Introduction
In September 2010, scientists at the Environmental Protection Agency came to a startling conclusion: Even a small amount of a chemical compound commonly found in tap water may cause cancer.
The compound, hexavalent chromium, gained infamy in the Oscar-winning film Erin Brockovich, based on the David-vs.-Goliath legal duel between desert dwellers in Hinkley, Calif., and Pacific Gas & Electric Co. The film ends in Hollywood fashion, with the corporate polluter paying $333 million to people suffering from illnesses.
But in real life, the drama continues. More than 70 million Americans drink traces of chromium every day, according to the Environmental Working Group, a nonprofit research organization.
And now, more than a decade after the film, EPA scientists cite “clear evidence” that the chemical compound, also known as chromium (VI), can cause cancer. The federal agency was poised to announce its findings in 2011, a step almost certain to trigger stricter drinking-water standards to prevent new cancers and deaths.
The chemical industry’s trade association and chief lobbyist, the American Chemistry Council, urged the EPA to wait for more research, a common practice to delay action on toxic chemicals. However, Vincent Cogliano, the soft-spoken head of EPA’s chemical-assessment program, rebuffed the powerful group, writing in an April 2011 letter that “strong” new research was already available.
Ten months later, the EPA reversed itself, quietly posting a notice on the Internet that it was pushing back the release of its findings for at least four more years. Environmentalists were stunned at the reason: The agency would wait for the results of new studies costing $4 million and paid for by the American Chemistry Council.
The EPA decided to wait at the urging of a panel of scientists chosen to give an unbiased review of the chromium findings. But the EPA doesn’t vet these scientists directly, instead handing the task over to outside contractors. An investigation by the Center for Public Integrity found that several of the panelists had worked on behalf of PG&E to defend the company in the Brockovich lawsuits.
President Obama pledged during his 2008 campaign to halt meddling and interference in government science. The president put restoring integrity to science on his short list of priorities in his first inaugural address, right after fixing the economy and before health care reform. “We’ll restore science to its rightful place,” he said.
The story of chromium (VI), full of twists and turns, offers a case study in how the Obama administration has failed to shield science at the EPA from industry influence.
Companies with a stake in chromium have borrowed from the Big Tobacco playbook, using science to create doubt. Ever since the brassy Brockovich knocked on doors in Hinkley to organize a class-action lawsuit, scientists paid by industry have tried to convince the courts and regulators that chromium (VI) poses no health risk.
Some of those scientists ended up on the panel chosen to review the EPA’s chromium findings, the Center for Public Integrity found:
- Three of the five panelists who urged delay had worked on industry’s behalf in the Hinkley court cases.
- One of those scientists was retained by PG&E in the company’s ongoing chromium cleanup in Hinkley at the same time he was serving on the EPA panel.
- Another scientist who urged the EPA to wait for the American Chemistry Council studies served as a consultant on those studies.
“You don’t have to be a rocket scientist to realize that this is corrupt and unacceptable,” contends Rena Steinzor, a law professor at the University of Maryland and president of the Center for Progressive Reform, a think tank that recently published a report on the chemical industry’s influence.
Those members served on the EPA’s toxic-chemical-assessment program, the Integrated Risk Information System. IRIS, as it is known, is the pure science upon which clean air and water rules are based. But IRIS has become a major bottleneck, delaying new federal and state air and water standards amid industry influence and other factors. Critics say the EPA has only itself to blame.
Since October, EPA Administrator Lisa Jackson has declined interview requests to discuss IRIS or loopholes that open the door for potential conflicts of interest. Yet Jackson is pushing reform before she leaves office this week that would address some of the conflicts unearthed in the Center’s review, and cited by environmental activists.
And recently the EPA decided to move up its timetable to complete its chromium assessment to later this year.
Case study of industry’s muscle
The issue of scientists with industry ties serving on special EPA peer review panels goes beyond chromium. One out of every six scientists appointed to such panels since Obama took office had been a primary author of research articles funded by the American Chemistry Council over the past dozen years.
In all, 11 of the 68 members appointed to EPA panels assessing chemical health hazards were significant authors on studies funded by the ACC, a review of the council’s research database reveals. That number does not capture all scientists backed by industry, just those with work funded by the ACC. The authors of the hexavalent chromium studies, for example, are not included.
One scientist who has served on several EPA panels and co-written more than a dozen ACC-funded studies said that working with industry does not necessarily suggest a conflict.
“Scientists by and large want to get at the truth, so this really becomes more a matter of a perception of a problem than a real problem, in my opinion,” said Frederick J. Miller, an independent consultant who once worked at the Hamner Institutes for Health Sciences, a North Carolina research institute formed in the 1970s by leaders from 11 major chemical companies.
“The people that serve on these panels … know if somebody is trying to make an argument that doesn’t hold water,” said Miller, who began his career in government.
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However, studies have shown that when industry pays for research, it may influence the outcome. A 1998 analysis of more than 100 articles published on secondhand smoke reported that 37 percent found no health risk. At least 74 percent of the articles exonerating cigarette smoke were written by scientists with ties to the tobacco industry.
The American Chemistry Council has a stake in the outcome of research. Lobby disclosure forms from 2011 reveal that the ACC lobbied the EPA on its assessments of three highly controversial chemicals: dioxin, formaldehyde and chromium (VI). The group boasts on its Web site that “in 2012, we helped defeat or amend 281 chemical regulation and product ban proposals.”
The ACC, whose members such as ExxonMobil, Dow Chemical, Merck and Procter & Gamble are a who’s who of the Fortune 500, is one of the freest-spending lobby groups on Capitol Hill. In 2011, it laid out $12.6 million on lobbying, four times the amount spent by the National Rifle Association.
David Fischer, a senior director at the ACC, defended the group’s research program. “We feel we have an obligation to step up and fund studies to assist the agency — whether it’s EPA or others — to answer questions that might be posed about chemicals that we manufacture,” he said.
Asked if any of the ACC’s studies had ever shown that a chemical was more toxic than previously thought, Fischer replied, “I’m not aware of one right at this moment.”
The ACC said it was not involved in selecting the peer reviewers studying chromium (VI). “EPA’s peer reviewers were selected by EPA. They were vetted in the normal peer review process from EPA and we from the ACC do not have any direct links to these people,” said Ann Mason, the ACC scientist who commissioned the group’s new studies on chromium.
However, few scientists in the world specialize in chromium, a compound used to add color to paints, make stainless steel, add finish to chrome and inhibit rust. During its lawsuits, PG&E hired several of these scientists as expert witnesses; some say the debate over the compound’s toxicity caused lasting splits in the tight-knit scientific world.
One of PG&E’s key experts was Steven Patierno, a former professor of pharmacology at the George Washington University School of Medicine and Health Sciences who had conducted numerous studies on the metal. Patierno, now the deputy director of the Duke Cancer Institute, has been an expert defense witness in seven chromium lawsuits. He hasn’t wavered in his view that drinking low doses of chromium (VI) does not cause cancer.
By early 2011, Patierno was selected for the peer review panel critiquing the EPA’s chromium (VI) findings. At a public meeting on May 12, 2011, he revealed a potential conflict of interest. There’s no recording or transcript of the meeting. Nothing in the EPA’s public record reveals the conflict. Two EPA officials who were there say they cannot recall what Patierno said. Patierno himself declined requests for an interview.
Jennifer Sass, a senior scientist at the nonprofit Natural Resources Defense Council, took notes at the meeting and said that Patierno revealed he was an investigator — though not a principal investigator — on the American Chemistry Council studies.
The ACC’s Mason disputes that Patierno was involved. But Travis O’Brien, one of the principal investigators on the studies and a former colleague of Patierno’s at George Washington University, told the Center for Public Integrity that Patierno was a consultant on the research.
Max Costa, now a professor at New York University’s medical school, knows Patierno well. When Costa taught at the University of Texas Medical School, Patierno worked in his laboratory. The two published research together. Costa said they became rivals when they took opposite sides in the PG&E lawsuit.
He argues that Patierno’s opinions are not credible because he works for the chrome industry. “He’s been a paid a large amount of money by them, and he’s totally biased because of that.”
Patierno levels the same charge against Costa, attacking his conclusions in a lawsuit as “unsubstantiated” and “severely flawed.” Patierno criticized the EPA for even citing Costa’s papers among hundreds of others in its report. In his peer review comments, Patierno said two of Costa’s articles should not be taken seriously because “they were written and published at a time when the senior author was actively engaged as an expert witness for the plaintiffs in high-profile hexavalent chromium lawsuits.”
Patierno was an expert witness for PG&E in the same lawsuits. When he was asked in a 2006 lawsuit if he discloses his expert-witness work for industry when submitting articles on chromium (VI), he answered no. Patierno said his articles were based on laboratory studies that were not relevant to his legal work.
Costa was originally listed as a candidate for the EPA peer review panel, according to documents obtained by the Center through a Freedom of Information Act (FOIA) request. Costa says he disclosed his work in the PG&E lawsuit but doesn’t know if that work disqualified him. An EPA official said privately said that Costa’s work as an expert witness may have kept him off the panel.
Industry ties and EPA panel
Patierno was not the only defense litigation expert who served on the EPA’s IRIS panel. Two others were John P. Wise Sr., a toxicology professor at the University of Southern Maine, and Joshua Hamilton, a chief academic and scientific officer at the Marine Biological Laboratory in Woods Hole, Mass., which is affiliated with Brown University.
Wise, who worked in Patierno’s laboratory as a graduate student, said that in 1997 he worked for a consulting firm and was assigned to do research for an industry client in the Hinkley lawsuit – but that he has not accepted industry money in the past 15 years. Wise added that he was never told the identity of the client and that he does not believe “such limited contact so long ago” influenced his opinion.
Hamilton was a defense expert in a PG&E chromium lawsuit that settled in 2006 and worked for the company as a consultant again starting in 2009, according to PG&E. PG&E acknowledged that it hired Hamilton in May 2011 — the same month the EPA panel met — to consult on the ongoing chromium cleanup in Hinkley. PG&E said it paid him $110,000.
Hamilton appeared before a California Regional Water Quality Control Board on June 8, 2011, to speak on behalf of PG&E about its cleanup of Hinkley. The EPA peer review panel issued its final comments one month later, on July 6, 2011.
Hamilton’s consulting work included criticism of the California EPA’s own scientific assessment of chromium (VI), which was nearly identical to the EPA’s.
In an eight-page statement to the water board dated July 9, 2011, Hamilton wrote that the state agency’s findings did not represent “established science.” He described California’s regulations as “overly protective.”
The PG&E director in charge of the Hinkley cleanup, Sheryl Bilbrey, said Hamilton’s work should not have affected his objectivity. “PG&E expects all of our experts to give us unbiased advice,” she said. “So we would never ask anyone to change their scientific opinion to fit something that we would want.”
Asked whether it was appropriate for an EPA peer reviewer to be working simultaneously for PG&E, the ACC’s Fischer said, “That sounds like a conflict of interest to me. Generally, the way you get around it is you just — you don’t appoint that particular scientist to that particular panel.”
It was not the first time Hamilton had been paid a substantial sum by PG&E. In 2001, Hamilton said he was surprised to get a $100,000 check in the mail before doing any work as an expert witness. According to his deposition, Hamilton talked to PG&E’s lawyers about the check and learned that it was on top of his hourly fee. PG&E ultimately paid Hamilton nearly $300,000 for his work on the lawsuit.
(Hamilton has since disclosed that he repaid the $100,000; see editor’s note below)
“That’s completely outrageous,” said Francesca Grifo, director of scientific integrity at the nonprofit Union of Concerned Scientists. “I don’t know how anybody could stand up logically and say I got $100,000 but it didn’t affect how I handled this.”
Hamilton declined interview requests.
EPA farms screening to consultants
Working for a chemical company appears to violate the EPA’s guidelines on conflicts of interest. The EPA’s Peer Review Handbook says peer reviewers should appear to be impartial, defined as not having anything that “may cause a reasonable person with knowledge of the relevant facts to question the expert’s ability to carry out official duties without bias or influence.”
The handbook offers, as an example of a conflict, a scientist paid to be an expert witness for a chemical company in a class-action lawsuit.
Yet, the EPA doesn’t ask scientists if they’ve worked as expert witnesses or have taken money from industry. Instead, it turns that job over to private companies, which handle conflict-of-interest reviews in secret. All of the information the vendors collect, including financial disclosure forms, is “considered private and non-disclosable to EPA or outside entities except as required by law,” the EPA policy says.
The contractor examines candidates’ published work, and prospective panelists fill out a questionnaire detailing potential conflicts. Once the panel is picked, the contractor certifies to the EPA that “no unresolved actual or potential conflict of interest issues” remain.
What’s more, the ethics guidelines are not binding on contractors, and the EPA handbook says the agency should not override decisions on conflicts of interest. “EPA should not attempt to make any changes in the contractor’s conclusions as this would compromise the independence of the peer review conducted by the contractor,” the handbook says.
The EPA said it set the system up this way to ensure impartiality. But, the Center found, this structure helps shield the very conflicts the agency aims to avoid.
A year ago, the Center sought information on the screening of IRIS panelists through a FOIA request. The EPA withheld most documents, including emails between the vendors and agency.
Officials at Eastern Research Group Inc., the Massachusetts firm that vetted the peer reviewers on the chromium (VI) panel, did not return emails and phone calls. An official at another company handling peer reviews, Versar Inc., said he was prohibited by EPA from talking.
The EPA’s administrator, Jackson, and its chemical-assessment officials declined requests for on-the-record interviews. But an EPA official acknowledged privately that the agency was not fully aware of the chromium (VI) peer reviewers’ ties to PG&E. The official defended the use of private vendors, contending that if the EPA chose peer reviewers, it could pick scientists it knew would be friendly.
However, the EPA routinely selects scientists for other advisory panels. Critics said it’s not clear how checking financial disclosure forms would taint the process. The Peer Review Handbook does note that checking disclosure forms would activate the Federal Advisory Committee Act, a law meant to make panels more open.
“It’s bizarre,” Grifo said of the EPA’s secretive screening process. “At its core it’s supposed to increase the public trust in the system. If it looks like the whole system is rigged to begin with, then why should a citizen trust it?”
The EPA said it was working to reduce the potential for conflicts. “We are exploring the best ways to provide for public review of contract-managed peer review panels and ensure that contractors are held accountable for their assessment of any conflicts of interest,” the agency said in a statement.
The ‘pure science’ bottleneck
Some 700 new chemicals hit the market each year, adding to the tens of thousands already in use. Yet the EPA has assessed only 557 chemicals since the IRIS program began in 1985. A typical review takes six to eight years, sometimes much longer. It took 27 years for the agency to issue a partial assessment of dioxin, a byproduct of plastics manufacturing and burning.
The Government Accountability Office (GAO) concluded in 2008 that the IRIS program was so bogged down that it was in danger of becoming obsolete.
In 2009, EPA Administrator Jackson made bold promises within her first weeks in office to fix the program. She pledged to finish many more assessments and to try to complete each one within two years. Since May 2009, the EPA said it completed 24 IRIS assessments, “double the number” completed in the same time period prior to May 2009.
Yet its overall progress remains slow, and in the past two years, the program produced as few assessments as ever. Last year, the EPA planned to complete 40 assessments. It finished three.
The reasons for the logjam are complex. But it has become common for industry and its allies inside the federal government to push for delay. “Even a single delay can have far-reaching, time-consuming consequences, in some cases requiring that the assessment process essentially start over,” the GAO reported.
In the case of chromium (VI), evidence shows that industry worked closely with the EPA as the agency conducted its assessment. On Oct. 8, 2009, a scientist at a law firm representing chemical companies complained in an email that the EPA was pushing ahead on its assessments without waiting for studies to address “gaps” in the science.
“EPA moved Chrom VI up by about two years after ‘we’ entered into a process of planning research with them to address gaps,” wrote Richard Canady, a former scientist at the White House’s Office of Management and Budget (OMB), who was then working at the private law firm of McKenna, Long & Aldridge. “I’d like to make a case for EPA planning ahead in cooperation with industry.”
Canady’s email was sent to Nancy Beck, a toxicologist at OMB who reviewed the EPA’s findings. Beck referred Canady to an American Chemistry Council official for help in gathering data. A 2009 investigation by a subcommittee of the House Science and Technology Committee criticized Beck for improperly interfering with IRIS assessments during the George W. Bush administration. Beck now works for the ACC. She did not return a call last week seeking comment; an ACC spokesman said Tuesday he would seek her perspective.
In a recent interview, Canady said he could not recall the precise details from his email and declined to reveal clients for which he was working. But Canady said he thought the process of planning research with the EPA “wasn’t that formal.” Instead, industry scientists would call EPA scientists to find out what new data would help them in their chromium (VI) assessment, he said.
His 2009 email also said, “Peter made a point to me the other day about how boron and methylene chloride were good examples of working together on developing data ahead of assessments in ways that influenced the outcome.”
Canady said this was a reference to Peter Preuss, then the director of the EPA’s National Center for Environmental Assessment, which oversees IRIS.
The EPA originally planned to issue its chromium (VI) assessment last summer, giving the ACC time to finish its new studies. However, under Jackson’s imperative to quicken assessments, the EPA moved up its timeline by six to nine months.
When the EPA’s Cogliano rebuffed the ACC’s request for a delay, the trade association turned its attention to the peer review panel.
Critics say the industry uses comments on chemicals that are under review to overwhelm the agency.
“There’s a very elaborate process that involves multiple opportunities for industry to pick away and blast away and confuse and overload the staff of IRIS, and the IRIS staff reacts by trying to address each and every one of industry’s concerns,” said law professor Steinzor.
“The chemical industry has made IRIS its leading target, one of its leading targets, for spoil in the current age of greed,” Steinzor said
Of the 49 public comments submitted to the EPA on chromium before the peer-review panel met, the American Chemistry Council and its research partners authored 29 of them, totaling 1,661 pages. In addition, 10 other comments totaling 137 pages came from industry urging the EPA to wait for the ACC studies.
As the EPA stood poised to announce potential new safeguards for chromium (VI), the ACC had hired a scientific consulting firm, ToxStrategies, to manage the $4 million studies of mice and rats given the chemical for 90 days.
The panel met May 12, 2011, at a Hilton hotel near Reagan National Airport. Patierno was highly critical of the EPA’s findings and suggested the agency “absolutely consider the extensive new data being provided.” Hamilton and Wise agreed.
In a recent interview, Wise said he wasn’t entirely familiar with ToxStrategies’ findings, which hadn’t yet been published. But he assumed the delay would be short, only a few months. The EPA initially said the delay would take four years. Later, the agency said the assessment would be done this year.
Anatoly Zhitkovich, a professor at Brown University who chaired the EPA peer review panel, was upset with the results and wrote his own review published in the journal Chemical Research in Toxicology, according to Costa, a close colleague. Zhitkovich declined an interview request, but his article supported the findings of the EPA.
In lobbying for delay, the American Chemistry Council quietly enlisted the help of a small office within the U.S. Small Business Administration.
SBA Chief Counsel for Advocacy Winslow Sargeant, an electrical engineer by training, submitted a comment to the EPA on Oct. 5, 2011, challenging its scientific conclusions and urging it to delay its chromium assessment pending completion of the ACC studies. Winslow cited the peer review comments from Hamilton and Wise to support his argument.
But emails obtained through FOIA by the advocacy group Center for Effective Government revealed that the ACC helped shape the SBA letter. An ACC lobbyist, Randy Schumacher, sent an email to Sargeant’s office on June 28, 2011, asking for its help.
“Administrator Jackson calling upon her to stop the Cr6 risk assessment process to do exactly as EPA’s peer reviewers deemed advisable,” Schumacher wrote. “Since it appears EPA needs to hear from more constituents for it to listen to its own peer review team, would SBA be willing to send a letter to Ms. Jackson to weigh in on this matter?”
Later emails from Schumacher suggested editing changes to Sargeant’s letter. The SBA official has not responded to interview requests.
Frustration prompts reform push
Now the EPA is in the process of revamping its IRIS program once more. Cogliano has proposed releasing the names of prospective peer reviewers in advance, giving the public an opportunity to explore conflicts. “This will improve transparency in the peer review process,” the EPA said in a statement. The changes could be formally announced this week, as Jackson departs.
The ACC’s Fischer says he’s in favor of a conflict-of-interest policy that allows industry to participate on peer review panels. “Bias in and of itself should not necessarily disqualify a particular scientist from serving on the panel,” he said. “Industry perspective is a bias but so [is] every other perspective.”
The EPA is also weighing whether to set “stopping points” for new research, a deadline after which no additional studies would be considered. Kenneth Olden, a senior EPA official who oversees IRIS, has proposed announcing assessments two years in advance, giving industry time to complete new studies.
Such proposals drew criticism at an EPA meeting in November, with an environmental group’s scientist stating bluntly that industry seeks delays because it wants IRIS to fail. His comments drew faint gasps from a conference room filled almost entirely with industry consultants.
“The practice of waiting for one more study to be completed, as has happened repeatedly under IRIS – especially when that study is to be conducted by an entity with a vested financial interest in tilting the outcome – simply must stop,” said the scientist, Richard Denison, with the nonprofit Environmental Defense Fund. “Simply put, a decision delayed is health protection denied.”
This story has been clarified to reflect that, as an employee of a consulting firm, John P. Wise Sr. worked for an industry client in the PG&E lawsuit but that he was never told the identity of the client. After the story was published, Joshua Hamilton provided proof that he repaid a $100,000 check from PG&E more than three years after he received it. Hamilton now says he was confused about the July 2001 check at the time he was deposed in August 2002. A 2001 letter he provided from PG&E that came with the check says it was prompted by the company’s Chapter 11 reorganization and was meant as “security for additional work you may be asked to perform on this matter.” The letter says that Hamilton could keep the full amount of the check until his final invoice, but he was expected to repay the $100,000 when his work was done.
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