House Republicans Disagree with Endocrine Society on Need for EDSP

This week the Endocrine Society issued a series of recommendations "that will strengthen the ability of the current screening programs to identify EDCs." And now comes word that House Republicans are circulating language for the pending fiscal year budget that tries to limit the scope of EPA's endocrine-disruptor screening program (EDSP).

The Republican language is couched as an effort to "avoid unnecessary chemicals testing." It also tries to limit budgetary spending in an effort to restrict EPA's ability to formulate and implement policies on hydraulic fracturing, mountaintop mining, and other environmental issues that EPA is mandated to oversee. 

It's unclear on what basis the House Republicans believe that endocrine testing is "unnecessary" given that the lead scientific organization in that field is recommending greater attention to the issue. Endocrine testing was mandated by the 1996 Food Quality Protection Act, and EPA is a decade behind development of the testing regime required by that law passed unanimously by Congress.

More information on EPA's Endocrine Disruptor Screening Program can be found here.

REACH-IT update scheduled for 11 July 2012

The European Chemicals Agency (ECHA) has announced that it will upgrade REACH-IT, the user interface needed to submit chemical dossiers for the REACH registration program.  The upgrade will occur on July 11, 2012. To prepare for the changeover, REACH-IT will be inaccessible from Friday 6 July 2012 at 14.00 hrs (Eastern European Time) until 11 July 2012 at 9.00 hrs, in order for ECHA to install the new version of the software and to migrate the data from the present to the new version of REACH-IT.

In addition to REACH-IT, ECHA has also recently released an updated IUCLID, now version 5.4.  IUCLID 5.4 must be used for all dossiers submitted beginning July 11th.  And not to be left out, ECHA has also released a new version of Chesar, the exposure and risk assessment tool needed to complete the analysis of risk. Various plug-ins to the IUCLID software, e.g., Technical Completeness Check, Fee Calculation, Dissemination, and CSR, have also all been upgraded and will be available as the release of the new REACH-IT.

More information can be found on the ECHA site.

Endocrine Society issues Statement of Principles on endocrine-disrupting chemicals and public health protection

The Endocrine Society, whose mission is "to advance excellence in endocrinology and promote its essential and integrative role in scientific discovery, medical practice, and human health," has issued a "statement of principles" regarding endocrine-disrupting chemicals and public health protection.  They propose "a streamlined definition for endocrine-disrupting chemicals (EDCs)" and offer recommendations "that will strengthen the ability of the current screening programs to identify EDCs."

The position statement is published in the September 2012 issue of the Society's journal, Endocrinology, in a paper authored by R. Thomas Zoeller and seven others.

Recommendations in the statement include:

• Basic scientists actively engaged in the development of new knowledge in relevant disciplines
should be involved in evaluating the weight-of-evidence of EDC studies, as well as in the design and
interpretation of studies that inform the regulation of EDCs;

• State-of-the-art molecular and cellular techniques, and highly sensitive model systems, need to be
built into current testing, in consultation with the appropriate system experts;

• Testing needs to include models of developmental exposure during critical life periods when
organisms may be most vulnerable to even very low-dose exposures;

• The design and interpretation of tests must incorporate the biological principle that EDCs act
through multiple mechanisms in physiological systems; and

• Endocrine principles, such as those outlined in this document, should be incorporated into
programs by the U.S. Environmental Protection Agency (EPA) and other agencies charged with
evaluating chemicals for endocrine-disrupting potential.

The statement also provides a list of principles intended to enhance the ability of current screening
programs to identify EDCs. Principles in the statement include:

• Environmental chemicals that interfere with any aspect of hormone action should be presumed to
produce adverse effects;

• EDC exposures during development can have effects on hormone action that cannot be corrected,
leaving permanent adverse impacts on cognitive function and other health parameters;

• People are exposed to multiple EDCs at the same time, and these mixtures can have a greater effect
on the hormone system than any single EDC alone; and

• The weight-of-evidence guidance developed by the EPA must be strengthened by adhering to
principles of endocrinology outlined here, including low-dose effects and nonlinear or nonmonotonic
dose-response curves.

More information can be found in the journal article.

Chesar 2.0 released and strongly recommended by ECHA for REACH

Announced by the European Chemicals Agency (ECHA):

ECHA launches a new generation of its Chemical Safety Assessment and Reporting Tool to further harmonise and improve information on the safe use of chemicals.

Helsinki, 20 June 2012 – Version 2.0 of Chesar is now available and can be downloaded from the revised Chesar website. ECHA has invested in the redesign of the IT technology of Chesar in order to enhance its stability and make it a better platform for further developments as part of the long term strategy for Chesar. Other improvements include: a redesigned user interface, more transparency in determining the scope of the required exposure assessment, a simplified risk characterisation and an updated version of the Targeted Risk Assessment (TRA) developed by ECETOC. The possibilities to import and export complete chemical safety assessments (CSAs) or CSA building blocks have also been extended.

With Chesar industry organisations can make available generic exposure assessments for the conditions of use in their sector. Single registrants may then import and use this information as a starting point for their own substance specific assessment. Using Chesar will contribute to efficiency and harmonisation in carrying out CSAs. Thus, ECHA strongly recommends (potential) registrants to systematically use Chesar for making chemical safety reports and exposure scenarios.

Today's release of Chesar 2.0 includes the functionalities for carrying out CSAs based on a IUCLID 5.4 dataset and to generate chapters 9 and 10 of the chemical safety report (CSR), with one exception: exposure estimations for consumer uses is not yet included in the current release, but will be included in version 2.1.

The full press release and more information are available here.