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.

ECHA Calls for Comment on 10 Chemicals to be Banned

ECHA, the European Chemicals Agency based in Helsinki, issued a request for comment yesterday on proposals to ban ten additional chemicals under the Authorization phase of REACH.  All of the chemicals have been on the "candidate list" of Substances of Very High Concern (SVHC).  Currently there are 84 substances on the candidate list, of which 14 have already been placed in Annex XIV for eventual removal from the marketplace.  The first sunset date is in early 2013, pending applications for authorization from manufacturers who want to keep the chemical on the market while they develop alternatives.

The ten chemicals out for public comment are:

• Pentazinc chromate octahydroxide 
• Arsenic acid
• Formaldehyde, oligometric reaction products with aniline (technical MDA)
• Potassium hyroxyoctaoxodizincated dichromate
• Strontium chromate
• 1,2-Dichloroethane (EDC)
• Dichromium tris(chromate)
• 2,2'-dichloro-4,4'-methylenedianiline (MOCA)
• N,N-Dimethylacetamide (DMAC)
• Bis(2-methoxyethyl) ether (Diglyme)

According to ECHA, interested parties may submit comments on the draft recommendation by September 19, 2012.


More information can be found on the ECHA site.

Australia IMAP Lists 3000 "Stage One" Chemicals for Assessment

The Australian chemicals agency, which goes by NICNAS, has announced that it will implement its new Inventory Multi-tiered Assessment and Prioritisation (IMAP) framework "in a staged manner." Beginning July 2012, "NICNAS will begin assessing around 3,000 existing chemicals," which are now designated “Stage One chemicals.”

The characteristics used to identify "stage one" chemicals are listed in the table on the NICNAS site and include a) chemicals for which NICNAS holds exposure data, b) chemicals identified as
a concern or for which action has been taken overseas, and c) chemicals detected in international studies analysing chemicals present in the blood in babies’ umbilical cords.

NICNAS has set up an online searchable database for anyone wishing to find out which chemicals are included in Stage One.

Factsheets on the program can be found here.

ECHA Drops Proposal to Restrict Four Phthalates

The European Chemicals Agency (ECHA) has dropped its plan to restrict the use of four phthalate chemicals. The proposal had been put forth last year on the chemicals commonly called DIBP, DBP, BBP, DEHP.  However, after review an expert committee determined that the proposed restrictions could not be justified, ECHA last week retracted the proposal.


Denmark had asserted in 2011 that the four phthalates could affect sexual development.  The expert committee disagreed - they noted that the "available data does not indicate that there is currently a risk from combined exposure to the four phthalates." The committee also concluded that regulatory actions already being put into place would result in significant reduction of exposures, thus making the proposed restrictions somewhat redundant, yet overly punitive.


The decision is the first time the expert committee has refuted a proposed restriction from ECHA.  


A summary of the Danish report can be read here.

The full proposal can be downloaded here.

Is EPA Ready to Use TSCA Section 6 Again?

Bloomberg BNA is reporting that EPA may be on the verge of pulling out the TSCA Section 6 rulemaking book again, something they haven't touched since 1991 with the failed attempt to regulate asbestos.  The article, penned by long-time Chemical Regulation Reporter writer Pat Rizzuto, notes that the suggestion was made by current Acting Assistant Administrator for Chemical Safety and Pollution Prevention Jim Jones.

According to Rizzuto, Jones said "We will try and exercise some muscle we have not exercised for decades."

His statements were made at a recent Environmental Council for the States (ECOS) forum.

Use of TSCA Section 6 authority has a high hurdle for EPA, who must demonstrate that the chemical in question poses a significant risk.  Since many existing chemicals often have little health and safety data available to review, and the request for such data requires demonstrating risk (something hard to do without data), the onus of Section 6 has been one of the major driving points for the recent attempts to reform TSCA. 

As has been noted many times here, it seems highly unlikely that Congress will make a serious attempt to pass TSCA reform legislation before the election...despite claims by all stakeholders that they are in favor of modernizing the 36 year old law.  It is perhaps that reality in mind that led to Jim Jones' suggestion - what better way to emphasize the need for TSCA reform than to fail again in using one of its primary authorities?  Perhaps this will give some impetus to Congress to change the law.

And even without Congressional action, maybe, just maybe the EPA can actually address the risks of some chemicals of concern.  As the article notes Jim Jones as saying: "If the chemical is safe, our work will be done."

If it isn't, EPA's work will have just begun.

The Bloomberg BNA article can be read in full here.

EPA Extends Reporting Deadline for Chemical Data Rule

News Flash - The USEPA has announced an extension of the reporting deadline for the CDR (formerly the IUR):

Jim Jones, EPA’s Acting Assistant Administrator for the Office of Chemical Safety and Pollution Prevention, has today signed a Federal Register Notice under the Toxic Substances Control Act (TSCA) to extend the Chemical Data Rule (CDR) reporting period by six weeks to August 13, 2012, from the original due date of June 30, 2012.

More details are available in the prepublication version of the Federal Register notice.

More on EPA's Work Plan Chemicals for 2013 and 2014

As noted previously, EPA has 18 additional chemicals that it will review and assess in 2013 and 2014. The list builds on the March 2012 release of the Agency’s work plan of 83 chemicals.  All are being assessed under the authority of the Toxic Substances Control Act (TSCA).  Each of the chemicals met a combination of various selection criteria as defined by EPA, including "specific hazards such as potential carcinogenicity or reproductive or developmental toxicity; chemicals presenting persistent, bioaccumulative, and toxic potential; and chemicals found in biomonitoring or reported in consumer products." Other listed chemicals, "such as the five chlorinated hydrocarbons, the three flame retardants, and the four fragrance chemicals, may present an effective opportunity to assess groups of related chemicals together."

Those 18 chemicals are:

•     1-Bromopropane
•     Five Chlorinated Hydrocarbons:
•         1,1-Dichloroethane
•         1,2-Dichloropropane
•         1,2-Dichloroethane
•         1,2-Dichloropropane
•         trans-1-2-Dichloroethylene
•         1,1,2-Trichloroethane
•     4-tert-Octylphenol
•     Three Flame Retardants:
•         Bis(2-Ethylhexyl)-3,4,5,6-tetrabromophthalate (TBPH)
•         2-Ethylhexyl-2,3,4,5-tetrabromobenzoate (TBB)
•         Tris(2-chloroethyl)phosphate (TCEP)
•     Four Fragrance Chemicals:
•         Ethanone, 1-(1,2,3,4,5,6,7,8-octahydro- 2,3,8,8-tetramethyl-2-naphthalenyl)-4-sec-Butyl-2,6-di-tert-butylphenol
•         Ethanone, 1-(1,2,3,4,5,6,7,8-octahydro- 2,3,5,5-tetramethyl-2-naphthalenyl)-
•         Ethanone, 1-(1,2,3,5,6,7,8,8a-octahydro- 2,3,8,8-tetramethyl-2-naphthalenyl)-
•         Ethanone, 1-(1,2,3,4,6,7,8,8a-octahydro- 2,3,8,8-tetramethyl-2-naphthalenyl)-
•     4-sec-Butyl-2,6-di-tert-butylphenol
•     2,4,6-Tri-tert-butylphenol
•     P,p'-Oxybis(benzenesulfonyl hydrazide)
•     Octamethylcyclotetrasiloxane (D4)

While EPA will compile data based on the sources listed in their Work Plan methodology, they would also "welcome the submission of additional relevant information on these chemicals, such as unpublished studies not already available through the existing literature, or information on uses and potential exposures."

Companies are asked to submit any relevant information to the Agency on or before August 31, 2012.

More information can be found on EPA's web site.

EPA Identifies Work Plan Chemicals for 2013 and 2014

From the USEPA:

As part of EPA’s comprehensive approach to enhance the Agency’s chemicals management program, EPA has identified 18 chemicals for review and assessment in 2013 and 2014.  This follows the March release of the Agency’s work plan of 83 chemicals for review and assessment under the Toxic Substances Control Act.  The work plan identified seven chemicals on which the Agency will conduct risk assessments in 2012 and indicated that EPA would identify the 2013 and 2014 chemicals this spring. These draft risk assessments will be posted for public review and comment as they are completed.  

I'll have more analysis on this shortly.

Additional information on this effort, including a list of the 18 chemicals, can be found at on EPA's web site.

Elsevier Discusses "Article of the Future" - Is This Open Access?

In the last post I talked about the efforts of some people to shift published research from the firewalled journal article to an open access format.  The argument is that the public, who indirectly fund a lot of basic scientific research via taxpayer-funded research grants, should have access to the research without having to pay for expensive journal subscriptions.  The blog I linked noted a significant scientific boycott of Elsevier, one of the major scientific journal publishing houses.

Today I'll introduce something that Elsevier is doing to harness the power of online publishing for its scientific journals.  In what they call the "Article of the Future" project, Elsevier notes their "ongoing initiative aiming to revolutionize the traditional format of the academic paper in regard to three key elements: presentation, content and context."  They have provided a short video on their web site as an overview of their progress:




As the video notes, the new access systems significantly enhance the amount of information that can be derived over the traditional "flat page" journal article.  But is it open access?  Not really since a subscription to the journal is still required, or at least access through academic libraries that have purchased online subscriptions for use by students in their individual schools.

So what is the solution?

Calls for Open Access Include a Boycott of Elsevier

Recently there has been a lot of talk about making scientific journals open access.  The argument is that much of science is funded by the taxpayers via government grants, etc., and therefore the public should have access to that research.  As we all know, most scientific research is published in peer-reviewed journals, and those journals are published by companies who obviously require a profit in order to continue to fund publishing the journals.

With the growth of the internet the argument is that costs of publishing have significantly decreased, and in fact many journals no longer even print a hard copy.  Digital rules.  Still, there are costs associated with the process and publishers need to cover those costs in order to remain in business.  No business, they say, no published journal on the internet - digital doesn't create itself.

It's a difficult issue.  Clearly the future of information is online.  So what business model is best for the changing times?

I came across this blog and video that advocates for complete open access and notes a scientist boycott of Elsevier, a publisher of many valuable scientific journals.  Is a boycott fair? Is Elsevier's right to have a profitable business trumped by the public's right to access to knowledge, at least knowledge derived from publicly funded research?  And given full open access, would the public even know what to do with the information presented in scientific journal papers?

What do you all think?

[Note: Tomorrow I will look at what Elsevier is doing to better use the power of the internet to enhance the communication of knowledge]

Lautenberg Joins "Stroller Brigade" to Push for TSCA Chemical Reform

Senator Frank Lautenberg joined a "stroller brigade" of mothers from 30 states yesterday in support of TSCA reform.  This follows on the heels of a call from Senator Dick Durbin to modernize the 36 year old law.  According to Safer Chemicals Healthy Families, the "National Stroller Brigade builds on 30 local events in support of the Safe Chemicals Act, in locations as diverse as Little Rock and Omaha.  Hundreds of moms – many with children in tow – flew or bused into Washington to deliver 130,000 petition signatures to their Senators."

Lautenberg introduced the Safe Chemicals Act in 2011 and some hearings were held in Congress, but no recent action has taken place and very few people think a bill can be passed during this election year.  Even if the bill did pass in the Senate it is unlikely to be taken up in the Republican-controlled House.  The stroller brigade was designed to try to encourage lawmakers to address the issue.

“If there is one overwhelming message from years of science, it’s that exposure to toxic chemicals early in our lives is responsible for some of the cancer, infertility, and other health problems that affect millions of Americans,” said Andy Igrejas of Safer Chemicals, Healthy Families. “However, Congress has been paralyzed. We’re here to break the gridlock and demand common sense limits on toxic chemicals.”

Lautenberg, Durbin and 14 other co-sponsors of the bill (all Democrats) are trying to get passage during this term.  All parties, including the chemical industry, agree that modernization of TSCA is necessary.  However, industry opposes the current bill. Democrats are frustrated that despite their altering the bill several times to make it more industry-friendly, industry has not sat down with Congressional staff to agree on what features would work for them.  This frustration was palpable during a Senate hearing last year. Industry, on the other hand, feels that the current bill is unworkable and that any TSCA reform bill must essentially start from scratch.

Given that all sides (Government, EPA, NGOs, and Industry) all agree that modernization is necessary, and that substantial reworking of the principles and proposed requirements has occurred as the various bills evolved, it seems that the lack of a successful TSCA reform is due to politics rather than science.

Lautenberg expressed his frustration in his press release:

“It’s shocking that toxic chemicals end up in everyday consumer products, and in our bodies, without anyone proving that they are safe. The stroller brigade is carrying an important message to Congress that we're not going to stand by and let our kids continue to be exposed to chemicals that make them sick.  Concerned moms are the best weapons we have in this fight.  With their help, I will keep advancing the Safe Chemicals Act to reform our broken toxic chemical laws and provide a healthier future for our families.”