USA: Guidance on the regulation of genetically modified animals

(20 November 2008) The US Food and Drug Administration (FDA) has issued guidance for the regulation of genetically engineered animals and products derived from them. The public was invited to give its opinion on the draft up to 18 November.

There are currently no authorised genetically engineered animals anywhere in the world, except in secure laboratories. To get commercial authorisation in the future, producers will have to submit proof, similar to the process with GM, corps that the animals or their derived products present no risk to humans or public health or to other animals and that the food processed from them is just as safe as conventional counterparts. It must also be proven that the raising of the animals and their commercialisation are no risk to the environment. Applicants must inform authorities about the method used to introduce the new DNA,  the gene construct and the stability of the new inherited trait.

The prospective guidelines apply to animals genetically engineered for pharmacological and high-value industrial purposes, such as for the production of fibers, as well as for farm animals traditionally used for food. Fast-growing GM salmon, for example, have been waiting years for authorisation in the US. In an advanced stage of development are pigs genetically engineered so that their manure is lower in phosphates, a major source environmental pollution, or so that their meat contains healthy Omega-3 fatty acids.

The guidelines will also allow the FDA to authorise genetically engineered pets, such as cats without allergens, as well as animals genetically engineered to resist certain pathogens, such as bird flu, and animals that are bred to produce organs for human transplants (xenotransplantation).

The guidance for regulation of genetically modified animals is not yet legally binding. The biggest criticism so far is that there are no provisions for the labeling of food and products from GM animals. Consumer organisations point to surveys in which the majority of US consumers demand such labelling.

Further information:

• FDA: Genetically Engineered Animals