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Why is the nanotech industry so intent on keeping EPA from doing its job?

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

Ten years and counting.  That’s how long EPA has been trying to gather the most basic information on nanoscale materials in commerce.  And that’s how long the nanotech industry has been throwing up roadblocks – despite its rhetoric that it supports EPA’s effort, which it sees (in theory) as a means to “favorably and efficiently address unwarranted concerns that have been raised” about the products of nanotechnology.  This “say-one-thing, do-another” approach is both unfortunate and ironic, given that it has stymied getting to a well-informed government oversight system for nanotechnology that the industry should recognize is in its own best interest.

The latest round comes in the wake of EPA’s proposal of a reporting rule under the Toxic Substances Control Act (TSCA) that would call on makers and processors of nanoscale materials – those in the size range of 1-100 nanometers (nm) – to provide the agency with information relating to the materials’ manufacture, processing and use, as well as available data relevant to understanding their potential exposures and health or environmental impacts. Here’s EPA’s succinct summary of the rationale for the rule:

Nanoscale materials have special properties related to their small size such as greater strength and lighter weight, however, they may take on different properties than their conventionally-sized counterpart. The proposal is not intended to conclude that nanoscale materials will cause harm to human health or the environment; Rather, EPA would use the information gathered to determine if any further action under the Toxic Substances Control Act (TSCA), including additional information collection, is needed.

Despite this modest, common-sense objective, the proposal was met with vociferous opposition from the nanotech industry.   Read More »

Posted in EPA, Health Policy, Nanotechnology, Regulation / Tagged | Read 2 Responses

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 »

Posted in Health Policy, Nanotechnology / Also tagged , , , | Comments are closed

Waiting for Godot: 405 days and counting at OMB on EPA’s modest proposal to identify chemicals of concern under TSCA

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

Yesterday, three legal scholars from the Center for Progressive Reform (CPR) sent a letter to Cass Sunstein, Administrator of the Office of Information and Regulatory Affairs (OIRA) in the White House Office of Management and Budget (OMB).  That letter rebutted on legal grounds the call made by the U.S. Chamber of Commerce in its own letter to Mr. Sunstein for OMB to force EPA to withdraw its proposal to use its authority under the Toxic Substances Control Act (TSCA) to list chemicals of concern.

EPA’s proposal, which entails use of its clear authority under Section 5(b)(4) of TSCA, has been stalled at OIRA for 405 days as of today, with OIRA refusing even to allow the proposal out for public comment.  I wrote an extensive blog post earlier about all of the reasons why EPA’s proposal is legally sound and makes good market sense.  That post – titled “Why is OMB blocking EPA from using even its limited authority under TSCA?” – went up way back in December, and there’s been no movement on the proposal since then.

CPR’s letter rebuts the Chamber’s claims, noting that it plain and simply “Gets the Law Wrong.”  EDF, too, has developed a legal analysis of EPA’s authority under TSCA to identify and list chemicals of concern, which is fully consistent with CPR’s analysis but goes further to address a few other legal aspects of the issue.  That’s why I’ve decided to post it here.

I’ll leave you to read our memo for the details, but provide its conclusion here as a teaser:

“EPA has clear authority under Section 5(b)(4) to list chemicals of concern and is not required to establish criteria in advance of the issuance of a proposed rule listing specific chemicals.  EPA’s authority also extends to the listing of categories of chemicals.  The legal threshold for action under Section 5(b)(4) should be interpreted as identical to that in Section 4(a), which requires only a “more than theoretical” basis for concluding that a chemical “may present” an unreasonable risk.  Even if Section 5(b)(4) is interpreted to mean something different from that in Section 4(a), it should be interpreted to be far less restrictive than the standard in Section 6.  In addition, Section 5(b)(4) does not require consideration of economic impact in the decision to list a chemical.  Finally, the statute is clear that listing of a chemical in a proposed rule under Section 5(b)(4) triggers export notification under Section 12, and may require the issuance of a SNUR [Significant New Use Rule] with respect to significant new uses of the chemical.”

It’s a sad state of affairs when even this modest step proposed by EPA to use its clear authority under TSCA is not even being allowed by OMB to see the light of day and benefit from public review and comment.

Samuel Beckett’s play, which I borrowed for the title of this post, is described as an absurdist play.  That pretty much sums up the endless review by OMB of EPA’s modest proposal.

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

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 »

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