South Korea expected to release a REACH-like chemicals law soon

With companies that make or import chemicals into Europe still reeling from the first deadline of REACH registration, the Ministry of Environment (MOE) in South Korea is planning to release a new chemicals law shortly.  The new law, the Chemical Regulation and Evaluation Act, is currently undergoing internal review within the MOE and other relevant government ministries and is expected to be released in late February for public comment.

Other countries have also been working on REACH-like chemicals laws, including Turkey, China, and many others.  In the US the talk of reforming the 34-year old Toxic Substances Control Act is in limbo.  Bills were introduced in both the House and Senate in 2010, but with the Republican party gaining control of the House and closing the gap in the Senate (and with hopes of taking over the Senate in 2012), the future of TSCA reform is highly uncertain at this point.

More details on Korea REACH and TSCA reform as they develop.

New California Study Shows High Incidence of Chemicals in Pregnant Women

A study published online today in Environmental Health Perspectives shows widespread evidence of many common chemicals in pregnant women.  The authors, who are at the University of California in San Francisco, "analyzed biomonitoring data from the National Health and Nutritional Examination Survey (NHANES) to characterize both individual and multiple chemical exposures in U.S. pregnant women."  Data for a total of 268 women were examined for 163 chemical analytes in 12 chemical classes.  According to the abstract,

We calculated the number of chemicals detected within the following chemical classes; polybrominated diphenyl ethers (PBDEs), perfluorinated compounds (PFCs), organochlorine pesticides, and phthalates, and across multiple chemical classes. 

Results showed that "the percent of pregnant women with detectable levels of an individual chemical ranged from 0 to 100 percent."  For "certain PCBs, organochlorine pesticides, PFCs, phenols, PBDEs, phthalates, polycyclic aromatic hydrocarbons (PAHs) and perchlorate" there was detection in "99 to 100% of pregnant women."  Interestingly, while much is being said about levels in pregnant women, the authors report that these levels were "similar or lower than levels in non-pregnant women."

Needless to say, the fact that pregnant women can be exposed to, and have detected, multiple chemicals raises the risk of transferring those chemicals to the growing fetus.  Other studies have demonstrated that umbilical cord blood and newborns often may already carry a body burden of chemicals.  Advocacy groups like Safer Chemicals Healthy Families were quick to jump on the results, saying:

"These findings should be a call to action for Congress and the Administration." said Andy Igrejas, director of the Safer Chemicals, Healthy Families coalition. "We've known for years that exposures in the womb to toxic chemicals have a profound effect on the health of children. Here we have confirmation that pregnant women are carrying these chemicals around in their bodies." 

TSCA reform bills, of course, were introduced in the last Congress and are expected to be ignored by the newly elected Congress, though both industry and advocacy groups hope that the new House leadership will make some effort to modernize the 34 year old law.  All parties seem to agree that a new law is needed; the questions now are what such a law would look like, and more fundamentally, whether any action will be taken at all given the divided Congress.

2010 - Warmest Meteorological Year, Tied for Warmest Calendar Year

The warming of the planet has been on a bit of a tear lately, with most of the hottest mean global annual temperatures occurring in the last 10-15 years.  Last month the National Air and Space Administration (NASA), one of the major climate science research agencies in the world, announced that the 2010 Meteorological Year (which runs from Dec. 2009 to Nov. 2010) was the warmest in NASA's 130-year historical record.  This week another climate research agency, the National Oceanographic and Atmospheric Administration (NOAA), reported that the 2010 calendar year (Jan. 1 through Dec 31) was tied with 2005 as the warmest in the record.

The NASA-reported Meteorological Year data show ocean and land average global temperature as 14.65˚C, which is 0.65˚C warmer than the average global temperature of the reference period between 1951 and 1980.  NOAA's data for the calendar year show that the average temperature in 2010 was 58.12˚F, the same as in 2005, both of which are 1.12˚F above the 20th-century average of 57˚C.

Overall, it was the 34th straight year that the average global temperatures were above the baseline average.  And this year did so despite the presence of a La Nina in the eastern Pacific, a phenomenon that generally dampens the warming effects somewhat.  The January to December 2010 (calendar) year temperature anomalies can be seen in the graphic below (source: NOAA National Climatic Data Center).

The bottom line is that the planet continues to warm dramatically.  According to NCDC, "the decadal global land and ocean average temperature anomaly for 2001–2010 was the warmest decade on record for the globe, with a surface global temperature of 0.56°C (1.01°F) above the 20^th century average. This surpassed the previous decadal record (1991–2000) value of 0.36°C (0.65°F)."

For more of the NOAA data, check out the National Climate Data Center web site.

2011 - International Year of Chemistry

For some reason I thought of Austin Powers, International Man of Mystery as I typed the title of this post.  In any case, 2011 has been officially declared the International Year of Chemistry by the UN General Assembly and led by IUPAC, the International Union of Pure and Applied Chemistry, and UNESCO, the United Nations Educational, Scientific, and Cultural Organization.  The main goals are to "increase the public appreciation of chemistry in meeting world needs, to encourage interest in chemistry among young people, and to generate enthusiasm for the creative future of chemistry. According to their web site:

The International Year of Chemistry 2011 (IYC 2011) is a worldwide celebration of the achievements of chemistry and its contributions to the well-being of humankind. Under the unifying theme “Chemistry—our life, our future,” IYC 2011 will offer a range of interactive, entertaining, and educational activities for all ages. The Year of Chemistry is intended to reach across the globe, with opportunities for public participation at the local, regional, and national level.

The American Chemistry Council (ACC), which represents much of the chemical industry in the United States, issued a press release in support of IYC 2011.  ACC said:

“Chemistry—our life, our future,” is the slogan of IYC 2011. During the year, a global chemistry experiment will be performed by many thousands of school children across the world, potentially becoming the biggest chemical experiment ever conducted.  Under the theme, “Water: A Chemical Solution,” students will focus on modules that examine the properties of their local water and the technological solutions chemistry makes available to humanity in supplying clean drinking water.  The global experiment will promote the goals of the IYC, including generating enthusiasm for science among young people around the world.

Experiment modules can be carried out by children of all ages in schools across all continents because they are adaptable to the skills and interests of students, and use equipment that is widely available at little or no cost.  Results will be electronically showcased as an interactive global data map at the end of 2011, demonstrating the value of international cooperation in science.

Besides the goals stated above, IYC 2011 will celebrate the 100th anniversary of Madame Curie’s Nobel Prize and the founding of the International Association of Chemical Societies.

More information on events and how you can get involved are on their web site at www.chemistry2011.org.

House Energy and Commerce Committee Gets New Chairs

No, not new furniture.  New Subcommittee chairs to go along with the Committee Chair, which went to Fred Upton of Michigan a few weeks ago.  Upton has now finished making assignments of chairs for the key Subcommittees.  According to Upton:

"We could not have a more talented and accomplished group of members on Energy and Commerce, ready to deliver the change the American people expect and demand," said Upton. "From repealing the job-killing health law to fighting rampant regulations, these subcommittees will be on the front lines as we work to fulfill our pledge to the American people to create jobs, cut spending, and reduce the size of government."

The Republican subcommittee chairs are:

Subcommittee on Commerce, Manufacturing and Trade: Chair – Mary Bono Mack (CA)

Subcommittee on Communications and Technology: Chair – Greg Walden (OR)

Subcommittee on Energy and Power: Chair – Ed Whitfield (KY)

Subcommittee on Environment and Economy: Chair – John Shimkus (IL)

Subcommittee on Health: Chair - Joe Pitts (PA)

Subcommittee on Oversight and Investigations: Chair – Cliff Stearns (FL)

It should also be mentioned that Joe Barton (TX) will be "Emeritus Chair" of the Committee as a sort of consolation prize for losing out to Upton.  The rest of the Republican subcommittee members can be seen here.

Henry Waxman, who chaired the committee during the last Congress, will be ranking Democratic member on the committee.  The Democrats have not yet named the ranking members of the subcommittees, but a list of the committee members can be found here.

Several Hundred Chemicals Classified as Carcinogens, Mutagens or Reproductive Toxins under REACH

As I noted last week, the European Chemical Agency (ECHA) received 3,114,835 notifications of 24,529 substances under its Classification, Labelling and Packaging (CLP) regulation. The deadline for notifying chemical classifications was January 3, 2011.  This includes those substances notified separately as well as classifications included in the November 30, 2010 REACH registration deadline.

The REACH registration deadline was for all substances manufactured or imported in the EU at greater than 1000 metric tons per year, but also for substances that met certain "very high concern" criteria no matter what tonnage at which they were on the market.  According to the ECHA registration numbers, about 400 substances registered met the criteria for being at least one (and possibly all three) of carcinogenic, mutagenic or a reproductive toxin (called CMR for short).  Another 150 or so were considered highly toxic to aquatic life.  These "substances of very high concern" (SVHCs) will get particular scrutiny as ECHA turns to evaluating the data dossiers received.  In fact, nearly 30 of these have already been identified by ECHA in their series of candidate list proposals.  Substances on the candidate list are likely then move to the Authorization Annex of REACH, which requires manufacturers to apply for "authorization" to continue producing the substance - though any authorization will be both time-limited (with a requirement to find a substitute within a short transition period) and use-limited (i.e., will only be authorized for very specific uses in which suitable health and environmental protections will be required to limit exposure during the transition period).

The next registration deadline under REACH is June of 2013 for substances of medium levels of production and use in the EU.  But in the interim REACH is undergoing an evaluation of the program to determine if changes are needed to improve both logistics and effectiveness.  Enforcement by the member states will also now be occurring, which likely will raise other issues in need of being addressed.

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.