Text: USDA Testimony on Biotechnology Products

The U.S. Department of Agriculture (USDA) detailed its role in controlling the environmental release of genetically-modified organisms in testimony to Congress October 19. Sally McCammon, science advisor for the Animal and Plant Inspection Service (APHIS), testified on the regulatory process to ensure the continued protection of U.S. farm animals and crops from pests and disease.

According to McCammon, APHIS has been regulating products of biotechnology for 13 years, using a stringent process to ensure that the environment is protected from the release of harmful organisms. Even before field testing an organism, plant breeders must follow federal procedure to receive APHIS approval for the field test. After field testing, breeders may apply for permission to market their product without regulation.

"Plant breeders normally do several years of field testing to evaluate agronomic and product quality characteristics of a new variety that has been developed in the laboratory or greenhouse," McCammon said.

McCammon concluded by emphasizing the importance of cooperation between all parties and agencies. "This task cannot be the sole responsibility of any one agency, one department, or the federal government. We must all work together to provide the public with accurate, scientific information about biotechnology," McCammon said. "We must ensure that our regulatory systems continue to protect public health, safety and the environment, and maintain the flexibility to respond to the constantly changing needs of the present and the future."

Following is the text of McCammon's testimony before the Basic Research Subcommittee of the House Science Committee:

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Statement of Dr. Sally L. McCammon

Animal and Plant Health Inspection Service
United States Department of Agriculture
Before the House Committee on Science Hearing on Biotechnology and Agriculture

October 19, 1999

Mr. Chairman and Members of the Committee, it is my pleasure to be here today to discuss the role of the United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) in regulating genetically modified products. My name is Dr. Sally L. McCammon, and I am the APHIS Science Advisor. I have worked on biotechnology issues for more than ten years.

One of the most far reaching issues confronting the USDA today is agriculture biotechnology. More than any other area of the Department, the Marketing and Regulatory Programs (MRP) mission area is directly affected by the emergence of biotechnology.

Within the NW mission area, several agencies are experiencing changes due to biotechnology issues. A number of Agricultural Marketing Service (AMS) programs are being affected by the introduction of biotechnology advances, such as the classification of transgenic varieties. of cotton, seed testing and identification technologies, and applications for the protection of plant varieties. The Grain Inspection, Packers and Stockyards Administration (GIPSA) is monitoring developments in biotechnology to assess the effect on the official U.S. Standards for Grain and the official grain inspection system.

The most significantly affected agency within MRP is the Animal and Plant Health Inspection Service (APHIS), which is charged with protecting the nation's livestock and crops from diseases and pests. As part of that mission, APHIS also regulates genetically engineered plants, microorganisms, and veterinary biological products. Our regulatory policies play a critical role in safely moving biotechnology products from the laboratory, to the field, and into the marketplace.

Our regulatory policies are rooted in the 1986 Coordinated Framework for the Regulation of Biotechnology, which is the foundation in the United States for a comprehensive Federal regulatory policy for biotechnology research and products. This Framework was based on the premise that the risks associated with the introduction into the environment of DNA-engineered organisms are the same as those associated with the introduction of unmodified organisms and organisms modified by other genetic techniques.

Under the Framework, three Federal agencies play integral, interdependent roles regulating genetically engineered products. APHIS is the lead agency for the oversight of the environmental release of genetically modified plants and animals. The Food and Drug Administration (FDA) is the lead agency on plants consumed as human food. The Environmental Protection Agency (EPA) is the lead agency for microbial products and pesticides.

APHIS biotechnology programs provide services including permitting and notification, granting of petitions to determine pest status, and licensing. These regulatory functions are administered by APHIS' Plant Protection and Quarantine (PPQ) and Veterinary Services (VS). An increasing number of sanitary and phytosanitary biotechnology trade issues are handled by the respective operational support staffs. In addition, many of the program laboratories, such as the National Wildlife Research Center, the PPQ Methods Development Labor Laboratories, and National Veterinary Services Laboratories, use the tools of biotechnology to develop methods for field operations.

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. Plant breeders normally do several years of field testing to evaluate agronomic and product quality characteristics of a new variety that has been developed in the laboratory or greenhouse. APHIS regulations, outlined in Title 7, Part 340 of the Code of Federal Regulations, provide procedures for obtaining a permit or for providing notification prior to importation, interstate movement or release of a regulated article into the United States. Regulated articles are considered to be organisms -- primarily plants and microorganisms - - and products altered or produced through genetic engineering that are plant pests, or that there is reason to believe are plant pests.

After several years of field testing under permit, an applicant can petition APHIS to be released from regulatory requirements through a determination of nonregulated status. If the petitioner provides evidence that there is no plant pest potential, the agency will grant the petition. Once a determination of nonregulated status has been made, the product - - and its offspring - - no longer requires APHIS review for movement or release in the United States. Depending on the organism and its intended use, however, the product may require additional review by the EPA and FDA.

APHIS finalized its first plant biotechnology regulations in 1987. Today, APHIS has processed more than 5,000 permits and notifications for field release of genetically modified organisms at 22,000 sites, and almost 50 petitions for deregulation. In 44 types of plants, field testing has occurred with genes for herbicide tolerance (28%), insect resistance (24%), product quality (19%), virus resistance (10%). agronomic properties (6%), fungal resistance (5%), and other properties including bacterial resistance (8%). Permits for field testing have also been issued to evaluate the risk for certain genetically engineered microorganisms that are plant pests and for a few biocontrol agents. National Environmental Policy Act (NEPA) analyses are conducted by APHIS as part of the process for review of petitions for nonregulated status. The majority of petitions have been for testing herbicide tolerance and pest and disease resistance. However, some are for product quality attributes such as altered oil profile and delayed ripening.

APHIS' Plant Protection and Quarantine maintains comprehensive field testing and petition databases. These databases are used not only by domestic customers and stakeholders but increasingly by foreign governments to verify that the U.S. Government has reviewed the risk for products considered for field testing or importation. These databases as well as information on APHIS biotechnology regulations and guidelines are available via the Internet at www.aphis.usda.gov.

APHIS Veterinary Services also has biotechnology risk assessment responsibilities. The Center for Veterinary Biologics (CVB) issues licenses for veterinary vaccines and diagnostics products manufactured by biological firms, and also provides training for these firms, foreign regulatory officials and research scientists in the regulatory processes for biotechnology-derived products, compliance with applicable Federal law and policy, and molecular biology laboratory technologies. In addition, the Center reviews and performs risk analyses of genetically engineered organisms. Also, the Genetically Engineered Arthropod Vectors of Animal Disease team assesses the risk involving genetic alteration of arthropods such as mites, ticks, and fleas as disease vectors for livestock.

Science informs the regulatory decision-making process at multiple levels. The available published scientific literature, particularly from peer-reviewed journals, is used by regulatory scientists in evaluating specific products. Applicants also cite the scientific literature in their applications for regulatory approval. The regulatory agencies also sponsor meetings of scientists to address specific issues, such as meetings on viral resistance and relevant biological factors for evaluating crop plants. For example, APHIS recently sponsored a workshop on the Ecological Effects of Pest Resistance Genes in Managed Ecosystems. In addition, the USDA has a biotechnology risk assessment grants program that funds research on issues associated with genetically engineered organisms. The National Academy of Science is reviewing the specific scientific issues pertaining to the USDA. All of this information is used by regulators to ensure that the most current science is available for regulatory decisions.

Internationally, APHIS works towards harmonization of regulatory approaches to product safety through the Organization for Economic Cooperation and Development (OECD), particularly the Working Group for Harmonization of Regulatory Oversight of Biotechnology, which focuses on environmental safety issues. APHIS also works with the International Plant Protection Convention (IPPC) and the Office des International Epizooties (OIE) on common standards and approaches to safety assessment of these agricultural products.

Mr. Chairman, biotechnology has the potential to create more and better sources of food, to reduce pesticide use, increase yields, and improve nutrition and quality of life. The success of the biotechnology regulatory system in the United States is due to the fact that regulatory agencies with established credibility and scientific expertise were designated to evaluate the products of biotechnology. There is now a 13-year history of evaluating the products of biotechnology for safety. In addition, advances in biotechnology have increased the ability of regulators to scrutinize product safety and the effect of product modification upon safety. The approach to review of biotechnology is constantly evolving due to new types of products and the availability of new scientific information.

We must proceed, however, with an awareness of unanswered questions and the concerns of others. Some in the public have voiced concerns about genetically engineered products, and Secretary Glickman strongly believes we have a responsibility to listen to these concerns, answer these questions and develop appropriate solutions.

In July, Secretary Glickman outlined five principals that should guide us in our approach to biotechnology in the 21st century. These principals are: (1) an arm's length regulatory process, where government regulators provide consumer and environmental protection without impeding the development of biotechnology products; (2) consumer acceptance, which is based on a sound and scientific regulatory process; (3) fairness to farmers, where the biotechnology developments result in real benefits to farmers, especially small and medium sized farms; (4) corporate citizenship, where biotechnology companies understand and respect the role of the regulator, the farmer, and the consumer, and (5) free and open trade, where agriculture commerce is not blocked' by unwarranted or unscientific claims.

This task cannot be the sole responsibility of any one agency, one Department, or the federal government. We must all work together to provide the public with accurate, scientific information about biotechnology. We must ensure that our regulatory systems continue to protect public health, safety, and the environment, and maintain the flexibility to respond to the constantly changing needs of the present and the future.

Thank you, Mr. Chairman, for the opportunity to present my remarks.

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