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 On the same day as the EPA and White House announcements, FDA released a "draft guidance to provide regulated industries with greater certainty about the use of nanotechnology, which generally involves materials made up of particles that are at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.”

European and Australian Chemical Agencies Agree to Cooperate on Chemical Safety

The European Chemicals Agency (ECHA) and the Australian Government's National Industrial Chemicals Notification and Assessment Scheme (NICNAS), have signed a memorandum of understanding (MOU) to "enhance co-operation" in an effort to "improve chemical safety."  The MOU will allow the two agencies to share expertise on technical matters on, among other things, "the hazards and emerging risks of chemical substances, risk management tools, scientific collaboration and information exchange."

This isn't the first cooperative arrangement for ECHA.   They signed a "statement of intent" with the USEPA last December in which the two agencies agreed to "share data, cooperate with each other on chemical reviews, and even exchange staff."

According to ECHA:

One of the anticipated areas of collaboration will be exchange of information. For example, the Memorandum of Understanding will promote the exchange of non-confidential information on hazards, uses and identity of chemical substances between ECHA and NICNAS. The agencies will also be sharing information on ways to more efficiently address chemicals of concern.

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

NGOs to Deliver Petition to White House Today to Call for Leadership on Chemicals

A coalition of NGOs and advocates for health and environmental safety are delivering a petition today to the White House calling for President Obama to implement last years findings by the President’s Cancer Panel.  Safer Chemicals, Healthy Families is a coalition of more than 100 organizations and "represents more than 11 million individuals and includes parents, health professionals, advocates for people with learning and developmental disabilities, reproductive health advocates, environmentalists and businesses from across the nation."  The petition has been signed by more than 70,000 people according to the group, and calls for strengthening of both the "failed" 1976 Toxic Substances Control Act (TSCA) and the "ineffective" 1938 Food, Drug, and Cosmetics Act (FDCA).  According to the petition:

Every minute, at least one American will die from cancer. What is particularly frightening about this statistic is that, contrary to general assumption, many of these cancers could have been prevented.

The petition urges "the President to 'most strongly use the power of your office' to eliminate human exposure to cancer-causing chemicals."  It goes on to say:

By setting the course for a national cancer prevention strategy that includes eliminating the use of cancer-causing chemicals, the President can reverse decades of failed policies that have allowed those chemicals to contaminate our lives and endanger our health.

The petition can be viewed on the Safer Chemicals, Healthy Families web site.

EPA Launches Online ECHO Database to Help Public Find Clean Drinking Water

The USEPA has launched a new searchable online database to help the public determine if their community meets federal clean drinking water standards.  The database, called ECHO, was developed by EPA along with state governments and "allows users to find inspection, violation, enforcement action, informal enforcement action, and penalty information about facilities for the past three years."

ECHO focuses on facility compliance and EPA/state enforcement of environmental regulations. Though the data included within ECHO have been in the public domain through Freedom of Information Act requests and mainframe computer subscription, the information was not available in a searchable Web format. ECHO makes it much easier for the public to obtain these data records on the Internet. 

Facilities regulated under the following environmental statutes are included in the ECHO database:

• Clean Air Act (CAA) Stationary Source Program, 
• Clean Water Act (CWA) National Pollutant Elimination Discharge System (NPDES), 
• Resource Conservation and Recovery Act (RCRA), and 
• Safe Drinking Water Act (SDWA).

The interface integrates the data from a variety of EPA databases.  ECHO includes "a snapshot of a facility’s environmental record, showing dates and types of violations, as well as the state or federal government’s response."  

Access to the ECHO database and more information can be found here.

More information about the data that are included can be found here.

ECHA Says Vast Majority of Intermediate Registrations Under REACH Do NOT Meet Requirements

In a rather stunning announcement, the European Chemicals Agency (ECHA) has issued a news release saying that the vast majority - 86% of the over 400 registration dossiers for intermediates screened - "seem not to contain sufficient information to demonstrate that these conditions are fulfilled."  Intermediates are substances that are manufactured for use in manufacturing other substances (and meet the definitions stipulated by REACH Article 3(15)), and that are manufactured and/or used under "strictly controlled conditions."  As intermediates they benefit significantly from reduced data requirements for registration.

ECHA is encouraging registrants of intermediates "to proactively reassess and, where necessary, update their registration dossiers."  If ECHA concludes that the dossier provided based on the intermediate requirements is insufficient, they may require "that a standard dossier be prepared instead."  Standard dossier data requirements will depend on the tonnage band of the production, but generally will include significantly more data - and more expensive data - then the intermediates dossier.

In order to demonstrate that a substance’s use fulfils the criteria of an isolated intermediate, a registrant should provide information on the identity of the transformation products resulting from the use of the substance and/or information on the manufacturing processes related to the registered substances. The registration dossier for an intermediate shall also include sufficiently detailed information on the risk management measures describing how strictly controlled conditions are ensured, including a description of the technical means used to rigorously contain the substance. This will enable ECHA to verify the intermediate status. 

ECHA says that it has "already communicated with registrants of a number of intermediate dossiers on missing or doubtful information, by inviting them to update the dossiers."  But they also are encouraging other registrants to reassess their dossiers and document that they are taking steps to provide any needed updates so that "that documentation can then be shown to inspectors on demand."

The ECHA announcement can be read here.