Thursday, January 29, 2009

US FDA's Statement on Genetically Modified Animals



The FDA has released its final statement on the production of genetically modified animals. The agency's guidelines assert that GM animals are to be regulated as animals receiving drug treatments, such as hormones or antibiotics. According this logic, the genetic modification - a change made to animal's DNA, often with the help of a virus - is the same as a chemical-based modification of the animal's system. The guidelines are merely a statement that current regulations are sufficient for GM animal production.
As readers may remember, cloning is not considered to be a genetic engineering process, but simply a form of assisted reproduction since the original DNA is not modified.
Currently, there are no genetically modified animals or products from such animals used for food. However, despite some reporting that we are now likely to see GM meat products in the supermarket, as a recent LA Times article speculates, we are far more likely to see products from GM animals in the form of drugs or other medical treatments. According to Q&A page on the FDA site:

Q: What kinds of GE animals are in development?

A. Many kinds of GE animals are in development. At this time, the largest class of GE animals is being developed for biopharm purposes—that is, they are intended to produce substances (for example, in their milk or blood) that can be used as human or animal pharmaceuticals. Another group of GE animals are under development for use as sources of scarce cells, tissues, or organs for transplantation into humans (xenotransplant sources). Yet others are intended for use as food and may be disease resistant, or have improved nutritional or growth characteristics. And others include animals that produce high value industrial or consumer products, such as highly specific antimicrobials against human and animal pathogens (e.g., E. coli 0157 or Salmonella).

More than likely, drugs produced by genetically engineered animals will be much less of a problem for consumers than meat, eggs or dairy products. How many people currently even know what most of the compounds in their medications are?
A question that I have, and one not addressed (that I could find) by the FDA, is when the genetic modification performed on an animal would cease to be treated as a drug treatment. For how many generations will offspring of GM animals, who will inherit the modification, be treated as if receiving drug treatments?

posted by ryan griffis  # 5:30 PM

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