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.