FDA begins process to transfer animal biotech powers from FDA
Agriculture Secretary Sonny Perdue announced that USDA is moving forward with an Advanced Notice of Proposed Rulemaking (ANPR) to solicit public input and feedback on transitioning portions of the Food and Drug Administration’s pre-existing animal biotechnology regulatory oversight to USDA.
“Our livestock producers need all the tools in the toolbox to help protect against animal diseases and continue to meet the challenge of feeding everyone now and into the future,” Perdue said. “If we do not put these safe biotechnology advances to work here at home, our competitors in other nations will.”
“Science-based advances in biotechnology have great promise to continue to enhance rural prosperity and improve the quality of life across America’s heartland and around the globe. With this effort, we are outlining a pragmatic, science-based, and risk-based approach that focuses on potential risk to animal and livestock health, the environment, and food safety in order to provide our farmers and ranchers the tools they need to continue to feed, clothe and fuel the world.”
Perdue said the initiative follows President Donald Trump’s executive order on agricultural biotechnology that called upon federal agencies to make regulatory improvements to rectify some of the long-standing barriers to innovation for U.S. agriculture.
But the publication of the rule in the Federal Register will start a 60-day comment period, which means that the process would be completed in the Biden administration, not the Trump administration.
Through this ANPR, USDA is proposing to establish “a flexible, forward-looking, risk-proportionate and science-based regulatory framework that provides a predictable pathway to commercialization and keeps pace with advances in science and technology for certain farm animals (cattle, sheep, goats, swine, horses, mules, or other equines, catfish, and poultry) developed using genetic engineering intended for agricultural purposes,” USDA said.
The National Pork Producers Council said that through the rule, the Trump administration announced its intention for USDA “to have primary oversight over gene-edited livestock.”
“Gene editing is a promising new technology that can help farmers breed healthier, more resilient animals,” NPPC said, describing itself as “the leading advocate for USDA regulatory oversight over the last two years when the U.S. Food and Drug Administration was claiming jurisdiction.”
“Gene editing is used to make specific changes within an animal’s own genome,” NPPC said.
“Gene editing will allow U.S. farmers to produce animals that are more disease-resistant, require fewer antibiotics and have a reduced environmental footprint. Many changes made through gene editing could be achieved through conventional breeding. However, the cost and timeframe for approval of these type of edits is prohibitive under the FDA. Notwithstanding its significant promise, 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.”
“Today’s announcement is a big step forward for America’s farmers, who have weathered significant challenges over the past few years,” said NPPC President Howard “AV” Roth, a pork producer from Wauzeka, Wis.
“FDA regulation of gene editing will result in an impractical, lengthy and expensive approval process. Thankfully, that is not the administration’s intended plan. This announcement represents a critical milestone to ensuring American agriculture maintains its global competitive edge.”
Last year, President Trump directed federal agencies to modernize the regulatory framework for agricultural biotechnology products by establishing regulatory approaches proportionate to the product’s risks, avoid unjustified distinctions across similar products, and promote future innovation and competitiveness. USDA will publish an ANPR on animal biotechnology as a keystone effort in fulfilling this Executive Order.
This ANPR will transition portions of FDA’s pre-existing animal biotechnology regulatory oversight to USDA. 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. USDA looks forward to FDA experts participating in the development of our review process.
Through this ANPR, USDA is proposing to establish a flexible, forward-looking, risk-proportionate and science-based regulatory framework that provides a predictable pathway to commercialization and keeps pace with advances in science and technology for certain farm animals (cattle, sheep, goats, swine, horses, mules, or other equines, catfish, and poultry) developed using genetic engineering intended for agricultural purposes.
USDA’s proposed safety review would cover molecular characterization, animal health (including noninfectious, infectious, and zoonotic diseases), efficacy (for disease and pest resistance traits), environmental considerations, food safety evaluation of any expressed substance (including allergenicity and compositional analyses of key components), and food storage and processing. USDA’s proposal would provide end-to-end regulatory oversight from pre-market reviews through post-market food safety monitoring of animals. USDA will continue to coordinate closely with the FDA to fulfill oversight responsibilities and provide the appropriate regulatory environment, ensuring the safety of products derived from new technologies, while fostering innovation at the same time.
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. USDA would promulgate regulations using the authorities granted to the Department through the Animal Health Protection Act, the Federal Meat Inspection Act, and the Poultry Products Inspection Act. Pursuant to these authorities, the Animal and Plant Health Inspection Service would conduct a safety assessment of organisms developed using genetic engineering that may increase an 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 animals developed using genetic engineering would not result in a product that is unsound, unhealthful, unwholesome, or otherwise unfit for human food.
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