Opinion: Where are the guidelines for the production of animals with intentional genomic alterations?

Genetic engineering has the potential to transform how we raise animals for meat and other products, making food safer, improving animal health and welfare, and shrinking animal agriculture’s environmental footprint. Pigs that are less likely to induce allergic reactions in humans. Cows with short hair that are better adapted to a changing climate or others that lack horns, preventing injury to other cows or farmhands. Salmon that reach market size in 18 months instead of 30. Animals that are resistant to viruses and disease, resulting in healthier animals and potentially less risk of transmission of viruses from animals to humans.

For millennia, farmers and ranchers had to encourage desirable traits by selective breeding, a notoriously painstaking and imprecise technique. But with the advent of genetic engineering, genes encoding favorable traits in one species (say, that hornless cow) could be spliced into the genomes of other animals. Newer technologies can make highly targeted changes at the base-pair level — one specific rung on the DNA ladder — enhancing precision and reducing the likelihood of “off-target effects” in which base pairs are unintentionally added to or deleted from the genome.

But realizing the benefits of animals with intentional genomic alterations depends on gaining consumers’ trust, which in turn requires a regulatory system that consumers can count on. Such a system must ensure our safety while allowing the modified animals to become available when appropriate. That system requires a science-based assessment of each new product overseen by a neutral party with consumers’ interests at heart.


The Food and Drug Administration, which currently oversees the safety and production of animals with intentional genomic alterations (IGA) has for about a year been trying to unveil a revised regulatory schema that it believes would foster the development of this emerging industry, while protecting the public. Unfortunately, the document detailing the FDA’s proposed regulatory changes is caught in the middle of an internal government debate over which federal agency, the FDA or the U.S. Department of Agriculture, should have the regulatory lead.

In the past, the federal government has struggled to find an effective and efficient manner to regulate IGA animals. All told, the regulatory review of the first such animal, the Atlantic salmon that reaches market size more quickly than wild salmon, took more than 20 years.


The government’s recent performance has signaled the potential for reviews to be more nimble. In 2020, in a thorough but more efficient process, FDA approved pigs that were genetically altered to be safe to eat for people with alpha-gal syndrome, which causes allergic reactions when a person previously bitten by a particular tick eats red meat. (The tick’s range is expanding thanks to climate change.) In the future, these animals might be the source of the blood thinner heparin or even organs for transplant in those sensitized to the alpha-gal sugar.

The federal government also appears to have started more clearly identifying low-risk genetic modifications. In 2022, the FDA determined that cattle whose genome was slightly modified to carry a tropical heat-resistance gene represented a low risk to public, animal, and environmental health; the agency allowed the sponsoring company to navigate a less burdensome review process. The decision seems to foretell a more flexible, risk-based approach to regulation that would allow low-risk animals to enter the market without facing excessive regulatory burdens. By harmonizing regulatory processes and the risks they are meant to address, government agencies can more appropriately focus attention and resources where they are needed.

The public should not have to settle for reading regulatory tea leaves. The most straightforward way for the public to know if the FDA or USDA has the right approach to IGA animals — the right balance between consumer protection and the availability of potentially useful products — is to release the FDA’s draft guidance documents. Instead, the proposal has languished at the Office of Management and Budget for a year, since April 2022.

This extended bureaucratic stalemate should not be allowed to continue. Regardless of whether and how regulation is divided between the two agencies, the White House should facilitate transparency and public debate by releasing FDA’s guidance documents. At that point, all stakeholders will be able to evaluate FDA’s proposed regulatory approach and better judge the best path forward.

Peter Lurie is president and executive director at the Center for Science in the Public Interest. Beth Ellikidis is vice president, agriculture and environment, for the Biotechnology Innovation Organization.

Source: STAT