EDF Health

Exhibit PV29: Why this EPA can’t be trusted to forthrightly assess chemical risks under TSCA

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

I blogged last week about the Environmental Protection Agency’s (EPA) illegal and hypocritical decision to deny the public access to health and safety studies conducted on the first chemical to undergo a risk evaluation under the reformed Toxic Substances Control Act (TSCA).  In its draft risk evaluation, now out for public comment, EPA relied on these secret studies to assert that the chemical, commonly known as Pigment Violet 29, or PV29, is safe, so EPA’s denial of public access matters a great deal.

EPA asserts that these studies are entitled to protection as confidential business information (CBI) under TSCA, when in fact TSCA explicitly does not extend CBI protection to such studies.  The only health and environmental information on this chemical that is public are brief summaries of those studies that were prepared by the companies that make the chemical, and were submitted to the European Chemicals Agency (ECHA) when the chemical was registered under the European Union’s REACH Regulation.  (EPA erroneously states that the studies were “summarized by ECHA.”  This is simply not the case:  Registrants, not ECHA, develop the summaries that are then made available in the registration “dossiers” for REACH chemicals.)

As we review EPA’s draft risk evaluation for PV29, we are finding that EPA’s assertions cannot be trusted even about what these summaries state are the findings of the underlying studies.  I’ll discuss one such case in this post.   Read More »

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Evidence grows linking DEHP exposure to reproductive toxicity: What is the state of regulation?

Lindsay McCormick is a Research Analyst.

Phthalates are chemical plasticizers found in a wide array of industrial and consumer products, including polyvinyl chloride (PVC) piping and tubing, cosmetics, medical devices, plastic toys, and food contact materials.  Because phthalates are often not strongly chemically bound to these products, they can leach out of those products and into the environment around us. Given this, it may not be surprising that phthalates and their metabolites can be measured in the bodies of nearly all people tested.

This post reports on important new research on DEHP and summarizes the state of regulation of the chemical in the U.S. and abroad.   Read More »

Also posted in Emerging Science, Health Policy, Health Science, Regulation, States / Tagged | Comments are closed

ECHA keeps the ball rolling on Authorisation under REACH

Alissa Sasso is a Chemicals Policy Fellow.

In our last update on the European Union’s Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), we noted a major milestone under the “A” of REACH, as the first application for an authorisation was passed to and is awaiting decision by the European Commission. The authorisation process is continuing to move along: as of May 19th, ECHA has received 13 applications for 35 uses of six different substances on the Authorisation list. Interest in ECHA’s authorisation work is also increasing, eliciting a greater variety of stakeholder input than in the first round.  Read More »

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A REACH milestone: First authorisation application passes the European Chemicals Agency

Alissa Sasso is a Chemicals Policy Fellow.

It’s been a while since we’ve posted an update on ongoing activities under the European Union’s Regulation on the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH).  The European Chemicals Agency (ECHA) has been quite busy in recent months.

The first application for authorisation (we’ll be using the English spelling of this term, as it is spelled in REACH) to use a Substance of Very High Concern (SVHC) cleared ECHA’s Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) on January 3rd. This is a significant step in the implementation of REACH in the EU. The authorisation process is intended both to manage the risks posed by SVHCs and to drive the replacement of these hazardous substances with safer alternatives.  And, as the final step in the process laid out under REACH for managing chemical substances, its execution is central to the success of REACH as a whole. This first application for authorisation was therefore a kind of test-run for ECHA, as well as the chemical industry, and sets the stage for the submission and review of future authorisation applications.

As we run through the details of this particular authorisation application, keep in mind that ECHA received seven other applications for authorisation last year, and will see even more activity in the coming year.  Read More »

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Public pressure gets the job done: South Korea passes new chemicals law, K-REACH

Alissa Sasso is a Chemicals Policy Fellow.

Two years ago, accidental use of a chemical in humidifiers in South Korea tragically took the lives of 18 people and captured national headlines. Nearly a year later another fatal accident occurred at a chemical plant, this time injuring thousands of people in the surrounding area as well.

Meanwhile, the South Korean National Assembly was negotiating a new comprehensive chemicals bill that some observers saw as leaning in favor of the business interests at the table. The tragedies brought the public spotlight to the issue and changed the political dynamic and policy outcome.  With the public calling for greater control over toxic chemicals, legislators reinstated many of the health-protective requirements that had been dropped due to industry pressure (Chemical Watch, subscription required). And on April 30th, 2013, the Assembly passed the “Act on the Registration and Evaluation of Chemicals”, known as “Korea REACH” or simply “K-REACH” (Chemical Watch, subscription required).  Read More »

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ECHA raises its sights: Several recent additions to the REACH Candidate List set precedents

Alissa Sasso is a Chemicals Policy Fellow.

The European Union is maintaining a steady pace as it works to address chemicals of concern: Last month, the European Chemicals Agency (ECHA) added 54 Substances of Very High Concern (SVHCs) to the Candidate List for Authorisation under its REACH Regulation, bringing the total number of substances on the list to 138. ECHA posted a press release listing the new SVHCs and describing some of the more interesting additions, which we’ve highlighted below.

For 23 of the additions, REACH’s Member State Committee (MSC) reviewed public comments during the comment period on draft SVHC proposals before voting unanimously to add all of them onto the Candidate List. The other 31 new additions were not challenged during the public comment period, and hence moved directly onto the candidate list without MSC consultation.

The majority of the new SVHCs, like most substances already on the list, are classified as carcinogen, mutagenic and/or toxic to reproduction (CMRs).  But it’s with the other new listings that it gets really interesting.  Read More »

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