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Presented to the TMA House of Delegates, April 2002
Introduction
Task Force Activities
Areas Discussed and Issues Clarified
Safety of Food for Human Consumption
Regulation of Food Biotechnology
Health Applications
Bioethics
Consumer Concerns
Phasing Out Antibiotic Markers
Substantial Equivalence for Pre-Market Evaluation
FDA Post-Market Monitoring
Continued Biodiversity
Conclusions
In May 2002, a multi-disciplinary Task Force on Genetically Modified Foods was appointed to address fundamental issues regarding food safety and research that physicians could make available to their patients. Paul B. Handel, MD, was asked to chair this unique task force with representation from scientists at Texas A&M University, government officials, legislators, consumers, agricultural experts, and physicians from the Councils on Public Health and Scientific Affairs.
Task force members included:
- John R. Asbury, MD, Temple, TMA Council on Public Health
- Jill M. Aslakson, Austin, policy director, Texas Healthcare & Bioscience Institute
- James M. Atkins, MD, Dallas, TMA Council on Scientific Affairs
- Fuller W. Bazer, PhD, College Station, executive associate dean, College of Agriculture and Life Sciences, Texas A&M University
- Alecia A. Hathaway, MD, MPH, Fort Worth, TMA Council on Public Health
- Edward A. Hiler, PhD, vice chancellor and dean, Agriculture and Life Sciences, Texas A&M University
- Reggie James, Austin, director, Consumers Union, Southwest Regional Office
- Raymond C. Lewandowski Jr., MD, Corpus Christi, TMA Council on Scientific Affairs
- Donald Patman, Waco, president, Texas Farm Bureau
- Susan Combs, Austin, commissioner, Texas Department of Agriculture
- Rep. David Swinford, Austin, chair, House Agriculture and Livestock, Texas House of Representatives
- Tom A. Vestal, PhD, College Station, associate professor & extension specialist, Department of Agricultural Education, Texas A&M University
- Karen Batory, MPA, Austin, director, TMA Division of Public Health and Quality
- Barbara James, BSN, RN, Austin, director, TMA Science and Quality Department
- Gayle Harris, Austin, director, TMA Public Health Department
- Hella Wagner, Austin, senior administrative assistant, TMA Division of Public Health and Quality
The task force held five meetings throughout its tenure and invited researchers in a variety of fields to educate the members about existing science on genetically modified foods. The task force did not conduct original research but rather reviewed current literature in an effort to begin policy development and identify opportunities to educate physicians. A report of the task force findings is attached.
Recommendation: Adoption of the attached Task Force Report on Genetically Modified Foods.
Introduction
Considering that 50 percent of all soy and 38 percent of all corn planted in the United States are genetically altered, consuming food free of this biotechnology is difficult. But is this food safe to eat? Are there risks in this food supply that are either different or greater than the traditional food supply, and do we have the appropriate consumer safeguards in place? In early May 2001, TMA President Tom B. Hancher, MD, appointed a Blue Ribbon Task Force on Genetically Modified Foods. Dr. Hancher's interest in genetic modification was well-timed, after several highly publicized events occurred that shook the public's confidence in food safety. In one case, genetically altered Aventis StarLink corn intended for animal feed got into the human food supply via taco shells. In another case, Aventis buried 5 million pounds of genetically modified rice, which had been approved for human consumption, over concerns of negative media coverage and potential liability.
Recognizing the complexity of issues surrounding genetically modified foods, Dr. Hancher specifically directed the task force to review the existing science on the safety of such foods and to develop recommendations that physicians could share with their patients. He encouraged discussion and debate about the risk and benefits of consuming these foods based on current scientific literature. The task force did not discuss in any depth the labeling of these products, agribusiness and globalization issues, or environmental concerns.
The task force membership was intentionally broad based, with major Texas stakeholders including consumers, producers, scientists, physicians, legislators, and state agency officials. Paul Handel, MD, a Houston urologist, was asked to chair the group. Dr. Hancher selected physicians for this task force from TMA's Councils on Public Health and Scientific Affairs; a list of participants is attached.
Task Force Activities
Between June 2001 and March 2002, the task force held five meetings, and members were polled routinely for topics to address. Recognizing the considerable talent in this group, the chair asked members at each meeting to present their work and contributions in the field or obtain outside expertise, and to update the group on newsworthy events or discussions in their respective organizations.
A number of presenters educated the task force about the important aspects of genetically modified foods. The variety in the list below demonstrates the breadth of issues covered.
- Genetically Modified Foods: Digestions and Allergens (Fuller Bazer, PhD, and Andy Vestal, PhD, Texas A&M University, College Station, Texas)
- Safety of Transgenic Foods (John Thomas, PhD, The University of Texas Health Science Center, San Antonio, Texas)
- Common Sense and Sound Science Regarding Food Biotechnology (Mark McLellan, PhD, Texas A&M University and President-Elect of the Institute of Food Technologists)
- Consumer and Environmental Perspectives (Reggie James, Consumers Union, and Neil Carman, PhD, Sierra Club)
- Enhancing Naturally Occurring Compounds in Fruits and Vegetables to Improve Human Health (Bhimu Patil, PhD, Citrus Research Center, Weslaco, Texas)
- Emerging Sciences and Collapsing Ethics: Biotechnologies and Bioethics That Are Shaping Our Future (Jim Wild, PhD, Texas A&M University)
- Food-Based Vaccines and Other Applications (John Howard, PhD, Prodigene, College Station, Texas)
- The FDA Perspective on Genetically Modified Foods (James Maryanski, PhD, FDA, Washington, D.C.)
- Unraveling the DNA Myth (Barry Commoner, PhD, Center for the Biology of Natural Systems, City University of New York, New York)
Supplementing these live presentations, the task force created an e-mail listserv so members could receive articles, press clips, and continuing education opportunities electronically. Also, the chair distributed numerous articles on genetically modified foods at the meetings; an extensive bibliography of these articles is available upon request.
Areas Discussed and Issues Clarified
The task force heard experts on a variety of topics throughout their review of genetically modified organisms (GMO) food safety. Highlights of the issues discussed follow.
Safety of Food for Human Consumption
In 2000, the Institute of Food Technologists (IFT) published a compendium of food technology, IFT Expert Report on Biotechnology and Foods, written, edited, and reviewed by 28 leading scientists. The report concludes that science-based research has found negligible risk associated with food biotechnology, and that there is no scientific evidence that unintended effects (e.g., unexpected toxic or antinutrient factors) have occurred in bioengineered foods brought to market.
Potential allergenicity also is an important component in determining the safety of food for human consumption. A review of human digestion included a detailed discussion regarding reactions and responses to food allergens. The World Health Organization/ Food and Agriculture Organization's decision tree for determining the allergenic potential of foods derived from genetically modified plants documented the safety assessment process used in biotechnology. Additional aspects of this process include microbiological, toxicity, and nutritional comparisons of the bioengineered plant with its conventional counterpart. Lastly, decreased usage of traditional pesticides and herbicides was seen as a potential benefit.
Regulation of Food Biotechnology
In 1986, the White House's Office of Science and Technology (OSTP) established federal policy for ensuring the safety of the biotechnology process and products. OSTP issued a statement in 1992 focusing on the risk-related traits of the bioengineered product, not the process by which the product was developed.
Federal oversight is the responsibility of the United States Department of Agriculture (USDA), Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA). Should new data reflect a question regarding the safety of a food, each of the entities has the legal authority to demand the immediate removal of the product from the marketplace.
USDA: Oversees safety of movement and cultivation of plants, plant pest issues, safety and labeling of meat and poultry products for human consumption, and safety of animal vaccines EPA: Oversees the safe use of pesticides, setting tolerances for pesticides and pesticide residues in and on crops, and identifies potential effects on non-target organisms FDA: Oversees safety and labeling of human food (except meat and poultry products), animal feed, human and animal pharmaceutical products, human vaccines, and enforcing pesticide tolerances
USDA and EPA oversee the possibility of the new plants crossing with other plant species - USDA for closed environments, EPA and USDA for field studies.
All pharmaceutical products and human and animal vaccines require federal approval prior to marketing the products. Food additives also must have this premarket approval, foods do not. FDA operates a voluntary consultation procedure for premarket review for human food, including bioengineered products and animal feed. One of FDA's new initiatives for bioengineered foods includes a proposed required notification to FDA 120 days prior to marketing a new food.
The FDA food safety assessment process includes reviewing the intended modifications of the new substance for identity, structure/function, source (allergenicity), digestibility, dietary exposure, and nutrition. Also reviewed are the unintended modifications - genetic stability and composition (nutrients and toxicants). The goal is that the new food must be as safe as today's food.
The United States also is involved in international efforts to establish standard definitions and requirements for food. One major player is the Codex Alimentarius Commission, established in 1962 by the World Health Organization/Food and Agriculture Organization. Codex has committees and task forces in place to develop standards and principles for labeling food and assessing safety.
Health Applications
To date, the majority of the products on the market has been foods that resist certain plant viruses (e.g., squash) or insects (e.g., potato and corn) or are herbicide-tolerant (e.g. soybeans and canola). Nutrient-enhanced: Commonly called "Golden Rice," this product has been engineered to contain increased amounts of beta-carotene. This is considered a functional food, as it is consumed as part of a usual diet and provides additional health benefits beyond basic nutrition.
Nutriceuticals: These products are isolated or purified from foods and sold as pills, powders, or capsules. Examples are digestive aids and growth stimulants.
Biopharmaceuticals: Cancer chemopreventive agents are components in certain foods, such as broccoli, citrus, and garlic, that block or suppress the function of certain carcinogens. Health-promoting compounds such as limonoids, vitamins, and flavonoids can also be isolated in foods, such as citrus and onions. Researchers are developing vaccines for hepatitis B, "traveler's disease," AIDS, and others from bioengineered plants. Therapeutics include proteins produced in plants that promote wound healing, antibodies, and other health benefits. Researchers are designing bioengineered foods to provide immunization benefits that could replace injections and oral medications.
Bioethics
As presented by Jim Wild, PhD, Texas A&M University, the bioethics dilemma can be described for many as the human mind saying "yes, I'm sure" to biotechnology while the heart says, "no, let's go slow." Science is engaged with a discovery of physical laws and potentials while man's mind is a separate spiritual and behavioral path, and there are many cultural, religious, and other diverse perspectives that must be weighed as well as the science related to biotechnology.
Risk-benefit analysis and personal biases and philosophies all influence the individual and corporate perceptions of the value/hazard consideration of the many applied aspects of biotechnology. Issues include anti-technology biases, environmental protection, toxic and allergenic foods, pharmaceutical abuses, escape of harmful genes from transgenic GMOs, and genetic chaos. Various ethical perspectives for making decisions must be considered, from egoistic philosophies to community-based concepts, from human-based perspectives to broad abiotic paradigms.
Currently, strange, dual standards exist in bioethics in the American society so that gene therapy in humans is accepted while simple genetic modification of foods is not. A look into the future includes designer foods, human health profiling, organ and cell replacement and repair, altering the perspectives of age, agriculture biosecurity, and biological counter-terrorism.
Consumer Concerns
As reported by the Consumers Union representatives on the task force, the public is concerned about the need to analyze existing risk versus future risk, requirements for labeling of genetically modified foods and ingredients, and the long-term effects of eating such foods. Questions remain about whether insects will become resistant to the pesticides in bioengineered crops. Related questions touch on whether herbicide-resistant crops will result in the development of superweeds, and whether toxins may be increased or nutrients decreased in genetically modified foods.
Additional concerns are allergenicity, the unpredictability of gene transfer in bioengineering, and that scientists, in their excitement, will proceed too rapidly and push too fast, ignoring the possibility of harm. Is the research funded by biotechnology entities biased? Does the current regulatory process have numerous opportunities where things can fall through the cracks? If the research indicates that the risks associated with consuming genetically modified foods are negligible, how can government and academia work together to assure the public of this?
Another point brought before the group was the lack of information given to the public regarding genetically modified foods and the existence of misinformation campaigns. The consensus was that consumers have been given a significant amount of biased information from industry and activist groups and are uncertain of biotechnology, which is not familiar to them (known risk versus unfamiliar risk). Also, consumers do not know what information they can trust, and they want unbiased information in order to make their own decisions. Finally, some consumers are angry because they perceive that they are fed GMOs without their knowledge or consent.
Phasing Out Antibiotic Markers
Scientists are phasing out the use of antibiotic markers in genetic modification to avoid the potential of emerging antibiotic resistance; within the next five years, these markers no longer will be part of the biotechnology process.
Substantial Equivalence for Pre-Market Evaluation
The term "substantial equivalence" means a genetically modified food is comparable to its traditional counterpart. The safety assessment process includes a quantitative evaluation of the inherent properties of the modified food (such as proteins, fats, carbohydrates, vitamins, minerals, toxins, and allergens) to determine if there are differences that impact the safety or nutrition of the new food.
FDA's use of substantial equivalence pre-dates the marketing of genetically modified foods; historically, FDA has used substantial equivalence as the convention for evaluating all new foods coming to market.
FDA Post-Market Monitoring
At this time, FDA considers the monitoring of genetically modified foods after the products have been on the market of minimal value because the safety assessment done in the pre-market phase shows the food to be safe. Also, numerous complicating factors emerge from such monitoring, which include the variety and types of food processing, individual eating habits, and others.
Continued Biodiversity
The task force heard a concern about the hypothetical loss of biodiversity should everyone plant a specific variety of species that disease then eradicates. This concern is reduced by the agriculture industry's having multiple varieties available in case one variety is lost from emerging resistance or disease.
Conclusions
The task force recommends the following points based on discussion throughout the meetings.
- No scientific evidence has been published that shows genetically modified foods released to market are unsafe to eat.
- Genetically modified foods should continue to be studied and monitored for safety.
- Consumers need to have access to credible and scientifically reliable information on genetically modified foods.
- Currently, institutional and commercial practices and agreements may impede sharing of research results, which slows scientific progress. More effort needs to be made on sharing genetic research data.
- Innovative partnerships between public and private entities should be created to encourage the ethical sharing of scientific research findings.
- Rigorous, effective and comprehensive governmental oversight is essential to the development of genetically modified products to ensure the highest level of public health safety.
- The risks of any genetically modified food - including the long-term effects of changing plant, bacterial, viral, and fungal flora - must be weighed against the benefits that any new food has to offer.
- For consumers to have confidence in genetically modified foods, they must see that the benefits outweigh the risks; such education must be made available in a non-biased, scientific way.
Last Published: 4/2/2005 Print this page
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