Many REACH Registrants Not in Compliance, Says ECHA Forum

Ever since the first REACH registration deadline of November 2010 ECHA has been doing inspections to see if registrants properly complied with the data and reporting requirements of REACH.  The answer is often - NO.  Recently the second report of ECHA's REACH Enforcement Forum estimated that about 20% of the companies they looked at were not in compliance.  In the first report the Forum had identified 24% compliance for the earlier group of companies inspected.

Most of the non-compliance was related to failure to comply with the new Safety Data Sheet requirements or failure to correctly register their substances.  Sometimes this meant no registration was submitted at all, other times there was a lack of preregistration, and in still others the company preregistered but did so incorrectly.  Possible penalties for non-compliance could include loss of registrations, public shaming of companies with multiple non-compliance, fines, and criminal complaints.


The report will be available on the ECHA web site.

EPA Releases Work Plan to Improve Evaluation of Chemicals in Endocrine Disruptor Screening Program

From the USEPA regarding the Endocrine Disruptor Screening Program:

"EPA is releasing an overview summary of the Agency’s work plan to improve the scientific methods used to evaluate chemicals that may impact the endocrine system in people and animals.  This work plan relies on scientific advancements in computational modeling, molecular biology, toxicology, and advanced robotics.  By incorporating these scientific advancements into evaluating chemicals under the Endocrine Disruptor Screening Program (EDSP), EPA will prioritize and screen chemicals with greater speed, efficiency, and accuracy, while minimizing the use of laboratory animals.  

The work plan, referred to as EDSP21, follows recommendations made by the National Research Council (NRC) in a 2007 report on toxicity testing.  Since EPA is required to complete registration review of registered pesticides by October 2022, new tools are needed to more quickly and efficiently screen and assess these pesticides.  Development and validation of these new tools will be a multiyear process.  As these new tools become ready for use, the EDSP will transition to rely on computational toxicology methods and high throughput screens to more quickly and cost-effectively assess potential chemical toxicity while minimizing the use of conventional whole animal studies.  The workplan summary describes this transition.

By way of background, EPA is required to screen pesticides and other chemicals for their potential to cause effects similar to those produced by estrogen and other natural hormones."  

The work plan can be downloaded from the EPA web site here.

ECHA Adds 20 More Chemicals to Substances of Very High Concern List

The European Chemical Agency (ECHA) has added twenty additional substances to the Candidate List of Substances of Very High Concern (SVHC).  This brings the list up to a total of 73 chemicals.  Eight of the newly added chemicals were automatically added since no comments challenging their inclusion were received from the public.  The other 12 received unanimous agreement of the Member State Committee.

Of the 20, all but one were added because they have been identified as carcinogenic and/or toxic for reproduction. For the first time, however, one chemical was added to the Candidate List on the basis of "equivalent concern."  Specifically, the substance 4-tert-octyl phenol was "identified as an SVHC because of its endocrine disrupting properties" and "probable serious effects to the environment."  The use of endocrine disrupting properties to list a chemical is somewhat controversial as there is still significant uncertainty surrounding the methodologies used to make the determination.  Validation of a suite of endocrine disruption tests is ongoing, with mixed results.

The Candidate List serves as a launching point for ECHA to add chemicals to the Annex XIV of the REACH regulation, also known as the Authorization List.  Chemicals that are put on Annex XIV are slated for replacement and manufacturers are required to apply for "authorization" for continued use, which is limited to specific uses, volumes and risk management measures, all while working against a deadline for substitution of less hazardous substances.


More information and the list of substances is available on ECHA's recently revamped web site.

NASA Reaffirms Scientific Integrity Policy

According to a press release issued on December 16th:

NASA has reaffirmed its commitment to science with the release of a new framework on scientific integrity. The framework summarizes the agency's policies and practices that strengthen and uphold scientific integrity. This represents the first time NASA has codified these policies under the umbrella of scientific integrity.

"Integrity is woven throughout the fabric of NASA, and science plays a leading role in that," NASA Administrator Charles Bolden said. "This framework reflects and strengthens our commitment to open, honest, unrestricted and fair science practices, and sustains a culture that promotes them."

To support this culture of transparency, the framework reaffirms NASA's public communications policy of 2006, which states NASA scientists may speak freely with the public about scientific and technical matters.

"The ability to accurately and widely communicate our amazing science discoveries is one of our highest priorities," said NASA Chief Scientist Waleed Abdalati at the agency's headquarters in Washington. "NASA set a high standard with its forward-looking communications policy in 2006, and today we welcome the opportunity to join other agencies that are re-dedicating themselves to the highest standards of scientific excellence and advancing public trust in our discoveries."

NASA and other federal agencies submitted scientific integrity policies in response to a memorandum issued by the White House Office of Science and Technology Policy in December 2010. NASA's framework expands on the President's Memorandum to Department and Agency Heads on Scientific Integrity issued March 9, 2009, and specifies how the agency will address key issues.

In addition to public communications, the framework addresses professional development of government scientists and engineers, peer review and other topics. In developing its framework, NASA leadership evaluated the agency's existing policies and sought opportunities to improve and build on them. The agency currently is revising certain policies, including directives on the use of federal advisory committees. NASA will continue evaluating and improving policies within the framework through its formal review and renewal process.

Click here to download a PDF and read NASA's Framework on Scientific Integrity.

ECHA to Delay Launch of CLP Classification Inventory

This just in from the European Chemicals Agency (ECHA) in Helsinki:

"ECHA has decided to delay the launching of the Classification and Labelling Inventory in order to ensure that the information provided by industry will be made publicly available in an accurate way that allows easy and functional access and navigation. The Agency will announce the new launch date by mid January. This is a key milestone project for ECHA because the public will have, for the first time, access to information on the self-classification of chemical substances by Industry."

EPA Releases Work Plan to Improve Evaluation of Chemicals in Endocrine Disruptor Screening

From EPA:

"EPA is releasing an overview summary of the Agency’s work plan to improve the scientific methods used to evaluate chemicals that may impact the endocrine system in people and animals.  This work plan relies on scientific advancements in computational modeling, molecular biology, toxicology, and advanced robotics.  By incorporating these scientific advancements into evaluating chemicals under the Endocrine Disruptor Screening Program (EDSP), EPA will prioritize and screen chemicals with greater speed, efficiency, and accuracy, while minimizing the use of laboratory animals.  

The work plan, referred to as EDSP21, follows recommendations made by the National Research Council (NRC) in a 2007 report on toxicity testing.  Since EPA is required to complete registration review of registered pesticides by October 2022, new tools are needed to more quickly and efficiently screen and assess these pesticides.  Development and validation of these new tools will be a multiyear process.  As these new tools become ready for use, the EDSP will transition to rely on computational toxicology methods and high throughput screens to more quickly and cost-effectively assess potential chemical toxicity while minimizing the use of conventional whole animal studies.  The workplan summary describes this transition.

By way of background, EPA is required to screen pesticides and other chemicals for their potential to cause effects similar to those produced by estrogen and other natural hormones."  
 

You can download and read a copy of the work plan on the Endocrine Disruptor page here.

ECHA Publishes Report on Experiences of Successful REACH Registrants

From the ECHA News Alert:

In July 2011, ECHA conducted a survey with companies who had successfully submitted a registration under REACH. The survey aimed to learn about the companies' experiences in preparing and submitting registrations and to identify areas in which the Agency could improve its services. Almost 900 companies responded to the survey; over 21% of the companies that registered their substances under REACH. The majority of responses came from large companies based in Germany, the United Kingdom, Italy, France and Spain. The share of SMEs (46%) having responded to the survey was significantly higher than their proportion among registrants.

The survey revealed interesting findings. For instance, 40% of companies prepared their dossiers with the support of consultants. According to the companies, the most important reasons for outsourcing the work were a limited capacity within the company or the desire to minimise the administrative burden within the company. With regard to the registration costs, the respondents indicated that the largest expenses were related to the registration fees, the collection of necessary information and consultancy services. The answers about the importance of various aspects in preparing for 2013 deadline showed that it is essential to have a sufficient knowledge of English as the language in which nearly all SIEFs are conducted, to nominate the Lead Registrant early, and to train staff on REACH / registration procedures.

ECHA was pleased to see that the companies appreciated the material provided by the Agency – 92% of respondents used it. 17% of registrants who submitted dossiers containing a Chemical Safety Report with an Exposure Scenario made use of the Chesar tool provided by ECHA.

Based on the feedback, ECHA is planning support for 2013 registrants: the Agency will continue developing and promoting the Chesar tool for Chemical Safety Assessments and Reports, it will work further to provide updated supporting material and will aim to further improve its communication channels. 

The report is available for download as a PDF here.

EU Member States Want REACH Revised to Better Address Small Company Concerns

Small and medium-sized businesses are disproportionately impacted by the high costs of compliance with the EU REACH chemical regulation, according to several Member State representatives at a recent forum. With the European Commission working on a review of the REACH regulation - a report is due to be published in 2012 - Member States are hoping that come changes can be made to assess the impacts on the smaller registrants that have less financial and technical resources.

The large production volume substances (greater than 1000 metric tonnes per year) were registered by November 30, 2010.  The mid-range production volume substances (greater than 100 metric tonnes per year) are due to be registered by May 31, 2013.  The smallest tonnages covered by REACH (greater than 1 tpy) must be registered by 2018. 

As production tonnages go down the amount and cost of data required for registration goes down. Registration fees also decrease, and there are additional discounts for small and micro companies.  Still, many small and medium sized companies feel that the cost of registration is prohibitive.  Besides the data requirements for REACH, companies that make or use hazardous substances are required to notify ECHA.

All of the concerns raised by Member States and other stakeholders will be considered by the Commission and included in their review.  It remains to be seen whether there are substantive changes made to the REACH regulation, or merely tweaks to make the system work more efficiently for the companies that will be registering by the 2013 and 2018 deadlines.

More information on the 2013 deadline and other aspects of REACH can be found on the ECHA web site.

ECHA to Set Up Expert PBT Group

One of the main set of criteria for identifying and classifying substances of very high concern (SVHC) in Europe under the REACH regulation are whether the substance exhibits Persistent, Bioaccumulative and Toxic (PBT) properties or Very Persistent/Very Bioaccummulative (vPvB) properties.  Now the European Chemicals Agency in Helsinki is putting together a PBT expert group.  The group would address scientific issues related to PBT, both those already identified and those yet to arise.

ECHA has already in place at least two guidance documents related to identification of PBTs - Part C and Chapter R.11.  Criteria are also discussed in Annex XIII of the REACH regulation.

The new group would be staffed by experts nominated by each EU Member State, as well as three representatives each from both industry and NGOs.

ECHA Gives "Guidance in a Nutshell" for Identifying Chemical Substances Under REACH

ECHA, the European Chemicals Agency based in Helsinki that manages the REACH chemical registration program, has published another in its series of "Guidance in a Nutshell" documents.  This one is on the "Identification and Naming of Substances Under REACH and CLP."  More detailed guidance documents are also available, but the "Nutshell" documents provide a concise summary of the basic information needed for compliance.  According to ECHA:

The objective of the Guidance in a Nutshell on identification and naming of substances under REACH and CLP is to give guidance for manufacturers and importers on recording and reporting the identity of a substance within the context of the REACH and CLP.  It briefly explains how to name the substance and also gives guidance on whether substances may be regarded as the same in the context of those Regulations.

In addition:

This document has been drafted according to the corrigendum on Guidance for identification and naming of substances under REACH and CLP which has been published at the same time. The corrigendum includes editorial corrections, the replacement of outdated information, the correction of examples and references aiming to improve readability.

The Nutshell guidance document can be downloaded from the ECHA site here.

EPA Makes Public Hundreds of Formerly Confidential Chemicals Studies

On November 28, 2011 the USEPA released an updating showing "EPA's progress reviewing case files submitted to the Agency under TSCA with chemical identities claimed as Confidential Business Information (CBI)."  They provided a series of charts "intended to help those tracking EPA's progress in reviewing CBI and declassifying it, where appropriate."  The move is "part of Administrator Lisa P. Jackson’s commitment to enhance the U.S. Environmental Protection Agency’s chemicals management program and increase transparency."

According to EPA, "Releasing the data will expand the public’s access to critical health and safety information on chemicals that are manufactured and processed in the U.S."

In a statement by outgoing Assistant Administrator for EPA’s Office of Chemical Safety and Pollution Prevention, Steve Owens noted that “EPA is increasing the availability of critical health and safety studies on chemicals that children and families are exposed to every day. We are making important progress in making this information public and giving the American public easy access to it...“over the next year, we expect to review several thousand additional studies on industrial chemicals and make many of these more accessible to the public.”

Highlights from the latest release:

• Since the beginning of EPA's efforts to increase transparency two years ago, a total of 577 chemicals have been declassified, resulting in a shift from the CBI portion of the TSCA Inventory to the public portion.
  
• CBI claims for chemical identity are being reviewed, and challenged where appropriate, in 100 percent of incoming TSCA filings that may contain health and safety studies.
  
• As of October 2011, EPA exceeded its FY 2011 goal, set forth in the FY 2011-2015 EPA Strategic Plan, to review, and challenge where appropriate, more than 1,125 existing TSCA cases with CBI claims for chemical identity, potentially containing health and safety studies.

EPA noted that:

 

Consistent with the guidance, the agency will request that the submitter voluntarily relinquish the CBI claims and make the newly available studies available to the public. EPA also challenged the chemical industry to make available information that was previously classified as CBI. To date, more than 35 companies have agreed to review previously submitted filings containing health and safety studies and determine if any CBI claims may no longer be necessary. 

Finally, EPA notes that "the newly available information can be found under a new “declassified tab” using the Chemical Data Access Tool, launched in December 2010 to assist the public in retrieving chemical health and safety information submitted to EPA under TSCA."

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

ECHA to Begin Authorizing Biocidal Products

The European Union has reached an informal agreement to allow the European Chemicals Agency (ECHA) to being taking responsibility for reviewing and authorizing biocidal products.  The agreement between the European Parliament and the EU Council would give broad powers to ECHA and update the current EU Biocides Directive.

In addition to allowing ECHA to review certain biocides applications at the EU level, companies would also maintain the ability to apply to individual Member States for authorization, after which they would obtain approval in other Member States through a process called mutual recognition.  This is how the process works under the current Directive, and this move to shift some of the responsibility to ECHA is part of the reevaluation of the Biocide process as the Directive is replaced by a Biocidal Products Regulation.  Like REACH, the new regulation would immediately apply across all Member States, whereas the Directive required each MS to pass its own individual implementation legislation.

ECHA's role is limited to only some of the product types of biocides beginning in 2012, and then by 2017 all of the 23 product types will be eligible for authorization at the EU level through ECHA.  The informal agreement also specifically requires that nanoscale active substances in biocidal products be assessed separately from their non nanoscale counterparts.

EPA Announces New Acting Director of Chemicals Office

 Jim Jones, a long-time EPA official, has been tapped by EPA Administrator Lisa Jackson to replace outgoing Office of Chemical Safety and Pollution Prevention (OCSPP) head Steve Owens.  Owens is leaving his position to return to his home in Arizona where his family had remained during his time in Washington.

Jim Jones' appointment is as an "Acting" Assistant Administrator for OCSPP, and will remain in that position while President Obama determines who he will nominate to run the office permanently.  The permanent nominee would have to receive Senate confirmation and, given that Republicans in the Senate are already blocking even a vote on the President's nominee to head the Office of Water (i.e., Ken Kopocis), there is quite a bit of uncertainty as to when a nominee for permanent AA will be announced.  With Congressional Republicans voting repeatedly to inhibit EPA's authority and the major cuts in EPA budget expected due to the failure of the Congressional Super Committee to agree on spending reductions, Jim Jones could be Acting AA for a long time.

Jones has been with EPA for roughly 20 years and has served in many capacities, the most recent being as head of the Office of Air.  No word yet on who will be tapped to replace Jones in the air office while he is Acting AA at OCSPP.

Senate to Hold TSCA Safe Chemicals Act Hearing This Week

Maybe the idea of TSCA reform isn't quite dead for this Congress.  A hearing will be held on Thursday, November 17, 2011 in the US Senate to examine the Safe Chemicals Act of 2011, a bill introduced early in the year by Democratic Senator Frank Lautenberg.  The hearing, to be chaired by Lautenberg and supported by ranking Republican member James Inhofe, includes both the full and subcommittees of the Senate Environment and Public Works committee (EPW).

The hearing follows on a series of five stakeholder meetings held between EPW staff and both industry and environmental advocacy groups.  It is the first sign in quite a while of potential movement in the seemingly futile attempt to modernize the Toxic Substances Control Act (TSCA).  The lack of movement is despite support for TSCA reform by both industry and advocacy groups.

Scheduled to provide testimony at the hearing are:

Mr. Ted Sturdevant
Director, Department of Ecology
State of Washington

Ms. Charlotte Brody Director of Chemicals, Public Health and Green Chemistry BlueGreen Alliance

Mr. Cal Dooley President and CEO American Chemistry Council

Mr. Robert Matthews McKenna Long & Aldridge

Dr. Richard Denison, Ph.D. Senior Scientist Environmental Defense Fund

More information on the hearing can be found on the EPW web site.

Book Review – What’s The Worst That Can Happen? by Greg Craven (Climate Change/Global Warming)

Subtitled “A Rational Response to The Climate Change Debate,” this book should be read by everyone interested in global warming and man-made climate change.  Craven is a high school physics and chemistry teacher, and he has developed a simple and effective way to help people sift through the heated debates and decide if we need to take action on climate change.  And we don’t even have to decide which side is “right” to do it.

The two sides, of course, are what Craven labels “the warmists” and “the skeptics.”   Warmists are defined as those that believe that the science is strong enough for us to need to take action, while skeptics are those that feel we do not need to take action.  With these two sides defined, Craven introduces a decision grid to aid the process.  In the end he shows us how he filled his decision grid, but also encourages readers to fill in their own grid and make their own decisions.

In between is the crux of the book.  He does a great job of explaining the nature of science and how “we never quite know for sure” (including for things like gravity), but that sometimes the evidence is so overwhelming that it is accepted by virtually everyone (e.g., gravity). He also clues us in to some quirks about our own brains and things like “confirmation bias.”  These set up a chapter on how to assess the credibility of various sources.  After all, unless you spend your life studying the science it’s likely you won’t be able to understand it all, so instead we need to know which sources of information are reliable and which are not so much. Craven then gives us some information on what each side is telling us and who is doing the telling, all fit nicely into his credibility spectrum.

He then demystifies the doomsday claims.

I’ll leave it to all to read the book and draw their own conclusions about the science.  But I definitely recommend that all of us use the tools Craven offers in this book.  And I recommend that all scientists learn how to communicate as easily as does Craven.

Steve Owens, Head of EPA's Toxic Chemical Program, To Resign

The head of EPA's Office that handles toxic chemicals is resigning.  Steve Owens announced his resignation to staff yesterday and will leave as of November 30, 2011.  According to his email, Owens has "made the difficult decision to leave EPA" mainly to rejoin his family in Arizona, where they remained during his entire two plus years working in Washington DC at EPA headquarters.  Owens had previously been the head of Arizona's Department of Environmental Quality (DEQ).

In his departure announcement, Owens thanked EPA Administrator Lisa Jackson for "her wonderful friendship and the remarkable vision and leadership she provides" to the Agency.  Similarly, in a statement from Jackson, the EPA Administrator thanked Owens for his contributions.  She noted that "his leadership has been vital to our efforts to assure chemical safety for our citizens and revamp our nation's outdated toxic substances standards."

Those standards remain in limbo at this point as the much anticipated TSCA reform legislation - an effort to modernize the 35-year old toxic chemicals law - has stalled in Congress.  Given the current actions of House Republicans to defund EPA and limit the Agency's authority even under the current TSCA law, plus the stalemate caused by the still year-away elections that could give control of the Senate to Republicans, it seems highly unlikely that any reform of TSCA is going to occur for many years.  While he doesn't mention it in his email, perhaps that is one of the reasons Owens has decided to relocate back to Arizona.

No information on possible replacements for Owens has been forthcoming, and any potential nominee would have to be confirmed by Congress, a prospect that is likely to be politically charged given the current climate.

EPA Finalizes Third TSCA Test Rule for HPV Chemicals

The USEPA is finally promulgating a final rule under Section 4 of TSCA "to require manufacturers, importers, and processors to conduct testing to obtain screening level data for health and environmental effects and chemical fate for 15 high production volume (HPV) chemical substances listed in this final rule."  The 15 chemicals represent only half of the 29 HPV chemicals that were listed in the the draft rule, which was originally proposed nearly two years ago on February 25, 2010.  According to EPA, based on comments received on the proposed rule, the remaining chemicals were dropped because they did not" meet the criteria for testing at this time."

For the 15 chemicals listed in this final rule, manufacturers will need to conduct the specified tests and provide the data to EPA prior to the deadline, which is set for the end of 2012.  EPA notes that "this test data is needed in order to help EPA to determine whether these 15 HPV chemical substances pose a risk to human health and/or environmental safety."  Required tests vary by chemical but can include physical-chemical properties, environmental fate and degradation, aquatic toxicity, mammalian acute and reproductive/developmental toxicity, and genotoxicity.

Companies that are effected by the rule must submit test plans for each chemical within 90 days of the effective date (i.e., 90 days from November 21, 2011).

The list of chemicals can be accessed here.

A full hyperlinked version of the Federal Register notice can be accessed here.

ECHA Sets Up Exposure Scenario Network to support REACH Chemical Evaluation

The European Chemicals Agency (ECHA) has teamed up with several European chemical trade associations to establish a "cross-sector collaborative network to share knowledge, techniques and approaches to building and applying (REACH) exposure scenarios."  The new network "aims at identifying good industry practices on drafting exposure scenarios" and sets up a mechanism for "building a dialogue between supply chain actors" in an effort to "improve the protection of human health and the environment."

The new network is called ENES, the Exchange Network on Exposure Scenarios.  The trade associations with whom ECHA worked to set up ENES include the European Chemical Industry Council (CEFIC), Eurometaux (the metals association), CONCAWE (the oil companies’ European association), the European Association of Chemical Distributors (FECC) and the International Association for Soaps, Detergents and Maintenance Products (AISE) on behalf of the Downstream Users of  Chemicals Coordination Group (DUCC).

According to the ECHA press release, the first meeting will be held in Brussels, on November 24 and 25, 2011. Besides the trade associations listed above, various "sectors of industry, NGOs, Member State authorities and other stakeholders will be invited to participate."


See the ECHA page here for more information.

Canada Moves Into Next Phase of Chemical Management Plan

Canada has issued a news release indicating that it will move into the next phase of its ongoing Chemical Management Plan.  This is an extension of the plan first launched in 2006.   The CMP was designed to apply the rigorous assessment used for new chemicals to 'legacy chemicals' that were introduced in Canada between January 1, 1984, and December 31, 1986.  The new phase is seen "as a continuation of Canada's world-leading initiatives in this area and it will ensure the protection of Canadians' health and safety, and their environment," according to Shannon Coombs, President, Canadian Consumer Specialty Products Association, who promised to "continue to work proactively with the government as the plan is implemented."

According to the announcement, new funding is being provided for this next phase of the Plan, "which will focus on:"

• Further improving product safety in Canada;
• Completing assessments of 500 substances across nine categories including phthalates, primarily used in plastics; and,
• Investing in additional research for substances like Bisphenol A, flame retardants, substances that affect hormone function and substances that affect the environment.

Canada anticipates that "approximately 1,000 additional substances will also be addressed in the next five years through other initiatives, including rapid screening of substances which pose little or no risk." Canada recently banned four chemicals as harmful to the environment.

More information on Canada's Chemical Management Plan can be found here.

Canada's Chemical Substance main page is here.

ECHA Issues 2012 Work Program - Sees Challenges Ahead

The European Chemicals Agency (ECHA) approved its 2012 work program last week and highlighted both its activities and its challenges ahead of the next REACH deadline.  Besides the mid 2013 REACH registration deadline, ECHA will take on an expanding role in the new Biocidal Products Regulation (which will replace the current Directive in 2013). In addition, ECHA will have ramped up activities related to other parts of the expansive REACH regulation, including the Evaluation (the "E") and Authorization (the "A") components, as well as Restrictions (the "missing R").  And of course there is still the continuing evaluation of substance dossiers for high productive volume chemicals submitted in the first registration period that ended on November 30, 2010.

All of this leaves ECHA worried that there may not be enough resources to meet obligations efficiently, both within ECHA and in the Member States.  The current economic situation in most of Europe, which has caused such severe spending cuts (austerity), has led ECHA Executive Director Geert Dancet to openly state his concerns that Member States may not have enough resources to fully conduct their role in chemical evaluation.

The developing Biocidal Products Regulation (BPR) also offers challenges to ECHA as the agency is expected to take on responsibility for authorizing biocides.  Under the current biocides directive this responsibility lies with each Member State.  ECHA would also take on new responsibilities related to the Prior Informed Consent Regulation, which involves identifying hazardous chemicals that could not be exported from Europe unless the country of destination is given sufficient information to assess risk.

During the September 29-30, 2011 meeting of the management board, the mandate of the Executive Director was extended.  According to the chairman, Dr. Thomas Jakl:

"After the first REACH registration deadline was impressively managed by ECHA in 2010, there is no time to rest on our laurels. Challenging further steps of the REACH and CLP implementation lie ahead and the legislator is in the process of entrusting important new regulatory tasks to the Agency. The continuation decision with regard to a selection process for the Executive Director reflects the high satisfaction of the Board with his achievements since 2007."

More information and a link to the work program can be found on the ECHA web site.

Summary of GHS Chemical Classification in Various Regions Now Available

The UN Globally Harmonized System of Classification and Labeling of Chemicals (usually referred to as simply GHS) was a way for governments to voluntarily attempt to bring into harmony what had been a wide range of classification schemes for chemicals.  Now the Organization for Economic Cooperation and Development (OECD) has created a summary table that brings together in one place the current status of individual government's and region's adoption of GHS.

The table can be seen here and shows which OECD member countries and other organisations have publicly posted their GHS classifications no the internet.  The table is based on a survey performed in 2011.  Where available, OECD has provided links to the appropriate documents and web access points (e.g., to the 1300+ page CLP in Europe).  Other links take you to web sites, for example, Korea's New Chemical Notification and Assessment.

The Fourth Revised Edition of the UN Globally Harmonized System of Classification and Labelling of Chemicals (the "Purple Book") can be downloaded on the United Nations Economic Commission for Europe (UNECE) site.

Is TSCA Reform Happening this Fall?

The short answer is, probably not.  But it does appear that Senator Frank Lautenberg's office will be pushing for a markup this fall of the draft bill introduced this past spring.  Lautenberg's "Safe Chemicals Act of 2011" included many industry-friendly changes from the original "Kid Safe Chemical Act" (including no longer mentioning kids in the name).  The bill introduced in April would have required companies to submit "basic hazard and exposure data to quickly determine the risk and assess the need for further testing or restrictions."

Over the summer the staffs of Senators Lautenberg and Inhofe held a series of stakeholder meetings in an effort to find common ground and a path forward.  These meetings included - separately - representatives from NGOs (e.g., Environmental Defense Fund) and industry (e.g., ACC and SOCMA).  Topics for the meetings included defining a "safety standard" and coming up with prioritization schemes that would focus efforts on those chemicals deemed most risky.  In August, EPA proposed such a prioritization scheme, which was countered by an alternative scheme by the American Chemistry Council.

Whether the markup happens or not will depend on the legislative calendar, but historically anything that doesn't get done by this fall will likely not get done during the 2012 election year.  With the initial changes Lautenberg already made and the Democrats' willingness to compromise the grand reform of TSCA for a more industry-friendly reform, the feedback from the stakeholder meetings suggest that any markup will further limit the extent of "modernization" of the 35-year old chemicals law.  Whether you believe that is a good thing or a bad thing may depend on from what perspective you bring to the table.

EPA Will Identify Priority Chemicals by Thanksgiving (or so)

EPA will identify chemicals to be prioritized sometime this fall as it tries to move forward under the old TSCA as Congress makes no progress on developing a new TSCA.  To do so EPA will take into consideration feedback they received from a variety of stakeholders in two recent outreach attempts related to their proposed prioritization process. 

EPA introduced its proposed prioritization scheme and "discussion guide" back in August.  They then had a webinar on September 7th to give an overview of the proposed scheme and to invite feedback.  Finally, EPA also invited the public to share their thoughts in an online discussion forum.  That discussion forum closed on September 14th.


All comments received from stakeholders are now being assimilated and reviewed by EPA staff, who are working to identify chemicals to be prioritized for review.  In general the feedback was very constructive and included both concerns for the data sources being proposed as well as suggestions for other data sources to include in the evaluation. Other stakeholders cautioned that the use of production volume as a surrogate for exposure could lead to chemicals with very low risk being prioritized while chemicals of low production volume by high exposure potential, and thus risk, might be left out.  Some stakeholders suggested the addition of additional health effects such as endocrine disruption, neurotoxicity and skin or respiratory sensitization be used early in the prioritization process, while others cautioned that the process could get bogged down in the minutia if too many factors were included in the first step.

More information on the EPA chemical prioritization can be found on the discussion forum web site and EPA's existing chemicals "Identifying priority chemicals for review" page.

ECHA Goes to Commission on REACH Testing Proposal

How many Member State Competent Authorities does it take to make a decision on REACH testing proposals?  Apparently more than they have.  The Member State Committee (MSC) at the European Chemicals Agency (ECHA) "could not find unanimous agreement based on scientific and technical arguments on a draft decision for a testing proposal."

Let's go to the Commission!  For the first time ECHA will employ Article 51(7) of the REACH Regulation and refer a case to the European Commission for decision making.

This non-decision by the MSC took place last week.  Not that they were stymied on all decisions.  They did agree on the draft decisions "for all five compliance checks" they were charged with reviewing.  And they did come to unanimous agreement on two of the four draft decisions on "testing proposal examinations." But two testing proposals were particularly tricky.  For one, the MSC refined the proposal during the meeting and expect to agree in writing shortly. 

The final testing proposal reached stalemate, hence the referral to the Commission.  The proposal:

"concerns a testing proposal examination where the registrant has proposed to perform a two-generation reproductive toxicity test in accordance with the EU test method B.35. This information would be necessary to fill the data gap regarding reproductive toxicity for the substance that is produced in quantities of over 1000 tonnes per annum.  Some MSC members preferred to ask the registrant to use the recently adopted OECD test guideline 443, the extended one-generation reproductive toxicity study (EOGRTS). Others wanted to maintain the present requirement of performing a two-generation study."

No information on when (or if) the Commission will make its decision.

More on what the Member States Committee does can be found on their web page here.

REACH Chemical Regulation Group Offers Advice and Recommendations

The Director's Contact Group (DCG) has issued a report on the "Achievements, Lessons Learned and Recommendations" garnered from its supporting role for last year's first REACH registration deadline.  The DCB was formed to deal with a wide range of issues related to REACH chemical regulation - 28 different issues in all.  And now the DCG has been renewed until the end of September 2013 so that it can address any issues that might arise with the next registration deadline, which is May 30, 2013.

The DCG report gives a summary of its achievements, and presents many of the lessons learned from the experience.  All of this sets the stage for recommendations that hopefully will ease the burden for companies preparing for the 2013 (and 2018) registration deadlines.  An annex of the report gives short summaries of the 28 issues addressed by the group to date.

Issues that are expected to be priority for the next deadline include:

• Organizational issues within SIEFs, the Substance Information Exchange Forums, that had mixed reviews during the first round of registrations,
• Guidance on how to deal with situations in which the companies have merged or spun off units during the registration period (which is especially important for the many small and medium size entities that are expected to be part of the second round),
• Guidance on communication within the supply chain, again a difficult issue for small and medium sized companies with less resources
• Updating of information technology tools like IUCLID, REACH-IT, and guidance documents

One thing that the DCG and ECHA agree on is that companies planning to register chemicals by May 2013 should "Act Now!"  Members say that industry cannot prepare early enough, and many (but not all) companies are heeding that advise. 

The DCG report can be downloaded as a PDF here.

More information on REACH can be found on the ECHA web site.

NSF Announces Steps to Improve Participation of Women in STEM Science Careers

The National Science Foundation (NSF) is announcing steps that will "make it easier for women to pursue careers in engineering and the sciences," according to an Op-Ed by Valerie Jarrett and Tina Tchen in yesterday's Washington Post.  They note that "women working in science, technology, engineering and math [STEM] careers earn 33 percent more than those in other occupations, and these 'STEM' skills will become even more important in high-growth, high-tech fields such as health-care technology and advanced manufacturing."

Jarrett and Tchen note that circumstances often work against women:

As with women throughout the workforce, however, women in STEM jobs are often expected to establish themselves professionally at the same time they are starting families. This forces women to choose between their careers and their responsibilities at home. Understandably, many of our most promising young scientists and engineers drop out of the pipeline. 

Ways that NSF is looking to make it easier for women in STEM careers include:

• Working with women researchers who need to delay the start of a funded project for a family-related reason,
• Options to add the lost time if female researchers interrupt research to have a baby,
• Support for research into the effectiveness of flexible workplace policies.

 For a more in-depth discussion, see the Washington Post article by Jarrett and Tchen. 

More information is on the National Science Foundation web site.

ECHA Starts REACH 2013 Campaign to Urge Chemical Companies to Act Now!

The European Chemicals Agency (ECHA) has launched a campaign to encourage chemical companies to "Act Now!" to meet their planned registration obligations for the second round of REACH.  The next registration deadline - for substances manufactured or imported at tonnages at or above 100 tonnes per year - is May 31 2013. 

ECHA's goal is to get companies thinking now about how they will fulfill the data requirements and interact with other members of SIEFs, including any data gathering and compensation to existing data holders.  Preparing for and submitting registrations earlier rather than all at the last minute is good for both ECHA and the registering companies.

To do this, ECHA has started a program called REACH 2013 - Act Now!

The web page provides "key information to support you in your preparations for the 2013 registration."  It includes "links to all the steps of the registration process: from the formation of the Substance Information Exchange Fora (SIEFs) to data sharing, dossier preparation and online submission."


According to the site, potential registrants need to be getting organized to do:

1. Substance identification, hazard information, data-sharing
1. Substance identification and sameness of substance: Confirm with the other pre-registrants that you have the same substance;
2. Hazard information: Collect all data available on the intrinsic properties of the substance to be registered;
3. Data sharing: As part of a joint registration, gather and share existing information, consider alternatives to testing and answer any information request from within your SIEF;
2. Chemical safety assessment: Carry out a chemical safety assessment in order to produce a chemical safety report based on the hazard information collected and knowledge on the uses.

 More information can be found on the ECHA web site.

ACC's Chemical Prioritization Tool - EDFs Analysis is One Thumb Up, One Thumb Down

Last week I reported on an analysis of the EPA's proposed chemical prioritization tool done by Richard Denison of the Environmental Defense Fund (EDF).  Today I report on Denison's follow up analysis on the counter-proposal prioritization scheme released by the American Chemistry Council the day prior to EPA's webinar.  I'll start with Denison's conclusion:

"While ACC’s tool has some serious flaws and is not something that EPA has the authority or resources to utilize under current TSCA, ACC has put forth a serious proposal for prioritization that should help to raise the level of debate over this critical issue in TSCA reform."

As suggested, Denison notes that the ACC proposal offers some "refreshing elements and acknowledgements."  He describes it as "substantive and specific" and is "welcome in several ways."  He goes on to summarize some of the areas he feels are constructive (see his full blog entry).  Notwithstanding these kudos, however, Denison does suggest that ACC's proposal seems better suited for a full TSCA Reform element and that implementation of the ACC plan is not likely to be possible under the current (and likely future) resource and funding constraints limiting EPA's activities.


Denison finds that there are "a number of quite problematic aspects of ACC's proposal," including:

• Overly rigid rules applied in lockstep: Denison finds ACC's proposed "equal basis" rule to be "sleight of hand" that will "rule out any types of information that may indicate a hazard or exposure of high concern unless it has been measured across basically all chemicals subject to prioritization."  The "high hazard and high exposure" rule would allow prioritization of only those chemicals "for which high hazard and high exposure can be demonstrated;" a proposal that Denison finds to be "simply shortsighted." He also critiques ACC's "persistent and bioaccumulative" rule, which he finds includes "extremely narrow definitions of P and B" that would avoid prioritizing chemicals that would in fact be either P or B (or both).
• Consistent use of the least conservative classification values: Denison points out that the ACC proposal relies on the classification criteria developed under GHS, which he generally supports.  However, he does quibble with what he feels are two limitations - GHS doesn't include every endpoint of concern and ACC chooses the least conservative values instead of adhering to GHS' cutoff values faithfully.  A choice where Denison feels "ACC fails badly."
• Over-relying on limited exposure information and discounting evidence of hazard: Denison notes that ACC's tool lumps together its health and environmental hazard rankings into a single score while combining scores for its three exposure elements, which "means that a chemical that harms both people and other organisms only gets counted once, while a chemical that is low-volume and used only as an intermediate and is not P or B gets credit for being of low concern for all three attributes."  The way the tool handles hazard vs exposure rankings also is likely to skew the results such as to avoid prioritization for chemicals that could indeed be problematic.

Despite these significant critiques, Denison feels that the ACC prioritization tool is a good effort and a basis for informed debate as the process moves forward.  Combined with his previous critique of the EPA prioritization proposal, there clearly is a path forward for enhancing chemical regulation and improving protection of the environment and human health.  But will it happen?

ECHA Risk Assessment Committee Adopts Seven Scientific Opinions

The following information comes from the ECHA web site:



The Committee for Risk Assessment (RAC) has adopted opinions on seven proposals for harmonised classification and labelling across Europe during its 17th meeting, held from 13-16 September 2011 in Helsinki.


Polyhexamethylene biguanide hydrochloride (PHMB)

RAC agreed with the proposal from France to classify PHMB as acutely toxic by the oral and inhalation route, damaging to the eye, as a skin sensitiser, as toxic to the respiratory tract after repeated exposure, suspected carcinogen and hazardous to the aquatic environment. The classification of this substance is not currently harmonised at EU level. PHMB is used as biocidal product (disinfectant).

Di-n-hexyl phthalate (DnHP)

RAC agreed with the proposal from France to classify DnHP for reproductive toxicity due to the potential for effects on unborn babies as well as on male fertility. The classification of this substance is not currently harmonised at EU level. DnHP is used in the manufacture of plastics.

Fenamiphos

RAC agreed with the proposal from the Netherlands to classify Fenamiphos as acutely toxic by the inhalation route and as an eye irritant. Fenamiphos already has a harmonised classification as acutely toxic by the oral and dermal route and as hazardous to the aquatic environment. RAC agreed with the proposal to replace the minimum classification for acute toxicity (indicate by an asterix) with the definite classification based on data. Further, RAC proposed an M-factor of 100 for chronic aquatic toxicity. Fenamiphos is used as a plant protection product.

Trichloromethylstannane (MMTC)

RAC agreed with the proposal from France to classify MMTC as toxic to reproduction. RAC did not agree with the proposal from France, to classify MMTC as mutagenic. The classification of this substance is not currently harmonised at EU level. MMTC is used as an industrial intermediate in the production of other organotin chemicals.

2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-methyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (MMT (EHMA))

RAC agreed with the proposal from France to classify MMT(EHMA) as toxic to reproduction. RAC did not agree with the proposal from France, to classify MMT(EHMA) as mutagenic. The classification of this substance is not currently harmonised at EU level. MMT(EHMA) is used as a heat stabiliser in PVC.

Benzenamine, 2-chloro-6-nitro-3-phenoxy- (Aclonifen)

RAC agreed with the proposal from Germany to classify Aclonifen as a suspected carcinogen, as a skin sensitiser and as hazardous to the aquatic environment. Aclonifen already has a harmonised classification as hazardous to the aquatic environment. Aclonifen is used as a plant protection product (herbicide).

Perestane

RAC agreed with the proposal from the UK to classify Perestane as acutely toxic by the oral, dermal and inhalation routes, skin corrosive and as toxic to the eye after single exposure and to remove the classification for mutagenicity. Perestane already has a harmonised classification as acutely toxic by the oral, dermal and inhalation routes, skin corrosive and mutagenic. Perestane is used as a biocide (surface disinfectant).

More information can be found on the ECHA web site.