Regulation of Transgenic Crops Intended for Pharmaceutical and Industrial Uses

  • Gregory D. Graff
Part of the Natural Resource Management and Policy book series (NRMP, volume 30)


The most interesting case in regulation of non-food agricultural biotechnology products is the manufacture of novel pharmaceutical and industrial products. The current regulatory situation in the United States has arisen out of a political economy driven largely by the food industry’s risk exposure. Yet, the resulting “zero tolerance” regulatory situation appears inefficient and unstable: set up for another incident such as befell Aventis and ProdiGene. The regulatory situation could be resolved by taking dissemination and susceptibility characteristics into account in setting containment requirements, including threshold allowances in the case of minor breaches of containment. A workable regulatory regime will need to be driven by major agricultural states’ political interests, along with the biotechnology and pharmaceutical industries, and mindful of the interests of the food industry. Countries intent on developing their domestic biotechnology industry might attract investment by providing a workable regulatory regime that ensures lower risk at lower cost.

Key words

agricultural biotechnology regulation plant-made Pharmaceuticals (PMPs) plant-made industrial products (PMIPs) molecular farming 


Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.


  1. bio-era. 2004a. “Crop Biomanufacturing, Part 1: The Economic Opportunity.” Bio Economic Research Associates (bio-era), Cambridge, MA (36pp).Google Scholar
  2. ____. 2004b. “Crop Biomanufacturing, Part 2: Implications for the Farm Sector.” Bio Economic Research Associates (bio-era), Cambridge, MA (14pp).Google Scholar
  3. Fox, J.L. 2003. “Puzzling Industry Response to ProdiGene Fiasco.” Nature Biotechnology 21(1): 3–4.PubMedCrossRefGoogle Scholar
  4. Lichtenberg, E. 2006. “Regulation of Technology in the Context of Risk Generation.” In R.E. Just, J.M. Alston, and D. Zilberman, eds., Regulating Agricultural Biotechnology: Economics and Policy. New York: Springer.Google Scholar
  5. Porter, M.E. 1998. “Clusters and the New Economics of Competition.” Harvard Business Review 76(6): 77–90.PubMedGoogle Scholar
  6. Stewart, P. A., and W. McLean. 2004. “Fear and Hope over the Third Generation of Agricultural Biotechnology: Analysis of Public Response in the Federal Register.” AgBioForum 7(3): Article 5.Google Scholar

Copyright information

© Springer Science+Business Media, LLC 2006

Authors and Affiliations

  • Gregory D. Graff
    • 1
  1. 1.University of CaliforniaBerkeley

Personalised recommendations