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Original Articles

Recent developments in biotechnology regulation

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Pages 167-178 | Published online: 19 Sep 2008

References

  • Stanley Pierce, Ph. D. is a Senior Partner at the law firm of Rivkin, Radier and Kremer, who heads the Environmental Science and Technology practice group.
  • Joseph J. Ortego is a Senior Partner at Rivkin, Radier and Kremer who heads a Business Litigation group.
  • February 1991 . National Bio Technology Policy , February , 1 President's Council on Competitiveness . CFR No. 39, February 27, 1992 (citing Report)
  • 1991 . Biotechnology in a Global Economy , Office of Technology and Assessment (HTIS) . [Hereinafter, Global Economy]
  • Biotechnology companies use a variety of techniques in Biotech research. These include chemical synthesis, peptide chemistry, sultransplants, gene therapy, antibody modification, carbohydrate chemistry and the development of “anti‐sense” molecules that are chemicals that are selectively block out messages in DNA which keep certain types of viruses from replicating.
  • CFR 39 at 6754.
  • 1992 . Agencies Are Blinded by Science . Natl. L. J. , Sept. 7 : 23 Col. 4
  • Pierce and Biblow . 1992 . Biotechnology Regulation to be Based on Risks, Leaders, Product Liability, Law and Strategy , March : 5
  • Global Economy at 16.
  • CFR 23 363.
  • Pierce and Biblow . 1992 . Biotechnology Regulation to be Based on Risks . Leaders Product Liability Law , 6 March
  • FR 6753. To the extent permitted by law, planned introductions into the environmental of organisms with modified heredity traits should not be subjected to oversight. Unless information concerning the risk posed by the introduction indicates that oversight is necessary. Id. citing 55 F.R. at 31120.
  • FR 39 at 6754.
  • Dr. Alvin Young is Director of Biotechnology for the United States Department of Agriculture and is the chair of this panel, for which this paper is prepared and a speaker at this conference.
  • Id.
  • FR at 6754.
  • FR at 6755. (citing 51 CFR 23303).
  • CFR at 6755.
  • CFR at 6756.
  • U.S. EPA SAB . 1990 . “Reducing Risk Setting Priorities and Strategies for Environmental Protection” . Exec. Sum. , September : 2
  • CFR at 6756.
  • CFR at 6757.
  • Tiedje , J. , Colwull , R. Grossman , Y. 1989 . Ecology , 70 April : 298 CFR at 6757
  • Id.
  • Id.
  • Biotechnology Reaches Beyond . 1992 . The High‐Tech West . News and Comment , Feb. 22 : 919
  • Global Economy at 16.
  • Id.
  • Id.
  • Id. at 12.
  • Global Economy at 13.
  • 1992 . Los Angeles Times , June 4 : 1 col. 3
  • Id.
  • Global Economy at 14.
  • Global Economy at 14.
  • Global Economy at 14.
  • 1992 . National Law Journal , June 8 : 39 col. 1
  • See. e.g. the Paris Union Convention, the Patent Corporation Treaty the Budapest Treaty, the Union for the Protection of New Varieties of Plans, and the European Plant Convention, cited in Global Economy at 14.
  • Global Economy at 14.
  • Global Economy at 17.
  • Stanley Pierce, Ph. D. is a Senior Partner at the law firm of Rivkin, Radier and Kremer, who heads the Environmental Science and Technology practice group.
  • Joseph J. Ortego is a Senior Partner at Rivkin, Radier and Kremer who heads a Business Litigation group.

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