EPA vs. Toxicology (and Its Own Procedures)

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The Environmental Protection Agency (EPA) and its Board of Scientific Counselors (BOSC) make a big deal about how they want public input -- and the law requires public comment -- so ACSH Advisors Dr. James Enstrom, Dr. Stan Young, and I presented our concerns about EPA toxicology and epidemiology to a meeting of the Human Health Risk Assessment (HHRA) subcommittee of the BOSC by phone (in the case of Enstrom and Young) and in person (me), on November 15 in Bethesda, MD.

The meeting, chaired by George Daston, a Ph.D. toxicologist from Procter and Gamble's offices in Cincinnati, took place from November 14th to 16th.

The members of the HHRA and the exec committee of the BOSC are mostly EPA-dependent academics or government agency types from the state level, university, and private advocacy backgrounds, and there are a few industry/private sector reps.

These are my personal impressions of the HHRA Committee meeting, two and a half days long, held in Bethesda, MD, a government suburb of Washington with hotels and cafes galore, home of many federal agency offices and the famous Bethesda Naval Medical Center, the go-to hospital for important elected government officials. Bethesda is definitely a government "company town" -- thanks to the American taxpayer.

The meeting was well attended -- and just down the street from the National Institutes of Health (NIH), a big source of EPA and enviro/toxicology research funding. At least fifty EPA employees were in the audience with nametags on, for what reason I don't know -- seemed like a lot of salaries warming seats. A few of them answered questions posed from the podium, but my impression is they were there to show the EPA colors, push the project-describing posters next door, and influence the HHRA.

Dr. Peter Preuss, Director of the EPA Office of Research and Development (ORD), sat at the committee table during the whole meeting, along with an EPA assistant to the committee. All the many presentations to this independent oversight committee, for two days and more, were from EPA-sponsored research partners or EPA officials. I am confident that every EPA official there was in charge of some advocacy for EPA. They surely didn't send their trench workers.

There were no scheduled or spontaneous presentations by anyone who might question the scientific methods or projects of the EPA. In the room next to the HHRA committee was a room full of posters of long-term projects for the EPA -- very elaborate presentations on very big, very busy boards that indicated how the EPA was going to pursue chemicals and toxins and eliminate them with a very energetic program.

Three long-term goals (LTGs) that were elaborately presented in the poster room and discussed at the HHRA -- every one incomprehensible to anyone outside of the EPA bubble -- were:

1. Integrated Risk Information System (IRIS) and other priority health hazard assessments.
2. State-of-the-science risk assessment models, methods, and guidance.
3. Integrated Science Assessments.

I would offer a Texas-based country boy's analysis of this mumbo jumbo: EPA is looking for toxins and will pursue any small toxic effect while asserting that the Agency is preventing a toxin catastrophe and protecting the anxious American public. The overactive agency will pursue any small or even phantom menace to the ends of the earth while demanding more funding for the effort.

Ten observations pertinent to the HHRA meeting:

1. EPA's long-term goal is to create more work for the EPA. Big surprise. One project that has a lot of support and is already up and running, asking for more money, is a major campaign to search for chemicals that can be touted as new sources of "concern" as causes of disease or cancer -- things to scare people about. ACSH's Morning Dispatch e-mails describe ACSH's concern about exaggerations regarding polyvinyl and trace amounts of "carcinogens" and "toxins" in everything from toys to makeup -- well, go to these EPA meetings and get the future in a nutshell. EPA is working 24/7 to make it impossible for ACSH or reasonable toxicologists to get a word in edgewise. Their sycophant media people are waiting anxiously to participate in the public panic campaign.

2. EPA is looking at small effects by dredging through chemical "studies" funded in their research portfolio either as NIH-sponsored or EPA-affiliate-sponsored projects, to create more "crises." A case was made for more staff to dredge the chemical studies and assess "risk." The EPA is quite proud of their newly created world of toxicology. Everything is a scary toxin when your business is scary toxins and panicking the public.

3. EPA is rushing ahead with a project in promoting genomics research to find another method of making really, really small effects into another toxin research bonanza and regulatory funding annuity for EPA and EPA-funded researchers. The idea is that there are thousands of genomes that might be impacted by hundreds or thousands of chemicals, and there are hundreds of toxic effects and diseases that could be considered. At the molecular level, a whole new world of biological possibilities and even plausibilities are opened up by immunologists and molecular biologists studying inflammation and mediators.

(See many recent articles in the New England Journal of Medicine about mediator cascades, which are supposedly an explanation for acute reactions "initiated" by exposure to air pollution, to get a sense of how these ideas work.)

When a researcher has so many toxicological possibilities -- so many potential correlations between chemical exposures and biological problems -- and enough computer power to seek correlations between them, a world of new research projects is opened up. Dr. Young, a real statistics expert, tells me it's easy to find statistically significant "effects" (that in reality are products of chance and persistent dredging of the statistics in a multiple-testing situation).

4. The BOSC is supposed to be an independent oversight committee for the EPA, but it is not independent at all. The EPA picks the members and sets the agenda, and the meetings are pep rallies for EPA projects, long- and short-term, well-attended by EPA employees and enviro-advocacy group reps. Talk about a set up for movin' on. I am, of course, "shocked" that a government agency would set something up to promote their agenda and achievements.

5. In the past two years of BOSC exec committee meeting minutes, there has been no public comment -- none. ACSH's recent amicus brief criticizing EPA's inappropriate use of linear modeling and violation of scientific integrity rules was submitted to the dioxin case court by thirty distinguished scientists -- but the BOSC and the HHRA were not aware of the dispute? EPA public supervisory committees were not aware of major objections to EPA science? Why would an oversight committee not put the amicus brief on the agenda? Unless -- unless -- the EPA doesn't recognize any dispute on science or opposition to EPA toxicological agendas and strategies.

I have reason to believe, based on a review of previous agendas and minutes, that the BOSC has never given any serious consideration to the linear modeling problems. The ACSH objections to linear modeling that are described so insightfully in the brief to the court are ignored by the BOSC and the HHRA.

6. The BOSC and its subcommittees are charged with oversight on EPA scientific integrity. Trust me, observer from Texas, the agenda for the HHRA was all about EPA projects and not about EPA scientific integrity. It was about EPA people, all the time, so the only time any dissent from EPA dogma would ever be heard at one of these meetings is during public comment period. The three-day meeting provided only fifteen minutes for public comment. The rule was three minutes per person. Otherwise, there were no agenda items that challenged the EPA canon.

7. In spite of the fact that I asked for public comment time five weeks in advance of the HHRA committee meeting and the meeting lasted over fifteen hours plus some executive sessions, the EPA refused to offer Drs. Enstrom and Young and Dunn more than three minutes per person. They were very nice but seemed a little nervous, and it is clear from the historical record of the minutes of the BOSC and the HHRA, that our presentation was unique in their experience. (I testified that the EPA should have less funding for chemical studies, making me the skunk at the EPA Bethesda garden party.)

8. In the materials forwarded to the HHRA subcommittee, I included many things, including the epidemiology and toxicology chapters of the Federal Judicial Center's Reference Manual on Scientific Evidence (2000, Second edition) that condemn the current EPA methodology, the ACSH amicus brief on dioxin that condemns the EPA linear modeling on toxicology, and Dr. Enstrom's compelling article about the efforts of EPA-sponsored scientists to eliminate dissent and condemn or vilify contrarian views. Dr. Enstrom points out the dangers of Lysenko-like politicized science in his essay, but the EPA is inclined to accept scientific censorship. I also submitted to the HHRA my commentaries on air standards proposals for 2006 and 2007, which point out EPA scientific integrity problems.

9. I asked if anyone at ACSH would participate in the presentation to the HHRA subcommittee and the BOSC. Now that I have done some reconnaissance on this matter, I renew my invitation to ACSH and others to help convey principles of sound science to BOSC.

10. Absent outside criticism, EPA is running free and about to embark on a very ambitious expansion of intrusive regulations: new chemical and genomic "threats," the world in "crisis," and the EPA in need of more funding and power so they can dredge more toxicology crises for use in the public forum.

This is a long-term project with important implications. The EPA will not relent in its efforts to promote the toxin-panic/chemophobe agenda. As a result, serious scientists must stand for something and smack down this junk science.

John Dale Dunn, M.D., J.D. is an ACSH Advisor.

See also: ACSH's publication America's War on "Carcinogens"