Consumer group critical of FDA guidance on GE animals

The FDA yesterday released draft guidelines on the regulation of GE animals in the marketplace, which set out the requirements and recommendations for producers of GE animals and products derived from them.

The agency is seeking public comments on the guidance until 18 November.

“Genetically engineering generally refers to the use of recombinant ​DNA​ (rDNA) techniques to introduce new characteristics or traits into an organism,”​ explained the agency.

The FDA claims that GE animals include food-use animals with new traits such as improved nutrition, faster growth or lower emission levels of environmentally harmful substances such as phosphate in their manure.

CFS claims the FDA process evaluating the safety of GE animals for the marketplace has major deficiencies:

“Under this draft, the public cannot know if the review of a product met the highest scientific standards until after its approval, and then they cannot avoid the product in the marketplace because it is not labelled,” ​said the anti-GM consumer group.

The organisation said the FDA should request the US Congress to amend the new animal drug legislation so that the process is transparent and it is also urging the regulator to require labelling on GE animals and products made from them so that the public can report any problems linked to the meat.

The FDA claims that, under the Federal Food, Drug, and Cosmetic Act (FD&C Act), it has been working with developers of GE animals to make them aware of their responsibilities to ensure that “food from these animals does not enter the ​US​ food supply unless the regulator has authorized such use”. ​

Randall Lutter, FDA deputy commissioner for policy, said that the agency has been involved for a long time in the scientific evaluation of GE animals and he argues that this is no longer a novel technology.

He said that genetic engineering is already widely used in agriculture to make crops resistant to pests or herbicides, while in food, the technology is used to produce microorganisms that aid in baking, brewing, and cheese-making.

“Many kinds of genetically engineered animals are in development, although none has yet been approved by the agency for marketing​.

"For example, some pigs have been genetically engineered to contain high levels of omega-3 fatty acids.”​

According to the FDA draft guidelines, in cases where the GE animal is intended for food use, the onus is on the meat producer to demonstrate that the food is safe to eat.

Dr Larisa Rudenko, senior adviser for biotechnology, FDA’s Center for Veterinary Medicine, said that the agency will evaluate the particular risks posed by each line of animal.

She said that the regulator will also ask producers to provide a plan of the controls they will be putting in place to ensure consistency in the future GE animals entering the marketplace with those that receive the initial FDA approval.