EDF Health

Selected tag(s): Data requirements

Ripples of REACH: Chemicals policy changes in Japan, Turkey and South Korea

By Allison Tracy / Published: April 5, 2011

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

The November 31st deadline for the first batch of registrations under REACH (the European Union’s Regulation for Registration, Evaluation, Authorization and Restriction of Chemicals) may have passed, but life is far from dull on the international scene of chemicals policy.  As discussed in a previous post, chemicals policy enhancements are ramping up across the globe, many of them mirroring the innovations introduced under REACH.

In this post, we’ll discuss significant advances in Japan, Turkey and South Korea that drive home the message that the ripples from REACH are ever-widening.  Read More »

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One solid step for REACH, one giant leap for chemicals policy

By Allison Tracy / Published: March 21, 2011

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

While efforts to improve U.S. chemical safety legislation have been at, shall we say, a stand-still for the past few months, our European counterparts have been buzzing with activity.  U.S. NGOs, industry, regulators and lawmakers should be paying really close attention to all that buzz as they deliberate the shape of U.S. chemicals policy in the new Congress.

The European Chemicals Agency (ECHA) is currently in the thick of processing registrations received by the first major deadline under REACH, the European Union’s chemicals regulation for the Registration, Evaluation, Authorization and Restriction of Chemicals.  November 30, 2010 was the first of three deadlines for registering existing chemicals (termed “phase-in substances” under REACH); it applied to the highest-volume and most hazardous chemicals on the market.  Some 4,700 new and existing chemicals have now been registered under REACH since it took effect in mid-2008, including about 3,500 existing chemicals subject to that first deadline based on high volume or toxicity.

In contrast to Las Vegas, what is happening in Europe is not staying in Europe.  That alone makes it worth paying attention to.  Read More »

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Enduring TSCA myths: Absence of evidence of harm = evidence of absence of harm

By / Published: February 7, 2011

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

A subcommittee of the Senate Environment and Public Works Committee held a hearing on reform of the Toxic Substances Control Act (TSCA) last week.  It’s good to have attention drawn to the issue so early in the new Congress.

But – especially if you missed Senator Lautenberg’s opening statement and the testimony of EPA Assistant Administrator Steve Owens – you may well have come away from the hearing with the impression that TSCA is basically working quite well and really only needs a few tweaks, or what the chemical industry loves to call “modernization.”

Nothing could be further from the truth, of course.  This 35-year-old law is not only outdated, it’s proven ineffectual in myriad ways.  The false impression that all TSCA needs is a little polishing-up was, unfortunately, bolstered by the invoking of two particularly pernicious myths about TSCA by some of the other hearing witnesses.

The first myth, which I’ll deal with in this post, is that EPA’s new chemicals program has worked very well – so often repeated by some former EPA officials that it has become virtual dogma.

The second myth, which I’ll address in a subsequent post, is that we can confidently rely on existing information to identify all of the chemicals of concern on the market today, and safely set aside the rest.  Read More »

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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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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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