The Food and Drug Administration has taken baby steps in helping advance approvals of gene-edited animals for food production, but the agency's insistence that changing an animal’s DNA is a “drug” and out of USDA’s purview could keep innovation decades away from producer adoption. 

In March, FDA made a low-risk determination for two “slick” cattle, with an “intentional genomic alteration” that results in a short, slick hair coat that enables them to more easily withstand heat. But you won’t find meat from these animals in the food supply any time soon.

Jon Oatley, a professor in the School of Molecular Biosciences in Washington State University’s College of Veterinary Medicine, recently undertook the investigational food use authorization process for five gene-edited pigs to demonstrate that food made from the animals is safe to eat and that it is possible for an academic institution to achieve this type of FDA authorization. 

Oatley-CRISPR-sausage-300.jpgJon Oatley, Washington State University

The pigs were originally gene-edited in a way that would enable researchers to use them to sire offspring with traits from another male pig. Known as surrogate sires, this technology first gene-edits male animals to be sterile by knocking out a gene that is specific to male fertility. In May, FDA authorized for the first time these five gene-edited research pigs to enter the food chain for human consumption. Oatley and his students enjoyed German sausages made of meat from those animals as another way to prove its safety. 

But at a cost of $200,000 and two years to collect the data and receive investigational food use authorization process, it revealed the cumbersome process to get valuable technology into producers’ hands. 

“We've got several projects that are getting to the point where we want to develop channels to get them out of the lab and into producers’ hands, and in order to do that one of the major steppingstones is navigating the federal regulatory approval process to do that,” Oatley said of this research and other projects conducted as part of WSU’s Functional Genomics Initiative.

The cattle genome was sequenced in 2009, and since then literally thousands of animals have been sequenced, revealing the incredible genetic variation from natural evolution.

“The basis of breeding programs is naturally occurring mutations that give us desirable phenotypes that we then select to be parents of the next generation,” Alison Van Eenennaam, professor of animal genomics and biotechnology at the University of California-Davis, told Agri-Pulse

“Every meal you've ever eaten is genetically distinct from every other meal that you've ever eaten. But it's not a food safety hazard,” said Van Eenennaam, who’s spent the past 20 years researching the development of useful traits for the market, only to be rebuffed by roadblocks from FDA’s regulatory process.

Unlike the genetically modified changes created by inserting a fragment of foreign DNA into a genome of an animal, the CRISPR gene-editing process can be used to speed up the introduction of useful genetic variants that already naturally occur in certain cattle breeds, such as “slick” hair coat.

“Most of the applications people are developing including shortening the tails, creating respiratory disease resistance or improving breeding efficacy, are making changes in DNA that do arise in nature,” Oatley said. “We’re just doing it in a more precise way because we have the availability of these molecular scissors that can identify a precise spot and create a precise change through a cut-and-paste kind of mechanism. It’s actually more precise and less messy than the conventional historical approach of selective breeding that is still being used to this day.”

Substances other than food that affect the structure or function of an animal are considered a “drug,” including molecular elements that alter the genome of an animal, which FDA says gives it oversight authority of gene-edited animals under the federal Food, Drug and Cosmetic Act. 

Currently, FDA requires researchers to first submit approval for any research animal to receive an FDA Investigational New Animal Drug (INAD) process during early-stage proof-of-concept, and the full New Animal Drug Application (NADA) process to achieve commercialization. But each individual animal is an individual drug, which means each is looked at individually, as opposed to looking at all animals with the same gene-edited alteration. 

“Both the INAD and NADA processes were designed for development of actual drugs and not for hereditary changes in the genome and are lengthy, expensive and intensive roads to gaining approval of animal-based products to enter the public domain,” seven researchers from the top universities in the country wrote in February. The academics were responding to President Joe Biden's 2022 executive order to examine areas of ambiguity in federal biotechnology regulation. 

Prior to the latest actions, FDA had only approved applications for five animals containing intentional genetic alterations since the mid-1990s, and many took more than a decade to approve. At the more extreme end of this range is genetically engineered salmon, which took 20 years to receive final FDA approval.

Oatley, the Washington State professor, said it was a long process, but one he hopes sets a precedent and template for other researchers and companies. Other countries, including Brazil and Argentina, have already deemed safe food derived from gene-edited animals.

“I knew it was going to be a challenge, but I decided it was a challenge worth taking on because it needed to be done in order to advance any of the science and technology development genome editing applications we’re doing in the lab at universities in order to get them into the hands of producers one day,” Oatley said.

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FDA, Oatley argued based on his experience, seems to be developing a road map as researchers go through the process of trying to determine what constitutes appropriate data for FDA to make an informed decision.

Now, he believes the agency should start over.

“This thing just needs to be broken down to the ground and rebuilt. We’ve got to stop trying to slot it into the old framework,” he said. “It’s got to be rebuilt so that it’s aligned to what is the state of the art of the technology, but also the state of the art of the intent for trait development.” 

Researchers and livestock industry groups say congressional action may be warranted to divert the oversight from FDA to USDA, which they believe is better equipped to evaluate the food safety risks, improve food security and address problems facing U.S. livestock producers. 

In his conversations with House Agriculture Committee staffers, Oatley suggested the easiest solution is breaking apart biomedical gene-edited animal use to be under FDA’s regulatory jurisdiction and sending ag trait development for food animals to USDA.

Van Eenennaam said another political avenue may coincide with changing how FDA also defines feed additives as drugs. She’s had conversations with senators to try to address the issue.

Andrew-Bailey-NPPC-300.jpgAndrew Bailey, NPPC

Andrew Bailey, the National Pork Producers Council's science and technology counsel, said there have been strong congressional and industry statements questioning FDA’s approach dating back to 2017. The FY23 omnibus bill in December also stated that the secretary of agriculture should develop regulations pertaining to the movement of animals modified or developed by genetic engineering and consult with the FDA commissioner.

“Our position is that [FDA’s] current system doesn’t work,” Bailey said in an interview with Agri-Pulse. “USDA understands this better anyway.”

“It’s not about deregulating or having less regulation, it’s about the right regulation,” he added.

The Biden administration's FY 2024 budget marked the first federal request for USDA funding toward 25 full-time employees and $5 million to regulate livestock biotechnology. The current regulations, the budget argued, are limited, and the department's 2024 agenda should include developing “technical and scientific services to support the oversight of certain animals intended for agricultural purposes that are modified or developed using genetic engineering.”

But while USDA seems to be advertising to Congress it wants more money to create an improved regulatory pathway for animal biotechnology, FDA has yet to cede its authority.

In an email to Agri-Pulse, an FDA spokesperson said, “FDA, USDA and EPA have complementary roles in oversight of biotechnology products — the same applies to [intentional genomic alterations] animals. We are working with USDA on a continuing basis toward a common goal of bringing innovative animal products of biotechnology to market.”

The spokesperson added over the last few years, the FDA created a new division composed of cellular and molecular biologists, geneticists, biological chemists, bioinformaticians, animal scientists and veterinarians who have specialized expertise to review animal biotechnology products. 

“Currently, FDA has 54 products enrolled in the program and this number is continuing to grow,” the spokesperson added.

Bailey said despite all the actions by FDA in recent months, the agency has not fundamentally changed how it wants to regulate gene-edited animals, and joint projects and webinars announced by FDA to help are all “window dressing.”

“All the problems that exist are going to keep on existing. Animals are not living drugs,” Bailey said. 

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