Rules on Bioengineered Animals
Thursday, September 18, 2008
The Food and Drug Administration will release today long-awaited regulatory guidelines governing genetic engineering of animals for food, drugs or medical devices.
Although none of the provisions is likely to surprise the biotech industry, their formal appearance after years of discussion is expected to energize a field whose commercial potential is huge but so far unrealized.
The agency's regulatory control of animals will be considerably stronger than its oversight of genetically engineered plants and microorganisms. The latter -- or substances derived from them -- are on the market and, in some cases, have proved controversial.
The guidelines tell companies what the FDA wants to know about their work at virtually every stage of creating an engineered animal.
For example, biotech firms will be asked to provide the molecular identity of snippets of DNA inserted in an animal's genome, as well as where the genetic message lands and whether it descends unaltered through subsequent generations. The FDA also wants to be told how the genetic alterations might change an animal's health, behavior and nutritional value.
The companies also should inform the agency how they will keep track of animals, prevent them from mingling with their non-engineered cousins and dispose of them when they die.
Genetically engineered animals -- salmon, pigs, cows and goats are in development -- are expected to have two main uses. Some will be food animals whose new genetic endowment makes them disease-resistant, faster-growing or more nutritious. Others will be genetically engineered to produce medically useful substances, such as hormones or antibodies, in their organs or body fluids.
Pigs that are able to more easily absorb phosphorus, and therefore need less feed supplementation, are being developed in Ontario. Goats that produce spider silk in their milk are being made in Wyoming.
Food that is produced from genetically engineered animals will not have to be labeled as such. However, if the genetic manipulation changes the nutritional content -- for example, by increasing a beneficial form of fat -- that must be declared on the label.
The specific requests in the guidelines are not mandatory. However, biotech companies seeking FDA approval to commercialize genetically engineered animals must follow federal drug laws. The guidelines are meant to show how they can do that.
The FDA has been providing the advice on an informal basis for about 10 years, said Eric Flamm, a policy adviser at the agency. The guidelines will be open for public comment for 60 days.
"We are simply clarifying what we've always done, and will continue to do," he said.