CAST Scientists Issue Evaluation of U.S. Biotechnology Regulatory Process

Excerpted from Council for Agricultural Science and Technology News Release
October 11, 2001

Washington, D.C. regulators need adequate resources to make more information available to the public about how decisions on biotechnology are made, according to a new Council for Agricultural Science and Technology (CAST) issue paper. The paper, "Evaluation of the U.S. Regulatory Process for Crops Developed through Biotechnology," includes recommendations for policy and research in agricultural biotechnology. It is particularly timely as EPA is making decisions regarding the registration fate of biotechnology-derived crops, such as Bt corn.

A group of nine science and policy experts prepared the issue paper for CAST, which represents 36 food and agricultural scientific organizations. "Having accepted the unenviable task of evaluating how U.S. regulatory agencies determine the safety of biotech crops, we decided to describe the process, then comment on how the process can be improved," explained food safety expert Bruce Chassy of the University of Illinois.

The paper's authors found that the U.S. regulatory process for evaluating biotechnology-derived crops is comprehensive and meets its charge of ensuring that biotechnology-derived foods are at least as safe as foods derived using traditional breeding techniques. "The greatest challenge is not having access to the documentation on how regulators come to their decisions," said Chassy. "We believe the public would have more confidence in the process if they knew the rationale for regulatory decisions to accept or reject new biotech crops. Safety testing data are available to the public. Now we need to provide adequate resources so the regulators can explain their decision-making rationale."

Four Key Questions Evaluated
The authors address four key questions:

(1) How are safety assessment and regulatory reviews conducted?
(2) Can obvious strengths and weaknesses of that process be identified?
(3) Can improvements be made in conduct and direction of independent research, in performance of safety assessments, in opportunities for consumer participation, or in any other aspects of the regulatory process that will both enhance the quality of the assessments and further ensure the ultimate safety of biotechnology-derived crop products? and
(4) Are there improvements to the regulatory review process for biotechnology-derived plants that will enhance public confidence in the process?

Policy Recommendations
The paper makes the following policy recommendations:

Retain the current case-by-case safety assessment approach and continue to emphasize regulatory conditions carefully tailored to address risks identified for individual biotechnology-derived plant products. Finalize the Food and Drug Administration's current proposal for a mandatory, premarket notification in lieu of the present policy of voluntary consultation for all food products of agricultural biotechnology. Provide the public with rapid, comprehensive accessibility to applications and supporting health and safety data submitted to regulatory agencies for biotechnology-derived products. Issue approvals for both food and feed use for crops intended to enter commodity streams. Provide the additional resources sorely needed for key regulatory review functions.

Research Recommendations
As for research, the paper recommends:

Conduct additional research on selected topics to ensure that present-day questions can be answered and that future developments will be assessed adequately. Develop rapid screening methods for biotechnology-derived crop proteins in raw agricultural commodities, such as grain and vegetables. Conduct additional research to support regulatory oversight and product stewardship of biotechnology-derived crops currently on the market. Carry out additional research on the potential health, safety, and environmental effects of biotechnology-derived products that are not designed to be substantially equivalent to their conventional counterparts (sometimes referred to as next-generation biotechnology-derived crops). Conduct additional research on food allergies and identification and characterization of allergenic food proteins.

Availability of Complete Paper
The complete paper, as well as many of CAST's other scientific reports, is available on the CAST web site, at <www.cast-science.org>.