EDF Health

EDF comments at National Academy of Sciences workshop on “weight of evidence” in chemical assessments

By / Published: March 29, 2013

Richard Denison, Ph.D., is a Senior Scientist.

This week I attended a workshop sponsored by the National Academy of Sciences’ Committee to Review the IRIS Process.  This committee was established in response to a rider attached to an “omnibus” spending bill passed by Congress in late 2011.  The committee’s charge is to “assess the scientific, technical, and process changes being implemented by the U.S. Environmental Protection Agency (EPA) for its Integrated Risk Information System (IRIS).”

EPA describes IRIS as “a human health assessment program that evaluates information on health effects that may result from exposure to environmental contaminants.”  The key outputs of IRIS assessments are one or more so-called “risk values,” quantitative measures of an “acceptable” level of exposure to the chemical for each cancer and non-cancer health effect associated with the chemical.  IRIS risk values are in turn used by regulators to set everything from cleanup standards at Superfund sites to limits in industrial facilities’ water discharge permits.

This week’s workshop – a detailed agenda is available here – was intended to provide expert input to the committee to inform its review of IRIS.  It focused on the complex and controversial issue known as “weight of evidence” (WOE) evaluation.  Here WOE refers to how EPA – in conducting an IRIS assessment of a particular chemical – selects studies, evaluates their quality, and assesses and integrates their findings, as well as how it communicates the results.  At issue in particular in a WOE evaluation is how the assessor determines the relative importance – or weight – to be given to each study.

One of the many issues that came up in the discussion of WOE is how to identify and assess the “risk of bias” in individual studies – a concept borrowed from the evaluation of the reliability of clinical trials used in drug evaluations.  (See this Powerpoint presentation by one of the committee’s members, Dr. Lisa Bero, which provides a nice overview of risk of bias in that setting).  Evaluating a study’s risk of bias is critical for assessing its quality and in turn the weight it should be given, because bias in studies can result in significant under- or overestimates of the effects being observed. 

One type of bias is so-called “funder bias.”  Dr. Bero and other researchers have documented through extensive empirical research that there is a significantly increased likelihood that a study paid for by a drug manufacturer will overstate the efficacy or understate the side effects of a drug.  As to studies of environmental chemicals, at the workshop and more generally, the chemical industry has pointed to adherence to Good Laboratory Practice (GLP) standards as a sufficient antidote to bias, including funder bias, a notion that has been heartily disputed by others.

But enough background.  My intent here is not to fully describe the workshop discussions, but rather to provide the comments I presented during the public comment period at the end of the meeting.  My comments addressed the issue of funder bias and also sought to urge the committee not to dive so deeply into the weeds in reviewing and proposing enhancements to EPA’s IRIS process that it loses sight of the need for a workable IRIS process that is able to provide in a timely manner information so critical to ensuring public health protection.

Read More »

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The chemical industry says formaldehyde and styrene don’t cause cancer. Only one of 52 scientists agree.

By / Published: March 26, 2013

Richard Denison, Ph.D., is a Senior Scientist.

Last week, the National Academy of Sciences (NAS) held a joint meeting of its two panels that are charged with reviewing the listings of formaldehyde and styrene as carcinogens in the 12th Report on Carcinogens, which was released in June 2011.

The 12th Report on Carcinogens (RoC) is the latest edition of a Congressionally mandated report developed by the National Toxicology Program (NTP).  It upgraded formaldehyde to the status of “known to be a human carcinogen,” and for the first time listed styrene as “reasonably anticipated to be a human carcinogen.”  That put the chemical industry into a real tizzy, what with the threat these listings pose to its profits from the huge volumes of these cash cows sold each year, not to mention the huge potential liability it faces.

Never one to go down lightly, the American Chemistry Council (ACC) has launched an all-out assault on the NTP and the RoC.  It is waging battle not only with the executive branch, but also in the courts and in Congress.  In late 2011, it managed to get its allies in Congress to slip into the Consolidated Appropriations Act of 2012, without any debate, a rider that mandated the NAS reviews of the formaldehyde and styrene listings in the 12th RoC that are now underway.

ACC also pushed legislation in the last Congress to shut down all funding for the RoC until the reviews are completed; failing on that front, earlier this month it demanded that NTP cease all work on the next (13th) edition of the RoC.  (For more background, see previous blog posts by EDF and NRDC.)

Lost in all this kerfluffle, however, are these salient facts:

  • The formaldehyde and styrene listings are the outcome of one of the most extensive scientific assessment processes on the planet, entailing reviews by four separate groups of expert scientists for each chemical.
  • ACC as well as the public had at least three separate formal opportunities for providing input to these expert bodies.
  • Of a total of 52 votes cast by these scientific panels on the NTP’s recommended listings, 51 of those votes supported the recommendations and only one opposed them. Read More »
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“Toxic Clout” shines a much-needed light on the chemical industry’s undue influence over toxic chemical decisions

By / Published: March 25, 2013

Rachel Shaffer is a research assistant.

Remember the 2000 hit film, Erin Brockovich?  It was the Hollywood version of a real-life investigation into the contamination of groundwater in Hinkley, California with a known human carcinogen called hexavalent chromium (or hexchrome for short).  

Well, hexchrome is back on (a slightly smaller) screen, this time featured in a two-part series by the Center for Public Integrity (CPI) and PBS NewsHour.

The series, which aired on public TV stations earlier this month, highlights the continuing problem of hexchrome contamination around the country, including the still-unresolved situation in Hinkley.  Some 70 million Americans are exposed to this carcinogen through the water they drink. 

But the program also dives into another, even more concerning problem:  Years of delay in finalizing EPA’s risk assessment for the toxic metal, a prerequisite to any effective regulation.  Why the delay? Unfortunately, it’s an all-too-familiar story:  the chemical industry is stalling the process.  

And what are the consequences?  As EDF’s Senior Scientist Dr. Richard Denison says in the series:  “Decisions delayed are health protections denied.”  The chromium standard for drinking water has not been updated since 1991 and does not reflect recent scientific findings indicating that the standard needs to be significantly lowered to protect public health.

Check out the CPI/PBS segments (links below) and the related articles in CPI’s Toxic Clout series, which is part of an ongoing investigation of excessive industry influence in science and policy.

                Part 1: Science for Sale

                Part 2: Decision Delayed on Dangerous Chemical in Drinking Water

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A mission corrupted: Your tax dollars pay for ACC to coach big industry on how to undercut EPA’s IRIS program

By / Published: March 5, 2013

Richard Denison, Ph.D., is a Senior Scientist.

On February 22, the Advocacy Office of the Small Business Administration, an agency of the Federal Government, held a meeting without any public notice and from which the press was barred.  And while the office’s mission is supposed to be to provide “an independent voice for small business within the federal government,” many if not most of the attendees were from large companies and the trade associations and Washington lobbyists that represent their interests.

This meeting was the latest in a long and continuing series of so-called “environmental roundtables” that serve as a basis for the SBA’s Advocacy Office to weigh in against environmental or workplace regulations that big business opposes.   

There are no records from these meetings that are made publicly available.  Agendas and attendee lists are not disclosed, though I was able to obtain an agenda for this particular meeting at the last minute.  I noted with interest that the first half of the meeting focused on the US Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS) program, which provides health assessments of chemicals used by public health and environmental officials around the world. 

The key draw in this meeting:  a senior official from the American Chemistry Council (ACC), whose dominant members are huge global chemical companies like ExxonMobil, BASF, Dow and DuPont – in short, Big Chem.   The ACC official spent a full hour coaching representatives of Big Chem and other global mining companies and automobile corporations like GM in how to pick apart and challenge recent documents developed by the IRIS program.  IRIS has become a focal point of the chemical industry’s multi-front attack on independent government science.  Here is the deck of Powerpoint slides used by the ACC representative and the other industry speaker.  Read More »

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Prevention as cure: Confronting the environmental contributions to breast cancer

By Sarah Vogel / Published: February 19, 2013

Sarah Vogel, Ph.D., is Managing Director of EDF’s Health Program.

Breast cancer is a personal issue for too many of us.  For six years I have watched the disease overtake a very dear friend’s life.  First diagnosed at 32, she underwent radical treatments— surgeries, radiation and chemo— and three years later faced metastatic breast cancer that is now ravaging her body. 

She is one of the three million women in the U.S. currently facing, or who have been treated for, for breast cancer.  She is also one of a growing number of women under 50 getting the disease with no family history of breast cancer. 

Many women today live longer with or after the disease due to remarkable advancements in medicine, but treatment is not a path anyone would choose.  It takes a heavy emotional and physical toll, and often comes with serious impacts on a women’s life, such as the loss of fertility and the risk of reoccurrence.  Medical costs for treatment of breast cancer totaled $17.35 billion in 2012. And even with advances in treatment, in 2012, more than 40,000 women died from the disease.  

The question every woman must ask is: “What can I do to prevent the disease for myself or my daughter?” Read More »

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6 years in the making: A new and improved snapshot of U.S. chemical manufacture

By / Published: February 11, 2013

Richard Denison, Ph.D., is a Senior Scientist.   Alissa Sasso is a Chemicals Policy Fellow.

Well, it’s finally hit the street:  Today, the Environmental Protection Agency (EPA) released information on the manufacture and use of nearly 7,700 industrial chemicals in 2011.  The data were collected last year under a revamped Chemical Data Reporting (CDR) program, and is the first update of such information since way back in 2005, the year of Hurricane Katrina and Star Wars Episode III.

In releasing the data, EPA Administrator Lisa Jackson noted:  “The CDR data also highlight the clear need for TSCA reform. Updating this critical law will ensure that EPA has access to the tools and resources it needs to quickly and effectively assess potentially harmful chemicals, and safeguard the health of families across the country.”

Getting even to this point has been a long and bumpy road.  Just getting from the proposed to a final CDR rule took over 16 months, with EPA having to endure not one but two nearly six-month regulatory reviews by the Office of Management and Budget and the chemical industry’s efforts to delay and dilute the rule.  It then took another year for EPA to collect the data, in no small part thanks to repeated efforts by the chemical industry and its allies in Congress to further delay the program.

Finally, it’s taken EPA six more months to compile and process the data in preparation for today’s release – though that’s a decided improvement over the 21 months it took EPA to release the data collected in the last cycle (the faster pace due in part to a requirement this time around for electronic reporting, a feature the chemical industry and its Congressional allies opposed).

So what do the new data reveal?  EPA has provided some nice summary materials, which we won’t duplicate here.  See especially the table on this page.  We’ll have more to say on this as we further analyze the data, but here are a few important things to note:

  • While 7,674 chemicals were publicly reported, these are limited to those being produced in or imported into the US in 2011 at volumes above the reporting threshold of 25,000 pounds per year per site.
    • The count excludes the likely much larger number of chemicals produced or imported at volumes below the reporting threshold, as well as the many chemicals exempt from reporting, such as most polymers.
  • Nearly 33,000 “records” have been made available by EPA.  Each record represents a single chemical reported by a single site of a company producing or importing that chemical.
    • In contrast to EPA’s reporting in the last cycle, a record for every single chemical-single site combination has been provided even if the information provided in the record is confidential business information (CBI).  In this way, the extent and nature of CBI claims is far clearer than was the case in the last cycle.
  • Extent of CBI claims:  Of all of the reported elements in these records that could potentially have been claimed CBI, about 16% were so claimed.  But that percentage varied a lot among the elements.
    • For 624 records (about 2%), the chemical identity was not provided and instead replaced with a unique identifier called an accession number.  These are new chemicals that are listed on the confidential portion of the TSCA Inventory, which are the only chemicals for which EPA allows chemical identity to be claimed CBI.
    • For 3,420 records (10.4%), the company claimed its identity to be CBI.
    • For 9,686 records (29.4%), the company claimed its domestically manufactured production volume to be CBI.
    • For 10,351 records (31.5%), the company claimed its exported volume to be CBI.

More to come, so stay tuned!

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