September 27, 2012

New Paper: How Chemicals Manufacturers Seek to Co-opt Their Regulators

This post was written by CPR President Rena Steinzor and Policy Analyst Wayland Radin.

Today CPR releases Cozying Up: How the Manufacturers of Toxic Chemicals Seek to Co-opt Their Regulatorsexposing the work of the International Life Sciences Institute (ILSI) and Toxicology Excellence for Risk Assessment (TERA), two industry advocacy groups that have undue influence on the regulation of toxic chemicals.  The two firms specialize in a particularly insidious brand of “dirty” science by recruiting EPA experts to co-author papers and participate in policy-making workshops that are heavily biased toward manufacturer interests. 

Americans might reasonably assume that toxic chemicals undergo rigorous, independent testing before they enter the stream of commerce. Regular readers know that’s hardly the case. The Toxic Substances Control Act (TSCA) grandfathered in tens of thousands of chemicals already in use, and new chemicals undergo only a perfunctory, 90-day “pre-manufacture review” by the EPA, which under even the best circumstances must rely on a comparison of the chemical structure of the new chemical to the structures of existing chemicals and whatever information the manufacturer has chosen to submit regarding the chemical. Because research by a chemical’s producer is often the primary resource available to regulators who make crucial public health decisions, independent experts have examined whether industry-sponsored studies produce different results than comparable government-funded work. An empirical review of 1,140 biomedical studies determined that "industry-sponsored studies were significantly more likely to reach conclusions that were favorable to the sponsor than were non-industry studies." Concerned by these findings, but unwilling to reject industry-sponsored science out of hand, the world’s most prestigious scientific journals require authors to disclose the source of their work so that potential biases are evident to readers.

Chemical manufacturers have long disliked these restrictions because they know that once a study is labeled as an industry work product, most people are unwilling to take its conclusions at face value, and some will find them unconvincing on any level. This discomfort has generated a search for ways to make industry research appear more credible, and that’s the subject of our report. One of the most effective methods of doing so is to recruit government scientists as co-authors for journal articles about the chemical in question. A second strategy: obtaining the active participation of government officials in industry-sponsored efforts to formulate “consensus” policy pronouncements regarding research design and risk assessment. These deliberations rarely include representatives from independent scientific organizations or public interest organizations, and government officials are typically a small minority of participants in comparison to scientists employed or largely funded by chemical manufacturers. Although their industry sponsors claim that such efforts represent “partnerships” that are balanced and therefore credible, the limited number of participating government scientists do not and cannot rehabilitate the credibility of these fundamentally biased discussions.

Our paper takes a close look at ILSI and TERA, arguably the most effective and active leaders in this intensifying effort to convert industry research into the result of an “industry/government partnership.” Both are self-styled “tri-partite” organizations that purport to represent a broad consensus among scientists from industry, government, and academia. ILSI is primarily funded by large agribusiness and TERA receives substantial financial support from chemical manufacturers and their customers. Both firms are structured as non-profit corporations. They rarely produce their own research, but rather compile and assess the research performed by other industry-sponsored scientists.

Government scientists have a commendable interest in developing their professional skills and judgment by participating in scientific dialogues sponsored by the private sector. They err, however, when they lend their names to industry-sponsored articles or committee deliberations designed to influence regulatory policy. Not only do such activities undermine the independence of their government employers, they undermine public confidence in regulatory agencies. Disclaimers to the effect that a government scientist is speaking in her “personal” capacity do little to restore public confidence.

We make several recommendations for curbing this undue influence. EPA and other government agencies should withdraw their employees from participation in activities sponsored by ILSI and TERA immediately. The agencies should revise their policies designed to protect against individual bias on the part of employees to incorporate stronger protections against undue industry influence when pursuing professional development opportunities. And the agencies should prohibit government employees from participating in private sector activities that are designed to influence a decision under the jurisdiction of the employer agency if such expert will be asked to endorse the final work product produced by the group.

Organization like ILSI and TERA are obscure but influential, as their sponsors surely intend. The EPA and other agencies need to address this undue influence in a fair way; the current system is not a fair deal for the public.

Rena Steinzor, Professor of Law, University of Maryland Carey School of Law. Bio.

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