ECHA Issues "Last Call" for Chemical Classification and Labeling Notifications

Have you notified your substance under the EU's Classification, Labeling and Packaging regulation (CLP)?  ECHA has issued a "last call" to companies who need to notify by the January 3, 2011 deadline.  All manufacturers and importers of substances that "are hazardous" according to the CLP regulation must notify the correct classification and labeling (C&L).  They also need to prepare updated safety data sheets (SDS) to reflect the new classification and labeling requirements.

For those companies who registered their chemicals under the first REACH registration deadline of November 3, 2010, they have already complied with the CLP and do not have to notify separately (assuming, of course, that they properly reported C&L in their REACH dossiers and have passed all the completeness, business rules, and financial checks).

The January 3, 2011 deadline is especially important for companies who manufacture or import dangerous chemicals at tonnages that do not require registration until 2013 or 2018.  That is because the C&L notification must be completed now, even though their registrations won't be due for up to several years.

For anyone still needing to notify, the REACH-IT system will remain open only between the hours of 10 am and 7 pm GMT (check your local time zone equivalent) from December 27 through 30, 2010.  It then will reopen for the last 24 hours on the last submission day (Monday, January 3, 2011).

More explanations of the classification and labeling notification requirements, along with access to various notification tools, can be found on the ECHA web site.

ECHA Recommends 8 Substances of Very High Concern be Subject to Authorization

While most attention has been on meeting registration deadlines and dealing with the new classification and labeling scheme, the European Chemicals Agency (ECHA) has also been busy at work assessing substances of very high concern (SVHC).  Yesterday ECHA recommended the addition of 8 chemicals to the candidate list for inclusion in the authorization annex based on carcinogenicity and/or reproductive toxicity issues.
The eight substances are:

• Diisobutyl phthalate – DIBP (toxic to reproduction). A substance used as plasticiser for nitrocellulose, polyacrylate and polyacetate dispersions;
• Diarsenic trioxide – As203 (carcinogen). A substance used in the manufacture of glass with special properties and of zinc;
• Diarsenic pentaoxide – As205 (carcinogen). A substance which could be used as a replacement for diarsenic trioxide, no known current uses in the EU;
• Lead chromate (carcinogen and toxic to reproduction). A substance used as pigment and in the manufacture of pyrotechnics;
• Lead sulfochromate yellow - C.I. Pigment Yellow 34 (carcinogen and toxic to reproduction). A pigment used to colour plastics and coatings;
• Lead chromate molybdate sulphate red - C.I. Pigment Red 104 (carcinogen and toxic to reproduction). A pigment with similar uses as lead sulfochromate yellow;
• Tris(2-chloroethyl)phosphate – TCEP (toxic to reproduction). A substance used as a plasticiser and viscosity regulator with flame-retarding properties for coatings;
• 2,4-Dinitrotoluene - 2,4-DNT (carcinogen). A substance mainly used in explosives and propellants for ammunition.

The European Commission makes the final decision on the inclusion of the substances in Annex XIV of the REACH Regulation.  This now makes 46 chemicals on the candidate list waiting for addition to Annex XIV, after which they would only be eligible for continued use if manufacturers or importers applied for authorization and could show a combination of controlled use and a plan for finding substitutes.  Any authorization would be limited both temporally and with restrictions in the specific uses allowed.

More on the ECHA recommendations and the authorization process can be found on the ECHA web site.

US and Europe Agree to Share Chemical Data

Last week the USEPA, which has responsibility for managing chemicals in the US, and ECHA, which does the same in the European Union, signed a statement of intent (SOI) to share data, cooperate with each other on chemical reviews, and even exchange staff (or perhaps in this age of budget cuts, just share video-conference call links).  The SOI acknowledges all the work that ECHA and industry have done in this past few years developing a system to submit and review health and safety data under the REACH program.

According to the SOI, the scope of the planned cooperation could include:

- scientific collaboration and information exchange, in particular with regard to the registration (i.e., inventory) as well as hazard and risk assessment of chemical substances;
- exchange of operational experience as well as experience in strengthening regulatory capacities, for instance through training programmes;
- communication activities;
- active disseminaton of public information and publications related to each other’s activities;
- information exchange on matters of common interest, including emerging risks from chemical substances or guidance development; and
- sharing information and experience on risk identification, risk assessment and risk management tools and other similar products and related expertise.

Suggestions that such a SOI have been offered by both EPA and personal for the last month or two, so this shouldn't come as a surprise.  With TSCA reform in a holding pattern in the US (pending the new leadership in the House), and REACH just passing its first major data submission milestone, both groups seek to maximize the value of the data they are collecting and introduce some much needed efficiency in the chemical review process.  This is especially important now that chemicals are manufactured and traded worldwide.  Larger multinational companies and their affiliates should benefit from the likely data sharing between jurisdictions, but smaller and medium sized companies will also benefit as the costs of compliance get reduced by the economies of scale (e.g., if an assessment in Europe is accepted largely as is for the US, that would certainly save the cost of having to do essentially the same thing twice).

The SOI can be downloaded as a PDF from the EPA web site.

Disclosure of Fracking Ingredients May Become More Transparent

Fracking has been in the news a lot lately.  Especially for the questions surrounding the chemicals used in the process.  What is fracking, you ask?  In short, fracking, which is a shortened form of hydraulic fracturing, is the process by which oil and gas explorers use chemicals and fluids under pressure to force the expansion of cracks (fractures) in rocks as a means to increase the output of a well.  Recently there has been a lot of pressure (no pun intended) on oil companies to publicly reveal the chemicals used in fracking fluids.  There has been resistance to this idea, largely on confidential business information grounds, but that might be changing.

This week the primary trade association for the oil industry, the American Petroleum Institute (API), joined with other oil and gas trade associations to endorse a plan in which companies would voluntarily disclose the chemicals found in fracking fluids. The plan was developed by Groundwater Protection Council (GWPC) and the Interstate Oil and Gas Compact Commission (IOGCC).   In endorsing the plan, API noted in its press release that:

 “The states are the proper authority for determining requirements for chemical disclosure; so a program developed by the GWPC, and endorsed by the IOGCC is a step toward a solution on disclosure,” said API’s CEO, Jack Gerard. “But it is critical that we ensure confidential business information is protected and we will work with the GWPC to improve the reporting elements — which ultimately should enable maximum participation and enhance the program’s overall effectiveness.”  

The key here is that the plan, which involves development of an electronic registry, is both voluntary and based in the states rather than being federal level mandatory requirements.  One concern from the NGOs, however, is that the proposed plan could delay any actual disclosure for quite some time as the registry is developed over several years.

Either way, all sides agree that hydraulic fracturing helps to improve the amount of oil and gas that can be extracted from any given well.  That's important both from a cost-effective and efficiency point of view, but also from the understanding that the more that can be extracted from wells already drilled reduces the pressure on drilling more wells.

Washington State Moves Forward on Children's Safe Chemical Rules in Lieu of TSCA Action

I have mentioned previously here that with TSCA chemical reform trudging through Congress on the federal level, the States have continued to move forward with attempts to protect human health and the environment on a more local scale.  One of these efforts is the Children's Safe Product Act (CSPA) passed by Washington State in 2008.  While Governor Gregoire has suspended rulemaking in general because of the state of the economy, she has exempted this particular rule to continue through the development process.  The goal of the proposed law is to focus on protecting children from toxic chemicals.

According to the Department of Ecology, which manages health and safety issues in Washington, the CSPA consists of two parts:

The first part "limited the amount of lead, cadmium and phthalates allowed in children's products sold in Washington after July 1, 2009. These standards were substantially preempted when the U.S. Congress passed the Consumer Product Safety Improvement Act (CPSIA) in July, 2008. The federal Consumer Product Safety Commission will enforce this act."  So this part is essentially dormant.

"The second part of the CSPA requires Ecology, in consultation with the Department of Health, to develop a list of chemicals that manufacturers must report on. As required by the law, chemicals on the list are toxic and have either been found in children’s products or have been documented to be present in human tissue (blood, breast milk, etc.). However, the mere presence of these chemicals in children’s products does not necessarily indicate that there is a risk of exposure." 

Rules to implement this second part of the CSPA are currently open for public comment until December 31st.  These draft rule list 59 chemicals considered to be of high concern to children.  Most are familiar to people in the chemical control business as they have been targeted by other states as well as federal and international laws.  The law stipulates that the chemicals selected must be known to be toxic, commonly found in products used by children, are used in home environments, and found in biomonitoring of human blood and tissue samples. 

Once the final rules are issued, "manufacturers of children's products must report to Ecology if their products contain these chemicals."  These notifications will be required by law on a particular schedule, but the CSPA does not stipulate what happens once they are notified.  Presumably the state is interested in collecting data on what chemicals, and in what volumes, are used in the state so they can take any needed action.

Inspector General Inquires into EPA's Voluntary Children's Chemical Evaluation Program

The Voluntary Children’s Chemical Evaluation Program (VCCEP), which advocacy groups had criticized for years as ineffective and a "stall" by industry, was halted by the Obama administration.  Now it seems EPA’s Inspector General (IG) has launched an inquiry into the program because EPA has indicated it intends to model other programs on VCCEP.  The IG says it will determine “whether there are alternative mechanisms for achieving children’s health protection goals from chemical exposure.”

VCCEP was a product of the 1998 Chemical Right to Know Initiative, "the goal of which was to give citizens information on the effects of chemicals to enable them to make wise choices in the home and marketplace."  VCCEP itself was launched in December of 2000, and for many years was a focal point for EPA to work with industry to assess the potential effects of 23 chemicals on children's health.  Of the 23, only 20 were actually sponsored, with the chemicals selected being some for which children had a high likelihood of exposure. The intent was to have companies that manufactured or imported these chemicals to volunteer to provide information on health effects, exposure, risk, and data needs. Thirty-five companies in 10 consortia responded.

Unfortunately, 10 years after it was initiated the program seems to have not gotten past its initial pilot program.  Like the voluntary High Production Volume Chemical Challenge, the voluntary nature of the program resulted in actual participation dropping off as soon as the program fell out of the public's field of view.

The goal of the IG review is to learn from this experience before EPA initiates a new effort to assess the effects of chemicals on children's health.  Given the slow movement of TSCA reform in Congress, and the change in power structure for the next two years leading into a presidential election, EPA and others are looking for ways to carry on their mandate to protect public health, especially that of children.

More information can be found on the VCCEP program web site.

AGU Fall Meeting Attracts Nearly 20,000 Scientists

It's December and if you're in San Francisco you might be one of the nearly 20,000 scientists attending the annual fall meeting of the American Geophysical Union, the worldwide scientific organization of mostly earth and space scientists (aka geoscientists).  From December 13-17th they will gather to present - and listen to - over 18,000 platform and poster presentations on the science.  For anyone who has never been to a scientific meeting before, this is what science is about when you get out of your lab or field site.  Knowledge.

With the Cancun climate meetings just wrapping up, the AGU meeting is guaranteed to have many animated discussions about science related to climate.  Scientists will find out what others have been working on, argue with each other in the hallways, and yes, laugh about the good old days back in the stone ages.

As big as this meeting is (and it's not even the biggest scientific meeting), only about a third of the worldwide membership will be able to attend.  According to its web site, "AGU membership encompasses more than 58,000 individuals from over 135 countries."  The goal of membership "is to unite Earth, atmospheric, oceanic, hydrologic, space, and planetary scientists by providing a dynamic forum for the geophysical community through scientific journals, meetings, electronic mail, a weekly newspaper, scientific and technical committee activities, and several online data and information services."

In other words, a way to share information about new discoveries, new data, and potential areas of further research.

Information about the fall meeting can be found here.  A PDF of the program book can be downloaded here (warning: it's 123 MB so takes a while to download).

ECHA Lets You Search REACH-Registered Substances - Is Your Chemical Legal?

November 30th has passed and (hopefully) all of the chemical substances pre-registered at manufacture or import above 1000 tonnes per year have now been registered (if not, realize that you cannot be manufacturing or importing them in Europe).  Now ECHA has made available a searchable database of information on registered substances. According to ECHA, 

The information in the database was provided by companies in their registration dossiers. You can find a variety of information on the substances which companies manufacture or import: their hazardous properties, their classification and labelling and how to use the substances safely, for example. 

In total (as of earlier this week), there had been 19,182 REACH registrations and over 1.4 million classification and labeling notifications.  Classification and labeling for substances must now be done in Europe in accordance with the new Classification, Labeling and Packaging Regulation (CLP), which implements the globally harmonized system (GHS) of classification and labeling the EU (needless to say "globally harmonized is more than a little bit of a misnomer given it is hardly harmonized globally).

US House Names Key Committee Chairs Affecting Climate Change Regulation

With the Republican party becoming the majority in the US House of Representatives in last month's election, that means there will be new chair people for the key committees and subcommittees.  The biggest news is that Fred Upton of Michigan will take over the chairmanship of the House Energy and Commerce Committee, which is the one with oversight authority for issues such as climate change and other energy and environmental issues.  Upton beat out Joe Barton of Texas, most famously known for his apology in a House hearing to BP President Tony Hayward.

The committee also would have jurisdiction over any attempt to roll back the health care law that was passed in this Congress.  Meanwhile, Ed Whitfield of Kentucky is hoping to take over the subcommittee chairmanship that Upton held.

Other key Republican committee assignments include Darrell Issa of California to chair the Oversight and Government Reform Committee.  Issa has said that he intends to hold hearings investigating climate scientists even though all investigations have exonerated all scientists of any wrongdoing while demonstrating the tendency of climate deniers to misrepresent both the state of the science and what scientists say about it.  The scrutiny of climate science is also part of Ralph Hall's intentions as the Texas Representative takes over the House Science Committee.

All of this means that science will be on trial, or depending on your point of view, the victim of witch hunts, by the incoming Republican leadership in the House.  Meanwhile the science continues to demonstrate with greater and greater certainty that the planet is warming due to man's activities.  So it will be interesting to see in the hearings that are very likely to occur whether scientists are able to take advantage of the opportunity to educate a few Congressman.

EPA Publishes Alternative Assessment Criteria for Design for the Environment

"EPA's Design for the Environment (DfE) works in partnership with industry, environmental groups, and academia to reduce risk to people and the environment by finding ways to prevent pollution. For more than 15 years, through partnership projects, DfE has evaluated human health and environmental concerns associated with traditional and alternative chemicals and processes in a range of industries. These analyses have empowered hundreds of businesses to select safer chemicals and technologies. DfE focuses on industries that combine the potential for chemical risk reduction with a strong motivation to make lasting, positive changes."

Recently they published an Alternative Assessment Criteria for Hazard Evaluation Document.

Short on time today, but will be back later.

ECHA Will Add 8 Chemicals to its Substances of Very High Concern List

Now that the European Chemicals Agency (ECHA) has succeeded (mostly) in handling the thousands of substance registrations due by November 30th, they will continue to look at Substances of Very High Concern (SVHCs).  To that end they will be adding eight SVHCs to its list of substances to be controlled under the Authorization part of REACH.

 

The substances are:

- Di-isobutylphthalate (DIBP)

- Diarsenic trioxide

- Diarsenic pentaoxide

- Lead chromate

- Lead sulfochromate yellow (C.I. Pigment Yellow 34)

- Lead chromate molybdate sulphate red (C.I. Pigment Red 104)

- Tris(2-chloroethyl)phosphate (TCEP)

- 2,4-dinitrotoluene (2,4-DNT)

 

But that isn't all. ECHA also has proposed another eight substances for inclusion on the candidate list, which depending on feedback from stakeholders, could also end up being added to the Authorization Annex under REACH. Those eight are:

 

- Chromium trioxide

- Acids generated from chromium trioxide and their oligomers

- Cobalt(II)sulphate

- Cobalt(II)dinitrate

- Cobalt(II)carbonate

- Cobalt(II)diacetate

- 2-methoxyethanol

- 2-ethoxyethanol

More to come.

EPA Brings to 1000 the Number of Chemicals Being Tested with ToxCast

Perhaps lost in all the attention with the REACH deadline was an announcement last week by the USEPA that ToxCast screening program has "entered a new phase," in which it will add another 700 chemicals for testing "potential toxicity to people and the environment."  About 300 chemicals, mostly pesticides, were tested in the first phase, which puts chemicals through a series of fast, automated assays to screen for possible toxicity.  The hope is that ToxCast will be able to rapidly screen the roughly 85,000 chemicals on the TSCA Inventory, as well as screen new chemicals before they are put on the market.  Those chemicals for which ToxCast suggests some concern would be put into a more comprehensive evaluation process.

More information on ToxCast can be found here.

ToxCast employs a battery of rapid assays. Rather than rely on animal testing to discern toxicity, the battery includes tests that look at such things as gene expression, real-time electronic sensing, in vitro genomics, biochemical markers, and for those that want to see actual organisms, zebra fish development.

More information on the chemicals being tested can be found here and more information on EPA's computational toxicology program is here.

Lisa Jackson Marks the 40-Year Anniversary of EPA

Forty years ago, Americans across the nation took up a call for cleaner air, safer water and unpolluted land.  They saw that to keep our families healthy, to build clean communities, and to make America stronger for the future, we needed to protect and preserve our environment.  That grassroots movement led to the creation of the U.S. Environmental Protection Agency.  At its formation, the EPA was tasked with repairing the damage already done to the environment and establishing guidelines to help Americans make their environment cleaner and safer.

That is how EPA Administrator Lisa Jackson starts off her "40th Anniversary Message" marking forty years of EPA's existence, which officially started December 2, 1970.  She goes on to say:

As we look to the past, we are also focused on the future.  The EPA is strongly committed to protecting and preserving our country's environment through taking action on climate change; improving air quality; ensuring chemical safety; cleaning up our communities; protecting America's waters; working for environmental justice; and building strong state and tribal partnerships.

The EPA has set up a whole page called EPA@40: Healthier Families. Cleaner Communities. A Stonger America.  The page highlights "40 years of achievements" (and a proclamation from President Obama).

See it all here.

The Final REACH Registration Numbers Are In - ECHA Reports Nearly 25,000 Registrations

Yesterday (November 30, 2010) marked the first deadline for registration of chemicals under the European Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program.  And the European Chemicals Agency (ECHA) has quickly issued a press release summarizing the results - "ECHA had received 24,675 registration dossiers, submitted for nearly 3,400 phase-in substances."

While companies have had almost 3 years to prepare dossiers on their chemicals, most of that time was spent working with other companies in consortia and navigating the new idea of SIEFs (Substance Information Exchange Forums).  According to ECHA:

T"the numbers of registrations increased steadily throughout the year, but from September 2010, the trend changed. Numbers soared dramatically - incoming registrations in a single month totalled four times the number of dossiers previously registered. The increase became more gradual again in October – an increase of 7% percent - with statistics increasing again over the last month."



About 12% of dossiers were submitted by "Lead Registrants," i.e., the company who volunteered to present the data developed by consortia and other groups of companies manufacturing or importing the same chemicals.  About 82% of the submissions were from "Member Registrants," those companies who contributed to consortium development of the dossier submitted by the Lead.  Only 6% of the submissions were from individual registrants, i.e., single companies that provided all the data for a chemical.


Nearly a quarter of submissions came from one country - Germany - which shouldn't be too surprising given the number of larger firms located there.  Most of the submissions (86%) came from large companies, with medium, small, and micro sized companies accounting for only 9%, 4%, and 1% of the submissions, respectively.


Only 580 of the nearly 25,000 dossiers contained testing proposals, for a total of 1,548 proposed tests.  ECHA will review all of these and any test proposed on animals will be subject to public consultation.



More details can be found in the ECHA press memo and registration statistics.