Today the FDA released formal regulatory guidelines governing genetic engineering of animals for food, drugs or medical devices. The specific requests in the guidelines, while not mandatory, are designed to show biotech companies seeking FDA approval for commercial use of GE animals how to follow federal drug laws. 

The new guidelines — while stronger than those for genetically modified plants and micro-organisms — drew criticism from groups worried about the hazards of bioengineered animals.

Now all genetically engineered animals — food animals and those genetically altered for research– will be under FDA regulation. Food from GE animals will not have to be labeled as such, though if the genetic manipulation changes the nutritional content, that must be declared on the label.

The guidelines state the FDA wants to be informed how the genetic alterations might change an animal’s health, behavior and nutritional value, as well as how companies will keep track of animals, prevent them from mingling with their non-engineered cousins and dispose of them when they die.

Companies would also have 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  will now be able to regulate genetically engineered animals without getting further authority from Congress, and  consumer and watchdog groups will not be included in the informational processes. Because open discussions about safety and effectiveness could reveal  a company’s proprietary or competitive information, the FDA is prohibited by law from informing the media or public.

"The first time that the public will learn about a genetically engineered animal will be the day it is approved,"  said Margaret Mellon of the Union of Concerned Scientists in the Washington Post.

The guidelines will be open for public comment for 60 days. 

Cockatrice: It’s what’s for dinner!