FDA starts planning transgenic GE animal commercial use

Genetically engineered (GE) animals are those modified by recombinant DNA (rDNA) techniques. After a decade of delays and procrastination, the US Food and Drug Administration (FDA) has finally issued a draft guidance (http://www.fda.gov/cvm/GEAnimals.htm) describing how it plans to regulate the commercial use of genetically engineered (GE) animals. The guidance document is being distributed for comment purposes only and not yet for implementations.

Accorging to FDA's opinion, GE animals currently being developed can be divided into six broad classes based on the intended purpose of the genetic modification:

1. to enhance food quality or agronomic traits (e.g., pigs with less environmentally deleterious wastes, faster growing fish);
2. to improve animal health (e.g., disease resistance);
3. to produce products intended for human therapeutic use (e.g., pharmaceutical products or tissues for transplantation; these GE animals are sometimes referred to as “biopharm” animals);
4. to enrich or enhance the animals’ interactions with humans (e.g., hypo-allergenic pets);
5. to develop animal models for human diseases (e.g., pigs as models for cardiovascular diseases); and
6. to produce industrial or consumer products (e.g., fibers for multiple uses).

Although commercial reporter mice can partially belong to the point 5, my first feelings are that there is still lot of work pending in order to fully understand, and then regulate, recombinant life engineering.