Selected tags: industry tactics

Stymied at every turn: EPA withdraws two draft TSCA proposals in the face of endless delay at OMB

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

The Environmental Protection Agency (EPA) has withdrawn two draft rules it had developed under authority of the Toxic Substances Control Act (TSCA).  EPA originally sent the proposed rules to the White House for its review way back in 2010 and 2011. 

Despite a clear requirement that White House reviews of draft proposed rules be completed within 90 days, the Office of Information and Regulatory Affairs (OIRA) [which is part of the Office of Management and Budget, OMB] sat on these two draft proposals for 1,213 and 619 days, respectively.  Faced presumably with the reality that OIRA was never going to let EPA even propose the rules for public comment, EPA decided to withdraw them.  Read More »

Posted in EPA, Health Policy, Regulation | Also tagged , , | Comments closed

Why can’t ACC tell the truth about the Safe Chemicals Act?

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

It’s very disheartening to see just how far the American Chemistry Council (ACC) has moved away from anything resembling a good-faith effort to debate and advance meaningful reform of the Toxic Substances Control Act (TSCA).  There’s more than enough in TSCA reform for stakeholders to debate and disagree about without adding distortions and outright falsehoods to the mix, yet ACC seems intent on doing just that.

The latest indication?  An April 16, 2013 post to ACC’s blog titled “A new year, but the same unworkable Safe Chemicals Act.”  The post purports to identify four fatal flaws in the Safe Chemicals Act of 2013, which was introduced on April 10 and is cosponsored by 29 Senators.  The first two utterly ignore or fault the legislation for major changes made to it to address industry concerns, while the latter two once again restate outright falsehoods ACC has made about the Act – claims that ACC knows are false.  Read More »

Posted in Health Policy, Industry Influence, TSCA Reform | Also tagged , , , , , , , | Comments closed

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

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 herewas 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 »

Posted in Health Policy, Health Science | Also tagged , , , , | Comments closed

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

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

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

Posted in Health Policy, Health Science, Industry Influence | Also tagged , , , | Comments closed

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

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 »

Posted in EPA, Health Policy, Health Science, Industry Influence | Also tagged , , , | Comments closed

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

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!

Posted in EPA, Regulation | Also tagged , , , | Comments closed

TERA’s Kids+Chemical Safety website: On non-profits, objectivity and independence

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

My recent post about the new American Chemistry Council (ACC)-sponsored website, Kids + Chemical Safety, engendered some comments that go directly to the issues of scientific objectivity and independence.

The website says “TERA [Toxicology Excellence in Risk Assessment, manager of the site] was founded on the belief that an independent non-profit organization can provide a unique function to protect human health by conducting scientific research and development on risk issues in a transparent and collaborative fashion and communicating the results widely.”  The “non-profit” descriptor – which TERA uses to describe itself no fewer than eight times on the site, including four times on this one page alone – seems intended to convey that TERA provides information that is purely objective and that it operates in a manner that is independent of who pays it to do its work.

It’s critical to recognize that being a non-profit does not conflate to, or somehow confer the right to claim, objectivity or independence.  The National Rifle Association is a non-profit that clearly has strongly held and expressed opinions.  EDF is also a non-profit, but I don’t pretend, as does TERA, that we don’t have a particular perspective and position.

So putting the issue of non-profit status entirely aside, we should judge TERA’s claim that its website provides information that is objective and independent based on its content, and that’s where it becomes quite clear that the information is neither.  Read More »

Posted in Health Policy, Health Science, Industry Influence | Also tagged , , , , | Comments closed

Chemicals R Us: New ACC-sponsored website says chemicals are safe and fun for kids!

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

[See also my more recent post on this topic here.]

I was alerted yesterday to a new website – kidschemicalsafety.org – funded by the American Chemistry Council (ACC) and run by its right-hand “non-profit,” TERA (Toxicology Excellence in Risk Assessment).  The website and an accompanying Facebook page are a wonder to behold, replete with photos of happy kids.  For the most part, I’ll leave it to you to explore.  But here are a few highlights.  Read More »

Posted in Health Policy, Health Science, Industry Influence | Also tagged , , , , | 2 Responses, comments now closed

Scientists push back against a bill that would pervert the whole concept of conflict of interest

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

This week, two letters – one signed by 13 prominent public health scientists and the other signed by the heads of 8 major national environmental organizations – were sent to the House Science Committee voicing strong opposition to H.R. 6564, the EPA Science Advisory Board Reform Act of 2012.

The sponsors of this legislation claim that it is needed to “enhance transparency and limit conflicts of interest” on the Environmental Protection Agency’s (EPA) Science Advisory Board (SAB) and its panels.  In fact, it would do the precise opposite.  Here’s how the scientists’ letter summarizes the impacts that would arise from passage of the bill:   

“This proposed legislation would only serve to reverse progress in bringing the best scientific advice and analysis to EPA.  The consequence would be to deprive EPA of needed scientific advice on the most complex and pressing environmental health problems of our day.” 

Among the most perverse provisions of this bill (and there are many) are two that would turn the very notion of conflict of interest on its head.  One would limit scientists that receive competitive grants through EPA’s extramural research program from serving on the SAB or its panels – claiming that such funding constitutes a conflict of interest.  The scientists’ letter goes directly at that provision:

“The underlying idea that scientists who obtain funding from EPA for any project have conflicts about all EPA matters is baseless and reflects a misunderstanding of who we are as scientists and our role in society.”

Another provision is even more perverse:  It would reverse longstanding conflict-of-interest policy and practice followed by virtually every authoritative scientific body in the world – including the National Academy of Sciences, the International Agency for Research on Cancer and the World Health Organization – by allowing unfettered access of industry representatives with direct conflicts of interest to serve on the SAB and its panels, as long as their conflicts are disclosed.

Who’s behind this radical legislation?  Here’s a hint:  The American Chemistry Council (ACC), which represents the chemical manufacturing industry, couldn’t wait to express its unequivocal support, stating it “cannot overstate the importance of this bill to Americans” in a press release titled “House Science Committee Proposes Common Sense Reform To EPA Scientific Advisory Process:  Proposed Legislation Would Improve Expert Panel Selection, Limit Conflicts of Interest and Enhance Systematic Reviews.”  And ACC’s been singing the bill’s praises all over town ever since (see, e.g., slide 6 of this ACC presentation).  Read More »

Posted in Health Policy, Industry Influence, TSCA Reform | Also tagged , , , | Comments closed
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