EDF Health

Our health protections at risk: TSCA reform undone by “regulatory reform”?

By Lindsay McCormick / Published: May 8, 2017

Lindsay McCormick is a Project Manager. Richard Denison, Ph.D., is a Lead Senior Scientist.

On February 24th, President Trump signed Executive Order 13777, calling on all government agencies to recommend regulations for “potential repeal, replacement, or modification.” As of this writing, EPA has received 46,050 comments on its regulatory reform process. Interestingly, the overwhelming majority of these comments come from individuals across the country voicing their support for strengthening EPA’s regulatory protections, demonstrating that Americans stand strong in their opposition to regulatory roadblocks and rollbacks.

In compliance with this executive order, EPA held a stakeholder meeting last week to identify “regulatory reform” opportunities under the Toxic Substances Control Act (TSCA).

The irony – and absurdity – of this process is that not even a year ago, Congress passed, with overwhelming bipartisan support, sweeping reforms to TSCA, finally providing EPA with new tools and authority to review and manage chemicals more effectively. The need for a credible regulatory agency—one able to make timely, independent, science-based decisions about chemical safety—was seen by all parties as essential to increase public confidence in the safety of chemicals. Under-regulation, not over-regulation, has been the clear problem in this arena for decades.  Read More »

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At last: EPA promulgates nanomaterial reporting rule

By / Published: January 11, 2017

Richard Denison, Ph.D., is a Lead Senior Scientist. Lindsay McCormick is a Project Manager.  

nanomaterial-infographic

Today, EPA issued its long-awaited rule to gather risk-relevant information on nanoscale materials. The new rule will finally allow EPA to obtain basic data on use, exposure, and hazards from those that manufacture or process these materials, which has long been recognized by experts as essential to understand and manage their potential risks.

Nanomaterials – a diverse category of materials defined mainly by their small size – often exhibit unique properties that can allow for novel applications but also have the potential to negatively impact our health and the environment.  Some nanomaterials:  more easily penetrate biological barriers than do their bulk counterparts; exhibit toxic effects on the nervous, cardiovascular, pulmonary, and reproductive systems; or have antibacterial properties that may negatively impact ecosystems or lead to resistance.

Read More »

Also posted in Emerging science, Regulation / Tagged | Comments are closed

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

By / Published: August 20, 2015

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 »

Also posted in Health policy, Regulation / Tagged , | Read 2 Responses

A hint of movement in the Super Slo-Mo that is nanoregulation at EPA under TSCA

By / Published: October 8, 2014

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 »

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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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Sludging through the nano lifecycle: Caution ahead

By / Published: September 23, 2010

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

Researchers at Virginia Tech have identified and characterized silver nanoparticles (AgNPs) in the sewage sludge produced by an operating municipal wastewater treatment plant.  The study is notable in several respects:  It is the first time AgNPs have been detected in a field-scale study, one of a real-world operation representative of a real-world exposure scenario to boot.  It shows that silver can exist in wastewater treatment products as nanoparticles.  It indicates such particles may be most likely to partition to sludge under common treatment technologies.  And it suggests that silver may be chemically transformed in the course of wastewater treatment.

The study did not demonstrate that the AgNPs detected in the sludge originated from products containing such nanoparticles, as some news stories have suggested, although the authors indicate such a source “is likely.”  But the findings have important implications for nano safety nonetheless.  Read More »

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