In the United States, the agencies that examine plants and plant products are the Environmental Protection Agency (EPA), the FDA of the U.S. Department of Health and Human Services, and the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA).

The USDA, through APHIS, regulates the development and field testing of genetically engineered plants, microorganisms, and certain other organisms under the authority of the Federal Plant Pest Act and the Plant Quarantine Act. APHIS regulations provide procedures for obtaining a permit or for providing notification of the intent to field test prior to importation, interstate movement, or release into the United States. Permission is granted based on the genes involved and the plant pests controlled by the transgenes.

APHIS has been reviewing applications for permits and notifications by industry, academia, and nonprofit organizations for field tests of transgenic crop plants since 1986, when it first proposed regulation of these products. After several years of field tests, an applicant can petition the agency to be released from requirements under the APHIS regulatory process. If the applicant can provide evidence that there is no plant pest potential (including the lack of change in disease and pest resistance, as well as the absence of the potential for new genetic material to create a new pathogen or pest), along with answers to a variety of other environmental questions, APHIS will grant the petition. At that time, the applicant is free to commercialize the plant line or use it in other breeding programs without going to APHIS for permission, subject to any necessary approvals from the EPA or FDA. To date, 51 petitions have been granted and more than 5,000 permits and notifications have been issued for field testing at more than 22,000 sites. Although no petitions have been denied, 13 have been withdrawn due to insufficient information or other application inadequacies.

APHIS maintains comprehensive field testing and petition databases that are used not only by domestic customers and stakeholders, but increasingly by foreign governments to verify that the U.S. government has reviewed the risks associated with products being considered for field testing or importation. These databases, as well as access to federal home pages on biotechnology regulation, are available at www.aphis.usda.gov.

The EPA's responsibility is to ensure the safety of pesticides, both chemical and biological, under the authority of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) through regulation of the distribution, sale, use, and testing of plants and microbes producing pesticidal substances. Under the Federal Food, Drug, and Cosmetic Act (FFDCA), the EPA sets tolerance limits for substances used as pesticides on and in food and feed, or establishes an exemption from the requirement of a tolerance if such a tolerance is not necessary to protect the public health (determined after evaluation by the agency).

The EPA issues experimental use permits for field testing of “pesticidal” plants and registrations for commercialization of these plants. The Bacillus thuringiensis (Bt) toxin, which occurs naturally in soil bacterium, is considered a biological pesticide. For plants containing Bt toxin, the manufacturer must prepare a resistance management plan as a condition for registration with the EPA. The plan has to describe how the manufacturer registering the plant product will assure that resistance does not build up in affected insect populations and reduce the effectiveness of Bt applied topically or used through the plant's genetics. The EPA also evaluates the new use of herbicides on herbicide-tolerant transgenic plants.

The FDA assesses food (including animal feed) safety and nutritional aspects of new plant varieties as part of a consultation procedure published in the 1992 Statement of Policy: Foods Derived From New Plant Varieties. Consistent with its 1992 policy, the FDA expects developers of new plant varieties to consult with the agency on safety and regulatory questions under the authority of FFDCA. FDA policy is based on existing food law and requires that genetically engineered foods meet the same rigorous safety standards as all other foods. The FDA biotechnology policy treats substances intentionally added to food through genetic engineering as food additives if they are significantly different in structure, function, or amount from substances naturally found in food. Many of the food crops currently being developed using biotechnology do not contain substances that are significantly different from those already in the diet and thus do not require premarket approval.

The EPA's jurisdiction under FIFRA is limited to pesticidal substances. For example, a plant that has been genetically modified to resist disease comes under FIFRA authority, whereas a plant that has been modified to resist drought does not. The former comes under EPA authority because the substance produced by the plant acts as a pesticide by affecting a pest. In the latter instance, a substance produced by the plant might result in, for example, deeper roots to enable the plant to access more water reserves. This transgenic plant would be subject to USDA regulation, and any food or feed produced would be subject to FDA authorities.

For plant pesticide varieties, the EPA has four categories: product characterization, toxicology, effects on nontarget organisms, and exposure and environmental fate. Product characterization includes reviewing the source of the gene and how the gene is expressed in a living organism, the nature of the pesticidal substance produced, modifications to the introduced trait as compared to that trait in nature, and the biology of the recipient plant. For toxicology, an acute oral toxicity test of the pesticidal substances on mice is required. At times, it has not been possible to make enough of the substance in the plant itself, so the EPA has allowed the exact same protein to be produced by bacteria and used for the testing. It should be noted that to date, all of the plant pesticides reviewed by the EPA are proteins plus the genes required to make these proteins within the plant. For these proteins, the EPA also requires a digestibility test to determine how long it takes for the protein to break down in gastric and intestinal fluids. The EPA also considers the potential of allergenicity. Determination of whether an introduced protein is likely to be an allergen is one of the major challenges for the federal agencies. The EPA and FDA work on this issue together.

For ecological effects, the EPA examines the exposure and toxicity of the plant pesticide to nontarget organisms, such as wildlife and beneficial insects. These tests are unique to the crop and pests involved. For example, during the review of the plant pesticide Btpotato, a test of potential effects of the introduced protein to ladybird beetles was conducted and showed that there were no adverse effects to these predators or the pesky Colorado potato beetles. For Bt-corn, tests were conducted on the potential effects on fish because field corn can be manufactured into commercial fish food. No effects were observed in the tests. EPA also has evaluated the degradation rates of the proteins in soil and plant residues.

Biosafety regulation is carried out in different countries by local agencies. In Canada, this regulation is administered by Health Canada, the Canadian Food Inspection Agency, and Environment Canada (EC). Together, these three agencies monitor development of plants with novel traits, novel foods, and plants or products with new characteristics not previously used in agriculture and food production. In Japan, all products derived from plant biotechnology are subject to rigorous testing procedures overseen by the Ministry of Agriculture, Forestry and Fisheries and the Ministry of Health, Labour and Welfare.

With a similar mandate, in Argentina the National Advisory Committee on Agricultural Biosafety (CONABia) and in Brazil the National Technical Commission of Biosafety (CTNBio) are in charge of biosafety regulation and monitoring. In Argentina, CONABia under the Ministry of Agriculture is responsible for harmonizing policies relating to biosafety. In Brazil, CTNBio under the Ministry of the Science and Technology has regulatory duties related to biosafety. CTNBio is composed of 36 members, including representatives from the scientific community in human, animal, plant, and environmental sciences, and other national leaders. This commission meets monthly to certify the safety of laboratories and authorize experiments with genetically modified organisms, and also evaluates requests to commercially release genetically modified products.

Ninety percent of the world's food is produced in North America, Europe, and Asia. More recently, Latin America has been increasing its contribution to the world food supply. For example, in 1979, Brazil produced about 39 million tons of grains. In 2000, that production increased to 84 million tons. The country was able to more than double its food production in a little less than 20 years. This increase is attributable to increased yields and the development of increased acres of farmland.

In the worldwide market, developing countries are small players in the global food supply. What role could biotechnology have for these countries? This science would allow increases in yield, improvement of nutritional quality, and reductions in agricultural production costs. This will be important, helping developing countries improve their economies by improving agriculture. One industry that is being strongly influenced by biotechnology is agro-chemical production. Worldwide, the agro-chemical industry is valued at about $20 billion (U.S.), annually. About $8 billion (U.S.) is related to agricultural chemicals used for control of diseases, insects, and weeds annually. In some crops, such as cotton, the cost of agro-chemicals accounts for nearly 40 percent of the total production cost. Biotechnology has made available pest-resistant cotton varieties that dramatically reduce the use of chemicals in crop management. This not only has a positive impact in reducing the costs for the farmer, but also benefits the environment by dramatically reducing the total amount of chemicals being used.

In the beginning of the 1990s, many people were skeptical of predictions that transgenic crop varieties would become a reality and would impact agriculture. The experience of the last six years, with the total area occupied with transgenic varieties reaching approximately 300 million acres, indicates that the initial forecasts about GMOs were wrong. In countries such as Argentina, more than 90 percent of the soybean acreage is planted with genetically modified soybean varieties. The continuous increase in farmland occupied with genetically modified varieties according to the 2001 census indicates their tremendous impact on agriculture worldwide. The acreage planted with transgenic soybean and cotton was, respectively, 63 percent and 64 percent of the total acreage in 2001. In the case of corn, the area planted with transgenics represented 24 percent of the total area, indicating stabilization in relation to the previous year. This stabilization is probably due to the reduction in the targeted insect pest population and to the smaller comparative advantage of the genetically modified varieties to normal corn hybrids when there is a low incidence of insects.

Transgenic Varieties

The first transgenic crops were field tested in the early 1980s. Currently, there have been more than 25,000 field tests worldwide, half of them in the United States and Canada. In Latin America, the largest number of field releases has occurred in Argentina. The commercialization of transgenic varieties began in the 1990s, with a tomato modified by Calgene. Today, transgenic varieties of various crop species are used in the United States, Canada, Mexico, Australia, France, Spain, China, Argentina, Uruguay, and other countries (see Figure 5-2). The plant species mainly have resistance to insects and diseases, tolerance to herbicides, and improved nutritional quality, as in the case of canola, in which the fatty acid composition was altered to make products more suitable for heart patients.

Figure 5-2. Global status of genetically modified crops in 2002.

The fast pace of biotechnology has raised many safety, ethical, and legal issues. One of the more sensitive issues came with the cloning of mammals from the somatic cells of adult animals. Dr. Ian Wilmut, at the Roslin Institute in Scotland, who worked with Dolly, the now famous cloned sheep, was the first to accomplish this. Today, there are clones of cattle, pig, monkeys, mice, and many other animals. News briefs covering the latest advancements and setbacks in this science are now commonplace. It is obvious that many questions remain unanswered.

Aside from the scientific questions, there exist social questions that need to be addressed. In the United States, there have been many public hearings in the federal legislature, and many states have subsequently banned human cloning. Additionally, some countries in Europe and elsewhere have raised concerns about the risks that cloned animals and transgenic crop varieties pose to the environment and human and animal health.