EDF Health

Striking the right balance between right to know and right to intellectual property protection

By / Published: April 13, 2012

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

There is clearly a need to balance the legitimate claims of companies to protect certain confidential business information (CBI) from public disclosure with the legitimate need for the market, consumers and the public to have access to information they need to make sound decisions about chemicals that are in commerce.  Unfortunately, most of TSCA’s provisions and their implementation by EPA have skewed this balance radically in the direction of denying the public’s right to know and creating an ill-informed chemicals marketplace.

The core problem is two-fold, constituting a vicious circle:  Too many CBI claims are made, and each of the infrequent examinations of such claims done by EPA has found a large fraction to be illegitimate, i.e., not meeting the well-established criteria for what constitutes a legitimate trade secret.  And because of the large number of claims made, EPA has lost the ability to review claims to ensure they are in fact legitimate and remain so over time; this lack of review has led directly to more claims being made, thereby completing the vicious circle.  Read More »

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Restoring the credibility of risk assessment: A vital need under TSCA reform

By / Published: April 6, 2012

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

The primary means by which chemical risks are to be judged under current legislative proposals for reform of the Toxic Substances Control Act (TSCA), including the Safe Chemicals Act of 2011 (S. 847), is through risk assessment – a key demand of industry.  Yet traditional risk assessments have often fallen short of protecting public health and have sometimes taken decades to identify a “safe” level of exposure to certain chemicals.  As a result, public and health and environmental community confidence in risk assessment is very low.  There are also major technical deficiencies in current risk assessment methodologies that must be addressed if it is to serve as a credible basis for determining chemical risks.  For example, we now know that there are many chemicals for which any level of exposure poses some risk, yet traditional risk assessment assumes a safe level exists for nearly all chemicals.

The Safe Chemicals Act includes provisions to ensure that EPA’s use of risk assessment incorporates the best available science, initially by requiring EPA to rely on the recent recommendations of the nation’s foremost scientific body, the National Academy of Sciences, as to how EPA can improve its practice of risk assessment. Implementing the recommendations is critical to restoring the credibility of and public confidence in risk assessment. Read More »

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ECHA gives a CoRAP: REACH substance evaluation kicks off with list of target chemicals

By Allison Tracy / Published: March 26, 2012

Allison Tracy is a Chemicals Policy Fellow.

Posts to this blog concerning REACH – the European Union’s regulation for the Registration, Evaluation, Authorization and Restriction of Chemicals – have dealt mainly with the “R” and “A”.  A few weeks ago, the European Chemicals Agency (ECHA) took a first big step to capitalize on the “E” (Evaluation).

Specifically, the final 2012-2014 Community Rolling Action Plan (CoRAP) was published on February 29th (see ECHA’s press release).  After many months of consultation with the Member States, ECHA has released the list of 90 chemicals that will be the first to undergo REACH’s substance evaluation process in 2012, 2013, and 2014.

Existing data guided the prioritization process that led to the production of this list, but REACH’s authorities granted for substance evaluation will allow ECHA and the Member States to gather new information to fill data gaps.  This new information will help to improve both governmental and public knowledge about the risks these chemicals may pose to human health and the environment.  Read More »

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Exposing our ignorance: EPA study reveals barren exposure data landscape

By Jennifer McPartland / Published: March 16, 2012

Jennifer McPartland, Ph.D., is a Health Scientist.

This past November, EPA scientists published a sobering paper, “The exposure data landscape for manufactured chemicals,” in the journal Science of the Total Environment.  The paper reveals how little systematic information we have about human and environmental exposures to the thousands of chemicals in use today.

The aim of the study was “to define important aspects of the [chemical] exposure space and to catalog the available exposure information for chemicals being considered for analysis as part of the U.S. EPA ToxCast screening and prioritization program.”  Its conclusion:  “The results suggest that currently available exposure data are insufficient to provide the evidence base required to inform risk assessment and public health decision making.”  Not good, but not surprising.  Read on for more detail. Read More »

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Smoke and Mirrors: ACC lawyers are working hard to rein in your right to know

By / Published: March 1, 2012

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

I’ve blogged here frequently about EPA’s efforts over the past couple of years to make more chemical information available to the public, especially health and safety information.  A key part of this, believe it or not, is simply making sure that when EPA shares a health study with the public – as required by law – you get to know the identity of the chemical that is the subject of that study.

EPA’s initial steps (see below) were met with a little grumbling on the part of the chemical industry, but not a whole lot.  After all, the industry says it wants the public to have more information about chemicals.  At #7 on the American Chemistry Council’s (ACC) top 10 principles for TSCA reform is:  “Companies and EPA should work together to enhance public access to chemical health and safety information.”

Times, apparently, have changed.  In recent weeks, ACC has launched a broadside attack on the EPA’s efforts to compel its member companies ever to name a chemical when submitting health and safety information to EPA.  My evidence?  A 36-page White Paper delivered by ACC to the office of the regulatory czar at the Office of Management and Budget, at a meeting held there on January 20.  The ACC document is a wonder of tortured logic, obfuscation and selective renditions of the history of TSCA.

Today, a response was mounted.  EDF and Earthjustice staff, as well as representatives of health-affected individuals, environmental justice communities and workers, held their own meeting with OMB officials.  And we delivered our own letter to OMB that thoroughly rebuts ACC’s White Paper.  It also points out that, way back in 1976, the drafters of TSCA actually wanted you to have access to health and safety information on chemicals – and they darn well didn’t expect you to have to guess at the identity of those chemicals.  Read More »

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More “A”-level work under REACH: ECHA adds eight chemicals to the Authorization List

By Allison Tracy / Published: February 15, 2012

Allison Tracy is a Chemicals Policy Fellow.

The European Commission has formally added eight more chemicals to the list of chemicals subject to authorization under the European Union’s Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals (REACH).  These eight chemicals, which were proposed for addition to the Authorization List (or Annex XIV) in December 2010, join the six inaugural chemicals that were formally listed last February (see EDF’s blog post on that occasion).  The full Authorization List is available on ECHA’s website; the list also specifies the corresponding sunset date by which time uses of a chemical must cease unless specifically authorized. Read More »

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