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CHAPTER 7. THE POLITICS OF GOVERNMENT OVERSIGHT.
1. OTA. A New Technological Era for American Agriculture A New Technological Era for American Agriculture (OTA-F-475), 1992. Office of Science and Technology Policy. Coordinated framework for regulation of biotechnology: announcement of policy and notice for public comment. (OTA-F-475), 1992. Office of Science and Technology Policy. Coordinated framework for regulation of biotechnology: announcement of policy and notice for public comment. FR FR 51:2330223393, June 26, 1986. 51:2330223393, June 26, 1986.2. USDA/APHIS Questions and Answers on Biotechnology Permits for Genetically Engineered Plants and Microorganisms Questions and Answers on Biotechnology Permits for Genetically Engineered Plants and Microorganisms (APHIS 21-35-001), April 1991. Also see: MacKenzie DR. Agricultural biotechnology, law, APHIS regulation. In: Murray TH, Mehlman MJ, eds. (APHIS 21-35-001), April 1991. Also see: MacKenzie DR. Agricultural biotechnology, law, APHIS regulation. In: Murray TH, Mehlman MJ, eds. Ethical, Legal, and Policy Issues in Biotechnology Ethical, Legal, and Policy Issues in Biotechnology. Vol. 1. New York: John Wiley & Sons, 2000:5666.3. Inst.i.tute for Food Technology. IFT expert report on biotechnology and foods: introduction. Food Technology Food Technology 2000;54(8):124136. Also see: 54(9):5361 (safety evaluation), 54(9):6274 (labeling), and 54(10):6179 (benefits and concerns). 2000;54(8):124136. Also see: 54(9):5361 (safety evaluation), 54(9):6274 (labeling), and 54(10):6179 (benefits and concerns).4. Kilman S. Growing pains: genetic engineering's biggest impact may eventually be in agriculture. The key word: eventually. WSJ WSJ, May 30, 1994: R7. OTA. Biotechnology in a Global Economy Biotechnology in a Global Economy (OTA-BA-494), 1991. Thomas JA. Biotechnology: therapeutic and nutritional products. In: Thomas JA, ed. (OTA-BA-494), 1991. Thomas JA. Biotechnology: therapeutic and nutritional products. In: Thomas JA, ed. Biotechnology and Safety a.s.sessment Biotechnology and Safety a.s.sessment. 2nd ed. Philadelphia: Taylor & Francis, 1998:283300.5. Bauman DE, DeGeeter MJ, Peel CJ, et al. Effect of recombinantly derived bovine growth hormone (BGH) on lactational performance of high yielding dairy cows (Abstract P 86). J Dairy Science J Dairy Science 1982;65(suppl):121. Pell AN, Tsang DS, Howlett BA, et al. Effects of a prolonged-release formulation of Sometribove (n-methionyl bovine somatotropin) on Jersey cows. 1982;65(suppl):121. Pell AN, Tsang DS, Howlett BA, et al. Effects of a prolonged-release formulation of Sometribove (n-methionyl bovine somatotropin) on Jersey cows. J Dairy Science J Dairy Science 1992;75:34163431. Liebhardt WC, ed. 1992;75:34163431. Liebhardt WC, ed. The Dairy Debate: Consequences of Bovine Growth Hormone and Rotational Grazing Technologies The Dairy Debate: Consequences of Bovine Growth Hormone and Rotational Grazing Technologies. Davis: University of California Sustainable Agriculture Research and Education Program, 1993.6. Violand BN, Schlittler MR, Lawson CQ, et al. Isolation of Escherichia coli Escherichia coli synthesized recombinant eukaryotic proteins that contain -N-acetyllysine. synthesized recombinant eukaryotic proteins that contain -N-acetyllysine. Protein Science Protein Science 1994;3:10891097. This amino acid replaced lysine in a "significant portion" of rBGH proteins. 1994;3:10891097. This amino acid replaced lysine in a "significant portion" of rBGH proteins.7. Brody JE. Of Luddites, cows, and biotechnology miracles. NYT NYT, November 17, 1993:C17.8. Schneider K. Stores bar milk produced by drug: five big chains take action-U.S. calls process safe. NYT NYT, August 24, 1989:A1,A18. Sun M. Market sours on milk hormone. Science Science 1989;246:876877. 1989;246:876877.9. Juskevich DC, Guyer CG. Bovine growth hormone: human food safety evaluation. Science Science 1990;249:875884. Office of Medical Applications of Research. 1990;249:875884. Office of Medical Applications of Research. Bovine Somatotropin Bovine Somatotropin. In: National Inst.i.tutes of Health Technology a.s.sessment Conference Statement National Inst.i.tutes of Health Technology a.s.sessment Conference Statement, December 57, 1990. Was.h.i.+ngton, DC, 1991. Miller H. Putting the bST human-health controversy to rest. Bio/Technology Bio/Technology 1992;10:147. 1992;10:147.10. GAO. Food Safety and Quality: FDA Strategy Needed to Address Animal Drug Residues in Milk Food Safety and Quality: FDA Strategy Needed to Address Animal Drug Residues in Milk (GAO/RCED-92-209), 1992. (GAO/RCED-92-209), 1992. Recombinant Bovine Growth Hormone: FDA Approval Should Be Withheld until the Mast.i.tis Issue Is Resolved Recombinant Bovine Growth Hormone: FDA Approval Should Be Withheld until the Mast.i.tis Issue Is Resolved (GAO/PEMD-92-26), 1992. (GAO/PEMD-92-26), 1992.11. Kimura T, Murakawa Y, Ohno M, et al. Gastrointestinal absorption of recombinant human insulin-like growth factor 1 in rats. J Pharmacological and Experimental Therapeutics J Pharmacological and Experimental Therapeutics 1997;283:611618. Chan JM, Stampfer MJ, Giovannucci E, et al. Plasma insulin-like growth factor-1 and prostate cancer risk: a prospective study. 1997;283:611618. Chan JM, Stampfer MJ, Giovannucci E, et al. Plasma insulin-like growth factor-1 and prostate cancer risk: a prospective study. Science Science 1998;279:563566. Hankinson SE, Willett WC, Golditz GA, et al. Circulating concentrations of insulin-like growth factor 1 and risk of breast cancer. 1998;279:563566. Hankinson SE, Willett WC, Golditz GA, et al. Circulating concentrations of insulin-like growth factor 1 and risk of breast cancer. Lancet Lancet 1998;351:13931396. Verdecchia P, Reboldi G, Schillaci G, et al. Circulating insulin and insulin growth factor-1 are independent determinants of left ventricular ma.s.s and geometry in essential hypertension. 1998;351:13931396. Verdecchia P, Reboldi G, Schillaci G, et al. Circulating insulin and insulin growth factor-1 are independent determinants of left ventricular ma.s.s and geometry in essential hypertension. Circulation Circulation 1999;100:18021807. Also see: rbST Internal Review Team, Health Protection Branch. 1999;100:18021807. Also see: rbST Internal Review Team, Health Protection Branch. rbST (Nutrilac) "Gaps a.n.a.lysis" Report rbST (Nutrilac) "Gaps a.n.a.lysis" Report. Ottawa: Health Canada, April 21, 1998.12. Cohen R. Milk: The Deadly Poison Milk: The Deadly Poison. Englewood Cliffs, NJ: Argus, 1998. Cohen R. Notmilk! Online: www.hungerstrike.com.13. Blaney DP, Miller JJ, Stillman RP. Dairy: Background for 1995 Farm Legislation Dairy: Background for 1995 Farm Legislation (USDA Agricultural Economics Report No. 705), 1995. Schneider K. Grocers challenge use of new drug for milk output. (USDA Agricultural Economics Report No. 705), 1995. Schneider K. Grocers challenge use of new drug for milk output. NYT NYT, February 4, 1994:A1,A14. Over 800 farmers report problems related to rBGH. Nutrition Week Nutrition Week, June 2, 1995:6.14. Cohen B. Ben & Jerry's Testifies Before FDA in Favor of BGH Labeling (press release). Waterbury, VT: Ben & Jerry's, May 6, 1993.15. Kolata G. When the geneticists' fingers get in the food. NYT NYT, February 20, 1994:E13. Also see: DuPuis EM. Nature's Perfect Food Nature's Perfect Food. New York University Press, 2002.16. OTA. U.S. Dairy Industry at a Crossroad: Biotechnology and Policy Choices U.S. Dairy Industry at a Crossroad: Biotechnology and Policy Choices-Special Report (OTA-F-470), 1991. BGH moratorium. (OTA-F-470), 1991. BGH moratorium. Nutrition Week Nutrition Week, August 6, 1993:5.17. Schneider K. U.S. approves use of drug to raise milk production: gain for biotechnology. NYT NYT, November 6, 1993:A1,A9. FDA. Animal drugs, feeds, and related products; sterile sometribove zinc suspension. FR FR 58:5994659947, November 12, 1993. 58:5994659947, November 12, 1993.18. Benson S, Arax M, Burstein R. A growing concern: as biotech crops come to market, neither scientists-who take industry money-nor federal regulators are adequately protecting consumers and farmers. Mother Jones Mother Jones, January/February 1997:3643,6671. Feder BJ. Monsanto has its wonder hormone: can it sell it? NYT NYT, March 12, 1995:A8. Stauber JC, Rampton S. Toxic Sludge Is Good for You: Lies, d.a.m.n Lies, and the Public Relations Industry Toxic Sludge Is Good for You: Lies, d.a.m.n Lies, and the Public Relations Industry. Monroe, ME: Common Courage Press, 1995:5559.19. Engelberg S. Democrats' new overseer is everybody's Mr. Inside. NYT NYT, August 19, 1994:A1,A16.20. Coghlan A. Milk hormone data bottled up for years. New Scientist New Scientist October 22, 1994:4. Millstone E, Brunner E, White I. Plagiarism or protecting public health? October 22, 1994:4. Millstone E, Brunner E, White I. Plagiarism or protecting public health? Nature Nature 1994;371:647648. 1994;371:647648.21. Wilson S. Fox in the cow barn. Nation Nation, June 8, 1998:20. Montague P. How Monsanto "listens" to other opinions. Ecologist Ecologist 1998;28(5):299300. Reporters win lawsuit to thwart Fox-TV cover-up. 1998;28(5):299300. Reporters win lawsuit to thwart Fox-TV cover-up. BGH Bulletin BGH Bulletin, undated, accessed December 15, 2001. Online: www.foxbghsuit.com.22. Schneider K. Lines drawn in a war over a milk hormone. NYT NYT, March 9, 1994:A12.23. Weldon VV. Testimony to the Joint Meeting of the FDA Food and Veterinary Medicine Advisory Committee Meetings, Was.h.i.+ngton DC, May 67, 1993 (written statement distributed at the meeting). Dr. Weldon was then vice president for public policy, Monsanto.24. After committees meet, BGH decision left to FDA. Nutrition Week Nutrition Week, May 14, 1993:23.25. FDA. Interim guidance on the voluntary labeling of milk and milk products from cows that have not been treated with recombinant bovine somatotropin. FR FR 59:62796280, February 10, 1994. 59:62796280, February 10, 1994.26. Schneider K. Maine and Vermont restrict dairies' use of a growth hormone. NYT NYT, April 15, 1994:A16.27. Kilman S. Dairy-food concerns launch products from cows not treated with hormone. WSJ WSJ, May 2, 1994:B7.28. Burros M. More milk, more confusion: what should the label say? NYT NYT, May 18, 1994:C1,C4.29. King & Spalding. Mandatory labeling of milk and other foods derived from dairy cows supplemented with bovine somatotropin would be unlawful and unwise (memorandum). Was.h.i.+ngton, DC, April 28, 1993. A cover letter discloses the author as Mr. Richard A. Merrill, the former FDA counsel. These materials were included as part of the briefing materials for the FDA Food Advisory Committee hearings of May 6, 1993.30. Schneider K. Question is raised on hormone maker's ties to F.D.A. aides. NYT NYT, April 18, 1994:A9.31. GAO. Letter from Acting General Counsel Robert P. Murphy to the Honorables George E. Brown, Jr., David Obey, and Bernard Sanders (B257122), October 19, 1994. Quotations: 15,23.32. Sanders B. GAO uncovers appearances of impropriety in FDA's approval of rBGH (press release). U.S. House of Representatives, October 30, 1994. The release included detailed summaries of the involvement of the three FDA employees.33. Bellow D. Vermont, the pure-food state. Nation Nation, March 8, 1999:1821. Brownlee S. Dollars for DNA: biotech seems near to living up to its hype. US News & World Report US News & World Report, May 25, 1998:48,50.34. Aldrich L, Blisard N. Consumer acceptance of biotechnology: lessons from the rbST experience. Current Issues in Economics of Food Markets Current Issues in Economics of Food Markets (USDA Agriculture Information Bulletin No. 747-01), December 1998. (USDA Agriculture Information Bulletin No. 747-01), December 1998.35. Hoban TJ. Consumer Awareness and Acceptance of Bovine Somatotropin (BST) Consumer Awareness and Acceptance of Bovine Somatotropin (BST). Was.h.i.+ngton, DC: Grocery Manufacturers of America, 1994. Grobe D, Douthitt R, Zepeda L. A model of consumers' risk perceptions toward recombinant bovine growth hormone (rBGH): the impact of risk characteristics. Risk a.n.a.lysis Risk a.n.a.lysis 1999;19:661673. 1999;19:661673.36. Gilbert S. Fears over milk, long dismissed, still simmer. NYT NYT, January 19, 1999:F7.37. Kessler DA, Taylor MR, Maryanski JH, et al. The safety of foods developed by biotechnology. Science Science 1992;256:17471749, 1832. 1992;256:17471749, 1832.38. FDA. Statement of policy: foods derived from new plant varieties: notice. FR FR 57:2298423005, May 29, 1992. Quotation: 22985. 57:2298423005, May 29, 1992. Quotation: 22985.39. FDA. Premarket notice concerning bioengineered foods: proposed rule. FR FR 66:47064738, January 18, 2001. 66:47064738, January 18, 2001.40. Ingersoll B. New policy eases market path for bioengineered foods. WSJ WSJ, May 26, 1992: B1,B6.41. Kim J. Genetic agriculture gets go-ahead. USA Today USA Today, May 27, 1992:3B.42. Burros M. Doc.u.ments show officials disagreed on altered food. NYT NYT, December 1, 1999:A18. Druker SM. Why Food and Drug Administration Policy on Genetically Engineered Food Violates Sound Science and U.S. Law Why Food and Drug Administration Policy on Genetically Engineered Food Violates Sound Science and U.S. Law (presentation to FDA hearing, Was.h.i.+ngton, DC, November 30, 1999), at (presentation to FDA hearing, Was.h.i.+ngton, DC, November 30, 1999), at www.biotech-info.net/druker.pdf.43. Millstone E, Brunner E, Mayer S. Beyond "substantial equivalence." Nature Nature 1999;401:525526. 1999;401:525526.44. Brozan N. Genetically engineered foods? Not in their their kitchens! kitchens! NYT NYT, July 30, 1992:B6. Chefs urge boycotting new foods. NYT NYT, June 3, 1992:C6.45. FDA. Foods Derived from New Plant Varieties Derived through Recombinant DNA Technology: Final Consultations under FDA's 1992 Policy Foods Derived from New Plant Varieties Derived through Recombinant DNA Technology: Final Consultations under FDA's 1992 Policy, July 2001, at www.foodsafety.gov/~lrd/biocon.html.46. Putnam JJ, Allshouse JE. Food Consumption, Prices, and Expenditures, 197097 Food Consumption, Prices, and Expenditures, 197097 (Statistical Bulletin No. 965), USDA, 1999. Fisher LM. Developer of the new tomato expects a financial bonanza. (Statistical Bulletin No. 965), USDA, 1999. Fisher LM. Developer of the new tomato expects a financial bonanza. NYT NYT, May 19, 1994:B7. Hilts PJ. Genetically altered tomato moves toward U.S. approval. NYT NYT, April 9, 1994:A7.47. Martineau B. Food fight. The Sciences The Sciences 2001;spring:2429. Martineau B. 2001;spring:2429. Martineau B. First Fruit: The Creation of the Flavr Savr Tomato and the Birth of Biotech Food First Fruit: The Creation of the Flavr Savr Tomato and the Birth of Biotech Food. New York: McGraw-Hill, 2001. Also see: Charles D. Lords of the Harvest: Biotech, Big Money, and the Future of Food Lords of the Harvest: Biotech, Big Money, and the Future of Food. Cambridge, MA: Perseus, 2001:126148.48. Redenbaugh K, Hiatt W, Martineau B, et al. Safety a.s.sessment of Genetically Engineered Fruits and Vegetables: A Case Study of the Flavr Savr Tomato Safety a.s.sessment of Genetically Engineered Fruits and Vegetables: A Case Study of the Flavr Savr Tomato. Boca Raton, FL: CRC Press, 1992. Stix G. A recombinant feast: new bioengineered crops move toward market. Scientific American Scientific American 1995;273:3839. 1995;273:3839.49. Seabrook J. Tremors in the hothouse. New Yorker New Yorker, July 19, 1993:3241. O'Neill M. Tomato review: no subst.i.tute for summer. NYT NYT, May 19, 1994:B7.50. McMurray S. New Calgene tomato might have tasted just as good without genetic alteration. WSJ WSJ, January 12, 1993:B1. Fisher LM. Monsanto to acquire 49.9% of biotechnology company. NYT NYT, June 29, 1995:D3.51. Safeway. A Guide to Safeway Double Concentrated Tomato Puree Produced from Genetically Modified Tomatoes: Help and Advice A Guide to Safeway Double Concentrated Tomato Puree Produced from Genetically Modified Tomatoes: Help and Advice. Kent, UK: Safeway, [undated, c. 1998].52. Rogers D. Stores dodge GM food row. Marketing Marketing (London), June 18, 1998:14. (London), June 18, 1998:14.53. Whitney CR. Europe loses its appet.i.te for high-tech food. NYT NYT, June 27, 1999:D3. Michael A. "GM-free" food labels are value-free. Nature Biotechnology Nature Biotechnology 1999;17:420. 1999;17:420.54. EPA. Proposed policy: plant-pesticides subject to the Federal Insecticide, Fungicide, and Rodenticide Act; and the Federal Food, Drug, and Cosmetic Act. FR FR 59:60496-60518, November 23, 1994. EPA. Plant-pesticides subject to the Federal Insecticide, Fungicide, and Rodenticide Act: proposed rule. 59:60496-60518, November 23, 1994. EPA. Plant-pesticides subject to the Federal Insecticide, Fungicide, and Rodenticide Act: proposed rule. FR FR 59:6051960535, November 23, 1994. 59:6051960535, November 23, 1994.55. Rissler J, Mellon M. The Ecological Risks of Engineered Crops The Ecological Risks of Engineered Crops. Cambridge, MA: MIT Press, 1996. National Research Council. Genetically Modified Pest-Protected Plants: Science and Regulation Genetically Modified Pest-Protected Plants: Science and Regulation. Was.h.i.+ngton, DC: National Academy Press, 2000.56. Miller H. A need to reinvent biotechnology regulation at the EPA. Science Science 1994;266:18151818. Wadman M. GM advisory panel is slanted, say critics. 1994;266:18151818. Wadman M. GM advisory panel is slanted, say critics. Nature Nature 1999;399:7. Environmental Defense Fund (EDF). EDF Cautiously Praises EPA's Proposed Genetic Engineering Rule (press release). New York, November 16, 1994. Plan to regulate gene-modified plants draws fire. 1999;399:7. Environmental Defense Fund (EDF). EDF Cautiously Praises EPA's Proposed Genetic Engineering Rule (press release). New York, November 16, 1994. Plan to regulate gene-modified plants draws fire. Illinois Agrinews Illinois Agrinews, August 1, 1997:A4.57. Hagmann M. EPA, critics soften stance on pesticidal plants. Science Science 1999;284:249. 1999;284:249.58. EPA. Regulations under the Federal Insecticide, Fungicide, and Rodenticide Act for plant-incorporated protectants (formerly plant-pesticides): final rule. FR FR 66:3777137817, July 19, 2001. Quotation: 37781. 66:3777137817, July 19, 2001. Quotation: 37781.59. EPA. Biopesticides Registration Action Doc.u.ment: Biopesticides Registration Action Doc.u.ment: Bacillus thuringiensis Plant-Incorporated Protectants, October 16, 2001, at Bacillus thuringiensis Plant-Incorporated Protectants, October 16, 2001, at www.epa.gov/opp00001/biopesticides/pips/bt_brad.htm.60. EPA. Pesticide labeling and other regulatory issues: final rule. FR FR 66:6475964768, December 14, 2001. 66:6475964768, December 14, 2001.
CHAPTER 8. THE POLITICS OF CONSUMER CONCERN:.
DISTRUST, DREAD, AND OUTRAGE.
1. Zepeda L. Don't ask, don't tell: U.S. policy on labeling of genetically engineered foods. In: b.u.t.tel FH, Goodman RM. Of Frankenfoods and Golden Rice: Risks, Rewards, and Realities of Genetically Modified Foods Of Frankenfoods and Golden Rice: Risks, Rewards, and Realities of Genetically Modified Foods. Madison: Wisconsin Academy of Sciences, Arts and Letters, 2001:121130.2. Poll Shows Broad but Limited Support for Labeling of Bioengineered Foods (press release). CSPI, May 16, 2001, at www.cspinet.org/new/labeling_gefoods.html.3. International Food Information Council. Most Americans can articulate expected benefits of biotechnology, November 2001, at www.biotech-info.net/IFIC_research.html.4. Fox JL. U.S. food labeling policy softens. Nature Biotechnology Nature Biotechnology 1999;17:847. Silva C, Leonard R. U.S. prepares to OK labels on GE foods. 1999;17:847. Silva C, Leonard R. U.S. prepares to OK labels on GE foods. Nutrition Week Nutrition Week, October 29, 1999:45.5. Genetically Engineered Food Right to Know Act Genetically Engineered Food Right to Know Act. H.R. 3377, 106th Congress, 1st Session, November 16, 1999.6. Biotech foods bill would mandate labeling, impose civil penalties. Food Regulation Weekly Food Regulation Weekly, November 15, 1999:1112.7. FDA. Biotechnology in the year 2000 and beyond; public meetings: notice. FR FR 64:5747057472, October 25, 1999. 64:5747057472, October 25, 1999.8. FDA. Report on Consumer Focus Groups on Biotechnology Report on Consumer Focus Groups on Biotechnology, February 2001, at www.foodsafety.gov/~comm/biorpt.html. The FDA conducted 12 focus groups from May 10 to 24, 2000.9. FDA. FDA to Strengthen Pre-market Review of Bioengineered Foods (press release). May 3, 2000. White House Briefing Room. Clinton Administration Agencies Announce Food and Agricultural Biotechnology Initiatives (press release). May 3, 2000.10. Pollack A. F.D.A. plans new scrutiny in areas of biotechnology. NYT NYT, January 18, 2001:A12. FDA. Premarket notice concerning bioengineered foods: proposed rule. FR FR 66:47064738, January 18, 2001. 66:47064738, January 18, 2001.11. Kilman S. FDA warns of misleading label on genetically modified foods. WSJ WSJ, December 20, 2001:B9. Weise E. FDA tries to remove genetic label before it sticks. USA Today USA Today, October 9, 2002:7D.12. Nestle M. Food biotechnology: truth in advertising. Bio/Technology Bio/Technology 1992;10:1056. 1992;10:1056.13. OTA. New Developments in Biotechnology: Patenting Life New Developments in Biotechnology: Patenting Life (OTA-BA-370). U.S. Congress, 1989. (OTA-BA-370). U.S. Congress, 1989.14. Stone R. Sweeping patents put biotech companies on the warpath. Science Science 1995;268:656658. Rural Advancement Foundation International. Monsanto's "Submarine Patent" Torpedoes Ag Biotech (press release), April 27, 2001, at 1995;268:656658. Rural Advancement Foundation International. Monsanto's "Submarine Patent" Torpedoes Ag Biotech (press release), April 27, 2001, at www.etcgroup.org/en/materials/publications.html?pub_id=262.15. Moon SE. Seed piracy: biotech industry faces a growing concern. Illinois Agrinews Illinois Agrinews, April 17, 1998:A9.16. Kilman S. Biotech industry s.h.i.+vers at threat to seed patents. WSJ WSJ, March 3, 1999:B1. Pioneer Hi-Bred International Pioneer Hi-Bred International v. v. J.E.M. Ag Supply (Farm Advantage J.E.M. Ag Supply (Farm Advantage). 99-1035 (U.S. Court of Appeals for the Federal Circuit), January 19, 2000. The U.S. Supreme Court confirmed the ruling, December 10, 2001 (534 U.S. 124).17. Fulmer M. Patent ruling aids seed biotech firms; Courts: a.n.a.lysts say the Supreme Court is taking a tough stance to strengthen intellectual property rights. Los Angeles Times Los Angeles Times, December 11, 2001:C3.18. s.h.i.+va V. Biopiracy: The Plunder of Nature and Knowledge Biopiracy: The Plunder of Nature and Knowledge. Boston: South End Press, 1997.19. Basmati patent shrinks. Science Science 2001;293:1761. Kurtenbach E. Patent application raises worries. Yahoo News, December 12, 2001. Online: dailynews.yahoo.com (no longer available). 2001;293:1761. Kurtenbach E. Patent application raises worries. Yahoo News, December 12, 2001. Online: dailynews.yahoo.com (no longer available).20. Svatos M. Patents and licensing, ethics, owners.h.i.+p of animal and plant genes. In: Murray TH, Mehlman MJ, eds. Encyclopedia of Ethical, Legal, and Policy Issues in Biotechnology Encyclopedia of Ethical, Legal, and Policy Issues in Biotechnology. Vol. 2. New York: John Wiley & Sons, 2000:844854. Also: Ho CM. International intellectual property issues for biotechnology (2000:761787).21. Andrews EL. U.S. resumes granting patents on genetically altered animals. NYT NYT, February 3, 1993:A1,D5. Also see: Rifkin J. The Biotech Century: Harnessing the Gene and Remaking the World The Biotech Century: Harnessing the Gene and Remaking the World. New York: Jeremy P. Tarcher/Putnam, 1998.22. Thompson PB. Food Biotechnology in Ethical Perspective Food Biotechnology in Ethical Perspective. London: Blackie Academic, 1997. Bruce D, Bruce A. Engineering Genesis: The Ethics of Genetic Engineering in Non-Human Species Engineering Genesis: The Ethics of Genetic Engineering in Non-Human Species. London: Earthscan, 1998. s.h.i.+va V. Protect or Plunder: Understanding Intellectual Property Rights Protect or Plunder: Understanding Intellectual Property Rights. London: Zed Books, 2001.23. Service RF. Seed-sterilizing "terminator technology" sows discord. Science Science 1998;282:850851. Steinbrecher RA, Mooney PR. Terminator technology: the threat to world food security. 1998;282:850851. Steinbrecher RA, Mooney PR. Terminator technology: the threat to world food security. Ecologist Ecologist 1998;28(5):276279. National Campaign for Sustainable Agriculture. U.S. Department of Agriculture is at it again!! Agency continues to fund terminator technology (leaflet). Pine Bush, NY, August 23, 1999. 1998;28(5):276279. National Campaign for Sustainable Agriculture. U.S. Department of Agriculture is at it again!! Agency continues to fund terminator technology (leaflet). Pine Bush, NY, August 23, 1999.24. Food gains for the world's poor are being threatened by furor over genetically modified (GM) foods (press release). New York: Rockefeller Foundation, June 24, 1999, at http://findarticles.com/p/articles/mi_hb5243/is_199906/ai_n20192882.25. Vidal J. How Monsanto's mind was changed. Guardian Guardian (London), October 9, 1999, at (London), October 9, 1999, at www.biotech-info.net/mind_change.html.26. Feder BJ. Monsanto says it won't market infertile seeds. NYT NYT, October 5, 1999:A1,C2.27. Feder BJ. Plant sterility research inflames debate on biotechnology's role in farming, NYT NYT, April 19, 1999:A18.28. Barboza D. After deal of 2 giants, shares plunge. NYT NYT, December 21, 1999:C1,C9. Kaiser J. USDA to commercialize "terminator" technology. Science Science 2000;289:709710. 2000;289:709710.29. USDA/Agricultural Marketing Service. National organic program: proposed rule. FR FR 62:6584965967, December 16, 1997. The rules for organic foods went into effect October 21, 2002. 62:6584965967, December 16, 1997. The rules for organic foods went into effect October 21, 2002.30. Burros M. U.S. proposal on organic food gets a gra.s.s-roots review. NYT NYT, March 15, 1998:F10. Fox JL. USDA appeases organic lobby. Nature Biotechnology Nature Biotechnology 1999;17:217. Revised organic proposed rule drops GMOs, antibiotics, sewage, irradiation. 1999;17:217. Revised organic proposed rule drops GMOs, antibiotics, sewage, irradiation. Food Regulation Weekly Food Regulation Weekly, March 13, 2000:89.31. Pear R. Tougher labeling for organic food: products of gene engineering cannot carry designation. NYT NYT, May 9, 1998:A1,A6.32. Pollack A. Unapproved canola seed may be on farms, makers say. NYT, April 16, 2002: NYT, April 16, 2002: C C4. Rieger MA, Lamond M, Preston C, et al. Pollen-mediated movement of herbicide resistance between commercial canola fields. Science Science 2002:296:23862388. Carroll J. Gene-altered canola can spread to nearby fields, risking lawsuits. 2002:296:23862388. Carroll J. Gene-altered canola can spread to nearby fields, risking lawsuits. WSJ WSJ, June 28, 2002:B6.33. Villar JL. GMO Contamination around the World GMO Contamination around the World. Amsterdam: Friends of the Earth International, October 2001, 2nd ed, August 2002. Quote: p. 9, at http://stopogm.net/files/GMOContaminationaroundtheworld.pdf. Also see: Barboza D. As biotech crops multiply, consumers get little choice. NYT NYT, June 10, 2001:A1,A28.34. Nigh R, Benbrook C, Brush S, et al. Transgenic crops: a cautionary tale (letters). Science Science 2000;287:19271928. Ross J. Tinkering with the tortilla: genetic engineering threatens Mexico's corn culture. 2000;287:19271928. Ross J. Tinkering with the tortilla: genetic engineering threatens Mexico's corn culture. Sierra Sierra, September/October 2001:2021.35. Quist D, Chapela IH. Transgenic DNA introgressed into traditional maize landraces in Oaxaca, Mexico. Nature Nature 2001;414:541543. Manning A. Gene-altered DNA may be "polluting" corn: cross-pollination is found in native varieties in Mexico. 2001;414:541543. Manning A. Gene-altered DNA may be "polluting" corn: cross-pollination is found in native varieties in Mexico. USA Today USA Today, November 29, 2001:15D.36. Suspect evidence of transgenic contamination (letters), and editorial note. Nature Nature 2002;416:600601. 2002;416:600601.37. Yoon CK. Journal raises doubts on biotech study. NYT NYT, April 5, 2002:A21. Chapela's tenure was approved by his department, then denied, appealed, and eventually granted. See Nature Nature doi:10.1038/435390b, May 25, 2005. Monbiot G. The fake persuaders. doi:10.1038/435390b, May 25, 2005. Monbiot G. The fake persuaders. Guardian Guardian (London), May 14, 2002, at (London), May 14, 2002, at www.guardian.co.uk/politics/2002/may/14/greenpolitics.digitalmedia. Worthy K, Strohman RC, Billings PR. Conflicts around a study of Mexican crops (letter). Nature Nature 2002;417:897. 2002;417:897.38. Mann CC. Has GM corn "invaded" Mexico? Science Science 2002;295:16171619. 2002;295:16171619.39. Christensen E. Food fight: how GATT undermines food-safety regulations. Multinational Monitor Multinational Monitor, November 1990:1214. Ritchie M. Trading away the family farm: GATT and agriculture (November 1990:2628). Aaronson SA. Taking Trade to the Streets: The Lost History of Public Efforts to Shape Globalization Taking Trade to the Streets: The Lost History of Public Efforts to Shape Globalization. Ann Arbor: University of Michigan, 2001:142173. Also see: The World Trade Organization. Online: www.wto.org.40. Brunner J. What's on WTO's plate regarding agriculture. Seattle Times Seattle Times, November 30, 1999:A23. The quotation is attributed to U.S. Secretary of State Madeleine Albright. McKibben B. Don't be fooled. Seattle Weekly Seattle Weekly, November 25, 1999:9.41. The global food fight. Time Time, July 31, 2000:4445.42. Pollack A. Setting rules for biotechnology trade. NYT NYT, February 15, 1999:A8. U.S. sidetracks pact to control gene splicing (February 25, 1999:C1,C4). Genetically modified food: food for thought. Economist Economist, June 19, 1999:1921.43. Pollack A. 130 nations agree on safety rules for biotech food. NYT NYT, January 30, 2000:A1,A8. Micklethwait J. Europe's profound fear of food. NYT NYT, June 7, 1999:A22.44. International Organisation of Consumers Unions (I.O.C.U.). Comments: Implications of Biotechnology for Food Labelling Comments: Implications of Biotechnology for Food Labelling. Testimony to the Joint FAO/WHO Food Standards Programme Codex Committee on Food Labelling, Ottawa, Canada, October 2428, 1994. Food fights. Economist Economist, June 1319, 1998:113114.45. USDA/FSIS. Codex Committee on Food Labeling: U.S.A., at www.fsis.usda.gov/Codex_alimentarius/Codex_Committee_Food_ Labelling/index.asp.46. Dorey E. EuropaBio unit created to boost agbio defense. Nature Biotechnology Nature Biotechnology 1999;17:631. Hencke D, Evans R. How US put pressure on Blair over GM food: special report. 1999;17:631. Hencke D, Evans R. How US put pressure on Blair over GM food: special report. Guardian Guardian (London), February 28, 2000, at (London), February 28, 2000, at www.guardian.co.uk/environment/2000/feb/28/food.freedomofinformation.47. Citizens' groups: the non-governmental order. Economist Economist, December 11, 1999:2021. Lagnado L. Raising the anti: for those fighting biotech crops, Santa came early this year. WSJ WSJ, December 14, 1999:A1,A8. Hodgson J. GM roundup. Nature Biotechnology Nature Biotechnology 1999;17:939. 1999;17:939.48. Environment-consumer coalition launches campaign for labeling, testing of biotech foods. FCN FCN, July 24, 2000:1011. Branch S. Kraft is criticized for genetically modified foods. WSJ WSJ, February 6, 2002:B18.49. See, for example, information posted by Ag BioTech InfoNet, online at: www.biotech-info.net; and by the Turning Point Project, at http://web.archive.org/web/*/http://www.turnpoint.org.50. Books not otherwise mentioned in these chapters are: Charles D. Lords of the Harvest: Biotech, Big Money, and the Future of Food Lords of the Harvest: Biotech, Big Money, and the Future of Food. Cambridge, MA: Perseus, 2001. Hart K. Eating in the Dark: America's Experiment with Genetically Engineered Food Eating in the Dark: America's Experiment with Genetically Engineered Food. New York: Pantheon, 2002. Lambrecht B. Dinner at the New Gene Cafe: How Genetic Engineering is Changing What We Eat, How We Live, and the Global Politics of Food Dinner at the New Gene Cafe: How Genetic Engineering is Changing What We Eat, How We Live, and the Global Politics of Food. New York: St. Martin's, 2001. Lappe M, Bailey B. Against the Grain: Biotechnology and the Corporate Takeover of Your Food Against the Grain: Biotechnology and the Corporate Takeover of Your Food. Monroe, ME: Common Courage, 1998. Teitel M, Wilson KA. Genetically Engineered Food: Changing the Nature of Nature Genetically Engineered Food: Changing the Nature of Nature. Rochester, VT: Park Street, 1999. Ticciati L, Ticciati R. Genetically Engineered Foods: Are They Safe? You Decide Genetically Engineered Foods: Are They Safe? You Decide. New Canaan, CT: Keats, 1998.51. Lewontin R. Genes in the food! New York Review of Books New York Review of Books, June 21:2001:8184.52. McHughen A. Pandora's Picnic Basket: The Potential Hazards of Genetically Modified Foods Pandora's Picnic Basket: The Potential Hazards of Genetically Modified Foods. Oxford: Oxford University Press, 2000.53. Nestle M. Food Politics: How the Food Industry Influences Nutrition and Health Food Politics: How the Food Industry Influences Nutrition and Health. Berkeley: University of California Press, 2002:120122.54. Brand W. FDA holds Oakland hearing to discuss genetic labeling. Media-NewsGroup, December 14, 1999. Pollack A. At U.S. hearing scientists back altered crops. NYT NYT, December 14, 1999:A25.55. Pew Initiative on Food and Biotechnology. State legislative activity in 2001 related to agricultural biotechnology. Pew agricultural biotechnology is at www.pewtrusts.org/our_work_detail.aspx?id=442. Grimm C. Current (FebruaryMarch 2001) state GMO legislation in the United States. Ag BioTech InfoNet, March 2001, cached at www.biotech-info.net/current_state_legislation.html.56. Greenberger RS. Motley group pushes for FDA labels on biofoods to help religious people observe dietary laws. WSJ WSJ, August 18, 1999:A20. Barboza D. Monsanto faces growing skepticism on two fronts. NYT NYT, August 5, 1999:C1,C2. Nixon L. Consumers pet.i.tion for GM food labels. Agweek Agweek, July 19, 1999:25. Economics could be key in biotech suit against Monsanto. Food Regulation Weekly Food Regulation Weekly, December 20, 1999:11.57. Hoge W. Britons skirmish over genetically modified crops. NYT NYT, August 23, 1999:A3. Service RF. Arson strikes research labs and tree farm in Pacific Northwest. Science Science 2001;292:16221623. Verhovek SH. S.U.V.'s, golf, and even peas join growing hit list of eco-vandals. 2001;292:16221623. Verhovek SH. S.U.V.'s, golf, and even peas join growing hit list of eco-vandals. NYT NYT, July 1, 2001:A1,A15.58. Peterson M. New trade threat for U.S. farmers. NYT NYT, August 29, 1999:A1,A28.59. Ramey TS, Wimmer MJ, Rocker RM. GMOs are dead. In: Mitsch FJ, Mitch.e.l.l JS. Ag Biotech: Thanks, but No Thanks? Ag Biotech: Thanks, but No Thanks? Deutsche Bank, July 12, 1999, at Deutsche Bank, July 12, 1999, at www.rag.org.au/baa/gmbank.htm. Also see: GAO. International Trade: Concerns over Biotechnology Challenge U.S. Agricultural Exports International Trade: Concerns over Biotechnology Challenge U.S. Agricultural Exports (GAO-01-727), June 2001. (GAO-01-727), June 2001.60. American Corn Growers a.s.sociation. Third Annual Survey Third Annual Survey, December 21, 2001, and Corn Growers Concerned Trade Legislation Will Backfire Corn Growers Concerned Trade Legislation Will Backfire, January 18, 2002.61. Wainio J, Gibson P. U.S. exports face high tariffs in some key markets. FoodReview FoodReview 2001;24(3):2938. 2001;24(3):2938.62. Nettleton JA. Food industry retreats from science. Food Technology Food Technology 1999;53(10):24. 1999;53(10):24.
CONCLUSION. THE FUTURE OF FOOD SAFETY:.
PUBLIC HEALTH VERSUS BIOTERRORISM.
1. GAO. Bioterrorism: Federal Research and Preparedness Activities Bioterrorism: Federal Research and Preparedness Activities (GAO-01-915), September 2001. (GAO-01-915), September 2001. Bioterrorism: Review of Public Health Preparedness Programs Bioterrorism: Review of Public Health Preparedness Programs (GAO-02-149T), October 10, 2001. (GAO-02-149T), October 10, 2001. Food Safety and Security: Fundamental Changes Needed to Ensure Safe Food Food Safety and Security: Fundamental Changes Needed to Ensure Safe Food (GAO-02-47T), October 10, 2001. (GAO-02-47T), October 10, 2001.2. Green E. Britain details the start of its "mad cow" outbreak. NYT NYT, January 26, 1999:F2. Brown P, Will RG, Bradley R, et al. Bovine spongiform encephalopathy and variant Creutzfeldt-Jakob disease: background, evolution, and current concerns. Emerging Infectious Diseases Emerging Infectious Diseases 2001;7:616. Balter M. Uncertainties plague projections of vCJD toll. 2001;7:616. Balter M. Uncertainties plague projections of vCJD toll. Science Science 2001;294:770771. Projections are imprecise because people ate meat from affected cows from 1980 to 1996, and the disease develops slowly. 2001;294:770771. Projections are imprecise because people ate meat from affected cows from 1980 to 1996, and the disease develops slowly.3. Brown P. On the origins of BSE. Lancet Lancet 1998;352:252253. 1998;352:252253.4. Other examples are kuru, a human disease specifically a.s.sociated with ritualistic cannibalism among the Fore people of Papua New Guinea, and prion diseases specific to mink, deer, cats, and a great variety of exotic animals. Two n.o.bel Prizes honor this work: to Carleton Gajdusek for studies of kuru and Creutzfeldt-Jakob disease (1976), and to Stanley Prusiner for discovering and naming prions (1997).5. Prusiner SB. Prion diseases and the BSE crisis. Science Science 1997;278:245251. But see: Chesebro B. BSE and prions: uncertainties about the agent. 1997;278:245251. But see: Chesebro B. BSE and prions: uncertainties about the agent. Science Science 1998;279:4243. Prions are believed to cause proteins in the brain and nervous system to fold improperly. Like other proteins, prions should be inactivated by acid in the stomach, and digested (disa.s.sembled) to amino acids by intestinal enzymes. They are not. Instead, they survive stomach acid and digestive enzymes, pa.s.s through the intestinal wall, get carried intact through the blood stream, and penetrate the "blood-brain barrier" that protects the brain from harmful substances. Prion proteins appear to be so tightly folded that they resist inactivation by acid, enzymes, and cooking temperatures. Their improbable behavior is the basis of skepticism and alternative hypotheses (such as a slow-acting virus), but most evidence now favors the existence of prions. 1998;279:4243. Prions are believed to cause proteins in the brain and nervous system to fold improperly. Like other proteins, prions should be inactivated by acid in the stomach, and digested (disa.s.sembled) to amino acids by intestinal enzymes. They are not. Instead, they survive stomach acid and digestive enzymes, pa.s.s through the intestinal wall, get carried intact through the blood stream, and penetrate the "blood-brain barrier" that protects the brain from harmful substances. Prion proteins appear to be so tightly folded that they resist inactivation by acid, enzymes, and cooking temperatures. Their improbable behavior is the basis of skepticism and alternative hypotheses (such as a slow-acting virus), but most evidence now favors the existence of prions.6. Urry M. Major called for fewer rules on meat hygiene. Financial Times Financial Times (London), June 27June 28, 1998:7. (London), June 27June 28, 1998:7.7. Collee JG, Bradley R. BSE: a decade on-part 1. Lancet Lancet 1997;349:636641 ( 1997;349:636641 (part 2 is is Lancet Lancet 1997;349:715721). Nathanson N, Wilesmith J, Griot C. Bovine spongiform encephalopathy (BSE): causes and consequences of a common source epidemic. 1997;349:715721). Nathanson N, Wilesmith J, Griot C. Bovine spongiform encephalopathy (BSE): causes and consequences of a common source epidemic. Am J Epidemiology Am J Epidemiology 1997;14;959969. 1997;14;959969.8. Will RG, Ironside JW, Zeidler M, et al. A new variant of Creutzfeldt-Jakob disease in the UK. Lancet Lancet 1996;347:921945. Anderson RM, Donnelly CA, Ferguson NM, et al. Transmission dynamics and epidemiology of BSE in British cattle. 1996;347:921945. Anderson RM, Donnelly CA, Ferguson NM, et al. Transmission dynamics and epidemiology of BSE in British cattle. Nature Nature 1996;382:779788. Scott MR, Will R, Ironside J, et al. Compelling transgenetic evidence for transmission of bovine spongiform encephalopathy prions to humans. 1996;382:779788. Scott MR, Will R, Ironside J, et al. Compelling transgenetic evidence for transmission of bovine spongiform encephalopathy prions to humans. Proceedings of the National Academy of Sciences Proceedings of the National Academy of Sciences 1999;96:1513715142. 1999;96:1513715142.9. Less beef, more brain (editorial). Lancet Lancet 1996;347:915. Darnton J. Britain ties deadly brain disease to cow ailment. 1996;347:915. Darnton J. Britain ties deadly brain disease to cow ailment. NYT NYT, March 21, 1996:A1,A7. Lanska DJ. The mad cow problem in the UK: risk perceptions, risk management, and health policy development. J Public Health Policy J Public Health Policy 1998;19:160183. 1998;19:160183.10. France will continue beef ban; British pledge to fight in court. NYT NYT, December 9, 1999:A6.11. FDA. Substances prohibited from use in animal food or feed; animal proteins prohibited in ruminant feed. FR FR 62:3093530978, June 5, 1997. The rules exempted blood, gelatin, cooked meats, and milk, but FDA eliminated the exemption for gelatin later that year ( 62:3093530978, June 5, 1997. The rules exempted blood, gelatin, cooked meats, and milk, but FDA eliminated the exemption for gelatin later that year (FR 62:5234552346, Oct 7, 1997). Stecklow S. Porous borders: despite a.s.surances, U.S. could be at risk for mad-cow disease. 62:5234552346, Oct 7, 1997). Stecklow S. Porous borders: despite a.s.surances, U.S. could be at risk for mad-cow disease. WSJ WSJ, November 28, 2001:A1,A6.12. Harvard Center for Risk a.n.a.lysis. Evaluation of the Potential for Bovine Spongiform Encephalopathy in the United States: Executive Summary Evaluation of the Potential for Bovine Spongiform Encephalopathy in the United States: Executive Summary. USDA/APHIS, November 26, 2001, at www.aphis.usda.gov/newsroom/ hot_issues/bse/background/doc.u.ments/mainreporttext.pdf.13. Becker E. U.S. mad cow risk is low, a study by Harvard finds. 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CDC and Florida Department of Health Investigate a Likely Case of New Variant Creutzfeldt Jakob Disease in a U.K. Citizen Residing in the U.S. (press release), April 18, 2002.18. Ferguson NM, Donnelly CA, Anderson RM. The foot-and-mouth epidemic in Great Britain: pattern of spread and impact of interventions. Science Science 2001;292:11551160. Keeling MJ, Woolhouse MEJ, Shaw DJ, et al. Dynamics of the 2001 UK foot and mouth epidemic: stochastic dispersal in a heterogeneous landscape. 2001;292:11551160. Keeling MJ, Woolhouse MEJ, Shaw DJ, et al. Dynamics of the 2001 UK foot and mouth epidemic: stochastic dispersal in a heterogeneous landscape. Science Science 2001;294:813817. Lyall S. A tenacious disease finds new victims in British herds. 2001;294:813817. Lyall S. A tenacious disease finds new victims in British herds. NYT NYT, August 5, 2001:A3.19. Enserink M. Barricading U.S. borders against a devastating disease. Science Science 2001;291:22982300. 2001;291:22982300.20. Cowell A. Cattle disaster still felt in Britain. NYT NYT, September 10, 2002: W1,W7.21. Andrews EL. Dutch farmers facing ma.s.s foot-and-mouth slaughter. NYT NYT, April 6, 2001:A4.22. Becker E. Prohibited meat entered U.S., a report finds. NYT NYT, August 14, 2001:A12. Stone R. Report urges U.K. to vaccinate herds. Science Science 2002;297:319321. 2002;297:319321.23. Robert Koch postulated that (1) anthrax bacteria always are present in the blood of animals sick with the disease but not in healthy animals, (2) inoculation of blood from an animal with anthrax into another animal also causes anthrax, (3) inoculation of anthrax bacteria isolated from the blood of a sick animal and grown in culture will transmit anthrax to the new animal, and (4) anthrax bacteria can be isolated from the new animal. 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