Implications of the Food and Drug Administration’s Regulation of Genetically Modified Organisms

By: Erin Hadi

Genetically Modified Animals (“GM Animal”) are the future of agriculture in the United States.  Currently, a GM Animal is engineered to contain a segment of recombinant DNA (“rDNA”) that introduces a new favorable trait or characteristic into the target animal.[1]  GM Animals have the potential to be a very efficient protein source depending on which traits are passed down. Rather than waiting for evolution and breeding to produce animals with the most desirable traits over multiple generations, GM Animals can reproduce the manufactured desirable trait within one generation. This leads to a more efficient system of breeding livestock.  An increased efficiency could lead to a lower of cost and increased availability of meat protein to consumers.  Americans largely rely on animal meat as a protein source and those who do would benefit from a more efficient option.

Some oppose the development of GM Animals for human consumption out of concern for potential negative health effects and animal welfare.[2]  It is currently unclear how consumption of disease-resistant GM Animals might affect human health or animal health.[3]  Another concern is that GM Animals that are not intended for consumption could make their way into the food supply unless control measures are created.[4] If a genetically modified salmon escapes from its contained aquatic environment, it can breed with another salmon that has not been genetically modified. At this time, the effects of such breeding are unknown but could be catastrophic to the entire ecosystem.  Rigorous legislation to appropriately regulate GM Animals before they are available for human consumption will alleviate these concerns.

Currently, the United States Federal Government has not enacted specific legislation to address the regulation of GM Animals.[5]  The FDA has taken it upon itself to interpret the Federal Food Drug & Cosmetics Act (“FFDCA”) to provide it with the authority to over GM Animals by defining them as a “new animal drug”.[6] The FDA does not consider the GM Animal itself to be the drug but does consider the rDNA inserted in the genome as the article intended to affect the structure or function of the body of the animal.[7] The rDNA is tested as a “drug” and the New Animal Drug applications (“NADA”) evaluation process ensures that GM Animals are safe for consumption. [8] GM Animals are currently approved by the FDA, but labeling standards are enforced by the USDA.

The National Bioengineered Food Disclosure Standard requires food manufacturers, importers and retailers to ensure bioengineered foods are appropriately disclosed.[9]  The USDA enforces this standard and regulates the labeling system for GM Animals, among other bioengineered food, even though it does not regulate GM Animals themselves.

The United States Food Safety and Inspection Services is responsible for ensuring that that all meat sold commercially be inspected and passed to ensure that it is safe, wholesome, and properly labeled under the Federal Meat Inspection Act. GM Animals should be regulated based on their intent.  If they are intended to be sold for human consumption, they should be regulated as such.  Inspecting GM Animals under the same criteria as all meat sold commercially will ensure that the same standard is being applied to all meat sold commercially.  GM Animals that are defined as “livestock” must be inspected for safety. This will alleviate safety concerns of consumers.  Consumers will be more trusting and willing to buy meat from GM Animals if they know it is as safe, if not safer, than non-GM Animal meat.

            As GM Animals are commercialized, they will enter the market for human consumption.  As they enter the market for human consumption, there will be a greater need for oversight and regulation. There will also be a greater need for consumer education.

[1] U.S. Food and Drug Administration, Development and Approval Process: Animal Drugs and Animal Food Additives, (accessed October 21, 2020).

[2] Mary Anne Angelo et al., Food, Agriculture, and Environmental Law, 104 (2013)

[3] Gijs Kleter & Harry Kuiper, Considerations for the Assessment of Safety of Genetically Modified Animals Used for Human Food or Animal Feed, 74 Livestock Prod. Sci. 275, 279 (2002)

[4] Supra note 2.

[5] Supra note 2 at 105.

[6]21 U.S.C. § 321(v)

[7] 21 U.S.C. §321 (g)(1)

[8] U.S. Food and Drug Administration, New Animal Drug Applications, (accessed October 21, 2020).

[9] U.S. Department of Agriculture, Establishing a National Bioengineered Food Disclosure Standard, (accessed October 21, 2020).