EPA Takes Next Step in Test Rule for BPA

Almost a year ago the EPA issued a Chemical Action Plan (CAP) for bisphenol-A, commonly called simply BPA, a chemical used in many plastics.  And just before the holiday break EPA took the next step in managing what it sees as potential risks of BPA by sending a proposed test rule to the Office of Management and Budget (OMB).  The proposed rule looks to require toxicity testing related to environmental effects, including the potential for endocrine disruption.

No human health-related testing is being proposed at this time since most human exposure seems to be through packaging and that comes under the jurisdiction of the Food and Drug Administration.  FDA and the Centers for Disease Control are undertaking new studies.  But EPA is looking at evaluating the potential for environmental exposures from BPA in surface, ground, and drinking waters, and also may request monitoring near landfills, soil and sediment, as well as other sources of BPA leakage.

It's unclear how long OMB will take in its review.

The CAP for BPA can be downloaded here.

Other action plans and information can be found on EPA's Existing Chemicals web site.

EPA Issues Final Test Rule for 19 Chemicals - With or Without TSCA Reform, EPA Moves Forward

In their continuing attempts to collect data on "orphan" chemicals, that is, those High Production Volume (HPV) chemicals for which no company volunteered to provide data under the HPV Challenge program, EPA has issued a final TSCA Section 4 Test Rule listing 19 specific chemicals and the tests they are requiring. The goal is to obtain the data EPA needs to assure "the safety of chemicals."  HPV chemicals are those produced in the US in quantities of 1 million pounds per year or more.

According to Assistant Administrator Steve Owens:

“This chemical data reporting will provide EPA with critical information to better evaluate any potential risks from these chemicals that are being produced in large quantities in this country. Having this information is essential to improve chemical safety and protect the health of the American people and the environment.”

Testing includes everything from physical/chemical properties to environmental fate to ecotoxicity to mammalian toxicity, which each chemical having a specific set of data being required within a specified period of time.

The 19 chemicals in this particular test rule are:

1. Acetaldehyde (CAS 75–07–0)
2. 1,3-Propanediol, 2,2-bis[(nitrooxy)methyl]-, dinitrate (ester) (78–11–5)
3. 9,10-Anthracenedione (84–65–1)
4. 1H,3H-Benzo[1,2-c:4,5-c']difuran-1,3,5,7-tetrone (89–32–7)
5. 2,4-Hexadienoic acid, (E,E)- (110–44–1)
6. Phenol, 4,4'-methylenebis[2,6-bis(1,1-dimethylethyl)- (118–82–1)
7. Methanone, diphenyl- (119–61–9)
8. Ethanedioic acid (144–62–7)
9. Methanesulfinic acid, hydroxy-, monosodium salt (149–44–0)
10. Phosphorochloridothioic acid, O,O-diethyl ester (2524–04–1)
11. 1,3,5-Triazine-1,3,5(2H,4H,6H)-triethanol (4719–04–4)
12. D-erythro-hex-2-enonic acid, gamma.-lactone, monosodium salt (6381–77–7)
13. D-gluco-heptonic acid, monosodium salt, (2.xi.)-   (31138–65–5)
14. C.I. Leuco Sulphur Black 1 (66241–11–0)
15. Castor oil, sulfated, sodium salt (68187–76–8)
16. Castor oil, oxidized (68187–84–8)
17. Benzenediamine, ar,ar-diethyl-ar-methyl- (68479–98–1)
18. Alkenes, C12-24 , chloro (68527–02–6)
19. Hydrocarbons, C>4 (68647–60–9)

ECHA says over 3.1 million chemical classification and labeling notifications received in Europe

By the January 3, 2011 deadline, the European Chemical Agency (ECHA) received 3,114,835 notifications of 24,529 substances under its Classification, Labelling and Packaging (CLP) regulation.  All of these notifications go on the C&L Inventory and are accessible on ECHA's website.  Any chemical substance that is hazardous or subject to registration under REACH were required to be notified.  In their press release, ECHA Executive Director Geert Dancet noted:

This is a perfect start for the International Year of Chemistry. The Classification and Labelling Inventory, which will be publicly available later this year, will significantly improve safety by providing up-to-date information on all the hazardous substances that are on the EU market today.

Many manufacturers and importers notified as part of their REACH registration that was due November 30, 2010.  But others who produced or imported less than 1000 metric tons per year, and thus have either a 2013 or 2018 REACH registration deadline, were also required to notify if their substances or mixtures were classified as hazardous according to the CLP.

As expected, the big three chemical manufacturing countries in the EU - Germany, the UK and France - were the source of the greatest number of notifications.  Between them they accounted for over half of all the notifications received.

What if you missed the deadline for notification? Do it NOW!  ECHA has provided some Q&A on the C&L Inventory and notification procedures if you haven't do so already.

More details on the notifications can be found in this PDF.

The New Congress is in Session with the GOP in Charge of the House - And Industry is Worried

Yes, you heard right.  With Republicans taking over control of the House of Representatives and gaining seats to increase their minority position in the Senate, it seems industry is more than a little worried about the outcome.  In short, industry likes regulatory certainty, even if it means more regulation.  Industry can plan and invest and make business decisions when they know what requirements they need to meet.  Uncertainty (ironically) is a big old wet blanket on innovation and investment.


So while industry isn't going to be out there begging for stronger regulations, they do see a quagmire of uncertainty as Republicans follow through on their promises to put their legislative efforts into oversight investigations rather than regulatory predictability. Areas of environmental regulation that could be in a state of unrest include climate change and TSCA reform.  With last year's attempt to pass cap-and-trade legislation effectively dead for at least the next two years, new House Energy and Commerce Chairman Fred Upton has said he will fight EPA rules regulating greenhouse gas emissions.  Fellow Republican John Shimkus, who lost his bid to chair the committee to Upton, has been assigned a key subcommittee chairmanship, from whence he has promised also to hold hearings on EPA's authority to regulate greenhouse gases.  On the TSCA reform side, what seemed like a clear path forward in the last Congress appears now to be in a state of confusion as to how, or if, legislation to reform the now 35 year old law can be accomplished.

All of this has industry very very worried.  There is a general feeling among industry leaders that attacking the EPA, which was started by a Republican President by executive order, could be going too far and would not only create a potential for backlash but effectively stymie industry attempts to rebuild their way out of the deep recession.  Many in industry actually very much want to see government incentives for innovative new technologies, including green technologies.  And that could be severely debilitating to the utility and other energy-intensive industries.

What industry most wants now is not some partisan gamesmanship from the GOP but rather some regulatory certainty, and for climate change and EPA's greenhouse gas emissions rules, industry acknowledges that some control of CO2 emissions is both an environmental necessity and offers a regulatory certainty that will allow them to innovate.  Without some sort of certainty, industry will continue to sit out the recovery while China and other countries continue to pass by us in development of new renewable technologies.

It's January 1st, where is California's Green Chemistry Law?

Not in California.  At least not yet.  The California Department of Toxic Substances Control (DTSC) has missed the January 1, 2011 deadline for issuing its final Safer Chemical Product Alternatives (SCPA) regulations - aka, the green chemistry regs.  The regulations remained unfinalized in part because of severe criticism that the draft regulations didn't go far enough.  Even the primary legislative sponsor of the green chemistry bill, Assemblyman Mike Fleuer, felt the rules were not strict enough.  Many critics felt the proposed rules had been watered down so much that they would actually reverse progress that had already been made to control chemicals.

The plan is to revisit SCPA this month (or so) and try to beef them up.  One major concern is that the proposed regulations would make it easier for manufacturers to replace chemicals that were identified as harmful with other chemicals in which no determination of safety had even been made at all.  Hardly the best option, as the world is full of examples of unintended consequences when eliminating one hazard without adequate assessment of the substitutes.

So it is back to the drawing board with an eraser and a thicker pencil.  The goal seems to be to "get it right" instead of just get it done by the deadline.  The delay also shifts the burden to the incoming Democratic Governorship of Jerry Brown, though outgoing Republican Governor Arnold Schwarzenegger had also supported the green chemistry initiative.

Whatever form the final SCPA regulations take could have far-reaching ramifications.  As has happened in the past, as California goes, so often go other states and/or federal level regulations.  While certainly not a universal truth, the state does tend to be a trendsetter in this regard, in large part because the size of its economy requires companies that want access to its market must comply or lose out.  And companies much prefer to have one set of rules to live by, not 50 individual sets of (often conflicting) rules.

Happy New Year!

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.