The Dake Page

EPA Will Not Change Chemical Data Reporting Deadline Despite House Request

2012-02-02T08:42:00.000-05:00

EPA has decided that it will would not change the reporting deadline for the new Chemical Data Reporting (CDR) rule despite a letter from Republican Representative Fred Upton, chair of the House Energy and Commerce Committee. The CDR requires chemical manufacturers to provide data during the period from February 1 to June 30, 2012. The letter from Upton, along with fellow Republican John Shimkus, argued that the reporting rule - which had been delayed by nearly a year already - was overly burdensome to industry. In their January 30, 2012 response, acting EPA toxics chief Jim Jones noted that “the EPA provided a five month reporting period for this first round of reporting to provide additional time for companies to review and understand changes in the reporting requirements, gather the necessary information, and file through the agency's electronic reporting system.”

Jones also noted that, “we believe that the current five month window for companies to report, along with their ability to engage the agency directly on any questions or issues they may have, provides an adequate opportunity for reporting by June 30, 2012.”

The final CDR was published on August 15, 2011, thus giving substantial time for industry to understand their obligations and prepare for the submission. EPA also recently provided guidance for submitting byproduct data, a key concern expressed in the Upton/Shimkus letter. Overall, EPA believes that it has provided substantial lead time and guidance for industry to comply and that the additional delays requested by the Republican members of the House are both unwarranted and would reduce the availability of vital, and Congressionally-mandated, health and safety information from the public.

More information on Chemical Data Reporting can be found on EPA's web site.

Japan Allows 1-week to Register New Chemicals - Don't Miss It

2012-01-31T08:14:00.000-05:00

Japan has announced that it will accept applications for manufacture or import of new chemicals meeting their small quantity criteria, but these applications must be filed during a single one-week period from February 28th to March 7th, 2012. This is in accordance with Japan's Chemical Substance Examination and Manufacturing Control law. For readers of Japanese, more information is available on the Environmental agency website.

The announcement was made by the Japanese Ministry of Economy, Trade, and Industry; the Ministry of Health, Labor, and Welfare; and the Ministry of the Environment. The application requirement applies to annual quantities of 1 to 10 metric tonnes and for only chemicals that are new to Japan (existing chemicals in Japan are not included in the requirement).

This annual event has been occurring for the last 8 years, with the number of applications growing from only about 100 in 2004 up to over 1000 by 2010.

ECHA Says "Only Representatives" Can Apply for Chemical Authorization

2012-01-30T08:10:00.000-05:00

According to the European Chemicals Agency (ECHA):

"In December 2011, the European Commission services informed ECHA that, in their view, an Only Representative (OR) of a non-EU manufacturer can also apply for authorisation. Following this, ECHA updated the webforms to allow ORs to send their applications while developing long term functionalities in REACH-IT. The relevant Data Submission Manual Part 22 - How to Prepare and Submit an Application for Authorisation using IUCLID 5 is also being updated and will be published once the new version of IUCLID is released, which is currently expected to be during summer 2012."

Previously it was assumed that only a European registrant could apply for authorization under REACH. Authorization is the process by which companies can apply to keep certain uses of their Substances of Very High Concern (SVHC) that have been targeted for banning on the market for a limited period of time while alternatives are developed.

More information on applying for authorization can be found on the ECHA site.

With No TSCA Chemical Reform on the Horizon, States Take the Lead

2012-01-26T13:36:00.000-05:00

With TSCA reform at the federal level highly unlikely to occur in this election year, the individual states are expected to step up their ongoing battle to protect human health and the environment from chemicals. According to Safer States, "at least 28 state legislatures will consider proposals to address continued concerns about toxic chemicals in consumer products." This builds on "over 80 chemical safety laws [that] have been passed with an overwhelming margin of bi-partisan support in statehouses across the country" during the last nine years.

Safer States is "a network of diverse environmental health coalitions and organizations in states around the country" and is a part of Safer Chemicals, Healthy Families, a "coalition of groups united by their common concern about chemicals in our homes, places of work, and products we use every day."

The organization has posted what they see as highlights of the 2012 state legislative efforts, as follows:

Identification and Disclosure of Chemicals Harmful to Children. At least 13 states, including Alaska, Connecticut, Florida, Illinois, Maryland, Massachusetts, Michigan, Minnesota, New York, New Jersey, Oregon, Vermont, and Washington will consider policies to identify and ultimately reduce exposures to chemicals of concern, including prioritizing chemicals for state action and requiring manufacturers of consumer products to disclose the chemicals in their products.
BPA Phase Outs. At least 20 states will consider policy to restrict the use of the hormone-disrupting chemical BPA in infant formula cans, other food packaging, children's products, and receipt paper. Alaska, Alabama, Arizona, Connecticut, Colorado, Georgia, Hawaii, Illinois, Iowa, Kentucky, Massachusetts, Maine, New Hampshire, New York, North Carolina, New Jersey, Tennessee, Virginia, West Virginia and Wisconsin are all states considering such legislation.
Tris Flame Retardant Phase Outs. At least four state legislatures will introduce policies to phase out the use of the flame retardant chlorinated Tris in children's products. Chlorinated Tris is a flame retardant that was removed from children's pajamas in the 1970s because of concerns over adverse health effects, including cancer, but has reappeared in other children's products. Connecticut, Maryland, New York, and Washington are legislatures considering such a ban. In addition, Alaska, Michigan, New Jersey and New York legislatures will consider policies to reduce exposure to the flame retardant decaBDE.
Green Cleaning in Schools. Earlier this month, Vermont passed policy requiring manufacturers to only sell environmentally preferable cleaning products to schools. Massachusetts, New Jersey, New York, and North Carolina are considering similar policy.
Cadmium Bans in Children's Products. At least 5 states will be introducing or have introduced policies to ban the use of cadmium in children's products, including Hawaii, Maryland, Michigan, New York, and Tennessee. Cadmium is linked to cancer and other health effects.
Other policies. Oregon has introduced policy to require the state to reduce toxics through its procurement process. New York is considering policy to restrict formaldehyde in beauty products. Massachusetts and Georgia are also considering policy to improve the safety of cosmetics. Other states have introduced individual chemical restrictions, such as lindane in Michigan and perchloroethelyene in Vermont.

Ironically, while the chemical industry has indicated that it prefers the reform of TSCA on the federal level rather than a patchwork of state and local laws, the lack of action on TSCA is serving as a catalyst for states and municipalities to create that patchwork in earnest.

The full Safer States press release can be viewed and downloaded as a PDF here.

Obama Nominates Jim Jones to Officially Head EPA Toxics Office

2012-01-24T07:33:00.000-05:00

The White House has announced that President Obama will nominate long-time EPA leader Jim Jones to be the Assistant Administrator of the Office of Chemical Safety and Pollution Prevention (OCSPP). Jones has been acting chief of the office since the departure of Steve Owens last October. Jones' nomination must be confirmed by the Senate, a prospect that led some to believe Obama would not officially nominate anyone during this contentious election year. Another nominee, Ken Kopocis to be Assistant Administrator of the Office of Water, has been held up by Republicans critical of ongoing rulemaking from that office.

Jones has previously served as Deputy Assistant Administrator in the Office of Air and Radiation as well as Deputy Assistant Administrator for the Office of Chemical Safety and Pollution Prevention. He previously also was Director of the Office of Pesticide Programs and "held a series of management positions in the EPA’s Office of Pesticide Programs" in a career that goes back to 1991 at EPA.

The Office of Chemical Safety and Pollution Prevention is charged with overseeing EPA's regulation of industrial chemicals and pesticides. EPA and many of the Office's programs have been mired in a seemingly constant battle to maintain funding for "protection of human health and the environment" as Congress tries to limit EPA's ability to do so. Several initiatives and rulemakings have also been hung up under review at the Office of Management and Budget.

The White House announcement of this and other key administration posts can be read here.

EPA Provides Guidance for Reporting Byproduct Data Under the Chemical Data Reporting Rule

2012-01-23T12:29:00.000-05:00

The USEPA will be providing additional information related to the Chemical Data Reporting (CDR) Rule, which was formerly the Inventory Update Rule (IUR). Many companies have been confused about what they actually have to report. And a recent workshop dealt with one specific type of chemical - byproducts.

More information will be coming sometime in January. Until then, those companies who are still trying to figure out their obligations can check EPA's Frequently Asked Questions (FAQ) page on the 2012 CDR, which can be found here.

Additional useful information is available from a workshop held January 19, 2012 at the Washington University Law School. The workshop, sponsored by law firm Bergeson & Campbell and the USEPA, looked specifically on how to report byproducts and recycled substances under the CDR. An overview and slide presentations, as well as case studies and an audio playback, can be downloaded here.

More information on the CDR can be found on EPA's web site.

California and EPA to Work Together on Green Chemistry Promotion

2012-01-20T07:36:00.000-05:00

The USEPA and the California Department of Toxic Substances Control (DTSC) have signed a formal Memorandum of Understanding (MOU) to cooperate on the development of green chemistry. The MOU is designed to use the combined resources of these two agencies to promote green chemistry and reduce the amounts of chemicals considered "toxic" in consumer products. According to the DTSC press release:

This formal agreement outlines principles by which DTSC and U.S. EPA will cooperate to reduce toxic chemicals in consumer products, create new business opportunities in the emerging safer consumer products economy, and reduce the burden on consumers and businesses struggling to identify what’s in the products they buy for their families and customers.

More information about the cooperative MOU can be found in the DTSC press release.

The MOU itself can be read here.

EPA Makes Available 2010 Greenhouse Gas Emissions Data from Large Facilities

2012-01-12T09:11:00.000-05:00

The USEPA has issued, for the first time, "comprehensive greenhouse gas (GHG) data reported directly from large facilities and suppliers across the country." The data are the first made accessible to the public through EPA’s GHG Reporting Program. According to EPA, "the 2010 GHG data released today includes public information from facilities in nine industry groups that directly emit large quantities of GHGs, as well as suppliers of certain fossil fuels."

The public can now go online to "view and sort GHG data for calendar year 2010 from over 6,700 facilities in a variety of ways—including by facility, location, industrial sector, and the type of GHG emitted. This information can be used by communities to identify nearby sources of GHGs, help businesses compare and track emissions, and provide information to state and local governments."

In their press release, EPA notes that "GHG data for direct emitters show that in 2010:

•Power plants were the largest stationary sources of direct emissions with 2,324 million metric tons of carbon dioxide equivalent (mmtCO2e), followed by petroleum refineries with emissions of 183 mmtCO2e.

•CO₂ accounted for the largest share of direct GHG emissions with 95 percent, followed by methane with 4 percent, and nitrous oxide and fluorinated gases accounting for the remaining 1 percent.

•100 facilities each reported emissions over 7 mmtCO2e, including 96 power plants, two iron and steel mills and two refineries."

To access EPA’s GHG Reporting Program Data and Data Publication Tool

President Obama "Stands With" the EPA

2012-01-11T08:02:00.000-05:00

President Barack Obama made his first visit to the USEPA to thank them for their service. The visit comes during a time when two of EPA's most visible leaders - Steve Owens and Paul Anastas - have recently stepped down to return to private and academic careers. According to his remarks:

The main reason I’m here is simple: I just want to say thank you. I want to say thank you to each and every one of you, because the EPA touches on the lives of every single American every single day. You help make sure that the air we breathe, the water we drink, the foods we eat are safe. You protect the environment not just for our children but their children. And you keep us moving towards energy independence.

Over the last 3 years the EPA has faced considerable political attack on its ability to carry out its functions, with Congress voting to cut its budget severely and blocking needed regulatory efforts to constrain greenhouse gas emissions to fight man-made climate change. Obama countered the artificial argument offered by some in Congress that human health and the environment must be sacrificed for economic reasons, saying:

Safeguarding our environment is also about strengthening our economy. I do not buy the notion that we have to make a choice between having clean air and clean water and growing this economy in a robust way. I think that is a false debate.

Finally, the President indicated he would stand up for the EPA so that they can do their jobs. He noted:

So all of you, and all of those who served before you, have made a difference. Our environment is safer because of you. Our country is stronger because of you. Our future is brighter because of you. And I want you to know that you’ve got a President who is grateful for your work and will stand with you every inch of the way as you carry out your mission to make sure that we’ve got a cleaner world.

The White House press release is available here.

The full text can be read here.

A video of the President's speech can be seen below.

GAO Finds that "Challenges" Remain with EPA's IRIS Chemical Assessment Program

2012-01-10T13:53:00.000-05:00

The Government Accountability Office (GAO) says that "EPA faces both long-standing and new challenges in implementing the IRIS program," a conclusion of which EPA agrees and backs further improvements to increase the transparency and efficiency of its chemical risk assessment program - the Integrated Risk Information System, or IRIS. GAO issued its final report on January 9, 2012 after issuing a preliminary report last year.

IRIS has come under attack from both industry and NGOs as either not adhering to "sound science" or "being too slow to complete assessments," respectively.

The GAO report, "Challenges Remain with EPA's Integrated Risk Information System (IRIS) Program," recommends the EPA present a workable time frame for each step of the IRIS assessment process. GAO also recommended that EPA work out how it will implement previous recommendations of the program offered by the National Academy of Sciences, and provide agendas for chemicals under review and when they will be completed.

The American Chemistry Council (ACC) welcomed the GAO report, saying in their press release:

The report by the Government Accountability Office affirms widespread recognition, including recent comments from the National Academy of Sciences (NAS), that despite a series of attempts to improve the process behind EPA’s Integrated Risk Information System, the program still falls short of meeting the benchmarks of objectivity, scientific accuracy and transparency. The report shows that these longstanding problems have yet to be addressed and EPA has not developed a clear plan for fixing IRIS.

And yet, a recent report by the Natural Resources Defense Council, an NGO, suggested that the chemical industry was engaging in a "delay game" to "duck" regulations. The NRDC report, "The Delay Game: How the Chemical Industry Ducks Regulations of the Most Toxic Chemicals," charges that weaknesses in TSCA "have allowed chemical companies to exploit the act by thwarting the EPA's attempts to finalize health assessments and delaying regulation of chemicals -- sometimes for decades."

How EPA will implement the GAO and NAS recommendations is uncertain, as is who will lead the effort since last week Paul Anastas, the head of EPA's Office of Research & Development, is leaving his position to return to academic life at Yale.

The GAO report can be downloaded as a PDF here.

Paul Anastas, Head of Office of Research and Development, to Leave EPA

2012-01-06T08:02:00.001-05:00

According to a tweet on the Agency's Twitter account, Paul Anastas will leave EPA in mid-February. Anastas, whom some refer to as "The Father of Green Chemistry," has served as Director of EPA's Office of Research and Development (ORD) for the last two years. He will return to Yale University where he once was Director of the Center for Green Chemistry and Engineering. According to Twitter:

Dr. Anastas announces departure frm EPA, mid February to return to @Yale & family. EPA experience "rewarding, challenging & enlightening"

In an email to colleagues Anastas indicated that he will pursue research similar to what he did before at Yale. Previously Anastas had advocated the development of "greener" chemicals, i.e., those with a smaller ecological footprint and/or less toxic. His research included the synthesis of green chemicals, polymers derived from biological sources rather than petroleum-based sources, and a variety of other practical methods used to develop safer chemicals.

Anastas writes in his email that he

"will continue to be part of the broader pursuit of sustainability through my work and research at Yale University. I have said before that while I can't always guarantee the win, I will always guarantee the fight. I have fought beside you in taking the necessary steps to protect the health and environment of the American public."

The EPA Twitter account tweeted on January 5th that:

EPA researchers will keep on the Path Forward Dr Anastas championed - Research for the 21st Century:

Given the current state of Congress and their unwillingness to confirm even the least controversial executive positions, it is uncertain when EPA Administrator Lisa Jackson and President Barack Obama will nominate a replacement to head ORD. Last fall the President appointed Jim Jones to be Acting Director of the Office of Chemical Safety and Pollution Prevention to replace outgoing Director Steve Owens. Most likely an Acting Director for ORD will be appointed, with some suggesting it could be Associate Assistant Administrator Ramona Trovato.

Climate Scientist, former IPCC Chair, Bob Watson Honored with Knighthood

2012-01-05T08:37:00.000-05:00

Climate scientist Bob Watson of the University of East Anglia has been awarded a knighthood. Watson is a professor of environmental sciences at UEA and also Director of the Tyndall Centre for Climate Change Research, where he has been since 2007. He was Chair of the Intergovernmental Panel on Climate Change (IPCC) from 1997 to 2002.

Besides his knighthood, the now Sir Bob Watson has been the recipient of numerous awards over his prestigious career, including the National Academy of Sciences Award for Scientific Reviewing, the AAAS Award for Scientific Freedom and Responsibility, and the insignia of Honorary Companion of St. Michael and St. George, which he received from the British government.

Prior to returning to his native Britain, Watson had been Director of the Science Division and Chief Scientist for the Office of Mission to Planet Earth NASA and later was Associate Director for Environment in the Clinton White House. He also served as a chief scientist with the World Bank and a variety of international environmental organizations.

He Chaired the IPCC during the development of the Third Assessment Report, which was published in 2001. According to Wikipedia, "In April 2002 the United States pressed for and won his replacement by Rajendra Pachauri as IPCC chair. According to New Scientist, "The oil industry seems to be behind the move." The industry campaign to oust Watson had begun days after George W. Bush's inauguration in January 2001, with a memo to the White House from Randy Randol of oil giant ExxonMobil asking "Can Watson be replaced now at the request of the US?"

According to the press release from the University of East Anglia, on receiving the news of his knighthood Watson said:

"I am delighted and humbled by this honour, which implicitly recognises the value of scientific knowledge in national and international environmental policy formulation. Of all the honours I have received this is very special, not only to me but also to my family and friends."

Photo credit: Courtesy of UAE.

ECHA Recommends 13 Substances of Very High Concern be Banned

2012-01-03T09:21:00.001-05:00

According to the European Chemicals Agency (ECHA):

"The European Chemicals Agency has submitted to the European Commission a recommendation that thirteen Substances of Very High Concern should in future not be used without authorisation. These substances are all classified because of their carcinogenic, mutagenic or toxic to reproduction (or a combination thereof) properties. They are used in applications where there is potential for worker exposure.

The thirteen substances and their main uses within the scope of authorisation are:

Trichloroethylene (carcinogen). A substance mainly used in surface cleaning, in textile scouring, in adhesives and as a heat transfer fluid.
Chromium trioxide (carcinogen, mutagen). A substance mainly used for metal finishing and as a catalyst.
Acids generated from chromium trioxide and their oligomers (group containing: chromic acid, dichromic acid, oligomers of chromic acid and dichromic acid) (carcinogen). A substance that could be used to replace chromium trioxide in many of its uses.
Sodium dichromate (carcinogen, mutagen, toxic for reproduction). A substance mainly used in metal surface treatment.
Potassium dichromate (carcinogen, mutagen, toxic for reproduction). A substance mainly used in metal surface treatment and as a processing aid.
Ammonium dichromate (carcinogen, mutagen, toxic for reproduction). A substance with currently no uses in the scope of authorisation. It could however be used to replace other chromium(VI) substances.
Potassium chromate (carcinogen, mutagen). A substance mainly used in metal surface treatment.
Sodium chromate (carcinogen, mutagen, toxic for reproduction). A substance mainly used in metal surface treatment.
Cobalt(II) sulphate (carcinogen, toxic for reproduction). A substance mainly used in surface treatment processes and as a water treatment chemical, oxygen scavenger and corrosion inhibitor.
Cobalt dichloride (carcinogen, toxic for reproduction). A substance mainly used in surface treatment processes and as a water treatment chemical, oxygen scavenger and corrosion inhibitor.
Cobalt(II) dinitrate (carcinogen, toxic for reproduction). A substance mainly used in surface treatment processes and as a water treatment chemical, oxygen scavenger and corrosion inhibitor.
Cobalt(II) carbonate (carcinogen, toxic for reproduction). A substance mainly used in fertilisers and in surface treatment processes.
Cobalt(II) diacetate (carcinogen, toxic for reproduction). A substance mainly used as a catalyst and in surface treatment processes."

More information can be found on the ECHA site.

Many REACH Registrants Not in Compliance, Says ECHA Forum

2011-12-29T09:53:00.000-05:00

Ever since the first REACH registration deadline of November 2010 ECHA has been doing inspections to see if registrants properly complied with the data and reporting requirements of REACH. The answer is often - NO. Recently the second report of ECHA's REACH Enforcement Forum estimated that about 20% of the companies they looked at were not in compliance. In the first report the Forum had identified 24% compliance for the earlier group of companies inspected.

Most of the non-compliance was related to failure to comply with the new Safety Data Sheet requirements or failure to correctly register their substances. Sometimes this meant no registration was submitted at all, other times there was a lack of preregistration, and in still others the company preregistered but did so incorrectly. Possible penalties for non-compliance could include loss of registrations, public shaming of companies with multiple non-compliance, fines, and criminal complaints.

The report will be available on the ECHA web site.

EPA Releases Work Plan to Improve Evaluation of Chemicals in Endocrine Disruptor Screening Program

2011-12-27T07:36:00.000-05:00

From the USEPA regarding the Endocrine Disruptor Screening Program:

"EPA is releasing an overview summary of the Agency’s work plan to improve the scientific methods used to evaluate chemicals that may impact the endocrine system in people and animals. This work plan relies on scientific advancements in computational modeling, molecular biology, toxicology, and advanced robotics. By incorporating these scientific advancements into evaluating chemicals under the Endocrine Disruptor Screening Program (EDSP), EPA will prioritize and screen chemicals with greater speed, efficiency, and accuracy, while minimizing the use of laboratory animals.

The work plan, referred to as EDSP21, follows recommendations made by the National Research Council (NRC) in a 2007 report on toxicity testing. Since EPA is required to complete registration review of registered pesticides by October 2022, new tools are needed to more quickly and efficiently screen and assess these pesticides. Development and validation of these new tools will be a multiyear process. As these new tools become ready for use, the EDSP will transition to rely on computational toxicology methods and high throughput screens to more quickly and cost-effectively assess potential chemical toxicity while minimizing the use of conventional whole animal studies. The workplan summary describes this transition.

By way of background, EPA is required to screen pesticides and other chemicals for their potential to cause effects similar to those produced by estrogen and other natural hormones."

The work plan can be downloaded from the EPA web site here.

ECHA Adds 20 More Chemicals to Substances of Very High Concern List

2011-12-22T12:21:00.000-05:00

The European Chemical Agency (ECHA) has added twenty additional substances to the Candidate List of Substances of Very High Concern (SVHC). This brings the list up to a total of 73 chemicals. Eight of the newly added chemicals were automatically added since no comments challenging their inclusion were received from the public. The other 12 received unanimous agreement of the Member State Committee.

Of the 20, all but one were added because they have been identified as carcinogenic and/or toxic for reproduction. For the first time, however, one chemical was added to the Candidate List on the basis of "equivalent concern." Specifically, the substance 4-tert-octyl phenol was "identified as an SVHC because of its endocrine disrupting properties" and "probable serious effects to the environment." The use of endocrine disrupting properties to list a chemical is somewhat controversial as there is still significant uncertainty surrounding the methodologies used to make the determination. Validation of a suite of endocrine disruption tests is ongoing, with mixed results.

The Candidate List serves as a launching point for ECHA to add chemicals to the Annex XIV of the REACH regulation, also known as the Authorization List. Chemicals that are put on Annex XIV are slated for replacement and manufacturers are required to apply for "authorization" for continued use, which is limited to specific uses, volumes and risk management measures, all while working against a deadline for substitution of less hazardous substances.

More information and the list of substances is available on ECHA's recently revamped web site.

NASA Reaffirms Scientific Integrity Policy

2011-12-19T08:23:00.000-05:00

According to a press release issued on December 16th:

NASA has reaffirmed its commitment to science with the release of a new framework on scientific integrity. The framework summarizes the agency's policies and practices that strengthen and uphold scientific integrity. This represents the first time NASA has codified these policies under the umbrella of scientific integrity.

"Integrity is woven throughout the fabric of NASA, and science plays a leading role in that," NASA Administrator Charles Bolden said. "This framework reflects and strengthens our commitment to open, honest, unrestricted and fair science practices, and sustains a culture that promotes them."

To support this culture of transparency, the framework reaffirms NASA's public communications policy of 2006, which states NASA scientists may speak freely with the public about scientific and technical matters.

"The ability to accurately and widely communicate our amazing science discoveries is one of our highest priorities," said NASA Chief Scientist Waleed Abdalati at the agency's headquarters in Washington. "NASA set a high standard with its forward-looking communications policy in 2006, and today we welcome the opportunity to join other agencies that are re-dedicating themselves to the highest standards of scientific excellence and advancing public trust in our discoveries."

NASA and other federal agencies submitted scientific integrity policies in response to a memorandum issued by the White House Office of Science and Technology Policy in December 2010. NASA's framework expands on the President's Memorandum to Department and Agency Heads on Scientific Integrity issued March 9, 2009, and specifies how the agency will address key issues.

In addition to public communications, the framework addresses professional development of government scientists and engineers, peer review and other topics. In developing its framework, NASA leadership evaluated the agency's existing policies and sought opportunities to improve and build on them. The agency currently is revising certain policies, including directives on the use of federal advisory committees. NASA will continue evaluating and improving policies within the framework through its formal review and renewal process.

Click here to download a PDF and read NASA's Framework on Scientific Integrity.

ECHA to Delay Launch of CLP Classification Inventory

2011-12-16T13:06:00.000-05:00

This just in from the European Chemicals Agency (ECHA) in Helsinki:

"ECHA has decided to delay the launching of the Classification and Labelling Inventory in order to ensure that the information provided by industry will be made publicly available in an accurate way that allows easy and functional access and navigation. The Agency will announce the new launch date by mid January. This is a key milestone project for ECHA because the public will have, for the first time, access to information on the self-classification of chemical substances by Industry."

EPA Releases Work Plan to Improve Evaluation of Chemicals in Endocrine Disruptor Screening

2011-12-14T08:15:00.000-05:00

From EPA:

You can download and read a copy of the work plan on the Endocrine Disruptor page here.

ECHA Publishes Report on Experiences of Successful REACH Registrants

2011-12-07T08:53:00.000-05:00

From the ECHA News Alert:

In July 2011, ECHA conducted a survey with companies who had successfully submitted a registration under REACH. The survey aimed to learn about the companies' experiences in preparing and submitting registrations and to identify areas in which the Agency could improve its services. Almost 900 companies responded to the survey; over 21% of the companies that registered their substances under REACH. The majority of responses came from large companies based in Germany, the United Kingdom, Italy, France and Spain. The share of SMEs (46%) having responded to the survey was significantly higher than their proportion among registrants.

The survey revealed interesting findings. For instance, 40% of companies prepared their dossiers with the support of consultants. According to the companies, the most important reasons for outsourcing the work were a limited capacity within the company or the desire to minimise the administrative burden within the company. With regard to the registration costs, the respondents indicated that the largest expenses were related to the registration fees, the collection of necessary information and consultancy services. The answers about the importance of various aspects in preparing for 2013 deadline showed that it is essential to have a sufficient knowledge of English as the language in which nearly all SIEFs are conducted, to nominate the Lead Registrant early, and to train staff on REACH / registration procedures.

ECHA was pleased to see that the companies appreciated the material provided by the Agency – 92% of respondents used it. 17% of registrants who submitted dossiers containing a Chemical Safety Report with an Exposure Scenario made use of the Chesar tool provided by ECHA.

Based on the feedback, ECHA is planning support for 2013 registrants: the Agency will continue developing and promoting the Chesar tool for Chemical Safety Assessments and Reports, it will work further to provide updated supporting material and will aim to further improve its communication channels.

The report is available for download as a PDF here.

EU Member States Want REACH Revised to Better Address Small Company Concerns

2011-12-06T09:19:00.000-05:00

Small and medium-sized businesses are disproportionately impacted by the high costs of compliance with the EU REACH chemical regulation, according to several Member State representatives at a recent forum. With the European Commission working on a review of the REACH regulation - a report is due to be published in 2012 - Member States are hoping that come changes can be made to assess the impacts on the smaller registrants that have less financial and technical resources.

The large production volume substances (greater than 1000 metric tonnes per year) were registered by November 30, 2010. The mid-range production volume substances (greater than 100 metric tonnes per year) are due to be registered by May 31, 2013. The smallest tonnages covered by REACH (greater than 1 tpy) must be registered by 2018.

As production tonnages go down the amount and cost of data required for registration goes down. Registration fees also decrease, and there are additional discounts for small and micro companies. Still, many small and medium sized companies feel that the cost of registration is prohibitive. Besides the data requirements for REACH, companies that make or use hazardous substances are required to notify ECHA.

All of the concerns raised by Member States and other stakeholders will be considered by the Commission and included in their review. It remains to be seen whether there are substantive changes made to the REACH regulation, or merely tweaks to make the system work more efficiently for the companies that will be registering by the 2013 and 2018 deadlines.

More information on the 2013 deadline and other aspects of REACH can be found on the ECHA web site.

ECHA to Set Up Expert PBT Group

2011-12-02T11:36:00.000-05:00

One of the main set of criteria for identifying and classifying substances of very high concern (SVHC) in Europe under the REACH regulation are whether the substance exhibits Persistent, Bioaccumulative and Toxic (PBT) properties or Very Persistent/Very Bioaccummulative (vPvB) properties. Now the European Chemicals Agency in Helsinki is putting together a PBT expert group. The group would address scientific issues related to PBT, both those already identified and those yet to arise.

ECHA has already in place at least two guidance documents related to identification of PBTs - Part C and Chapter R.11. Criteria are also discussed in Annex XIII of the REACH regulation.

The new group would be staffed by experts nominated by each EU Member State, as well as three representatives each from both industry and NGOs.

ECHA Gives "Guidance in a Nutshell" for Identifying Chemical Substances Under REACH

2011-11-30T08:34:00.000-05:00

ECHA, the European Chemicals Agency based in Helsinki that manages the REACH chemical registration program, has published another in its series of "Guidance in a Nutshell" documents. This one is on the "Identification and Naming of Substances Under REACH and CLP." More detailed guidance documents are also available, but the "Nutshell" documents provide a concise summary of the basic information needed for compliance. According to ECHA:

The objective of the Guidance in a Nutshell on identification and naming of substances under REACH and CLP is to give guidance for manufacturers and importers on recording and reporting the identity of a substance within the context of the REACH and CLP. It briefly explains how to name the substance and also gives guidance on whether substances may be regarded as the same in the context of those Regulations.

In addition:

This document has been drafted according to the corrigendum on Guidance for identification and naming of substances under REACH and CLP which has been published at the same time. The corrigendum includes editorial corrections, the replacement of outdated information, the correction of examples and references aiming to improve readability.

The Nutshell guidance document can be downloaded from the ECHA site here.

EPA Makes Public Hundreds of Formerly Confidential Chemicals Studies

2011-11-29T08:07:00.000-05:00

On November 28, 2011 the USEPA released an updating showing "EPA's progress reviewing case files submitted to the Agency under TSCA with chemical identities claimed as Confidential Business Information (CBI)." They provided a series of charts "intended to help those tracking EPA's progress in reviewing CBI and declassifying it, where appropriate." The move is "part of Administrator Lisa P. Jackson’s commitment to enhance the U.S. Environmental Protection Agency’s chemicals management program and increase transparency."

According to EPA, "Releasing the data will expand the public’s access to critical health and safety information on chemicals that are manufactured and processed in the U.S."

In a statement by outgoing Assistant Administrator for EPA’s Office of Chemical Safety and Pollution Prevention, Steve Owens noted that “EPA is increasing the availability of critical health and safety studies on chemicals that children and families are exposed to every day. We are making important progress in making this information public and giving the American public easy access to it...“over the next year, we expect to review several thousand additional studies on industrial chemicals and make many of these more accessible to the public.”

Highlights from the latest release:

Since the beginning of EPA's efforts to increase transparency two years ago, a total of 577 chemicals have been declassified, resulting in a shift from the CBI portion of the TSCA Inventory to the public portion.
CBI claims for chemical identity are being reviewed, and challenged where appropriate, in 100 percent of incoming TSCA filings that may contain health and safety studies.
As of October 2011, EPA exceeded its FY 2011 goal, set forth in the FY 2011-2015 EPA Strategic Plan, to review, and challenge where appropriate, more than 1,125 existing TSCA cases with CBI claims for chemical identity, potentially containing health and safety studies.

EPA noted that:

Consistent with the guidance, the agency will request that the submitter voluntarily relinquish the CBI claims and make the newly available studies available to the public. EPA also challenged the chemical industry to make available information that was previously classified as CBI. To date, more than 35 companies have agreed to review previously submitted filings containing health and safety studies and determine if any CBI claims may no longer be necessary.

Finally, EPA notes that "the newly available information can be found under a new “declassified tab” using the Chemical Data Access Tool, launched in December 2010 to assist the public in retrieving chemical health and safety information submitted to EPA under TSCA."

More information can be found on EPA's web site.

ECHA to Begin Authorizing Biocidal Products

2011-11-28T08:53:00.000-05:00

The European Union has reached an informal agreement to allow the European Chemicals Agency (ECHA) to being taking responsibility for reviewing and authorizing biocidal products. The agreement between the European Parliament and the EU Council would give broad powers to ECHA and update the current EU Biocides Directive.

In addition to allowing ECHA to review certain biocides applications at the EU level, companies would also maintain the ability to apply to individual Member States for authorization, after which they would obtain approval in other Member States through a process called mutual recognition. This is how the process works under the current Directive, and this move to shift some of the responsibility to ECHA is part of the reevaluation of the Biocide process as the Directive is replaced by a Biocidal Products Regulation. Like REACH, the new regulation would immediately apply across all Member States, whereas the Directive required each MS to pass its own individual implementation legislation.

ECHA's role is limited to only some of the product types of biocides beginning in 2012, and then by 2017 all of the 23 product types will be eligible for authorization at the EU level through ECHA. The informal agreement also specifically requires that nanoscale active substances in biocidal products be assessed separately from their non nanoscale counterparts.

EPA Announces New Acting Director of Chemicals Office

2011-11-23T08:09:00.000-05:00

Jim Jones, a long-time EPA official, has been tapped by EPA Administrator Lisa Jackson to replace outgoing Office of Chemical Safety and Pollution Prevention (OCSPP) head Steve Owens. Owens is leaving his position to return to his home in Arizona where his family had remained during his time in Washington.

Jim Jones' appointment is as an "Acting" Assistant Administrator for OCSPP, and will remain in that position while President Obama determines who he will nominate to run the office permanently. The permanent nominee would have to receive Senate confirmation and, given that Republicans in the Senate are already blocking even a vote on the President's nominee to head the Office of Water (i.e., Ken Kopocis), there is quite a bit of uncertainty as to when a nominee for permanent AA will be announced. With Congressional Republicans voting repeatedly to inhibit EPA's authority and the major cuts in EPA budget expected due to the failure of the Congressional Super Committee to agree on spending reductions, Jim Jones could be Acting AA for a long time.

Jones has been with EPA for roughly 20 years and has served in many capacities, the most recent being as head of the Office of Air. No word yet on who will be tapped to replace Jones in the air office while he is Acting AA at OCSPP.

Senate to Hold TSCA Safe Chemicals Act Hearing This Week

2011-11-15T14:06:00.000-05:00

Maybe the idea of TSCA reform isn't quite dead for this Congress. A hearing will be held on Thursday, November 17, 2011 in the US Senate to examine the Safe Chemicals Act of 2011, a bill introduced early in the year by Democratic Senator Frank Lautenberg. The hearing, to be chaired by Lautenberg and supported by ranking Republican member James Inhofe, includes both the full and subcommittees of the Senate Environment and Public Works committee (EPW).

The hearing follows on a series of five stakeholder meetings held between EPW staff and both industry and environmental advocacy groups. It is the first sign in quite a while of potential movement in the seemingly futile attempt to modernize the Toxic Substances Control Act (TSCA). The lack of movement is despite support for TSCA reform by both industry and advocacy groups.

Scheduled to provide testimony at the hearing are:

Mr. Ted Sturdevant
Director, Department of Ecology
State of Washington

Ms. Charlotte Brody
Director of Chemicals, Public Health and Green Chemistry
BlueGreen Alliance

Mr. Cal Dooley
President and CEO
American Chemistry Council

Mr. Robert Matthews
McKenna Long & Aldridge

Dr. Richard Denison, Ph.D.
Senior Scientist
Environmental Defense Fund

More information on the hearing can be found on the EPW web site.

Book Review – What’s The Worst That Can Happen? by Greg Craven (Climate Change/Global Warming)

2011-10-28T07:53:00.000-04:00

Subtitled “A Rational Response to The Climate Change Debate,” this book should be read by everyone interested in global warming and man-made climate change. Craven is a high school physics and chemistry teacher, and he has developed a simple and effective way to help people sift through the heated debates and decide if we need to take action on climate change. And we don’t even have to decide which side is “right” to do it.

The two sides, of course, are what Craven labels “the warmists” and “the skeptics.” Warmists are defined as those that believe that the science is strong enough for us to need to take action, while skeptics are those that feel we do not need to take action. With these two sides defined, Craven introduces a decision grid to aid the process. In the end he shows us how he filled his decision grid, but also encourages readers to fill in their own grid and make their own decisions.

In between is the crux of the book. He does a great job of explaining the nature of science and how “we never quite know for sure” (including for things like gravity), but that sometimes the evidence is so overwhelming that it is accepted by virtually everyone (e.g., gravity). He also clues us in to some quirks about our own brains and things like “confirmation bias.” These set up a chapter on how to assess the credibility of various sources. After all, unless you spend your life studying the science it’s likely you won’t be able to understand it all, so instead we need to know which sources of information are reliable and which are not so much. Craven then gives us some information on what each side is telling us and who is doing the telling, all fit nicely into his credibility spectrum.

He then demystifies the doomsday claims.

I’ll leave it to all to read the book and draw their own conclusions about the science. But I definitely recommend that all of us use the tools Craven offers in this book. And I recommend that all scientists learn how to communicate as easily as does Craven.

Steve Owens, Head of EPA's Toxic Chemical Program, To Resign

2011-10-26T07:44:00.000-04:00

The head of EPA's Office that handles toxic chemicals is resigning. Steve Owens announced his resignation to staff yesterday and will leave as of November 30, 2011. According to his email, Owens has "made the difficult decision to leave EPA" mainly to rejoin his family in Arizona, where they remained during his entire two plus years working in Washington DC at EPA headquarters. Owens had previously been the head of Arizona's Department of Environmental Quality (DEQ).

In his departure announcement, Owens thanked EPA Administrator Lisa Jackson for "her wonderful friendship and the remarkable vision and leadership she provides" to the Agency. Similarly, in a statement from Jackson, the EPA Administrator thanked Owens for his contributions. She noted that "his leadership has been vital to our efforts to assure chemical safety for our citizens and revamp our nation's outdated toxic substances standards."

Those standards remain in limbo at this point as the much anticipated TSCA reform legislation - an effort to modernize the 35-year old toxic chemicals law - has stalled in Congress. Given the current actions of House Republicans to defund EPA and limit the Agency's authority even under the current TSCA law, plus the stalemate caused by the still year-away elections that could give control of the Senate to Republicans, it seems highly unlikely that any reform of TSCA is going to occur for many years. While he doesn't mention it in his email, perhaps that is one of the reasons Owens has decided to relocate back to Arizona.

No information on possible replacements for Owens has been forthcoming, and any potential nominee would have to be confirmed by Congress, a prospect that is likely to be politically charged given the current climate.

EPA Finalizes Third TSCA Test Rule for HPV Chemicals

2011-10-24T08:00:00.000-04:00

The USEPA is finally promulgating a final rule under Section 4 of TSCA "to require manufacturers, importers, and processors to conduct testing to obtain screening level data for health and environmental effects and chemical fate for 15 high production volume (HPV) chemical substances listed in this final rule." The 15 chemicals represent only half of the 29 HPV chemicals that were listed in the the draft rule, which was originally proposed nearly two years ago on February 25, 2010. According to EPA, based on comments received on the proposed rule, the remaining chemicals were dropped because they did not" meet the criteria for testing at this time."

For the 15 chemicals listed in this final rule, manufacturers will need to conduct the specified tests and provide the data to EPA prior to the deadline, which is set for the end of 2012. EPA notes that "this test data is needed in order to help EPA to determine whether these 15 HPV chemical substances pose a risk to human health and/or environmental safety." Required tests vary by chemical but can include physical-chemical properties, environmental fate and degradation, aquatic toxicity, mammalian acute and reproductive/developmental toxicity, and genotoxicity.

Companies that are effected by the rule must submit test plans for each chemical within 90 days of the effective date (i.e., 90 days from November 21, 2011).

The list of chemicals can be accessed here.

A full hyperlinked version of the Federal Register notice can be accessed here.

ECHA Sets Up Exposure Scenario Network to support REACH Chemical Evaluation

2011-10-13T07:40:00.000-04:00

The European Chemicals Agency (ECHA) has teamed up with several European chemical trade associations to establish a "cross-sector collaborative network to share knowledge, techniques and approaches to building and applying (REACH) exposure scenarios." The new network "aims at identifying good industry practices on drafting exposure scenarios" and sets up a mechanism for "building a dialogue between supply chain actors" in an effort to "improve the protection of human health and the environment."

The new network is called ENES, the Exchange Network on Exposure Scenarios. The trade associations with whom ECHA worked to set up ENES include the European Chemical Industry Council (CEFIC), Eurometaux (the metals association), CONCAWE (the oil companies’ European association), the European Association of Chemical Distributors (FECC) and the International Association for Soaps, Detergents and Maintenance Products (AISE) on behalf of the Downstream Users of Chemicals Coordination Group (DUCC).

According to the ECHA press release, the first meeting will be held in Brussels, on November 24 and 25, 2011. Besides the trade associations listed above, various "sectors of industry, NGOs, Member State authorities and other stakeholders will be invited to participate."

See the ECHA page here for more information.

Canada Moves Into Next Phase of Chemical Management Plan

2011-10-10T10:04:00.000-04:00

Canada has issued a news release indicating that it will move into the next phase of its ongoing Chemical Management Plan. This is an extension of the plan first launched in 2006. The CMP was designed to apply the rigorous assessment used for new chemicals to 'legacy chemicals' that were introduced in Canada between January 1, 1984, and December 31, 1986. The new phase is seen "as a continuation of Canada's world-leading initiatives in this area and it will ensure the protection of Canadians' health and safety, and their environment," according to Shannon Coombs, President, Canadian Consumer Specialty Products Association, who promised to "continue to work proactively with the government as the plan is implemented."

According to the announcement, new funding is being provided for this next phase of the Plan, "which will focus on:"

Further improving product safety in Canada;
Completing assessments of 500 substances across nine categories including phthalates, primarily used in plastics; and,
Investing in additional research for substances like Bisphenol A, flame retardants, substances that affect hormone function and substances that affect the environment.

Canada anticipates that "approximately 1,000 additional substances will also be addressed in the next five years through other initiatives, including rapid screening of substances which pose little or no risk." Canada recently banned four chemicals as harmful to the environment.

More information on Canada's Chemical Management Plan can be found here.

Canada's Chemical Substance main page is here.

ECHA Issues 2012 Work Program - Sees Challenges Ahead

2011-10-06T08:35:00.000-04:00

The European Chemicals Agency (ECHA) approved its 2012 work program last week and highlighted both its activities and its challenges ahead of the next REACH deadline. Besides the mid 2013 REACH registration deadline, ECHA will take on an expanding role in the new Biocidal Products Regulation (which will replace the current Directive in 2013). In addition, ECHA will have ramped up activities related to other parts of the expansive REACH regulation, including the Evaluation (the "E") and Authorization (the "A") components, as well as Restrictions (the "missing R"). And of course there is still the continuing evaluation of substance dossiers for high productive volume chemicals submitted in the first registration period that ended on November 30, 2010.

All of this leaves ECHA worried that there may not be enough resources to meet obligations efficiently, both within ECHA and in the Member States. The current economic situation in most of Europe, which has caused such severe spending cuts (austerity), has led ECHA Executive Director Geert Dancet to openly state his concerns that Member States may not have enough resources to fully conduct their role in chemical evaluation.

The developing Biocidal Products Regulation (BPR) also offers challenges to ECHA as the agency is expected to take on responsibility for authorizing biocides. Under the current biocides directive this responsibility lies with each Member State. ECHA would also take on new responsibilities related to the Prior Informed Consent Regulation, which involves identifying hazardous chemicals that could not be exported from Europe unless the country of destination is given sufficient information to assess risk.

During the September 29-30, 2011 meeting of the management board, the mandate of the Executive Director was extended. According to the chairman, Dr. Thomas Jakl:

"After the first REACH registration deadline was impressively managed by ECHA in 2010, there is no time to rest on our laurels. Challenging further steps of the REACH and CLP implementation lie ahead and the legislator is in the process of entrusting important new regulatory tasks to the Agency. The continuation decision with regard to a selection process for the Executive Director reflects the high satisfaction of the Board with his achievements since 2007."

More information and a link to the work program can be found on the ECHA web site.

Summary of GHS Chemical Classification in Various Regions Now Available

2011-10-04T11:32:00.000-04:00

The UN Globally Harmonized System of Classification and Labeling of Chemicals (usually referred to as simply GHS) was a way for governments to voluntarily attempt to bring into harmony what had been a wide range of classification schemes for chemicals. Now the Organization for Economic Cooperation and Development (OECD) has created a summary table that brings together in one place the current status of individual government's and region's adoption of GHS.

The table can be seen here and shows which OECD member countries and other organisations have publicly posted their GHS classifications no the internet. The table is based on a survey performed in 2011. Where available, OECD has provided links to the appropriate documents and web access points (e.g., to the 1300+ page CLP in Europe). Other links take you to web sites, for example, Korea's New Chemical Notification and Assessment.

The Fourth Revised Edition of the UN Globally Harmonized System of Classification and Labelling of Chemicals (the "Purple Book") can be downloaded on the United Nations Economic Commission for Europe (UNECE) site.

Is TSCA Reform Happening this Fall?

2011-10-03T14:05:00.001-04:00

The short answer is, probably not. But it does appear that Senator Frank Lautenberg's office will be pushing for a markup this fall of the draft bill introduced this past spring. Lautenberg's "Safe Chemicals Act of 2011" included many industry-friendly changes from the original "Kid Safe Chemical Act" (including no longer mentioning kids in the name). The bill introduced in April would have required companies to submit "basic hazard and exposure data to quickly determine the risk and assess the need for further testing or restrictions."

Over the summer the staffs of Senators Lautenberg and Inhofe held a series of stakeholder meetings in an effort to find common ground and a path forward. These meetings included - separately - representatives from NGOs (e.g., Environmental Defense Fund) and industry (e.g., ACC and SOCMA). Topics for the meetings included defining a "safety standard" and coming up with prioritization schemes that would focus efforts on those chemicals deemed most risky. In August, EPA proposed such a prioritization scheme, which was countered by an alternative scheme by the American Chemistry Council.

Whether the markup happens or not will depend on the legislative calendar, but historically anything that doesn't get done by this fall will likely not get done during the 2012 election year. With the initial changes Lautenberg already made and the Democrats' willingness to compromise the grand reform of TSCA for a more industry-friendly reform, the feedback from the stakeholder meetings suggest that any markup will further limit the extent of "modernization" of the 35-year old chemicals law. Whether you believe that is a good thing or a bad thing may depend on from what perspective you bring to the table.

EPA Will Identify Priority Chemicals by Thanksgiving (or so)

2011-09-30T15:21:00.000-04:00

EPA will identify chemicals to be prioritized sometime this fall as it tries to move forward under the old TSCA as Congress makes no progress on developing a new TSCA. To do so EPA will take into consideration feedback they received from a variety of stakeholders in two recent outreach attempts related to their proposed prioritization process.

EPA introduced its proposed prioritization scheme and "discussion guide" back in August. They then had a webinar on September 7th to give an overview of the proposed scheme and to invite feedback. Finally, EPA also invited the public to share their thoughts in an online discussion forum. That discussion forum closed on September 14th.

All comments received from stakeholders are now being assimilated and reviewed by EPA staff, who are working to identify chemicals to be prioritized for review. In general the feedback was very constructive and included both concerns for the data sources being proposed as well as suggestions for other data sources to include in the evaluation. Other stakeholders cautioned that the use of production volume as a surrogate for exposure could lead to chemicals with very low risk being prioritized while chemicals of low production volume by high exposure potential, and thus risk, might be left out. Some stakeholders suggested the addition of additional health effects such as endocrine disruption, neurotoxicity and skin or respiratory sensitization be used early in the prioritization process, while others cautioned that the process could get bogged down in the minutia if too many factors were included in the first step.

More information on the EPA chemical prioritization can be found on the discussion forum web site and EPA's existing chemicals "Identifying priority chemicals for review" page.

ECHA Goes to Commission on REACH Testing Proposal

2011-09-28T10:36:00.000-04:00

How many Member State Competent Authorities does it take to make a decision on REACH testing proposals? Apparently more than they have. The Member State Committee (MSC) at the European Chemicals Agency (ECHA) "could not find unanimous agreement based on scientific and technical arguments on a draft decision for a testing proposal."

Let's go to the Commission! For the first time ECHA will employ Article 51(7) of the REACH Regulation and refer a case to the European Commission for decision making.

This non-decision by the MSC took place last week. Not that they were stymied on all decisions. They did agree on the draft decisions "for all five compliance checks" they were charged with reviewing. And they did come to unanimous agreement on two of the four draft decisions on "testing proposal examinations." But two testing proposals were particularly tricky. For one, the MSC refined the proposal during the meeting and expect to agree in writing shortly.

The final testing proposal reached stalemate, hence the referral to the Commission. The proposal:

"concerns a testing proposal examination where the registrant has proposed to perform a two-generation reproductive toxicity test in accordance with the EU test method B.35. This information would be necessary to fill the data gap regarding reproductive toxicity for the substance that is produced in quantities of over 1000 tonnes per annum. Some MSC members preferred to ask the registrant to use the recently adopted OECD test guideline 443, the extended one-generation reproductive toxicity study (EOGRTS). Others wanted to maintain the present requirement of performing a two-generation study."

No information on when (or if) the Commission will make its decision.

More on what the Member States Committee does can be found on their web page here.

REACH Chemical Regulation Group Offers Advice and Recommendations

2011-09-27T16:20:00.000-04:00

The Director's Contact Group (DCG) has issued a report on the "Achievements, Lessons Learned and Recommendations" garnered from its supporting role for last year's first REACH registration deadline. The DCB was formed to deal with a wide range of issues related to REACH chemical regulation - 28 different issues in all. And now the DCG has been renewed until the end of September 2013 so that it can address any issues that might arise with the next registration deadline, which is May 30, 2013.

The DCG report gives a summary of its achievements, and presents many of the lessons learned from the experience. All of this sets the stage for recommendations that hopefully will ease the burden for companies preparing for the 2013 (and 2018) registration deadlines. An annex of the report gives short summaries of the 28 issues addressed by the group to date.

Issues that are expected to be priority for the next deadline include:

Organizational issues within SIEFs, the Substance Information Exchange Forums, that had mixed reviews during the first round of registrations,
Guidance on how to deal with situations in which the companies have merged or spun off units during the registration period (which is especially important for the many small and medium size entities that are expected to be part of the second round),
Guidance on communication within the supply chain, again a difficult issue for small and medium sized companies with less resources
Updating of information technology tools like IUCLID, REACH-IT, and guidance documents

One thing that the DCG and ECHA agree on is that companies planning to register chemicals by May 2013 should "Act Now!" Members say that industry cannot prepare early enough, and many (but not all) companies are heeding that advise.

The DCG report can be downloaded as a PDF here.

More information on REACH can be found on the ECHA web site.

NSF Announces Steps to Improve Participation of Women in STEM Science Careers

2011-09-26T14:13:00.000-04:00

The National Science Foundation (NSF) is announcing steps that will "make it easier for women to pursue careers in engineering and the sciences," according to an Op-Ed by Valerie Jarrett and Tina Tchen in yesterday's Washington Post. They note that "women working in science, technology, engineering and math [STEM] careers earn 33 percent more than those in other occupations, and these 'STEM' skills will become even more important in high-growth, high-tech fields such as health-care technology and advanced manufacturing."

Jarrett and Tchen note that circumstances often work against women:

As with women throughout the workforce, however, women in STEM jobs are often expected to establish themselves professionally at the same time they are starting families. This forces women to choose between their careers and their responsibilities at home. Understandably, many of our most promising young scientists and engineers drop out of the pipeline.

Ways that NSF is looking to make it easier for women in STEM careers include:

Working with women researchers who need to delay the start of a funded project for a family-related reason,
Options to add the lost time if female researchers interrupt research to have a baby,
Support for research into the effectiveness of flexible workplace policies.

For a more in-depth discussion, see the Washington Post article by Jarrett and Tchen.

More information is on the National Science Foundation web site.

ECHA Starts REACH 2013 Campaign to Urge Chemical Companies to Act Now!

2011-09-23T16:32:00.000-04:00

The European Chemicals Agency (ECHA) has launched a campaign to encourage chemical companies to "Act Now!" to meet their planned registration obligations for the second round of REACH. The next registration deadline - for substances manufactured or imported at tonnages at or above 100 tonnes per year - is May 31 2013.

ECHA's goal is to get companies thinking now about how they will fulfill the data requirements and interact with other members of SIEFs, including any data gathering and compensation to existing data holders. Preparing for and submitting registrations earlier rather than all at the last minute is good for both ECHA and the registering companies.

To do this, ECHA has started a program called REACH 2013 - Act Now!

The web page provides "key information to support you in your preparations for the 2013 registration." It includes "links to all the steps of the registration process: from the formation of the Substance Information Exchange Fora (SIEFs) to data sharing, dossier preparation and online submission."

According to the site, potential registrants need to be getting organized to do:

Substance identification, hazard information, data-sharing

Substance identification and sameness of substance: Confirm with the other pre-registrants that you have the same substance;
Hazard information: Collect all data available on the intrinsic properties of the substance to be registered;
Data sharing: As part of a joint registration, gather and share existing information, consider alternatives to testing and answer any information request from within your SIEF;

Chemical safety assessment: Carry out a chemical safety assessment in order to produce a chemical safety report based on the hazard information collected and knowledge on the uses.

More information can be found on the ECHA web site.

ACC's Chemical Prioritization Tool - EDFs Analysis is One Thumb Up, One Thumb Down

2011-09-21T14:27:00.000-04:00

Last week I reported on an analysis of the EPA's proposed chemical prioritization tool done by Richard Denison of the Environmental Defense Fund (EDF). Today I report on Denison's follow up analysis on the counter-proposal prioritization scheme released by the American Chemistry Council the day prior to EPA's webinar. I'll start with Denison's conclusion:

"While ACC’s tool has some serious flaws and is not something that EPA has the authority or resources to utilize under current TSCA, ACC has put forth a serious proposal for prioritization that should help to raise the level of debate over this critical issue in TSCA reform."

As suggested, Denison notes that the ACC proposal offers some "refreshing elements and acknowledgements." He describes it as "substantive and specific" and is "welcome in several ways." He goes on to summarize some of the areas he feels are constructive (see his full blog entry). Notwithstanding these kudos, however, Denison does suggest that ACC's proposal seems better suited for a full TSCA Reform element and that implementation of the ACC plan is not likely to be possible under the current (and likely future) resource and funding constraints limiting EPA's activities.

Denison finds that there are "a number of quite problematic aspects of ACC's proposal," including:

Overly rigid rules applied in lockstep: Denison finds ACC's proposed "equal basis" rule to be "sleight of hand" that will "rule out any types of information that may indicate a hazard or exposure of high concern unless it has been measured across basically all chemicals subject to prioritization." The "high hazard and high exposure" rule would allow prioritization of only those chemicals "for which high hazard and high exposure can be demonstrated;" a proposal that Denison finds to be "simply shortsighted." He also critiques ACC's "persistent and bioaccumulative" rule, which he finds includes "extremely narrow definitions of P and B" that would avoid prioritizing chemicals that would in fact be either P or B (or both).
Consistent use of the least conservative classification values: Denison points out that the ACC proposal relies on the classification criteria developed under GHS, which he generally supports. However, he does quibble with what he feels are two limitations - GHS doesn't include every endpoint of concern and ACC chooses the least conservative values instead of adhering to GHS' cutoff values faithfully. A choice where Denison feels "ACC fails badly."
Over-relying on limited exposure information and discounting evidence of hazard: Denison notes that ACC's tool lumps together its health and environmental hazard rankings into a single score while combining scores for its three exposure elements, which "means that a chemical that harms both people and other organisms only gets counted once, while a chemical that is low-volume and used only as an intermediate and is not P or B gets credit for being of low concern for all three attributes." The way the tool handles hazard vs exposure rankings also is likely to skew the results such as to avoid prioritization for chemicals that could indeed be problematic.

Despite these significant critiques, Denison feels that the ACC prioritization tool is a good effort and a basis for informed debate as the process moves forward. Combined with his previous critique of the EPA prioritization proposal, there clearly is a path forward for enhancing chemical regulation and improving protection of the environment and human health. But will it happen?

ECHA Risk Assessment Committee Adopts Seven Scientific Opinions

2011-09-20T16:19:00.000-04:00

The following information comes from the ECHA web site:

The Committee for Risk Assessment (RAC) has adopted opinions on seven proposals for harmonised classification and labelling across Europe during its 17th meeting, held from 13-16 September 2011 in Helsinki.

Polyhexamethylene biguanide hydrochloride (PHMB)

RAC agreed with the proposal from France to classify PHMB as acutely toxic by the oral and inhalation route, damaging to the eye, as a skin sensitiser, as toxic to the respiratory tract after repeated exposure, suspected carcinogen and hazardous to the aquatic environment. The classification of this substance is not currently harmonised at EU level. PHMB is used as biocidal product (disinfectant).

Di-n-hexyl phthalate (DnHP)

RAC agreed with the proposal from France to classify DnHP for reproductive toxicity due to the potential for effects on unborn babies as well as on male fertility. The classification of this substance is not currently harmonised at EU level. DnHP is used in the manufacture of plastics.

Fenamiphos

RAC agreed with the proposal from the Netherlands to classify Fenamiphos as acutely toxic by the inhalation route and as an eye irritant. Fenamiphos already has a harmonised classification as acutely toxic by the oral and dermal route and as hazardous to the aquatic environment. RAC agreed with the proposal to replace the minimum classification for acute toxicity (indicate by an asterix) with the definite classification based on data. Further, RAC proposed an M-factor of 100 for chronic aquatic toxicity. Fenamiphos is used as a plant protection product.

Trichloromethylstannane (MMTC)

RAC agreed with the proposal from France to classify MMTC as toxic to reproduction. RAC did not agree with the proposal from France, to classify MMTC as mutagenic. The classification of this substance is not currently harmonised at EU level. MMTC is used as an industrial intermediate in the production of other organotin chemicals.

2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-methyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (MMT (EHMA))

RAC agreed with the proposal from France to classify MMT(EHMA) as toxic to reproduction. RAC did not agree with the proposal from France, to classify MMT(EHMA) as mutagenic. The classification of this substance is not currently harmonised at EU level. MMT(EHMA) is used as a heat stabiliser in PVC.

Benzenamine, 2-chloro-6-nitro-3-phenoxy- (Aclonifen)

RAC agreed with the proposal from Germany to classify Aclonifen as a suspected carcinogen, as a skin sensitiser and as hazardous to the aquatic environment. Aclonifen already has a harmonised classification as hazardous to the aquatic environment. Aclonifen is used as a plant protection product (herbicide).

Perestane

RAC agreed with the proposal from the UK to classify Perestane as acutely toxic by the oral, dermal and inhalation routes, skin corrosive and as toxic to the eye after single exposure and to remove the classification for mutagenicity. Perestane already has a harmonised classification as acutely toxic by the oral, dermal and inhalation routes, skin corrosive and mutagenic. Perestane is used as a biocide (surface disinfectant).

More information can be found on the ECHA web site.

Denmark Proposes Restriction of Four Phthalates under REACH Chemical Regulation

2011-09-19T11:35:00.000-04:00

Denmark has proposed to restrict "the placing on the market and use of certain articles containing four classified phthalates (DEHP, BBP, DBP and DIBP)." These common phthalates are found in a variety of professional and consumer products, including PVC and in dispersions, paints and varnishes. The primary rationale for these restrictions is that these "phthalates are all reported to affect reproductivity."

The Danish proposal is part of the REACH chemical regulation process, in which substances of very high concern can be proposed by Member States to be restricted from further use. All interested parties (e.g., manufacturers and formulators, as well as other Competent Authorities) can comment on the proposal. All comments will be "reviewed and taken into account by ECHA’s Committees for Risk Assessment (RAC) and Socio-economic Analysis (SEAC)." By September 2012 these Committees would provide their opinions, which will be the basis for final decisions on whether to restrict the substances from use in commerce

Comments are requested by December 16, 2011, though officially the 6-month public consultation being announced today ends in March 2012.

According to the ECHA news release:

The widespread use of phthalates is raising concern, regarding human exposure from consumer articles. The dossier addresses the combined exposure based on common effects seen with exposure to these phthalates.
In the report, Denmark suggests a ban for the placing on the market of articles intended for indoor use and articles that may come into direct contact with the skin or mucous membranes, containing one or more of these four phthalates in a concentration greater than 0.1 % by weight of any plasticised material.

More information can be found on the ECHA site.

Avoiding Paralysis by Analysis - EDF's Analysis of the EPA TSCA Chemical Prioritization Proposal

2011-09-15T15:44:00.000-04:00

Last week the USEPA held a webinar to introduce their proposal for how they will attempt to prioritize TSCA chemicals for closer assessment. One day prior to the webinar the ACC announced its own competing prioritization scheme. Earlier this week, Environmental Defense Fund Senior Scientist Richard Denison offered his views on the EPA scheme, which he called "a sensible approach to identifying chemicals of concern." [Note: Denison will be addressing the ACC proposal in a following post on the EDF web site.]

The "paralysis by analysis" noted to in the title refers to the futility of asking EPA to evaluate the entire TSCA Inventory akin to the Canadian approach. The Canadian approach was actually "mandated by statute" (via the 1999 amendments to the CEPA) and both Environment Canada and Health Canada were given "seven years and a major infusion of new resources" just to complete the first phase of the process. According to Denison, with nearly four times as many chemicals on the Inventory, and "without the authority and the resources, well, that's just a recipe for paralysis by analysis" to ask EPA to do the same.

Which is why the EPA proposal is so reasonable, according to Denison. He indicates that EDF and the Safer Chemicals Healthy Families coalition "generally support EPA's approach and believe it strikes the right balance between clarity and transparency and avoiding paralysis by analysis." Denison does, however, offer a series of 10 additional suggestions for improving the EPA proposal. The full list can be seen on the EDF blog page, but include broadening the sources of data specified in Step 1 (perhaps by including some of the source from Step 2), consideration of the published literature, adding specific criteria for children's health and exposure, expanding the range of "vulnerable subpopulations" beyond just children's health, and providing additional clarity on how EPA plans to move from Step 1 to Step 2.

Overall, Denison finds that the attempts by EPA to reintroduce "action" into their proposed prioritization and action plan process are much needed. He welcomes EPA looking at chemicals in commerce to identify those for which it would be prudent to take a closer look at their potential risk. And with the additional actions suggested, he believes that it is a good step in the right direction.

To read EDF's analysis and the full list of suggestions, see Richard Denison's blog entry for September 13, 2011.

Congressional Briefing Says Animal Testing Should be Replaced with Alternative Methods

2011-09-14T08:30:00.000-04:00

Yesterday there was a briefing held on Capitol Hill to update lawmakers on the status of non-animal test methods for assessing the toxicity of chemicals. Led by Dr. Paul Locke of the Johns Hopkins Center for Alternatives to Animal Testing (CAAT), the briefing discussed the "3Rs" in US chemical law and policy. Speaking at the briefing was Representative James Moran, who is ranking member of the House Appropriation Committee's subcommittee on Interior, Environment and Related Agencies.

Moran is also co-chair of the Congressional Animal Protection Caucus (CAPC), a group staffed by both parties that seeks to raise awareness of animal welfare issues in Congress. CAPC replaced the "Friends of Animals Caucus" that had existed in previous Congresses. The briefing was in conjunction with CAPC.

Dr. Locke outlined the 3Rs, i.e., finding alternative testing methods that refine existing tests by minimizing animal distress, reduce animal usage, or replace whole animal tests. Ultimately, CAAT and other organizations would like to see a shift to all non-animal testing such as those being developed as part of Tox21, the testing program that came out of the National Academy of Sciences report "Toxicity Testing for the 21st Century: A Vision and a Strategy."

Representative Moran concurred. During the meeting he said that "virtually all animal tests are outdated in terms of efficiency and effectiveness." He strongly suggested that the robotic tests being advanced by Tox21 could help rapidly screen the thousands of existing chemicals that so far have received no technical review, and do so more effectively than the standard animal tests.

More information on CAAT and the briefing can be found here.

Inspector General Seeks More Answers as EPA Nears Key Deadline for Endocrine Disruptor Chemicals

2011-09-12T12:37:00.000-04:00

The Inspector General (IG) has issued a further response to EPA's continuing attempts to address issues raised by the IG regarding how EPA will assess potential endocrine disrupting chemicals. The IG also seeks clarification that the EPA will indeed provide additional feedback by September 30, 2011. The deadline is supposed to be when EPA will complete its prioritization approach for selecting chemicals for testing.

The crux of the concerns raised by the IG relate to an oft-repeated industry question about how EPA will use the Tier 1 screening data already underway for List 1 Test Orders. Industry filed a petition asking EPA to "fully analyze the Tier 1 screening data received in response to the list 1 test orders and revise the guidance to be developed to reflect what is learned by the analysis in order to ensure scientifically sound determinations and to protect the public health and the environment." Last month EPA issued a Federal Register notice seeking public comment on the industry petition.

The IG's memorandum indicates that they are satisfied with EPA's response to recommendations 4 and 5 pending agreed upon Agency action. The IG also was satisfied with responses to recommendations 3(a) and 6. However, while the IG indicates that EPA is showing progress in developing a "mutually satisfactory solution" for recommendations 1, 2 and 3(b), the IG was "seeking additional information regarding OCSPP's planned corrective actions for these recommendations." They also wanted to have clarification of what would be completed by September 30, 2011 and what would not be completed until a Management Plan is published on June 30, 2012.

The IG memorandum can be read here and downloaded as a PDF.

European Chemicals Agency Publishes Chemical Safety Data Sheet Guidance

2011-09-08T15:38:00.000-04:00

The European Chemicals Agency (ECHA) has added to its already voluminous library of guidance documents that support the REACH chemical control law. The new "Guidance on the Compilation of Safety Sheets" (Version 1.0, September 2011) provides information on:

what is new in SDSs according to REACH by comparison with the previous legislation
issues to consider when compiling an SDS;
details of the requirements for information to be included in each Section of an SDS, in particular detailing the changes arising from the revisions of Annex II of REACH;
the timetables for implementation of Annex II and its amended Annexes;
who should compile the SDS and what competences the author should have.

The guidance document can be downloaded as a PDF file on the ECHA Guidance web site.

ACC Proposes TSCA Prioritization Tool to Improve Chemical Review Process

2011-09-06T15:59:00.000-04:00

The American Chemistry Council (ACC), a trade association representing many large chemical manufacturers, has proposed a new prioritization tool "to increase effectiveness of EPA's chemical review process." The press release comes in a preemptive strike a day before EPA holds a webinar in which it will describe its own proposal for prioritizing chemicals.

ACC states that "EPA does not have a systematic way to determine which chemical uses need further characterization" and worries that "EPA may be wasting time, energy and resources gathering additional information on already well-understood chemicals." According to their fact sheet and an accompanying powerpoint presentation, ACC's prioritization tool "would be administered by EPA" to:

Evaluate chemicals against transparent, consistent, scientifically-based criteria focused on the hazard associated with the chemical, how the chemical is used and how people or the environment are exposed to the chemical;
Ascribe a score based on the criteria;
Rank order chemicals based on their scores and the professional judgment of EPA officials;
Utilize the rankings to determine which chemicals should be given full risk assessments

Individual criteria for ranking chemicals would include human health hazards (e.g., carcinogenicity or reproductive/developmental toxicity), potential environmental effects, the industrial, commercial and consumer uses, persistence and bioaccumulation potential, production volume, and other factors such as use in children's products or detected in biomonitoring programs.

EPA's prioritization scheme to be discussed tomorrow (September 7, 2011) differs significantly from the ACC plan. ACC has clear scoring criteria for all chemicals where the EPA plan relies more on prior listings of chemicals by other regulatory bodies. ACC's plan also gives greater weight to potential exposure (i.e., focus on risk) whereas EPA's plan would rely more on hazard for at least its first steps.

More information on the ACC prioritization proposal can be found on their TSCA prioritization page, including links to criteria documents, presentation and background information.

EPA Kicks Off Initiative to Find Alternatives to Phthalates

2011-09-02T13:21:00.000-04:00

The kickoff meeting of a partnership between the USEPA and interested parties was held August 24, 2011 in the Washington DC area. The goal is for EPA and industry to work within the Design for the Environment (DfE) framework to "evaluate phthalates and potential alternatives based on a range of human health and environmental endpoints, and provide this information to stakeholders for informed decision making."

Participants in the kickoff meeting included a variety of stakeholders ranging from manufacturers, state and local regulatory agencies, trade associations, international regulatory bodies, and NGOs. Individual manufactures and users of phthalates present included ExxonMobil, BASF, IBM, Dow Chemical, and others. It is expected that future activities will include development of a list of existing potential alternatives and an evaluation of the potential environmental and human health effects of those alternatives that seem most viable. The next meeting of the partnership initiative is will be in October 2001, with early spring 2013 planned for a final report on the project.

An action plan on which this DfE initiative is based was released in December of 2009. The phthalates identified in the action plan for assessment are:

Dibutyl phthalate (DBP)
Diisobutyl phthalate (DIBP)
Butyl benzyl phthalate (BBP)
Di-n-pentyl phthalate (DnPP)
Di(2-ethylhexyl) phthalate (DEHP)
Di-n-octyl phthalate (DnOP)
Di-isononyl phthalate (DINP) and associated chemical*
Di-isodecyl phthalate (DIDP) and associated chemical*

*each are a mixture of two phthalates

The partnership participants will decide on which substances offer the potential as alternatives. Collaboration with ongoing reviews by the US Consumer Product Safety Commission (due to use of phthalates in children's toys and baby bottles) and the Green Chemistry in Commerce Council will also be part of the review process.

More information the Design for the Environment Program can be found here.

More Walrus Haulouts in Alaska Due to Lack of Arctic Sea Ice

2011-09-01T15:14:00.000-04:00

I have previously noted reports of large walrus haulouts onto land due to the lack of Arctic sea ice, and now there are additional reports. You can read more about it in this summary here. The original report came from this source here.

More information on radio-tracking of walrus populations can be found on the US Geological Survey Alaska Science Center page.

A short 2-page FAQ on the science behind the walrus haulouts can be seen here.

ECHA Publishes New "Example Exposure Scenarios" for REACH Chemical Registration

2011-08-31T08:52:00.000-04:00

The European Chemicals Agency (ECHA) has now developed some "practical examples of how to generate exposure scenarios (ESs) for risk characterization under the REACH chemical substance regulation. The ESs were developed in collaboration with industry groups in the cleaning products and construction chemicals industries.

According to ECHA:

The new example exposure scenarios are featured in two publications that are now available on the ECHA website. These are useful for both registrants and downstream users receiving extended safety data sheets (SDSs) for registered REACH substances. The publications provide descriptions of both professional and consumer use of the substances. One document presents an example ES that refers to the widespread use of a substance in floor coatings applied by workers. The other document contains an example ES on the use of cleaning products by consumers. In both example ESs, the substances are classified as hazardous to human health but with a relatively low hazard level.

ECHA also notes that each publication includes:

exposure scenarios, exposure estimations and risk characterisations for the CSR and for communication via the SDS;
a description of the methodologies applied;
learning points and conclusions from the exemplification process;
open questions where further work is needed.

More information and links to the example ESs can be found here.

EU Proposes to Ban 20 Chemical Substances

2011-08-30T08:25:00.000-04:00

ECHA, the European Chemicals Agency based in Helsinki, has proposed a list of 20 chemical substances for eventual banning under the EU REACH program. The August 29, 2011 proposal would label these chemicals as "substances of very high concern" (SVHC), which would make them eligible for placement on the "candidate list." Once on the candidate list the substances may then be placed on Annex XIV of REACH, which requires manufacturers to apply for authorization for continued use. Any authorization would be limited to specific uses that can control for the hazardous properties of each substance, and authorization is for a limited time period - just long enough for companies to find substitutes.

Nineteen of the 20 substances are proposed because of their "potentially serious effects on human health." These are classified as carcinogenic and/or toxic for reproduction. One substance is proposed to be identified as a "substance of equivalent concern...because of its endocrine disrupting properties and potential for serious effects to the environment."

The substances are listed in the table of the ECHA press release here.

Interested parties have until October 13, 2011 to comment on any of the proposed SVHCs. ECHA notes that comments "should focus primarily on the hazardous properties that qualify the chemicals as SVHCs and on the substance identity." They also ask for "further information on the uses, exposures and availability of safer alternative substances or techniques."

Unless dropped from the list based on comments received, these 20 will join the 53 substances already on the Candidate List. Some of these have already been added to Annex XIV.

More information on the REACH authorization process can be found on ECHA's web site.

EU Adds Five Pesticides to PIC, Japan Considers Three More Chemicals for Prior Informed Consent

2011-08-25T09:02:00.000-04:00

The European Union (EU) voted last week to add five new pesticides to the Prior Informed Consent (PIC) list under the Rotterdam Convention. Meanwhile, Japan is considering the addition of three other pesticides to the PIC list. The Rotterdam Convention stipulates that "severely hazardous pesticide formulations that present a hazard under conditions of use in developing countries or countries with economies in transition may also be nominated for inclusion in Annex III." Once listed a "decision guidance document" must be prepared that defines how the chemical will be banned or severely restricted.

The five pesticides added to the PIC list by the EU are guazatine, indolylactic acid, 1,3-dichloropropene, ethalfluralin, and thiobencarb. Beginning on October 1st of this year these pesticides will be restricted for export to developing countries, i.e., the countries must be informed of the hazards prior to the sale and use in that country. Meanwhile, last week also saw Japan propose to add alachlor (a herbicide) and aldicarb and endosulfan (both insecticides) to the PIC list. Japan currently has restrictions on use and export of 36 chemicals under the Rotterdam Convention treaty.

The EU action followed on a decision not to include the five pesticides on the EU list of approved pesticides, which means they will be effectively banned from use in the EU. This action was taken because no manufacturer successfully applied for continued authorization of these chemicals.

More information on the additions to the PIC list can be found in the Official Journal of the European Union or on the Rotterdam Convention home page.

EPA Issues Final Plan to Review Regulations in an Effort to Remove Regulatory Burdens on Industry

2011-08-24T16:01:00.000-04:00

The USEPA this week issued its final regulatory review plan in accordance with an Executive Order signed by President Obama earlier this year. The goal of the review is to modify or eliminate regulations that are overly burdensome or costly. EPA wants to develop a "21st century approach to environmental protection."

Under the plan, EPA will review a total of 35 separate regulations. About half (16) fit into the category of "early actions" and will be reviewed during 2011, with the rest scheduled for longer term actions in subsequent years. For the early action list EPA "intends to propose or finalize an action to modify, streamline, expand, or repeal a regulation or related program." The 16 regulatory topics to be reviewed in 2011 include:

Gasoline and diesel regulations
Equipment leak detection and repair
Regulatory certainty for farmers
Modern science and technology methods in chemical regulation
Electronic online reporting of health and safety data under TSCA, FIFRA, FFDCA
National Priorities List rules
Quick changes to some TSCA reporting requirements
National Pollutant Discharge Elimination System (NPDES)
National primary drinking water regulations
Combined Sewer Overflows (CSOs) and integrated planning for wet weather infrastructure
Vehicle regulations, e.g., GHG and fuel economy standards and emissions standards
Multiple air pollutants, e.g., coordinating emission reduction regulations
NSPS reviews and revisions under the Clean Air Act
Clean Air Act Title V Permit program simplification
Innovative technology, i.e., seeking to encourage innovation
Costs of regulations, i.e., seeking to improve cost estimates

EPA notes that the actions it has taken just in the last few months have resulted in streamlined regulations and savings of up to $360 million per year. Overall the EPA expects this regulatory review to result in $1.5 billion in savings over the next five years. EPA further noted that it expects to conduct regulatory reviews on a "predictable, transparent, five-year cycle," including public requests for nominations of additional regulations for review.

The full EPA final regulatory review plan can be downloaded from the White House web site.

Melting Arctic Sea Ice Forces Walruses Onto Land

2011-08-22T16:31:00.000-04:00

A US Geological Survey study suggests that the fast melting of Arctic sea ice is the reason why walruses are coming up onto land in exceptional numbers. Normally walruses spend much of their time on sea ice, where they rest from their feeding dives, avoid predators, and even give birth. But when the sea ice is scarce they hop up onto land. Radio transmitters on tracking collars show researchers that walruses appear to be spreading out and spending substantial time looking for sea ice.

Last September saw 10,000 to 20,000 walruses haul up onto land, coinciding with the lowest ice extent of the year. But this year the Arctic sea ice has been melting at near record pace, with July setting a new record for the lowest extent in that month. Weather conditions in the Arctic suggest that August ice melt could be accelerated, which could mean the September minimum will be much lower than last year, and with less ice there could be more walruses up on land. That puts them at greater risk, both from land predators, density-based aggression, and inability to find food.

More information on this study, as well as other walrus research, can be found on the USGS site.

EPA to Discuss TSCA Chemical Prioritization Process in Upcoming Webinar - Invites Comments

2011-08-18T11:47:00.003-04:00

The USEPA is reevaluating and seeks to enhance their current chemicals management program as authorized under the Toxic Substances Control Act (TSCA). As part of this reevaluation EPA has scheduled a webinar on the prioritization factors and data sources the Agency plans to use to identify priority substances. EPA is also inviting the public to share their thoughts in an online discussion forum.

The discussion forum seeks comments on two steps in the process. The first step is prioritization and is split into two substeps - the priority factors to be used to identify substances of high priority, and the sources of data for those factors. The second step is to look at additional factors and sources for further analysis beyond the prioritization step.

More information and links to the discussion forum for each of the steps can be found on the
EPA discussion forum site. All comments will be reviewed by the EPA, though since this is not a formal rule-making EPA will not respond directly to each comment. The online forum is now open and will remain open through 5:00 pm EDT on September 14, 2011.

In conjunction, EPA is inviting participation in a webinar that will discuss the prioritization factors and data sources. The webinar will be held on Wednesday, September 7, 2011 from 1:30 to 4:30 pm EDT. Interested parties may register for the webinar here.

Prior to the webinar or submitting comments in the online discussion forum, all are encouraged to read EPA's background paper and discussion guide, which lays out the current thought process. This can be downloaded as a PDF file here.

Google Maps to Show Electric Vehicle Charging Station Locations

2011-08-16T15:01:00.000-04:00

Google has taken yet another step to help people find everything from the nearest grocery store to photos of the neighborhood dog. And now Google will show you where to charge your electric car. The new service, called Electric Car Stations, was created as part of the Department of Energy's National Renewable Energy Laboratory's Alternative Fuels and Advanced Vehicles Center.

The Electric Car Stations service is a community-based source of information on local electric recharging stations. Through Google Maps, members enter the locations of charging stations, complete with photos, hours of operation, and any pertinent comments. And if you have an iPhone you can go one better - there's an App for that! The PlugShare app allows users to update information while on the fly (or at least on the road).

The Alternative Fuels and Advanced Vehicles Center can be found online here. The color-coded map lets you know the best, and the worst, states for finding a station. Not surprisingly California boasts over 500 stations (but don't expect to recharge on your trip through the oil state of Oklahoma). The site also provides information on other alternative fuels like compressed natural gas, high ethanol blends, propane, biodiesel, liquified natural gas, and even hydrogen.

By the way, this isn't just limited to the United States. Google Maps also has data for electric vehicle charging stations in Paris, London, Rome, Berlin, Madrid and Stockholm. Search the keywords "ev charging station" and add the location to get an address and phone number.

As more stations are added, Google (and members) will update the database. Right now there are over 600 charging stations in the US listed. More to come.

Agencies Propose Using Fewer Animals to Identify Eye Hazards from Chemical Exposure

2011-08-15T09:24:00.000-04:00

Two interagency projects have combined to propose a new alternative testing method that will reduce the number of animals used to determine if chemical exposures will lead to eye hazards. The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), have issued a Federal Register notice requesting public comments on the proposal.

The Federal Register notice can be downloaded here.

Specifically, the interagency groups evaluated the classification criteria using results from testing only 3 animals instead of the usual 6 to 18 animals. They determined that "using a classification criterion of at least 1 positive animal in a 3-animal test to determine eye hazards will provide the same or greater level of eye hazard classification as current FHSA requirements, while using 50% to 83% fewer animals."

Based on their analysis, ICCVAM has developed draft recommendations "to use this classification criterion for ocular safety testing procedures that use only a maximum of 3 animals per test substance." The goal is to limit the use of animals in testing for the safety of chemicals. Non-animal test methods are also being developed, and these reduced-animal tests are one step towards eliminating animal testing whenever possible.

With the Federal Register notice these groups are requesting public comments. Comments are due by September 26, 2011 and can be done online at the NICEATM-ICCVAM web site here.

EPA Seeks Public Comment on Industry Petition for Guidance on Endocrine Disruptor Chemicals

2011-08-12T12:42:00.001-04:00

The USEPA on August 10, 2011 published a notice in the Federal Register "seeking public comment on a June 21, 2011 petition" from three major trade associations requesting the Agency "develop and publish guidance explaining the criteria by which EPA will make its decisions on data received in response to the test orders issued under the Endocrine Disruptor Screening Program" (EDSP).

Almost two years ago EPA initiated the EDSP Tier 1 screening for a list of 67 chemicals for the potential of being endocrine disruptors. Orders for testing were issued in the months following, with manufacturers of the initial list of chemicals being required to conduct eleven Tier I screening assays. The goal of the suite of assays is to "determine the potential for a chemical to interact with estrogen, androgen and thyroid hormone systems." Chemicals that were identified as possible disruptors could be subject to a second tier of assays designed to further evaluate and quantify endocrine effects. Last month the Inspector General faulted EPA for not moving fast enough to identify endocrine disruptor chemicals, and this response is unlikely to speed up the process.

Herein lies the reason for the industry petition. Despite efforts to develop higher level assays, the exact assays to be required and the criteria for selecting them remains uncertain. Crop Life America (CropLife), the Consumer Specialty Products Association (CSPA), and the Responsible Industry for a Sound Environment (RISE) filed the petition in an effort to better understand how EPA will use the Tier 1 screening data. Particularly, the trade associations want EPA to "fully analyze the Tier 1 screening data received in response to the list 1 test orders and revise the guidance to be developed to reflect what is learned by the analysis in order to ensure scientifically sound determinations and to protect the public health and the environment." In other words, what exactly are you going to do with the data received, and can you at least figure out what it all means before jumping into requiring the suite of tests for hundreds of other chemicals. And definitely don't even think about requiring Tier 2 tests before you know whether the Tier 1 tests provided any reliable information.

The Federal Register notice can be downloaded as a PDF here.

More information on EPA's Endocrine Disruptor Screening Program can be found on their web site.

States Pick Up the Slack - Pass Chemical Laws While Federal TSCA Reform Goes Nowhere

2011-08-11T15:46:00.000-04:00

According to an article in the online publication, Sustainable Business News, nine states "passed legislation to protect the public from toxic chemicals this year." Overall, "18 states have passed over 80 chemical safety laws in the last nine years by an overwhelming margin with broad bipartisan support." And this state-level dominance of chemical safety laws is expected to continue for the foreseeable future, primarily because the federal government has failed to take action to modernize the 35-year old Toxic Substances Control Act.

It's not from wont of trying. Senator Lautenberg again introduced a version of his Safe Chemicals Act in 2011, and is holding a series of stakeholder meetings to try to fine-tune the proposal with stakeholder support from industry, NGOs, and academia. This follows on several other attempts by Democrats in both the House and Senate to update TSCA, so far to no avail despite the public claims by industry to want modernization of the law.

The biggest reason why industry says they would like TSCA reformed is because they don't want to have to deal with the patchwork of state and local laws that are sometimes conflicting and always more susceptible to more local concerns. But despite the attempts by legislators to address stakeholder input, industry has to date found the bills "unworkable" and "non-starters." So while nothing happens at the federal level, the states jump in to protect their citizens.

According to the article:

On the state level, there's been bipartisan support for protecting children's health and the environment from dangerous chemicals. 99% of Democrats and 86% of Republicans supported the policies listed below.

Actions in various states have included banning BPA in thermal receipt paper, baby bottles, sippy cups, plastic storage and beverage containers, and other products, as well as restrictions and bans on heavy metals like cadmium in children's jewelry and brominated flame retardants in children's products. Other states have initiated broader programs to identify "priority chemicals of high concern," reduce the use of toxic chemicals, or pass laws to ensure "Kids Safe Products." A list of actions can be found in the Sustainable Business news article.

More information on state-level action to protect human health and the environment can be found here.

Whether all this state activity will stimulate federal action or not remains to be seen. As Congress focuses on cutting programs, many of which are health and safety related actions such as those at EPA (which expects to get substantial funding cuts), the states are forced to spend even more money doing what many of them feel is a federal role. On the other hand, as more and more states put pressures on industry, perhaps there will be more impetus for industry to recommend TSCA reform bills that they can support.

EPA's Design for the Environment (DfE) Issues Final Alternatives Assessment Criteria

2011-08-10T13:00:00.000-04:00

The USEPA Office of Pollution Prevention and Toxics has released its final alternatives assessment criteria for evaluating human and environmental effects in accordance with its Design for the Environment (DfE) program. DfE helps companies, states and other organizations to "identify safer alternatives to chemicals that may pose a concern to human health and the environment." More information on the DfE program can be found on EPAs web site.

DfE Alternatives Assessments are "multi-stakeholder partnerships convened to evaluate priority chemicals and functional alternatives." The goal is to "inform substitution to safer alternatives and reduce the likelihood of unintended consequences that might result if poorly understood alternatives are chosen." In other words, they don't want to replace one bad chemical with another bad chemical just because they don't know enough about it. According to DfE, its "expertise and focus is on chemical hazard," and encourages stakeholders to "assist with the selection of the scope of the alternatives assessment, help EPA consider economic realities, and identify likely functional alternatives for evaluation."

So whereas REACH in the EU specifies substances of very high concern and requires authorization for continued use (along with a substitution plan), the DfE program works directly with companies and other stakeholders to fix the problem together.

EPA is currently preparing DfE alternatives assessments for Bisphenol A (BPA), Decabromodiphenyl ether (decaBDE), and Nonylphenol ethoxylate (NPE) surfactants. The draft reports for public comment are expected to be released by EPA later this year. In addition, EPA has underway an alternatives assessment for Hexabromocyclodecane (HBCD) in polystyrene insulating foam. And EPA also plans to conduct an alternatives assessment for phthalates with a kickoff meeting scheduled for August 24, 2011.

Version 2.0 of the Alternatives Assessment Criteria document can be downloaded as a PDF here.

More information and links to the phthalates kickoff meeting signup materials can be found in the right sidebar of the DfE page.

Women in STEM: A Gender Gap to Innovation - New Report Suggests Women in Science Still Make Less Money than Men

2011-08-09T11:48:00.000-04:00

A new report concludes that women in science still make less money than their male counterparts, though that "gender wage gap" was smaller than that gap "compared to others in non-STEM occupations." The report, "Women in STEM: A Gender Gap to Innovation," examined women working in Science, Technology, Engineering, and Mathematics (STEM) jobs. It was released by the Department of Commerce and is based on an American Community Survey conducted in 2009 by the Census Bureau.

The report concludes that:

Women are underrepresented both in STEM jobs and STEM undergraduate degrees, and have been consistently over the last decade.
The relatively few women who receive STEM degrees are concentrated in physical and life sciences,
in contrast to men, who are concentrated primarily in engineering.
Women who do receive STEM degrees are less likely to work in STEM jobs than their male counterparts, though they experience a smaller gender wage gap compared to others in non-STEM occupations.

The report suggests that the under-representation of women in the sciences may be a combination of a variety of factors. One factor is that these fields "may be less accommodating to people cycling in and out of the workforce to raise a family. Other factors may be the lack of female role models, the different choices men and women typically make in response to incentives in STEM education and employment, and "perhaps
strong gender stereotypes discourage women from pursuing STEM education and STEM jobs." The report cautions that it "does not - and cannot – explain why gender differences in STEM exist, it does aim to provide data and insight that will enable more informed policymaking."

The findings provide definitive evidence of a need to encourage and support women in STEM with a goal of gender parity. Given the high-quality, well-paying jobs in the fields of science, technology, engineering and math, there is great opportunity for growth in STEM in support of American competitiveness, innovation and jobs of the future.

The full report can be downloaded as a PDF and read here.

EPA Issues Draft Scientific Integrity Policy

2011-08-08T10:47:00.000-04:00

The USEPA has issued a draft scientific integrity policy, following similar documents by NOAA and the Department of the Interior, and in response to President Obama's Executive Order calling for all agencies to develop such a policy. The draft policy comes as no surprise, as EPA in June named long-time EPA staffer William Sanders as the "Scientific Integrity Officer."

The 12-page document, which can be downloaded as a PDF here, essentially formalizes integrity policies that have already been in force at EPA for years. It covers all scientific staff and is designed to:

Ensure that their work is of the highest integrity, free from political influence.
Represent their own work fairly and accurately
Represent and acknowledge the intellectual contributions of others.
Avoid conflicts of interest and ensure impartiality.
Be cognizant of and understand the specific programmatic statutes that guide the employee’s work.
Welcome differing views and opinions on scientific and technical matters as a
legitimate and necessary part of the scientific process.
Accept the affirmative responsibility to report any breach of this Scientific
Integrity Policy.

The policy specifies four areas in which these goals are to be achieved, "a) the culture of scientific integrity at EPA, b) public communications, c) the use of Federal advisory committees and peer review, and d) professional development of government scientists and engineers."

The draft policy also "establishes a Scientific Integrity Committee," which is charged with implementing the policy across EPA. The makeup of the committee is still under development, but will be responsible for "implementing, reviewing, and revising as needed" the policy.

The draft policy is open for public comment through September 6, 2011 and should be emailed to osa.staff@epa.gov.

More information, contact info, and links to the policy can be found in EPA's news release.

Cadmium to be Added to Priority Testing List Under Toxic Substances Control Act

2011-08-04T16:20:00.000-04:00

The TSCA InterAgency Testing Committee (ITC) has added cadmium and 103 other cadmium compounds to the Priority Testing List. The action came in the 68th semiannual report to the EPA Administrator by the ITC. According to the ITC, the action is necessary because EPA and the Consumer Product Safety Commission believe there is reason for concern about cadmium in children's toys, jewelry, and a variety of other consumer products.

The ITC report was published in the Federal Register on August 1, 2011.

The main concerns identified for cadmium include developmental effects in animals such as fetal teratogenicity. Conclusive evidence of harm in humans has not been seen, but the animal effects led to the ITC's decision to include cadmium on their list for further assessment. This action in the US mirrors to some extent a similar action in the EU in the spring.

The ITC list is a rolling list, and several chemicals were removed for various reasons. Currently the priority list "includes 2 alkylphenols, 16 chemicals with insufficient dermal absorption rate data, 178 HPV Challenge Program orphan chemicals, and cadmium and 103 cadmium compounds."

The full ITC report can be viewed on the Regulations.gov web site.

Washington State Adopts Children's Safe Product Rule to Control Chemicals of Concern to Children

2011-08-03T15:12:00.001-04:00

Washington State has adopted a new rule implementing the state's 3-year old Children's Safe Product Act law. Amongst other things, the rule requires companies to report all children's products manufactured or imported for sale in Washington that contain any of 66 "Chemicals of High Concern to Children" (CHCC) that exceed the "Practical Quantification Limit" (PQL). The PQL is defined as "the lowest concentration that can be reliably measured within specified limits of precision, accuracy, representativeness, completeness, and comparability during routine laboratory operating conditions."

The rule provides for a phase-in period for reporting different categories of products and the size of the manufacturer and size of the products. Within 12 months, the largest companies who are making products that are likely to come in contact with the skin of children or be placed in a child's mouth, must make their first report. First reporting extends out to as long as 84 months (7 years) for "tiny" companies making products with limited potential for contact with children's skin. After the first notice date, reporting must occur annually on the anniversary of the first notice date.

The list of 66 Chemicals of High Concern to Children includes many of the same chemicals usually seen on such lists, including formaldehyde, benzene, Bisphenol A, many phthalates, brominated flame retardants, PFOS, and heavy metals such as mercury, cadmium and molybdenum.

Information on the new rule can be found on the Washington State Department of Ecology web site.

A PDF of the full rule can be downloaded and read here, including the list of 66 CHCCs.

EPA Issues its IUR Rule - Sets New Submission Period!

2011-08-02T16:18:00.000-04:00

Several weeks ago I noted that OMB had finally finished its review of the Inventory Update Rule (IUR), and today EPA announced that published the rule. This new rule, now called the "Chemical Data Reporting" rule (CDR), increases "the type and amount of information" EPA collects from manufacturers on commercial chemicals. The "improved" rule also "requires that companies submit the information electronically to EPA" in an attempt to streamline the reporting process. It also limits the confidentiality claims that can be made by reporting companies.

According to EPA's press release:

The CDR rule, which falls under the Toxic Substances Control Act inventory update rule (IUR), requires more frequent reporting of critical information on chemicals and requires the submission of new and updated information relating to potential chemical exposures, current production volume, manufacturing site-related data, and processing and use-related data for a larger number of chemicals. The improved information will allow EPA to better identify and manage risks associated with chemicals.

Companies will have to start reporting under the new requirements during the next data submission period, which has been set for February 1, 2012 to June 30, 2012. EPA had suspended the previous reporting period last May when it became clear that the OMB review would not be complete in time for manufacturers to comply.

Companies will be required to start following the new reporting requirements in the next data submission period, which will occur February 1, 2012 to June 30, 2012.

The full Chemical Data Reporting rule can be reviewed on EPA's IUR web page.

Canada to Ban Four Categories of Chemicals

2011-08-01T09:27:00.000-04:00

Canada issued a proposed regulation in the Canada Gazette on July 23, 2011 designed to essentially ban four groups of chemicals. According to the proposal, the four chemicals are Benzenamine, N-phenyl-, reaction products with styrene and 2,4,4-trimethylpentene (BNST), short-chain chlorinated alkanes, polychlorinated naphthalenes (PCNs) and tributyltins (TBTs) for non-pesticidal uses. All four were assessed in accordance with the Canadian Environmental Protection Act of 1999 (CEPA), which concluded that all four may be harmful to the environment. Health Canada determined that short-chain chlorinated alkanes also constitute a danger in Canada to human life or health.

Interestingly, three of the chemical classes are already no longer manufactured or used in Canada. So the main impact will be on the ban of BNST, which is an antioxidant additive in vehicle engine oils and industrial lubricants. Under the regulations, there would be a two-year transition period in which BNST could still be used for specific uses so that industry has time to conduct research to find alternatives. The transition period would also allow manufacturers to gain product performance certification for any product modifications using BNST subsitutes.

For all four chemical classes Environment Canada and Health Canada believe risk management measures are necessary to prevent harm to the environment and human health. Also, they determined that all four "meet the criteria for persistence and bioaccumulation potential as set out in the Persistence and Bioaccumulation Regulations."

The regulations as proposed would also modify existing restrictions on hexachlorobenezene (HCB), which is commonly found as an impurity in chlorinated solvents and other manufactured products. HCB would be moved from Part 2 to Part 1 of the schedule of toxic substances, which would put it on a track for full banning.

The public may provide comment on the draft regulations until October 6, 2011. More information is available in the Canada Gazette online.

NOAA Issues Draft Scientific Integrity Policy for Public Comment

2011-07-29T12:09:00.000-04:00

The National Oceanic and Atmospheric Administration (NOAA) has issued a draft scientific integrity policy for public comment. It joins a similar release by the Department of the Interior in February as a response to President Obama's executive order requiring federal agencies to provide guidance on how they will ensure scientific integrity. NOAA would like interested parties to provide feedback by August 20, 2011.

The policy, which can be read in full here, establishes Codes of Conduct and Ethics and identifies eight "Principles of Scientific Integrity." They include such things as how NOAA employees conduct, publish, and communicate research and results, and the benefits and limitations of NOAA scientists' participation in professional organizations, as well as rules for receiving awards. The primary goals are to ensure transparency, maintain the highest of levels of scientific integrity, and assist in the accurate communication of scientific findings to the public and policy-makers.

To support this policy, among other things, NOAA will facilitate the free flow of scientific information online and in other formats, document the scientific findings considered in decision-making, and ensure selection of scientific staff "based on a candidate's integrity, knowledge, credentials, and experience relevant to the responsibility of the position."

The new draft policy was welcomed by at least one scientific organization, the American Geophysical Union, which issued a press release.

The link for the NOAA scientific integrity policy, and instructions for providing feedback to the Agency, can be found here.

Environmental and Health Organizations Say "Fully Fund the National Children's Study"

2011-07-28T16:28:00.000-04:00

A group of national and state environmental and health organizations have written a letter to the Senate and House Committees on Appropriations calling for full funding of the National Children’s Study. The study was "authorized by the Children’s Health Act of 2000," and is "one of the most comprehensive national efforts to study environmental, social and genetic influences on children’s health, including air, water, diet, noise, family dynamics and community and cultural influences." Unfortunately, it has never been properly funded.

According to a press release by the Environmental Working Group, one of the 24 organizations that signed the letter, it includes:

“There are great and growing concerns about the increased rate of chronic and acute disease in the United States, and the National Children’s Study is designed to help all Americans have a better understanding of the links between those diseases and our environment. However, to ensure the study’s success, it is critical that it continue to receive the necessary funding throughout each and every stage. No study has ever followed children from before birth to age 21, but to do so the National Children’s Study must receive sufficient and consistent funding.”

Further, the letter says that "the study will examine how the events and exposures of early life can lead to specific outcomes including birth defects, asthma, obesity, diabetes, and mental health disorders among other possible outcomes." It suggests that "science continues to emerge and show that early exposures, especially those during vulnerable times of development, are linked to future adverse health effects."

EPA Gives Advance Notice - Wants Input on Whether to Require Toxicity Testing on Bisphenol A

2011-07-27T16:19:00.000-04:00

The USEPA is considering a rulemaking in which they would require additional toxicity testing on bisphenol-A, known commonly as BPA. Yesterday EPA published an "Advanced Notice of Proposed Rulemaking" asking for public comment on whether and/or how they should require testing "to determine the potential for BPA to cause adverse effects, including endocrine-related effects, in environmental organisms at low concentrations." The notice is subject to a 60-day comment period.

According to the Federal Register notice, BPA is a high production volume (HPV) chemical and "is a reproductive, developmental, and systemic toxicant in animal studies and is weakly estrogenic." The concern is that while there have been quite a few studies conducted, many of these have what some believe are significant flaws, thus calling into question their validity and/or ability to be used for regulatory purposes. BPA is a common ingredient in plastics and has come under intense scrutiny for its potential to be an endocrine disruptor. Given the disagreement over the scientific evidence and the significant ramifications of a BPA ban (and the similarly significant ramifications of a lack of BPA should the potential adverse effects be demonstrated), EPA is seeking to conduct definitive testing to settle the science.

In addition to toxicity testing, EPA is also considering environmental monitoring to determine the levels of BPA in "surface water, ground water, drinking water, soil, sediment, sludge, and landfill leachate in the vicinity of expected BPA releases." At present, the advanced notice is focused "only toward the environmental presence and environmental effects of BPA." While EPA continues to work with the Department of Health and Human Services on potential human health issues, it "is not considering any additional testing specifically in regard to human health issues at this time."

The full Federal Register notice can be viewed here. The deadline for public comment is September 26, 2011.

Inspector General Says Voluntary Children's Chemical Safety Program Failed to Protect Children

2011-07-25T11:06:00.000-04:00

As I noted back in December 2010, EPA's Inspector General's office had launched an inquiry into the Voluntary Children’s Chemical Evaluation Program (VCCEP) program because of complaints that it was ineffective. The IG has now completed their report and the findings are not good. In it's report released on July 21, 2011, the IG found that the VCCEP pilot program "did not achieve its goals to design a process to assess and report on the safety of chemicals to children." Further, the IG found that the design of the VCCEP pilot itself was flawed, and "did not allow for desired outcomes to be produced."

Specific problems include "a flawed chemical selection process" and a "lack of an effective communication strategy." The IG also specifically pointed at the lack of industry effort, "who chose not to voluntarily collect and submit information," as well as EPA's "decision not to exercise its regulatory authorities" under TSCA to "compel data collection."

The IG report recommends that EPA should design and implement a new process that:

identifies the chemicals with highest potential risk to children
applies the TSCA regulatory authorities as appropriate for data collection
interprets results and disseminates information to the public, and
includes outcome measures that assure valid and timely results.

In a response from EPA included in the report, EPA concurred with the IG's findings and indicated that work was ongoing in the existing chemicals program in an attempt to address the IG's concerns. The IG wasn't necessarily satisfied with EPA's response, and stressed the importance of having a workable program to protect children from chemical exposure.

The full report from the EPA's Inspector General can be downloaded here.

Updated QSAR Tools Made Available to Assess Chemicals

2011-07-22T12:50:00.000-04:00

Quantitative Structure-Activity Relationships (QSAR) are computer based tools that allow the estimation of chemical properties and toxicity based on a chemical's structure rather than from doing animal testing. QSARS, and their more qualitative cousins, SARs, are commonly used as screening tools to determine whether animal testing is needed. They are routinely used by the USEPA to assess premanufacture notice (PMN) submissions for new chemicals, which generally have very little actual testing data included. With the advent of REACH, the EU has also shifted to a greater acceptance of SARs and QSARs in lieu of actual laboratory testing.

To this end the European Chemicals Agency (ECHA) has made various QSAR tools developed by industry and governments available to companies registering chemicals under the REACH chemical registration law that went into force in 2007. ECHA has now released an updated, Version 2.2, of the "OECD QSAR Toolbox" for "grouping chemicals into categories" and "to fill data gaps by read-across, trend analysis and to assess the (eco)toxicity hazards of chemicals." The goal is to provide data for decision-making while reducing costs and unnecessary vertebrate animal testing. According to ECHA, users of the QSAR Toolbox can:

Identify analogues for a chemical, retrieve experimental results available for those analogues and fill data gaps by read-across or trend analysis;
Categorise large inventories of chemicals according to mechanisms or modes of action;
Fill data gaps for any chemical by using the library of (Q)SAR models;
Evaluate the robustness of a potential analogue for read-across;
Evaluate the appropriateness of a (Q)SAR model for filling a data gap for a particular target chemical;
Build (Q)SAR models.

More information on the OECD QSAR Toolbox can be found here.

Senators Lautenberg and Inhofe Staffs Hold Stakeholder Meetings on Safe Chemicals Act of 2011

2011-07-20T18:16:00.000-04:00

Way back in April Senator Frank Lautenberg introduced his newest iteration of TSCA reform called the Safe Chemicals Act of 2011. Last year the Democratic-controlled House took the lead in holding stakeholder meetings to fine tune the 2010 versions of the bill. With the House controlled by Republicans this year it is left to the 87 year old Lautenberg to initiate stakeholder meetings in the Senate in an attempt to give TSCA reform at least some semblance of movement during the current Congressional term. Since Republican Senator Inhofe had previously volunteered to work in a bipartisan manner with the Democratic Lautenberg, their staffs have begun meeting with various stakeholders to discuss key issues in the debate.

In June there were separate meetings between staffers and industry and environmental/health advocacy groups (NGOs). Those meetings primarily dealt with the differing opinions on what should be the "safety standard." It's unclear at this stage whose viewpoint would win out, but in the past industry has made it clear that the previously proposed standard was unworkable. At least one more stakeholder meeting with industry representatives was held last week, this time to discuss a prioritization scheme. A separate meeting with NGOs was due to occur, but it is unclear if it has yet happened. NGOs had previously pushed to have minimum data sets required for all chemicals, in line with the production volume based tiered requirements currently being compiled by REACH registrants. This is a fundamental point of difference between the two main groups of stakeholders.

Additional meetings on other key elements of Lautenberg's bill are expected to occur in coming weeks.

Whether a TSCA reform bill can even be taken up for floor discussion in this current Congress is a question mark, though it is safe to say that the likelihood is exceedingly small. The current contentious environment and uncompromising attitudes of many in the House make passage of any TSCA reform law nearly impossible. Which means that the EPA must work under the current 35-year old law, the same law that all stakeholders have said is in dire need of modernization.

China Lists Hazardous Chemicals

2011-07-19T07:54:00.000-04:00

China has now posted its first list of "hazardous chemicals for priority management" as party of their efforts to update their chemical health and safety management program. This first list contains 60 chemicals and was released by SAWS, China's State Administration of Work Safety, in late June 2011.

The list can be viewed here in Chinese only.

Chemicals listed for priority management include common substances like benzene, methanol, chlorine, and ammonium hydroxide, as well as methyl hydrazine, acrylic acid, hexachloropentadiene, and methyl tert butyl ether (MTBE). There are also some substances and mixtures that are listed based on their classification as flammable gases or liquids, pyrophoric liquids or solids, or substances that emit flammable gases when in contact with water.

For chemicals on the list, SAWS will engage in prioritized inspections of facilities that manufacture, store or use the chemicals. Companies will also be required to prepare emergency response plans to deal with spills and accidents involving chemicals on the list.

Additional lists are expected in the future.

GAO Tells Congressional Panel It Will Review Changes to IRIS Chemical Assessment Process

2011-07-15T15:05:00.000-04:00

At a House Science Committee hearing this week, GAO environmental department director David Trimble testified that the GAO was currently undertaking a review of EPA's revised 2009 IRIS assessment process and how EPA was proceeding in implementing changes recommended by the National Academy of Sciences. Trimble indicated that the 2009 revisions "appeared to represent significant improvement, but the viability of the IRIS program will depend on effective and sustained management and oversight." The process revisions were initiated by EPA Administrator Lisa Jackson following extensive complaints about the quality of assessments performed during the Bush Administration.

IRIS refers to the Integrated Risk Information System, a human health assessment program that "evaluates quantitative and qualitative risk information on effects that may result from exposure to environmental contaminants...The information in IRIS is intended for those without extensive training in toxicology, but with some knowledge of health sciences."

In their continuing efforts to improve the oft-maligned program, EPA on July 12, 2011 announced plans "to further strengthen and streamline" IRIS and implement the April 2011 recommendations by the National Academy of Sciences. According to EPA:

The most recent improvements include: reducing volume and redundancy of assessments; fuller discussion of methods and concise statements of criteria used in studies for hazard evaluation; clearer articulation of the rationale and criteria for screening studies; implementing uniform approaches for choosing studies and evaluating their findings; and describing the determinants of weight that were used in synthesizing the evidence. In addition, EPA is working to set up a dedicated advisory committee that will exclusively focus on the quality, transparency and scientific rigor of IRIS assessments. EPA will also create a peer consultation step early in the development of major IRIS assessments. Continually improving the IRIS program is an ongoing priority for the Agency, and these efforts work towards this goal.

The full testimony of David Trimble can be read here.

US Senators Propose Banning Chemicals of High Concern Due to Endocrine Disruption

2011-07-14T11:54:00.000-04:00

Senators John Kerry and Jim Moran, both Democrats, have introduced legislation that would effectively ban certain uses of chemicals found to pose a high concern for endocrine disruption. The bill, called the Endocrine-Disrupting Chemicals Exposure Elimination Act, would establish a research program to determine if candidate chemicals are endocrine disruptors, then ask an expert panel to rank them as either "high," "substantial," "minimal," or "no" concern. The bill would require this panel to assess up to ten chemicals per year. It would also require an exposure reduction strategy for those deemed to be of high concern.

The bill comes as Congress has seemingly reached a stalemate on how to proceed with reform of the 35-year old Toxic Substances Control Act (TSCA). Senator Frank Lautenberg introduced the latest version of his Safe Chemicals Act earlier this year, and while at least one in a series of non-public stakeholder meetings have been held to fine-tune the bill, no obvious path forward on passage appears to be in the works. Likewise, it is unclear what chances the Kerry/Moran bill will have in passage given the clear lack of any action being taken by the Republican-controlled House.

According to Kerry's press release:

Today, there are approximately 80,000 known chemicals in our environment that are potentially harmful, yet many of these chemicals are not tested to determine their effects on human health. This includes common products Americans use every day such as household cleaners, cosmetics or personal care products. There is an increased rate of disorders affecting the human endocrine system, which children developing in the womb are particularly vulnerable to.

In introducing the bill, Senator Kerry noted that:

“We have a responsibility not just to inform Americans of the dangers, but to protect them from chemicals with the potential to cause serious illnesses from birth defects to cancer. It’s just common sense.”

EU Commission to Ban Biocide Uses for Eight Chemicals

2011-07-13T09:16:00.000-04:00

Last week the European Commission issued a decision "concerning the non-inclusion of certain substances in Annex I, IA or IB to Directive 98/8/EC," i.e., to ban specific uses for eight biocidal chemicals. The decision gives manufacturers and formulators until July 1, 2012 to phase out use of the substances for the biocidal product types indicated. After that date they will be banned from being placed on the market.

The substances and product types for which they will be phased out are:

Formaldehyde: Human hygiene products, drinking water disinfectants, fibre/leather/rubber materials, vermin

2-Chloroacetamide: Veterinary hygiene products, in-can preservatives, metalworking fluids preservatives

Thiabendazole: Private and public health area disinfectants, metalworking fluids preservatives

2,2'-dithiobis[N-methylbenzamide]: metalworking fluids preservatives

Sulphur dioxide: Human hygiene products, private and public health area disinfectants, in-can preservatives, film preservatives, metalworking fluids preservatives

Reaction product of dimethyl adipate, dimethyl glutarate, dimethyl succinate with hydrogen peroxide/Perestane: Food and feed area disinfectants

Oligo(2-(2-ethoxy)ethoxyethylguanidinium chloride): Human hygiene products, drinking water disinfectants, in-can preservatives, metalworking fluids preservatives

Poly(hexamethylendiamine guanidinium chloride): Human hygiene products, drinking water disinfectants, in-can preservatives, metalworking fluids preservatives

Any other uses not listed are still authorized to continue beyond the phase out date. In all cases, the uses above were not supported by the manufacturers.

EU Science Committees Call for Comments on How REACH Can Handle "Chemical Mixtures"

2011-07-12T09:07:00.000-04:00

Three scientific committees of the European Commission have issued a "preliminary opinion" on how REACH and other chemical regulations can address the risks of chemical mixtures. The three committees - the Scientific Committee on Consumer Safety (SCCS), the Scientific Committee on Health and Environmental Risks (SCHER) and the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) - are now opening a public consultation and asking for feedback on the document, "Toxicity and Assessment of Chemical Mixtures."

REACH, the European chemical regulation, is a substance-based law, though some substances as defined can include mixtures of either discrete or variable composition chemicals. Still, there is concern that mixtures of chemicals, sometimes called "chemical cocktails," could have greater toxicity than the sum of the toxicities for the individual chemicals. This paper by the three committees attempts to address this concern, though no new amendments to the REACH law were proposed at this time.

According to the press release, the main conclusions of this preliminary opinion are:

Chemicals with common modes of action may act jointly to produce combined effects that are larger than the effects of each mixture component alone.
For chemicals with different modes of action (i.e. acting independently), no robust evidence is available that exposure to a mixture of such substances is of health concern if each individual chemical is present at or below their no effect levels.
For chemicals that interact, interactions (including antagonism, potentiation, synergies) usually occur at medium or high-dose levels (relative to the lowest effect levels). At low exposure levels they are either not occurring or toxicologically insignificant.

The deadline for comments is September 9, 2011. Commenters are asked to use a special web site to assist the EU in compiling what they expect to be a significant number of comments.

OMB Review of Inventory Update Rule Complete - Expects to Publish Soon

2011-07-11T09:58:00.000-04:00

After a long and anxious wait, the Office of Management and Budget (OMB) has finally completed its review of EPA's inventory update reporting rule (IUR) changes. The delay in OMB review had caused EPA to suspend the reporting period, which was supposed to have run from June 1 to September 30, 2011. The proposed rule revised the amounts and types of information that chemical manufacturers and others had to report to EPA under the IUR. While OMB hasn't released its findings yet, it appears they will approve the rule but recommend some changes.

Basically the IUR is designed to provide EPA with key information on chemical production and processing in the United States. The data companies are required to submit includes information that can help EPA - and the public - assess exposure to the chemicals that are on the reporting list. These data, along with hazard data such as toxicity and environmental fate information, are used to identify potential risks to the public.

Since OMB does not expect to publish their findings for several days or even weeks, EPA must wait before they can set a new reporting deadline. In the past EPA representatives have tried to ease industry anxiety by insisting there would be adequate lead time for companies to collect the information needed prior to a new reporting period. Obviously, most of the data that need to be submitted are the same as has been done by industry for several previous IUR reporting periods, and with the EPA changes already identified in the proposed rule, industry should already be in a position to start collecting data. Because of the OMB delay, EPA will likely be under pressure to set the new reporting period sooner rather than later to avoid disrupting the next cycle of IUR reporting, so it would behoove companies to start the process internally while waiting for publication.

India Meets Criteria to Join OECD "Mutual Acceptance of Data" Program

2011-07-08T08:54:00.000-04:00

India has now met all of the requirements to be accepted into the OECD Mutual Acceptance of Data (MAD) program. It did so by demonstrating that it could successfully conduct health and safety testing under Good Laboratory Practices (GLPs), which is the standard for such testing in all thirty-four of the OECD countries (which includes EU countries, the US and Canada, among others). The achievement allows Indian chemical manufacturers to conduct and provide single tests in support of their products in all OECD countries. This makes it easier and less costly to enter the marketplace.

The achievement is important because OECD consists of mostly economically developed countries, and India joins Brazil, Singapore and South Africa as the only developing countries to meet the tough OECD standards. Being able to enjoy the benefits of the MAD program will greatly enhance marketability. MAD is the system in which the results of a set of health and safety studies can be submitted in support of a product, and acceptance by a rapporteur member state is deemed acceptance by all member states.

ECHA Reports that REACH and CLP Chemical Regulations are "Working Well"

2011-07-06T16:29:00.000-04:00

The European Chemicals Agency (ECHA) recently published two reports, both required by law, in which they conclude that despite many industry misgivings prior to enactment, the REACH and CLP regulations are "working well and that the various actors responsible for the work are responding as required." REACH is the chemical control law in Europe and the CLP is the Classification, Labeling and Packaging Regulation. ECHA attributes the success largely to "the commitment and collaborative work between industry, stakeholders, the Member States, the European Comission and ECHA."

According to their press release, ECHA offers "three key lessons" from the experience:

The uncertainty over the number of registrations for the first deadline was a challenge to manage and more accurate estimates would be helpful in future.
Close working relationships with industry and stakeholders are vital to ensure success and the Agency can help by providing stable tools and guidance.
The interrelationship between the various elements of the two regulations is important and has become increasingly apparent. For example, ambiguities in substance identification can lead to problems in forming Substance Information Exchange Fora (SIEF), evaluation and risk management activities.

The report, which can be downloaded here as a PDF, offered recommendations for improving implementation of the laws in the future.

A second report on the implementation of efforts to reduce unnecessary animal testing can also be downloaded as a PDF here.

UPDATE - Only 3 of the 4 chemicals added to Rotterdam Convention PIC list

2011-06-27T08:14:00.001-04:00

Last week I reported that the parties to the Rotterdam Convention were in discussion to add four chemical substances to the Prior Informed Consent (PIC) list. The four substances were chrysotile asbestos, endosulfan, alachlor and aldicarb. Well, now that the Fifth Conference of the Parties is over, they decided only to list three of the four. Parties could not reach a consensus on the addition of chrysotile asbestos due to opposition from several countries, led by Canada and later joined by Kazakhstan, Kyrgyzstan, Peru and the Ukraine.

Agreement to list the herbicide alachlor and the insecticide aldicarb was reached quickly. The addition of endosulfan was a bit more contentious because Cuba had argued that listing would cause significant implementation problems for developing countries. After promises were made to provide technical and financial guidance the agreement to list endosulfan was reached.

These three chemicals will be added to Annex III to the Convention. Further discussion on chrysotile asbestos will no doubt occur in future meetings of the parties.

More information on Rotterdam and Prior Informed Consent can be found here.

European Commission Will Not Seek New Legislation for Nanomaterials

2011-06-24T10:05:00.000-04:00

At a meeting of the European Commission this week commissioners confirmed that the EU plans to deal with nanoscale materials primarily through its REACH chemical regulation rather than develop entirely new legislation specific to nanomaterials. Commissioners noted that creating something new was simply not feasible at this time.

The Commission will, however, work with ECHA and other regulatory bodies to develop additional guidance documents to assist stakeholders in adequately characterizing and evaluating any specific risks posed by nanoscale materials. While most nanomaterials are nano-sized versions of existing chemicals, the small size often results in differences in key physical-chemical, fate and transport, and potentially toxicity properties. The goal is to find a balance between the need for additional information for the risk assessment and creating a massive new regulatory burden for companies, many of whom may be small or medium sized entities.

At this point there is quite a bit of uncertainty for industry, which must deal with a regulatory system that isn't yet predictable or consistent. Even the definition of what the regulatory bodies believe constitutes a nanomaterial is not clear. Still, industry is generally in agreement that nanomaterials should be dealt with through REACH rather than have to deal with entirely new legislation.

EPA to Initiate Chemical Safety for Sustainability Plan

2011-06-22T07:48:00.002-04:00

The USEPA is set to launch a Chemical Safety for Sustainability initiative. The plan is to use innovative approaches to assess chemical hazard and exposure so this can be accurately communicated to the public. According to their web site:

EPA scientists and their partners are embracing the principles of green chemistry to produce safer chemicals. They are also integrating a diversity of scientific disciplines to develop new prediction techniques, pioneering the use of innovative technologies for chemical toxicity testing, and designing tools to advance the management of chemical risks. Chemical safety for sustainability includes research in computational toxicology, nanotechnology, endocrine disrupting chemicals, human health, and pesticides.

As part of this ongoing process EPA recently made available two new chemical databases - ToxCastDB and ExpoCastDB. These supplement the ToxCast robotic screening testing program started earlier by EPA. The most recent announcement of the Chemical Safety for Sustainability initiative was made during the first meeting of the National Research Council's Committee on Science for EPA's Future, part of the National Academies of Sciences.

The three main areas of focus for the program are:

Providing scientific knowledge, tools and models for integrated evaluation strategies
Improving assessment and informing management for chemical safety
Targeting high priority research needs for immediate and focused attention

GAO Calls for Improved National Priorities for Climate Change

2011-06-21T16:11:00.000-04:00

The Government Accountability Office (GAO) has issued a report calling on the federal government to improve and clarify national priorities related to climate change. Acknowledging that "climate change poses risks to many environmental and economic systems, including agriculture, infrastructure, and ecosystems," GAO noted that national priorities need to be set and "better align them with federal funding decisions." While "funding for climate change activities reported by OMB increased from $4.6 billion in 2003 to $8.8 billion in 2010," GAO noted that it "is organized in a complex, crosscutting system."

Two key factors were identified that "complicate efforts to align funding with priorities."

First, notwithstanding existing coordinating mechanisms...federal officials do not have a shared understanding of strategic priorities. This is in part due to inconsistent messages articulated in strategic plans and other policy documents....Second, respondents indicated that since mechanisms for aligning funding with priorities are nonbinding, they are limited when in conflict with agencies' own priorities.

GAO came up with two recommendations:

1) To improve the coordination and effectiveness of federal climate change programs and activities, the appropriate entities within the Executive Office of the President, including the Council on Environmental Quality, Office of Energy and Climate Change Policy, Office and Management and Budget, and Office of Science and Technology Policy, in consultation with Congress, should work together with relevant federal agencies and interagency coordinating bodies to clearly establish federal strategic climate change priorities, including the roles and responsibilities of the key federal entities, taking into consideration the full range of activities within the federal climate change enterprise.

2) To improve the coordination and effectiveness of federal climate change programs and activities, we recommend that the appropriate entities within the Executive Office of the President, including the Council on Environmental Quality, Office of Energy and Climate Change Policy, Office and Management and Budget, and Office of Science and Technology Policy, in consultation with Congress, should work together with relevant federal agencies and interagency coordinating bodies to assess the effectiveness of current practices for defining and reporting federal climate change funding and aligning funding with priorities, and make improvements to such practices as needed for Congress and the public to fully understand how climate change funds are spent.

For more information and to download a highlights page and the full report, go to the GAO page here.

Four chemicals to be added to the Rotterdam Convention PIC list?

2011-06-20T08:36:00.000-04:00

The fifth meeting of the Conference of the Parties (COP5) to the Rotterdam Convention starts today and will continue through Friday, June 24, 2011 in Geneva Switzerland. On the agenda are decisions regarding the inclusion of four substances to the Prior Informed Consent (PIC) list. The four substances are chrysotile asbestos, endosulfan, alachlor and aldicarb. If the decision is inclusion, the chemicals will be added to Annex III to the Convention.

The participants of COP5 also hope to adopt a strategic plan related to management of industrial chemicals worldwide, with emphasis on "synergies between the Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and Their Disposal, the Rotterdam Convention and the Stockholm Convention on Persistent Organic Pollutants."

Alachlor and aldicarb are expected to be approved for PIC listing, while chrysotile asbestos and endosulfan may garner significant additional discussion as several participating countries have expressed their concerns based on economic reasons, i.e., that PIC listing is equivalent to blacklisting the chemicals from the market.

More information on the Rotterdam Convention and Prior Informed Consent can be found here and here.

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

2011-06-17T12:46:00.002-04:00

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:

Chromium trioxide;
Chromic acid, Oligomers of chromic acid and dichromic acid;
Sodium dichromate;
Potassium dichromate;
Ammonium dichromate;
Potassium chromate;
Sodium chromate;
Trichloroethylene;
Cobalt(II) sulphate;
Cobalt dichloride;
Cobalt(II) dinitrate;
Cobalt(II) carbonate;
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

2011-06-16T14:22:00.000-04:00

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

2011-06-15T07:53:00.000-04:00

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

2011-06-13T16:38:00.000-04:00

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

2011-06-10T09:13:00.000-04:00

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

2011-06-09T19:21:00.000-04:00

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"

2011-06-08T12:07:00.000-04:00

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

2011-06-07T21:55:00.000-04:00

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

2011-06-06T16:49:00.000-04:00

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

2011-06-02T10:48:00.000-04:00

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

2011-06-01T16:05:00.000-04:00

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

2011-05-31T12:01:00.000-04:00

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.