Henry I. Miller, MD
The long-awaited report from the US National Academy of Sciences on proposed EPA regulation of biotech plants as "plant pesticides" was released this week [5 April]. On procedural, scientific and policy grounds the report corrupts the reputation and credibility of the Academy. It is not only internally inconsistent and scientifically obtuse, but conflicts directly with previous reports by the Academy and other prominent scientific groups.
The EPA now has a clear path to introduce a regulatory scheme that has been condemned repeatedly by the scientific community.
The committee members and the invited reviewers were included with apparent disregard for obvious conflicts of interest, including ideological opposition to biotechnology and having worked on the policy under review while employed at EPA. Three members of the twelve-person committee (Stanley Abramson, Fred Betz and Morris Levin) are former EPA staffers who had helped to craft and defend the policy while in the government; and another (Rebecca Goldburg) has produced a litany of anti-biotechnology tracts over the past decade. And during the formal review process, the document was reviewed by another former EPA official (Lynn Goldman) who was instrumental in crafting and defending the policy in question, and by another anti-biotechnology crusader (Jane Rissler).
Given the makeup of the committee and reviewers, it is not surprising that the chairman concluded that the federal agencies responsible for regulating biotech plants, including the EPA, "have generally done a good job," but the scientific community strongly disagrees. A 1996 report on the same EPA "plants as pesticides" policy by eleven scientific societies (coordinated by the Chicago-based Institute of Food Technologists), which represent 80,000 biologists and food professionals, excoriated the EPA's unscientific approach and warned of a number of negative consequences for agriculture and consumers, were the EPA's policy to be implemented. They predicted that it would:
- "Discourage the development of new pest-resistant crops, thereby prolonging the use of synthetic chemical pesticides;
- Increase the regulatory burden for those developing pest-resistant varieties of crops, while also increasing federal and state bureaucracy;
- Limit the use of biotechnology for the development of pest-resistant plants to those developers that can pay the increased costs associated with additional regulation ...;
- Handicap the United States in competition for international markets because of U.S. government policy that new pest-resistant varieties, or products from these varieties, be identified as containing their own 'pesticides'; and
- Limit the use of valuable genetic resources and new technologies to improve crop protection from pests and diseases."
Or compare the just-released NAS report to the findings published in October 1998 by the Council on Agricultural Science and Technology, an international consortium of 36 scientific and professional groups, which echoed the eleven societies' criticisms of the EPA policy. Its issue paper, "The Proposed EPA Plant Pesticide Rule," characterized the EPA's policy approach as "scientifically indefensible" and observed that treating gene-spliced plants as pesticides would "undermine public confidence in the food supply."
How could the NAS have gone so far wrong in its assessment of the EPA policy? A partial explanation is buried on page 12 of the Executive Summary of the just-released report: "the committee has chosen to take EPA's proposed rule and the overarching [federal governmental] coordinated framework as given."
In other words, the committee, composed largely of individuals who were known to favor the EPA approach, decided not to review the scientific basis for the EPA's policy: The committee simply rejected its original charge. They produced a report that accepts and even endorses a policy that calls into question a long history of breeding pest resistance into plants that has produced enormous improvements in food production and safety, worldwide; a policy that would have prevented the Green Revolution, that has been of inestimable benefit to millions of starving people in developing countries. The EPA policy imposes regulations regardless of the actual levels of risk, thereby violating a fundamental principle of regulation -- that the degree of scrutiny should be commensurate with risk. It also contradicts the seminal finding of an earlier Academy committee that in 1989 concluded that "the nature of the process [of genetic modification] is not a useful criterion for determining whether the product requires less or more oversight." The just-released report's agreement with the 1989 study on this point ("the committee agrees that the properties of a genetically modified organisms should be the focus of risk assessments, not the process by which it was produced [emphasis in original]") emphasizes the logical inconsistency of simply ignoring the central, fundamental tenet of the EPA's approach to regulation -- namely, that the use of gene-splicing techniques should serve as the trigger to regulation.
The committee that produced the just-released Academy report specifically (and conveniently) ignored the part of the federal framework that governs regulatory approaches such as EPA's "plants as pesticides" policy. That guidance is contained in a 1992 statement of policy from the White House Office of Science and Technology Policy, "Exercise of Federal Oversight Within Scope of Statutory Authority: Planned Introductions of Biotechnology Products into the Environment," which sets forth the appropriate basis for agencies' oversight. It describes "a risk-based, scientifically sound approach to the oversight of planned introductions of biotechnology products into the environment that focuses on the characteristics of the ... product and the environment into which it is being introduced, not the process by which the product is created. Exercise of oversight in the scope of discretion afforded by statute should be based on the risk posed by the introduction and should not turn on the fact that an organism has been modified by a particular process or technique."
In short, merely the use of gene-splicing is not an appropriate trigger for oversight -- yet the current report simply ignores that fundamental tenet of the federal framework and chooses to accept EPA's contrary approach as a given.
Perhaps the most troubling aspect of the report is that it and the process behind it are products of the internationally esteemed National Academy of Sciences. How could this have happened? When the committee was first established, several eminent scientists expressed reservations to the President of the Academy about its composition, the potential conflicts of interest, and the fact that none of the members of the committee, except the chairman, was a member of the National Academy.
The most significant result of this ill-conceived report will be to advance unwarranted and debilitating regulatory barriers to the development of much needed pest control strategies that can reduce farmers' reliance on chemical pesticides. The warnings of the eleven societies' report - decreased choices available to farmers for defending against disease and pests, increased reliance on chemical pesticides, and all the rest -- apply as well to this Academy report. The prestige of the Academy attached to this report and the now-inevitable EPA announcement of its "plants as pesticides" regulation may spell the end of the new biotechnology applied widely to agriculture and world food production needs.
Henry I. Miller is a Senior Research Fellow at Stanford University's Hoover Institution, an Adjunct Scholar at the Competitive Enterprise Institute, and the author of Policy Controversy in Biotechnology: An Insider's View (R.G. Landes Co., 1997).
(posted without permission)
