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17 conflicted reviewers

March 15, 2008

EPA Axes Panel Chair at Request of Chemical Industry Lobbyists: 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.