Genetically Engineered Animals on the Shelves

Posted September 26, 2008 at 6:40pm

For years, buying genetically modified beef or fish at the grocery store has been prohibited.

That could be changing soon as the Food and Drug Administration moved forward earlier this month with its proposed guidelines on how to regulate genetically engineered animals. The move is expected to clear the way for them to eventually enter the food supply.

First developed in the 1980s, genetically engineered animals have had their DNA altered to introduce new traits into the animal. While genetically modified plants are widely used in agriculture, so far the FDA has not approved any genetically engineered animals for food or medical treatments.

Currently, there are at least two dozen applications at the FDA awaiting approval, including one for genetically engineered Alaskan salmon.

The public has until Nov. 18 to comment on the proposed regulations.

The FDA’s proposal was welcome news for groups like the Biotechnology Industry Organization that have been lobbying the agency for years to put forth guidelines that will give the industry a better idea of what it will need to do to garner approval for genetically engineered animals.

“We feel like publication of a regulatory process is a first step toward actually moving those applications,” said Barbara Glenn, managing director of animal biotechnology for BIO. “Our members have been working on a lot of these steps, and likely many of them have been met. This moves the process along to potentially have one approved someday.”

BIO has been supporting a mandatory approval process as a way to ensure consumer confidence.

The regulatory process would enable not only genetically engineered animals for food to be approved. The animals could also be used for medical treatments such as organ transplants and genetically engineered so that they are less prone to disease, said Jennifer Greiner, director of science and technology at the National Pork Producers Council.

Animals could also be genetically engineered to be leaner, and therefore healthier, for humans to eat.

The council has been supportive of the FDA moving forward with the regulations.

Not everyone is happy with the proposal, of course.

Consumer groups such as the Center for Science in the Public Interest and the Center for Food Safety have raised concerns about whether the FDA’s proposal for approving genetically engineered animals is too secretive. The groups say it is likely the approval process will be closed to the public until after the food animal has been approved by the agency.

Another area that has caught their attention is how the agency will make sure to consider environmental oversight in coordination with agencies like the Environmental Protection Agency.

BIO’s Glenn refuted the consumer groups’ concerns.

The biotech industry supports transparency to the fullest extent of the law, and expects that the FDA will be in line with the environmental regulations put forth by the EPA, she said.

This isn’t the first time the Center for Food Safety has gotten involved with how the FDA is regulating genetically modified animals.

In 2004, the group brought a lawsuit, along with the Center for Technology Assessment, asking a judge to require the FDA to regulate the genetically modified GloFish. The fish, which was originally intended to help scientists study pollution, was marketed as the first genetically modified house pet.

The Center for Food Safety was concerned that if not regulated it could open the door for less regulation of all genetically modified animals, according to the center’s legal director, Joseph Mendelson.

The consumer group lost that battle in 2004 when the court dismissed the case on the grounds that it was up to the FDA whether to enforce the matter.

“Basically, it means enforcement is at the whim of the agency,” Mendelson said. “It’s a big loophole for them to say we aren’t going to enforce against this treatment.”

More traditional agriculture groups like the International Dairy Foods Association have also taken an interest in the proposal.

The IDFA has come out in support of a “rigorous review” of the approval process, according to Clay Hough, senior vice president for the group. They also expect to have input in the public comment process.

“It’s important to do a careful and deliberative process,” IDFA spokeswoman Peggy Armstrong said. “The most important thing for us is that we maintain the trust of consumers in our products.”

One area in which there does not appear to be a consensus is whether the FDA should require labeling of modified food animals. The National Farmers Union, for one, is in favor of labeling the food, citing the concern that foreign countries have had in accepting U.S. products that have beef hormones.

“Our concern is always that you have to be very careful as you go down this road because consumers are our customers,” said Tom Buis, president of the National Farmers Union. “We have always supported labeling of the products to let the consumer make the choice. If they want it, that’s a different story. They should be able to make their choice.”

Congress has yet to weigh in on the FDA’s proposal, although it could just be a matter of time.

Genetically modified foods have been on the market since the 1990s, and while their supporters say they can be a boon to reducing world hunger, detractors wonder about the long-term health effects and potential impact on biodiversity. BIO’s Glenn said it would premature for Congress to now try to put a legislative mechanism in place.

But consumer groups say they are encouraged by Members such as Rep. Dennis Kucinich (D-Ohio) stepping forward on issues like food labeling and liability issues.

“The statues were never designed for technology,” Mendelson said. “More oversight would be better to increase transparency and serve everyone much better.”