Saturday, September 20, 2008

Classroom Discussion Topic: FDA Guidelines for Genetically Engineered Animals

Tastes just like chicken?

If you eat, take drugs, or have a pet, the FDA has a little something special just for you.

This week the agency released a draft of the guidelines it intends to follow when genetically engineered animals are up for approval for commercial use. Although these procedures have already been in use for quite a while, this release spells out the process for the first time, and also includes a one month period for public comment.

As spelled out by the FDA, GE animals fall into 6 categories:

· Biopharm animals are those that have undergone genetic engineering to produce particular substances, such as human insulin, for pharmaceutical use.

· Research animals may be engineered to make them more susceptible to particular diseases, such as cancer, in order to gain a better basic understanding of the disease for the development of new therapies or in order to evaluate new medical therapies.

· Xenotransplant animals are being engineered so they can be used as sources for cells, tissues or organs that can be used for transplantation into humans.

· Companion animals that are modified to enrich or enhance their interaction with humans (i.e., hypoallergenic pets).

· Disease resistant animals may be used either for food use or biopharm applications. These animals have received modifications that make them resistant to common diseases, such as mastitis (a very painful infection of the udder) in dairy cows, or particularly deadly diseases, such as bovine spongiform encephalopathy (BSE).

· Food use animals have been engineered to provide healthier meat, such as pigs that contain healthy omega-3 fatty acids at levels comparable to those in fish.

The toughness of the approval process varies by category. For pets, not so much. For food, the rules are fairly stringent.

The information provided along with the draft regulation is surprisingly readable and informative for government work. It defines genetic engineering, discusses the areas of concern surrounding the safety and effectiveness of GE animals, and provides a clear step by step overview of the approval process. It’s also up front about several features of the guidelines that are obvious topics for classroom debate and passionate letters to the editor: many of the steps are suggestions, not regulations; the agency can waive the rules whenever it sees fit; and the big one – GE foods will not have to be labeled. The FDA is also glad to admit that its guidelines do not take into account the wider ethical questions of genetic engineering.

It's very easy to use genetic engineering in the classroom for the shock and awe of it all - when you play on people's fears, at least they stay awake. It's a little harder to have a balanced, thoughtful discussion of this complicated topic, but the FDA guidelines, which weave together the science, economics, and legalities of GE in one nice, topical package, are a good jumping off point.

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