March 13, 2006

Dr. Julie Gerberding
Director, CDC
Center for Disease Control
1600 Clifton Road, NE
Atlanta, GA 30333

Dr. Gerberding:

In December, Environmental Working Group outlined how ChemRisk, an
environmental consulting firm hired by the Center for Disease Control
(CDC) to work on a key project at the Los Alamos National Laboratory
(LANL), had violated basic ethical standards of the scientific
community in some of its previous work. We urged the CDC review the
allegations we presented in our letter, cancel ChemRisk's current
contract with the Los Alamos Historical Document Retrieval and
Assessment (LAHDRA) project, and bar the firm from seeking future
contracts from the CDC or other government agencies. In January, we
wrote to you again after it became clear that ChemRisk—as part of its
work on the LAHDRA project—would have direct responsibility for
investigating hexavalent chromium, a chemical they're known to have
been dishonest about.

EWG understands that you are investigating the allegations, and we
glad to hear that the CDC is taking the matter seriously. We are
writing again to bring your attention to a recent peer-reviewed
scientific paper and supporting documents that clearly establish how
ChemRisk's manipulation of the Chinese data on hexavalent chromium in
water was not a one-time offense, but part of a larger pattern of
producing questionable scientific studies intended to weaken public
health protections to benefit its corporate clients.

The documents also show how ChemRisk's founder and president Dennis
Paustenbach has been directly involved in the firm's unethical
activities. EWG, therefore, is also urging you to consider whether Dr.
Paustenbach belongs on the Board of Scientific Counselors for CDC's
National Center for Environmental Health (NCEH) and Agency for Toxic
Substances and Disease Registry (ATSDR). It is highly inappropriate to
allow any scientist who has been engaged in serious ethical misconduct
to serve on such an important advisory board. Dennis Paustenbach must
be removed from his position when his term expires in June, and barred
from being considered for similar appointments at the CDC and other
federal agencies.

Enclosed you will find a copy of an article by George Washington
University School of Public Health professor David Michaels that was
published Feb. 23 in the peer-reviewed online journal Environmental
Health. [1] In "Selected science: an industry campaign to undermine an
OSHA hexavalent chromium standard," Michaels and his co-authors
describe how several environmental consulting firms hired by the
chromium industry manipulated scientific data and engaged in other
unethical activities to influence a workplace exposure limit pending
under the Occupational Safety and Health Administration (OSHA).
Michaels' reports:

. . . [OSHA] was petitioned in 1993 and sued in 1997 and 2002 to
lower the workplace Cr(VI) exposure limit, resulting in a court order
to issue a final standard by February 2006. Faced with the threat of
stronger regulation, the chromium industry initiated an effort to
challenge the scientific evidence supporting a more protective
standard. This effort included the use of "product defense"
consultants [ChemRisk and Exponent] to conduct post hoc analyses of a
publicly-funded study to challenge results viewed unfavorably by the
industry.

The industry also commissioned a study [by the consulting firm
ENVIRON] of the mortality experience of workers at four low-exposure
chromium plants, but did not make the results available to OSHA in a
timely manner, despite multiple agency requests for precisely these
sorts of data. The commissioned study found a statistically
significant elevation in lung cancer risk among Cr(VI)-exposed workers
at levels far below the current standard. This finding changed when
the multi-plant cohort was divided into two statistically underpowered
components and then published separately. The findings of the first
paper published have been used by the chromium industry to attempt to
slow OSHA's standard-setting process. The second paper was withheld
from OSHA until it was accepted for publication in a scientific
journal, after the rulemaking record had closed.

Michaels' article describes ChemRisk's role in the industry campaign
only briefly, focusing more on the activities of ENVIRON and Exponent.
Several documents released in conjunction with the article, however,
bring to light how ChemRisk has repeatedly worked to produce science
with the intent to undermine public health protections for chromium
and other toxic chemicals. The most important of these internal
industry documents stem from a February 13th, 1996 meeting between
ChemRisk and a chromium industry trade association known as the Chrome
Coalition.

According to court records, the Chrome Coalition is "organized for the
purposes ofÉ serving as a facilitator for the chromium industry to
respond to proposed regulatory efforts affecting the chromium industry
and to recommend and/or participate in litigation affecting the
chromium industryÉ [and] promoting the chromium industry through
distributing information regarding its benefits and positive
contributions." [2] Although OSHA had stated as far back as 1976 that
its 52 µg/m3 Permissible Exposure Limit [PEL] for airborne hexavalent
chromium was associated with increased lung cancer rates in chromium
industry workers, the agency didn't move to change the standard—partly
due to the Coalition's efforts—until two lawsuits were filed beginning
in the late 1990s. [1]

In 1996 the Chrome Coalition sought proposals from environmental
consulting firms—including ChemRisk—on how they could help keep the
PEL as high as possible. [1,3,4] On February 13th, ChemRisk founder
and president Dennis Paustenbach, along with several of his
colleagues, met with the Chrome Coalition to present ChemRisk's
proposal. At the meeting, Paustenbach "presented his view of the
action that should be taken to address all the issues relating to the
cancer risk associated with exposure to chromium." [3] The proposal
included five "immediate steps," each of which involved scientific
analyses specifically designed to challenge the OSHA's pending PEL,
costing between $15,000 and $500,000+ a piece. [3]

Paustenbach also discussed "several other strategies" such as
"pitting" the American Conference of Governmental Industrial
Hygienists Committee that comes up with their Threshold Limit Values
for chemical hazards (denoted as ACGIH-TLV) "against the OSHA-PEL
Committee." [3] And in a move that is reminiscent of earlier attempts
ChemRisk made to hide its involvement with the 1997 study published by
the Journal of Occupational and Environmental Medicine (JOEM),
Paustenbach also explained how he had talked to a key researcher at
Johns Hopkins University working on an important and unfinished
epidemiological study of cancer incidence in chromium workers.
Incredibly, Paustenbach discussed with the researcher "the possibility
of pro bono confidential involvement of ChemRisk" in the study. He
suggested to the Chrome Coalition that "if this were to come about,"
such a tactic could be used to "forestall the rulemaking" at OSHA. [4]

Notably, many of the same ChemRisk employees who produced the
fraudulent JOEM paper were at the meeting with the Chrome Coalition,
including Brent Finley, Bill Butler, and Deborah Proctor. [4] The
documents also indicate that a "T. Ye" would be helping with the
chromium work; this almost certainly refers Tony Ye, the ChemRisk
employee who prepared much of the 1997 JOEM paper and served as the
translator for Dr. Zhang in China. And, of course, it is clear from
the documents that Dennis Paustenbach himself played a large role in
the presenting ChemRisk's proposal to the Chrome Coalition. [3,4]

The documents also explain how ChemRisk had previously been successful
in weakening other pending OSHA standards. [3,4] One document, for
example, describes how Paustenbach gave the Coalition "a detailed
comparison between ChemRisk's activities specific to the benzene
rulemaking and similar expected results using the same effort for the
Cr+6 rulemaking." [4] Another document explains how ChemRisk cited the
"establishment of a PEL for benzene of 0.5 ppm rather than 0.1 ppmÉ as
a recent instance of a large scale effort that produced a result
industry could live with that was not as low as OSHA had originally
intended to go." [3] Paustenbach also describes similar successes
ChemRisk had had with the OSHA standard for 1,3-butadiene. [4]

Paustenbach was highly confident that ChemRisk's work could influence
the OSHA standard—even going so far as to say that he was "quite
certain that a positive impact can be made" on the chromium standard.
The phrase "positive" used here refers, of course, to an impact that
would benefit the interests of the chromium industry—not worker
health. [4] Paustenbach and his colleagues at ChemRisk were apparently
successful in convincing the Chrome Coalition that their proposed
scientific analyses would influence the chromium standard, as the two
parties entered into a contract several months later. [5]

It is important to note that EWG is not taking issue with the merits
of the scientific analyses that ChemRisk went on to produce for the
Chrome Coalition (although such a critique might be warranted), nor
with the simple fact that ChemRisk has worked repeatedly for the
chromium industry. Rather, we are highlighting how Dennis Paustenbach
and ChemRisk have been engaged for many years in a practice of
designing scientific studies to help its industry clients to undermine
public health protections; how much of ChemRisk's work has focused on
challenging the claim that hexavalent chromium is carcinogenic—or as
carcinogenic as agency scientists have believed; and how ChemRisk not
only hid its involvement with the 1997 JOEM study as detailed in our
first letter, but also investigated hiding its involvement in another
epidemiological study of cancer and hexavalent chromium exposure.

In summary, ChemRisk's activities described in the attached documents
are further evidence for the charges we laid out in our first letter.
They call into question the basic ethical standards of Dennis
Paustenbach and ChemRisk, and whether the firm's work can really be
considered "objective" by any measure of the word—particularly when it
comes to work involving hexavalent chromium.

The success or failure of the LAHRDA project hinges on public trust.
The public must not only feel assured that LANL is making all relevant
documents available for review, the public must also be confident that
the CDC and its contractors are acting with scientific and ethical
integrity. Only then will the public be convinced that the final
exposure characterization is complete and accurate. It is now
abundantly clear that CDC's principal LAHDRA contractor, ChemRisk,
does not have the necessary scientific or ethical integrity to
engender public trust. Similarly, it is also clear that ChemRisk
founder and president Dennis Paustenbach has been directly involved in
the firm's unethical behavior.

EWG urges the CDC to act promptly to cancel ChemRisk's current
contract with the LAHDRA project, and bar the firm from seeking future
contracts from the CDC or other government agencies. EWG also urges
the CDC to remove Dennis Paustenbach from the NCEH/ATSDR Board of
Scientific Counselors, and bar him from being considered for similar
appointments at the CDC and other federal agencies.

Thank you for your ongoing attention to this matter. As before, if you
have any questions or would like more information, please let us know.

Sincerely,

Renee Sharp
Senior Analyst
Environmental Working Group

Richard Wiles
Vice President
Environmental Working Group

References

[1] Michaels, D., C. Monforton and P. Lurie. 2006. Selected science:
an industry campaign to undermine an OSHA hexavalent chromium
standard. Environmental Health. Published on-line on February 23,
2006. Available at http://www.ehjournal.net

[2] Affidavit of Dr. Joel Barnhart, Vice President of Elementis
Chromium and chair of the Chome Coalition. December 17, 2004. U.S.
Bankruptcy Court for the Western District of Pennsylvania. Available
at:
http://www.biomedcentral.com/content/supplementary/1476-069X-5-5-S5.pdf

[3] Chrome Coalition ad hoc PEL Committee. February 13, 1996. "Special
Meeting/Interview with ChemRisk Committee Discussions and
Recommendations." Available at:
http://www.biomedcentral.com/content/supplementary/1476-069X-5-5-S1.pdf

[4] Chrome Coalition ad hoc PEL Committee. February 13, 1996. "Special
Meeting with ChemRisk." Available at:
http://www.biomedcentral.com/content/supplementary/1476-069X-5-5-S2.pdf

[5] Agreement between Chrome Coalition and ChemRisk. September 10,
1996. Available at:
http://www.biomedcentral.com/content/supplementary/1476-069X-5-5-S3.pdf