|
There is currently no formal environmental regulation of most conventionally improved crops,
so it is clear that the standards being set for transgenic crops are much higher than for their conventional counterparts
National Academies, National Research Council
Environmental Effects of Transgenic Plants: Scope and Adequacy of Regulation (2002)
Plants and foods produced using biotechnology are among the most stringently tested in history. The U.S. food regulatory system enjoys a high degree of public confidence as a result of rigorous scientific reviews within a decision-making framework entirely open to public participation. This approach to regulation provides full access to documents on which decisions are based and is carried out completely in the public eye as required by law. The U.S. regulatory system has helped ensure that biotechnology products are safe for producers, consumers and the environment. To date, no approved biotechnology plant or food has harmed human health or the environment.
Biotechnology products in the United States are regulated according to a system, the Coordinated Framework for the Regulation of Biotechnology (Coordinated Framework), established by the Office of Science and Technology Policy in 1986. Deriving its mandate from existing laws to regulate the safety of food and agriculture, it assigns lead responsibility for biotechnology products to the appropriate regulatory agency and sets out principles for coordinated and cooperative reviews in areas where responsibilities or authorities overlap. The regulation of agricultural biotechnology products is handled by three agencies: the U.S. Department of Agriculture, the Environmental Protection Agency and the Food and Drug Administration.
Each of these agencies employs a transparent regulatory process that relies on rigorous, science-based assessments of biotechnology products. Databases on product applications and approvals are maintained by the agencies and provide relevant information on each biotechnology plant they review. While the regulatory system has performed well, expert reviews of the regulatory system have suggested ways to improve it.
BIO believes that regulatory policies and decisions must continue to be based on sound science and that biotechnology-derived products be held to the highest standards of health and environmental safety. Maintaining this approach will allow the benefits of crop biotechnology to be shared with producers, consumers and the environment and help maintain the free flow of agricultural products in international trade.
For a good overview of U.S. regulation of agricultural biotechnology, click here.
Office Of Science And Technology Policy
Issue in Brief:
Setting a Rigorous, Science-Based Regulatory Framework
The overall federal regulatory structure for biotechnology products was established by the Coordinated Framework for Regulation of Biotechnology, which was published by the Office of Science and Technology Policy and adopted by relevant federal agencies in 1986. The Coordinated Framework provides a regulatory approach intended to ensure the safety of biotechnology research and products using existing statutory authority and building upon agency experience with agricultural, pharmaceutical, industrial and other products developed through traditional breeding techniques. Oversight of biotechnology-derived plants rests with the USDA, EPA and FDA.
Subsequently, these regulatory agencies agreed to a common set of principles to govern decisions concerning the exercise of discretionary regulatory authority. These principles were included in the Statement of Scope published by OSTP in 1992; they lay out a scientific, risk-based approach to regulation that focuses on the characteristics and relative risks of the product, not the method used to produce it.
The Coordinated Framework anticipated that agencies might need to develop specific regulations or guidelines under existing statutory authority. It also anticipated elaboration of federal biotechnology policy consistent with scientific advances and product development. Consistent with this approach, in 2000, OSTP, working with the President's Council on Environmental Quality (CEQ), oversaw an interagency assessment, using case studies, of federal environmental regulations covering agricultural biotechnology. This assessment was undertaken to ensure that U.S. regulations keep pace with the latest science.
The increase in the number and diversity of field tests of biotechnology-derived food and feed crops since 1986, both in the United States and other nations, led to an examination of existing confinement standards. In August 2002, OSTP proposed new federal actions that would improve field-testing requirements of biotechnology-derived crop plants and establish early food-safety assessments for new proteins produced by these new plant varieties at USDA, EPA and FDA. Rules and guidance developed under this notice would help prevent the unintended presence of intermittent, low levels of genes and gene products of bioengineered crops under development in commercial seed lots, bulk commodities, and processed food and feed until all appropriate safety standards have been met.
BIO strongly endorses the science-based approach taken by OSTP and is confident that the confinement standards and accelerated safety testing measures will help ensure a safe food supply. For consumers, this enhancement adds yet another layer of assurance to the regulatory review of agricultural crops intended for both food and feed.
Resources:
Office of Science and Technology Policy:
U.S. Department Of Agriculture, Animal And Plant Health Inspection Service
Issue in Brief:
Ensuring Biotech Crops Are Safe to Grow
Under authority in the federal Plant Pest Act, USDA's Animal and Plant Health Inspection Service (APHIS) governs the field testing of agricultural biotechnology crops to ensure that there is no adverse effect on the environment. Under regulations issued in 1987, APHIS oversees the field testing of biotechnology-derived plants as "regulated articles." A petition for nonregulated status must be granted by APHIS before commercial growth and sale of any biotech crop.
The growing familiarity with rDNA-altered crops led APHIS to introduce in 1993, and later expand in 1997, an expedited procedure for approving field testing of agricultural biotechnology crops. Instead of submitting a formal application for a permit, plant breeders wanting to field test plants that meet certain eligibility requirements and performance standards must submit a notification letter to the agency. The criteria and standards required to conduct field testing take into account factors specific to the test crop, including the agronomic characteristics of the host plant and familiarity with the test protein, while requiring strict confinement measures to limit the test crop's pollen flow and persistence in the environment.
Operating under these performance standards, academia and industry have maintained an active and productive research program that has resulted in the safe development of more than 40 transgenic crops. To date, there have been no instances of a biotechnology-derived plant approved for field testing that created an environmental hazard or exhibited any unpredictable behavior compared with similar crops modified using traditional methods.
Resources:
U.S. Department of Agriculture, Animal and Plant Health Inspection Service:
- Plant Pest Act.
- "Genetically Engineered Organisms and Products; Simplification of Requirements and Procedures for Genetically Engineered Organisms," Federal Register May 2, 1997, 62(85): 23945-23958.
- "Genetically Engineered Organisms and Products; Notification Procedures for the Introduction of Certain Regulated Articles; and Petition for Nonregulated Status," Federal Register March 31, 1993, 58(60): 17044-17059.
- "Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There Is Reason to Believe Are Plant Pests," Federal Register, June 16, 1987, 52(115).
- User's Guide for Release Permits.
- User's Guide for Introducing Genetically Engineered Plants and Microorganisms.
Environmental Protection Agency, Office Of Pesticide Programs
Issue in Brief:
Ensuring Biotech Crops Are Safe for the Environment
The Environmental Protection Agency (EPA) has regulatory authority under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and the Federal Food Drug and Cosmetic Act (FFDCA) for insect-protected crops because they produce their own protection against pests. The agency also regulated bioengineered microorganisms under the Toxic Substances Control Act.
Pest-Protected Plants
The EPA regulates environmental exposure to pest-protected plants to ensure there are no adverse effects to the environment or any beneficial, nontargeted insects or other organisms. The Agency also is required to establish a safe level of pesticide residue in foods, known as a "tolerance."
In July 2001, EPA announced new rules governing crops that produce their own pesticides. The new rules largely formalize EPA's existing process for regulating plant-incorporated protectants and do not change significantly EPA's current system for scientifically evaluating a plant-incorporated protectant. Exemptions were made for products developed through conventional breeding and certain nucleic acids involved in the production of the pesticidal substance in the plant.
In meeting its oversight responsibilities, EPA requires detailed information on the plant, including the source of the added gene, how the gene is expressed, the nature of the pesticidal substance it produces and the biology of the recipient plant. EPA considers the data on the allergenicity and toxicity of the substance. For ecological effects, EPA requires field tests to examine the exposure and toxicity of the plant pesticide to nontarget organisms, such as wildlife and beneficial insects, and to evaluate the degradation rates of the proteins in soil and plant residues.
The EPA also makes insect resistant management (IRM) plans a central part of its registration decisions, and seed companies require purchasers of their seeds to implement such plans. These agreements require farmers to maintain refugiums of non-pest-resistant crops to help maintain the genetic basis of susceptibility and delay the emergence of pesticide resistance.
New plant varieties that pass EPA's rigorous review process receive a tolerance exemption. The EPA registered its first plant pesticide in March 1995 and has since registered tolerance exemptions for pest-protected varieties of corn, potato, cotton, cucumber, watermelon and papaya. To date, EPA has found no documented case of environmental harm caused by a plant pesticide produced through biotechnology.
Microorganisms
In 1997, EPA issued a final rule on biotech microorganisms. These rules are designed to identify risk while at the same time allowing this important research and product development to move forward. Subject to the rule are biotechnology microorganisms used commercially as industrial enzymes, in agriculture and for environmental remediation.
Resources:
Pest-Protected Plants:
- Environmental Protection Agency, Office of Pesticides, Biopesticides.
- Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).
- EPA's Regulation of Biotechnology for Use in Pest Management (June 2003).
- "Plant-Incorporated Protectants; Final Rules and Proposed Rule," Federal Register July 19, 2001, 66(139): 37772-37817.
- "Exemption from the Requirement of a Tolerance Under the Federal Food, Drug and Cosmetic Act for Residues of Nucleic Acids That Are Part of Plant-Incorporated Protectants (Formerly Plant-Pesticides)," Federal Register July 19, 2001, 66(139): 37817-37830.
- "Exemption from the Requirement of a Tolerance Under the Federal Food, Drug and Cosmetic Act for Residues Derived Through Conventional Breeding from Sexually Compatible Plants of Plant-Incorporated Protectants (Formerly Plant-Pesticides)," Federal Register July 19, 2001, 66(139): 37830-37854.
- FIFRA Science Advisory Panel, Biopesticide Meetings.
Microorganisms:
Food And Drug Administration, Center For Food Safety And Applied Nutrition
Issue in Brief:
Ensuring Biotech Crops Are Safe to Consume
Foods developed through biotechnology face the same regulatory requirements the FDA uses to safeguard all foods in the marketplace under the Federal Food Drug and Cosmetic Act. They are judged on their individual safety and nutrition, not the methods used to produce them.
Legal responsibility rests squarely with the food company to ensure the safety of any product it places into commerce. Foods produced through biotechnology must adhere to the same safety standards that apply to traditionally produced foods.
In 1992, FDA published a Statement of Policy laying out its approach to biotechnology food products. FDA's approach is based on many decades of agency experience dealing with a complex array of new fruits, vegetables and grains that have been modified using conventional methods and safely introduced into the food supply.
The FDA may require that genetic modifications that significantly alter the nutritional value of a food using genetic material from outside the traditional food supply or use known allergens be subject to strict premarket testing and regulatory oversight. The FDA also requires that any genetically modified food product that significantly alters a food's nutritional value or uses material from a known allergen be clearly labeled. For example, any product that used a gene from a peanut, which is a potential allergen, would be subject to testing and labeling requirements. (For more on the FDA's policy on labeling, click here.)
The FDA also has the authority to order unsafe products off the market. According to the FDA's "Q&A" on biotechnology: "We are confident that food derived from plants developed by new biotechnology will be just as safe as those produced by traditional biotechnology."
Based on input from the public-including BIO-at three public meetings the FDA held throughout the country, in January 2001 the agency proposed a change in the rules that would require companies to submit data and information on bioengineered foods before commercial distribution. This will be a change from the current system, which relies on a voluntary premarket consultation, however, it should bed noted that all biotech crops in the marketplace have been through the voluntary consultation, and that BIO members view the process as mandatory. In addition, biotech companies are unable to market their product without completing this process. BIO believes that this change to a formal review will help maintain consumer confidence in and support for biotechnology as an essential tool in modern food production. Increasing the openness and accountability that will flow from these changes will provide U.S. consumers with renewed grounds for confidence in the safety of our food supply. It is BIO's hope that FDA will issue its mandatory premarket notification rule at the earliest possible time.
Resources:
Food and Drug Administration, Center for Food Safety and Applied Nutrition, Biotechnology:
- Federal Food, Drug, and Cosmetic Act.
- Draft Guidance for Industry-Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals (September 2002).
- "Premarket Notice Concerning Bioengineered Foods," Federal Register January 18, 2001, 66(12): 4706-4738.
- Guidance for Industry, Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering, Draft Guidance (January 2001).
- Guidance for Industry: Use of Antibiotic Resistance Marker Genes in Transgenic Plants (September 4, 1998).
- Guidance on Consultation Procedures Foods Derived from New Plant Varieties (October 1997).
- "Statement on Policy: Foods Derived from New Plant Varieties; Notice," Federal Register May 29, 1992, 57(104): 22984-23001.
Biotechnology Product Applications And Approvals By U.S. Regulatory Agencies
The USDA, EPA and FDA all maintain comprehensive databases of biotechnology product applications and approvals that are available to the public. Each regulatory agency posts this information on its Web page. All of these databases are updated periodically and provide a great resource. (For information on international product approvals, click here.)
Resources:
U.S. Department of Agriculture:
Environmental Protection Agency:
Biopesticide Registration Action Documents (BRADs):
Food and Drug Administration:
Expert Evaluations Of The Federal Regulatory Process
Resources:
- General Accounting Office, Genetically Modified Foods-Experts View Regimen of Safety Tests as Adequate, but FDA's Evaluation Process Could Be Enhanced, GAO-02-566 (May 2002).
"GM foods pose the same types of inherent risks to human health as conventional foods . . . While some consumer groups, as well as some scientists from the European Union, have questioned the ethical or cultural appropriateness of genetically modifying foods, experts whom we contacted from these organizations also believe the tests are adequate for assessing the safety of these foods."
- National Research Council, Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation (2002).
"[T]he committee finds that the transgenic process presents no new category of risk compared to conventional methods of crop improvement but that specific traits introduced by both approaches can pose unique risks. There is currently no formal environmental regulation of most conventionally improved crops, so it is clear that the standards being set for transgenic crops are much higher than for their conventional counterparts."
- Council for Agricultural Science and Technology, Evaluation of the U.S. Regulatory Process for Crops Developed Through Biotechnology (October 2001).
"Agencies must maintain the flexibility to assure that rigorous, science-based safety assessments are conducted for each new product or product category. Agencies should strive to coordinate their activities to form a seamless and consistent regulatory system."
- National Research Council, Genetically Modified Pest-Protected Plants: Science and Regulation (2000).
"The committee is not aware of any evidence that foods on the market are unsafe to eat as a result of genetic modification."
Other Resources:
For more links, click here.
|
Printer Friendly