Rules On Bioengineered Animals

The U.S. Food and Drug Administration (FDA) announced the pending release of regulatory guidelines governing the genetic engineering of animals for food, drugs, or medical devices. The voluntary guidelines stipulate the details that biotech firms should disclose to the FDA regarding each stage of bio-engineering involving animals for these purposes.

The FDA’s reporting guidelines for biotech companies will require those companies to:

• Provide the molecular identify of snippets of DNA inserted in an animal’s genome, as well as where the genetic message lands and whether it remains unaltered through subsequent generations. 
• Inform the FDA about how genetic alterations might change an animal’s health, behavior, and nutritional value.
• Disclose how companies will track animals and prevent them from mixing with non-engineered animals and how they will be disposed of when they die.

The guidelines are not mandatory, but biotech companies who seek FDA approval to commercialize genetically engineered animals must follow food and drug laws. In addition, this action may “drive investor confidence,” though critics suggest that the public will only learn about a genetic animal the day it is approved, requiring people to put their trust in the FDA.