EDF Health

Selected tag(s): Test rule

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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State-level nano regulation: Yes, indeed, the industry “should have seen it coming” – it caused it!

By / Published: September 10, 2010

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

I just read an interesting column by John DiLoreto, CEO of NanoReg, that appears online at Nanotechnology Now.  It’s titled “We Should Have Seen It Coming: States Regulating Nanotechnology.”  It nicely describes the important role states play in advancing environmental policy and regulation – especially when the feds are asleep at the wheel.  And it also gives a neat rundown of the various state actions aimed at nanomaterials that are underway.

But, search as I might, I couldn’t find a single acknowledgment in Mr. DiLoreto’s latest column – or in his earlier related column titled “What Drives the Regulation of Nanomaterials?” – of the role the nanotechnology industry itself played in bringing all of this on itself.

That’s quite an omission, in my view, given that the industry’s actions (or, more accurately, the lack thereof) played a central role in getting us to where we are (or, more accurately, aren’t) today on nanotechnology oversight.  That includes driving states to feel they had to step in to fill the federal void.   Read More »

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(How) Can ChAMP get back on track?

By / Published: May 7, 2009

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

As I noted in our first post on ChAMP, after getting off to a strong start in 2007, EPA’s abrupt decision in 2008 to steer ChAMP in the direction of cranking out hasty risk decisions was entirely its own.  Can ChAMP be put back on track?  Read More »

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Nano Confessions: EPA all but concedes mandatory reporting and testing are needed

By / Published: January 12, 2009

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

It’s been nearly a year since EPA launched its voluntary Nanoscale Materials Stewardship Program (NMSP) – and over three years since EPA was urged, by a diverse group of stakeholders, to do so only in conjunction with the development of mandatory reporting rules as a backstop and to limit the duration of the basic part of the program to at most six months.

EPA ignored that advice, and proceeded with an open-ended voluntary program and no development of backstop rules.  Now EPA has issued its first evaluation of the NMSP.  So what did EPA find? Read More »

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