By KEVIN WALKER
Michigan Correspondent WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has issued its final guidance for industry on the regulation of genetically engineered (GE) animals.
According to FDA officials and the guidance paper itself, the final guidance is a set of recommendations for producers of genetically engineered animals, not a set of laws or regulations.
“I am very pleased to announce that today we’re releasing the final version of FDA’s guidance for industry on the regulation of genetically engineered(GE) animals containing heritable recombinant DNA (rDNA) constructs,” said Randall Lutter, deputy commissioner for policy at the FDA in a teleconference on Jan. 15.
“This guidance clarifies how the FDA is regulating genetically engineered animals and provides recommendations to producers on how they can meet their obligations under federal law and regulations. It serves to reassure stakeholders that FDA has clear standards.”
The guidance, which is about 26 pages, states that genetically engineered animals that are consumed as food fall under the agency’s responsibilities according to the Federal Food Drug and Cosmetic Act. Larisa Rudenko, senior advisor for biotechnology at the FDA’s Center for Veterinary Medicine (CVM), stated that new GE animals are not drugs, “they contain drugs.”
“For all animals traditionally consumed as food, or that produce food, you must come in and open an investigational new animal drug file,” Rudenko said. She also stated that producers should come in and make an application as soon as possible.
The guidance paper said much the same: “Developers of GE animals should contact CVM early in the development of their GE animal; developers whose animals are already well under development also should contact CVM. We intend to issue additional guidance to describe more fully how various components of the New Animal Drug provisions of the Act apply to biopharm animals and how CVM will implement them.”
The FDA’s process for deciding whether a new GE animal lineage would be approved was the subject of quite a bit of discussion. According to Rudenko, the CVM’s Veterinary Advisory Board Committee would make decisions on all GE applications for new animal lineages. Lutter said that details of the review process still have to be worked out; he also stated that the FDA has “a lot of discretion” about how reviews are done.
According to Rudenko, the agency will use three considerations when evaluating an application to develop and market a new GE animal. These include animal health, food health and environment.
Bernadette Dunham, director of the CVM, said that the FDA will review a GE animal that’s used for food in the same way it would review any drug that would normally be reviewed at CVM, that is, it would go through the agency’s human food safety review.
Dunham was enthusiastic about GE animals.
“This technology, the introduction of recombinant DNA constructs into animals, holds great promise for the health of both animals and humans,” Dunham said. “Genetic engineering provides the scientific community with some of the most powerful tools available to help introduce resistance to diseases in animals.”
Dunham used as an example mastitis in cattle, which she described as very painful and difficult to treat infection of the udder. Dunham said this disease also costs the dairy industry millions of dollars every year. She said that GE can be used to introduce resistance to mastitis in cattle.
Dunham said that GE can benefit the environment. She said that some fish, for example, have been genetically engineered to grow to market size faster, which means that non-farmed fish don’t have to be harvested in such great numbers. But Dunham also said that the agency wants to make sure that the introduced traits do to animals what the producers or developers claim they do and that they are safe for animals and humans.
Rudenko sounded this theme as well. When prompted by a reporter to give a timetable for when the first application would be approved, she refused to provide any guidance for that.
“We will not approve any application until we are convinced of the safety and effectiveness of the rDNA construct,” she said. “I think that the public should be reassured that we’re not rushing into anything.”
Sheila Burkhardt, a spokeswoman for the Michigan Milk Producers Assoc, said that she’s aware of research being done in the area of genetic engineering to introduce resistant to mastitis in cattle, but isn’t aware of any application for this in FDA’s pipeline right now.
The draft guidance can be viewed in its entirety online at www.fda.gov/cvm/guidance/fguide187.pdf |
