Comments on Docket No. FDA-2008-D-0394,
“Draft Guidance for Industry: Regulation of genetically engineered animals
containing heritable rDNA constructs”
Submitted by Michael Hansen, PhD
Consumers Union (CU), the non-profit publisher of Consumer Reports magazine, appreciates the opportunity to comment on Docket No. 2004D-0369, “Draft Guidance for Industry: Regulation of genetically engineered animals containing heritable rDNA constructs.” We commend FDA for requiring such animals to go through a mandatory safety assessment. However, we believe FDA’s decision not to require labeling of milk and meat from such animals denies consumers of their right to choose what they eat, and is contrary to existing law and legal precedents.
We commend the Food and Drug Administration (FDA) for stating their intent in this Guidance to require environmental and human safety assessments before genetically engineered animals, or food products derived from them, are permitted to be commercialized. This is a step forward from the way FDA regulates genetically engineered plants, which do not have to go through a mandatory human safety assessment. However, we feel the proposal does not go far enough and has some serious deficiencies and ambiguities.
A major problem with this proposal is that it is simply Guidance for Industry and so is not legally binding: “This draft guidance . . . does not create or confer any rights for on any person and does not operate to bind FDA or the public.” We urge the FDA to publish a legally binding regulation for genetically engineered animals, and not just a non-binding “guidance.”
A second problem is lack of transparency. FDA has decided to regulate all genetically engineered animals under the New Animal Drug provisions of the Food Drug and Cosmetic Act, arguing that the rDNA construct inserted into the animal’s genome is a drug. This is an important and positive step, although we do have specific comments on the kind of safety data that should be required, which we discuss below. However, the down side of using the New Animal Drug provisions of the FDCA is that there is not enough transparency. Virtually all the safety data may remain confidential until after the GE animal is approved. Although we commend FDA for stating that for the first few GE animals that they approve, FDA will have public meetings of their Veterinary Medicine Advisory Committee (VMAC) to get public input on the health and safety data, we believe that, in general, safety and health data should not be considered confidential business information. After the first few approvals, FDA may decide not to hold VMAC meetings for GE animal approvals and so the transparency and chance for the public to comment on GE animal applications will disappear. We urge FDA to release all safety information on GE animals prior to approval so that the public can evaluate these data and make public comment, and to hold VMAC meetings to receive input on all pending approval decisions.
Another problem with this proposal is that GE animals may not receive an appropriate environmental review. FDA is not actually the appropriate agency to assess the potential environmental impacts of GE animals, which can be very serious. With GE fish and shellfish, the potential for release/escape into the environment could be fairly large. This is particularly true with engineered salmon, which would be kept in net pens in the ocean. For example, AquaBounty has a GE salmon engineered with a growth hormone gene to make it grow to adult size faster and to make the adult fish bigger. Since many fish choose mates on the basis of size, research has suggested that the growth hormone trait could, under the right conditions (larger size for the GE males and reduced fitness in the offspring of GE males), lead to potential extinction of a wild population. GE pigs also have a significant potential to escape and become feral; wild boar are pests in many parts of the US. The National Research Council has ranked taxa of GE animals in terms of their ability to become feral, likelihood of escape from captivity, mobility and historical evidence of environmental disruption. From high to low the NRC ranking consists of insects, shellfish, fish, mice-rats, cat, pig, goat, horse, rabbit, dog, chicken, sheep and cattle. Consequently, we feel that the issue of environmental impacts of GE animals should not be assessed by FDA, but should be assessed by the Environmental Protection Agency (EPA) and other governmental agencies as necessary. FDA should request EPA to seek authority from Congress to do environmental assessments for all GE animals, to ban those animals that pose a significant risk to the environment, and to approve only those that can be shown to present a reasonable certainty of no harm to the environment.
The final problem with the proposed guidance is that the FDA is not requiring labeling of meat and milk products derived from GE animals. We strongly disagree with this FDA decision. For the reasons explained below, we believe that genetic engineering is a material fact that consumers want to know; if food produced from GE animals are not labeled, then we believe that the labels would be false misleading under Secn 403(a) of the Food Drug and Cosmetics Act (FDCA). In October, 2008, the Consumer Reports National Research Center polled over 1,000 people nationwide on various food labeling issues; some that 95% of consumer polled agreed that “food products made from genetically engineered animals should be labeled as such” with 78% strongly agreeing with this statement . This clearly shows consumers overwhelmingly desire food from GE animals to be labeled as such; in other words, whether an animal has been genetically engineered is a material fact that should be displayed on the label. FDA could also require labeling of GE animals as a risk management measure to deal with the scientific uncertainty associated with GE animals and to track any unexpected health effects that may occur.
For the complete comments, click here (PDF format).