ECHA to publish total tonnage band for registered substances

ECHA has taken a decision on the method by which it will calculate the total tonnage bands for substances on ECHA's registered substances database. The total tonnage bands for registered substances will be published on the ECHA website during June 2012.

More information in the ECHA press release.

ECHA launches public consultations on two proposals for harmonised classification and labelling

ECHA, the European Chemicals Agency responsible for the evaluation of chemicals under the REACH program, has opened a public consultation on proposals to harmonize classification of two substances.  According to their news release:

ECHA  invites the parties concerned to comment on two new proposals for harmonised classification and labelling (CLH): Fenoxaprop-P-ethyl and 8:2 Fluorotelomer alcohol (8:2 FTOH). The public consultation will be open for 45 days and will end on 1 June 2012. The CLH reports and the dedicated webform to post the comments are available on the ECHA website.

ECHA's Committee for Risk Assessment (RAC) will consider the comments received during the public consultation when developing its opinion on the CLH proposal. The Commission takes into account the RAC opinion when it decides whether the proposal for harmonised classification and labelling is accepted and if so, the substance is added to the list of hazardous substances for which harmonised classification and labelling has been established (Annex VI, part 3 of the CLP Regulation).

More information can be found on the ECHA site.

EPA Proposes Rule to Require Electronic Reporting for Chemical Information

From EPA:

The U.S. Environmental Protection Agency (EPA) has announced a proposed rule to require electronic reporting for certain information submitted to the agency under the Toxic Substances Control Act (TSCA).The action is an important milestone in the agency’s effort to increase transparency and public access to chemical information in order to help Americans protect their health and environment. Electronic reporting will increase the speed with which EPA can make information publicly available, increase accuracy, and provide the public with quick and easier access to chemical information. 

More in the press release.

Prepublication PDF here.

ECHA to Update REACH-IT and IUCLID 5 Software for REACH Chemical Assessments

According to an ECHA press release:

The European Chemicals Agency (ECHA) is going to release a new version of IUCLID 5 in late May 2012 and subsequently a new release of REACH-IT. Later this year, ECHA will start publishing more information on chemical substances.

Helsinki, 11 April 2012 - The new IUCLID 5.4 release will bring about changes mainly on how certain substance information included in the Chemical Safety Report (CSR) is reported. In addition, certain information included in the Safety Data Sheet (SDS) will be made publicly available. As a continuation of the IUCLID 5 update, a new version of REACH-IT will be released later in the summer. The new REACH-IT release will accept only IUCLID 5.4 dossiers. ECHA publishes a Question and Answer (Q&A) document to inform stakeholders in advance about the impact on the upcoming submissions of registration and other dossiers.

More information

ECHA Updates REACH Guidance on Data Sharing for Chemical Regulation

The European Chemicals Agency (ECHA) has updated its guidance on data sharing.  The update takes into consideration information and experience obtained during the REACH registration process and since the original publication of the guidance in 2007.

According to ECHA,"the text has been throroughly revised amending both content and structure." Changes to content include improvement of the "overall coherence" and to create a more focused document that helps companies avoid "unnecessary testing." Duplicative material covered in other guidance has been removed and/or made more consistent.  Two new sections have been added to make the document clearer, including more comprehensive discussions of the data sharing process for phase-in and non-phase-in substances. Additional new sections cover the "data sharing dispute processes" and "post-registration data sharing obligations."

More information can be found on the ECHA site.

EPA to Decommission Important Chemical Identification Tool Due to Lack of Funding

The USEPA has announced that it will soon decommission an important chemical identification tool "due to lack of funding support." The Analog Identification Methodology (AIM) tool was "designed to help identify publicly available, experimental toxicity data on closely related chemical structures."  Once decommissioned, AIM will no longer be available on EPA's website.  Funding to EPA has been severely cut by Congress 9with threats of even more cuts) for a variety of programs designed to protect health and safety of humans and the environment. 

AIM has been a valuable tool for industry to identify chemicals that are similar to the ones for which they are filing PreManufacture Notices (PMN).  PMNs are filed prior to putting a new chemical on the market.  Without the AIM tool industry will have less certainty as to whether they have provided the proper information to ensure an efficient approval process.  Under TSCA, EPA has 90 days to inform industry if their PMN raises concerns for the new chemical; without concerns being raised the submitter is allowed to put the chemical into production after the 90 days.  Without use of AIM as a screening tool there is a potential for more concerns to be raised in order to give more time to review the PMN.

EPA is asking all those in industry, NGOs, and consultants who use the AIM tool to email coordinator Kelly Mayo-Bean (mayo.kelly@epa.gov) with a note indicating their use of the the tool and its importance in their work.  Ms. Mayo-Bean will compile comments and provide to management in hopes of having the funding and tool reinstated in the future.

Canada Confirms Order Designating Four Chemicals as CEPA Toxic

Canada has published an "Order Adding Toxic Substances to Schedule 1 of the Canadian Environmental Protection Act, 1999." The order confirms the CEPA toxic designation of four chemicals, thus allowing for Canada to regulate them.  The four chemicals are:

• Propane, 2-nitro- (Chemical Abstracts Service [CAS] (see footnote 2) Registry No. 79-46-9), hereafter referred to as “2-nitropropane”; 

• Benzene, 1-methyl-2-nitro- (CAS No. 88-72-2), hereafter referred to as “2-nitrotoluene”;

• Phenol, 2,6-bis(1,1-dimethylethyl)-4-(1-methylpropyl)- (CAS No. 17540-75-9), hereafter referred to as “DTBSBP”; and

• Methylium, [4-(dimethylamino)phenyl]bis[4-(ethylamino)-3-methylphenyl]-, acetate (CAS No. 72102-55-7), hereafter referred to as “MAPBAP acetate.”

Draft regulations have been proposed for at least one of the chemicals.  According to the Canada Gazette:

The Order adds the four above-mentioned substances to Schedule 1 to CEPA 1999, thereby allowing the Ministers to meet their obligation to publish proposed regulations or other instruments no later than July 31, 2012, and finalize them no later than January 31, 2014. Developing an implementation plan or a compliance strategy or establishing service standards are not considered necessary if no specific risk management proposals are made. An appropriate assessment of implementation, compliance and enforcement will be undertaken during the development of proposed regulations or control instrument(s) respecting preventive or control actions for these substances.  

More information can be found in the Canada Gazette notice.

EPA Proposes New Rules to Limit New Uses of Potentially Harmful Chemicals

Yesterday the USEPA "proposed that companies be required to report to EPA all new uses, including in domestic or imported products, of five groups of potentially harmful chemicals." These Significant New Use Rules - SNURS - were identified in action plans for five chemicals issued over the last two years. The chemicals include uses "in a range of consumer products and industrial applications, including paints, printing inks, pigments and dyes in textiles, flame retardants in flexible foams, and plasticizers.".

The five chemicals EPA targets, as noted in their press release, are "polybrominated diphenylethers (PBDEs), benzidine dyes, a short chain chlorinated paraffin, hexabromocyclododecane (HBCD), and phthalate di-n-pentyl phthalate (DnPP). The agency is also proposing additional testing on the health and environmental effects of PBDEs."

“Although a number of these chemicals are no longer manufactured or used in the U.S. they can still be imported in consumer goods or for use in products. Today’s proposed actions will ensure that EPA has an opportunity to review new uses of the chemicals, whether they are domestically produced or imported, and if warranted, take action to prohibit or limit the activity before human health or environmental effects can occur,” said Jim Jones, EPA’s acting assistant administrator for the Office of Chemical Safety and Pollution Prevention. “These actions also signal EPA’s ongoing commitment to the American people that the agency is taking significant steps to make sure that the chemicals manufactured and used in this country are safe.”

More information on the SNURS can be found at the EPA web site.

Just a few weeks ago EPA also released a set of documents in their Chemical Work Plan for prioritizing and conducting risk assessments. 

ECHA QSAR Toolbox version 2.3 now available for REACH

ECHA has announced the release of the newest version (Version 2.3) of the OECD QSAR Toolbox for use in REACH and other regulatory actions.  According to their press release, "the software helps registrants and authorities to use Quantitative Structure-Activity Relationship ((Q)SAR) methodologies to group chemicals into categories and to fill data gaps by read-across, trend analysis and to assess the (eco)toxicity hazards of chemicals under REACH. This helps to reduce costs and unnecessary testing on vertebrate animals."

While many chemicals do have existing or new data to meet many endpoints, they often have data gaps.  QSARs can be used both to meet some data requirements and provide an estimate of certain properties that allows decision-making on whether new testing is needed.

For more information see here.

The QSAR Toolbox and guidance documents can be downloaded here.

REACH Won't Work for TSCA Reform, Says Industry Based on Indiana Report

The US chemical industry is pointing to a new academic report as proof that the European REACH chemical management system is not a good fit for implementing in the US.  The report from Indiana University comes while Congress has effectively punted on pursuing reform of the 35 year old Toxic Substances Control Act (TSCA). 

The full report, for preparation of which the authors acknowledge receiving "unrestricted financial support from the American Chemistry Council, Dow, and DuPont," presents information about REACH and offers the following five findings:


FINDING #1: U.S. Policymakers Should Consider Simplifications of the REACH program.

FINDING #2: If a REACH-like system is adopted in the United States, more public disclosure of safety-related information and opportunities for public participation should be provided.

FINDING #3: In considering how to streamline REACH for application in the United States, more focus should be on priority-setting based on risk and the opportunity to reduce risks to human health and the environment.

FINDING #4: Since some of the frustration and burden in the early years of REACH implementation has been linked to ambiguity in program design, a REACH-like system in the United States should provide clarification about critical standards, processes, and tools.

FINDING #5: If the United States chooses to adopt a REACH-like system of registration, unnecessary burdens on industry can be lessened by allowing for mutual, cross-Atlantic recognition of registration dossiers.

The full report can be downloaded as a PDF file here.

The Hockey Stick and the Climate Wars by Michael E. Mann - A Book Review

If you ever wanted to know how it feels to be hunted by a pack of rabid wolves, Michael Mann’s The Hockey Stick is the book for you. The “hockey stick” graph became an icon in the Climate Wars, at least in the sense that it gave a target for the climate denialist industry to focus on in their efforts to deny the science. For those who are confused the bottom line is this – the hockey stick is robust, joined by a dozen other graphs into a veritable hockey team, and represents one small piece of multiple lines of evidence that demonstrate our planet is being warmed by human activity.

Mann begins by discussing how the hockey stick was “Born in a War” during the mid-1990s. As his own research was just beginning to develop, the climate denialist industry was already hard at work attacking other scientists like Ben Santer in what Mann calls the “Serengeti strategy.” In “Climate Science Comes of Age” and “Signals in the Noise” Mann takes us through the state-of-the-science and how his emerging research relates to the research of other scientists, including future co-author Raymond Bradley. In “The Making of the Hockey Stick” Mann gives us both the history and the science that led to the seminal paper commonly referred to as MBH98 and its follow up paper MBH99. The hockey stick papers. In short, the hockey stick is merely a reconstruction of northern hemisphere temperatures going back a millennia or so and based on a range of proxy data, that is, data from corals, ice cores, tree rings and other sources of long-term information that are used to define atmospheric temperatures. This one (relatively) simple graph was the result of “a substantial body of work.”

But as the science developed so too did the attacks on that science by fossil fuel industry lobbyists and their allies. The hockey stick graph became part of the 2001 Third Assessment Report of the IPCC, and was perceived as a major threat to the denialist industry’s interests. It was actually only one of three figures used in that IPCC report showing the same sort of pattern of historical temperatures. As Mann discusses, the MBH papers didn’t even attempt to establish causality, but this fact – like most facts – didn’t seem to slow the denialist desire to set up the hockey stick as THE pedestal of climate change…and then proceed to try to tear it down.

Mann goes on in ensuing chapters to discuss the “Origins of Denial” (e.g., going back to the tobacco industry’s “doubt is our product” strategy), and the various critiques of the hockey stick. Some of the more interesting chapters have to do with the political attacks on Mann and his co-authors. The chapter “Say It Ain’t So, (Smokey) Joe!” refers to Joe Barton (“I apologize to BP” for holding them accountable for the Deepwater Horizon spill). Barton called a House hearing on the hockey stick based solely on an opinion piece written in the Wall Street Journal. Barton was universally chastised for abusing his position to carry on a political intimidation. Even other Republicans like Sherwood Boehlert and John McCain rebuked Barton’s clear attempts to harass scientists.

In “A Tale of Two Reports,” Mann relates the findings of two evaluations of the hockey stick paper – one by the National Academy of Sciences (NAS) commissioned by Sherwood Boehlert, and one by a statistics professor named Edward Wegman commissioned by Joe Barton. The NAS review was conducted by a team of highly qualified scientists and looked intensively at the research. The Wegman team consisted of Wegman, one of his graduate students, and one other co-author. The NAS review universally reaffirmed the veracity and robustness of the MBH hockey stick. The Wegman report disagreed. Not surprisingly, evidence later determined that Wegman had collaborated with denialist organizations, had passed off much of Stephen McIntyre’s faulty work as his own, and as much as 1/3 or more of the Wegman report had been plagiarized. Despite reaffirmation by the NAS, the addition of a dozen other independent reconstructions all showing the same thing, and voluminous evidence from multiple lines of investigation all showing that the hockey stick accurately represents the state-of-the-science, the denialist bloggers still repeat the false talking points coming out of Wegman’s ethically-challenged and factually-deficient report.

There is much more in the book, of course, and along the way Mann also discusses the ubiquitous inability of any denialist argument to stand up to even the most basic scientific scrutiny. He discusses the cadre of industry-sponsored blogs that serve as an echo chamber for denialist talking points, even long after they have been thoroughly debunked many times (including, for example, the falsehood that the hockey stick is broken).

Mann further discusses attempts to intimidate climate scientists in chapters called “Heads of the Hydra” (whenever one false talking point is debunked, two more false talking points are tossed out and/or recycled from the ones already debunked), “The Battle of the Bulge” (about how the denialist industry has made a last ditch effort to harass and intimidate scientists now that the science has become undeniable), and “Climategate: The Real Story” (how the denialist industry coordinated an orchestrated disinformation campaign). Mann’s recounting of how the “hide the decline” false talking point required the convenient omission of 23 words and the combining of two completely unrelated topics for the denialists to create their fake scandal is enlightening.

The final chapter “Fighting Back” is about how climate scientists have started to defend themselves and the science against the vicious harassment and intimidation of the climate denial lobby. One example he lists is Virginia Attorney General Cuccinelli’s witch hunt that was working its way up through the courts. Just this past week the Virginia Supreme Court ruled that Cuccinelli had no basis for pursuing what all parties acknowledge is nothing more than a politically motivated attempt to intimidate scientists who are doing research politicians find ideologically inconvenient.

In an Epilogue, Mann notes that his views of the “role of the scientist” have evolved over the last 10 years. Previously Mann, like most scientists, believed the role of the scientist was to do scientific research and that others should take on the duty of communicating it to the public. Now he believes that it is a responsibility of all scientists to ensure that their science is accurately communicated, and sometimes that means being out there to correct the intentional disinformation pushed by the science denial lobby. All scientists should consider this advice.

I highly recommend this book.  I also highly recommend the book Global Warming and Political Intimidation by Raymond S. Bradley, the “B” of MBH98/99. Like Mann, Bradley has experienced first hand the “Serengeti Strategy” of harassment.

Photo Credit and to order the book: Amazon.com

EPA Releases Chemical Work Plan - Names Chemicals for Risk Assessment

EPA has "developed a work plan that identifies existing chemicals for risk assessment over the next several years."  Today they "posted the methodology for developing this work plan, the work plan chemicals identified using the methodology, and seven chemicals for risk assessment development in 2012." EPA also posted an "existing chemicals program strategy," that "includes risk assessment and risk reduction, data collection and screening, and public access to chemical data and information."

We'll examine the strategy and work plans in more detail over the coming days, but here's a quick synopsis. Last September EPA announced that it would seek to identify existing chemicals for risk assessment under TSCA since the TSCA reform legislation was likely not to be seriously discussed in Congress for some time.  In a two-step process, EPA identified criteria for prioritizing chemicals based on their hazards, likelihood for exposure, and persistence/bioaccumulation. Scores for each segment are compiled from a variety of sources (to be discussed in future posts), categorized into high, moderate or low ranks, and given an overall score ranging from 1 (low) to 3 (high).  Chemicals receiving high scores in all or most of the segments get higher priority for assessment.

Since EPA resources are limited, and likely to get even more limited due to pending budget cuts, they have designated only seven chemicals for the 2012 work plan.  Another 76 chemicals have been designated for future year work plans.  

More details will come in future posts.  The seven chemicals listed for 2012 will be subject to EPA risk assessments.  They are:

• Antimony & Antimony Compounds
• 1,2,3,6,7,8-Hexahydro-3,6,6,7,8,8-hexamethylcyclopentag]-2-benzopyran (HHCB)
• Long-chain chlorinated paraffins (C18-20)
• Medium-chain chlorinated paraffins (C14-17)
• Methylene chloride
• N-Methylpyrrolidone
• Trichloroethylene (TCE) 

ECHA Proposes to List 13 Chemicals as Substances of Very High Concern Under REACH

The European Chemicals Agency (ECHA) has proposed to add 13 additional chemicals to their candidate list of Substances of Very High Concern (SVHC).  Each of the chemicals "is classified as carcinogenic, mutagenic or toxic for reproduction."  Stakeholders and other interested parties are urged to comment on the proposed listings.  Besides toxicity, "information on the uses of the substances is invited."

The public consultation "will be open for 45 days and will end on 12 April 2012."  After the consultation period, ECHA will consider all comments and then make final decisions on including the substances on the candidate list.  Eventually these substances could be included on the REACH Annex XIV Authorisation List. If that happens then companies will have to apply for authorisation, that is, apply to have their substance remain on the market, usually only for specific controllable uses, limited volumes, and for a limited period of time while substitutes are developed.


More information and the list of chemicals can be found on the ECHA web site.

Book Review – A Contract with the Earth by Newt Gingrich and Terry L. Maple

This is a rather odd book to review. On the one hand former Speaker Newt Gingrich teams up with the CEO of the Palm Beach Zoo to argue for a “Contract with the Earth” in which all of us, without partisanship, become stewards of the environment. Published in 2007, they note that “as a nation” we must remove our addiction to oil: “By weaning industrial societies from their dependence on fossil fuels, the world would be a far better place.” They implore both parties to take the environment seriously, pleading that “surely our energy problems rise to the level of a presidential crusade.”
Later they quote a coalition of corporate CEOs that together represent an Energy Security Leadership Council:

“America’s oil dependence threatens the prosperity and safety of the nation. Continued policy paralysis is unacceptable precisely because we can take action to improve our energy security. Many challenges lie ahead, but we have no doubt that efforts of the American people will meet with success.”

That was during the Bush administration.

Which gets us to the other hand. While the book argues forcefully for bipartisan (or more accurately, non-partisan) action to deal with climate change, pollution, protection of endangered species, biodiversity, and other environmental values, it is also rife with political innuendo and denialism. Given Gingrich’s recent statements that contradict the profoundly persuasive arguments in this book, it’s unclear whether the self-contradictions are a result of the differing views of the two authors or of the lead author’s political pandering induced by a run for the White House.

Ignoring that aspect for the moment, the book does offer some compelling ideas for how to rid ourselves of our oil addiction and invest in the development of renewable energy. They quote Espy and Winston’s book Green to Gold, in that “smart companies seize competitive advantage through strategic management of environmental challenges.” In other words, smart innovative companies can make a buck and save the planet too! Gingrich and Maple advocate an entrepreneurial approach to dealing with climate change, quoting the Republicans for Environmental Protection:

“America is ready to meet the challenges posed by global warming. America has the best scientists. America’s businesses lead the world in developing and marketing innovative technologies that transform lives. All that remains is leadership that will channel the unrivaled power and creativity of markets toward developing the solutions we need soon to protect our atmosphere, strengthen American economy, and bring clean prosperity to the world’s developing nations.”

As I read those final words it struck me – perhaps Newt Gingrich should go back and read his own book.

Photo credit: Amazon.com