-Caveat Lector- LANDMARK LAWSUIT CHALLENGES FDA POLICY ON GENETICALLY ENGINEERED FOOD EMINENT SCIENTISTS, HEALTH PROFESSIONALS, AND RELIGIOUS LEADERS DEMAND ADEQUATE SAFETY TESTING AND MANDATORY LABELING CHARGE AGENCY WITH IGNORING SIGNIFICANT HEALTH RISKS,VIOLATING CONSUMER RIGHTS, AND INFRINGING RELIGIOUS FREEDOM On May 27, 1998, the Alliance for Bio-Integrity led an unprecedented coalition of scientists, health professionals, religious leaders, and consumers in filing a lawsuit against the U.S. Food and Drug Administration (FDA) to obtain mandatory safety testing and labeling of all genetically engineered foods. The suit alleges that current FDA policy, which permits such altered foods to be marketed without testing and labels, violates the agency's statutory mandate to protect public health and provide consumers with relevant information about the foods they eat. It also charges that the policy violates religious freedom. The Alliance assembled the coalition and coordinated the suit, which was filed in U.S. District Court in Washington, D.C. and was followed by a press conference at the National Press Club which was televised by C-Span. The Washington-based International Center for Technology Assessment (CTA) collaborated in organizing the suit and is serving as lead counsel. Both the Alliance for Bio-Integrity and the CTA are nonprofit organizations dedicated to the protection of human health and the environment through sustainable and safe technologies. The Need for Stronger Safety Testing The FDA does not require testing of genetically engineered foods because it regards them to be as safe as their natural counterparts. This policy is based on the assumption that piecemeal, haphazard insertion of genes from distant and dissimilar species into an organism's DNA is substantially equivalent to sexual reproduction between like organisms, in which entire sets of genes are combined in a harmonious and ordered manner. The lawsuit alleges that this assumption is false, since it ignores the unpredictable disruptions that the foreign genes can cause in their new system. Through these disruptions, familiar foods can become toxic or carcinogenic. Such disruptive influence remains the most probable explanation for the contamination of a genetically engineered food supplement, L-tryptophan, with a novel and highly toxic ingredient. This toxin caused dozens of deaths and thousands of serious illnesses. There is also a substantial risk that foreign DNA can cause foods to become allergenic, especially since many engineered foods contain substances that have never been in the human food supply. To emphasize the scientific unsoundness of the FDA's policy, many distinguished scientists and health professionals from institutions such as Northwestern University Medical School, NYU Medical School, Rutgers University, and the University of California at Berkeley have agreed to join as plaintiffs. They support the allegation that FDA policy does not adequately screen for the many risks associated with genetically engineered foods and must require rigorous long-term testing before any product is marketed. (A list of the scientist plaintiffs appears at the end of this document.) The Need for Labeling: Both Secular and Religious Reasons At least 36 different genetically engineered whole foods are currently being sold without identifying labels. These include potatoes, tomatoes, soy, corn, squash and many other fruits and vegetables to which a variety of new genes from different species have been added. These genetically reconfigured foods are also used as ingredients in processed foods and have been found in a number of mass consumed products such as soy-based baby formulas and popular corn chip brands. Because of FDA's failure to require labeling, millions of American infants, children and adults are consuming genetically engineered products each day without their knowledge. As a purely secular matter, the plaintiffs allege that because such foods have been implanted with foreign genes and the substances they produce, FDA policy violates those sections of the Food, Drug and Cosmetic Act which (a) require that substances added to food be labeled, (b) prohibit "false or misleading" labeling, and (c) mandate disclosure of material facts. While this lack of labeling restricts the right of all consumers to make informed choices, it is especially injurious to people with uncommon food allergies. Numerous individuals with such allergies pleaded for labeling during FDA's formal comment period in 1992 but were ignored. Some of them have now joined as plaintiffs. As a spiritual matter, millions of Americans feel obligated to refrain from some or all genetically altered foods on the basis of religious principle. Many Jews and Muslims want to avoid foods with substances from specific animals while devout vegetarians want to avoid substances from any animal. Additionally, a considerable portion of the population is religiously motivated to avoid all genetically altered foods in order to separate themselves from an enterprise they view as irresponsibly and arrogantly disrupting the integrity of God's creation. Virtually all the religious plaintiffs share this motivation, even those who also must avoid foods with genes from particular species. These plaintiffs represent a broad spectrum of faiths, including an Episcopal chaplain, a Catholic priest who is president of the North American Coalition on Religion and Ecology, a prominent Buddhist, three rabbis (orthodox, conservative and reform) and a synagogue. They allege that by refusing to label, the FDA is significantly infringing their right to the free exercise of religion as guaranteed under both the First Amendment of the Constitution and the Religious Freedom Restoration Act (RFRA). Although RFRA was struck down by the Supreme Court as it applies to the states, the U.S. Department of Justice asserts that it still applies to the federal government. This is very significant, since RFRA requires the FDA to demonstrate a "compelling interest" in a policy that restricts the religious freedom of so many Americans. As in the case of allergy sufferers, the FDA has received repeated pleas from religious individuals but has ignored them. (A list of religious plaintiffs appears at the end of the document.) What the Suit Can Accomplish: Reining in Gene-Altered Foods This suit could have major impact, since if it is fully successful, it will result in a court-imposed moratorium on the marketing of all genetically engineered foods. Each product would then have to undergo rigorous long-term testing and could only be marketed if it can first be proven safe. Further, any such products approved for sale would have to be clearly labeled as genetically engineered. A Wake Up Call to the Public "This suit sends a clear message that government policy on genetically engineered food is unsound from the standpoints of both science and religion and endangers the public," says the founder and president of the Alliance for Bio-Integrity, Steven M. Druker. "Gene-altered foods and have not been proven safe through standard tests. Rather, the FDA approves them on the basis of unsubstantiated assumptions. Eminent scientists say these assumptions are contrary to fact; religious leaders say they're at odds with a God-centered world-view." Professor Philip Regal of the University of Minnesota, an internationally recognized expert on plant biology (and a plaintiff), states: "Over the last fifteen years, I and other scientists have put the FDA on notice about the potential dangers of genetically engineered foods. Instead of responsible regulation we have seen bureaucratic bungling and obfuscation that have left public health and the environment at risk." "The FDA has placed the interests of a handful of biotechnology companies ahead of their responsibility to protect public health," says Andrew Kimbrell, Executive Director of the International Center for Technology Assessment (CTA), and co-counsel on the case. Rabbi Harold White, Director of Jewish Chaplaincy and Lecturer in Theology at Georgetown University (and a plaintiff), urges: "Everyone who believes the biosphere developed through the purposeful plan of a benevolent God should reject gene-altered foods to preserve the dignity of that plan. Since the dawn of life on earth, Divine intelligence has systematically prevented genetic transfers between widely differing species. Limited human intelligence should not rush to make them commonplace." How You Can Help As a nonprofit organization, the Alliance for Bio-Integrity depends on donations. It is recognized by the IRS as a 501(c)(3) organization to which contributions are tax deductible. To support the lawsuit and help the Alliance continue its important activities, please send your contribution to: Alliance for Bio-Integrity P.O. Box 110 Iowa City, IA 52244 If you are religiously opposed to either all or some genetically engineered foods, you can also assist by sending a declaration expressing your beliefs. If you have a degree in the life sciences or are a health professional, you can send a declaration registering your opinion that FDA policy is scientifically unsound. These declarations can be used as evidence in court. LIST OF SCIENTIST PLAINTIFFS Following are the nine scientists who are plaintiffs in the law suit against FDA policy on genetically engineered foods: Dr. Richard Strohman, Emeritus Professor of Molecular and Cell Biology at the University of California, Berkeley. He has written extensively on biotechnology issues. Dr. Philip J. Regal, Professor of Ecology, Behavior and Evolution at the University of Minnesota. Among the nation's most distinguished plant biologists. Has written extensively on the genetic engineering of plants and the ecological and human health risks associated with it. Dr. John Fagan, Professor of Molecular Biology at Maharishi University of Management. Recipient of Research Career Development Award from the National Cancer Institute. Has written extensively on the hazards of genetic engineering. Gained world-wide attention in 1994 when he returned a $613,000 grant to the NIH as an ethical stand against genetic engineering. Dr. Liebe Cavalieri, Molecular Biologist, Professor, Division of Natural Sciences, State University of New York at Purchase. Has written extensively on biotechnology issues. Dr. David Ehrenfeld, Professor of Biology, Rutgers University. Has written on the dangers of genetically engineered foods. Dr. David Fankhauser, Professor of Biology and Chemistry, University of Cincinnati. Hanif Khalak, Computational Biologist, The Institute for Genomic Research, Rockville, MD. Though he does research that facilitates applications of biotechnology for curing human disease, he thinks that the current applications of biotech in food production are based in scientifically flawed assumptions. Dr. Gary Kaplan, MD, PhD, Director of Clinical Neurophysiology, North Shore University Hospital; Assoc. Professor of Clinical Neurology, NYU School of Medicine. Dr. Rama Dwivedi, Associate Director, Targeted Mutagenics, Department of Pediatrics, Northwestern University Medical School. Although he performs biotechnology for medical purposes, he believes that the program to genetically reconfigure food organisms, as currently conducted, is unsound. PLAINTIFFS WITH RELIGIOUS OBJECTIONS TO GENE-ALTERED FOODS There are seventeen plaintiffs who object to consuming genetically engineered foods on the basis of religious principle. Many of them are listed below. Christian Clergy 1. The Rev. Dr. Colin B. Gracey, (Episcopalian) head of the Religious Life Office at Northeastern University in Boston and University Chaplain. 2. The Rev. Dr. Donald B. Conroy, (Roman Catholic) President of the North American Coalition on Religion and Ecology, Washington, D.C. 3. The Rev. Dr. Margaret Mitchell, (Baptist) The Olivet Health & Education Institute, Cleveland, OH. 4. The Rev. Paul C. Kucynda, Pastor of Holy Spirit Orthodox Church, Wayne, NJ. 5. The Rev. Samuel Kedala, Pastor of Holy Spirit Orthodox Church, Wantage, NJ. 6. The Rev. Dr. John Reigstad, pastor of the Evangelical American Lutheran Church (ELCA), Jesup, Iowa; Lecturer in Religion at Wartburg College, Waverly, Iowa. 7. The Rev. Dr. DeWitt Williams, director of the Health Ministries (North American division) of the Seventh-day Adventist Church. Jewish 8. Rabbi Harold S. White, (Reform) Director of Jewish Chaplancy and Lecturer in Theology, Georgetown University, Washington, D.C. 9. Rabbi Alan Green, (Conservative) Beth Israel Synagogue, Winnipeg (a U.S. citizen). 10. Rabbi Jossi Serebryanski, (Orthodox) A kosher supervisor for O.K. Labs, Brooklyn, NY. Buddhist 11. Dr. Ron Epstein, Chancellor of the Americas Dharma Realm Buddhist University; Research Professor, Institute for World Religions, Berkeley, CA. Hindu 12. Gayatri Pariwar-Yugnirman, a Hindu religious organization in the Chicago metropolitan area with a membership of approximately 1,000. <http://www.biointegrity.org/Lawsuit.html> ------------------------------------------------------------------------ InTheShadows is a discussion list dedicated to keeping up-to-date with new technologies, advancements in medicine, environmental concerns, 'conspiracy theories', politics, and, of course, UFO stuff. Discussion is encouraged. Bashing and soapboxing will get you bounced off the list. 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