EDF Health

A ray of sunlight up ahead: ECHA to release more information through REACH dossiers

By Allison Tracy / Published: April 26, 2012

Allison Tracy is a Chemicals Policy Fellow.

After many months of increasing the quantity but not the quality of dossiers available to the public for chemicals registered under REACH, the European Chemicals Agency (ECHA) has recently announced two improvements.  (REACH is the European Union’s regulation for the Registration, Evaluation, Authorization and Restriction of Chemicals.)  According to the agency, the public will soon have access to more data from the dossiers that were submitted by companies as part of the first wave of REACH’s Registration process.

In a press release issued a couple of weeks ago, ECHA announced that it will publish information from registered chemicals’ Safety Data Sheets – including the identity of the registrant and whether the chemical was found to be Persistent, Bioaccumulative and Toxic (PBT).  And last week, ECHA said it will also publish (by June) the aggregate production volume ranges (called “tonnage bands”) for chemicals registered under REACH.  These decisions will improve ECHA’s record on disclosure and transparency by increasing the amount of both hazard and exposure data available to the public on chemicals in use.  Read More »

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Estimating chemical risk: Breadth (prevalence) may be just as important as depth (magnitude of effect)

By Jennifer McPartland / Published: April 23, 2012

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

Earlier this month Dr. David Bellinger at Boston Children’s Hospital published a very interesting paper in Environmental Health Perspectives offering a new way to consider the importance of various risk factors for child neurodevelopment—such as pre-existing medical conditions, poor nutritional status or harmful chemical exposures—at the population level.  “A Strategy for Comparing the Contributions of Environmental Chemicals and Other Risk Factors to Neurodevelopment of Children” argues that, in evaluating the contribution of a risk factor to a health outcome, it is critical to consider not only the magnitude of its effect on the health outcome, but also the prevalence of that risk factor in the population.

Dr. Bellinger argues: “Although a factor associated with a large impact would be a significant burden to a patient, it might not be a major contributor to the population if it occurs rarely.  Conversely, a factor associated with a modest but frequently occurring impact could contribute significantly to population burden.”  The former “disease-oriented” approach has generally been used to estimate the burden of harmful chemical exposures to population health, rather than the latter “population-oriented” approach.  Relying solely on the former approach, he contends, may result in an underestimation of the impact of a chemical exposure or other risk factor on public health.  Read More »

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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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