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News Release
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For Immediate Release:
July 28, 2004
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Contact:
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Safety of Genetically Engineered Foods:
Approaches to Assessing Unintended Health Effects
National Research Council
Institute of Medicine
Public Briefing
July 28, 2004
Opening Statement
by
Bettie Sue Masters
Robert A. Welch Foundation Distinguished Professor in Chemistry,
University of Texas Health Science Center, San Antonio
and
Chair, Committee on Identifying and Assessing Unintended Effects of
Genetically Engineered Foods on Human Health
Good morning. On behalf of the National Academies and the Committee on Identifying and Assessing Unintended Effects of Genetically Engineered Foods on Human Health, I would like to welcome everyone in the room and those joining us via live audio webcast. It is a pleasure to be here today with four of my fellow committee members to present the report Safety of Genetically Engineered Foods: Approaches to Assessing Unintended Health Effects. This report was requested by the U.S. Department of Agriculture, The U.S. Department of Health and Human Services' Food and Drug Administration, and the U.S. Environmental Protection Agency.
The Academies formed a study committee of 13 individuals representing many areas of expertise including biochemistry, epidemiology, food safety, allergenicity, nutrition, food policy, and toxicology. Special attention was paid to ensure committee membership that constructively represented public concern about the safety of genetically engineered foods and provided a balance of both specialized scientific expertise and broad knowledge of public health issues. Four of those committee members are with me today. They are Dr. Lynn Goldman from the Johns Hopkins School of Public Health, Dr. Dean DellaPenna from the University of Michigan, Ms. Jennifer Hillard from the Consumer Interest Alliance of Canada, and Dr. Sanford Miller of Virginia Polytechnic Institute and State University.
Genetic engineering and other new technologies are among the many advances made to traditional breeding of plants, animals, and microorganisms to enhance food quality and increase productivity. Genetic engineering, along with nontargeted, nontransgenic methods, are components of the entire range of genetic modification methods used to alter these organisms. Any technology used to modify genes, whether genetic engineering or other methods, carries the potential for introducing unintended compositional changes that may have adverse effects on human health. Preventing adverse health effects by maintaining a safe food supply requires the use of appropriate scientific methods to predict and identify unintended compositional changes that may result from genetic modification of plants, animals, and microorganisms intended for use as food.
Important advances in our ability to analyze the nucleic acids, proteins, and small molecules that comprise food have occurred over the past decade because of concurrent advances in technology and instrumentation. Despite these advances, however, our ability to interpret how these changes in food composition may affect human health is limited. The complexity of food composition challenges the ability of modern analytical chemistry and bioinformatics to identify compositional changes and determine their biological relevance. These challenges to predicting and assessing unintended adverse health effects of genetically modified, including genetically engineered, foods are underscored by imbalances between these highly advanced analytical techniques and our limited abilities to interpret their results.
Currently, safety assessments conducted prior to commercial release focus on comparing a genetically modified product with its conventional counterpart to identify uniquely different components. Typically, these comparisons are made by analyzing major classes of food and nutritional components, as well as toxins, toxicants, antinutrients, and any other characterizing components.
In addition to this premarket safety assessment, products can be assessed after commercial release to verify the effectiveness of premarket screening and monitor for unanticipated adverse effects. This approach has not been used to evaluate any of the genetically modified, including genetically engineered, products currently on the market, although it shows potential as an approach for monitoring both anticipated and unanticipated effects of products that are not equivalent to their conventional counterparts, or that do contain significantly altered nutritional and compositional profiles.
The task presented to this committee by the sponsors was to outline science-based approaches to assess or predict unintended health effects of genetically engineered foods in order to assist in their evaluation. The committee was charged to compare genetically engineered foods with foods derived from other genetic modification methods for frequency and magnitude of compositional changes resulting from the modification process and to assess the likelihood that elevated toxin or allergen levels could potentially occur by different methods. The committee was further charged to identify (1) appropriate scientific questions involving and (2) methods for determining unintended compositional changes in food from genetically engineered organisms and to outline methods to assess the potential short- and long-term consequences of such changes for human health. In a separate, short subreport, the committee evaluated methods to detect potential unintended compositional changes in and health effects from foods derived from cloned and transgenic animals.
In response to its charge, the committee made recommendations that included: 1) a model for decision-making, 2) improvements in tracking foods released into the marketplace, and 3) research needs and gaps in data that should be filled. In addition, as a model for decision-making, the committee developed a framework to help agencies identify appropriate unmodified foods to which genetically modified foods can be compared; to increase the knowledge and to increase the understanding of the biological effects of secondary metabolites in foods; to develop more sensitive tools for assessing potential unintended effects from the complex mixtures of components that make up foods; and to improve methods for tracing exposure to genetically modified foods. This model system, which can guide the agencies in selecting and validating methods to detect and assess compositional changes in food, serves as the basis for the committee's recommendations for how best to overcome current limitations in methods to assess foods. These recommendations include the committee's general recommendation and specific recommendations for safety assessment tools to assess unintended effects prior to commercialization, analytical methodologies, tools to validate the assessment of food products after commercial release, and research needs.
Based on the committee's finding that evidence evaluated to date indicates that unexpected and unintended compositional changes can potentially arise with all forms of genetic modification, including genetic engineering, the general recommendation from this report is that unintended compositional changes resulting from any form of genetic modification be assessed on a case-by-case basis. Modified foods should be assessed only when warranted, based on the presence of novel compounds or levels of naturally occurring compounds that are higher or lower than those found in the conventional counterpart, taking into account the organism modified and the nature of the introduced trait.
Prior to commercial release of any new genetically modified food, the committee recommends that the appropriate federal agencies determine if evaluation of the food for potential adverse health effects due to intended or unintended compositional changes is warranted by elevated concern, such as identification of a novel substance or levels of a naturally occurring substance that exceed the range of recommended or tolerable intake. For those foods warranting further evaluation, the committee recommends that safety assessment begin prior to commercial release of the product and continue in the post-commercialization phase when safety concerns are present.
In addition, the committee recommends the development and employment of standardized sampling methodologies, validation procedures, and performance-based techniques for targeted analyses and profiling of genetically modified foods. Sampling methodology should include comparing the modified food to an unmodified variety of a species, developed under a variety of environmental conditions, as well as comparing the modified food to commonly consumed commercial varieties of food.
When warranted by changes, such as altered levels of naturally occurring components, vulnerabilities in specific populations of consumers, or unexplained clusters of adverse health effects, the committee recommends improving the tracking of potential health consequences from commercially available foods that are genetically modified, including those that are genetically engineered.
The final recommendations apply to the need for research and technology development. A significant research effort should be made to support analytical methods and technologies, bioinformatics, and epidemiology and dietary survey tools that can detect health changes in the population that could result from various forms of genetic modification. Furthermore, research is needed to determine whether and how changes in genetically modified foods are relevant to human health. This includes developing new tools that can be used to assess potential unintended adverse effects, improved DNA-based immunological and biochemical tags for selected genetically modified foods entering the marketplace, and improved techniques that enable toxicological evaluation of whole foods and complex mixtures.
In summary, genetic engineering of plants and animals is a relatively new application of biotechnology used for food production. Genetically engineered foods do not have a long history of use, and the implications of the process of genetic engineering are not completely understood. Thus, this report is intended to guide policy-makers in choosing appropriate methods to evaluate these foods -- and other genetically modified foods -- for safety prior to marketing. It also assesses the likelihood of unintended compositional changes occurring because of genetic engineering, compared to other methods of modifying foods. The report also provides a roadmap to guide the process of evaluating methods to identify and assess genetically engineered foods for safety prior to release into the marketplace. Its purpose is to be enabling but not prescriptive, while providing a scientific basis for the decision process.
Thank you. This concludes my opening statement. My colleagues and I would be glad to take your questions now. Those of you listening to the live webcast can submit questions via e-mail using a link to the National Academies home page. We ask those of you in the room to step to the microphone, and we ask each of you to identify yourself by name and organization when asking your questions.
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