The US Food and Drug Administration (FDA) is actively considering the implementation of genetically modified animals for use in medical experiments and as a food source as outlined in their document Draft Guidance for Industry: Regulation of genetically engineered animals containing heritable rDNA constructs.
Although no genetically engineered animals have been approved, the FDA is definitely moving towards the approval process. The FDA website reports that, “… so far not approved or authorized any GE animals for use in food. However, we are reviewing applications requesting approval of GE animals intended for food use”. One such company Aqua Bounty Technologies hopes to have their genetically engineered salmon approved for human consumption by 2011. The salmon would be engineered to grow at an accelerated rate.
The FDA is considering allowing genetically modified animal use in the following cases:
Biopharm animals are those that have undergone genetic engineering to produce particular substances, such as human insulin, for pharmaceutical use.
Research animals may be engineered to make them more susceptible to particular diseases, such as cancer, in order to gain a better basic understanding of the disease for the development of new therapies or in order to evaluate new medical therapies.
Xenotransplant animals are being engineered so they can be used as sources for cells, tissues or organs that can be used for transplantation into humans.
Companion animals that are modified to enrich or enhance their interaction with humans (i.e., hypoallergenic pets).
Disease resistant animals may be used either for food use or biopharm applications. These animals have received modifications that make them resistant to common diseases, such as mastitis (a very painful infection of the udder) in dairy cows, or particularly deadly diseases, such as bovine spongiform encephalopathy (BSE).
Food use animals have been engineered to provide healthier meat, such as pigs that contain healthy omega-3 fatty acids at levels comparable to those in fish.
Concerns with the FDA approving genetically modified animals range from the ethics of using genetically modified animals, possible human health effects, species’ monopoly and/or genetically-modified species domination, species extinction, animal cruelty, a furtherance of animal experiments and the impact on the environment. GeneWatch UK reports that, “There are serious concerns about animal welfare in both the production of GM animals and the effects of the modification, particularly because of the unpredictability inherent in the technology”.
The FDA is reporting, “…most GE animals that are being developed at this time are intended to pass their new GE traits on to their offspring… it is at least theoretically possible that certain GE traits might be widely adopted”.
The Consumer Union had the opportunity to comment on the proposed Draft Guidance for Industry: Regulation of genetically engineered animals containing heritable rDNA constructs and expressed a number of concerns with the FDA regulation process as currently outlined. The concerns ranged from the regulatory process not being legally binding to lack of transparency and GE animals not receiving adequate environmental review.
Their response also explains that they oppose the FDA’s decision to not label genetically modified animal products. “We strongly disagree with this FDA decision…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)”. Additionally, Consumer Reports National Research Center conducted a poll in October 2008 of more than 1000 people on various food labeling issues and found that 95% of consumers polled agreed that, “food products made from genetically engineered animals should be labeled as such”.
The FDA is no longer accepting public input on their controversial proposal. It is expected that an announcement will be made shortly regarding their decision.
Resources
Read the Consumer Union’s full comments here.
Visit the FDA Website to read up on the FDA’s position on genetically modified animals. Even though the ability to make official comments on the FDA draft proposal has closed, individuals can still contact their local and federal politicians and express their opinions on this issue.
GeneWatch UK: http://www.genewatch.org/
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