slaughterhouse, backed up by DNA sequences. The companies that sell the animals moreover should want that to protect their patents.”
Hanson also criticized the timing of the proposal. “We will be commenting, but there really is no excuse for this coming out one month from the end of the Trump administration.”
USDA has asked for comments for 60 days after the ANPR appears in the Federal Register.
This story has been updated with comments from NCBA and NASDA.
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