[1]U.S. Congress, Office of Technology Assessment, New Developments in Biotechnology: Patenting Life (Washington, D.C.: U.S. Government Printing Office, 1989), p. 9.

[2] In this paper the term "bioindustry" refers to the cluster of companies that produce engineered biological products and their supporting businesses. "Biotechnology" refers to the use of the biological sciences (such as gene manipulation) to discover, evaluate, and develop products for bioindustry. The term "bioscience industry", is not used here because it refers only to biopharmaceudicals and medical devices.

[3] Sheldon Krimsky, Biotechnics and Society: The Rise of Industrial Genetics (New York: Praeger, 1991), p. xii. [4] The development and manufacturing of medical devices are usually included in biotechnology but are not dealt with in detail here. [5] Edward J. Blakely and Kelvin W. Willoughby, "Choosing a Strategy for Local Industry Development from Biotechnology: Transfer or Incubate," Institute of Urban and Regional Development, Biotechnology Industry Research Group, University of California at Berkeley, May 1990, p. 10.

[6] President's Council on Competitiveness, Report on National Biotechnology Policy ( [Washington]: The Council, 1991), p. 3.

[7] Ibid., p, 2.

[8] Ibid.

[9] W. French Anderson. "Gene Therapy," Scientific American, September 1995, p. 124.

[10] Sacramento Bee. "Way to alter genes in sperm discovered," November 11, 1994, p. A-4.

[11] The vector carries the genetic material into the cell.

[12] I. Carmen, "Biconstitutional Politics Decision Making," CBPE 92-9, Center for Biotechnology Policy and Ethics, Texas A&M University, May 1992.

[13] E. Marshall, "Less Hype, More Biology Needed for Gene Therapy," Science, December 15, 1995, p. 1751.

[14] R. Hartman, "Beyond Moore: Issues of Law and Policy Impacting Human Cell and Genetic Research in the Age of Biotechnology," The Journal of Legal Medicine, September 1993, p. 475.

[15] Jim Detjen, "Fight Against Cystic Fibrosis Gains," Sacramento Bee, September 2, 1994, p. A10.

[16] G. Kolata (1995). "Scientists Claim Gene Therapy's First Success," New York Times, October 20, 1995, p. A-13.

[17] Robert, Langer and Joseph P. Vacanti, "Artificial Organs," Scientific American, September 1995, p. 133.

[18] Peter Aldhous, "Genome Initiatives Tackle Developing World's Big Killers," Science, June 24, 1994, pp. 1848-9.

[19] U.S. Congress, Office of Technology Assessment, A New Technological Era for American Agriculture, OTA-F-474 (Washington, D.C.: U.S. Government Printing Office, August 1992), p. 9.

[20] Ibid., p. 4.

[21] California Department of Food and Agriculture. "Recombinant Bovine Somatotropin (BST) Consensus Document." Not dated but probably February 1994.

[22] The implications for animal and public health of the use of this product are a matter of debate. There is some evidence that animals treated with the hormone are more sensitive to infections and muscular skeletal problems. See U.S. Congress, Office of Technology Assessment, A New Technological Era for American Agriculture, OTA-F-474 (Washington, D.C.: U.S. Government Printing Office, August 1992), p. 5.

[23] California Department of Food and Agriculture, "Recombinant Bovine Somatotropin (BST) Consensus Document," not dated but probably February 1994.

[24] Lacy, Lacy, and Busch, "Emerging Trends."

[25] G. Kidd and J. Dvorak, "BST off to fast Start, Despite early Stumbles," Bio/Technology, January 1995, p. 13.

[26] Comstock, G. "What Obligations Have Scientists to Transgenic Animals?" Discussion Paper CBPE 92-8 (College Station, Texas: Center for Biotechnology Policy and Ethics, Texas A&M University, 1992).

[27] Lacy, Lacy, and Busch, "Emerging Trends," p. 8.

[28] Sacramento Bee, "Milk a goat for medications? FDA Says OK," August 31, 1995, p. A-12.

[29] R. Weiss, "Scientists are closing in on mass-producing animals," San Jose Mercury News, 7 March 1996, sec. 20-A. Cloning is a technique for making certain that the genetic material in an unlimited number of eggs is identical.

[30] Lacy, Lacy, and Busch, "Emerging Trends," p. 9.; and Biotechnology Industry Organization, Agriculture and the New Biology (Washington, D.C.: The Association, 1987).

[31] Ibid.

[32] Ibid., p. 10.

[33] Insect-resistant-crop research involves introduction of a bacterium-based insect control gene into plants. This gene produces insect control proteins that are lethal to different insects. Some kill moths and butterflies, beetle and fly larvae, but are not toxic to honeybees and lady bugs. The Industrial Biotechnology Association claims that: "three-quarters of the research on genetically engineered herbicide tolerance involves a new class of herbicides that are environmentally benign."

[34] C. Gasser and R. Fraley, "Genetically Engineering Plants for Crop Improvement" (1989) as cited by Biotechnology Industry Organization, in Agriculture and the New Biology (Washington, D.C.: The Association, 1987).

[35] Ernst and Young. Biotech 95: Reform, Restructure, Renewal (San Francisco: Ernst & Young, 1994), p. 23.

[36] American Medical Association Council on Scientific Affairs, "Biotechnology and the American Agricultural Industry," Journal of the American Medical Association, March 20, 1991, p.1431.

[37] D. Goodman, B. Sorj, and J. Wilkinson, "From Farming to Biotechnology: A Theory of Agro-Industrial Development," as quoted in W. Lacy, L. Lacy, and L. Busch, "Emerging Trends, Consequences, and Policy Issues in Agricultural Biotechnology," in M. Halberg, M., Bovine Somatotropin and Emerging Issues: An Assessment (Boulder Colorado: Westview Press, 1991), p. 8.

[38] President's Council on Competitiveness, Report on National Biotechnology Policy ([Washington]: The Council, 1991), p. 3.

[39] U.S. Congress, Office of Technology Assessment, Potential Environmental Impacts of Bioenergy Crop Production, OTA-BP-E-118 (Washington, D.C.: U.S. Government Printing Office, September 1993), p. 5.

[40] For a technical discussion pertinent to the techniques, see Juan L. Ramos, et al., "The Behavior of Bacteria Designed for Biodegradation," Bio/Technology, December 1994, p. 1349.

[41] Reported by Glenn Zorpette, in a box titled "Food Indigo," Scientific American, July 1995, p. 29.

[42] Stephen M. Edgington, "Environmental Biotechnology," Bio/Technology, December 1994, p. 1339.

[43] Federal Coordinating Council for Science, Engineering, and Technology, Biotechnology for the 21st Century: Realizing the Promise (Bethesda, MD:: National Institutes of Health, 1993), p. 3.

[44] "Nanotechnology" refers to efforts to develop molecular manufacturing techniques. "Molecular manufacturing is the construction of objects to complex, atomic specifications using sequences of chemical reactions directed by nonbiological molecular machinery. Molecular nanotechnology comprises molecular manufacturing together with its techniques, its products, and their design and analysis." See: K. Drexler, Nanosystems: Molecular Machinery, Manufacturing, and Computation (New York: John Wiley and Sons, Inc., 1992), xvii, 1.

[45] San Jose Mercury News, "Sunnyvale firm will develop biochemical 'super chip,'" September 22, 1994, p. F-1

[46] Gene Levinson, "Artificial Life: Biotechnology of the 21st Century?" Bio/Technology, February 1995, p. 122.

[47] "The Fly on the Wall and the Jedi Knight," RAND Research Brief, September 1994. The possible use and development of biotechnology military weapons is not examined in this paper.

[48] Daniel Thomas, "Nanotechnology's Many Disciplines," Bio/Technology, May 1995, p. 439.

[49] Kevin Kelly, Out of Control (Menlo Park, CA: Addison-Wesley, 1994), p. 310.

[50] Daniel Thomas, "Nanotechnology's Many Disciplines," p. 441.

[51] Marc W. Kirschner, Elizabeth Marincola, and Elizabeth Olmsted Teisberg, "The Role of Biomedical Research in Health Care Reform," Science, October 7, 1994, p. 49.

[52] Federal Coordinating Council for Science, Engineering, and Technology, Biotechnology for the 21st Century, p. 3.

[53] Los Angeles Times. "Drug Price Rise May Add Presure For Controls," February 1, 1994, p. A-12.

[54] D. Hicks, Advanced Industrial Development, (New York: Oelgeschlager, Gunn and Hain, 1985), p. 68.

[55] Peter Drucker, "The Age of Social Transformation," Atlantic Monthly, November, 1994, p. 54.

[56] Lacy, Lacy, and Busch, "Emerging Trends," p. 26.

[57] Sano Shimoda, "Agbiotech will vertically integrate agribusiness," Bio/Technology, November 1994, pp. 1062-1064.

[58] U.S. Congress, Office of Technology Assessment, A New Technological Era for American Agriculture, OTA-F-474 (Washington, D.C.: U.S. Government Printing Office, August 1992), p. 99

[59] Ibid., p. 99 and p. 149.

[60] For example, Rhone-Poulenc is working with Calgene to develop bromoxynil-tolerant seeds for several crops. Bromoxynil is a weed killer developed by Rhone-Poulenc. Development of the seed must await E.P.A. approval of the weed killer. See Mike Ward, "Modified Seeds reach European Market First," Bio/Technology, July 1994, p. 660.

[61] President's Council on Competitiveness, Report on National Biotechnology Policy ([Washington]: The Council, 1991), p. 5.

[62] "Feds Investigating Y-1s Production," Science News, July 9, 1994, p.30.

[63] Ernst & Young LLP, Biotech 95: Reform, Restructure, Renewal (San Francisco: Ernst & Young, 1994), p. i.

[64] Ernst & Young LLP, Biotech 96: Pursuing Sustainability ((San Francisco: Ernst & Young, 1996), p. 9.

[65] Federal Coordinating Council for Science, Engineering, and Technology. Biotechnology for the 21st Century: Realizing the Promise, (Bethesda, MD:: National Institutes of Health, 1993), p.1.

[66] "Occupations in Biotechnology" (Draft), Labor Market Information Division, California Employment Develoment Department, Number 2007, 1996, p.1.

[67] Ernst & Young LLP, Biotech 96: Pursuing Sustainability ((San Francisco: Ernst & Young, 1996), p. 9

[68] Labor Market Information Division., "Occupations in Biotechnology", p. 3.

[69] Collaborative Economics, Inc., "The Health Care Technology Industry Cluster in the Bay Area," prepared for the Competitive Growth Industries Project of the Bay Area Defense Conversion Action Team, August 17, 1994.

[70] Kelvin W. Willoughby and Edward J. Blakely, "Making Money from Microbes: Finance and the California Biotechnology Industry," Working Paper Number 89-166, Center for Real Estate and Urban Economics, Institute of Business and Economic Research, University of California at Berkeley, 1989.

[71] Edward J. Blakely and Kelvin W. Willoughby, "Choosing a Strategy for Local Industry Development from Biotechnology: Transfer or Incubate," Institute of Urban and Regional Development, Biotechnology Industry Research Group, University of California at Berkeley, May 1990, p. 11.

[72] Suzanne Huttner, UCLA Systemwide Biotechnology Research and Education Program, interview with Gus Koehler, August 23, 1994.

[73] California Health Care Institute, California's Industry of the Future (La Jolla: KPMG Peat Marwick LLP, 1996), pp. 6-7.

[74] Association of Bay Area Governments (ABAG), Biotechnology in the San Francisco Bay Area (San Francisco: ABAG, September 1988), pp. 4-8-9.

[75] Bay Area Bioscience Center and the Bay Area Council, The Emerging Bioscience Skills Gap ([Oakland]: [The Center], December 1991), p. ii.

[76] Economic Development Corporation of Los Angeles County, "Southland Technology Leader," 1995, p. 59.

[77] Greater San Diego Chamber of Commerce Economic Bulletin, April 1994, p. 6.

[78] The Occupational Research Unit, California Employment Development Department, recently released for review a draft study of new estimates of current and future biotechnology employment. These new estimates are lower than the precedings ones. This is probably due to differing definitions of which firms define the industry leading to the use of different SIC codes to estimate employment.

[79] Greater San Diego Chamber of Commerce Economic Bulletin, April 1994, p. 3.

[80] California Health Care Institute, The Health Care Technology Industry: What's Growing in California. ([La Jolla]: [The Institute], October 1993), p. 6.

[81] Systemwide Biotechnology Research and Education Program University of California, "California Biotech Facts" (mimeographed sheet), [1994?].

[82] California Trade and Commerce Agency, Office of Economic Research. "Biotechnology: A California Industry Profile" (pamphlet), July 1993, p. 4.

[83] Kelvin W. Willoughby and Edward J. Blakely, "The Economic Geography of Biotechnology in California," Working Paper Number 90-176, Center for Real Estate and Urban Economics, Institute of Business and Economic Research, [University of California at Berkeley], 1990, p. 17.

[84] ABAG, Biotechnology, p. 2-4.

[85] Bay Area Bioscience Center. "Gene Acres," June, 1992, p. 2.

[86] Maureen Stapleton, "Memo to the Honorable Mayor and City Council of San Diego, concerning the Transportation and Land Use Committee Meeting," November 1992.

[87] Roger E. Shamel and Michele Keough, "Places to Go for Companies Going Places," Bio/Technology, August 1994, p. 771.

[88] SRI, "Analyzing Economic Clusters in Pennsylvania: A Tool for Targeting Economic Development Services" (Menlo Park, CA: Center for Economic Competitiveness, Aug. 18, 1991).

[89] W. Powell and P. Brantley, "Competitive Cooperation in Biotechnology: Learning Through Networks," in N. Nohira and R. Eccles, Networks and Organizations (Boston Mass.: Harvard Business School Press: 1992).

[90] A. Saxenian, Regional Advantage (Boston: Harvard University Press: 1994). Also see Gus Koehler, Small Business Networks: Tools to Promote Economic Success (Sacramento: California Research Bureau, 1995).

[91] Willoughby and Blakely, "Economic Geography," p. 25.

[92] Edward J. Blakely and Kelvin W. Willoughby, "Choosing a Strategy for Local Industry Development from Biotechnology: Transfer or Incubate," Institute of Urban and Regional Development, Biotechnology Industry Research Group, University of California at Berkeley, May 1990, p. 19.

[93] Roger E. Shamel and Michele Keough, "Places to Go for Companies Going Places," Bio/technology, August 1994, pp. 770-773.

[94] Ibid., p. 770.

[95] Ibid., p. 772.

[96] Willoughby and Blakely, "Economic Geography," p.35.

[97] Alex Brownstein, "Why Not New York?" Bio/Technology, August 1994, p. 776.

[98] Davis Enterprise, "Biotech firm picks Vacaville," November 2, 1994, p. A.1.

[99] Roger E. Shamel and Michele Keough, "Places to Go for Companies Going Places," Bio/Technology, August 1994, p. 772.

[100] "Germany - Biotechnology Trade Show," American Embassy, Düsseldorf, November 10, 1993.

[101] Wall Street Journal, "The Trailing Edge: Some Germans Fear They're Falling Behind in High-Tech Field," April 27, 1994, p. A1.

[102] Robert L. Koenig, "Germany Loosens some Red Tape," Science, January 20, 1995, p. 326.

[103] P. Kahn, "Blending Biology, Technology, and Economic Development," Science, Feb. 10, 1995, p. 785.

[104] "Indonesia - Biotechnology Laboratory Equipment," American Embassy, Jakarta, February 1994.

[105] "Netherlands -Environmental, Biotech Research," American Embassy, The Hague, September 1, 1993.

[106] "Singapore Government Stepping up Investment in Biotech Companies," American Embassy Singapore, July 1, 1993.

[107] "United Kingdom - Biotech Market Overview," American Embassy London, October 1, 1993.

[108] "United Kingdom - Biotech Market Overview," American Embassy London, October 1, 1993.

[109] "United Kingdom - Biotech Market Overview," American Embassy London, October 1, 1993.

[110] "U.K. Biotechnology - A sector in Transition," American Embassy London, July 28, 1993.

[111] "Biotech investors remain anxious over F.D.A., Europe and health care reform," "Calbio Summit 94'," supplement to the San Diego Daily Transcript, p. 3.

[112] California Health Care Institute and Ernst and Young LLP (1996). Exporting an Industry: The Impact of FDA Regulation on California's Biomedical Industry (La Jolla: Ernst and Young LLP, April 1996), p. 1.

[113] California State Assembly, Committee on Agriculture (staff), "Background Paper on Biotechnology Prepared by the Assembly Committee on Agriculture Staff," March 7, 1994.

[114] David Kessler and Karyn Feiden, "Faster Evaluation of Vital Drugs," Scientific American (March 1995), 48.

[115] Sheila Shulman, Peg Hewitt, and Michael Manocchia, "Studies and Inquiries into the FDA Regulatory Process: An Historical Review (Boston: Tufts Center for the Study of Drug Development, Tufts University, September 9, 1994), p. 36.

[116] Henry I. Miller, M.D., "Remarks for the California Legislature Assembly Committee on Agriculture, March 7, 1994" (photocopy).

[117] Davis Enterprise, "USDA will relax its biotech regulations," August 25, 1995.

[118] Organisms that produce or that are capable of producing a disease.

[119] Federal Register, June 16, 1987, 52 FR 22892.

[120] 51 CFR 23315.

[121] Susan Huttner, Systemwide Biotechnology Research and Education Program, personal communication, Sept., 1994.

[122] Tufts Center for the Study of Drug Development, White Paper on Four Areas of Relevance to New Drug Development and Review in the United States (Boston: Tufts Center for the Study of Drug Development, Tufts University, September 9, 1994), p. 1.

[123] Tufts Center for the Study of Drug Development, White Paper on Four Areas of Relevance to New Drug Development and Review in the United States, p. 2.

[124] President's Council on Competitiveness, Report on National Biotechnology Policy ([Washington]: The Council, 1991), p. 14.

[125] Ibid., p. 11.

[126] U.S. Congress, Office of Technology Assessment, A New Technological Era for American Agriculture, OTA-F-474 (Washington, D.C.: U.S. Government Printing Office, August 1992), p. 202.

[127] Interagency Task Force on Biotechnology, State of California (ITFB), California's Biotechnology: Permits and Regulations-- a Description. ([Sacramento]: [The Task Force], 1986).

[128] Executive Order d-46-85.

[129] Executive Order d-46-85.

[130] ITFB, California's Biotechnology, pp. 1-2.

[131] Ibid.

[132] Ibid., p. 3.

[133] Executive Order W-67-93, October 1993.

[134] University of California Systemwide Biotechnology Research and Education Program, "Guidance for State Governments on Oversight of Biotechnology," Molecular Biology Institute, University of California, Los Angeles, September 1990.

[135] Ibid., p.3.

[136] 51 Federal Register 23302, June 26, 1986.

[137] Association of Bay Area Governments, Biotechnology in the San Francisco Bay Area (San Francisco: ABAG, September 1988), p. 2-7.

[138] City of Chula Vista, "High-tech/biotech Zone Issue Paper," Revised draft of April 6, 1994.

[139] Research and development facilities include common elements in their design. Standardized designs mean that the facility is reusable, and is attractive to investors. The Association of Biotech Companies has adopted standards developed by The Nielsen Capital Group for single-tenant start-up bio-pharmaceutical research and development facilities. Ibid., p. 16.

[140] Ibid., pp. 25-30.

[141] Ibid., pp. 30-31.

[142] J. Kotkin and S. Levy, "California: A Twenty-First Century Prospectus," (Center for the New West, and Center for the Continuing Study of the California Economy, Feb. 28, 1996), 29.

[143] San Diego Union, "Biomed Summit Termed Success," March, 20, 1992.

[144] City of Chula Vista "High-tech/biotech Zone Issue Paper," p. 14.

[145] E. Blakely, "The Economic Development Potentials of California's Biotech Industry," Working Paper No. 498, Biotech Industry Research Group, Institute of Urban and Regional Development, University of California at Berkeley, April 1989, p. 19.

[146] California Health Care Institute and Ernst and Young LLP, "Exporting an Industry: The Impact of FDA Regulation on California's Biomedical Industry. (La Jolla: California Health Care Institute, April 1996), p. 2.

[147] U.S. Congress, Office of Technology Assessment (OTA), New Developments in Biotechnology: Patenting Life (Washington, D.C.: U.S. Government Printing Office, 1989).

[148] Ibid., p. 8.

[149] N. Hettinger, "Owning Varieties of Life," Center for Biotechnology Policy and Ethics, Texas A&M University, 1994), p. 6

[150] OTA, New Developments in Biotechnology: Patenting Life, p. 18.

[151] George Kidd and James Dvorak, "Agracetus' cotton patent draws opposition," Bio/Technology, July 1994, p. 659.

[152] D. Savage, "Patenting U.S. Technology in the Global Marketplace," Gray, Cary, Ware, and Freidenrich: 1994.

[153] Ernst & Young LLP, Biotech 95: Reform, Restructure, Renewal (San Francisco: Ernst & Young, 1994), p. 14.

[154] Science, "Biotech Industry Wins Concession on GATT," September 30, 1994, p. 1999.

[155] Science, "Rules Would Drop Need for Clinical Data," January 6, 1995, p. 23.

[156] N. Hettinger, "Owning Varieties of Life: Biotechnology, Intellectual Property, and Environmental Ethics" (College Station, Texas: Center for Biotechnology Policy and Ethics, Texas A&M University, 1994), p. 7.

[157] T. Beardsley, "Patently Obvious," Scientific American, September 1995, p. 45.

[158] Ibid.

[159] Hettinger, "Owning Varieties of Life: Biotechnology, Intellectual Property, and Environmental Ethics," p. 18.

[160] Angus Wright, Professor of Environmental Studies, Sacramento State University, personal communication, August 1994.

[161] Los Angeles Times, "As Scientific Puzzle Unravels, a Legal Issue Tangles More," April 11, 1994, p. B6.

[162] "BIOCOM: 1994/1995 Issues Agenda For the Bioscience Industry in California," prepared by the San Diego Biocommerce Association for CALBIO Summit '94, October 1994.

[163] N. Hettinger, "Owning Varieties of Life: Historical, Conceptual, and Ethical Dimensions." Center for Biotechnology Policy and Ethics" (College Station, Texas: Texas A&M University, 1992), p. 18.

[164] Runningen, R. "Intellectual Property Protection -- NAFTA Fact Sheet," U.S. Department of Agriculture.

[165] Hettinger, "Owning Varieties of Life: Historical, Conceptual, and Ethical Dimensions."

[166] Harris, T. "Gene Ownership," Science, July 29, 1994, p. 589.

[167] Moore v. Regents of the University of California, 793 P.2d 479, 271 Cal. Rptr. 146 (1990), cert. denied, 111 S. Ct. 1388 (1991).

[168] R. Hartman, "Beyond Moore: Issues of Law and Policy Impacting Human Cell and Genetic Research in the Age of Biotechnology," The Journal of Legal Medicine, September 1993, p. 463.

[169] Ibid, p. 467.

[170] Moore v. Regents of the University of California, 793 P.2d 479, 271 Cal. Rptr. 146 (1990), p. 479. Hartman feels that not one of the federal statutes cited by the court resolves bioengineeering issues. She believes that an important distinction can be drawn between cell lines whose products can be used by more than one person, and the sale of body parts that can help only one person (transplantation). Ibid.

[171] Andrew Kimbrell, The Human Body Shop (San Francisco: Harper/Collins, 1993), p. 22.

[172] Susan Hassler, "European Patent Legislation: A Missed Opportunity," Bio/Technology, April 1995, p. 305.

[173] New York Times, "Harvard's New Test-Tube Business," Sunday, August 22, 1993.

[174] Encylopaedia Britannica Yearbook of Science and the Future, 1995, p. 430.

[175] L. Busch, W. Lacy, J. Burkhardt, and L. Lacy, Plants, Power and Profit: Social, Economic, and Ethical Consequences of the New Biotechnologies (1991), as cited W. Lacy, L. Busch, and L. Lacy. "Public Perceptions of Agricultural Biotechnology," in B. Baumgardt, and M. Martin, eds., Agricultural Biotechnology: Issues and Choices (West Lafayette, Indiana: Purdue University Press, 1991), p. 21.

[176] J. Kassirer, and M. Angell, "Financial Conflict of Interest in Biomedical Research," New England Journal of Medicine, August 19, 1993.

[177] M. Barinaga, "Confusion on the Cutting Edge," Science, July 31, 1992.

[178] J. Mervis, "Final Rules Put Universities in Charge," Science, July 21, 1995, p. 295.

[179] Paul B. Thompson, Robert J. Matthews, and Eileen O. van Ravenswaay, Ethics, Public Policy, and Agriculture. (N.Y.: Macmillan, 1994), p. 120.

[180] NewYork Times, "Genetic Engineering Can Spred Allergies," March 14, 1996, A-10.

[181] Susan Phillips, "Genetically Engineered Foods," CQ Researcher, August 5, 1994, p. 679.

[182] New York Times, "Genetic Engineering...."

[183] Rebecca Goldburg, Senior Scientist, Environmental Defense Fund, argues that: "In both genetic engineering and conventional breeding you are altering foods -- but you now have access to a virtually unlimited number of traits that can be added, and that is certainty not true of conventional breeding." This seems to be particularly true for genetically unique or pathogenic sources or other materials that humans have not been exposed to. See Paul B. Thompson, Robert J. Matthews, and Eileen O. van Ravenswaay, Ethics, Public Policy, and Agriculture (N.Y.: Macmillan, 1994), p. 120.

[184] American Medical Association Council on Scientific Affairs, "Biotechnology and the American Agricultural Industry," Journal of the American Medical Association, March 20, 1991, p. 1431.

[185] Foods derived from transgenic livestock, which involves introduction of genetically modified microorganisms or the expression of a gene from another species, have also provoked concern. In this case, as with the agricultural examples above, the American Medical Association's Council on Scientific Affairs believes that similar safety issues as those identified above for plants must be addressed. See Thompson,. Matthews, and van Ravenswaay Ethics, p. 120.

[186] Susan Phillips, "Genetically Engineered Foods," CQ Researcher, August 5, 1994.

[187] American Medical Association Council on Scientific Affairs, "Biotechnology and the American Agricultural Industry," Journal of the American Medial Association, March 20, 1991, p. 1431.

[188] Grocery Manufacturers of America, "Safe Foods Developed Through Biotechnology: Nutritious, Healthful, Abundant and Good Tasting," 1993.

[189] California State Assembly, Committee on Agriculture (staff), "Background Paper on Biotechnology

Prepared by the Assembly Committee on Agriculture Staff," March 7, 1994.

[190] The definition of a food additive is: [A]ny substance which (when used as intended) directly or indirectly becomes a component or otherwise affects the characteristics of any food, unless the substance is generally recognized as safe. . . . [F]or foods derived from new plant varieties, the transferred genetic material and intended expression products could be subject to food additive regulation, if the material or expression products are not [generally recognized as safe]. Transferred genetic material (nucleic acids) is presumed to be [generally recognized as safe], and therefore, not a food additive. The expression products may or may not be [generally recognized as safe]. . . . The initial determination of whether a product is [generally recognized as safe] is generally made by the manufacturer prior to marketing." See: G. Eng, "Legal Aspects of Food Labeling for Foods Derived from Biotechnology," California Department of Health Services, Office of Legal Services, February 3, 1994.

[191] Federal Register, Vol. 57, No. 104, May 29, 1992; and Henry I. Miller, M.D., "Foods of the Future: The New Biotechnology and F.D.A. Regulation," Journal of the American Medical Association, February 17, 1993.

[192] "Common Questions About Biotechnology and Food Safety," U.C. Systemwide Biotechnology Research and Education Program, Molecular Biology Institute, Los Angeles.

[193] California State Assembly, Committee on Agriculture (staff). "Background Paper on Biotechnology

prepared by the Assembly Committee on Agriculture Staff," March 7, 1994.

[194] Deborah Blum, The Monkey Wars (London: Oxford University Press, 1994).

[195] P. Thompson, "Animal Welfare and Animal Rights: An Overview," Discussion Paper CBPE 92-1, (College Station, Texas: Center for Biotechnology Policy and Ethics, Texas A&M University, 1992).

[196] Ibid., p. 32.

[197] J. Fletcher, F. Miller, and A. Caplan, "Facing Up to Bioethical Decisions," Issues in Science and Technology, Fall 1994, p. 77.

[198] Ibid.

[199] J. Rote, "Biotechnology: A Regulatory Review" (Sacramento: Assembly Office of Research, 1985), p. 8.

[200] New Creation Institute, et al., "Statement, Consultation on Respect for Life and the Environment," printed in US Congress, Office of Technology Assessment, New Developments in Biotechnology: Patenting Life (Washington, D.C., U.S. Government Printing Office, April 1989), p. 134. Other issues go far beyond this paper. For example, certain species appear to be capable of demonstrating preferences through the application of conscious, practical reasoning. If so, some would claim that they have inherent "natural rights." Should scientists be restricted from using such animals to create new transgenic animals?

[201] G. Comstock, "Should We Genetically Engineer Hogs?," quoted in J. Dekker and G. Comstock, "Ethical and Environmental Considerations in the Release of Herbicide Resistant Crops," Agriculture and Human Values, Summer 1992, p. 4.

[202] P. Thompson, "Animal Welfare and Animal Rights: An Overview."

[203] G. Comstock, "Should We," p. 4.

[204] For a review of the issues see: Andrea L. Bonnicksen, "Human Embryos and Genetic Testing: A Private Policy Model," Politics and the Life Sciences, February 1992, pp. 53-62.

[205] Sacramento Bee, "Leaders of many U.S. Faiths Unite to Fight Gene Patents," May 14, 1995.

[206] "Broad Coalition Challenges Patents on Life," posted on the Internet (pol-sci-tech@igc.apc.org), June 6, 1995, by Philip L. Bereano, University of Washington.

[207] R. Hartman, "Beyond Moore: Issues of Law and Policy Impacting Human Cell and Genetic Research in the Age of Biotechnology," The Journal of Legal Medicine, September 1993, p. 471.

[208] Sacramento Bee, "Limits put on studies of embryos," December 3, 1994, p. A6.

[209] Jeffrey L. Fox, "NIH Panel gives green light to embryo research," Bio/Technology, November 1994, p. 1067.

[210] Kimbrell, The Human Body Shop, p. 62.

[211] Rachel Nowak, "Xenotransplants Set to Resume," Science, November 18, 1994, p. 1149.

[212] Ibid.

[213] Science, "F.D.A. Airs Qualms Over Xenotransplants," January 6, 1995.

[214] U.S. Congress, Office of Technology Assessment, Genetic Monitoring and Screening in the Workplace, OTA-BA-455 (Washington, D.C.: U.S. Government Printing Office, October 1990), p. 17.

[215] Ibid.

[216] Ibid., pp. 17-18.

[217] Ibid., p. 17. Issues regarding genetic monitoring and screening and workers compensation are unresolved.

[218] U.S. Congress, Office of Technology Assessment, Genetic Monitoring and Screening in the Workplace.

[219] K. Hudson, K. Rothenberg, L. Andrews, M. Kahn, and F. Collins, "Genetic Discrimination and Health Insurance: An Urgent Need for Reform," Science, October 20,1995, p. 391.

[220] U.S. Congress, Office of Technology Assessment, Genetic Tests and Health Insurance: Results of a Survey: Results of a Survey--Background Paper, OTA-BP-BA-98 (Washington, D.C.: U.S. Government Printing Office, October 1992), pp. 33-34.

[221] The states are: Alabama, Arizona, Florida, Iowa, Louisiana, Maryland, Montana, New Jersey, North Carolina, Ohio, Rhode Island, Tennessee and Wisconsin,

[222] D. Gordon, "Genes R Us," State Legislatures, August 1994, p. 27.

[223] Ibid., p. 30.

[224] Sacramento Bee, "Job Bias on Basis of Genetics Outlawed," April 7, 1995, p. A8.

[225] K. Hudson, et.al.,"Genetic Discrimination...", p. 391.

[226] K. Hudson, et.al.,"Genetic Discrimination...", p. 393.

[227] This example is suggested by Kathy A. Fackelmann, "Beyond the Genome: the Ethics of DNA Testing," Science News, November 5, 1994, p. 299.

[228] Science, "Gene Tests: Who's Minding the Store?" July 22, 1994, p. 465.

[229] Ibid.

[230] Jane Rissler and Margaret Mellon, Perils Amidst the Promise: Ecological Risks of Transgenic Crops in a Global Market (Cambridge, Massachussetts: Union of Concerned Scientists, 1993), p. 1.

[231] Patricia Ahl Goy and John H. Duesing, "From Pots to Plots: Genetically Modified Plants on Trial," Bio/Technology, May 1995, p. 454.

[232] Russ Hoyle, "EPA Okays First Pesticidal Transgenic Plants," Bio/Technology, May 1995, p. 434.

[233] Henry I. Miller, M.D., "Remarks for the California Legislature Assembly Committee on Agriculture," March 7, 1994.

[234] Ibid.

[235] Hoyle, Russ. "EPA Okays," p. 434.

[236] Sheldon Krimsky, Biotechnics and Society: The Rise of Industrial Genetics (New York: Praeger, 1991), p. 98.

[237] Scientific American, "What Goes Around Comes Around for Life's Master Molecule," June 1994, p. 26.

[238] See series of letters in Science, Vol. 264, June 17, 1994.

[239] Russ Hoyle, "Let's finally get the threat of virus-resistant plants straight," Bio/Technology, July 1994, p. 663.

[240] Jeffrey L. Fox, "EPA Finally Issues TSCA and FIFRA Rules," Bio/Technology, October 1994, p. 967.

[241] Russ Hoyle, "Let's finally get the threat of virus-resistant plants straight," Bio/Technology, July 1994, p. 663.

[242] San Jose Mercury News, "What EPA regulations cost you," August 1, 1994, p. 7B.

[243] Scientific American, "What Goes Around," p. 26.

[244] Amal Kawar and Richard Sherlock, "Theoretical Issues in the Regulation of Genetically Engineered Organisms: The Case of Deliberate Release," Politics and the Life Sciences, February 1989 (Vol. 7, No. 2), p. 129

[245] J. Dekker, and G. Comstock, "Ethical and Environmental Considerations in the Release of Herbicide Resistant Crops," Agriculture and Human Values, Summer 1992, p. 31.

[246] Richard Stone, "Large Plots are Next Test for Transgenic Crop Safety," Science, December 2, 1994, p. 1472.

[247] Hoyle, "Let's finally," p. 662.

[248] Ibid.

[249] "Altered plants pass new traits to weeds," San Jose Mercury News, 7 March 1996, Sec. A-1.

[250] Stone, "Large Plots," p. 1472.

[251] Ibid.

[252] Ibid., p. 1473.

[253] Charles Seife, "A Harebrained Scheme," Scientific American, February 1996, p. 26.

[254] Ibid.

[255] Association of Bay Area Governments (ABAG), Biotechnology in the San Francisco Bay Area (San Francisco: ABAG, September 1988), p. 4-10. For a more recent profile of European industry needs see Sally Hayward and Martin Griffin, "Europe at BioWork: Challenges and Prospects," Bio/Technology, July 1994, p. 667.

[256] Bay Area Bioscience Center and the Bay Area Council, The Emerging Bioscience Skills Gap, p iii.

[257] Bay State Skill Corporation, "The Massachusetts Biotechnology Industry/Education Resource Directors" 1991.

[258] ABAG, Biotechnology, p. 2-8.

[259] Desmond Mascarenhas, "A Vital Interest: Science Education and the Biotech Industry," Bio/Technology, July 1994, p. 671.

[260] Sally Hayward and Martin Griffin, "Europe at Biowork," p. 667

[261] City of Chula Vista, "High-tech/biotech Zone Issue Paper," Revised draft of April 6, 1994, p. 21.

[262] Bay Area Bioscience Center and the Bay Area Council, The Emerging Bioscience Skills Gap, p. iv.

[263] B.J. Spalding, "Biopharmaceutical Firms Up R&D Spending 89%," Bio/Technology, July 1994, p. 653. [264] The Survival Index is calculated by dividing the net burn rate into existing cash, cash equivalents, short-term investment, and long term marketable securities. Net burn rate is defined as the sum of the net cash flows from operating activities per month, plus net cash flows from investing activities per month, plus capital spending per month. [265] Ernst & Young LLP, Biotech 95: Reform, Restructure, Renewal, p. 54.

[266] Ernst & Young LLP, Pursuing Sustainability, p.15.

[267] For a good overview of one venture capital company's activities see: Brobeck, Phleger and Harrison (1994), "Life Sciences Group," pamphlet.

[268] Companies in just the Bay Area accounted for 20 percent of the $20 billion equity capital raised in the past 15 years for U.S. biotechnology companies.

[269] Ernst & Young LLP, Pursuing Sustainability, p. 13.

[270] San Jose Mercury News, "Betting on Biotech,"

[271] San Francisco Chronicle, "Bay Biotech Firms Land U.S. Grants," Oct. 26, 1994.

[272] Ernst & Young LLP, Biotech 95: Reform, Restructure, Renewal, p. 32.

[273] Ernst & Young LLP. Biotech 95: Reform, Restructure, Renewal, p. 32.

[274] Science, "Biotech on a Roll," January 12, 1994, p. 151.

[275] Peter Drake and Gregory Brown, "The Biotech Sector's Clarion Call for Cash," Bio/Technology, January 1995, p. 12.

[276] Booz, Allen & Hamilton, Foreign Investment in Bay Area Bioscience (Oakland, CA: Bay Area Bioscience Center, 1991), p. i.

[277] Ibid., p. 9.

[278] Ibid., p.16.

[279] Ibid., pp. 4-15.

[280] "Corporate Partnering: A Strategy for High Technology Companies," Fenwick and West, and Von Gehr International, 1994, pp. 2-3.

[281] Ibid, p. 11.

[282] S.J. Barley, J. Freeman, and R. Hybels, "Strategic Alliances in Commercial Biotechnology," in N. Nohria and R. Eccles, Networks and Organizations (Boston: Harvard Business School Press, 1992).

[283] Booz, Allen & Hamilton Foreign Investment, p. 12.

[284] Ibid., p. i.

[285] Ibid., p. 18-19.

[286] Ibid., p. ii.

[287] Bay Area Bioscience Center, "Gene Acres," June, 1992, p. 2.

[288] Mark Dibner, Gregory N. Stock, and Noel P. Greis, "Away from Home: U.S. Sites of European and Japanese Biotech and R&D," Bio/Technology, December 1992, p. 1535.

[289] Ibid., pp. 1537-1538.

[290] Foreign direct investment also tends to improve manufacturing productivity. Locating of foreign firms in Germany and the United States: (1) directly contribute to higher levels of domestic productivity, (2) prove that leading edge productivity can be achieved from local labor and many local inputs, (3) put competitive pressure on other domestic producers, and (4) transfer knowledge of best practice to other domestic producers through the natural movement of personnel. Moreover, foreign direct investment has provoked less political opposition than trade because it creates jobs instead of destroying them. Thus, foreign direct investment is likely to grow faster than trade. McKinsey Global Institute, Manufacturing Productivity (Washington, D.C.: McKinsey and Company, 1993), p. 4.

[291] United Nations Centre on Transnational Corporations, Transnational Corporations in World Development (New York: United Nations, 1988).

[292] W. Walker, Technological Innovation, Corporate R&D Alliances and Organizational Learning ( Santa Monica: RAND, 1995), pp. IV-V.

[293] Federal Coordinating Council for Science, Engineering and Technology, Biotechnology for the 21st Century, p.3.

[294] Fiscal Year 1992 Presidential Budget.

[295] President's Council on Competitiveness, Report on National Biotechnology Policy ([Washington]: The Council, 1991), p. 2.

[296] Federal Coordinating Council, Biotechnology, p. 2.

[297] B. Baker, "Biomedical Funding May be More Stable Than Other Research Areas," Bio/Science, April 1995, p. 250.

[298] Federal Clearinghouse for State and Local Initiatives, 1993.

[299] Lacy, Lacy, and Busch, "Emerging Trends," p. 18.

[300] The six states surveyed in 1993 are: Colorado, Massachusetts, New Jersey, North Carolina, and Washington.

[301] San Diego Business Journal, "City-Backed bond program could tie biotechs to town," September 1992 (vol. 30, No. 38), p. 7.

[302] M. Dibner, "Biotech Centers Represent a Major Force in Development and Support of the Industry," Genetic Engineering News, October 1, 1995, p. 4. The following data are drawn from this article.

[303] Ibid., p. 4, p. 5.

[304] Ibid, p. 36.

[305] Ibid..

[306] L. Zucker, M. Brewer, and M. Darby, "`Who Knows' Determines the `Where' and `When': The founding of New Biotechnology Enterprises," UCLA Systemwide Biotechnology Research and Education Programs, 1993.

[307] Systemwide Biotechnology Research and Education Program, University of California, "California Biotech Facts."

[308] Susanne Huttner, Systemwide Biotechnology Research and Education Program, August 23, 1994 (personal communication).

[309] Systemwide Biotechnology Research and Education Program, University of California, "California Biotech Facts" (mimeographed sheet), [1994?].

[310] D. Friedman, et al., "The New Economy Project Final Report" (Los Angeles: The New Economy Team, UCLA, 1994), p. II-32.

[311] W. Lacy, L. Lacy, and L. Busch, "Emerging Trends, Consequences, and Policy Issues in Agricultural Biotechnology," in M. Halberg, Bovine Somatotropin and Emerging Issues: An Assessment (Boulder, Colorado, Westview Press, 1991), p. 21.

[312] B.J. Spalding, "Biopharmaceutical Firms Up R&D Spending 89%," Bio/Technology, July 1994, p. 653.

[313] Ernst and Young LLP, Biotech 96: Pursuing Sustainability, 1995, p. 14-15.

[314] George Kidd and James Dvorak, "Agbiotech firms increase R&D spending 43.6%," Bio/Technology, August 1994, p. 755.

[315] Brent N. Cavan, "Improving Clinical Trials Cost Management in Biotech Companies," Bio/Technology, March 1995, p. 226.

[316] California Health Care Institute and Ernst and Young LLP, "Exporting an Industry: The Impact of FDA Regulation on California's Biomedical Industry. (La Jolla: California Health Care Institute, April 1996), p. 1.

[317] California Health Care Institute and Ernst and Young LLP, "Exporting an Industry: The Impact of FDA Regulation on California's Biomedical Industr, p. 9. The data is drawn from J. DiMasi, Tufts Center for the Study of Drug Development, 1995.

[318] San Jose Mercury News. "Betting on Biotech," May 20, 1996, p. 6E.

[319] Mark-M. Struck, "Biopharmaceutical R&D Success Rates and Development Times," Bio/Technology, July 1994, pp. 674-7.

[320] Washington State Biotechnology Targeted Sector Advisory Committee, "Washington State Biotechnology" (1991), p. 10.

[321] Ernst and Young's survey of the CEOs of 265 bioindustry companies is reported in Biotech 95: Reform, Restructure, Renewal (San Francisco: Ernst & Young, 1994), p. 25.

[322] Stephen M. Edgington, "Surviving the '90s: Can Biotech Master Clinical Trials?," Bio/Technology, October 1994, pp. 977-981.

[323] Ernst and Young's survey of the CEOs of 265 bioindustry companies is reported in Biotech 95: Reform, Restructure, Renewal (San Francisco: Ernst & Young, 1994), p. 22.

[324] California Health Care Institute and Ernst and Young LLP, "Exporting an Industry: The Impact of FDA Regulation on California's Biomedical Industry, p. 11.

[325] For example, Abbott and three other companies competed with each other to develop and market an HIV blood screening kit. Abbott reached the market first by speeding along its product development and the testing process, resulting in 80 percent of a $200 million annual market. See: S. Wheelwright, "Commercializing Biotech Products," Bio/Industry, Vol. 12, September 1994, p. 877.

[326] J. Avery, "Success Rates and Valuation," a letter to the editor, Bio/Technology, October, 1994, p. 953.

[327] City of Chula Vista "High-tech/biotech Zone Issue Paper," Revised draft of April 6, 1994,

p. 17.

[328] R. Mc Kown, "Contract Manufacturing in the Biotech Industry: Growing to Meet Demand," Genetic Engineering News, October 1, 1995, p. 6.

[329] R. Mc Kown, "Contract Manufacturing" in the Biotech Industry: Growing to Meet Demand," Genetic Engineering News, October 1, 1995, p. 7.

[330] Ibid.

[331] City of Chula Vista "High-tech/biotech Zone Issue Paper," Revised draft of April 6, 1994, p. 17.

[332] Ibid., p. 10.

[333] John Hodgson, "Still Waters Run Deep," Bio/Technology, October 1994, p. 983.

[334] Chula Vista, "High-tech/biotech."

[335] J. Rote, "Biotechnology: A Regulatory Review" (Sacramento: Assembly Office of Research, 1985), p. 8.

[336] Chula Vista, "High-tech/biotech," p. 12.

[337] U.S. General Accounting Office, Radioactive Waste: Status of Commercial Low-Level Waste Facilities, GAO/RCED-95-67.

[338] Jan Dunbar, Sacramento City Fire Department, personal communication, July 1, 1994.

[339] David Zacetti, Office of Emergency Services, personal communication, July 1, 1994.

[340] Ken Widder, Molecular Biosystems, San Diego, personal communication, July 5, 1994.

[341] Chula Vista, "High-tech/biotech," p.14.

[342] P. Galletti, "Embargo on Biomaterials" (letter to the editor), Science, May 20, 1994, pp. 1065-67.

[343] Ibid.

[344] Ibid.

[345] A recent RAND Policy Brief reported that: "Even under optimistic assumptions about the state's fiscal future, California's public colleges and universities will have to turn away thousands of potential students."See: RAND, Institute on Education and Training "Does California's Fiscal Future Bode Ill for Education?" Policy Brief, January 1966, 3.

[346] Gus Koehler, Small Business Networks: Tools to Promote Economic Success (Sacramento: California Research Bureau, 1995).

[347] P. Doeringer and D. Terkla, "Business Strategy and Cross-Industry Clusters," Economic Development Quarterly, August 1995, p. 225; and Koehler, Small Business Networks.

[*] Page numbers refer the pages in this study that discuss the issue.

[348] D. Henton and T. Quigley, "The Role of Federal Investment in Precompetitive R&D," Joint Venture: Silicon Valley and Defense/Space Consortium, May 1, 1995.

[349] B. Dixon, "Debating Biotechnology," Bio/Technology, August 1994, p. 746; and Louise Dughan, "Plant Biotechnology: the 'Jury' Decides," Bio/Technology, December 1994, p. 1346.

[350] George Kidd and James Dvorak, "A gutsy map of the future of agribotech," Bio/Technology, November 1994, p. 1064. This article reviews efforts of the Center for the Exploitation of Science and Technology, London, England, to provide a detailed map of the conditions that British decision-makers should consider in planning for the future of agbiotech.

[351] John Portz and Peter Eisinger, "Biotechnology and Economic Development: The Role of the States," Politics and the Life Sciences, February 1991, p. 234.

[352] Ibid., p. 236.

[353] R. Florida, "Technology Policy for a Global Economy," Issues in Science and Technology, Spring 1995.

[354] Koehler, Small Business Networks.

[355] For further details on developing small business networks see Koehler, Small Business Networks.

[356] Vicki Glaser, "Pheromone firms cooperate to speed approvals," Bio/Technology, March 1995, p. 219.

[357] "Permit Streamlining Best Practices II," Santa Clara Valley Manufacturing Group, Facility's Managers Committee, July 20, 1995.

[358] Ernst and Young. Biotech 95: Reform, Restructure, Renewal (San Francisco: Ernst & Young, 1994), p. 44.

[359] California Economic Strategy Panel, Collaborating to Compete in the New Economy (Sacramento: California Trade and Commerce Agency, February 1996), p. 19.

[360] Gus Koehler, New Challenges to California State Government's Economic Development Engine (Sacramento: California Research Bureau, 1994), p. 74.

[361] Ibid.

[362] Desmond Mascarenhas, "A Vital Interest: Science Education and the Biotech Industry," Bio/Technology, July 1994, p. 673.

[363] Ibid., p. 672.

[364] Targeted Sector Advisory Committee, "Washington State Biotechnology," Targeted Sector Advisory Committee, [1993?], p. 9.