Legal Research on Biotechnology

by Alexandra Carr

Table of Contents

A Crisis in the Making:


In the Court Room

Not a Final Thought


A Crisis in the Making: Genetic Engineering in the 21st Century

The proponents of using genetic engineering to alter agricultural products claim that this technology will enable farmers to feed the growing world population more efficiently. There is great debate as to whether there is any need for this technology and whether the world population will be fed through more traditional agricultural techniques. Some claim that traditional farming techniques will fail to feed the world's population as it grows. To date, there are about eighteen billion dollars worth of genetically engineered crops grown each year. It is almost certain that the growing of genetically engineered agricultural products will increase.

Today, the issue of genetic engineering of crops includes environmental, ethical, developmental, economic, pharmaceutical, medical, scientific, and consumer aspects. These problems pose new interactions between patent law, health and safety laws, environmental regulation, and science. The legislator's task today is to deal with a problem that has at least four or five aspects, which may be one of the reasons why the regulation of genetic engineered food products is so difficult and why it generates such a high potential for legal conflicts.


Genetically engineered crops are regulated through the regulation responsibilities delegated to the Food and Drug Administration (FDA), United States Department of Agriculture (USDA), National Institutes of Health (NIH) and the Environmental Protection Agency (EPA). The FDA is responsible for ensuring that the final products are safe. Genetically engineered crops are given limited review by the FDA because the process of genetic engineering is likened to natural evolution. Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the EPA is charged with regulating pesticides. The EPA has largely left the decisions to regulate genetically engineered products to the biotech companies by implementing minimal standards. In the United States there are few legal restrictions to the creation, testing and release of genetically modified crops.

A constitutional amendment adopted in 1992 required the federal government to consider not only the safety of humans, animals, and the environment, but also the "dignity of creation" when regulating genetic engineering. The obvious concern is that the new genetic engineering technology gives mankind the means to "act like God" and humans will misuse the technology and ignore the interests of future generations.

The FDA recently proposed a reaffirmation of its 1992 policy on genetically engineered foods. The proposal affirms the FDA's 1992 position the it will not require mandatory pre-market safety testing of genetically engineered foods. Joseph Mendelson, Legal Director for the Center for Food Safety, sums up the FDA proposal by stating: (1) the proposal does not require mandatory pre-market safety testing, (2) does not require pre-market environmental review, (3) does not require mandatory labeling of GE (genetically engineered) foods, (4) limits voluntary non-GE labeling, (5) only requires a letter of notification prior to the marketing of a GE food, and (6) is unlikely to provide the public with adequate information on GE foods for independent review.

Also consider the Federal Food, Drug, and Cosmetic Act :

The Administrator shall consider the risks and benefits of public health pesticides separate from the risks and benefits of other pesticides. In weighing any regulatory action concerning a public health pesticide under this Act [7 USCS §§ 136 et seq.], the Administrator shall weigh any risks of the pesticide against the health risks such as the diseases transmitted by the vector to be controlled by the pesticide.

Thus, it is obvious that current environmental law and Federal legislation leaves genetic engineering regulation discretion in the hands of the biotech companies with few required legal guidelines.

In the Court Room

In a recent case, Alliance for Bio-Integrity v. Donna Shalala, et. al., 116 F. Supp. 2d 116 (2000), plaintiffs challenged a policy statement made by the defendants that proposed that "genetically engineered foods were presumptively not harmful, as violative of the Administration Procedures Act, of 21 U.S.C.S. §321 of the Federal Food, Drug and Cosmetic Act, of the National Environmental Protection Act, 42 U.S.C.S. §4321, and of the Free Exercise Clause of the U.S. Constitution amendment I as incorporated into the Religious Freedom Restoration Act, 42 U.S.C.S. §2000." The plaintiff's also seek FDA mandatory safety testing and labeling of all genetically engineered foods. It is evident in this recent court decision that substantial deference will be afforded to a government defendant. Plaintiff's motion was denied and summary judgment was granted. The court held that the defendant's statement did not constitute a final determination and that the statement "did not impinge on any of the plaintiff's religious beliefs, or negatively effect the environment."

Additionally, a class action lawsuit has recently been filed against Aventis CropScience. The plaintiff alleges the company failed to act as required by its EPA registration for the genetically modified corn variety known as Starlink.

The plaintiff also alleges that Aventis failed to take other precautions to prevent Starlink from entering the human food supply chain. Fortune magazine recently featured an article titled, "Reaping a Biotech Blunder." Brian O'Reilly stated, "Everybody ignored the safety rules on a kind of biotech corn called Starlink. Luckily, no one died from eating it. But what if someone had?" Federal regulators have threatened to ban Starlink until its safety has been determined. The courts have yet to determine the fate of Aventis' Starlink corn.

The process of genetically engineering foods results in the material change of such foods. The U.S. Congress has previously required that all food bear labels that reveal material facts to consumers. Federal agencies have failed to uphold Congressional intent by allowing genetically engineered foods to be marketed, sold and used without labeling that reveals material facts to the public. Consumers desire to know whether the food they purchase and consume contains or is produced with a genetically engineered material for a variety of reasons, including the potential health risks, concerns about potential environmental risks associated with the genetic engineering of crops, and religiously and ethically based dietary restrictions. Consumers have a right to know whether the food they purchase or consume contains or was produced with genetically engineered material.

On July 3, 2000, the Supreme Court of Colorado decided in favor of a proposed initiative concerning the labeling of genetically engineered foods. The Court found that the Initiative Title Setting Board of Colorado was within its discretion when it set out the labeling requirements for genetically engineered food and drink. Furthermore, the Court rejected the defendant's claim that the "initiative intended to effect a fundamental change in constitutional roles of the legislature and the electorate."

Furthermore, negligence law does not provide a sufficient remedy. Courts often require that physical harm be proven by plaintiffs who claim economic losses due to the defendant's negligence. One may also have difficulty in showing that the biotech firms had a duty to protect organic farmers who use the same chemicals without quantity restrictions, thus making a negligence claim very difficult to maintain.

Not a Final Thought

Does the tone and the direction of the above-mentioned decisions and disputes give us a true sense of the proper way genetic engineering should be monitored and regulated? Or are we unable to make insightful legal decisions in an area whose ramifications no one currently understands?