Sound Science on Trial

Friday, 04 June 2010 20:55

The Daily Caller
By Amy Kaleita
June 4, 2010

Activist organizations have long sought to impose European-style regulations based on “the precautionary principle” as the law of the land in the United States. Simply put, this rule would give regulators carte blanche to use any controversy, no matter how specious, to ban products. Activists especially want to import EU-style bans on genetically modified crops, pesticides and other technologies that are integral parts of many of today’s farming operations. And they are increasingly finding allies within Congress and the regulatory agencies who want to follow their lead.

Only one real obstacle remains in their way—a vast body of sound science practices developed by independent scientists at the EPA and their advisors.

To demolish this last obstacle, activist organizations like the National Resources Defense Council are mounting a sophisticated and lavishly funded campaign to discredit sound science and the EPA by alleging that past studies that found these technologies safe to use were somehow “tainted” by corporate involvement.

In fact, the NRDC and its NGO allies have made a steady practice of denouncing “industry-funded studies” as worthless PR at best, as conspiracies to hoodwink regulators and the public at worst. The national target of this campaign is now atrazine, a common herbicide used by corn and other farmers for more than fifty years. When EPA re-registered atrazine for use in 2006, among the 6,000 studies on atrazine it had in its files were multi-million dollar industry-funded studies. Critics say those studies should be dismissed out of hand, since anything funded by industry is by definition biased and untrustworthy.

The truth is that chemical and agribusiness companies don’t fund safety studies as PR exercises. They fund these studies because the law requires them to do so. In the Federal Insecticide, Fungicide, and Rodenticide Act, as amended in the last few decades, Congress places the burden of proving safety on pesticide companies.

For a pesticide like atrazine to be regulated, it must undergo a battery of tests designed by the EPA and often carried out by independent, third party laboratories. All data must adhere to rigorous Quality Assurance Protocols, and documentation can run to hundreds of pages. Moreover, the process is completely transparent. All the raw data is available to EPA auditors, who will often sit down with the scientists to examine the data, point by point. If EPA determines that a test is not sufficient, it will readily require companies to fund and perform additional tests.

By comparison, the typical peer-reviewed study undergoes no such oversight, documentation, or audit. A peer-reviewed manuscript will often contain only a few paragraphs explaining the methodology behind the study, and little information, if any, about quality assurance procedures.

It is unusual in the peer-review process for reviewers to have access to the raw data presented in the paper, and study authors can and do decide for themselves whether or not to respond to all the comments and questions submitted by the reviewers. Authors certainly do not respond directly to reviewers, or have any direct dialogue with them.

The absurdity of dismissing industry funded studies in favor of peer review is highlighted in the case of atrazine. On the one side are a handful of controversial studies by a scientist at UC Berkeley, Tyrone Hayes, claiming to have found that the compound produces adverse effects on amphibian development. He has become a favorite speaker on the anti-pesticide, activist circuit.

In 2005, EPA published a 95-page white paper concluding that Hayes’s work and other studies on atrazine were “scientifically flawed.” Referring to Hayes’s claims that his own previous studies and others confirmed his findings, the Deputy Director of the Office of Pesticides testified that the EPA “has never seen either the results from any independent investigator published in peer-reviewed scientific journals or the raw data from Dr. Hayes’ additional experiments that confirm Dr. Hayes’ conclusions.”

In an abundance of caution, however, the EPA asked the primary producer of atrazine to fund two of the most extensive and far-reaching studies of their kind to look into the issues that had been raised. Carried out in two separate labs in the United States and Germany, these massive studies were thoroughly audited and inspected, data point by data point, by the EPA. Both studies refuted the Hayes’s conclusions.

This hasn’t slowed Hayes down, however. Just last year, a member of the Society of Environmental Toxicology and Chemistry expressed serious concerns about some of Dr. Hayes’ talks given at professional and public meetings, noting that they included “inflammatory and libelous attacks,” and that he gave audience members the dangerous impression that “it is okay to present provocative conclusions without supporting data.”

None of this has given the activist community any pause, however. And their steady drumbeat is even having its effect on the EPA itself, which cited a recent NRDC report on atrazine as the reason for instigating the new and hurried review of the chemical, only a few short years after the previous positive review.

In this way, “inflammatory” accusations and “provocative conclusions without supporting data” may ultimately trump science-based regulatory policy as it has always been practiced in the United States and open the door up for a very different kind of regulation — one based on which activist group screams the loudest and is most effective at instilling unjustified fears in the name of “precaution.”

Amy Kaleita, Ph.D., is a senior environmental policy fellow at the California-based Pacific Research Institute.