EDF Health

A hint of movement in the Super Slo-Mo that is nanoregulation at EPA under TSCA

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

Nearly 4 years ago, EPA sent to the White House Office of Management and Budget (OMB) a pair of draft proposed rules that would require reporting of certain information by makers of nanomaterials.  The proposed rules under the Toxic Substances Control Act (TSCA) seemed by all measures to have fallen into a black nano-hole. 

But earlier this week, a smidgen of movement was discernible on the EPA regulatory tracker entry for this long-dormant activity.  What appears to have happened is that EPA has withdrawn the original proposed rules and resubmitted one of them to OMB.  Dropped, apparently, is the proposed significant new use rule (SNUR), which would have required companies proposing to commercialize a nanomaterial for a new use to first notify EPA so that it could conduct a safety review.  Retained is the other half of the original pair of proposed rules, an information reporting rule under the authority of section 8(a) of TSCA.  While details are not yet available, that proposal would require companies currently making nanomaterials to report basic information to EPA.  Read More »

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Chemical Safety Reform: Will the Center Hold?

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

Copyright © 2014, Environmental Law Institute®, Washington, D.C. www.eli.org
Reprinted by permission from The Environmental Forum®, May/June 2014

Compromise is tough. It can be thankless and unsatisfying, and, by definition, you don’t get everything you want. But it’s the only way reform of the Toxic Substances Control Act will happen. Nearly everyone, from environmentalists to industry honchos, agrees TSCA is badly broken. But start talking about how to fix the problems and you’ll find there are legitimate core principles held by different stakeholders that are difficult to reconcile. Here are just three examples:

New chemicals. The common-sense notion that new chemicals should be shown safe before entering the market, versus the desire not to hinder innovation or U.S. companies’ ability to compete globally by getting chemicals to market quickly;

Preemption. The appeal of a single federal oversight system that does not impede interstate commerce, versus the view that states have the right to act to protect their residents; and

Confidential business information. The right of citizens, consumers, and the market to information on potential risks of chemicals they may use or be exposed to, versus assurance that legitimate trade secrets submitted to regulators will not generally be disclosed.

As an active participant in the past decade’s debate, I’ve seen firsthand how such conflicting principles complicate — politically and substantively — prospects for achieving reform. I’ve also learned that progress comes only when both sides accept they have to give something to get something. Conversely, progress stalls when stakeholders get greedy. The past year has seen both tendencies.

The late Senator Frank Lautenberg (D-NJ) assessed the landscape last year and saw the need for compromise. He took the political risk of working on legislation with Senator David Vitter (R-LA), who had been about to introduce his own legislation. The result was the first-ever bipartisan legislation to reform TSCA, the Chemical Safety Improvement Act.

Sadly, Senator Lautenberg died shortly after CSIA was introduced. But the legislation remains very much alive, and although it was (and is) far from perfect, there has been major progress thanks to the continuing work of Senator Vitter and Senator Tom Udall (D-NM) to address major concerns raised about the bill and strengthen its health protections.

Additional progress is endangered, however, as some players have fallen back to their core principles and hardened their positions. And after holding a promising series of constructive, balanced hearings on TSCA, the House majority floated reform legislation — albeit a discussion draft rather than a bill — that tilts heavily in industry’s favor.

These challenges have led some stakeholders to consider forgoing the present opportunity and either opt to retreat to the status quo or try to forestall action and wait for more political advantage in the future. In my view, this notion of an easier path any time in the foreseeable future is illusory. The conflicting needs of stakeholders are so fundamental, and the political climate so polarized, that counting on them to change appreciably is wishful at best.

The only recourse is to do the hard work of negotiating to forge a legitimate and fair compromise that delivers an efficient and effective chemicals management system. Let me use my earlier three examples to illustrate what common ground looks like:

New chemicals. EPA should make an affirmative determination of safety before market entry, but using a standard that allows prompt review based on the limited information available for a new chemical. Where that information is insufficient, EPA should be able to require more — or impose conditions sufficient to address potential risks even in its absence;

Preemption. States should be able to act to address a chemical’s risks wherever EPA has not, or when they can make the case for going further. Preemption should apply prospectively, and when, but only when, the agency has all the information it needs to make a definitive safety decision and takes final action on a chemical. Requirements that do not directly restrict a chemical’s manufacture or use — such as for reporting, warnings, monitoring or assessment, which do not unduly impede interstate commerce — should remain available to states; and

Confidential business information. Legitimate trade secrets should be protected, but not information on health and environmental effects or general information on a chemical’s use. Identities of chemicals should generally be available once they enter commerce. Up-front substantiation and EPA approval of claims should be required. Claims should generally be time-limited but renewable upon resubstantiation. State and local governments, medical personnel, first responders, and health and environmental officials should have access to confidential business information.

The opportunity before us is apparent: Our best chance to fix an outdated law that serves nobody’s interests. The alternative — sticking with a piecemeal system that undermines consumer confidence and puts our health at risk — is no alternative at all. All it takes to seize this opportunity is to agree that compromise doesn’t have to be a dirty word.

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

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

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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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 »

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EDF comments at EPA’s public stakeholder meeting on its IRIS Program

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

I provide in this post the comments I delivered as a panelist at the Environmental Protection Agency’s (EPA’s) November 13, 2012 Public Stakeholder Meeting on its Integrated Risk Information System (IRIS) program.  EPA describes IRIS as “a human health assessment program that evaluates information on health effects that may result from exposure to environmental contaminants.”

 

The theme of my comments today is the critical need to restore balance to the IRIS program.  In my view, the program’s structure and practice have over time tilted badly toward allowing one set of interests and desirable attributes of chemical assessments to wholly dominate over another, equally critical set.  Let me explain.  Read More »

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