ECHA Recommends 13 Chemicals for REACH Authorization (i.e., for the EU "to be banned" chemicals list)

The European Chemicals Agency (ECHA) has recommended thirteen additional chemicals for inclusion on its Annex XIV Authorization list.  These chemicals had been listed on ECHA's "candidate list" of Substances of Very High Concern" (SVHC).  Following consultation and comment, the 13 chemicals could be added to the list of chemicals that will be phased out from continued use, unless the manufacturer/importer applies for an "authorization" for an extended phase out period.  This is the third time ECHA has recommended a set of chemicals for inclusion on Annex XIV.


The following substances are on the third recommendation list:

1. Chromium trioxide;
2. Chromic acid, Oligomers of chromic acid and dichromic acid;
3. Sodium dichromate;
4. Potassium dichromate;
5. Ammonium dichromate;
6. Potassium chromate;
7. Sodium chromate;
8. Trichloroethylene;
9. Cobalt(II) sulphate;
10. Cobalt dichloride;
11. Cobalt(II) dinitrate;
12. Cobalt(II) carbonate;
13. Cobalt(II) diacetate.

According to ECHA's press release:

Using the web forms available on ECHA’s website, interested parties are invited to comment, in particular on the uses that should be exempted from the authorisation requirement.

More information about how to comment and the authorization process can be found here.

EPA Makes Available Two New Chemical Toxicity Databases

The USEPA has announced that it is making available two new databases to make it easier for people to find chemical data.  One database is the Toxicity Forecaster database (ToxCastDB) containing toxicity information.  The other is a database of chemical exposure studies (ExpoCastDB), which can be used to evaluate how much chemical to which people may be exposed.  Both are searchable.

The Toxicity Forecast database (ToxCastDB) can be used to download toxicity data from more than 500 rapid chemical tests that have been conducted on more than 300 environmental chemicals.  "ToxCast uses advanced scientific tools to predict the potential toxicity of chemicals and to provide a cost-effective approach to prioritizing which chemicals of the thousands in use require further testing."  Another 700 chemicals are currently being screened using ToxCast, with the data expected to be available by next year.

The ExpoCast database "consolidates human exposure data from studies that have collected chemical measurements from homes and child care centers."  According to EPA's press release, "data include the amounts of chemicals found in food, drinking water, air, dust, indoor surfaces and urine."  Additional external and internal chemical exposure data will be added as they become available. 

The new databases link together two important pieces of chemical research — exposure and toxicity data — both of which are required when considering potential risks posed by chemicals. The databases are connected through EPA’s Aggregated Computational Toxicology Resource (ACToR), an online data warehouse that collects data on over 500,000 chemicals from over 500 public sources.

Users can now access 30 years worth of animal chemical toxicity studies that were previously only found in paper documents, data from rapid chemical testing, and various chemical exposure measurements through one online resource. The ability to link and compare these different types of data better informs EPA’s decisions about chemical safety.
 

More information and links to the databases can be found on the EPA web site.

ECHA Forces Private Company to Close its REACH Chemicals Database

As part of its REACH chemical regulation program, the European Chemicals Agecny (ECHA) has created a database portal called REACH-IT by which companies are required to submit their REACH data dossiers and conduct other business with ECHA online.  ECHA has now forced one company, Eugachem, to stop selling information it had inappropriately obtained on pre-registered chemicals.

The first step of REACH was for companies to "pre-register" their existing chemicals, i.e., inform ECHA via the REACH-IT system that they intended to register existing chemicals in Europe.  This pre-registration gave companies the benefit of a grace period during which they could stay on the market while they developed their data dossiers.  Any chemicals not pre-registered would be considered "new" chemicals, and companies had to provide the data dossiers to ECHA prior to going on the market.

According to ECHA, they first became aware in June 2009 that the company Eugachem was selling information on pre-registrations; information that they had obtained from another company that had pre-registered the entire EINECS list (the former list of all existing chemicals in Europe). The company was essentially sued in the German courts and ECHA "considered Eugachem’s use of this information as a breach of ECHA’s copyrights in the REACH-IT database and the other company’s transfer of this information to Eugachem as a breach of ECHA’s terms and conditions of use of REACH-IT."

As a result of court action:

Eugachem has now agreed to discontinue the service and to destroy all data on pre-registered substances in its possession. The company that transferred the data to Eugachem has agreed to use the data that has been or will be taken from the REACH-IT database only within the scope of the “Terms and conditions of use and services of REACH-IT”. It further agreed to no longer transfer such data to third parties, and to identify those pre-registrations which it actually needs for fulfilling its obligations under REACH. Its other pre-registrations will be deleted.

More information and a reminder by ECHA of the terms and conditions of use of REACH-IT can be found on the ECHA web site.

NASA Launches Aquarius/SAC-D Satellite to Collect Global Warming/Salinity Data

In case you missed it, last Friday NASA, along with the Space Agency of Argentina, launched the international "Aquarius" satellite.  According to NASA, Aquarius "is a focused effort to measure Sea Surface Salinity and will provide the global view of salinity variability needed for climate studies." A Delta II rocket lifted off from Vandenberg Air Force base carrying the Aquarius/SAC-D spacecraft.  Within an hour it had "separated from the rocket's second stage and began communicating with ground controllers and unfurling its solar arrays."

The mission of Aquarius is to investigate the salinity of the oceans.  Within a few months, "Aquarius will collect as many sea surface salinity measurements as the entire 125-year historical record from ships and buoys."  These data will be invaluable in the investigation of the water cycle, ocean circulation, and climate change.

Regarding the climate aspects, the blog RealClimate, run by a group of world renowned climatologists, has a great summary of why the data Aquarius collects is so important.

You can follow the progress of Aquarius on the NASA web site here.

Nanotechnology News You Can Use

Nanotechnology is a hot topic these days, mainly because people are trying to figure out how, or even whether, to regulate them compared to the same chemical in non-nano form.  Nano, of course, refers to very small sized versions (usually < 100 nanometers) of chemicals that may already have widespread use (e.g., carbon, titanium dioxide, etc.).  The question comes down to whether the small size gives the substance different physical-chemical properties and/or makes it more likely to cause toxicity.

On June 9, 2011, the White House issued a memo instructing regulators in all federal agencies to use "flexible, adaptive, and evidence-based approaches that avoid, wherever possible, hindering innovation and trade while fulfilling the federal government's responsibility to protect public health and the environment."  The memo cautioned agencies to "avoid making scientifically unfounded generalizations that categorically judge all applications of nanotechnology as intrinsically benign or harmful,” and offered ten principles to address concerns.


Meanwhile, on the same day, the USEPA announced a proposed policy for obtaining information on what nanoscale materials are contained in pesticide products.  The proposal relies on a case-by-case approach to determine if a nanoscale ingredient should be considered "new active or inert ingredient" despite having a non-nano form already registered under FIFRA, the US pesticide law.

Finally, the FDA has gotten into the act by "taking the 'first step' toward greater regulatory certainty around nanotechnology." On the same day as the EPA and White House announcements, FDA released a "draft guidance to provide regulated industries with greater certainty about the use of nanotechnology, which generally involves materials made up of particles that are at least one billionth of a meter in size. The guidance outlines the agency’s view on whether regulated products contain nanomaterials or involve the application of nanotechnology."  The guidance names "certain characteristics – such as the size of nanomaterials used and the exhibited properties of those materials – that may be considered when attempting to identify applications of nanotechnology in regulated products."

All of these announcements reflect a worldwide effort to better characterize nano-scale materials and their safety to the public and environment.

 

EPA Goes Transparent Again - Removes Confidentiality Claims for 150+ Chemicals

In its continuing efforts to make chemical information more transparent, the USEPA has decided to make public "the identities of more than 150 chemicals contained in health and safety studies that had been claimed confidential by industry."  EPA is taking this, and other actions, to "provide the public with greater access to information on the chemicals that are manufatured and used in the United States."  According to Steve Owens, Assistant Administrator for EPA's Office of Chemical Safety and Pollution Prevention:

“A health and safety study with the chemical name kept secret is completely useless to the public.” 

As expected, the NGO advocacy community responded positively to the announcement, though they would prefer even more information to be released to the public.  The chemical industry, led by the American Chemistry Council, noted that it supported "EPA's mission to promote public understanding of the potential risks posed by chemicals in commerce," but also was concerned that "critical information needed by businesses to innovate and succeed in a competitive international marketplace” needed to be kept confidential."

 More information can be found at the EPA site here.

EPA Gets a "Scientific Integrity Officer"

The USEPA now has its first scientific integrity officer.  EPA named William Sanders, an EPA veteran who is currently the Director of the National Center for Environmental Research (NCER) at EPA to the position.  Sanders will be in charge of implementing EPA's new scientific integrity policy, which was initiated by executive order from President Obama and is due to be completed some time in the fall.

Sanders' appointment comes before an expected report from the Inspector General's office within EPA, which will include advice on what steps need to be taken to ensure the integrity of all scientific work done at EPA.  The IG recently faulted EPA for its lack of action identifying endocrine disruptor chemicals as required by two laws passed in 1996.  The upcoming IG report, expected this summer, reviewed EPA internal policies and processes and will provide advice on maintaining scientific credibility, identifying and dealing with scientific misconduct, and record keeping. 

Sanders has been at EPA for more than three decades in a variety of roles.  According to sources, the role as NCER chief has caused some to question his ability to take on the new appointment.  Apparently morale has been dropping since he started at NCER, with many employees choosing to leave.  Still, the scientific integrity officer role will allow Sanders to oversea the new integrity policy and incorporate the suggestions from IG and others.

Scientists say Carbon Release to Atmosphere 10 Times Faster than in the Past

Specifically, in the the Paleocene-Eocene Thermal Maximum (PETM), which was about 55.9 million years ago, and according an the international team of research geologists, is "the best analog we have for current global warming."  And that rate of carbon release "may not allow sufficient time for the biological environment to adjust."

As noted in a recent Science Daily article, there are some uncertainties with the core data during this time period because the cores contain layers of calcium carbonate, and "when large amounts of greenhouse gases -- carbon dioxide or methane -- are in the atmosphere, the oceans become more acidic, and acid dissolves calcium carbonate."  The concern is the change may appear more abrupt than it actually was because of the incomplete record.  So the fact that the PETM rate may have been perhaps slower than we think emphasizes even more the fact that the current rate of carbon release is 10 times faster.  In short, it could be more than 10 times.

"We looked at the PETM because it is thought to be the best ancient analog for future climate change caused by fossil fuel burning."

According to the researchers, "The outcome was a warming of from 9 to 16 degrees Fahrenheit and an acidification event in the oceans."  And that's not good.  Furthermore, according to Lee R. Kump, a professor of geosciences at Penn State:

"Rather than the 20,000 years of the PETM which is long enough for ecological systems to adapt, carbon is now being released into the atmosphere at a rate 10 times faster. It is possible that this is faster than ecosystems can adapt."

For those who want to read the original journal article, the full citation is:

Ying Cui, Lee R. Kump, Andy J. Ridgwell, Adam J. Charles, Christopher K. Junium, Aaron F. Diefendorf, Katherine H. Freeman, Nathan M. Urban, Ian C. Harding. Slow release of fossil carbon during the Palaeocene–Eocene Thermal Maximum. Nature Geoscience, 2011; DOI: 10.1038/ngeo1179

NGO Calls on Chemical Industry to Initiate Biomonitoring of Chemicals in People

The Environmental Working Group (EWG), long known for its reports on chemicals found in people, cosmetics, and sunscreens, has written a letter to USEPA Administrator Lisa Jackson urging her to use EPA's authority to compel the chemical industry to conduct biomonitoring studies.  EWG argues that "biomonitoring studies are regularly conducted by academic and government scientists and have become vital elements in determining toxic pollutants found in the bodies of Americans and the health risks these chemicals may pose," but that there was "little evidence that industry is submitting biomonitoring studies to EPA." According to EWG President Ken Cook:

“Logically, the chemical industry should be conducting the same basic studies to understand the safety of its chemicals for the public. And if not, then why not?”

According to their news release, the NGO "strongly advocates that regulators and industry test for synthetic chemical contaminants in people, especially in human umbilical cord blood. These tests demonstrate how readily chemicals enter and accumulate in our bodies, even during the earliest stages of development.”  Cook argues that section 8(d) of TSCA gives EPA the authority to require the submission of "unpublished health and safety studies, as well as authority under TSCA 8(e) to require immediate notification of any evidence of "substantial risk."

The letter from EWG to Administrator Jackson can be read and downloaded as a PDF here.

Inspector General Faults USEPA for Inaction on Endocrine Disruptor Chemicals, Recommends Fixes

The Office of Inspector General (IG) at the USEPA has issued a report on EPA's Endocrine Disruptor Screening Progam (EDSP), and the results are not good.  Fourteen years after it was mandated in the Food Quality Protection Act (FQPA) and Safe Drinking Water Act (SDWA), "EPA's EDSP has not determined whether any chemical is a potential endocrine disruptor."  In fact, according to the IG report, "EDSP has not developed a management plan..., or established outcome performance measures to track program results."

In addition, EDSP has "missed milestones for assay validation and chemical selection established by the 2001...NRDC...settlement agreement."  What's more, even though the EDSP noted that it "was unaware of the complexities, resources, and time needed to validate assays until years after the 2001 settlement agreement was signed," it made only rudimentary adjustments to its milestone schedule.  To the IG, the lack of management plan by EPA and the EDSP severely restricts its ability to meet the requirements of the statute.  The IG notes that the EDSP "plans to develop a management plan" but "had not done so at the time of our review."

To correct these deficiencies, the Inspector General report makes the following recommendations:

• define and identify the universe of chemicals for screening and testing
• develop and publish a standardized methodology for prioritizing the universe of chemicals for screening and testing
• finalize specific Tier 1 and Tier 2 criteria to evaluate testing data
• develop performance measures
• develop a comprehensive management plan, and
• hold annual program reviews.

EPA responded to the IG's report but the IG felt the response was inadequate for some of the recommendations.  They consider the first three and last of the six recommendations "unresolved."

Clearly more effort on the part of EPA, and of Congress to provide funding to EPA so they can do what Congress has mandated, is necessary.

The Inspector General's report, 11-P-0215, can be downloaded as a PDF here.

Head of Royal Society Says Freedom of Information Laws are Being Used to Harass Scientists

Sir Paul Nurse, president of the prestigious Royal Society in London, says that freedom of information (FOI) laws are being misused in organized attempts to harass climate scientists.  While emphasizing that FOI laws are important tools needed to ensure transparency, Nurse, the Nobel Prize winner for Medicine in 2001, argues that anti-climate science lobbying groups have orchestrated an organized campaign of requesting "data and other research materials" for the primary purposes of intimidating climate scientists and slowing down both research and legitimate communication of the science.

According to The Guardian online, another scientist, Bob Ward of Grantham Research Institute, complained that FOI requestors weren't interested in the science but rather the requests were "being used in an aggressive and organized way" to look for problems and errors.  And according to Chris Mooney in relation to another FOI fishing expedition involving Michael Mann in the US, the climate science deniers will twist whatever they receive into whatever they need it to be to confirm their predetermined belief.  Just as they did for the infamous climategate emails, which despite six separate investigations exonerating all the scientists involved, yet the climate denial industry continues to treat as a condemnation of the science (which it wasn't).

The UK FOI requests have been overly burdensome on researchers, as requests have included "among other things, all drafts of scientific papers prior to their publication in journals, with annotations, explaining why changes were made between successive versions."  Again, the intent isn't to understand better the science or the research. According to Nurse, the net result is that which the organized campaigns intended - intimidation and time taken away from doing research.

Scientists, of course, need to be more open and transparent, but then they, like all of us, produce many emails a day on things that aren't particularly interesting or controversial.  To have to organize them for FOI release even though they have no meaning limits their ability to do research.  To have to spend even more time correcting the often intentional misinterpretation (or disinterpretation) of their words by climate change deniers is a burden no professional should have to bear. 

FOI is important for transparency, and the Royal Society and others are looking for ways to bring the process up to speed with modern technology.  But unfortunately there are many who are abusing FOI, not to improve transparency, but to harass climate scientists and disinform the public.  The harassment has to stop.

Seven New "Substances of Very High Concern" Named by ECHA's Member State Committee

The Member State Committee (MSC) of the European Chemicals Agency (ECHA) in Helsinki, Finland, has named an additional seven substances as Substances of Very High Concern (SVHC) under the REACH chemical regulation in Europe.  Listing of these chemicals is based on them being CMR, i.e., being either carcinogenic, mutagenic, or reproductive toxins.  The seven substances are:

• 2-ethoxyethylacetate
• strontium chromate
• 1,2-benzenedicarboxylic acid, di-C7-11 branched and linear esters (DHNUP)
• hydrazine
• 1-methyl-2-pyrrolidone
• 1,2,3-trichloropropane
• 1,2-benzenedicarboxylic acid, di-C6-8 branched alkyl esters, C7-rich (DIHP)

All seven new substances are to be listed on the candidate list.  DHNUP and DIHP will join other phthalates on the candidate list.  Ultimately, substances on the candidate list could be added to Annex XIV of REACH, which means they would be subject to banning unless manufacturers successfully apply for authorization for continued use. Authorization is normally for a very limited period of time (e.g., 4-5 years), generally is restricted to specific uses, and must be accompanied by a plan to find suitable, less hazardous, substitutes.

Once the MSC formally presents its recommendations to ECHA, the Agency will add the substances to the candidate list.

The ECHA announcement can be read here.

The current candidate list can be found here.

ECHA Issues New Substance Evaluation Criteria for REACH Chemical Assessments

The European Chemicals Agency (ECHA) has issued "selection criteria" for substance evaluation under the REACH program.  These criteria will be used by ECHA and the Members States to identify candidate substances for the first Community Rolling Action Plan (now called CoRAP after someone pointed out the inadequacy of its original acronym, CRAP).

According to ECHA:

Substance evaluation aims to clarify whether a given substance constitutes a risk to human health or the environment in cases where insufficient information is available. Substance evaluation will be conducted only in relation to a selected number of substances which will be chosen according to risk-based criteria. The prioritisation criteria cover hazard information, exposure information and tonnage of substances including the aggregated tonnage from the registrations submitted by several registrants. The first set of criteria is adopted by ECHA according to Executive Director's decision taken on 26 May 2011. ECHA and the Member States are using these criteria to identify possible substances that may be listed on the CoRAP and evaluated by Member States. In addition to this the Member States can also propose substances to be prioritised at any time on other risk-based grounds too. In the future, this first set of criteria will be further refined by ECHA in cooperation with the Member States.

The criteria identified by ECHA include the following:

Hazard related selection criteria:

• Suspected PBTs, vPvBs, and PBT-like substances
• Known PBTs/vPvBs
• Suspected endocrine disruptors
• Suspected CMRs
• Known CMRs
• Suspected sensitizers
• Known sensitizers

Exposure related selection criteria:

• Wide dispersive use
• Number of sites of use
• Pattern and amount of releases/exposure
• Number and type of reported uses and exposure scenarios
• Incorporation into mixtures or articles used by the public
• Potential size of the exposed population
• Number of using sites if emission is due to industrial use
• Consumer use and exposure of sensitive subpopulations such as children
• Aggregated tonnage

Risk related selection criteria:

• The risk assessment in the chemical safety report shows the risk characterization ratio is not well below 1 for human and/or environmental exposure
• Cumulative exposure from related substances with critical hazardous properties

More information on the criteria can be downloaded as a PDF file here.

Actress Jessica Alba joins Senator Lautenberg to Support TSCA Reform

Who knew Senator Frank Lautenberg could attract Hollywood actresses to support chemical law reform.  But this week that is exactly what the 87 year old New Jersey Senator did on May 24th, 2011.  He even posted a Twitter photo to prove it. 

Jessica Alba joined Lautenberg to support his Safe Chemicals Act of 2011, the newest version of his many attempts to reform the Toxic Substances Control Act (TSCA).  Alba said that she was supporting TSCA reform because she is pregnant and is concerned about products intended to be used by young children that may contain chemicals not adequately tested.  She also is a spokesperson for the NGO coalition, Safer Chemicals, Healthy Families.

Unfortunately, it's unlikely that Alba's support will change the reality of the current stalemate in Congress.  While in Lautenberg's Senate the Democrats still hold a tiny majority, the House is now under the control of the Republican party, who show no inclination to take any regulatory overhaul other than cutting programs and budgets for agencies such as EPA that are charged with "protecting human health and the environment."  This despite industry assertions that they believe TSCA is in need of reform, aka, modernization.  Needless to say the NGOs believe TSCA reform is needed an have already deemed Lautenberg's newest iteration of the bill to have given in to industry concerns (too much in their opinion).

So it seems all parties say they want TSCA reform, but then don't seem inclined to actually act upon it.

According to Lautenberg:

“Under current policy, EPA can only call for safety testing after evidence surfaces demonstrating a chemical is dangerous. As a result, EPA has been able to require testing for just 200 of the more than 80,000 chemicals currently registered in the United States, and has been able to ban only five dangerous substances.”