EDF Health

Selected tag(s): Data requirements

EPA announcement on ChAMP

By / Published: June 19, 2009

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

It probably goes without saying that EDF welcomes EPA’s decision to suspend the development and posting of risk-based prioritizations under its Chemical Assessment and Mangement Program (ChAMP).  EDF has been arguing (see our earlier posts) that ChAMP’s “rush to risk” has taken EPA badly off-track.  But we have also identified many useful things that EPA’s existing chemicals program can and should be doing with the data it obtained through the HPV Challenge (whether called ChAMP or not) .

We look forward to working with EPA to craft a new approach, grounded in a return to developing scientifically defensible hazard, not risk, characterizations and transparently identifying and addressing data gaps and data quality problems.

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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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Questionable Risk Decisions under ChAMP: The Fatty Nitrogen Derived Cationics Category

By / Published: May 1, 2009

Cal Baier-Anderson, Ph.D., is a Health Scientist and Richard Denison, Ph.D., is a Senior Scientist.

This example raises some new issues as well as some we discussed in the earlier examples:  EPA relies on a highly flawed “category approach” that ignores major differences in the properties and structures of the 13 members of this category.  It compounds this problem by unquestioningly accepting data from inadequate studies to assert low toxicity, rather than demanding that sufficient studies be provided.  As a result, it fails to identify, let alone require to be filled, the enormous gaps in the data available for many of the category members.  EPA ignores or dismisses without explanation its own earlier comments raising serious concerns about the quality and completeness of data provided by the sponsor of these chemicals under the HPV Challenge.  Finally, this example once again shows how EPA’s heavy reliance on self-reported use information from manufacturers paints an incomplete and potentially very misleading picture of the actual uses of industrial chemicals.  Read More »

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REACHing for nano

By / Published: April 2, 2009

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

In a previous post, I argued that the European Union’s REACH Regulation for chemicals goes a long way to address the regulatory needs for nanomaterials – despite the fact that REACH never mentions nano and was not developed with nano in mind.  I also noted, however, that REACH will clearly need more than fine-tuning to ensure adequate nano oversight.  Apparently at least some in the European Parliament agree.  Read More »

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Nano reporting goes mandatory

By / Published: February 10, 2009

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

It had to happen sooner or later. After several years spent by the UK and US governments conceptualizing, vetting, proposing, again vetting, developing, yet again vetting, and finally launching and reporting on their voluntary reporting programs for engineered nanoscale materials – only to have them largely spurned by the intended targets – other governments observing all this have decided that mandatory approaches are needed. 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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