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FDA to adopt more transparent process for GE animals
Thu Jan 15, 2009 2:19pm

By Christopher Doering
http://www.reuters.com/article/scienceNews/idUSTRE50E6VQ20090115

WASHINGTON (Reuters) - The Food and Drug Administration said on Thursday it would make the process it uses to approve genetically engineered animals more transparent, but consumer groups expressed concern the government was not going far enough to protect the pubic.

The guidelines being finalized by the FDA bring the decades-old technology of genetic engineering for animals one step closer to the dinner table. Officials from the FDA would not speculate when the first of the applications, which are in various stages of development, would be approved.

"We recognize that many people have strong views on these subjects," said FDA Deputy Commissioner Randall Lutter.

He vowed the FDA guidelines would provide a "rigorous and predictable science-based framework" to review genetically engineered animals in a timely and transparent manner.

Genetically modified cattle, pigs, fish and goats are being produced for a variety of uses. Some produce pharmaceuticals in their milk or blood. Others are resistant to diseases, such as mad cow, or produce more healthful meat or milk.

FDA said its framework would help producers know what the government will need to determine safety and verify that the genetically engineered trait is doing what it claims.

A draft document outlining the process, first issued in September and later opened to public comment, was criticized by some groups as being secretive and lacking transparency.

In response to more than 28,000 comments from consumers, food and pharmaceutical companies, and others, FDA said it would now hold a public advisory committee meeting before making a decision on an application.

"FDA has made some small but important changes to increase the transparency of the regulatory process, but it really depends on how they implement the new practice," said Gregory Jaffe of the Center for Science in the Public Interest.

He said key questions included what information FDA will release, when will it be released and how the public can participate in the process.

The FDA also said it would make public when it intends to exempt a producer from having to submit an application. Certain animals being used for research and not being consumed as food, such as rats or mice, would qualify.

The framework being finalized by FDA requires producers of genetically engineered animals to describe what DNA they have inserted into the animal, how it behaves in the animal, the impact on the animal's health, and show the product is not different from traditional food.

Labeling would be required only if there is a significant change in the food, such as if pork from pigs is engineered to produce meat with higher levels of omega-3 fatty acids.

"We think it's outrageous that they're not going to require labeling," said Michael Hansen, a senior scientist with Consumers Union. "So many consumers want this."

The FDA said it has the authority to regulate genetically engineered animals through the Federal Food, Drug and Cosmetic Act. The measure identifies a drug as anything that changes the "structure or any function" of a person or animal.

(Editing by Walter Bagley)