*EPF418 05/09/2002
Byliner: Official Outlines U.S. Food Safety Regulatory System
(Agriculture Dept. scientist says food reviews intense) (1930)

(The following article appears in the May 2002 issue of the State Department's electronic journal, Economic Perspectives. The issue is titled: Food Security and Safety. The entire journal can be viewed at: http://usinfo.state.gov/journals/journals.htm)

The U.S. government, with more than 16 years' experience in evaluating biotechnology products, has instituted the most thorough and scientifically-based regulatory system anywhere in the world, says Sally McCammon, chief scientist with the U.S. Department of Agriculture's Animal and Plant Health Inspection Service. McCammon outlines the roles played by key U.S. regulatory agencies and their approach to food safety, and describes the mechanisms in place to ensure that those regulatory bodies see the most current scientific information available before they release any genetically engineered product to the U.S. market.

Following is the text of McCammon's article:

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ENSURING SAFE FOOD

By Sally L. McCammon, Science Advisor, Animal and Plant Health Inspection Service, U.S. Department of Agriculture

Few food issues have raised as much interest, particularly internationally, as has the safety of genetically engineered foods. And few foods have been as thoroughly examined, dissected, tested, and regulated. The fact is that genetically modified foods developed in the United States have gone through the most intense regulatory and scientific review that exists anywhere in the world and would not be found in the U.S. marketplace unless regulators were completely convinced about their safety. This article reviews the U.S. regulatory process and the key agencies responsible for the safety of U.S. food supply and, consequently, the U.S. food exports.

THE U.S. REGULATORY FRAMEWORK

In 1986 the White House issued the Coordinated Framework for the Regulation of Products of Biotechnology proactively establishing a strong commitment by the U.S. government to the safe development of biotechnology products from the laboratory, through field-testing and development, and into the marketplace. Over the last 16 years, the United States has gained considerable experience in evaluating the products of biotechnology for safety. The framework's underlying assumption is that the risks from the products of biotechnology are the same in kind as those of similar products -- risks to agriculture, the environment, and human health. Thus, existing U.S. laws and regulations for addressing these risks have been deemed adequate to address any risks posed by products developed using biotechnology, and no new "gene law" has been considered necessary.

To assure safety, the U.S. regulatory structure is based on risk rather than process, and its success is due to the fact that regulatory agencies with established credibility and expertise evaluate these products. Many aspects are evaluated when determining safety. Regulations establish procedures and criteria by which different types of products are evaluated, including those produced using biotechnology, products such as vaccines, plant varieties for food, pesticides, animal products, and pharmaceuticals. Certain products of modern biotechnology can easily be assessed under existing regulations, while other products require new regulations.

The U.S. regulatory agencies that examine plants and plant products intended for use as food are the Environmental Protection Agency (EPA), the Food and Drug Administration (FDA) of the Department of Health and Human Services, and the Animal and Plant Health Inspection Service of the U.S. Department of Agriculture (USDA-APHIS). A new genetically engineered plant could be reviewed by one or all three of these agencies, depending on the plant and trait engineered into it. For instance, a Bacillus thuringiensis (Bt) gene in a food crop would be reviewed by USDA-APHIS, EPA, and FDA; a plant with modified oil content for food would be reviewed by FDA and USDA-APHIS; and modified flower color in a horticultural crop would be reviewed by USDA-APHIS alone. It can take five years of field-testing, under USDA-APHIS oversight, for the developer of a new plant variety to evaluate the new line and to collect the data needed to pass through the regulatory system. Another two years may be needed for USDA-APHIS, EPA, and/or FDA to complete their reviews. Multiple agencies reviewing the same product from different perspectives provide a comprehensive system for assuring safety.

The United States has built upon its experience using a science-based approach to evaluating other products to evaluate the products of modern biotechnology. Science-based means that the review of the product is done using scientific criteria relevant to that product. The approach is constantly evolving due to new types of products and the availability of new scientific information. Science is the basis by which regulatory officials can assure and build upon credibility, remain current, and assure a rational basis for decision-making. Science and the legal processes are inextricably linked for regulations that evaluate biological products.

THE REGULATORS' ROLES

Under the authority of the Plant Protection Act, USDA-APHIS regulates the development and field-testing of genetically engineered plants, microorganisms, and certain other organisms. USDA-APHIS regulations provide procedures for obtaining permission to release (field test), import into the country, or move interstate within the United States. After several years a developer may petition USDA-APHIS for non-regulated status. The USDA-APHIS review process evaluates agricultural and environmental safety issues. Particular attention is paid to evaluating any changes in agronomic characteristics of the new plant line. Although usually not related to the change intended, such unintended changes could impact food safety as well as agricultural and environmental safety. Fortunately, over 98 percent of these "off-types" are discarded by developers early in the development process. Only the healthiest and well-characterized lines survive the selection in the subsequent development process and are sent to regulators for evaluation.

To date 53 petitions have been granted and almost 8,000 permits and notifications issued for field-testing at almost 30,000 sites. Although no petitions have been denied, 21 have been withdrawn due to insufficient information or other inadequacies in the application.

Under the Federal Food, Drug, and Cosmetic Act (FFDCA), 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). 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) by regulating the distribution, sale, use, and testing of plants and microbes producing pesticidal substances. Both EPA and USDA-APHIS review many transgenic plants for agricultural and environmental effects.

EPA issues experimental use permits for field-testing of "pesticidal" plants and registrations for commercialization of these plants. The 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 describes 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. EPA also evaluates the new use of herbicides on herbicide-tolerant transgenic plants, while USDA-APHIS evaluates the herbicide-tolerant plant.

FDA assesses the 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. FDA expects developers of new plant varieties to consult with the agency on safety and regulatory questions under the authority of the FFDCA. FDA policy is based on existing food law and requires that genetically engineered foods meet the same rigorous safety standards as are required of 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 currently 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 pre-market approval.

Although the FDA system currently is voluntary, every new plant line that is commercialized in the United States has been evaluated by the FDA through this consultation process. In public meetings held in 2000 no concerns with the substance of the FDA review were voiced for those products already reviewed by FDA. In 2001 FDA proposed to make this review mandatory, and it is currently studying the almost 100,000 comments received before finalizing this rule.

The FDA's assessment includes evaluating the composition of major nutrients and levels of toxicants that many plants produce naturally, and determining potential for allergenicity, particularly assessing whether the inserted genes are from allergenic sources. Also evaluated is whether a new method of food preparation must be used as a result of the genetic change, or whether the food is changed so that it is unrecognizable. The food safety issues addressed assess whether the food is safe and wholesome.

If there is any material change to the food, then labeling is required. Labeling of food in the United States must be truthful and not misleading. To provide guidance to developers of food involving genetic engineering, the FDA also provided draft guidance in 2001 on Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering.

Transparency is built into the U.S. system at every step, beginning with the initial passage of laws by Congress, and public input is important to assuring that concerns are addressed. Regulations developed to implement these laws consider all public comments before the regulations are finalized. Public comment is also invited for decision documents such as environmental assessments and future evaluations. Comprehensive field-tests, petition databases, and U.S. regulations and regulatory decisions are accessible at http://www.aphis.usda.gov.

A SCIENCE-BASED REGULATORY APPROACH

Science informs the decision-making process of U.S. regulators at many levels. Regulators evaluating specific products use the available published scientific literature, particularly from peer-reviewed journals. Applicants cite this literature in their applications for regulatory approval. The U.S. National Academy of Sciences (NAS) or other parts of the scientific enterprise may be asked to identify the scientific issues and recommend approaches to evaluating particular types of products. Meetings of scientists can be called to address specific issues, as have past meetings on Bt, viral recombination, and relevant biological factors for evaluating crop plants. Information can even be requested on specific products. The EPA meets with its scientific advisory panels. The FDA refers questions to its Food Advisory Committee. Recently, the NAS reviewed the scientific underpinnings of the regulatory decisions made by USDA. The USDA also has a Risk Assessment Grants Program that specifically funds research on emerging issues with genetically engineered organisms. Regulators use all of this information to assure that the most current approaches and information are available to inform regulatory decisions.

CODEX ALIMENTARIUS

Internationally, the appropriate scientifically based standards, guidelines, and recommendations for evaluating the food safety of transgenic products as they move into the international marketplace are being developed by the representatives of national governments in the ad hoc Intergovernmental Codex Task Force on Foods Derived From Biotechnology under the Codex Alimentarius. The first international Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants as well as the Principles for the Risk Analysis of Foods Derived from Modern Biotechnology, both currently in draft status, are slated for adoption in 2003 by the Codex Alimentarius Commission. These standards are a milestone in agreement on the approaches to assuring food safety of the products of modern biotechnology.

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(Distributed by the Office of International Information Programs, U.S. Department of State. Web site: http://usinfo.state.gov)

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