One-stop science shop has become a favorite of industry—and Texas

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Michael Dourson left the U.S. Environmental Protection Agency 20 years gone to start a nonprofit consulting house that—unlike the federal government—would affect swiftly to evaluate chemical hazards. Toxicology Excellence towards Risk Assessment, or TERA, would have existence a sort of one-stop body of knowledge shop, Dourson decided: It would appreciate the risks of cancer and other diseases associated by exposures to certain chemicals. It would look closely-review research and publish those findings in a database. It would constitute conferences to educate government and industry officials. Dourson’s organization filled a break left by the EPA, which has evaluated the security of only 558 of 84,000 chemicals in c~tinuance the market today. The EPA’s supineness has created major business opportunities in quest of firms like TERA because few express agencies have the resources to escort their own risk-assessment studies, which are time-consuming and complex. Dourson, a toxicologist who worn out 15 years with the EPA, describes TERA during the time that an independent firm that aims to countenance public health by bringing together scientists from body politic, academia and industry. Through TERA, he has created a self-sustaining reticulated of supporters in which clients, regulators and fellow-reviewers often overlap. The firm’s extent has helped make Dourson an influential figure in the field of hazard assessment—a niche discipline that is used to decide how much of a particular chemical is agreeable in the environment. The results of these studies adjust thousands of public health decisions on all sides the country, including the setting of drinking water standards and air pollution guidelines. “People get to to us specifically because they not to be present to build a collaboration,” Dourson, 62, afore~ in a recent telephone interview from his duty in Cincinnati. But an investigation by the Center for Public Integrity and InsideClimate News shows the constant has close ties to chemical manufacturers, tobacco companies and other industry interests. More than 50 percent of the peep-review panels TERA has organized because 1995 were for studies funded ~ means of industry groups. TERA also runs a hazard-assessment database that receives financial and in-sort support from many companies and control agencies. Some of those groups be delivered of also paid TERA to peer-criticise studies they hope will be included in the database. A 2011 study up~ the body acrylamide—a possible carcinogen found in French fries and potato chips— shows the extent of overlapping interests. The acrylamide study, which aimed to evaluate the chemical’s spoken cancer risk, was funded by Burger King, Frito-Lay and other pabulum companies. Four of its eight authors were TERA scientists, with Dourson the lead. TERA also selected the panel that reviewed the study. The study’s finding—which is 10 times less protective than the EPA’s cancer put in peril for acrylamide—is now posted on the TERA database. The identities of the study’s funders are buried in footnotes. “TERA goes uncovered of its way to describe itself as a nonprofit, to emphasize it works on this account that government, not just industry…when in actuality [Dourson] and his group engage in labor-funded activities all the time,” uttered Richard Denison, lead senior scientist at the Environmental Defense Fund. Dourson isn’t fazed ~ means of such complaints. “We get criticized through everyone,” he said. “But that doesn’t make some ~ in. the fact that TERA is mediocre.” No state has taken superior situation of TERA’s services more than Texas, whither a rush of oil and elastic fluid production has created air pollution problems that the Center and InsideClimate News regard been investigating for 20 months. Dourson is a conclude friend of Michael Honeycutt, who heads the science of poisons division at the Texas Commission adhering Environmental Quality (TCEQ), the primary enforcer of the Clean Air Act and other founded on environmental laws in Texas. His course of life has evaluated the toxicity of 45 chemicals because 2007 through its risk assessment program. Two-thirds of the resulting guidelines are inferior protective than they used to be. The TCEQ gave TERA a four-year, $600,000 stipulate to help review the agency’s chemical evaluations. Texas has hosted three conferences place on by the Alliance for Risk Assessment – some affiliate of TERA. Honeycutt sits without interrupti~ the alliance’s steering committee and his intervention has petitioned the committee to lord-review the agency’s work. Luke Metzger, the counsellor of Environment Texas, reacted strongly whenever told of the relationship between Honeycutt and the relationship by the Center and InsideClimate News. “If it’s not unlawful, it certainly raises eyebrows about whether it’s legitimate,” he said. Honeycutt is “supposed to exist working on behalf of all Texans,” Metzger reported. Steering taxpayer dollars toward a dense whose decisions Honeycutt influences “farther on erodes the quickly diminishing trust we consider in him.” In an email, TCEQ prolocutor Terry Clawson said Honeycutt receives ~t one compensation from the Alliance for Risk Assessment and recuses himself from the steering committee whenever the TCEQ proposes a project. Opportunities in favor of bias Risk assessment creates inherent opportunities according to bias because scientists often make their decisions ~ dint of. extrapolating findings from animal studies to paroxysm humans. Risk assessors decide which questions to request and which studies to rely without interrupti~, a process that environmentalists and efforts sympathizers can both use to stretch forth conclusions more favorable to their interests. Scientists ofttimes have to “make assumptions, and constitute decisions at various points,” related Maria Morandi, a consultant who formerly worked as a health scientist at the University of Texas Health Science Center in Houston. “So there is a large potential for predisposition, depending on who’s doing the impost.” Dourson said he created TERA to the degree that a 501(c)(3) organization in the same state he could host conferences that conduct together representatives of government, academia and industrial art. He said he viewed conflict-of-benefit rules that prevented EPA scientists from receiving circulating medium to attend industry events as one impediment to good science. He points to the class of groups TERA has worked through as evidence of the firm’s neutrality. But Rena Steinzor, a enactment professor at the University of Maryland who specializes in common health regulation, accuses TERA of “whitewashing the toil of industry.” About one-third of TERA’s business comes from assembling peer-review panels, Dourson said. In one and the other case, TERA selects a group of experts, vets them by reason of potential conflicts of interest and manages the gathering logistics. Having a study reviewed ~ the agency of a disinterested panel of experts is of great weight because it can give legitimacy to a scientist’s operate. An InsideClimate News and the Center dissection of the 68 panels and workshops listed in successi~ TERA’s website shows that ~ numerous are fairly balanced with respect to the scientists’ affiliations. Scientists who usually be in action for industry are often paired with an equal number of government and of the university researchers. But a further analysis shows that TERA repeatedly uses experts from a core form into ~s of companies and consulting firms. At the culminating point of the list is Dourson himself, who sits without ceasing 69 percent of the panels that TERA has organized (other TERA scientists open on an additional 11 percent). Dourson usually chairs ~ one panel he is a part of. Dourson afore~ TERA has a short list of the public with a general toxicology background that it trusts to prevail on its panels. He said that limit happens to include him. According to TERA’s latest founded on tax filing, Dourson was paid $152,392 in 2012. “We are not going to contact public health by choosing someone in successi~ a panel who is not a trustworthy chair,” he said. A military of the panels on TERA’s website in addition shows that more than 50 percent of the studies reviewed were funded ~ means of the chemical industry. Of the 240 scientists who’ve served up~ the body TERA panels over the years, alone a few came from the environmental common. Ruthann Rudel is director of careful search at the Silent Spring Institute, a nonprofit study center in Massachusetts that focuses in successi~ breast cancer and other women’s freedom from disease issues. Rudel served on the affiliation steering committee until 2011 and attached nine TERA panels from 1997 to 2007. She before-mentioned most risk assessors work for form of productive effort groups, and she sometimes felt like a lone stand-in for the environmental hale condition perspective. TERA’s panels are “to all appearance more polarized in reality than it looks” for the reason that TERA gets to select the individual scientists, she reported. “Many people in government are very supportive of the industry points of survey, and in universities also, there’s a sort of privatization of the research.” “I struggled often” by whether to join the TERA panels, she afore~. “By participating, I was giving it some legitimacy. But at the same time, each time I went, I felt like the things I contributed changed the consequence in a material way, so whether I wasn’t there, it would be obliged been worse.” ‘Decidedly pro-industry’ It’s stingily impossible to keep up with the to the end of time-expanding array of chemicals made and used in the United States. The EPA’s Integrated Risk Information System – IRIS – has evaluated not so much than one percent of the roughly 84,000 chemicals registered by the agency. Some of the assessments that receive been delayed for more than a decade are in the place of chemicals known to cause cancer, including arsenic, formaldehyde and hexavalent chromium. In 2008, the Government Accountability Office afore~ IRIS was in danger of congruous obsolete because the EPA was completing sole a handful of chemical assessments reaped ground year, due in part to civic interference. The Obama administration has failed to fare up the process, largely because of squeezing from Congress and lobbying by the chemical persistence. The EPA’s inaction means that the without more information about some chemicals comes from their manufacturers—and difficult to absorb the flood of corporate-funded science is like “hard to bear to stop Niagara Falls,” Rudel declared. “They have lots of pecuniary means and lots of bright people, end fundamentally what they want and want to do is limit liability and precinct the cost of complying with regulations,” she afore~. The flaws in this system became obvious when an estimated 10,000 gallons of crude MCHM—a chemical used by the coal industrial art —leaked from storage tanks into West Virginia’s Elk River in January. As 300,000 family were ordered not to use their tap-room water, regulators scrambled to figure ~right a safe exposure level for the national. They had little information to operate with: The Material Safety Data Sheet created by manufacturer Eastman Chemical used the term “no data available” 152 ages, including in a section on whether the chemical causes cancer. In the aftergrowth of the spill, TERA was hired ~ dint of. a state contractor to convene a array of health experts. The panel’s do ~-work was to review the MCHM exposure thresholds set by the Centers beneficial to Disease Control and Prevention, which based its decomposition on information provided by Eastman Chemical. TERA selected four body politic and university scientists and made Michael Dourson the body of jurors chair. Though Dourson later conceded that he had antecedently done work for Eastman Chemical, the clash of interest screening report for the body of jurors did not disclose this. The array recommended a short-term exposure proportion eight times more stringent than the CDC’s. Despite that consequence, Denison, of the Environmental Defense Fund, raised questions with respect to Dourson’s role in the case. TERA is “often chosen on this account that of the perspective and approach they take, which is decidedly pro-industry,” he declared. Dourson said TERA’s relationship with state governments proves the firm is exempt from arbitrary control and neutral—a claim its clients are afterwards able to tout. In 2003, whereas Michael Honeycutt became section manager of the TCEQ’s toxicology department, he began overhauling the outdated method Texas was using to review the toxicity of chemicals released into the conduct and water by polluters. The TCEQ hired TERA in 2005 to survey its methodology. And TERA later endorsed TCEQ values according to the carcinogens arsenic and hexavalent chromium that were abundant looser than those used in California or by the EPA. Texas pointed to TERA’s go over again as a scientific stamp of approval. Working with regard to Big Tobacco When Dourson launched TERA, any of his first projects was to bring into being a database of risk values. Dubbed the International Toxicity Estimates on account of Risk Assessment, or ITER, it was described ~ means of Dourson as an expansion of the EPA’s limited IRIS database. “The ITER database is not intended to refund IRIS but to supplement it through a more extensive data set that has been independently nobleman reviewed,” Dourson said, according to minutes of a 1995 conference of the American Industrial Health Council, a things being so-defunct trade group funded by the tobacco sedulousness. From its inception, TERA’s toil caught the attention of that endeavors, which was in desperate need of picture. rehabilitation. In 1997, TERA received funding from the Center as antidote to Indoor Air Research to study the soundness impacts of secondhand smoke. A 1999 study palaestra Dourson as one of the co-authors. But the center sprang from the tobacco industry’s hard pockets and was later discovered to in a primary manner fund research that played down the movables of secondhand smoke. It was disbanded in 1998 ~ means of a judge who saw it at the same time that a tool to bolster the credibility of tobacco products. Philip Morris revived the assemblage a few years later. Dourson defended his resolution to work with the tobacco industry. “Jesus hung out with prostitutes and charge collectors. He had dinner with them,” he said. “We’re an independent assemblage that does the best science beneficial to all these things. Why should we shut out anyone that needs help?” Dourson eventually stopped operating for the industry because, he said, “they should not be selling cigarettes.” Meanwhile, TERA continued to spread out its ITER database. TERA claims it is the without more website where risk-assessment values from multiple sway agencies are displayed in tables that remit for easy comparison, along with detailed explanations of their methodologies. Scientists speak this feature is useful because agencies ofttimes come up with different toxicity values beneficial to the same chemical based on not the same studies and analytical methods. In the brace decades since its conception, the database has gained some credibility: the National Library of Medicine links to it, fair-minded below the library’s link to the EPA’s IRIS database. But the website in like manner publicizes industry-funded studies. For a ~-simple, TERA will organize a peer-notice critically panel for groups that want their results displayed ~ward ITER. Those clients have included Dow Chemical, Frito-Lay and the International Copper Association. If the study passes TERA’s write a critical notice of, then the value is entered onto ITER next to the government numbers. Dourson describes the device as a public service. “If we don’t bring out those values then the public won’t observe them,” he said. TERA’s critics suppose the database is misleading and creates a interfere of interest, especially since some of the groups that be favored with paid for ITER reviews—including the American Chemistry Council, the chemical industry’s direct trade association —have also supported ITER end monetary or in-kind donations. “The total thing is self-reinforcing,” said Sheldon Krimsky, a Tufts university professor who studies abuse of public trusts in science. “It stinks. I would survey this [ITER] as being full of conflicts and not deserving of being taken seriously.” Of the 28 ITER panels listed forward TERA’s website, half were convened in quest of industry groups such as Dow Chemical. Most of the rest were achieved for Health Canada, the Canadian public health agency. Unlike the industry studies whose funders are not clearly identified ~ward ITER, the Health Canada studies that give currency to TERA’s review are conspicuously labeled since Health Canada products. Dourson says TERA does not put forth every study it is asked to retrace for the database. He said TERA alone considers studies that have been published in companion-reviewed journals. But getting something published in a comrade-reviewed journal doesn’t necessarily validate the be in action, said Adam Finkel, executive director of the University of Pennsylvania’s Penn Program attached Regulation and a former director of health standards programs for the Occupational Safety and Health Administration. He before-mentioned there is a difference between peep reviewers who closely scrutinize the science—EPA’s IRIS studies, towards instance, pass through layers of incorporeal, external and public review—and others who judge, “I laughed, I cried, I ate the popcorn.” Finkel cited Regulatory Toxicology and Pharmacology, put ~ whose editorial board Dourson sits, while an example of a publication that is “surpassingly clubby and provides an outlet according to a certain one-sided part of the appearance.” The journal has published sundry industry-backed studies that minimize the danger of bisphenol-A (BPA), a chemical used in diet packaging that’s been linked to a kind of health problems, including cancer, asthma, inclination disease and reproductive problems. According to PubMed, a seat that tracks scientific publications, 19 of the 33 studies Dourson has co-authored in his move rapidly were published in Regulatory Toxicology and Pharmacology. Krimsky says that’s not necessarily a problem. “But when you be careful a substantial number” of studies ~ the agency of a board member published in his have journal, “you start to awe if the peer review is virtuous a rubber stamp.” In 2002, added than 40 health experts from academia, guidance and environmental groups wrote to the journal’s editors expressing disturb over its apparent conflicts of premium and lack of editorial independence. Among other things, they cited the deed that the journal receives financial livelihood from a number of corporations and exchange in commerce groups, including Dow AgroSciences, Proctor & Gamble and the American Chemistry Council. Tracey Woodruff, a framer EPA scientist who is now a professor at the University of California-San Francisco Medical School, uttered TERA’s actions show it’s “also conflicted.” “I would not be on one of their committees,” she declared. Dourson said the only conflict of advantage that bothers him is a monetary one. “If there’s a monetary conflict of interest, you’re finished,” he said. That, he before-mentioned, is different than having a predisposition, which is unavoidable. No paper trail As TERA’s renown grew, Dourson helped found the Alliance against Risk Assessment in 2007. It’s a loosely organized dispose created by TERA and two other nonprofits: Noblis, a investigation firm, and Concurrent Technologies Corporation, that helped TERA expand ITER back in the 1990’s. Although Dourson says the league is an independent entity, he dominates its lead. He has been a permanent fixture without interrupti~ the alliance’s steering committee because that its inception, just as he is a fixed board member—and president—of TERA. The alliance displays a long list of sponsors ~ward its website, including the American Petroleum Institute, the TCEQ and Georgia Pacific. But there is no paper trail for the group. No corporate filing exists, and TERA’s nonprofit assess tribute upon filings don’t mention the making similar connection. A joint agreement between the three groups that stretch the alliance wouldn’t require a severed filing, said attorney Marcus Owens, a quondam director of the Internal Revenue Service’s tribute-exempt division. But that means “it’s virtually impossible to figure out how much money is involved in the etc.,” Owens said. “It would exist buried in the financial statements.” Tax records pretence founding members Noblis and Concurrent Technologies one and the other earned revenues of approximately $200 the masses in 2012. TERA took in candid over $2 million. One of the alliance’s principally significant projects is a series of conferences it organized succinctly after the alliance was conceived. The purpose of the meetings, according to the relationship, was to expand upon the tools and materials of a 2009 report on jeopardize assessment science from the National Academy of Sciences. Dourson reported the request came from the TCEQ, which has hosted three of the eight conferences at its Austin headquarters. Rudel, the previous alliance steering committee member, said workshop participants did reason about the report’s findings but in like manner spent a lot of time criticizing sections unfavorable to industry. The National Academies’ mention, dubbed the Silver Book, was “a same mobilizing event” in the TERA common, said Woodruff, the UCSF scientist. The alliance’s conferences were “essentially formed to accord to … the things they didn’t like.” Rudel said one the biggest points of debate was the report’s recommendation in the place of evaluating non-carcinogens. The traditional come nearly up held that they all have a threshold—a equivalent below which the chemical is completely sound. But the report said scientists shouldn’t assume the whole of non-carcinogens have thresholds that testament protect everyone, partly because individuals be seized of different reactions to chemical doses. Woodruff and Rudel declared that recommendation could lead to stricter regulations. “That’s the clothes that’s looming that’s absolutely freaking everybody out,” Rudel afore~. Finkel, the Penn professor, attended the principal three alliance conferences but quit since he felt participants were using his credit and viewpoint to help legitimize the clump. Finkel was part of the National Academies team that wrote the Silver Book. The copartnership presents itself as a neutral dispose representing diverse interests, Finkel said. But for the period of his time there, he found that it was overly dubious of government risk-assessment methods in which case assuming “that any ‘data’, in ~ degree matter how half-baked, emerging from unit of their favored private-sector labs or reason-tanks, must be correct.” “After a though, one [starts to] wonder why it for aye comes out that way,” he uttered.

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