EPA Axes Panel Chair at Request of Chemical Industry Lobbyists
Saturday, March 15, 2008

EPA Axes Panel Chair at Request of Chemical Industry Lobbyists

At the request of a chemical industry lobbyist, the Environmental Protection Agency removed the chair of an expert peer review panel charged with setting safe exposure levels for a toxic fire retardant that contaminates human blood and breast milk, according to documents obtained by Environmental Working Group (EWG). After doing the industry’s bidding, EPA then retroactively stripped all of the chair’s comments from the panel’s published report and republished the altered document.

In a letter to the EPA, a lobbyist for the American Chemistry Council argued that the panel chair, Dr. Deborah Rice of the Maine Center for Disease Control and Prevention, should be thrown off the panel because she exhibited an “appearance of bias” when she represented her agency's position in favor of restricting uses of Deca in her testimony before the Maine legislature. EPA acquiesced and removed Dr. Rice from the panel. The Agency first tried to cover up its actions by stripping any mention of Dr. Rice and all of her comments from the original published review document, and reposting the altered document on the web with no indication that any changes had been made. Months later EPA officials issued a disclaimer that Dr. Rice had been removed for a “perception of a potential conflict of interest.” The omission of the chair’s comments from the review document could result in a significantly weaker safety standard for the chemical, which EPA intends to propose at the end of March 2008.

EPA’s sacking of Dr. Rice reveals a dangerous double standard where scientists and experts working for state or federal health agencies can be removed from EPA advisory panels simply because they express the views of their agency in public as a part of their job responsibilities. Meanwhile, numerous scientists with direct financial ties to the manufacturers of chemicals under review, or with publications and public statements touting the safety of chemicals they are evaluating, remain as active participants on these panels.

Deca is a developmental neurotoxin used in electronics and other consumer products, from a family of fire retardants known as PBDEs (polybrominated diphenyl ethers). The targeted expert, Dr. Deborah Rice, was the panel member most knowledgeable about Deca risks. A retired EPA scientist and life-long public servant, Dr. Rice co-authored an important study on Deca toxicity to the brain and nervous system during development. She also spearheaded a regulatory review mandated by Maine law, to investigate the feasibility of replacing Deca with less toxic chemicals. Her transgression, according to the industry complaint, was that in testimony before the Maine legislature, Dr. Rice displayed an “appearance of bias” simply by stating her agency’s position in support of state legislation to restrict Deca.

EPA Stacks Panels With Industry-Biased Scientists

EPA has institutionalized the practice of loading key public health advisory panels with individuals sympathetic to or employed by the chemical industry. EWG examined seven EPA panels established in 2007 that use non-EPA scientists to evaluate the agency's proposed safe daily exposure levels, or "reference doses,” for important commercial chemicals where the agency is concerned about human exposure. In this small snapshot we identified 17 individuals who were employees of companies that make the chemicals under review, scientists whose work was funded by industries with a financial stake in the panel outcome, or scientists who have made over-reaching public statements about the safety of the chemical in question.

To our knowledge, EPA’s decision to remove Dr. Rice as chair of the Deca review panel represents the first time EPA has kicked a scientist off any panel for expressing concern about a chemical's health risks. Removing panelists because they state their concerns about a chemical's toxicity, while promoting scientists with clear financial ties to the regulated industry, sends a dangerous signal that EPA will not tolerate the views of individuals who believe in precaution in the face of evidence that a chemical presents a legitimate health risk.

Chemical Industry Used Allies inside the Agency to Bump Panel Chair

The chemical industry’s trade association, the American Chemistry Council (ACC), submitted their demand for Dr. Rice’s removal to Dr. George Gray of EPA’s Office of Research and Development (ACC 2007). Before joining EPA Dr. Gray headed up an organization funded by the ACC called the Harvard Center for Risk Analysis, well-known for their studies and advocacy to dismiss concerns about chemical safety.

ACC acted on behalf of their Brominated Flame Retardant Industry Panel (BFRIP) in making their demands to EPA. Recent media reports reveal that other efforts by the Bromine Industry to keep Deca on the market have included hiring a lobbyist who also represented the tobacco industry and the National Association of State Fire Marshalls in advocating for increased use of chemical fire retardants in place of fire-safe cigarettes and other commonsense methods to reduce fire risk (Shin 2008).

Rice's Removal From the Panel Could Weaken the Safety Standard

EWG’s line-by-line comparison of the panel report before and after EPA stripped Dr. Rice’s comments from the document shows that the altered document is now missing major concerns relevant to Deca’s risks to humans, particularly infants, children, and other vulnerable populations. EPA’s failure to consider these points could substantially influence their decision on an appropriate safety standard for the chemical:

  • Dr. Rice noted that EPA had no scientific basis for its assumption that a single day of Deca exposure linked to brain damage in animal studies is the most critical period of vulnerability for animal and human brain development. EPA’s recognition of this data gap would result in an additional factor of safety applied to the Agency’s daily safe dose (the reference dose, or RfD). Now the panel’s recognition of the data gap and the Agency’s baseless assumption is completely missing from the panel review document.
  • Dr. Rice noted that Deca risks should be considered in tandem with risks from related PBDEs that are also common blood and breast milk pollutants. Since all congeners being evaluated show the same type of neurotoxicity, health risks from these fire retardants would be additive. This comment reflects a view of additive chemical risks widely accepted across the scientific community but absent from EPA’s proposed methods for assessing Deca risks. Because the agency removed her comments, the panel review document no longer reflects this important point. EPA’s failure to consider additive risks would result in a vastly less protective health standard for Deca.

The EPA Double Standard

Over the past seven years it has become common practice for scientists with conflicts of interest and well-known, pro-industry biases to serve on and even lead EPA advisory panels. Some examples include: Direct financial conflict – Scientists employed by the companies who make the chemicals under review. Dr. Robert Schnatter sits on EPA’s expert panel charged with producing an assessment of the cancer potential of the chemical ethylene oxide, a mammary carcinogen used as a fumigant and hospital equipment sterilizer. Schnatter works for ExxonMobil, a manufacturer of the chemical he is charged with reviewing. EPA chose Schnatter for the panel despite the obvious contradiction his appointment presents to their policy to “always make every effort to use peer reviewers who do not have any conflict of interest...” (EPA 2006). Public statements that could indicate bias. Dr. Rice was removed from the PBDE panel for making public statements indicating that she had formed an opinion about the safety of the chemical. Yet similar statements have been made by many other reviewers examining other chemicals, almost always to the effect that the chemical under review is safe. Consider Lorelei Mucci, of the Harvard School of Public Health, who sits on a panel slated to review EPA’s proposed revisions to the safety standard for acrylamide, a contaminant of baked and fried food (EPA SAB 2008). Dr. Mucci has made numerous public statements discounting the health risks of acrylamide. As just one example, in August 2007 she claimed in the media that “The intake of acrylamide, no matter how much is consumed, is not a breast-cancer risk factor” (Riddell 2007). At the time she made this statement, findings from laboratory and epidemiology (human) studies conflicted on this point. Just months after her statement, a new study found more than double the incidence of estrogen-related breast cancers among women with high exposures to acrylamide in food compared to women with lower exposures (Thonning 2008). For her history of similar statements, reports of Dr. Mucci’s work have been characterized by respected scientist Dale Hattis as “scientific overreaching” (Hattis 2003). Career consultants with a clear record of work to weaken health standards on behalf of industrial clients. EPA panel chair and industry consultant Dr. Betty Anderson secured a panel decision to support EPA’s proposed 3-fold weakening of the health standard for a plastics chemical and common human pollutant called dibutyl phthalate (DBP) (EPA 2006b). The year that Dr. Anderson reviewed EPA's draft standards, her employer, Exponent, was under contract with ACC's Phthalate Ester Panel to discredit a key epidemiological study that found everyday exposures to DBP were linked to reproductive system defects in baby boys (Exponent 2006). The next year Exponent released a defense of a phthalate used in children's toys funded by the Toy Industry Association (TIA 2007). In her work for chemical makers, Anderson clearly expressed her goal to weaken health standards. Memos written by Anderson and housed in the national tobacco library show that she lobbied EPA for a more than 3-fold weakening of health protections on behalf of R.J. Reynolds. She first designed work to “bolster our position that [safety factors] used by EPA… can be dropped” (Anderson 1999a), and then relayed her success to her client at Reynolds: “I believe EPA has conceded a 10-fold [safety] factor reduction to 3…” (Anderson 1999b). She also advocated for two types of studies that could further weaken health standards: “Both or either [type of study] could remove the factor of 3.” Remarkably, in that statement she is predetermining findings from studies she had yet to design (Anderson 1999b). In another example that illustrates the same type of conflict, frequent EPA consultants James Swenberg and Vernon Walker conduct industry-funded research to demonstrate that mutagenic chemicals do not cause cancer in humans. Their findings conflict with a wealth of established scientific evidence. Dr. Swenberg was a panelist for 1,1,1-trichloroethane, and both were consultants to the ethylene oxide panel. Scientists who consult to companies that make the chemicals under review. EWG’s review revealed that in 2007 EPA panels included at least 13 additional members whose employers have worked for or have been funded by companies who make the chemicals they are charged with reviewing. Industry consultants are inherently conflicted as panel members, since companies hire consultants who will represent what they consider to be their best interests. On panels, a consultant's support for strengthening health standards could compromise their chances to win contracts from chemical manufacturers, while their expressions of rationale for weakening health standards immediately raise their prospects for future contracts. It takes a unique consultant, one willing to risk losing future personal income, to support strengthening public health protections when it’s needed. Click here for detailed information about potential conflicts among industry consultants.

Recommendations

EWG calls on EPA to clarify their guidance with respect to public statements by panel members, and commit to a transparent process for resolving allegations of bias. In order to restore public confidence in the peer review process EPA must:

  • Reinstate Dr. Rice as the chairperson of the PBDE (Deca) expert review panel;
  • Remove the altered panel review document from public record and restore the original panel review document that included Dr. Rice’s comments; and
  • Promptly issue an updated health standard for Deca that adequately protects public health and that thoroughly considers Dr. Rice’s comments, including the issue of additive risks from multiple related fire retardants that widely contaminate the U.S. population.

However, EPA’s double standard for panel experts is much broader than the single panel assessing Deca health standards. In order to maintain the integrity of peer review for agency decisions, EPA must:

  • Collect information regarding all current and past financial ties between prospective panelists and companies who might benefit from weakened safety standards;
  • Create formal, public records of their determination of bias for each scientist selected as reviewer; and
  • Release all records of any similar instances in which EPA has removed panel members or published altered versions of EPA expert reviewer submissions.

EWG is submitting a Freedom of Information Act request to EPA to turn over all documentation collected by the Agency or its contractors regarding potential conflicts of interest for external review panels during 2006 and 2007. This includes a request for files documenting inter-agency discussions of potential conflicts for individual reviewers, including Dr. Rice, and any communication with outside parties (like ACC) about the external reviewers.

 

Review Panel Timeline

Documents obtained by EWG reveal that EPA dismissed the chair of its high-profile external review panel at the request of the American Chemical Council (ACC) representing the interests of the companies who produce the toxic fire retardants under consideration (BFRIP). EPA’s move is in conflict with its own voluntary guidance documents. These require, at a minimum, that handling of allegations of bias be transparent and well documented for the public (EPA 2006).

Timeline of EPA and industry actions

EPA is updating its 1989 Deca safety standard and creating new standards for other PBDE fire retardants as well, including Tetra, Penta, and Hexa PBDE. The process began with a literature review in 2002. In late 2006, EPA posted its draft risk calculations for public comment and announced the expert review meeting (EPA-NCEA 2007d).

12/22/2006 EPA posts draft health standards for Deca and other PBDEs in the Federal Register, and announces the first expert panel meeting.
mid-Feb 2007 Dr. Rice of Maine CDC testifies before Maine Legislature on the need for use restrictions on Deca.
2/22/2007 PBDE Expert Panel convenes, with Dr. Rice as chair.
3/22/2007 EPA posts final Expert Panel report as a pdf file. The document includes Dr. Rice's comments.
5/3/2007 ACC demands that EPA kick Dr. Rice off the expert panel.
6/15/2007 ACC meets with EPA to discuss concerns with the process.
8/13/2007 EPA kicks Dr. Rice off of the panel, strips her comments from the Expert Panel report, and republishes the altered version. The document contains no mention of Dr. Rice and no record of EPA's actions to remove her comments.
9/21/2007 ACC writes EPA. The chemical lobby requests that EPA post the reasons for removing Rice on EPA's website.
11/26/2007 EPA posts 3rd version of Expert Panel comments. This version adds a disclaimer about the removal of Dr. Rice, and notes that EPA is not considering her comments in its final safety standard for Deca.
1/8/2008 EPA responds to second ACC letter
3/28/2008 EPA is expected to issue its final safety standard for Deca.

 

In January and February 2007, before the External Review panel met, Dr. Rice's agency, Maine CDC, released a joint report with Maine EPA, reviewing the need for use restrictions for Deca PBDE and the suitability of alternative fire retardants. Dr. Rice was a co-author. The report concluded that "safer alternatives are available to meet flammability standards for TVs, mattresses and residential upholstered furniture" (Rice 2007a). Dr. Rice was asked to testify before the Maine Legislature and offer her opinion about a bill that would restrict Deca in products sold in Maine. She presumably echoed the Agency conclusion in testimony in February 2007. Dr. Rice was in a unique position to make such comments as she was the co-author of a low dose study (Rice 2007b) that confirmed the neurological deficits observed in the principal study used to derive the reference dose for Deca PBDE (Viberg 2003).

 

Deca in consumer products, people,
and the environment
Over the past 5 years, numerous investigations have substantiated the widespread accumulation of PBDEs in people, wildlife and the environment. In response to these findings, bromine companies agreed to voluntarily phase-out 2 of the 3 forms of PBDEs in 2005. The third form, Deca, is still in widespread use in televisions and computer monitors, although 2 U.S. states recently passed restrictions and many other states are considering similar legislation. CDC recently reported that nearly all of the 2,000 people they tested have detectable concentrations of many PBDEs in them. CDC’s tests did not include Deca due to analytical difficulties, but Deca has recently been reported in human samples from Europe, Central America, Asia and several small studies in the United States (Athanasiadou 2008; Bi 2006; EWG 2003; Qu 2007). Laboratory studies show single day exposures during sensitive periods of brain development result in permanent changes to rodent attention and behavior (Rice 2007b; Viberg 2003; Viberg 2008). It is not currently known how those doses compare to the daily exposure for Americans, but EPA’s draft risk calculations are a first step to set daily safe exposure levels for people. EPA’s external review committee was reviewing the risk calculations to translate these studies into daily safe exposure values for human beings.

2/22/2007 PBDE Expert Panel convenes. The EPA contractor convened the advisory panel of 5 scientists to provide EPA with a rigorous review of the scientific basis for the agency's proposed health standards. Expert reviewers were asked to answer a set of questions from EPA regarding the completeness of the Agency's literature review, the adequacy of data and the appropriate use of uncertainty factors in EPA’s derivation of a daily safe exposure level, or Reference Dose (RfD) (EPA-NCEA 2007e). 3/22/2007 EPA posts Expert Panel comments. The document contains the individual comments from 5 reviewers (EPA 2007a). Dr. Rice is listed as panel chair. She raises several issues that others did not address. Nonetheless the 5 expert reviewers are generally in agreement with EPA’s selection of low dose studies and the general steps taken to translate those to daily safe exposures that do not risk human health. 5/3/2007 ACC demands that EPA remove Dr. Rice from the Deca panel. ACC’s Sharon Kneiss wrote to ORD Assistant Administrator George Gray a former head of a consultant group that receives ACC funding, to ask that he personally intervene in the process (ACC 2007). ACC, acting on behalf of BFRIP, the Brominated Flame Retardant Industry Partnership, alleges that the panel is not an “independent, third-party review” because Dr. Rice is a “fervent advocate of banning deca-BDE.” In an interview with a local paper Dr. Rice stated that “there is no question” that Deca PBDE should be eliminated from commerce because it was a persistent toxin that accumulates in the food chain. ACC alleged that, “[T]here is no doubt that [Dr. Rice] has taken a very public position concerning a regulatory determination that is fundamental to the very issues presented to the panelists in the draft IRIS Toxicological Reviews” (ACC 2007). ACC fails to note that Dr. Rice’s testimony was solicited by the legislature and offering her expert opinion was in fact a requirement of her job. However, unlike industry-employed scientists (who often serve in this capacity) Dr. Rice has no direct or indirect financial incentive to sway panel findings. 6/15/2007 ACC meets with EPA in person to express concerns about Dr. Rice and the proposed risk values. There is no public record of the discussion during this closed door meeting. 8/13/2007 EPA posts 2nd version of Expert Panel comments as a pdf file. All of Dr. Rice’s comments are omitted. In August, EPA posts an identically formatted document that omits Dr. Rice’s name and all of her comments (EPA 2007d). The new pdf file was placed on the same webpage, and the title page still listed the date of the report to be February 2007 (EPA-NCEA 2007b). 9/21/2007 Nancy Sandrof of ACC writes EPA on behalf of Bromine producers (BFRIP). ACC writes a second letter requesting that EPA post the reason for removing Rice on EPA's website and take steps to assure that Dr. Rice's comments not influence the other reviewers or the overall outcome. They ask that EPA not use the Viberg study--showing neurological impacts to mice given a single dose of Deca--for the risk assessment and request a delay in the publication of final values. 11/26/2007 EPA posts 3rd version of Expert Panel comments as a pdf file. Document contains 4 reviewers, EPA discloses Rice's removal. In November, EPA posted a third version of the Expert Panel comments with a new disclaimer that reads: "Notice: EPA modified this report in August, 2007 to include only four of the five reviewers’ comments. One reviewer’s comments were excluded from the report and were not considered by EPA due to the perception of a potential conflict of interest" (EPA-NCEA 2007c). The new pdf file was placed on the same webpage as the previous 2 versions. However the webpage now has a similar disclaimer. The report title page still lists the report date of February 2007. 1/8/2008 George Gray of EPA responds to ACC. Dr. Gray writes the Bromine Manufacturers via ACC to confirm that they have posted a disclaimer about the removal of Dr. Rice. An EPA review showed that she did not influence the other panelist. He confirms that EPA will continue to use the Viberg study as a point of departure for RfDs, as every external reviewer agreed with this decision. He hints that a yet-to-be-published EPA study has confirmed low-dose neurotoxicity after single or repeat doses. Finally, he clarifies that the IRIS assessments have been delayed to provide time to address final interagency review comments. 3/28/2008 Final RfD expected. It is unclear what effect removing Dr. Rice and her comments will have on the final PBDE values. EWG’s line-by-line comparison of the panel report before and after EPA stripped Dr. Rice’s comments from the document shows that the altered document is now missing at least two major concerns relevant to Deca’s risks to humans (EPA 2007a):

  • Dr. Rice noted that EPA had provided no scientific basis for its assumption that the single-day exposure for PBDE-induced brain damage demonstrated in animal studies could be used to predict daily PBDE exposures to humans. EPA had used single-day exposures as sub-chronic (multi-day) exposures and had used an uncertainty factor of 3 rather than 10 to translate them to the PBDEs that impact humans from conception through adulthood. EPA’s rationale was that the study targeted a “unique critical window of vulnerability.” However the only citation was a university thesis that cited a 1968 publication identifying post-natal day 10 in rodents as a critical day.
  • Dr. Rice objected to this, and cited a review article she co-authored in Environmental Health Perspectives that discussed many periods of brain vulnerability to developmental toxicants. EPA’s recognition of this data gap would result in an additional factor of safety applied to the Agency’s safe dose (the reference dose, or RfD). Now Dr. Rice's comment and publication exposing the Agency’s baseless assumption is completely missing from the panel review document.
  • Dr. Rice noted that health risks of PBDEs would be additive. Tetra, Penta and Hexa congeners are exclusively sold and used in mixtures and it would be impossible for a person to be exposed to them independently. Deca and the other congeners are commonly detected in people and household samples, which indicate daily exposure to all 4 types. Each group shows the same pattern of low dose toxicity after single day exposures. Health risks from these fire retardants would be additive. This comment reflects a view of additive chemical risks widely accepted across the scientific community but absent from EPA’s proposed methods for assessing Deca risks. Dr. Rice was the only panelist to note this important deficiency in EPA’s method. Because the agency removed her comments, the panel review document no longer reflects this important point. EPA’s failure to consider additive risks will result in a vastly less protective health standard for each chemical.
  • Dr. Rice suggested different combinations of Uncertainty Factors be used in the translation of single day rodent exposures to daily safe ingestion values for humans. The overall impacts are concentrations 3 to 35 times lower than proposed by EPA.

Other tactics of the bromine manufacturers to protect the use of their toxic products have recently come under scrutiny. On January 26th, 2008 the Washington Post published an exposé linking tobacco companies' efforts to fight fire-safe cigarettes with the same bromine-producing chemicals who had converging interests, as both benefited from an increased reliance on chemical fire retardants to combat cigarette ignitions. The Washington Post reported that a single lobbyist, Peter Sparber, represented both tobacco and bromine producers, and funneled money to the National Association of State Fire Marshalls, who for more than a decade fought for increased use of chemical fire retardants in place of less toxic methods to control ignition sources like cigarettes (Shin 2008). EPA has now acceded to demands of the bromine industry to alter documents that will be used to set agency health standards. The result of these actions could compromise public health protections from these ubiquitous and toxic pollutants.

 

17 conflicted reviewers

EPA has only voluntary guidance to govern the selection of external reviewers. Of critical importance in peer review is independence of experts who are validating EPA's work. EPA's Peer Review Handbook highlights the independence of reviewers as the core issue in panelist selection:

“EPA should always make every effort to use peer reviewers who do not have any conflict of interest or an appearance of a lack of impartiality, and who are completely independent” (EPA 2006).

EPA does not expressly prohibit the inclusion of reviewers with a financial stake in the panel outcome: “In fact, experts with a stake in the outcome — and therefore an appearance of conflict — may be some of the most knowledgeable and up-to-date experts because they have concrete reasons to maintain their expertise" (EPA 2006). Yet Dr. Rice, who has no financial conflict, was removed by EPA from the Deca panel, while the agency continues its widespread inclusion of industry-affiliated scientists, some with very direct financial conflicts of interest. EWG reviewed 7 External Review panels convened to assess new health standards for EPA's IRIS program in 2007. We found indications of direct or potential conflict of interest for 17 panelists. These scientists receive direct payments from industries who stand to benefit from weakened regulation, have a history of advocacy to reduce safety standards for chemicals, or have made broad public statements about the safety of chemicals under review.

Public statements that could indicate bias

Dr. Rice was kicked off of the Deca review panel because of an apparent "appearance of bias" when she testified before the Maine legislature on behalf of her employer, the Maine CDC, in favor of restrictions on the chemical to protect health. Yet other scientists who have made public pronouncements about chemicals remain on EPA panels. EPA Guidance states "[A]s a general rule, experts who have made public pronouncements on an issue should be avoided" (EPA 2006), but the agency has a double standard when sticking to this guidance, as evidenced by our investigation of Dr. Lorelei Mucci of EPA's acrylamide panel: Acrylamide and Lorelei Mucci. EPA’s Science Advisory Board has convened an External Review panel that met for the first time on February 20th, 2008 to review EPA’s work to update the safety standard for acrylamide, a carcinogenic pollutant in food and a chemical used in a wide range of industries (EPA SAB 2008). The panel includes Lorelei Mucci, an epidemiologist at Channing Labs at Brigham and Women’s Hospital and Harvard School of Public Health in Boston, who has made numerous public statements discounting acrylamide’s cancer-causing potential. For this and other statements, reports of Dr. Mucci’s work have been characterized by respected scientist Dale Hattis as “scientific overreaching” (Hattis 2003). Our review of her published studies and public statements shows that Dr. Mucci has on numerous occasions drawn inferences from her study findings that inappropriately discount links between acrylamide and cancer. In one case she noted that “There is little evidence of an association between any specific baked or fried potato product and cancer risk” [emphasis added by EWG] (Riddell 2007). Dr. Mucci’s study in fact found a 60% increased cancer risk in people when she assessed acrylamide exposures from all foods combined, although the study group was too small for that result to reach statistical significance (Mucci 2003). She further stated to the media that “The levels individuals are generally exposed to through food do not appear to increase the risk," even though these statements were critiqued by toxicologists of the sponsoring health agency, who note that a single study cannot support a complete discounting of risk (Payne 2003). In addition to the cancers studied by Dr. Mucci, acrylamide has been linked to pancreatic cancer in exposed workers, and thyroid and reproductive and central nervous system cancers in rodent studies, associations that have not been assessed in humans (EPA 2007i). In August 2007 Dr. Mucci was widely quoted in media reports following her presentation at a chemical industry conference of preliminary study findings, saying, for example, “The intake of acrylamide, no matter how much is consumed, is not a breast-cancer risk factor” (Riddell 2007). Just 5 months after these first widespread reports, a new study was published measuring a more than doubling of risk of estrogen-related breast cancers among women with high exposures to acrylamide in food (Thonning 2008). This new work relied on direct measurements of acrylamide bound to women’s red blood cell hemoglobin, instead of the crude diet surveys used in Mucci’s studies. ACC and other industry groups have vigorously defended the inclusion of expert reviewers from industry, even those who have a direct financial stake in the outcome of panel decisions, stating “…bias (or ‘partiality’ under government ethics rules) is both unavoidable and unobjectionable” (Barrow 2006).

Career consultants with a clear record of work to weaken health standards on behalf of industrial clients

Two panelists with clear links to polluting industries have made well-documented attempts to influence EPA health standards by carefully designed research to erode traditional safety factors. Dibutyl phthalate and Dr. Elizabeth (Betty) Anderson. Chemical industry consultant Betty Anderson chaired EPA’s 2006 panel that has recommended that EPA weaken by a factor of 3 the safety standard for the plasticizer chemical called dibutyl phthalate (DBP) (EPA-NCEA 2006a). This chemical is used in food packaging, nail care products, and a wide range of plastic consumer products, and is also a ubiquitous pollutant in people. Anderson had no particular expertise in toxicity of this chemical to qualify her as panel chair. However Anderson's employer, Exponent, was simultaneously under contract with ACC's Phthalate Ester Panel to discredit a key epidemiological study that found everyday exposures were linked to reproductive system damage in baby boys (Exponent 2006). Exponent scientists concluded that "data from this study are not sufficient to show any correlation between phthalate exposure and changes to the anogenital distance in the infant males." ACC's Phthalate Ester Panel is made up of manufacturers and users of the chemical including: BASF Corporation, Eastman Chemical Company, ExxonMobil Chemical Company, Ferro Corporation and Teknor Apex Company. The Panel has collectively funded more than $15 million dollars of research, not including research conducted by individual companies (ACC 2008). Exponent later completed a risk review for toy manufacturers to defend the use of a related phthalate in children's toys (TIA 2007). The proposed weakening of EPA’s safety standard that Anderson's panel recommended is remarkable given the volume of scientific studies published since EPA first established DPB safety standards in 1990 indicating that the chemical is toxic in lower amounts than previously believed. In studies of people, at what are considered “background” levels of exposure (Marsee 2006), DBP is now linked to sperm damage, asthma, obesity, insulin resistance, and birth defects of the male reproductive system (NTP 2003). Dr. Anderson achieved the same magnitude of reductions in EPA health protections for a different chemical (phosphine) as a consultant to the tobacco industry. Anderson’s conflicts have been the subject of recent investigative reports, and include issues surrounding her work on asbestos and with the tobacco industry (McDaniel 2005; NRDC 2007; Thacker 2007). She chaired the EPA panel on DBP the year after her work with R.J. Reynolds to weaken health standards was discovered and published in a scientific journal. A 2005 publication in Environmental Health Perspectives and a 2006 investigative report by science writer Paul Thacker, published in Environmental Science & Technology, revealed that in 1999 Dr. Anderson, then of the firm Sciences International, helped R.J. Reynolds Tobacco fend off EPA restrictions on a chemical fumigant called phosphine, in part with her offer to use her official position with a scientific journal to expedite study publications:

“I believe that the approach with the greatest likelihood of affecting EPA’s position is to prepare and publish in a peer-reviewed journal a scientific paper or article that describes the current science on the toxicity of phosphine.” … “Since I am currently Editor-in-Chief of the international journal Risk Analysis, perhaps the peer-review process could be expedited, if we decide that it is the journal of choice” (McDaniel 2005; Thacker 2006).

Risk Analysis published Anderson’s paper in October 2004, and did not disclose that two of Anderson’s co-authors were employed by R.J. Reynolds Tobacco Co. Anderson has defended her actions by noting that the study was not, in the end, expedited (Anderson 2006). R.J. Reynolds considered their work with Anderson to be among its important accomplishments, according to a 1999 company document: “R&D led the Phosphine Coalition in addressing the scientific issues involved when the Environmental Protection Agency (EPA) proposed a new phosphine exposure standard,” … “The efforts of the Coalition saved [Reynolds] many millions of dollars” (Thacker 2006). Documents in the national tobacco papers library reveal that her influence went beyond her journal connection. Notes of a meeting between EPA, Anderson and her clients disclose that “the meeting was very cordial and the Coalition participants were very encouraged by the Agency's reaction to Dr. Anderson's ideas for relaxing the current proposed exposure standard of 0.03 ppm” (Seckar 1999). Anderson’s own memo reveals her hand in convincing EPA to reduce its safety factor for health standards: “I believe EPA has conceded a 10-fold [safety] factor reduction to 3…” and she strategizes on other measures to reduce the safety factor by still more: “I believe it will be difficult, though not impossible, to demonstrate the relationship between the pharmacodynamics in animals and humans is deserving of a factor of 3 if the right studies can be designed” (Anderson 1999). The DBP panel Anderson chaired proposed to EPA a 3-fold weakening of EPA’s the safety standard. EPA has yet to finalize the standard. In addition to Dr. Anderson, the 2006 DBP external review also included Edwin Garner, who was employed by Research Triangle Institute International, a contractor who performed a number of industry-funded studies of phthalate toxicity (Fennell 2004; Tyl 2004 among others). Ethylene Oxide, James Swenberg and Vernon Walker. Frequent EPA panel members Dr. Jim Swenberg of the University of North Carolina and Dr. Vernon Walker of the industry-funded Lovelace Respiratory Research Institute conduct industry-funded research to demonstrate that mutagens do not cause cancer in humans, work at odds with findings from a large body of scientific evidence. Chemical manufacturers, including the Chemical Manufacturers Association (now the ACC) and International Institute of Synthetic Rubber Producers, have funded their original research (CSPI 2006) into the relationship between mutation and cancer in rodents, and potential impacts to humans (Rusyn 2005; Swenberg 2000; Walker 2000; Walker 1990). Dr. Swenberg was a panelist for 1,1,1-trichloroethane (EPA-NCEA 2007f) and both were consultants to the ethylene oxide panel (EPA-NCEA 2007h). EPA’s draft assessment ethylene oxide values, released in September 2006, proposed tightening the agency’s 1985 inhalation standard of 3.6 parts per billion to 0.06 parts per trillion, based on compelling new evidence of cancer in exposed workers (EPA-NCEA 2007h). This dramatic strengthening of the health standard raised significant concerns among manufacturing industries. The assessment is based upon the agency conclusion that the chemical was a carcinogen via gene mutation. This evidence was vigorously disputed by Drs. Swenberg and Walker in a series of publications funded by chemical trade associations (Rusyn 2005; Swenberg 2000; Walker 2000; Walker 1990). As consultants to the Science Advisory Board’s ethylene oxide review panel, the scientists promoted their research along with a new “framework” for evaluating genotoxicity and risk assessment that contradicted EPA’s proposed approach (EPA-NECA 2007h). The framework attempts to distinguish between chemicals that cause mutations to DNA and chemicals that cause cancer. This was used to discount observations of cancer in exposed workers, arguing that while ethylene oxide was a known mutagen, those mutations did not lead to cancer. Dr. Swenberg’s framework was lifted from an ACC-funded publication he co-authored, and added as an appendix to the peer reviewer’s comments. The paper co-authors Vernon Walker and Richard Albertini, prepared ACC’s public comments to EPA on the mutagenicity issue, which employed identical logic (Albertini 2006). Drs. Swenberg and Walker’s fingerprints can be found on the external review panel conclusions. The review panel's cover letter to EPA describes a division within the review committee with respect to the proper characterization of ethylene oxide as a human carcinogen (EPA-SAB 2007a). Dr. Swenberg’s influence on the treatment of mutagenic chemicals has potentially major implications for EPA’s evaluation of carcinogens. Safety values for carcinogenic chemicals include an additional 10-fold uncertainty factor to account for greater vulnerability of children if they are exposed during development. The move to classify a known mutagen as a “non-carcinogen” would allow regulators to skirt the 10-fold uncertainty factor and permit greater exposures of children and others to mutagenic chemicals.

Scientists employed by the companies who make the chemicals under review

EPA Guidance identifies financial ties to a regulatory decision as a clear conflict of interest. “Generally, a conflict of interest arises when the person’s financial interests are affected by his/her participation in a particular matter, when he/she, his/her associates or other individuals whose interests are imputed...would derive benefit from incorporation of their point of view in an Agency product, and/or when their professional standing and status or the significance of their principal area of work might be affected by the outcome of the peer review” (EPA 2006). The most direct type of financial conflict is employment by or stock ownership in a company who would be directly impacted by the proposed value. We did not have any information regarding financial holdings of panelists and were unable to gauge this potential for conflict, though we did find that at least 1 panelist was directly employed by a company who manufactured the chemical in question. Ethylene Oxide and Robert Schnatter. EPA selected Robert Schnatter of ExxonMobil to sit on their expert panel charged with producing an assessment of the cancer potential of the chemical ethylene oxide. ExxonMobil manufactures ethylene oxide. The chemical is used to make other common chemicals, to fumigate spices, and to sterilize medical equipment (EPA 2006b). It is also considered a potential contaminant in many types of personal care products (CIR 2006c), and is a confirmed mammary carcinogen (Rudel 2007). An employee in this situation might disagree with his employer on the need for stronger public health protections, but might feel inhibited from expressing anything but the position of company executives. Schnatter’s inclusion on a panel reviewing a chemical manufactured by his employer clearly violates EPA’s policy to “always make every effort to use peer reviewers who do not have any conflict of interest...” (EPA 2006).

Scientists who consult to companies who make the chemicals under review

Acrylamide and Dale Sickles. EPA selected Dr. Sickles for its expert review panel on the common food contaminant and carcinogen acrylamide (EPA-NCEA 2007i). His scientific research at the University of Georgia has been funded by companies who manufacture or market acrylamide for industrial uses, including CYTEC and American Cyanamid, according to a review by the Center for Science in the Public Interest (CSPI 2007). 1,1,1-Trichloroethane and Matthew Reed. Dr. Reed, of Lovelace Respiratory Research Institute, was an external reviewer for petrochemical 1,1,1-Trichloroethane (EPA-NCEA 2007f). He coordinates inhalation health effect studies for the National Environmental Respiratory Center. The center is funded by chemical, petroleum, motor vehicle, and power generation industries (LRRI 2008). 2,2,4-Trimethylpentane, Susan Borghoff, Brian Short and Deborah Barsotti. These 3 scientists were reviewers for the 2,2,4-trimethylpentane panel (EPA-NCEA 2007e). The Borghoff and Short, along with previously mentioned panelist James Swenberg and Vernon Walker, have co-published 4 peer reviewed articles that were funded by the Chemical Industry Institute for Toxicology (CIIT), and led them to conclude that the toxicity mechanism did not apply to humans (Short 1989a; Burnett 1989; Short 1989b; Short 1987). Borghoff's work with CIIT was supported by Lyondell Chemical Company, which manufactures this chemical (TERA 2007). Short, of Allergan, Inc., has published 7 research papers funded by the Chemical Industry Institute for Toxicology (CIIT) (including 4 mentioned above on the chemical he reviewed) (Short 1989a; Burnett 1989; Short 1989b; Short 1987; Borghoff 1993; Borghoff 1990; Swenberg 1987). Barsotti was another panelist. Her employer MACTEC Engineering's clients include Dow, DuPont, ExxonMobil, Shell Oil and Unocal, and manufacturers of the chemical she reviewed (MACTEC 2008). Ethylene oxide and James Klaunig. Dr. Klaunig from Indiana University School of Medicine, served on the ethylene oxide panel (EPA-NCEA 2007h). Dr Klaunig has received research support from ethylene oxide manufacturer DowAgro and the American Chemistry Council (CSPI 2006). His work on a related chemical, 2-butoxyethanol, was funded by the ACC’s Ethylene Glycol Ethers Panel, which later merged with the Ethylene Oxide Panel (Klaunig 1999). Food contaminants and the International Life Sciences Institute (ILSI). The acrylamide review panel included 3 panelists who were affiliated with ILSI, Deborah A. Cory-Slechta, Penelope Fenner-Crisp, Jeffrey Fisher (EPA-NCEA 2007a). ILSI receive the base of their funding from food producers, including Proctor and Gamble, plaintiffs in a lawsuit challenging California’s attempt to label acrylamide-containing foods. One panelist, Jeffrey Fisher, also participated in the 1,1,1-Trichloroethane panel (EPA-NCEA 2007f). TCE is also a food contaminant. ILSI has come under substantial scrutiny in Europe, where they attempted to publish a book on alcohol addiction without revealing (and in fact obscuring) that the alcohol industry had funded the publication. Publishers were unable to determine the degree to which the alcohol industry had exhibited editorial control of the process, but concluded that ILSI had falsely represented themselves as a ‘non-profit scientific entity,’ deliberately obscured the role of the alcohol industry funding (Edwards 2001; Room 2002). WHO barred ILSI from participation in global food standards due to the influence of food producers (Heilprin 2006). EPA, however, appeared to have no qualms about including 3 ILSI members on their expert panels for 2 common food contaminants. Nitrobenzene, Bruce Allen and Richard Pleus. Both Allen and Pleus sat on EPA’s expert panel for nitrobenzene in 2007 (EPA-NCEA 2007d). Nitrobenzene is primarily used to make aniline, and in dyes, drugs, pesticides and synthetic rubber. Allen lists among his previous clients ACC, Ciba-Geigy, CIIT, Lockheed Martin, the US military and other governmental bodies (GBA Associates 2008). Pleus works for the consulting firm Intertox with heavy involvement with polluters. Dr. Pleus serves as an expert for the media on behalf of the Council on Water Quality — a group funded by Lockheed Martin, Aerojet, Tronox and American Pacific Corporation, in these companies’ efforts to influence EPA health standards for the rocket fuel ingredient and common water contaminant perchlorate (Council on Water Quality 2008). Tetrahydrofuran and Nancy Kerkvliet. Kerkvliet was a panelist on EPA's tetrahydrofuran review (EPA-NCEA 2007j). She is faculty at Oregon State University is also on the Board of Directors of the Annapolis Center, an industry-funded research group (CSPI 2008). The Annapolis Center "... actively argues against the idea that global warming is the result of burning fossil fuels. They also advocate increased logging for better forest health and question rising mercury levels among other things. The Annapolis Center is funded primarily by the National Association of Manufacturers." (Exxon Secrets 2004) The recent panels have included other experts who work for some well-known industry-oriented consulting groups: Exponent and ChemRisk, both of whom have a long history of collaboration with polluting industries including expert testimony, risk assessments and original bench science. At a minimum these panelists should be asked to disclose their personal business relationship to chemical manufacturers. Another contractor, Sciences International, wrote or co-authored the IRIS toxicity review documents for at least 6 chemicals, each of these between 2001 and 2004.

 

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