EDF Health

Selected tag(s): Risk assessment

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

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

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

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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EPA proposes yet another TSCA workaround: Creative, yes, but why not just give it the authority it needs?

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

One thing I’ve learned in observing EPA try to operate under the Toxic Substances Control Act (TSCA) over the years is that – faced with limited authority and significant evidentiary and resource burdens – the Agency often has to resort to a workaround to get something it needs to do done.

Can’t ban a nasty chemical?  Wait until it’s voluntarily withdrawn and then pounce on it with a Significant New Use Rule (SNUR) to try to wedge the door closed.  Witness PFOS and penta and octaBDE.  (Under TSCA, without a SNUR in place on a chemical, a new producer or importer could start up without even letting EPA know; where EPA has issued a SNUR for a chemical, advance notification is required and EPA least has a chance to weigh in before production or import proceeds.)

Can’t require an up-front minimum data set for new chemicals?  Recommend to companies that for certain chemicals they submit such a data set along with the pre-manufacturing notice (PMN) they’re required to file, or risk having EPA extend the review of their new chemical or negotiate with them to do the testing.  EPA has made such “recommendations” for those relatively few new chemicals where the company “anticipates” at the outset producing it in large amounts in the first three years or where significant release or exposure is projected. 

The latest such workaround?  EPA’s simultaneous issuance of a proposed test rule and a proposed SNUR for a batch of high production volume (HPV) “orphan” chemicals that no company agreed to sponsor under the Agency’s voluntary HPV Challenge Program.

Necessity is the mother of invention, they say, and these creative new proposals are a case in point.  But, my oh my, there’s gotta be a better way…. Read More »

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New Ways in the Ancient World: Japan and China advance their chemicals policies

Allison Tracy is a Chemicals Policy Fellow.

This isn’t the first time on this blog that we’ve observed that chemicals reform is popping up all over the world.  Whatever their strengths and shortcomings, the 1999 amendments to the Canadian Environmental Protection Act and the European Union’s REACH Regulation got the ball rolling.  The momentum of chemicals reform is reaching around the globe as governments pay more attention to the risks posed by chemicals.  In this post, we will focus on recent developments in Japan and China.

Japan and China are two of the U.S.’s top competitors, so it’s noteworthy that they have not allowed themselves to fall behind in chemicals management.  Why are they expanding their chemicals regulations?  Do they know something we don’t?  Read More »

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A sea of red herrings is behind opposition to EPA’s proposal to enhance chemical reporting

Richard Denison, Ph.D., is a Senior Scientist. Allison Tracy is a Chemicals Policy Fellow.

With the chemical industry and now Congressional Republicans mounting a last-minute effort to derail the EPA’s long-time-in-coming enhancements to its Inventory Update Reporting (IUR) rule (see our last post), it’s worth examining their main objections.  That examination reveals a sea of red herrings.  Here are a few of the smelliest ones, discussed in detail in this post:

Red herring #1:  EPA has failed to indicate how it will use the information it collects.

Red herring #2:  Small businesses would be excessively burdened.

Red herring #3:  More frequent reporting is a “needless” burden on the industry.

Red herring #4:  EPA is expanding the IUR from data reporting to data-gathering.

Red herring #5:  EPA’s requirement for retroactive reporting is unfair.

Red herring #6:  Requiring electronic reporting is too inflexible.

Read More »

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