Korea Joins Effort to Reduce Animal Testing of Chemicals - Find Alternative Methods

Europe has one (ECVAM), the United States has one (ICCVAM), and now Korea has one (KoCVAM).  Last week the Republic of Korea (i.e., South Korea)'s Center for the Validation of Alternative Methods (KoCVAM) officially joined a collaborative effort to find alternative chemical test methods.  The international agreement, the International Cooperation on Alternative Test Methods (ICATM), "was officially created in April 2009, when an agreement was signed between validation bodies from Europe, USA, Canada and Japan." 

The goal of collaboration is to develop and validate chemical testing methods that reduce, or preferably eliminate, the need for live animals (i.e., in vivo methods).  The non-animal methods (in vitro) can include any number of tests ranging from excised tissues, artificially grown tissues or cells, and genetic methods, as well as computer generated structure activity relationship (SAR) modeling.  The formal addition of KoCVAM to the agreement, it's fifth member, occurred during the 50th annual meeting of the Society of Toxicology in Washington DC.

With REACH entering its next stage, which includes review of proposed testing plans from the first registration deadline, and new chemical control efforts in Korea, Turkey, Switzerland and (maybe) the United States, a great deal of effort is being made to find alternatives to traditional animal testing.  REACH specifically encourages the use of non-animal methods such as QSARs, in vitro, ex vivo, and read-across from data available for related chemicals. 

For more information.

TSCA Oral History Project - From Inception to Reform (with Video)

The Chemical Heritage Foundation, a Philadelphia based policy center, has an ongoing program they call the TSCA Oral History Project.  Videos of two recent events are now on their web site.

The first video includes speakers from a November 19, 2010 seminar called "From Inception to Reform: Unpacking the History of the Toxic Substances Control Act through Archives and Oral Histories."  The main speakers were Jody Roberts and Jessica Schifano.

Of perhaps even greater interest was another public discussion held on March 3, 2011 at the American Association for the Advancement of Science headquarters in Washington, DC.  It featured some of the key players in the chemicals regulatory framework over the years, specifically:

• James V. Aidala
• Charles M. Auer
• Charles L. Elkins
• Mark A. Greenwood
• Glenn E. Schweitzer

Each offered their insights into the history of the Toxic Substances Control Act and what factors are important in the (sometimes) continuing debate over how to reform it.  You can watch the YouTube video below:



More information can be found at the Chemical Heritage Foundation's web site.

ECHA Committee Adopts First Proposals to Restrict Chemical Substances Under REACH

A key committee responsible for determining chemicals that should be restricted under REACH has issued its first two opinions.  The Committee for Risk Assessment (RAC) decided on March 8-11, 2011 that dimethylfumarate (DMFu) should be restricted in articles and lead and lead compounds should be restricted in jewelry.  Both of these chemical substances will now be severely restricted from being used.

The RAC found that:

There is a serious risk to consumers from the use of articles treated with DMFu and that the suggested restriction on the production and placing on the market of articles containing DMFu is appropriate in order to reduce the risk to consumers.

There will now be a temporary ban of the inclusion of DMFu in articles placed on the market in the EU until March 15, 2102, after which a decision will need to be made on whether to make the ban permanent.  DMFu had been used as an anti-mold agent, but there had been "several reports in many Member States of severe skin reactions (dermatitis) in consumers exposed to DMFu in articles, such as leather sofas and shoes." 

The RAC also found that:

Lead contained in jewellery may significantly contribute to the exposure of children to lead by them putting it in their mouths, and that a restriction is therefore appropriate...[A]fter assessing the dossier and the information submitted during the public consultation...basing the restriction on the content of lead in articles unless it could be demonstrated that lead is not released should a child put a piece of jewellery in his or her mouth. 

The main concern is the increased exposure to children, whose behavior often includes sucking or even swallowing small jewelry, and the well-known severe adverse effects to development of the central nervous system in children.

Along with the RAC determinations were parallel determinations on these two substances by the Committee for Socio-economic Analysis (SEAC).  More information on both can be found on the ECHA web site.  The opinions will also be available soon following the links.

House Republicans (but not Paul) Vote Three Times to Deny Science

House Republicans continued their denial of climate science today by voting three times against amendments offered by the Democrats in the Energy and Commerce Committee. The Committee, chaired by Rep. Fred Upton (R-MI), was considering amendments to its proposed bill that would politically repeal EPA's scientific endangerment finding on greenhouse gases.  The bill would in fact block EPA's ability to take any science based regulatory action on greenhouse gases. 

The first amendment was offered by Ranking member Rep. Henry Waxman (D-CA):

"Congress accepts the scientific finding of the Environmental Protection Agency that 'warming of the climate system is unequivocal, as is now evident from observations of increases in global average air and ocean temperatures, widespread melting of snow and ice, and rising global average sea level.'"

It was defeated 20-31, with all Republican members voting to deny EPA's scientific findings.

The second amendment was offered by Rep. Diana DeGette (D-CO) and read:

“’the scientific evidence is compelling’ that elevated concentrations of greenhouse gases resulting from anthropogenic emissions ‘are the root cause of recently observed climate change.’”

This amendment was defeated 21-30, again with all Republicans voting against the amendment.

The third amendment was offered by Rep. Jay Inslee (D-WA) and it said that human-caused climate change is a threat to public health and welfare. Again, the vote was 21-31 with all Republicans voting against the scientific consensus. 

It should be made clear that the US National Academies of Sciences last year noted that:

A strong, credible body of scientific evidence shows that climate change is occurring, is caused largely by human activities, and poses significant risks for a broad range of human and natural systems….

In addition, recent studies have documented that very nearly all active climate researchers concur that the planet is warming and greenhouse gases are the predominant factor.  Also, the most recent IPCC report, the National Academies of all of the major countries of the world, and pretty much all of the major scientific organizations on the planet concur that the climate is changing and that human activity is the major cause.  The US National Academies called it "settled fact."  So when Republicans unanimously vote against basic scientific principles they are in fact voting to deny the science.

Read more about the vote in articles in The Hill and Politico.

How to help the earthquake and tsunami victims in Japan

The Associated Press lists some ways to help victims of the earthquake and tsunami in Japan.  Please do all you can.

— AMERICAN RED CROSS — U.S. mobile phone users can text REDCROSS to 90999 to add $10 automatically to your phone bill. Or visit http://www.redcross.org or call 1-800-RED-CROSS.

— INTERNATIONAL MEDICAL CORPS — Sending relief teams and supplies to the area. Call 1-800-481-4462, or visit http://internationalmedicalcorps.org .

— SAVE THE CHILDREN — The relief effort providing food, medical care and education to children is accepting donations through mobile phones by texting JAPAN to 20222 to donate $10. People can also call 1-800-728-3843 during business hours or visit www.savethechildren.org/japanquake to donate online.

— GLOBAL GIVING — The non-profit which works through grassroots efforts says Americans can text JAPAN to 50555 to give $10 through their phone bill. Or visit http://www.globalgiving.org/ .

— INTERACTION — The group is the largest alliance of U.S.-based international nongovernmental organizations and lists many ways to help on its site, http://www.interaction.org .

— NETWORK FOR GOOD — The aggregator of charities has a list of programs and ways to donate to relief efforts. Visit http://www.networkforgood.org.

European Chemicals Agency (ECHA) Meets Deadline for Chemical Dossier Completeness Checks

The European Chemicals Agency (ECHA) has reported that it has met its statutory obligation to finish "completeness checks" on chemical dossiers submitted for REACH registration.  REACH required ECHA to complete these reviews within three months following the deadline, which for the first group was November 30, 2010.  The completeness check requirement applies only to registrations for phase-in substances submitted in the last two months before the first registration deadline.  A total of 15,366 dossiers were submitted during that two month period.  According to ECHA:

Registration numbers have been granted for 20 175 of the 20 723 dossiers that were submitted by the first registration deadline, resulting in a total of 3 483 phase-in substances being registered under REACH. Dissemination of information from these dossiers has been accelerated.

The completeness check is only to "check that all required elements have been provided," i.e., that some data are there.  Much of this check is done automatically and registrants can pre-check their dossiers using a Technical Completeness Check (TCC) tool made available to all via the ECHA web site.  ECHA then repeats the TCC upon receipt and also may check other business rules.  This completeness check is different from a compliance check, which involves ECHA staff actually reviewing the substance of the data submitted.

Information about the chemicals registered and access to dossiers once they have been disseminated can be found here.

Chemical Industry Calls for Improvements to US Regulatory System

Representatives from the chemical industry called on Congress to improve the federal regulatory system," including a requirement for cumulative impact assessments of proposed rules, to protect U.S. innovation, investment and jobs."  Testifying before the House Subcommittee on Regulatory Affairs, Stimulus Oversight & Government Spending (yes, it's a long title), American Chemistry Council (ACC) Vice President of Regulatory and Technical Affairs Michael Walls noted:

"If manufacturing is to make a significant contribution to economic recovery, including the creation and maintenance of well-paying jobs, it is imperative that we have an accurate understanding of the impact of proposed regulations on industry.  The full regulatory burden for a particular sector can only be known if the cumulative impact of overlapping regulations is identified."

In particular, Walls indicated that industry felt “the lack of cumulative impact assessments is a fundamental shortcoming in the way government agencies develop and evaluate proposed rules.”  According to the ACC press release, Walls offered four recommendations to improve the economic analysis of proposed rules:

1. Conduct cumulative impact assessments to identify the full regulatory burden being created by a proposed rule.
2. Track the sectors affected by new regulations so the most heavily regulated sectors can be easily identified and regulations can be streamlined appropriately.
3. Seek input from the businesses that will be affected before developing rules in order to better understand the effects that a potential rule may have.
4. Conduct a more comprehensive analysis of the impact of a proposed rule on jobs that considers the type and quality of jobs being affected.  

More information, including Walls' testimony (PDF), can be found on the ACC web site.

US House Hearing Today on Climate Science - With (Mostly) Actual Climate Scientists

Today, March 8, 2011, there will be a hearing of the Subcommittee on Energy and Power entitled "Climate Science and EPA's Greenhouse Gas Regulations."  The subcommittee is a part of the House Committee on Energy and Commerce, now chaired by Republican Fred Upton.  Upton was responding to a request by former chair and now ranking member Democrat Henry Waxman requesting "a hearing on the science of climate change" prior to moving forward on Republican attempts to craft legislation restricting EPA's ability to regulate CO2 and other greenhouse gases.  Author and Blogger Chris Mooney points out that Democrats wanted even more scientists to testify, and that former subcommittee chair Bobby Rush had noted in the hearing Upton had called last month "Don't you find it strange that this hearing is being conducted with no scientists at all?" 

So unlike past hearings in which Republicans called as witnesses non-scientists like fiction writer Michael Crichton and professional speaker Lord Viscount Christopher Monckton, as well as industry scientists such as the Cato Institute's Pat Michaels, this hearing will have a full set of actual practicing climate scientists to testify.  While it is nice to see that the committee will rely on scientists for input on the science, the line up does tend to represent, as Joe Romm put it, "the usual suspects," presumably because the number of actual climate scientists who disagree with the scientific consensus is pretty limited.

The invited witnesses are:

Dr. John R. Christy
Director, Earth System Science Center
University of Alabama in Huntsville

Dr. Christopher Field
Director, Department of Global Ecology
Carnegie Institution of Washington
Stanford, CA

Dr. Knute Nadelhoffer
Director, University of Michigan Biological Station
University of Michigan

Dr. Roger Pielke, Sr.
Senior Research Scientist,
Cooperative Institute for Research in
Environmental Sciences
University of Colorado at Boulder

Dr. Donald Roberts
Professor Emeritus,
Uniformed Services University of the Health Sciences
Bethesda, MD

Dr. Richard Somerville
Distinguished Professor Emeritus,
Scripps Institution of Oceanography
University of California, San Diego

Dr. Francis W. Zwiers
Director, Pacific Climate Impacts Consortium
University of Victoria
Victoria, British Columbia

While most are climate scientists, the inclusion of Dr. Roberts is rather puzzling since he is a medical doctor and retired professor of health sciences who is most notable for his writings supporting the use of DDT.  For the rest who actually study climate, all agree that the planet is warming and that human activity is a major factor, though perhaps some equivocate on the degree of human influence.

For those in Washington DC, the hearing will take place at 10:00 a.m. in 2123 Rayburn House Office Building.  A webcast will be posted on the Committee's web site.

Public Comment Period Open for Draft Greenhouse Gas Emissions Inventory

Last week in the February 28 edition of the Federal Register, EPA announced the availability of the draft 1990-2009 Greenhouse Gas Emissions Inventory.  The public can now offer comments by March 25, 2011.
The document summarizes "the latest information on U.S. anthropogenic greenhouse gas emission trends from 1990 through 2009" and are "presented by source category and sector."  The inventory contains estimates of carbon dioxide (CO2), methane (CH4), nitrous oxide (N2O), hydrofluorocarbons (HFC), perfluorocarbons (PFC), and sulfur hexafluoride (SF6) emissions.

This emissions inventory is critical for understanding and developing policy options to address climate change.  According to the Executive Summary, the inventory adheres to both

1) a comprehensive and detailed set of methodologies for estimating sources and sinks of anthropogenic greenhouse gases, and

2) a common and consistent mechanism that enables Parties to the United Nations Framework Convention on Climate Change (UNFCCC) to compare the relative contribution of different emission sources and greenhouse gases to climate change.

The full draft inventory report is available on EPA's dedicated web page, where it can be looked at by chapter online or downloaded as PDF documents.  The linked web page explains how to submit comments.

Comments will be accepted from the public up to March 25, 2011, though comments received after that date will be incorporated into the next edition.

Eight Scientific Organizations Offer Expertise to Solve New Chemical Testing Questions

The testing of chemicals for health and safety has been a big issue for a long time, but recently there has been heightened awareness of the problem.  The potential of Congressional action to reform the nation's chemical control law and comments being offered from all quarters on the sufficiency, or lack of sufficiency, of chemical testing has helped show some of the shortcomings in our assessment process.  Now eight scientific societies have offered the expertise of their 40,000 research scientists and clinicians. 

In a letter published in the prestigious scientific journal "Science," the societies note that "the need for swifter and sounder testing and review procedures cannot be overstated." They warn that "recent scientific evidence has established direct links between exposures that occur during fetal development and adult disease."  The point out that biomonitoring data collected by the Centers for Disease Control and Prevention (CDC) "have established that most, if not virtually all Americans, are exposed to contaminants in the environment that cause serious health effects in animal models."

One important point made by these societies, which are generally medical, genetic, reproductive health type societies instead of the traditional toxicology societies, is that there is a need to develop and validate "improved testing guidelines and better methods of assessing risks." These new methods could move away from animal models and include non-animal markers such as endocrine function, genomic fingerprinting, and other less invasive and perhaps faster and more sensitive types of studies that could be used to more rapidly identify chemicals for more in-depth study.

And so they are offering their help.  Addressing their letter mainly to the FDA and EPA:

"We ask that you use our scientific boards to provide access to leading scientists in diverse fields. These experts can help ensure that the most up-to-date scientific methodology and scientific understanding are used when devising and refining regulatory guidelines, and when reviewing scientific data pertinent to risk assessment and risk management decisions."

The letter is in the most recent issue of Science.  The eight scientific societies are (click on the name for more information about each):

• The American Society of Human Genetics
• The American Society for Reproductive Medicine
• The Endocrine Society
• The Genetics Society of America
• The Society for Developmental Biology
• The Society for Pediatric Urology
• The Society for the Study of Reproduction
• The Society for Gynecologic Investigation

Study Suggests the Pacific Northwest Could Lose All Lodgepole Pine Trees Due to Global Warming

A new study in the journal Climatic Change by scientists at Oregon State University suggests that the Pacific Northwest, a cherished old-growth forest region of the US, could lose virtually all lodgepole pine trees by 2080.  Researchers say that warming temperatures have changed the ecosystem dynamics such that conditions favor increased infestations by bark beetles.  The combined effects of global warming appear to be driving the effects already seen, and continuing warming is likely to make conditions even worse.

Part of the problem is that warming temperatures have reduced the spring frosts that inhibited the growth of competing trees.  Without them the soil has less moisture and more adaptable trees like Douglas fir are able to move into the areas previously dominated by lodgepole pines. For centuries lodgepole pines have dominated higher elevations in the Cascades (along the Pacific US) and the Rocky Mountains (further east).  This may not be the case a century from now.

The researchers estimate that lodgepole would cover "less than 6,000 square miles in America" by the year 2080, which is only "about 17 percent of its current range."  This change in ecosystem dynamics is important, as lodgepole pine is one of the first species to repopulate areas that have been decimated by fire.  They also can get a start growing in post-volcanic soil, a critical attribute in the active volcanic region that characterizes the Cascade range. [Remember Mount St. Helens, anyone?]  But now the trees are being hard hit by both soil conditions and bark beetle infestations.  Recently the Agriculture Secretary, Tom Vilsack, had "to allocate $35 million for tree removal" in the Rocky Mountains because beetles had killed more than 5,000 square miles of lodgepole pine and spruce forest."  And that is just since the late 1990s.



The abstract of the study in Climatic Change can be viewed here.

Source article by Jeff Barnard in the Seattle Times.

EPA Delays Greenhouse Gas Emissions Reporting Program to "Ensure the Requirements are Practical"

The deadline for reporting greenhouse gas (GHG) emissions is March 31, 2011.  Or not.  Yesterday the EPA announced that it was "extending this year’s reporting deadline" so that it could provide a reporting tool to affected industries.  EPA noted that after "conversations with industry and others, and in the interest of providing high quality data to the public this year," the deadline would be delayed.  The agency will finalize what it calls a "user friendly online electronic reporting platform," which they hope to have available this summer so that the data can be received and published later this year.


The GHG Reporting Program is being designed to address mandates from Congress, even as the new Congress is working to limit EPA's ability to follow through on those mandates.  Despite the likelihood of budget cuts EPA is continuing to develop GHG data reporting requirements "for a wide range of different industries."  According to EPA:

This program will provide Congress, stakeholder groups and the public with information about these emissions while helping businesses identify cost effective ways to reduce emissions in the future.

EPA says they need the extension "to further test the system that facilities will use to submit data and give industry the opportunity to test the tool, provide feedback, and have sufficient time to become familiar with the tool prior to reporting."

More information on the Greenhouse Gas (GHG) Reporting Program can be read here.

European Chemicals Agency Publishes Evaluation of REACH Chemical Registrations

By now readers should know that REACH is the EU's chemical control law, the Registration Evaluation Authorization (and Restriction) of Chemicals regulation.  November 30, 2010 was the deadline for manufacturers and importers to register their hazardous or high production volume chemicals.  And now the European Chemicals Agency (ECHA) has released a report evaluating registration dossiers, as well as substance evaluations.  The goal is to summarize progress to date and provide useful feedback to future REACH dossier submitters.

There are actually three different evaluation processes. One is the "compliance check," in which ECHA "examines the quality and adequacy of data provided by the registrant." The second is examination of "testing proposals," in which ECHA "decides whether testing is necessary and may then provide permission for the tests to be performed." The third is "substance evaluation," in which the Member States prepare a dossier on chemicals they believe "there is a suspicion that certain uses of a substance may cause harm to human health or the environment."


The Evaluation report concludes that there were "quality problems in a considerable proportion of dossiers in 2010," though ECHA is still in the early stages of review. In an effort to improve future submissions, the gives specific recommendations for registrants, including:

• The identity of the registered substance needs to be clearly described;
• Any adaptation to the standard testing regime must meet the conditions set out in Annexes VII to XI of the REACH Regulation, and a clear justification for any adaptation must be provided;
• The robust study summaries should contain enough detail to allow an independent assessment of the information provided;
• Classification and labelling should be in line with the hazards identified or with the harmonized classification and labelling of the substance;
• A proposal to do testing must be submitted first (for tests under Annex IX and X) before the test is done. Doing a test before getting ECHA's decision may lead to legal action;
• Registrants have an obligation to share data resulting from animal tests and to share the costs before submitting the dossier.

The full Evaluation progress report for 2010 can be downloaded as a PDF file here.

With No Federal Action, Wal-Mart Takes the Lead in Banning Chemicals - Is Retail Regulation the Future?

Is retail regulation the wave of the future?  At this site I have talked a lot about the attempts to reform the Toxic Substances Control Act (TSCA).  So far TSCA reform efforts have failed to produce any federal action to modernize the now 35-year old law.  But now, into this gap in federal-level regulation have come the "retail regulators."  Retail regulation is when influential retail stores like Wal-Mart, Toys-R-Us and Sears make unilateral buying decisions that could effectively ban chemicals of concern.  Call it The Wal-Mart Factor.

A recent article by Lyndsey Layton in the Washington Post discusses how Wal-Mart is "stepping ahead of federal regulators and using its muscle as the world's largest retailer to move away from a class of chemicals researchers say endanger human health and the environment."  Those chemicals, polybrominated diphenyl ethers (PBDEs), have been used as flame retardants in a wide range of consumer products, including computers, furniture, and toys.  With a worldwide buying power rivaling many national economies, when Wal-Mart speaks, manufacturers listen.  And since manufacturers and formulators aren't likely to make one product for Wal-Mart and another version of the same product for other distributors, chemical bans by Wal-Mart have the ripple effect of eliminating chemicals from products sold elsewhere.

As the article points out, this is not the first foray into retail regulation by big box stores.  Toys R Us, Sears, Kmart, Whole Foods, and others have started telling suppliers that products containing chemicals such as BPA, PVC, PBDEs and others will no longer be accepted.  This is caused many suppliers to reformulate their products to replace components of toxicological concern with those that are less hazardous.  The result, in effect, is a market-based ban on certain chemicals.  Though it should be clear that the reason Wal-Mart and the other retailers have made the decision to ban is because state legislatures have been taking action to limit chemicals in which health and safety studies have raised concerns. 

Since unilateral decisions by retailers and varied state-level action could create a patchwork of "regulation" across the country, this would seem to be more impetus for moving forward with federal-level action.  Such federal action should include a modernized and rational TSCA reform legislation that encourages both innovation by retailers and manufacturers and protection of human health and the environment.