EDF Health

Selected tag(s): Office of Management and Budget (OMB)

Regulating nanomaterials to life, not death

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 »

Posted in Health Policy, Nanotechnology, Regulation / Also tagged , , , , | Read 3 Responses

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

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 »

Posted in EPA, Health Policy, Regulation / Also tagged , , , | Read 1 Response

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

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 »

Posted in EPA, Health Policy, Regulation / Also tagged , , , , , , , , | Read 1 Response

EPA seeks to improve TSCA data reporting; a real litmus test looms for the chemical industry

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

While I was on vacation last week, EPA’s proposed rule to improve chemical information reporting under its so-called Inventory Update Rule (IUR) was finally published in the Federal Register.  (I say “finally” because the proposal languished for almost 6 months over at OMB, nearly double the 90 days such mandatory reviews are supposed to take.  That unfortunate delay is curious given the relatively modest changes that appear to have been made by OMB – mostly limited to compelling EPA to shift a few elements from proposals to options open to comment, and requiring EPA to expand the range of issues on which it now seeks comment.)

I won’t summarize the EPA proposals here; EPA’s factsheet does a good job of that, and Daniel Rosenberg at NRDC has also nicely recapped the proposal on his blog.  Suffice it to say that the proposed changes would go far to address the many failings of the current IUR, which amply manifested themselves in the last reporting cycle and severely hampered EPA’s ability to assess high production volume (HPV) chemicals under its ill-fated ChAMP Initiative.

So how will the chemical industry react?  Here’s why I’ll be watching intently.  Read More »

Posted in EPA, Health Policy, Regulation / Also tagged , , , , , , , , | Read 1 Response