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Industry Muscle Targets Federal 'Report on Carcinogens'

August 1st 2013

asbestos hazard

In the 1980s, toxicologist James Huff was a bane of industry’s existence.

A blunt Philadelphian, Huff helped supervise animal tests here at the National Institute of Environment Health Sciences, part of the National Institutes of Health. Mice and rats were dosed with chemicals, and Huff and his colleagues publicized the results when tumors sprouted. People needed to know about “blowout” carcinogens, Huff said. He didn’t care who was upset.

Now, three decades later, Huff cites industry’s growing and “perverse” influence on science. “They’re more clever, more sophisticated,” said Huff, 75, who retired this year but remains a guest researcher at NIEHS. “They spend a lot of time in Congress.”

Increasingly, industry is targeting Huff’s former employer and its parent, the Department of Health and Human Services — in particular, HHS’s Report on Carcinogens. Two lobby groups sued the agency after two widely used chemicals were listed in the report. In a victory for industry, lawmakers mandated additional, ongoing scientific reviews of the document. And, a trade association representing makers of fiber-reinforced plastics claimed credit for a congressional hearing last year that evolved into an open airing of industry grievances.

All this comes while the chemical industry is building muscle: In the midst of a prodigious expansion due to the availability of cheap natural gas, it spent $55.7 million on lobbying in 2012 — twice what it spent 10 years earlier, according to the Center for Responsive Politics.

The push may be having an effect. In June, for instance, two Republican members of the House Committee on Science, Space and Technology sent a letter to the director of the NIH, complaining about a journal article by NIEHS Director Linda Birnbaum.

The article — “When environmental chemicals act like uncontrolled medicine” — was published in the peer-reviewed Trends in Endocrinology & Metabolism. Birnbaum cited striking increases in diseases such as prostate cancer and breast cancer over the past 40 years and concluded, “Clearly we must look to the environment as the primary cause of such increases because the human genome has not changed over the same time period.”

Her conclusion did not sit well with Reps. Paul Broun of Georgia and Larry Bucshon of Indiana. “Some of Dr. Birnbaum’s statements sound less like a presentation of scientific data and more like an opinion,” Broun, who chairs the Science Committee’s Subcommittee on Oversight, and Bucshon, who chairs the Subcommittee on Research, wrote in a June 13 letter to Birnbaum’s boss, NIH Director Francis Collins.

It was unclear, they contended, “whether the article represents Dr. Birnbaum’s personal views or reflects Administration policy,” raising “questions about the NIH commitment to transparency.”

The Republican-controlled Science Committee is facing transparency questions of its own. Critics, including a former member, say the committee has become a surrogate for industries that feel threatened by researchers like Birnbaum, who told the Center for Public Integrity her article was “appropriately cleared” by NIH officials.

“The tenor of the hearings in the last two years has been to attack scientists — particularly environmental scientists like Linda Birnbaum — on behalf of the industries that are affected,” said Brad Miller, a former Democratic congressman from North Carolina who served on the committee for a decade until January 2013. “I think it does affect the agencies’ conduct. They try to do their analyses in a defensive crouch because they are anticipating criticism for everything they do.”

Birnbaum, who oversees the NIEHS’s National Toxicology Program, which has tested nearly 2,900 chemicals for carcinogenicity and other health effects, has become a favorite target. Miller, now with the liberal Center for American Progress, said he suspects Broun and Bucshon wrote their letter “because her scientific work has caused some discomfort” in industry circles.

Broun is a physician and U.S. Senate candidate who has called man-made climate change a “hoax” and characterized evolution and the Big Bang theory of the universe’s early development as “lies straight from the pit of hell.” Bucshon, also a physician, is a self-described “long-term friend of coal.” Since 2010, each has received donations from political action committees for coal, oil and chemical companies. Both declined interview requests from the Center.

In a written statement, Science Committee Chairman Lamar Smith, R-Texas, said the committee “invites a balanced panel of witnesses from across the spectrum” to hearings and encourages “an open, public and full discussion of issues.” Smith has received contributions from oil and chemical company PACs; the money, he said, had no impact on his actions.

‘Show trials’
Miller maintained that a number of committee hearings since the GOP takeover of the House in 2011 have been “show trials” designed to intimidate government scientists and promote pro-business positions.

On April 25, 2012, for example, the Subcommittee on Oversight (then called Investigations and Oversight) and the House Committee on Small Business’s Subcommittee on Healthcare and Technology convened to examine the science behind the Report on Carcinogens, a congressionally mandated document updated every few years by the National Toxicology Program.

The hearing turned into a gripe session for proponents of styrene, a chemical used in automobile and boat parts, rubber carpet backing, disposable cups and other products, that had appeared for the first time in the report the year before. Styrene had been listed as “reasonably anticipated to be a human carcinogen,” based on studies that found excesses of leukemia and lymphoma among workers exposed to the chemical and mouse studies that produced lung tumors. An industry group, the Styrene Information and Research Center, already had sued the Department of Health and Human Services over the listing, and its allies were eager to vent in Room 2318 of the Rayburn House Office Building.

Broun opened the hearing by saying that “concerns have been raised about how the [Report on Carcinogens] is developed and how its findings are communicated.” He called it a “highly influential” document used by regulatory agencies to make policy and cautioned against “arbitrary or capricious” condemnation of chemicals. “When concerns and fear are promoted with little actual risk,” Broun said, “commerce, small businesses and everyday citizens are impacted with no appreciable benefit to their safety.”

Rep. Paul Tonko, D-N.Y., deemed the witness lineup “very disappointing. In theory, we are examining the National Toxicology Program’s 12th Report on Carcinogens. In reality, we are hearing the objections of one industry to the listing of one chemical. There is virtually no balance here, in my opinion, today.”

Birnbaum explained that preparation of the report, which lists 240 substances as either known or probable cancer-causing agents, was a multi-step process that “included expert advisory reviews, independent external peer review and drew upon the scientific expertise” of agencies such as the Centers for Disease Control and Prevention. Public comments were solicited six times, she said. Critics were not persuaded.

A toxicologist with Dow Chemical Co., speaking on behalf of the styrene research group, questioned the scientific rigor of the National Toxicology Program. The vice president of a small manufacturer of custom showers and vanity tops said the listing of styrene “could make it very difficult for us to stay in business.”

The environmental affairs manager of a company that makes ballistic panels for the military said the firm had been receiving “anonymous phone calls saying things like ‘You do know that styrene causes cancer, don’t you?’ ” An official with the Small Business Administration warned that users of styrene faced tort lawsuits, higher insurance costs and more regulations.

Then-Congressman Miller, who’d chaired the Investigations and Oversight subcommittee before Broun took over, reminded his colleagues that “the styrene industry’s lobbyists do take credit for having scheduled this hearing.”

The American Composites Manufacturers Association later reported in its newsletter that it had convinced Congress to hold two hearings and a roundtable discussion on styrene and had “built a record” against the National Toxicology Program. “Unlike the industries that conceded after their product was listed,” the association said, “ACMA continues to work to remove styrene” from the report.

‘Truth in testimony’
“When substances are found to be harmful, we should make every reasonable effort to minimize the public’s exposure,” Rep. Smith wrote to the Center. He noted, however, that witnesses testifying before the Science Committee had seen room for improvement in the Report on Carcinogens, whose classifications “have the potential to be confusing.”

All witnesses sign “truth in testimony” agreements, Smith wrote, in which they disclose “relevant financial information. This agreement includes all information that is required to be disclosed under House Rules.”

Those rules allow wiggle room. A witness is asked, for example, whether he or she has received federal grants or contracts — but not whether they’re a paid consultant for, say, a chemical company. Democrats on the Science Committee tightened the rules to require such disclosure, but Republicans undid the change after they assumed control. Smith explained that the current rules maintain a “fair balance,” allowing the public to view the witness forms online without revealing too much “personal or sensitive financial information.”

Witnesses’ bonds to industry aren’t always obvious. At a May 2011 hearing, for instance, Michael Economides, identified as a professor of chemical and biomolecular engineering at the University of Houston, testified against stricter regulation of the controversial oil and gas drilling technique known as hydraulic fracturing. Under questioning from Miller, Economides said he was paid $1 a year by the university as an adjunct professor but made about $1 million annually from his oil and gas consulting firm.

In a telephone interview, Economides said, “I’m independent. I don’t belong to the oil companies. I just happen to know the technology and I teach it.” His résumé is publicly available, he said: “I don’t have anything to hide.” Other witnesses who presented themselves as independent scientists or testifying on their own behalf turned out to have strong industry ties.

At a hearing in June, Jeffrey Holmstead, head of the Environmental Protection Agency’s air office under George W. Bush and now a partner at Bracewell & Giuliani, a Washington lobbying firm, said he was speaking in his personal capacity when he argued against a tougher EPA standard for ozone, a form of smog generated by industrial operations and motor vehicles. Holmstead’s firm has brought in nearly $24 million in fees from electric utilities and oil and gas companies since he took over its Environmental Strategies Group in 2006, records show.

“I didn’t consult with any clients before preparing my testimony or give anyone a chance to look at it, so it’s not as if I’m representing anyone’s point of view other than my own,” Holmstead said by phone. “I actually think [ozone regulation] is a very important issue, and it kind of trivializes it if you’re just talking about disclosure stuff.”

But Science Committee member Donna Edwards, D-Md., said, “It seems to us that there were instances that people appeared before our committee as independent experts when in fact they were industry lobbyists. We need to know that in advance.”

When Miller was its chairman, it was not uncommon for the Investigations and Oversight subcommittee to go after research and regulatory agencies for doing too little to protect public health, not too much. The Agency for Toxic Substances and Disease Registry, part of the CDC, was skewered at hearings on high levels of formaldehyde in trailers supplied to victims of hurricanes Katrina and Rita by the federal government, and on a cancer cluster linked to tainted well water at the Marine Corps’ Camp Lejeune in North Carolina.

Now, Miller said, hearings are constructed to “attack science as being incomplete, haphazard, half-assed. You’re never going to get a scientist to say, ‘No, we don’t need more research, we’re certain of this result.’ We need to have action on environmental exposures on the basis of the science we have at this point. We’re pretty sure there are chemicals that are doing bad stuff to adults and especially children.”

Tangling with industry
Birnbaum, director of the NIEHS and the National Toxicology Program since 2009, believes industry attacks on public health research have become more strident. She disputes allegations that her agency cherry-picks science to build cases against certain chemicals.

“We are the one federal agency that is not only developing new tests but conducting new tests and evaluating the potential toxicity of a variety of environmental chemicals and other kinds of public health hazards,” Birnbaum said. “Our evaluations are extremely transparent.”

James Huff joined the National Toxicology Program as it was ramping up in 1980 and remains an ardent defender. Huff tangled repeatedly with industry over the branding of chemicals as confirmed or likely carcinogens following animal tests, known as bioassays. NIEHS had inherited the nascent bioassay program from the National Cancer Institute.

“They had a slew of publications that were sitting around,” Huff said of the NCI. “One of the things I was asked to do was scientifically beef up the technical reports that came out from each bioassay on rats and mice. We started knocking them out and presenting them at national meetings.”

Between 800 and 1,000 animals are used for each experiment; they eat, drink, inhale or absorb through the skin the chemical being tested. After two years, the animals that are still alive are killed and their organs examined for tumors.

“There’s nothing that has been as successful as the bioassay” for identifying human carcinogens, Huff said. “The problem is, it’s expensive, and it takes a long time, and then you have to fight industry when it’s one of their chemicals.”

This happened, for instance, with 1,3-butadiene, a chemical used to make synthetic rubber that was tested by the National Toxicology Program in the 1980s. “It was so carcinogenic that there were hardly any animals left after 50 weeks, so we cut the experiment down to 60 weeks instead of 104,” Huff said.

Representatives of the rubber industry asked Huff and his colleagues not to present or publish their results until the industry did its own studies. “We said, ‘Hell no, we’re not waiting,’ ” Huff recalled. “They were just devastated that we were coming out with this stuff.”

At the time, the workplace exposure limit for the chemical was 1,000 parts per million. It was lowered to 1 ppm in 1997, largely “because of our studies,” Huff said. Even that limit may be too high: “We still don’t know at what dose in animals butadiene is not a carcinogen.”

Some industry-backed scientists are dismissive of bioassays, saying tumors in rodents don’t necessarily portend tumors in humans. Huff, whose name appears on some 400 peer-reviewed papers, says industry has become more “formidable” in challenging such tests. “They know more. Government, likewise, seems to be more receptive to their arguments.”

As of August 2011, the American Chemistry Council, a trade association that represents companies such as Dow and ExxonMobil, had 53 panels devoted to chemicals from acetone to vinyl chloride, the council’s CEO and president, Cal Dooley, wrote in responses to questions from Rep. Edwards. The panels spring into action – with research and advocacy – when regulations are proposed or products otherwise come under scrutiny. They and other council divisions spent a combined $45.5 million on research from 2008 to mid-2011, Dooley wrote.

Years ago, Huff said, “You either got funded from the National Academy [of Sciences] or NIH or you didn’t get any money. The whole thing has shifted. There’s been a ton of money coming in from industry.”

This phenomenon carries risks, a 2012 report by the Union of Concerned Scientists, a nonprofit environmental advocacy group, concluded: “When funding their own studies, corporations may terminate or fail to report research with negative findings, tailor study designs to lead to desired outcomes, and overreport positive results. Companies may rely on the names of respected academics to publish corporate-funded research. And they may attack scientists whose research proves inconvenient.”

There is no reason to anticipate a letup. The natural gas drilling boom under way in Texas and other states, made possible by hydraulic fracturing of shale deposits, has prompted expansion plans by a host of chemical companies that use ethane – a natural gas liquid – as a feedstock. In a recent report, the American Chemistry Council said that nearly 100 projects, valued at $71.7 billion, had been announced as of the end of March.

Backlash against carcinogens report
Birnbaum, a toxicologist with more than 600 peer-reviewed publications on her curriculum vitae, spent 19 years with the EPA — “the federal government’s worst offender when it comes to overreaching regulations,” according to Congressman Smith — before coming to NIEHS.

She was sorely tested by the 12th Report on Carcinogens, the 2011 document that listed styrene as “reasonably anticipated” to cause cancer and bumped up formaldehyde — used in adhesives for pressed-wood products and as a preservative in mortuaries and medical laboratories — from “reasonably anticipated” to “known to be a human carcinogen,” mainly on evidence that it can trigger leukemia. Two years earlier, a working group of the International Agency for Research on Cancer, part of the World Health Organization, had found “sufficient evidence” that formaldehyde caused leukemia.

The Report on Carcinogens’ 462-page styrene background document had 551 scientific references; the 512-page formaldehyde background document had 798. “We followed a very detailed process, which had been vetted extensively,” Birnbaum said.

Nonetheless, the report’s publication touched off a burst of activity. In June 2011, the Styrene Information and Research Center sued the Department of Health and Human Services, contending the styrene listing was “contrary to the weight of scientific evidence and opinion” and asking that it be struck from the report. This May, the U.S. District Court for the District of Columbia ruled in HHS’s favor, saying the report’s conclusions were well-documented and decrying the styrene group’s “scattershot approach in attacking [HHS’s] listing decision.”

The styrene research center — whose lobbying expenditures went from zero in 2009 to $570,000 in 2011, records show — did not appeal. Scientific evidence available to the National Toxicology Program while the Report on Carcinogens was under review “supported a conclusion that styrene does not represent a human carcinogen concern at any levels of exposure which the workers or the public might reasonably experience,” the group wrote the Center.

The American Chemistry Council twice sued HHS, seeking to obtain data underlying a federally funded study out of the University of California, Berkeley, linking formaldehyde to leukemia. The study helped inform the listing in the Report on Carcinogens. Dissatisfied with what it received through a Freedom of Information Act request, the chemistry council claimed HHS had violated federal law by refusing to release information. HHS said it had turned over all the pertinent records it could find. This month, the D.C. district court granted an HHS motion for summary judgment dismissing one of the council’s cases; the second is pending.

In a statement to the Center, the council said it is seeking the raw Berkeley data “in order to analyze inconsistencies in the published report and to carefully evaluate the potential implications [of] the authors’ conclusion.” It added, “The federal government is denying open access to data that was funded by the American taxpayer and is preventing a comprehensive analysis of the data through time-consuming and expensive litigation.”

Marianne Engelman Lado, an attorney with the nonprofit environmental law firm Earthjustice, which intervened in the styrene case, suspects another motive: A “fishing expedition” for data that can be reanalyzed to create uncertainty. “They have turned things upside down so that industry science is somehow objective and academic science that is in part funded by the government but is independent is somehow less reliable,” Lado said.

Although industry litigation has had no discernible effect, lawmakers did attach a rider to a 2012 appropriations bill setting aside $1 million for reviews of the styrene and formaldehyde listings by two National Academy of Sciences panels. The results aren’t expected until August 2014.

“I think the whole thing is unnecessary,” Birnbaum said. “That was money that came out of the assistant secretary of health’s budget which, I think, probably could have been better spent.” The aim, Huff said: “Delay the game.”

Jim Morris and Chris Hamby write for The Center for Public Integrity, from where this article is reprinted.


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