Sally L. McCammon, Ph.D.
Science Advisor
Animal and Plant Health Inspection Service
United States Department of Agriculture



Under the coordinated Federal framework for the regulation of biotechnology, the USDA's Animal and Plant Health Inspection Service (APHIS) works, along with the Environmental Protection Agency (EPA) and the U.S. Department of Health and Human Services' Food and Drug Administration (FDA), to ensure that genetically engineered organisms do not harm people or the environment. Biotechnology regulatory activities currently include permitting and notification, deregulation, and licensing functions. APHIS regulates these products under the Federal Plant Pest Act (FPPA), the Plant Quarantine Act (PQA), and the Virus, Serum, Toxin Act (VSTA).

Under the FPPA and the PQA, APHIS has oversight over the field testing through commercialization phases of the development of transgenic plants. To date, approximately 5,000 permit/notifications for field release of genetically modified organisms (GMO) at 25,000 sites, and 50 petitions for deregulation (a step leading to commercialization) have been granted for 13 plant species. Thus, when a company, academic research institution, non-profit organization, or public sector scientist wishes to field test a biotechnology-derived plant, they must first contact APHIS for permission. The field testing of biotechnology-derived plant products can be initiated in two ways. The first entails obtaining a permit from APHIS prior to testing to ensure that the test is conducted in accordance with all regulatory requirements.

Field testing must be done to assure that the test is confined. There must be no escape or establishment of the plant and all plant material must be accounted for at the end of the test. APHIS issues field testing permits annually, and each permit requires specific information from the tester about the plant, including all new genes and gene products, their origin, the purpose of the test, how the test will be conducted, and specific precautions that will be taken to prevent the escape of pollen, plants, or plant parts from the field test site. Before authorizing a field test, APHIS reviews the permit application for possible effects on the environment, endangered or threatened species, non-target species, and the potential for any gene transfer to cultivated wild or weedy species. In addition, if our Agency approves a new biotechnology-derived plant for field testing, our officials and their State counterparts may inspect the field test site before, during, and after a test to ensure that it is conducted and managed safely.

Based on the Agency's experience, APHIS has streamlined the permit process for approving field testing. Most applicants can now use a simplified procedure in which they provide APHIS with a notification of the intent to field test. APHIS has 30 days to review and approve this notification prior to field testing. Although these simplifications have reduced the time involved in the overall permitting process, these field tests are still required to meet all the same safety standards as required under the original procedure. In addition, if APHIS approves a new biotechnology derived plant for field testing, APHIS officials and State agricultural counterparts may inspect the field test site before, during, or after a test to ensure that it is conducted and managed safely.

After several years of laboratory and field testing, a developer may decide to commercialize the genetically engineered variety and petition APHIS to be released from regulatory oversight. In other words, the developer will submit a petition for APHIS' determination of non-regulated status. Upon receipt of a petition, APHIS thoroughly evaluates the scientific information provided for technical completeness. Specifically, APHIS examines the biology and genetics of the plant, the nature and origin of the genetic material used, possible effects on other organisms in the environment and agricultural products, and all field test reports.

Depending upon the particular plant line, APHIS evaluates a variety of potential effects such as: 1) the potential for creating plant pest risk; 2) disease and pest susceptibilities; 3) the expression of gene products, new enzymes, or changes to plant metabolism; 4) weediness, and impact on sexually compatible plants; 5) agricultural or cultivation practices; 6). effects on nontarget organisms, including humans; 7) effects on other agricultural products; and 8) the potential for gene transfer to other types of organisms.

APHIS also completes an environmental assessment of the new variety to ensure the plant poses no significant risk to the environment, other plants, or non-target species, including humans. Our agency evaluates all available scientific information, including the information provided by the developer in the petition. The Agency then determines whether the new transgenic plant: 1) exhibits no plant pathogenic properties; 2) is no more likely to become a weed than the non-engineered plant; 3) is not likely to increase the weediness of any other plant with which it is sexually compatible; 4) will not cause damage to processed agricultural commodities; and 5) is not likely to harm other organisms that are beneficial to agriculture.

APHIS either approves or rejects the petition for technical completeness. If rejected, the developer may choose to either amend and resubmit the petition or withdraw the petition. APHIS publishes both the petition and the environmental assessment in the Federal Register for public comment. APHIS considers public comments before making a decision and publishing the final environmental assessment and a decision that the transgenic plant is no longer regulated. Copies of these APHIS decision documents are available to the public.

If it is determined that the new plant poses no significant risk to other plants in the environment and is as safe to use as more traditional varieties, APHIS finalizes the environmental assessment and writes a determination of nonregulated status. Once granted, this determination enables the new plant to be cultivated, tested, or used for traditional crop breeding without any additional APHIS action. Essentially, this determination permits the plant to be widely grown and commercialized.

In most cases, however, the developer is still subject to oversight by the Environmental Protection Agency and the Department of Health and Human Services' Food and Drug Administration.

Under the VSTA, the Center for Veterinary Biologics (CVB) is responsible for assuring that

veterinary biological products are pure, safe, potent and efficacious. The techniques of biotechnology are with increasing frequency being applied by manufacturers to develop products being presented to CVB for licensure. Biologics, including vaccines, diagnostics, and immunotherapeutics often use monoclonal antibodies, recombinant DNA, or other biotechnology methods. Of approximately 2000 licensed products, 79 are biotechnology products, and 36 of 101 licensed firms are involved in biotechnology products. Biotechnology products include monoclonal antibodies, killed rDNA agents, genetically engineered purified antigens, live deletion mutants, and live vectored antigen vaccines, as well as vaccines using transposons, recombinant cytokine adjuvants, and up-regulation of natural antigens. Naked DNA vaccines and plant-expressed antigens for oral (feed) vaccination are products presently being addressed by the Center, and disease-resistant transgenic animals are on the horizon.

Since science is the basis for the regulatory decisions made by APHIS and the other agencies that approve products, the Secretary of Agriculture has asked the National Academy of Sciences to establish a standing committee on Biotechnology, Food and Fiber Production, and the Environment. The first project of this committee will evaluate the environmental effects associated with the commercialization of transgenic crops. The academy will provide APHIS with an independent review of the scientific underpinnings of its regulatory decisions.

Internationally, APHIS participates in initiatives to ensure international harmonization of regulatory review of biotechnology products and to assure that scientific principles are used as the basis for review. These initiatives are critical in reaching agreement on the safety and development of review processes for these products globally from the first field tests to the latest commercial applications. APHIS is the lead agency to two of the standard-setting bodies, the Office Internationale des Epizooties and the International Plant Protection Convention (including North American Plant Protection Organization) designated under the Agreement on Application of Sanitary and Phytosanitary Measures (SPS) of the World Trade Organization (WTO). APHIS has always played a lead role in the work done on technical review of plants at the Organization for Economic Cooperation and Development (DECD). Work in these and other international venues will continue to provide guidance and information to the international community on the practical means for reviewing the products of modern biotechnology.



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