Biotechnology – An Overview


Background

A uniformly accepted definition of biotechnology does not exist.  Under the broadest definition, the use of biological sciences to develop products, conventional plant and animal breeding techniques, conducted since the dawn of civilization, fall under biotechnology.  In the popular press, biotechnology generally refers to newly-developed scientific methods used to create products by altering the genetic makeup of organisms and producing unique individuals or traits that are not easily obtained through conventional breeding techniques.  These products are often referred to as transgenic, bioengineered, or genetically modified because they contain foreign genetic material.  Agriculture is one of the first industries radically affected by this new technology on both a fundamental production level and a legal level.

A vast array of products derived from biotechnology impact agriculture in many ways.  Cattle hormones produced in bacteria are used to increase milk production in dairy cows.  Plants engineered to produce huge quantities of particular proteins survive herbicide application that kills unmodified plants of the same species.  Tomatoes modified to resist bruising during shipment are allowed to ripen on the vine.  Corn plants that produce the precursors of plastics decrease the need for petroleum in the plastics industry.  Rice modified to produce high levels of vitamin A may enable third world countries to prevent blindness in children.  Cotton plants designed to produce a bacterial toxin contain their own insecticide.  Farm-raised salmon grow twice as fast as their wild counterparts.  Biotechnology companies indicate that this list is only the beginning and that the possibilities are limited only by imagination.

However, consumer acceptance of these products varies across the globe.  The relatively recent development of this technology has presented novel legal issues for private parties and governments as the law attempts to keep pace with scientific advancement through regulation, assignment of liability, protection of intellectual property rights, and international dispute resolution.  The limitless possibilities and exotic combinations of organisms pose a remarkable challenge for law and policy makers.


Regulation

Under the policy statement contained in the Coordinated Framework for Regulation of Biotechnology, regulation of biotechnology products in the United States is handled by three agencies: the Food and Drug Administration (“FDA”), the United States Department of Agriculture (“USDA”), and the Environmental Protection Agency (“EPA”).  Because federal policy takes the position that biotechnology itself has no inherent dangers, biotechnology products are regulated under existing laws in the same manner as non-biotechnology products, with no specialized regulatory law or agency having sole authority over biotechnology.  The regulatory burden falls on a particular agency based on the product’s intended use and chemical composition.  Due to their novel combination of traits, some products may require regulation under multiple agencies. Both the transgenic organism and the products produced from it may be regulated.

The FDA is responsible for regulation of food, feed, human drugs, and animal drugs; the EPA regulates pesticides and toxic substances; and the USDA oversees meat, poultry, and egg products, plant pests and noxious weeds, and animal biologics.  Under this regulatory structure, transgenic plants are regulated by the USDA as potential plant pests and may be regulated by the EPA if they produce pesticides or potentially toxic chemicals.  Transgenic animals may be regulated by the FDA under the theory that the genetic manipulation is an animal drug, and if the genetic change produces either a drug, food, or biologic, then that product may also be regulated by the FDA.  The potential for EPA regulation exists if the transgenic animal produces potentially toxic chemicals.  The EPA also has the ability to regulate microorganisms under their authority to regulate toxic substances.

The regulation of products derived from transgenic organisms offers other ways for agencies to regulate biotechnology.  Whole foods, food additives, dietary supplements, and drugs obtained from transgenic plants are regulated by the FDA.  Foods derived from transgenic animals may be regulated by the FDA under the theory that the genetic material is an animal drug; transgenic meat, poultry, and egg regulation falls to the USDA; pesticide and chemical products will be regulated by the EPA.

United States regulation of biotechnology is a complex structure in which three agencies work together to regulate technology that did not exist when current regulatory laws were enacted.  Much of the current regulatory framework is untested and will continue to evolve as new transgenic organisms and products are brought to market.

Labeling

Some states have enacted legislation that requires foods derived from biotechnology to have labeling indicating so. Connecticut, the first state to pass such legislation, requires labeling of genetically engineered food sold in its state. Connecticut’s law provides that some foods are misbranded unless identified as being genetically engineered. Maine and Vermont passed their own legislation to require labeling for products derived from biotechnology, but Maine’s law has been repealed. These states require companies to label food or seed stock that are entirely or partially produced by genetic engineering. Connecticut requires labels to be in text-form and must use the language described in the statute. Vermont’s law also requires a text label but allows for different labeling phrases that can indicate if a product was possibly, partially, or completely produced using biotechnology. For Connecticut’s law to go into effect, surrounding states would have to pass comparable labeling law, but this provision has not been met. Vermont’s legislature did not include this provision, and the state’s labeling disclosure requirement is currently in effect.

Federally, the FDA and USDA have regulated genetically modified product labels. Both agencies examine whether a label is false or misleading, which is called misbranding. The FDA is responsible for bioengineered human and animal food, drugs, and cosmetic products, and does not have the authority to pre-approve labels of these products. The USDA is responsible for inspecting labels of genetically modified meat, poultry, and egg products, verifying all labels are not misleading. The USDA has pre-marketing authority on labels and requires manufacturers to submit labels for approval before the product enters commerce.

Labeling products modified by biotechnology was voluntary until recently, when Congress passed the National Bioengineered Food Disclosure Standard. Under this federal legislation, the USDA is responsible for enforcing mandatory labeling disclosures of genetically modified food or food that may be genetically modified. Animals that solely consumed feed produced from biotechnology are not considered genetically modified and exempt from the labeling requirement. Parties that must label its bioengineered products are food manufacturers, importers, packaging retailers, and retailers that sell bulk food items. Restaurants and food manufacturers with low annual revenues are exempt from the labeling requirements. Different from state legislation, the federal law allows parties to choose either a symbol, text, or electronic or digital link as its form of disclosure label.

Federal labeling laws and regulations preempt all state biotechnology labeling laws. This means state laws may not impose different or additional requirements that contrast from federal labeling laws and regulations. The states that previously enacted mandatory labeling laws will now have to follow the standards of the federal regulations, which means these states must allow the various forms of labels. However, states can administer their own remedies for violations of this federal standard.


Liability

Liability for biotechnology damages generally follows traditional common law actions, as no unique actions have developed solely for damage from transgenic products.  Damage from the use of biotechnology usually consists of contamination of non-genetically modified organisms by genetically modified ones.

One possible theory for liability may be in an action for trespass.  When transgenic pollen moves from the field where it is produced onto another’s property, a physical invasion may occur.  If this invasion results in damage, then an action for trespass may be an appropriate choice.

Strict liability may also be an avenue for the recovery of damages if a farmer is damaged by a neighbor’s transgenic crop.  This approach allows recovery by the injured party despite precautions taken by the other party, and also requires that growing transgenic crops be deemed an abnormally dangerous activity.  Demonstrating that raising transgenic crops is an abnormally dangerous activity is becoming more difficult with the widespread use of such crops.

Negligence is also a potential method of establishing liability by requiring that biotechnology companies and farmers using transgenic crops utilize reasonable precautions to prevent damage to other parties.  Entities that fail to reasonably protect others from the risks associated with transgenic organisms may face liability in the form of negligence actions.

Private nuisance is also a theory that may be used to confer liability onto users of biotechnology.  Liability may arise if it can be shown that the use of transgenic organisms unreasonably interfered with the quiet use and enjoyment of a neighbor’s land and caused significant harm.

Public nuisance allows a private party to recover damages and to prevent further harm to the public.  There is no requirement of distinct harm to land rights.  The required harm must be an unreasonable interference to a right common to the public.  In order to recover, the individual who pursues the action must have been damaged in a special manner distinct from the harm suffered by the general public and must prove that growing a particular transgenic crop interfered with a right common to the general public.

These theories of liability attempt to use traditional legal causes of action on new and expanding technology.  Other potential liability for farmers may arise under biotechnology agreements and contracts.  Most seed companies that sell biotechnology seed require that farmers sign a technology agreement.  These agreements often give seed company representatives the right to access farmers’ property for inspection, limit the ability of farmers to save seed, and control production practices involving the biotech seed.  The terms of these technology agreements may leave farmers who do not carefully follow the agreement open to liability for breach of contract.

Marketing of crops may also be an avenue of liability for farmers through cross-contamination of their crop by transgenic crops.  Farmers who are under contract to deliver crops free from biotechnology may be unable to provide such a marketable commodity due to contamination.  Farmers who certify that their crop is free from biotechnology may be liable due to contamination from sources beyond their control or knowledge.


Intellectual Property

Intellectual property rights provide incentives for the development of new products by rewarding inventors or developers with protections such as exclusive rights for the making, using, and selling of the new product.  Biotechnology research is expensive, and its products are lucrative while the technology itself is easily detected by scientific tests.  These factors are leading to a rapid development of intellectual property rights in biotechnology, and in turn the development of intellectual property rights fuels the scientific advancement of biotechnology.

Until the Plant Patent Act of 1930 (“PPA”), living organisms were considered unpatentable because they are products of nature and presumably did not meet the requirements of utility patents.  The PPA allows developers of new and distinct plants to prevent the asexual reproduction, sale, and use of patented plants.  It does not protect sexually reproduced plants.

The Plant Variety Protection Act of 1970 (“PVPA”) provides protections to breeders who create new and distinct varieties of sexually produced plants.  It prevents the unauthorized sale or growing of a protected plant.  The protection includes both the plant and its seeds and lasts for twenty years.  The PVPA also contains an exemption for farmers who save seed for their own use and one for research using the protected plant.

In 1980, the Supreme Court decided that living organisms were able to be patented under general patent law if the organism met the patent requirements.  This has resulted in patents both on the technology used to create transgenic organisms and the new organisms themselves.  Varieties created with traditional breeding methods are also able to be patented.  The patent limits the sale, use, and manufacture of the protected plants for seventeen years without the exemptions allowed under the PVPA.  Due to the elimination of the PVPA exemptions for their products, biotechnology companies are able to assure a greater return on their investment for transgenic research and development that has fueled the biotechnology revolution in agriculture.  Patent holders may allow others to use their protected process or product by granting a license.

Typically, when farmers buy transgenic seed they are being granted a license by the patent holders to use that seed on a limited basis in their farming operation.  The technology agreements that farmers normally sign upon purchase of transgenic seed also contain provisions designed to protect the intellectual property rights of the patent holders.

Patents are issued on a national basis, and a patent must be obtained in each country where protection for the biotechnology product is desired.  Generally, patent systems have existed in only developed countries, but biotechnology has driven the development of patent law internationally in both developed and developing countries.  The Agreement on Trade Related Aspects of Intellectual Property Rights (“TRIPS”) mandates that all countries of the World Trade Organization (“WTO”) develop patent or other intellectual property rights protection systems.

The spread of these systems has also caused debate about farmers’ rights.  The farmers’ rights debate is based on the idea that biotechnology companies are given free access to traditional plant varieties used and developed by farmers for generations.  The farmers are then required to pay for the genetic modifications made to their traditional varieties without receiving any benefit for the basic genetic information that they provided to the biotech company.


International Issues

In addition to the intellectual property issues, biotechnology has fueled numerous international disputes because different areas of the world vary in their level of acceptance of the technology.  The European Union has used safety concerns to prevent importation of transgenic crops.  Advocates of biotechnology allege that these concerns are not based on legitimate science and are an illegal trade barrier under WTO agreements.  Other groups fear that biotechnology will damage the ecosystems of developing countries or that developing countries will be unable to pay for access to the technology that may benefit them most.  Others argue that biotechnology is key to feeding the world’s hungry by developing high yielding crop varieties for all parts of the world, and that biotechnology benefits the environment.  As these disputes are addressed, many international legal issues will be confronted.