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Tufts OpenCourseware
Authors: Kathleen Merrigan, Ph.D., William Lockeretz, Ph.D.


  • Merrigan, Kathleen A., “Principles of U. S. Governance,” in GE Crops: Decision Making Under Uncertainty, Iain Taylor (ed.), Haworth Press.
  • Pew Initiative on Food and Biotechnology, Future Fish: Issues in Science and Regulation of Transgenic Fish, Overview” and “A Look at the Science: How transgenic fish are created and examples of current research, Jan 2003.
  • National Research Council, Environmental Effects of Transgenic Plants: The scope and Adequacy of Regulation, Executive Summary, The National Academy Press, 2002.
  • Fact Sheet on US GMOs, found at:
  • Executive Summary, Genetically Engineered Crops and Pesticide Use in the United States: The First Nine Years, Chuck Benbrook, Biotech Infonet, Technical Paper #7, October 2004.

Key Questions

Principles of US Governance

  • What is the significance of the Asilomar guidelines?
  • What are the three principles that form the foundation of regulation of biotechnology in the US?
  • What is the significance of the concept of substantial equivalence?
  • Are all foods containing biotech products reviewed by the FDA before they hit the market shelves?
  • Why does the biotech food industry seek voluntary consultation with the FDA before introducing their products?
  • What is the Coordinated Framework? Which federal agencies are involved? How is the responsibility divided?
  • What are the important federal acts which provide these agencies with regulatory power? Are these acts adequate for regulating agricultural biotechnology products?
  • How effective is the Coordinated Framework? Has there been any proposal to make it more efficient?
  • What are the arguments driving the debates on labeling of biotech food products?
  • Does budget allocation in the USDA indicate that biotechnology is a priority for the agency?
  • How has biotechnology research in the universities evolved, considering the stakeholders involved and funding available for basic, applied and commercial research?
  • Can university-industry collaboration pose a problem for regulating biotechnology and reassuring the public about the safety of their food?
  • Does the USDA consider environmental risk evaluation of biotechnology as an important issue?
  • The author does not find it impressive that the budget for risk analysis of biotech products was increased in 2002. Why?
  • Will the next generation of Americans be more accepting of biotech products?
  • Which are the federal acts that provide the basis for intellectual property rights concerning biotechnology in the US?
  • What is the basis for obtaining a patent?
  • What are the significant debating points with reference to biotech patents?
  • What trigger points leading to shifts in biotechnology regulation does the author expect in future?
  • For anyone not happy with the present regulatory system, what does the author suggest?

Future Fish

  • How are the transgenic fish regulated? What are the points of contention with reference to this?
  • Why is genetic transformation of fish an attractive option for researchers and the industry compared to that of other animals?
  • What are the traits that are being focused for transformation in transgenic fish?
  • What are the environmental concerns when traditional aquaculture is considered?
  • What is meant by net fitness? What is its significance in discussing the environmental risks that may be posed by transgenic fish?
  • What are the different scenarios projected with reference to any gene flow that might occur from transgenic fish?
  • What scientific means are being explored in order to mitigate gene flow and invasive species risks of transgenic fish?
  • What are the risks involved regarding toxin accumulation capacity and allergenic properties of transgenic fish?
  • What are the elements important for a regulatory system that would ensure that such a system functions efficiently? How does the process of transgenic fish regulation by FDA compare with such a system?

Environmental Effects of Transgenic Plants

  • Are environmental regulations for transgenic plants different from those for crops that were bred conventionally?
  • What is the debate pertaining to APHIS regulating transgenic plants based on the Federal Plant Pest Act and Federal Plant Quarantine Act? What does the committee recommendation on this?
  • Why are novel genes introduced in transgenic plants considered risky in general by the public? What does the committee state with reference to this?
  • What are the similarities that the committee finds between transgenic and conventionally bred plants?
  • What is the committee opinion about regulating conventionally bred crops?
  • What does risk analysis of transgenic crop involve?
  • What is the committee opinion about the involvement of other stakeholders in addition to the government agencies ( which have the regulatory mandate) in risk analysis of transgenic crops?
  • What are the different scientifically rigorous methods outlined by the committee for risk analysis? Which one does it favor?
  • Why does the committee favor case-by-case risk analysis for transgenic crops?
  • How important is the social dimension to any exercise attempting environmental risk assessment?
  • What are the three processes through which APHIS regulates transgenic plant products?
  • Which is the process considered for allowing commercialization of transgenic plants? How transparent is the process? What is the committee recommendation?
  • What is the process involved for field testing of transgenic plants? Is there any limit on the area (acres) that can be test planted?
  • What are the focal areas of APHIS environmental assessments of transgenic plants with pesticidal properties?
  • What is the relevance of confidential business information in assessing the scientific base and regulatory mechanisms followed by APHIS?
  • What is the advantage of post commercialization testing and monitoring of transgenic plants? What approaches does the committee suggest for such monitoring?
  • Would a common monitoring system, as proposed by the committee to keep track of environmental impact of agriculture, erase the line of distinction between conventional and transgenic crops over time? Is this advisable?

Genetically Engineered Crops and Pesticide Use in the United States: The First Nine Years

  • With reference to which crops and traits has genetic engineering been extensively exploited in the US?
  • What is the extent of adoption of GE crops in the US?
  • What has been the effect of the GE crops on pesticide usage in the US?
  • Why are farmers applying increasing quantities of herbicides to their crops?
  • Is there a difference in the extent of resistance development in the herbicide tolerant GE crops compared to the Bt crops?
  • Does technology development exclusive of genetic engineering combined with relevant regulatory processes hold promise for reducing pesticide usage in agriculture?