Drug agency opens door to market approval for transgenic animals.
After ten years of anticipation and back-room wrangling, on 18 September the US Food and Drug Administration (FDA) published a document outlining how it proposes to regulate genetically engineered animals. The proposed regulations effectively treat such animals as drugs in order to provide grounds for FDA regulation.
In a 25-page draft "guidance" (pdf) the agency responsible for the safety of US food and medicines effectively opened its regulatory doors to genetically engineered animals, be they intended as pets, as livestock bound for the dining table or as living drug factories. Although the proposed regulations are non-binding, the industry is expected to follow them closely as a guide to gaining marketing approvals. The guidelines will be finalised after a 60-day comment period.
The FDA is trying to regulate this technology under laws that were never intended to regulate genetically engineered animals Doug Gurian-Sherman , Union of Concerned Scientists
The guidance covers details of what the FDA will need to know about the identification, characterization, manufacturing processes and labelling of the animals in question, as well as the evidence it will require of their safety and efficacy in the use envisaged. It suggests that the FDA will focus its regulatory attention on situations in which transgenic animals may have environmental impacts, pose risks to animal or human health, or seem to raise safety questions the producers have not addressed.
The agency has premised the rules on an unusual reading of the federal Food, Drug and Cosmetic Act, saying that the inserted DNA used to modify an animal can be regulated as a "new animal drug" under the 1938 law from which the agency draws much of its regulatory clout. Under this interpretation, the same gene inserted into two different animals of the same species on separate occasions creates two different entities to regulate, because DNA integrates itself into the genome pretty much at random. However, the offspring of genetically modified animals will be, in regulatory terms, the same thing as their parents.
We are not interested in having an application from every postdoc making a knockout mouse Larisa Rudenko , FDA
The guidance is being released now "because commercialization of these animals is no longer 'over the horizon'," Randall Lutter, the FDA's deputy commissioner for policy, told reporters on a conference call on Thursday. "Genetic engineering of animals is here and has been for some time," added Larisa Rudenko, a senior adviser for biotechnology at the agency's Center for Veterinary Medicine. "As regulators, we intend to provide a rigorous, risk-based regulatory path," ensuring the health of both the animals and people.
The new regulations are unlikely to have an impact on most bench scientists. The agency says genetically engineered laboratory animals are a "principal" case where it would exercise its discretion not to regulate. "In general we are not interested in having an application from every postdoc and grad student making a knockout mouse for this that or the other thing," said Rudenko.
The guidance is going to ensure that we can reach the very compelling benefits of genetic engineering of animals. Barbara Glenn , BIO
The agency says it will also take what some would see as a light touch in not requiring foods from genetically engineered animals to be labelled as such unless the engineering was specifically designed to change their nutritional values, or if it did so by chance. With respect to food safety, the proposed regulations are similar in substance to those agreed in July by a 176-nation task force that considered how best to assess the safety of foods from genetically engineered animals.1
The biotechnology industry, which has long urged the agency to issue such rules, praised the draft. Barbara Glenn, the managing director for animal biotechnology at the Biotechnology Industry Organization in Washington DC, says that about a dozen of her group's 1,200 member companies are currently developing genetically engineered animals. "The guidance is going to ensure that we can reach the very compelling benefits of genetic engineering of animals," she says. "It simply allows industry to move forward."
Behind closed doors
Consumer groups, by contrast, were highly critical. They said that the guidance was far too vague, leaving consumers to trust that FDA will conduct adequate assessments of animals' environmental and safety impacts.
They also noted that because the animals will be dealt with as new drugs, the assessment of their safety will be conducted behind closed doors at the agency — guarded by law as proprietary information, as is the case with conventional drug applications.
"The FDA is turning somersaults to try to adequately regulate this technology under laws that were never intended to regulate genetically engineered animals," says Doug Gurian-Sherman, a senior scientist at the Union of Concerned Scientists in Washington DC. "It may be that a new law and new regulations that are better adapted and more specifically designed to address the unique types of concerns that these animals raise would be a better approach."
Codex Alimentarius Commission: Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Animals; in ALINORM 08/31/34, Appendix II.
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Wadman, M. FDA to regulate genetically engineered animals. Nature (2008). https://doi.org/10.1038/news.2008.1120