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Selected tag(s): Risk assessment

House TSCA reform discussion draft: Major problem #1 – EPA regulatory hoops

By / Published: March 4, 2014

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

Imagine the following scenario under a new TSCA based on the House discussion draft issued last week:  A major consumer products company decides to expand its line of air fresheners with a new peppermint flavor.  After introducing the new product, information surfaces indicating that one of the product’s ingredients that imparts that aroma causes mutations in a standard genetic toxicity test.

Based on the high hazard and exposure potential, EPA designates the chemical as high priority, requires additional data to be generated, and conducts its safety assessment, concluding the chemical is very likely to be a human carcinogen and poses significant risk when inhaled at levels associated with normal use of the air freshener.

EPA’s safety determination concludes the chemical “will result in an unreasonable risk of harm to human health,” and so EPA initiates the requisite rulemaking to restrict use of the chemical.  Under the House discussion draft (section 6(f)(4)), here’s what EPA would have to prove in order to take any regulatory action:

  • its restriction is “proportional” to the risk involved;
  • the restriction “will result in net benefits;”
  • the restriction is “cost-effective” compared to all alternative restrictions;

AND, here’s the real kicker:

  • there are “technically and economically feasible alternatives that materially reduce risk to human health or the environment compared to the use proposed to be prohibited.”

In other words, before it could act, EPA would have to find a safer, ready-off-the-shelf alternative peppermint flavor for the consumer products company to use instead of the human carcinogen.  And all of the burden of proof – of proportionality, net benefits, cost-effectiveness, technical feasibility, economic feasibility and comparative safety – would rest entirely on EPA and none of it on the company that markets the product or makes the chemical for that intended use.

Something just doesn’t smell right, wouldn’t you say?

These provisions of the House discussion draft would take what is arguably the most fatal flaw in current TSCA – EPA’s inability to regulate dangerous chemicals due to an onerous and paralyzing cost-benefit analysis requirement – and actually make it worse.  While the draft would strike TSCA’s requirement that EPA show any restriction it proposes is the “least burdensome,” it would replace it with evidentiary and analytic burdens that are even more onerous and paralyzing.

There’s a far better and fairer way to deal with the scenario I’ve outlined:  Give EPA the authority to grant exemptions for certain uses of an unsafe chemical – but only for uses that are critical or essential.  That would ensure EPA can effectively restrict non-critical or essential uses of dangerous chemicals.

The seeds of this exemption approach are planted in the Senate’s Chemical Safety Improvement Act (in section 6(c)(10)), although there are other major problems with those provisions of CSIA as introduced (happily, considerable progress toward resolving those problems has been made in the ongoing negotiations on CSIA).

Here’s how an exemption process should work:  EPA would have authority to grant exemptions for uses of an unsafe chemical it finds to be critical or essential.  And companies who believe their use of a chemical is critical or essential could seek such an exemption – but the burden would be on them to show there are no safer, viable alternatives.  The exemptions would be time-limited, and renewable if the need for the exemption is demonstrated to remain.  And EPA would have full authority to impose conditions on such uses needed to protect human health and the environment.

But to force EPA – as the House discussion draft would do – to have to find for a company viable, safer alternatives to a dangerous chemical for each and every use of that chemical it proposes to restrict is simply preposterous.

 

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Doublespeak is alive and well in the ACC-backed “SAB Reform Act”

By / Published: December 19, 2013

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

George Orwell would be proud. 

Yesterday a Senate copycat of a House bill called the “EPA Science Advisory Board Reform Act of 2013” was introduced.  The Senate bill has yet to be made publicly available, but that didn’t stop the American Chemistry Council (ACC) from sending out its own release strongly supporting the bill, literally within minutes of the issuance of a press release by the bill’s main sponsors.

Assuming (as stated in the release) that the Senate bill is the same as the House bill, H.R. 1422, no wonder ACC loves this bill: 

  • Tired of having your companies’ scientists and hired consultants excluded from SAB panels because of conflicts of interest?  Write a bill that eliminates such a pesky rule, and then say the bill “eliminates conflicts of interest.”
  • Frustrated by the time limit placed on comments from the army of industry commenters that typically show up at SAB panel meetings?  Bar the setting of any time limit so you can stack the deck, and then say the bill “promotes fairness” and “strengthens public participation.”
  • Unhappy with how many independent academic scientists are seated on SAB panels?  Require not only that panel members be willing to devote their time to review lengthy EPA documents, but that they respond in writing to every public comment received – a massive expansion in the workload placed on panel members, given the flood of industry comments typically provided – and then say the bill “promotes transparency.”
  • Upset with academic scientists on SAB panels that receive government grants not always supporting the industry position?  Claim that they are the ones who have conflicts of interest, single them out for disclosure of their grants and contracts – with no mention of industry consultants – and then say the bill “increases disclosures” related to potential conflicts.  (An earlier version of the bill would actually have set a 10% quota for government-funded scientists on SAB panels; happily that was removed after an outcry.)
  • Want to slow down the pace of EPA risk and hazard assessments?  Require that every single such assessment be sent to SAB for review, exponentially expanding the SAB’s workload and adding months or years to the process of finalizing assessments, and then say the bill merely “enables SAB reviews” of such documents.

Despite its grand claims, the EPA SAB Reform Act is nothing more than a thinly veiled attempt by ACC and its Hill allies to heavily stack the deck in its favor when it comes to independent scientific reviews of EPA work products.

When the House bill was introduced earlier this year, more than a dozen of the country’s premier public health scientists weighed in strongly opposing the bill, as did a group of prominent environmental NGOs.  See those letters for more details.

While the bill clearly parrots the talking points of the chemical industry when it comes to peer review of government chemical assessments, it should be noted that the bill would apply to any and all aspects of SAB’s work, not just that on chemicals.  So scientists in all fields of endeavor relating to protection of health and the environment ought to be concerned.

 

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EDF comments at EPA workshop on applying systematic review methodology to IRIS assessments

By / Published: August 27, 2013

Rachel Shaffer is a research assistant.

Lately, much of the attention of the environmental health community has been focused on Capitol Hill and the Lautenberg-Vitter chemical safety reform bill that would amend the antiquated Toxic Substances Control Act (TSCA). Yet significant – if somewhat esoteric – developments are underway at EPA that will also have major impacts on how the safety of chemicals is assessed.  EPA has been implementing improvements to its Integrated Risk Information System, commonly known as “IRIS.” The purpose of the IRIS program is to evaluate information on the effects of potential exposures to environmental substances and provide health hazard assessments, which are then used to support regulatory decisions across the agency.  And while it isn’t directly affected by TSCA or its reform, IRIS provides both indirect and direct support to the office at EPA that does administer TSCA.  

In other words, what happens in IRIS doesn’t stay in IRIS.

So… what’s IRIS up to? Read More »

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

By / Published: May 6, 2013

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 »

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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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