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Proceedings of the Pew Initiative conference: “Impacts of Biotech Regulation on Small Business and University Research: Possible Barriers and Potential Solutions”
Washington, DC
March 7, 2005

Conference proceedings on the impact which biotech regulation has on small businesses and university research

Since agricultural biotechnology was first introduced in the mid-1990s, stakeholders have debated whether or not the regulatory system places undue burdens on small businesses and university researchers, who typically lack the financial and technical resources of larger companies. USDA’s announcement in January 2004, that the Animal and Plant Health Inspection Service (APHIS) at the United States Department of Agriculture (USDA) would review the way it regulates agricultural biotechnology can provide an opportunity to reconsider the impacts of regulation on small businesses and university research without jeopardizing product safety.

In June 2004, the Pew Initiative on Food and Biotechnology and APHIS co-sponsored a roundtable discussion to illuminate the many concerns related to existing regulations for agricultural biotechnology, the way those regulations are implemented and potential changes. Proceedings from that discussion, titled “Impacts of Biotech Regulation on Small Business and University Research: Possible Barriers and Potential Solutions,” are now available on the Pew Initiative website.

Highlights include:

  • Executives from small biotech firms discussed how regulatory costs affect business decisions and how uncertainty in the regulatory system can dampen investor interest and potentially deny firms the resources needed to bring innovative new products to the marketplace.
     

  • The current regulatory system is not one in which university scientists fit easily. Not only are university researchers generally not trained to deal with the regulatory process, their career advancement is not helped by conducting the kind of studies needed for regulatory approvals. Consequently, many university scientists are disengaged from the regulatory process and are less likely to push basic research towards commercializing products that could benefit farmers and consumers alike.
     

  • Participants noted a number of options which could improve the regulatory process for small businesses and university scientists. Suggestions included better guidance from agency officials about what it takes to gain approval; streamlining the regulatory approval process so that genetic changes (‘events’) already approved for use in one crop could be used in related crops with reduced government oversight; and the creation of a public-private partnership to foster innovation by small businesses and for smaller market products by assisting the collection of field trial data necessary for regulatory approval.

Proceedings and highlights from the conference can be viewed and downloaded at http://pewagbiotech.org/events/0602.

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