Administration wants easier biotechnology approval

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Federal leaders want easier paths to bring genetically modified products to markets, including genetically modified animals.

An executive order issued in June tells the Department of Agriculture, Food and Drug Administration, and Environmental Protection Agency to find ways they can create a faster and easier approval process for those products, as well as give biotechnology companies clear rules and risk-based decisions. The order directed government entities to conduct the regulatory review within 180 days and consider which regulations could be waived for low-risk products.

"Biotechnology can help the Nation meet its food production needs, raise the productivity of the American farmer, improve crop and animal characteristics, increase the nutritional value of crop and animal products, and enhance food safety," the order states. "In order to realize these potential benefits, however, the United States must employ a science-based regulatory system that evaluates products based on human health and safety and potential benefits and risks to the environment.

"Such a system must both foster public confidence in biotechnology and avoid undue regulatory burdens."

In October 2018, FDA officials published the Plant and Animal Biotechnology Innovation Action Plan, an eight-page document that describes the agency's efforts to clarify and otherwise update science-based policies to support innovation and give companies efficient and predictable regulatory processes. The plan document gives examples of some of the projects that could benefit from the plan, indicating biotechnology researchers are investigating the potential to breed pigs resistant to African swine fever, animals that produce tissues for transplantation into humans, and mosquitoes with reduced ability to carry Zika virus.

As part of that plan, FDA officials announced they were creating the pilot Veterinary Innovation Program, which now is helping guide biotechnology developers through the FDA's approval process. FDA employees will help biotechnology developers address potential challenges, minimize the number of studies conducted to support approval, and understand the effects of any changes in science or regulations, FDA information states.

The program is available to organizations that are developing genetically modified animals, cells, tissues, and cell or tissue products intended for medical uses, animal husbandry, or food production, FDA information states. As of late June, 11 companies were participating in the Veterinary Innovation Program, and four more were likely to enroll soon, according to Juli Putnam, spokeswoman for the FDA Center for Veterinary Medicine.