According to the US Food and Drug Administration, genetically engineered animals are considered a form of "Animal Drug". As such, the US FDA has released a set of guidelines, 10 years in the making, governing the approval of Genetically Engineered (GE) animals. The guidelines were released on the 15th January and can be perused over at the FDA site. While there is no doubt that it is an area needing tight regulation, the critics are concerned the FDA is the correct body to evaluate the approval of genetically modified animals and the possible environmental impacts that could occur if that animal was to escape. Questions are also being raised as to the approval process, which is largely a decision made in private, and how flexible that process will be for the large range of genetic animals currently being tested. Only time will tell how the approval process will impact the world of GE animals and whether it will be a hindrance on research or not.