Biotech Report Looks at Regulations

Pew Initiative aims to identify issues that need change in biotech review process. Compiled by staff

Published on: Apr 1, 2004

Biotech crops have been commercialized on a large scale since 1996, but it looks like the process for bringing the next generation of products to market could undergo some change. A new report "Issues in the Regulation of Genetically Engineered Plants and Animals" from the Pew Initiative on Food and Biotechnology notes that a range of options exists to "enhance the regulatory review process to address new challenges future products" will present.

The report points to current ag biotech products and their wide adoption without evidence of food safety or environmental problems as a positive result. However, the report's writers note that the complex future products headed to market may "challenge the ability of the existing Coordinated Framework for Regulation of Biotechnology…to continue to protect public health and the environment and maintain public trust." That framework involves USDA, the U.S. Environmental Protection Agency and the U.S. Food and Drug Administration.

"The ability of the current regulatory review system to keep pace with technology and manage the environmental and food safety issues raised by future products has emerged as an important part of the debate over agricultural biotechnology," says Michael Rodemeyer, executive director of the Pew Initiative. "By analyzing the strengths and weaknesses of the Coordinated Framework's ability to address future products and identifying a range of options to enhance the Framekwork, we hope to provide policymakers and interested parties with a unique and valuable resource."

The report doesn't contain recommendations, but it does analyze current legal approaches taken by agencies and examines the issues future products may raise. Here's a look at some of those issues:

  • EPA and USDA face challenges with respect to their ability to management potential environmental risks raised by biotech plants. USDA's Animal and Plant Health Inspection Service (APHIS) may not have the necessary regulations in place to oversee biotech plants that can't easily be defined as "plant pests"; consider broad environmental risks posted by a plant; or quickly and fully manage environmental issues once a plant has been "deregulated" and enters the marketplace.
  • FDA lacks legal authority to require developers to prove the safety of all foods derived from biotech plants - including imported foods - before they go to market.
  • Federal agencies have not addressed how, or if, they intend to regulate biotech animals. The report states that FDA and/or USDA should exercise regulatory oversight of GE animals. Biotech-derived animals may offer a host of new challenges in the environment, as has been warned by experts at Purdue University who worry over genetic release of such organisms.

Check out the executive summary of the report, or the report itself, by visiting Pew Initiative Report