The Food and Drug Administration on Thursday helped pave the way for genetically engineered meat and fish to end up on American dinner tables.
The agency said genetically engineered animals, created for human use or consumption, will be regulated in the same way as veterinary drugs, meaning they will go through a safety review process.
But consumer groups said Thursday that the review process might not be stringent enough and expressed concern about environmental consequences.
The agency underscored Thursday that it will not require package labeling that explicitly explains to consumers that an animal has been genetically altered, also drawing sharp criticism from food safety groups.
The agency has been reviewing genetically engineered animals and animal products since the early 1990s but had never formally or publicly clarified the approval process for bringing them to the marketplace. On Thursday, it issued guidelines for the first time.
The FDA has yet to approve a genetically engineered animal for human consumption, but it is currently reviewing between 40 and 50 applications.
Earlier this year, the agency declared meat and milk from cloned animals safe to eat.
A cloned animal is, in effect, an exact replication of another animal. A genetically engineered animal is one whose genetic material has been altered with genetic material of another animal to give the new animal desirable characteristics or traits.
Proponents say genetically engineered animals have uses that could dramatically improve human health, pointing to “biopharm” animals that are created to generate ingredients for medicines, or those raised for organ transplantation into humans.
Officials say it likely will be years before genetically engineered meat ends up on store shelves, though one company is likely closer than most.
Aqua Bounty of Massachusetts is hoping to market its genetically engineered salmon, which grows to maturity in less time than wild or farmed salmon, but it awaits approval.
Researchers at the University of Missouri-Columbia have cloned and genetically engineered pigs that manufacture heart-healthy omega-3 fatty acids, though it’s not clear when or if the pork will reach stores.
Consumer groups on Thursday said the public issuance of the guidelines was a positive step because it makes clear that the agency will regulate genetically engineered meat, unlike genetically engineered plants, which are not reviewed by the agency.
Food safety groups say they’re also concerned about the unknowns, particularly if genetically engineered animals mate with native populations.
Several states, including Oregon and Washington, have prohibited transgenic fish because of concerns that they could mingle with their native fish.