Stopping the Real Pests
February 12, 2004
By Henry I. Miller, MD
Fellow, The Hoover Institution
Tech Central Station
P.O. Box 33705

Washington, DC 20033


Fax: 202-572-6278
To submit a Letter to the Editor:

It's great news that most Americans now identify themselves as environmentalists. Unfortunately, a small number have embraced environmentalism with religious fervor, basing their beliefs more on faith and dogma than on science and data.

Not unlike fundamentalists engaged in a jihad against unbelievers, these radical environmentalists pursue an agenda that has less to do with protection of the environment than with antipathy toward business, profits, and certain products and technologies. Ironically, their efforts to achieve their own narrow vision of what constitutes a "good society" often are inimical to protection of the environment -- a variation on the admission by Peanuts cartoon character Linus van Pelt, "I love humanity; it's people I can't stand."

For example, exploiting a technicality that links the Endangered Species Act (ESA) to pesticide registration, environmental groups have filed a spate of nuisance lawsuits that attempt to prevent the Environmental Protection Agency from registering or re-registering pesticides. These suits take advantage of a legal technicality that links pesticide registration to the Endangered Species Act (ESA). They allege that by failing to put in place a process for consultation with the federal agencies that administer the ESA -- the National Marine Fisheries Service and Fish & Wildlife Service -- before registering a pesticide, the EPA has not complied fully with the law. This in spite of the fact that the Fish & Wildlife Service's ESA Consultation Handbook makes it clear that "[t]he Services cannot force an action agency to consult."

The environmentalists' lawsuits are not substantive but procedural: No actual damage to threatened or endangered species from the EPA's actions (or inactions) has been demonstrated. And never mind that pesticides control vermin, increase agricultural productivity, reduce the need to convert wild lands into farmland, prevent the growth of harmful fungi and bacteria on crops, reduce prices to consumers -- and that they undergo exhaustive testing and regulatory review to ensure their safety.

Substantive or not, the lawsuits constitute a nuisance and distraction for EPA officials, who must expend vast effort and expense on defending the agency in court - resources that could be better spent reviewing and approving new products, and on prosecuting dishonest manufacturers and polluters.

Although the ESA requires all federal agencies to ensure that their actions take into account possible adverse effects on endangered species, Congress recognized the value of pesticides by expressly directing that pesticide registration by the EPA under the Federal Insecticide, Fungicide and Rodenticide Act should "minimize the impacts to persons engaged in agricultural food and fiber commodity production and other affected pesticide users and applicators."

This is not the only instance in which misguided activists and their lawyers have obstructed government agencies charged with protecting public and environmental health. Last November, an activist coalition filed a lawsuit that seeks to stop the field testing of crop plants that produce pharmaceuticals -- so-called "biopharming." Again, the grounds for the suit were purely procedural. The groups claimed that "neither USDA nor any other government agency has prepared an Environmental Impact Statement ..." to evaluate the safety of the field trials, and that this "lack of oversight violates the National Environmental Policy Act and the Endangered Species Act." And during my tenure at the FDA, the agency was constantly diverted and distracted by the need to defend against bad-faith lawsuits and by the need to respond to annoying, insubstantial "citizens' petitions."

The hidden agenda in all of these cases is activists' opposition to the use of certain kinds of technologies or products, and animus toward the companies that use or make them.

There is good news to report, however, about the lawsuits that are attempting to halt pesticide registration. The EPA, which boasts vast and comprehensive experience with assessing the potential risks of pesticides to plant and animal species -- including those listed as threatened or endangered under the ESA -- and other federal agencies have devised an appropriate solution to the procedural problem. The National Marine Fisheries Service and Fish and Wildlife Service, which administer the ESA, on January 30th proposed a rule that will eliminate the requirement for the EPA to consult with other agencies as the agency reviews and registers pesticides. This technical revision will not only assure greater consistency in the assessment of pesticides, but by freeing regulators to more expeditiously license more environment-friendly products, it will also better protect endangered species and their habitats. And, of course, it will moot the lawsuits.

Confounded by incomplete data and incessant pressure from radical groups and commercial interests, the formulation of environmental policy is difficult, to be sure, and assessing the risks and benefits of pesticides can be devilishly complex. This proposed rule will draw the battle lines clearly. Brandishing pseudo-facts, half-truths and warnings of apocalypse, the anti-pesticide, anti-technology, anti-agribusiness groups will oppose it, while genuine environmentalists will support it.

This change will not fix other existing flaws in the ESA, but it will prevent the legislation from interfering with the development and registration of an important class of agricultural and consumer products.


Henry Miller is a physician and fellow at the Hoover Institution. He was an official at the National Institutes of Health and FDA from 1977 to 1994. His most recent book, "The Frankenfood Myth: How Protest and Politics Threaten the Biotech Revolution," will be published later this year by Praeger Publishers.


Henry's bio:


Dr. Henry I. Miller is an academic researcher, author and commentator. He graduated from the Massachusetts Institute of Technology with a Bachelor of Science degree in Life Sciences and attended the University of California, San Diego, receiving the M.S. (Molecular Biology) and M.D. degrees. After completing his clinical training in internal medicine as a Clinical Fellow in Medicine at Harvard Medical School, Dr. Miller was a Research Associate in the laboratory of Philip Leder at the National Institutes of Health.

Dr. Miller joined the FDA in 1979 and served in a number of posts involved with the new biotechnology, among them Special Assistant to the FDA Commissioner and founding director of the FDA's Office of Biotechnology. During his government service, Dr. Miller wrote and lectured frequently on the regulatory requirements for biotechnology products, and participated frequently on various expert and policy panels as a representative of the FDA or the US government. As the FDA's contact person for the Securities and Exchange Commission, he reviewed the accuracy of claims made by companies in their prospectuses about the likelihood and timing of drug approvals.

Dr. Miller is currently at Stanford University, where he is a fellow at the Hoover Institution. His research focuses on the relationship between science and regulation, the costs and benefits of government regulation, models for regulatory reform, and federal and international oversight of biotechnology. Other research areas include various aspects of bioterrorism and the need for better oversight of nutritional supplements.

Dr. Miller is the author of more four hundred articles in scholarly and popular publications. He writes frequently for such publications as the Financial Times (London), Wall Street Journal, Los Angeles Times, Chicago Tribune, Washington Times, Biotechnology Law Report, Trends in Biotechnology, and Nature Biotechnology. He is the author of Policy Controversy in Biotechnology: An Insider ' s View (R.G. Landes Co. and Academic Press, 1997) and ' To America ' s Health: A Proposal to Reform the Food & Drug Administration ' (Hoover Institution Press, 2000). Dr. Miller is a director of Consumer Alert, a national consumer advocacy organization; a director of the American Council on Science and Health; an Adjunct Scholar at the Competitive Enterprise Institute; and a scientific advisor to the George C. Marshall Institute.


Henry's Article Archives: