3. Regulation of Biotechnology

Biotechnology products are regulated primarily by three federal authorities: the Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), and the U.S. Department of Agriculture (USDA). The FDA has jurisdiction over new human and animal drugs as well as older drugs produced in new ways. The FDA also has jurisdiction in ensuring the safety of new foods and of new or increased amounts of substances in foods or food additives. The EPA has jurisdiction over any product that may have pesticidal properties and for any new chemical substance for introduction into the U.S. market that is not regulated under any other statutory authority. The USDA has broad statutory powers to regulate agricultural research and agricultural products to protect crops and livestock from pests, disease, or harmful plants. Along with the federal regulation, several states, including North Carolina, have also developed legislation to control certain aspects of biotechnology.

North Carolina's Genetically Engineered Organisms Act

North Carolina was one of the first states to formulate and enact legislation specifically regulating biotechnology. The North Carolina Genetically Engineered Organisms Act regulates the release into the environment and the commercial use of genetically engineered organisms. (The federal agencies listed above also regulate these activities.) The state law, administered by the North Carolina Department of Agriculture (NCDA), requires that a permit be obtained from the NCDA for field testing of genetically engineered microbes, plants, or animals. Organisms produced by traditional breeding methods, such as hand pollination of crop plants and artificial insemination of animals, do not require a permit. The law and regulations are formulated to work with existing federal regulatory procedures, and the NCDA cooperates with federal regulatory agencies in the permit review process. The legislation regulating biotechnology must address the concerns of the general public, farmers, and the business community.

Food Safety

As evidenced by the previous discussion, biotechnology offers increased opportunities for improving or developing food production systems, especially from an environmental standpoint. Moreover, the potential benefits extend to improving the nutritional quality, safety, flavor, convenience, and cost of the food supply. However, acceptance by both regulatory agencies and consumers will depend on ensuring that foods resulting from the application of biotechnology are indeed safe to eat. To suggest that we should not be concerned about the safety of these foods would be misleading. Any changes in the composition of foods or in the methods used to handle, process, preserve, and distribute them must be evaluated to determine their impact on food safety. However, we must be careful not to exaggerate the safety issue beyond its true dimensions. We must remember that all of our food has been genetically modified through the years.

The U.S. Food and Drug Administration, in late May of 1992, announced its policy for foods derived from genetically engineered plant varieties. In essence, the policy statement reaffirmed that genetically engineered foods will be judged on the characteristics of the food and not on how the plant genes may have been manipulated. The policy also stated that the anticipated regulatory approach will be "identical in principle" to that applied to foods - genetically modified by traditional plant breeding practices. Thus, it appears that the FDA views the safety considerations for genetically engineered products to be no greater than for products genetically modified by traditional practices.

The FDA's policy on the regulation of genetically engineered foods should not be viewed as fixed. On the contrary, as we expand our understanding of this new tool, policies governing its application will undoubtedly be modified. Just as policies change to reflect new understanding, so, too, can consumer attitudes. For those who are skeptical, even fearful, we hope that wise and prudent application of this technology will result in benefits that diminish these concerns.

Examples of Important Elements of FDA Policy on Food Safety

When the intended product or products of gene expression are already
present at generally comparable or greater levels in currently consumed
foods, there is unlikely to be a safety question that would
warrant FDA review.
Substances that are expected to become components of food as a result
of genetic engineering of a plant and whose composition is such, or has
been altered such, that the substance is no longer Generally Recognized as
Safe (GRAS) will be subject to regulation as food additives. This means that
producers would be required to submit a formal food additive petition to the
FDA to obtain approval to use the "additive" in question.
Opinions have been expressed about requiring special labeling of foods
derived from genetic engineering. FDA policy indicates that the method of
developing new plant varieties is not important information and therefore
would not usually be required on food labels. However, consumers must be
informed by appropriate labeling if a food derived from a new plant variety
differs from its traditional counterpart enough that the common or usual name
no longer applies to the new food or if there is a safety or usage issue to
which the consumer must be alerted. In explaining this requirement, the FDA
has used the following example. If a peanut protein has been introduced into
a tomato and there is insufficient information to demonstrate that the
introduced protein will not cause an allergic reaction in a susceptible
population, then the label must declare the presence of the peanut protein.
The purpose of the declaration is to alert consumers who are allergic to
peanuts so they can avoid the tomato, even if the basic taste and texture of
the tomato remain unchanged.
Some genetic modifications will not come under the authority of the FDA
but will fall under jurisdiction of the EPA. This category includes (1)
substances intended to kill insects; (2) substances intended to protect plants
from viral, fungal, or bacterial infection; and (3) substances that are plant
regulators. The EPA has not yet released its final policy on biotechnology.
The FDA's jurisdiction includes genetic modifications that result in the
expression of (1) substances intended to alter the nutritional composition of
foods, (2) substances intended to enhance the plant's resistance to chemical
herbicides, and (3) substances intended to alter the flavor and texture of foods.