Report on Carcinogens

Don't blame the messenger, calls to save NTP's Report on Carcinogens

cmonforton — Tue, 11 Sep 2012 11:50:33 +0000

Don't blame the messenger, calls to save NTP's Report on Carcinogens

Let's say you're curious to know whether there's evidence that a particular compound is carcinogenic to laboratory animals or to humans. Maybe you're wondering about UV radiation from tanning beds, or wood dust, or the drug tamoxifen. Do you want to rely solely on the opinion of the compound's producer or an industry trade association, or might you like to know the views of a panel of independent scientists?

Hearing from the latter was the vision for the U.S.'s Report on Carcinogens. It is a program put in place in 1978 by Public Law 95-622 with amendments to the Public Health Service Act, and managed by the National Institute for Environmental Health Science's (NIEHS) National Toxicology Program (NTP). Since 1980, twelve issues of the Report on Carcinogens have been published. The current report was about six years in the making and was released in June 2011. It lists 54 substances as "known human carcinogens" ---from asbestos and cyclosporin A, to silica and tobacco smoke --- and about 180 substances classified as "reasonably anticipated to be human carcinogens."

But when you're the maker or user of a compound that is being considered for the report, you might go to great lengths to avoid being listed in it. Daniel Rosenberg at NRDC's Switchboard lays out the chemical industry 's 10-year efforts to shield formaldehyde and styrene from the cancer-causing label. The industry shenanigans caused some delays with the report's release, but when it was published last year both compounds appeared with their respective cancer labels: styrene listed as "reasonably anticipated to be human carcinogen" and formaldehyde classified as a "known human carcinogen." The evidence on the association between formaldehyde exposure and cancer (i.e., nasopharyngeal, sinonasal and lymphohematopoietic) is substantial (here, here, here, here, here, here, here, here, here, here, here.)

With the scientific evidence against them, the chemical industry is now following a tried and true strategy. They "blame the messenger" noted Adam Finkel, ScD, MPP, CIH, Professor of Environmental and Occupational Health at the University of Medicine and Dentistry of New Jersey. And with powerful friends on Capitol Hill, the chemical industry can do more than blame the messenger, they can threatened to defund her.

Representative Denny Rehberg (R-MT), chair of the House Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies, (who is also running for the U.S. Senate) drafted an appropriations rider (here at p.52) prohibiting NTP from using any funds for the ROC until the National Academy of Sciences completes a peer review of the ROC's process and listing criteria for formaldehyde and styrene.

The public health community has taken strong exception to Congressman Rehberg's rider. More than 70 scientists, physicians and other public health advocates sent a letter last week to Members of Congress explaining the importance of the ROC.

"It] is a model for how to summarize the state-of-the-science on chemicals and cancer. As occupational and environmental health scientists, we firmly believe that building scientific consensus in the U.S. about chemical carcinogens is essential for effectively and efficiently protecting the public’s health and worker health. Furthermore, by providing the public with updated scientific consensus evaluations of the potential cancer risks from workplace and environmental contaminants, it informs American businesses wishing to establish scientifically grounded programs to create safer workplaces and safer products."

"...With budget riders like this one, the American Chemistry Council (ACC) is working to delay and ultimately destroy the ROC and other government programs that provide the public with unbiased, authoritative scientific assessments of the hazards of its member company’s products. Honest, hard-working Americans and their families rely on Congress to protect their right to know about health risks from toxic chemicals in their homes, workplaces, schools, and consumer products."

As Richard Denison at Environmental Defense Fund (EDF) notes:

Both formaldehyde and styrene are produced by dozens of companies in the U.S., each in amounts totaling tens of billions of pounds annually – major cash cows for the chemical industry.

That's millions of dollars in profit potentially threatened by a cancer-causing label. The industry can't win on the science evidence, so they'll use their power and influence to blame the messenger and get their friends in the House of Representatives to lead the bandwagon. May wiser heads prevail in the U.S. Senate.

cmonforton Tue, 09/11/2012 - 07:50

Doubt and other products: The National Toxicology Program’s Report on Carcinogens, bad for whose business?

egrossman — Wed, 23 May 2012 12:27:52 +0000

Doubt and other products: The National Toxicology Program’s Report on Carcinogens, bad for whose business?

by Elizabeth Grossman

As it pursues its anti-regulatory agenda, the Republican-led House of Representatives appears to be setting its sights on a non-regulatory program, the National Toxicology Program’s Report on Carcinogens (RoC). The House Republicans’ scrutiny of the RoC coincides with industry objections to the Report’s listing of styrene as a possible carcinogen. It also follows a strategy common to previous debates over chemical regulation – that of sowing doubt about scientific findings in hopes of averting action on a hazardous substance.

For those not familiar with it, the RoC was established by Congress in 1978 as part of the Public Health Service Act, and is prepared by the National Toxicology Program (NTP) and published biennially by the Secretary of Health and Human Services (HHS). It is a cumulative list of substances that have been classified, based on a review of existing scientific studies, as either “known” or “reasonably anticipated to be” human carcinogens to which a significant number of people in the United States are exposed.

As Linda Birnbaum, director of the National Toxicology Program and National Institute of Environmental Health Sciences explained at a Congressional hearing on the RoC last month, the Report is not a regulatory document and does not assess risk, set safety limits, or specify how listed substances may be used. Its information, however, is used by the Environmental Protection Agency, Occupational Safety and Health Administration (OSHA), and other government agencies as well as by businesses, consumers, and non-governmental organizations. OSHA, for instance, uses RoC listing to inform its Hazard Communication standard and to determine information required on safety data sheets.

Styrene lawsuit in response to RoC listing

The 12^th Report on Carcinogens was published in June 2011. Among its newly classified substances was styrene – listed as “reasonably anticipated to be a human carcinogen.” The listing was immediately challenged in a lawsuit from the Styrene Information and Research Center (SIRC), a trade association representing styrene and styrene product manufacturers, and the Dart Container Corporation, which describes itself as the world’s largest manufacturer of foam cups. The lawsuit against HHS, which is ongoing, calls the listing “arbitrary, capricious, an abuse of discretion and not in accordance with the law.” It claims the listing puts some 750,000 U.S. jobs at risk and asks that it be withdrawn. On May 18^th, United Steelworkers, the Environmental Defense Fund (EDF), and occupational health physician Peter Orris filed papers to intervene in the suit on behalf of HHS and to defend the RoC’s styrene listing.

“This case is about the public’s right to have scientifically sound information on the link between styrene exposure and cancer,” said Marianne Engelman Lado, the Earthjustice attorney representing the groups in a press statement.

The RoC based its listing of styrene on what it calls “limited evidence” of carcinogenicity from human studies and “sufficient evidence” from animal studies. Studies of workers exposed to styrene showed increased incidence of lymph system cancers – lymphoma and leukemia – and DNA damage to lymph cells. In animals, styrene exposure caused lung and mammary gland tumors. While there is general population exposure to styrene from products, through food (styrene is fat soluble), air, and drinking water, occupational exposures are the highest and most direct. Workers can be exposed during production of styrene itself, polystyrene and other plastics products, as well as materials and products that combine styrene and fiberglass and what’s called styrene-butadiene rubber.

“Thousands of our members are exposed to styrene on the job,” said Mike Wright, United Steelworkers director of Health, Safety and Environment in a press statement. “They have a right to know the truth – that our government has found that styrene exposures may lead to cancer in humans – and this listing makes it publicly known. It’s time for the chemical industry to stop denying that truth, and instead put its resources into ensuring that styrene and other toxic chemicals are used as safely as possible.”

Complex industry strategies

A look at chemical industry lobbying records shows that considerable resources have been spent on trying to “shape policymaking regarding the classification of styrene.” Since 2010 the styrene industry has spent about $1 million lobbying Congress, federal agencies, and the Obama Administration on styrene health and safety issues. Among the lobbyists’ stated goals was a possible hearing on the health assessment of styrene.

Such a hearing was held on April 25^th, jointly by the House Committee on Science, Space, and Technology Subcommittee on Investigations and Oversight and the Committee on Small Business Subcommittee on Healthcare and Technology. Much of the prepared testimony appeared to be designed to cast doubt on the NTP’s process for preparing the Report on Carcinogens and to show that tagging styrene as a possible carcinogen creates hardships for businesses that use the substance. But what emerged in questioning showed that a market shift prompted by consumer interest in alternative materials is already underway and, for some companies, offers a distinct business opportunity.

John Barker of the Strongwell Corporation, which makes styrene-based building, infrastructure, and military equipment, said the RoC listing has “caused great confusion” for his employees. Their focus “on a matter that should be of no concern,” he said, “will make it harder for employees to give full attention to safety issues that are important.” He said that despite extensive measures Strongwell has taken to ensure the safety of its processes, it had also been compelled to put significant amounts of money into reserves to cover possible liability suits. Further regulation by OSHA, he feared, could bring burdensome compliance costs. Bonnie Webster of Monroe Industries, a small business that produces molded bathroom fixtures, testified similarly, stressing that the liability and insurance costs – and material access issues that a RoC styrene listing might prompt – were already an onerous concern.

In contrast, Ally LaTourelle of Bioamber, Inc., a company that produces biobased polymers, plastics, and other chemical products – including some that can be used instead of styrene – described consumer interest in styrene alternatives as a business opportunity. Market demand created by interest in non-toxic products, she said, has helped spur a nearly 20 percent annual growth rate in “green building products,” from which her company is benefitting.

And both Strongwell and Monroe Industries, it turns out, are also making products from materials other than styrene, some using bio-based resins. While there is no guarantee that bio-based materials are safe, their production (including by a company like Bioamber, working at a multi-million-dollar industrial-scale) suggests that the market is capable of responding to demands for alternatives, whether they come from regulators or consumers.

The future of the RoC

The styrene industry’s lawsuit against the RoC is not unprecedented. Previous RoC listings – for benzene, dioxin, and environmental tobacco smoke, for example – have been challenged, but these suits have all failed, including those that challenged the legal basis of the Report. And public interest groups, including EDF, have been granted intervener status to support HHS in previous suits against the Report. “We strongly support the listing and are concerned about any bad precedent” the industry suit might set,” explained EDF senior scientist Richard Denison.

Dr. Lynn Goldman, Dean of the George Washington University School of Public Health who led the EPA’s Office of Pollution Prevention, Pesticides, and Toxic Substances in the Clinton Administration, pointed out in an interview that the NTP has responded to public concern about and improved the RoC process, and that it continues to do so. She described the RoC as an “extremely important” and “unbiased” source of information. While noting that there have been legitimate concerns raised about the process over the years, what’s happening now is part of a “shoot the messenger strategy,” said Goldman. “People don’t like their substances being listed no matter what.”

“Although the listing of a substance in the RoC does not constitute a regulation or a rulemaking per se, listing determinations often trigger regulatory action by Federal and State agencies, product deselection, and product liability suits,” wrote the American Chemistry Council in its letter to Congress submitted for the April 25 hearing record. But the question regarding product “deselection,” commented David Levine, CEO and co-founder of the American Sustainable Business Council, is this: for whose business is it bad?

Elizabeth Grossman is the author of Chasing Molecules: Poisonous Products, Human Health, and the Promise of Green Chemistry, High Tech Trash: Digital Devices, Hidden Toxics, and Human Health, and other books. Her work has appeared in a variety of publications including Scientific American, Salon, The Washington Post, The Nation, Mother Jones, Grist, and the Huffington Post. Chasing Molecules was chosen by Booklist as one of the Top 10 Science & Technology Books of 2009 and won a 2010 Gold Nautilus Award for investigative journalism.

egrossman Wed, 05/23/2012 - 08:27