EDF Health

Regulating nanomaterials to life, not death

By / Published: January 28, 2011

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

As we enter a new year and legislative season, we face a changed political climate where the thought of new regulation is anything but de rigueur.  I will argue in this post that a little regulation would have done – and still could do – the world of nanotechnology a world of good.

Come again?

Back when the debate over nanomaterial safety really got started, which I would place ‘round about 2004 (or was that just my first involvement in it?), there seemed to be broad agreement on first-order needs to ensure that nanotechnology would survive and thrive.  The aim was to “get it right the first time,” by identifying and addressing potential risks up front and in the open.  That meant we needed to adequately fund and direct risk research.  We also needed to make sure adequate regulatory authority existed to address potential risks, ideally before they arose.

Most fundamentally, there was virtual consensus on the need for prompt action to ensure regulatory agencies had at hand the basic information they needed to understand the lay of the nano-land:  what nanomaterials are already being produced and are in the pipeline; in what applications and products are they being used; and where along the nanomaterial lifecycle are the most likely points for potential releases and exposures.

With respect to this most fundamental of needs, I’m sorry to say that, in 2011, we are essentially no closer to achieving it than we were in 2004.  Read More »

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A near-sisyphusian task: EPA soldiers on to require more testing under TSCA

By / Published: January 5, 2011

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

The Environmental Protection Agency (EPA) announced yesterday that it has finalized a rule requiring testing [UPDATE 1/7/11:  The published rule is available here] to determine basic health and environmental effects for 19 high production volume (HPV) chemicals.  While I welcome this as well as any other effort to close the huge safety data gaps that exist even for the most widely used chemicals, the back story behind this rule reveals why it is actually a perfect poster child for what’s wrong with the Toxic Substances Control Act (TSCA).

For starters, consider that it took EPA two and a half years to move the rule from the proposed stage to finalization.  And that doesn’t count the several preceding years EPA had to spend developing information sufficient to make the findings it has to make to justify proposing a test rule.

Then consider that the rule addresses only 19 of the many hundreds of HPV chemicals on the market today for which even the most basic, “screening level” hazard data are not publicly available.

And it gets worse.  Read More »

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Why is OMB blocking EPA from using even its limited authority under TSCA?

By / Published: December 20, 2010

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

On May 12 of this year, the Environmental Protection Agency (EPA) sent a proposed rule to the Office of Management and Budget’s (OMB’s) Office of Information and Regulatory Affairs (OIRA) for its review, which is supposed to be completed within 90 days.  The proposed rule is not considered a major rule, is classified as “not economically significant,” imposes no unfunded mandates and is unequivocally allowed under EPA’s statutory authority under the Toxic Substances Control Act (TSCA).

The proposed rule would establish a so-called “chemicals of concern” list and populate it with one chemical and two chemical categories.  All of these chemicals are well-studied, already widely identified to be chemicals of significant concern and subject to numerous regulations by governmental bodies both in the U.S. and abroad.

Yet, as of today – more than seven months after receiving the draft of the proposed rule from EPA – OMB has not allowed EPA to release it for public notice and comment.

In 1976, when passing TSCA, Congress gave EPA the express authority to establish and populate a “chemicals of concern” list.  There’s simply no excuse for OMB’s delay.  Read More »

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Irresponsible Care: ACC seeks an exception to swallow the IUR Rule

By / Published: November 29, 2010

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

I noted in an earlier post that the American Chemistry Council (ACC) is seeking major delays in the implementation of enhanced chemical information reporting requirements that EPA has proposed under its TSCA Inventory Update Rule (IUR).  But ACC isn’t content with just delaying the enhanced reporting.  It’s also seeking an exemption so large that it literally threatens to swallow much of the rule.

The proposed exemption is called for in a footnote on page 2 of the comments ACC filed on the proposed rule:  “Exemptions should be provided for any company engaged in an acquisition or divestiture during the years since the last reporting cycle.”

Just how large an exemption would that be?  Read More »

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Reporting deferred is right-to-know denied: ACC seeks major delays in EPA chemical reporting program

By / Published: November 2, 2010

Richard Denison, Ph.D., is a Senior Scientist. Allison Tracy is a Chemicals Policy Fellow.

Well, in its comments on EPA’s proposed rule to enhance chemical information reporting under the TSCA Inventory Update Rule (IUR), it took the American Chemistry Council (ACC) all of 5 paragraphs to get through the lip service it no doubt felt it had to pay to supporting EPA’s proposals “in principle,” and then proceed to devote 31 pages to arguments opposing virtually every element of EPA’s proposals.

Cunningly on its part, ACC’s arguments often do not oppose outright the EPA proposals.  Rather, it seeks to put off their implementation for as long as possible.  EPA’s proposed rule calls for reporting in 2011 that would provide information for years 2006 and forward.  In contrast, ACC would have EPA put off implementation of all of its proposed IUR enhancements, with the result that both EPA and the public would not get any of the additional information until at least 2015.

Like we said in the title of this post:  Reporting deferred is right-to-know denied.

We’ll be posting more about ACC’s comments in the coming weeks, but in this post, we’ll consider the core argument ACC makes for deferral:  that “the business of chemistry is product-focused, not substance focused.”  ACC would have us believe their member companies don’t know what chemicals are in any of the products (i.e., mixtures of chemicals) they make and sell.

This argument warrants – ahem – additional scrutiny.  Read More »

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Public health advocates to the chemical industry: Stop hobbling EPA

By / Published: October 12, 2010

Richard Denison, Ph.D., is a Senior Scientist.  Allison Tracy is a Chemicals Policy Fellow.

Today, EDF joined with 32 other environmental justice, health and environmental organizations to file comments [PDF] with EPA that strongly support its effort to improve its ability to obtain – and share with the public – robust information about the production, processing and use of chemicals in the U.S.

While the details of EPA’s proposed rule and many of our comments are heavily wonky, the motivation and goals are far from it:  To make sure that EPA, the marketplace and the public have the information they need to guard against harm from dangerous chemicals.  That requires knowing a whole lot more than we do today about what chemicals are in commerce, in what quantities, how they’re used – essential to understanding how we may be exposed.

Robust information is the lifeblood of a sound chemicals management system.  Government needs access to comprehensive, reliable information to inform policy, programmatic and regulatory decisions it must make to carry out its mission.  The market needs access to such information to inform the myriad decisions made every day by producers, sellers and users of chemicals and products and materials made using chemicals.  And researchers, the public and groups that work in the public interest need access if they are to have confidence in, and be able meaningfully to contribute to, decisions and actions taken by government and the private sector.

In an earlier post, we made the point that the chemical industry’s reactions to these modest proposals will be a litmus test for how serious it is in acting on its rhetoric about the need for EPA and the public to have more and better information on chemicals.  With the comment period closing today for EPA’s proposed rule, look here in the coming weeks for our assessment on industry’s comments.

What follows is a summary of our comments, indicating both what we support and what more is needed.  Read More »

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