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.