ChemCon Americas Conference Debates REACH, TSCA Reform, GHS

This past week has been the ChemCon Americas conference in Philadelphia, where mostly industry representatives, regulatory experts, and scientists get together to discuss important issues affecting the chemical industry.  And this week was no exception.  Hot topics included the scramble to make the November 30th REACH deadline, the confusion over how various countries are implementing (or not implementing) GHS, and the uncertainty over what may or may not happen with TSCA reform in the United States.

Representatives from EPA continued to make the case that the 34-year old Toxic Substances Control Act just does not give them the authority to efficiently review tens of thousands of existing chemicals grandfathered onto the TSCA Inventory (for later review). With the chairmanships of the House set to switch from the Democratic Waxman and Rush to "Republicans to be named later," there still seems to be the belief that some form of TSCA reform will happen in the next Congress.  Meanwhile, a lawyer representing industry interests reminded attendees that the individual states are pressing forward with their own versions of reform, perhaps presenting industry with an even more complicated patchwork of regulations to monitor.

REACH also received attention.  A representative from the European Chemicals Agency (ECHA) encouraged companies to keep on pushing to meet the fast approaching deadline.  Tens of thousands of registrations have been received and many more are expected in the mad rush during the next two weeks.  Oh, and then there is the CLP - Europe's version of the Globally Harmonized System for classification and labeling, for which companies must notify all of their chemicals by January 3rd (even those not scheduled for REACH registration until 2013 or 2018).  And let's not forget Turkey. And China and Japan. And New Zealand and Australia.  And cosmetics?

No wonder everyone looks a little knackered.

Canada Lists 4 Chemicals to its Schedule 1 List of Toxic Substances

While the US struggles with what to do to modernize the Toxic Substances Control Act (TSCA), Europe has been busy with the first registration phase of it's Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program and Canada is well into its Chemical Management Plan evaluating their Inventory of existing chemicals.  As part of that process Canada recently proposed to add four additional chemicals its Schedule 1 "list of toxic substances" under CEPA (the Canadian Environmental Protection Act of 1999).   

The four substances are:

Vanadium pentoxide: A naturally occurring substance in the environment, "used primarily in Canada in the manufacture of ferrovanadium and as a catalyst in the production of sulphuric acid." According to Environment Canada, "vanadium pentoxide is released to air, to water and to land, mainly through combustion of fossil fuels and wood fuels from industrial activities."  It "was identified as a high priority for assessment because of its classification as a carcinogen by national and international agencies."

Potassium bromate: A man-made substance "used primarily in Canada in industrial and commercial applications," including "as an oxidizing reagent in laboratories, in the dying of textiles, and in permanent wave neutralizing solutions in the cosmetics industry."  While it appears there is limited current reporting of use in Canada, and no reported consumer uses, the substance was listed "based principally on the weight-of-evidence assessment or classification from international or other national agencies..., the critical effect of exposure...is carcinogenicity," as well as reports of genotoxicity and "a variety of non-cancer effects."

TGOPE: A thankfully brief acronym for a long chemical name, TGOPE "is a man-made component of epoxy resin used as an adhesive or binding agent" used primarily "in the manufacture of paints, coatings designed for industrial use and certain consumer epoxy-patch adhesives." Exposure is expected to be minimal because it is it seems to have limited current manufacture in Canada (but is imported) and has limited consumer uses (mostly epoxy adhesives).  Health effects assessments have not been identified, but "in vitro experiments and weight-of-evidence assessment or classification from several other analogues...show that TGOPE may cause cancer."

Methyl eugenol: Mainly "a naturally occurring organic substance in the essential oils of several plant species," used primarily "as flavour ingredients in food and beverages and as fragrance ingredients and emollients in personal care, cosmetics and other household products." According to the Canadian assessment, "the substance may also be produced synthetically."  Exposure is "mainly from its naturally occurring presence in food and beverages with smaller contributions from the use of personal care products and citronella-based personal insect repellents."  Canada has determined "that methyl eugenol may cause cancer," and may also "be genotoxic in a range of experimental studies...Therefore, it cannot be precluded that the substance may have interacted with the genetic material."

More information on these four substances can be found here.  In addition to these four listed, there were 13 substances from "Batch 9" that were not found to meet the criteria for listing.  These can be seen here.

White House Names Two Nanotechnology Scientists as 2009 Presidential Early Career Award Winners

The White House Office of Science and Technology Policy has named two scientists from the Department of Energy’s Argonne National Laboratory as 2009 Presidential Early Career Awards for Scientists and Engineers (PECASE) winners.  According to Argonne National Labs, the PECASE awards are "the nation’s highest honor for researchers in the beginning stages of their independent research careers."  The two are materials scientist Dillon Fong and nanoscientist Elena Shevchenko, who "were selected by the for their contributions to meeting America’s scientific and technological missions and the country’s economic, energy, health and security needs."

Shevchenko heads "the NanoBio Interfaces Group in Argonne’s Center for Nanoscale Materials." Nanoparticles (also called nanoscale materials or simply nanomaterials) "are small assemblies of particular materials that have special properties."  According to Argonne National Labs, "Shevchenko’s work specifically examined how nanoparticles self-organize to form more complicated materials."

Fong "works in Argonne’s Materials Science Division, where he investigates the formation and structure of complex oxide thin films." In his research, he asks "questions like how these thin film crystals grow, and how much of this growth can we control?" And "do these materials behave when they are only a few nanometers thick?"

Read more about their achievements at the links and in the Argonne press release.  Both scientists will receive their awards later this year at the White House.

American Cleaning Institute Finds Fault with California "Safer Products" Regulations

The American Cleaning Institute (ACI; formerly the Soap and Detergent Association) has filed comments to the California Department of Toxic Substances stating that the new regulations are "bureaucratic, punitive, and adversarial."  In their press release, ACI states:

California’s proposed regulations for “safer consumer product alternatives” are bureaucratic in the extreme, resource intensive for California government and the regulated community, punitive and adversarial, according to the American Cleaning Institute. 

ACI's detailed comments (93 pages, including attachments) urge the California DTSC to work with stakeholders to address proposals in need of "significant revision" as the current proposal would not accomplish "the goals
of the state’s Green Chemistry Initiative."  ACI complained about many parts of the proposed regulations, including their overly broad scope, a "flawed" chemical prioritization process, onerous reporting requirements, and what they see as "disincentives" to the development of safer consumer productes.

The full ACI comments can be read here.

ECHA Makes Available QSAR Toolbox 2.0 to Facilitate Chemical Assessments

ECHA and OECD are making available an assessment software that they call "The Toolbox."  It is intended to that the toolbox "tools" will be used by "governments, chemical industry and other stakeholders in filling gaps in (eco)toxicity data needed for assessing the hazards of chemicals."  The Toolbox incorporates information and tools from various sources into a logical workflow, including a crucial element -  grouping chemicals into chemical categories.

The fundamental features of the Toolbox are:

1. Identification of relevant structural characteristics and potential mechanism or mode of action of a target chemical.
2. Identification of other chemicals that have the same structural characteristics and/or mechanism or mode of action.
3. Use of existing experimental data to fill the data gap(s).

According to OECD, "the goal of Phase 2 development is to ensure that the category approach to filling data gaps works uniformly for all discrete organic chemicals and for all regulatory endpoints."  It is a two year work plan which began in the 4th Quarter of 2008.  "The work plan has five thematic areas namely Information Technology, Chassis Development and Additional Functionalities, Database Compilation, (Q)SAR Library and Expert System Compilation, and Training. The implementation of the features is divided between two versions."


This Version 2.0 was released in October 2010 and Version 3.0 is planned for release in October 2012.

More information and a place to download the toolbox can be found here.

Post-Election Questions - Will EPA Step Up Action, Step Down Action, or No Changes Ahead?

Now that their has been a change in the majority party in the House (or more accurately, there will be starting when the next Congress takes their seats in January 2011), how will this effect EPA's ongoing rule-making and actions?  While we don't really know the answer to that question yet, there are a few insights we can presume.

First, despite what many suggest, EPA doesn't just get to make up regulations when they feel like it.  They are bound by, and compelled by, laws passed by Congress to regulate the release of chemicals and other environmental issues.  They are required by law to move forward, and are often sued by either - and sometimes both - sides of the issue to act (or not to act).  The recent greenhouse gas (GHG) endangerment finding wasn't something they pulled out of a hat; the Court found that EPA MUST take an endangerment stand.

Second, many programs are simply ongoing activities.  While the top of the EPA hierarchy are political appointees, the vast majority of EPA staff are career professionals who simply go to work each day and do their jobs.  So work moves forward no matter what political tug-of-war may be keeping the press busy.

That said, Congressional action, or inaction, can significantly impact EPA effectiveness.  Many in the incoming majority in the House have indicated a desire to step up oversight of EPA.  So it is likely that the EPA Administrator and other senior officials will be spending more time in hearings looking at possible overstep of EPA authority rather than the many hearings held over the last two years geared towards finding a path forward to address key issues like chemical right-to-know, children's exposure, GHG emissions and climate change. 

As I mentioned in my last post, the future of the TSCA reform law is uncertain.  All stakeholders have expressed a desire, and acknowledged the need, to modernize the 34-year old law.  But doing so will require the new Congress to focus on moving forward instead of looking toward the past.  It's unclear whether that is the case.  In the end it will probably come down to industry pushing for a new law to 1) avoid a patchwork of ever-increasing state laws and 2) put in place a manageable, i.e., doable, law that protects public health and the environment.

Future of TSCA Chemical Reform Law Uncertain After Election Results

The mid-term elections in the United States have put the future of the TSCA reform into question, for a variety of reasons:

1) The current House bill was introduced by California Representative Henry Waxman and Illinois Representative Bobby Rush, who served as chairs of the relevant committee and subcommittee, respectively. Both won reelection, but with the Republicans gaining control of the House that means Waxman and Rush will be demoted to ranking members.  While the new chairs have yet to be determined, they will be Republicans and are likely to have a different vision of how to proceed.  If they proceed at all.

2) The current bills in the House and Senate probably lean slightly more toward the environmental and health advocacy position (though they might disagree with that characterization).  With Republicans now the majority in the House the new bills, which would have to be reintroduced in the next Congress anyway, will likely lean more toward the industry position (though like the advocacy side, there is quite a bit of differences of opinion between various industry stakeholders).

3) Several potential chairs of key environmental, health, and oversight committees have indicated a desire to undertake oversight hearings. So while there were many hearings on TSCA reform during the last year or two, those hearings were on finding a path forward for reform.  The will likely be some of those as well under the new chairs in the House, but the oversight committee is likely to be holding hearings on whether EPA is overstepping its current authority under TSCA as it exists now.  This could dilute the effort towards reforming the law.

There are other reasons that yesterday's election creates additional uncertainty in the continuing attempts to reform the 34-year old chemical control law, and I'll take a look at those as more information on the changed legislative dynamics in Washington becomes available.

International Scientists Sign "San Antonio Statement" Calling for Regulation of Brominated Flame Retardants

Recently a group of scientists met to discuss the growing concern about "the persistent, bioaccumulative, and toxic properties of brominated and chlorinated organic flame retardants (BFRs and CFRs, respectively) and the exposure to humans and wildlife as a result of intensive use."  The result is the “San Antonio Statement on Brominated and Chlorinated Flame Retardants.”

The signatories, nearly 150 scientists from 22 countries, are all "experts on the health effects and environmental fate of BFRs and CFRs and environmental contaminants in general. The International Panel on Chemical Pollution (IPCP), an international network of scientists working on various aspects of chemical pollution, also has approved the statement."

The San Antonio statement includes 20 points that acknowledge the scientific concern for these substances, and the fact that three brominated flame retardants have already been listed in the Stockholm Convention treaty for global elimination. They note that these materials are persistent and "can undergo long-range environmental transport."

The full San Antonio Statement in published in the online edition of Environmental Health Perspectives.  There is also an introduction to the Statement by NIEHS Director Linda Birnbaum and IPCP Board member and Professor Ake Bergman.

Director of Columbia Center for Children's Environmental Health Testifies at Toxic Chemicals Hearing

Last, but not least, of the witnesses in Tuesday's Senate subcommittee hearing on "Toxic Chemicals and Children's Environmental Health" in New Jersey, was Dr. Frederica Perera.  Dr. Perera is Director, Columbia Center for Children's Environmental Health (CCCEH), Professor of Public Health, Department of Environmental Health Sciences, Mailman School of Public Health Columbia University.  In her testimony, she focused on "endocrine disrupting chemicals and neurodevelopmental disorders, noting that an estimated 5-17% of United States children have been diagnosed with a learning or attention disorder."


She reported largely based on the work done at CCCEH, which since 1998 has "conducted international studies of cohorts of mothers and children followed from pregnancy."  Even back then, she noted, "we knew that there were ever-increasing human exposures to environmental toxicants and that rates of neurodevelopmental disorders and chronic illnesses such as childhood asthma and cancer were on the rise."  She made it clear "that these diseases had multiple causes, environmental exposures such as lead, mercury and polychlorinated biphenyls were known to contribute," but also said that it had "become evident over the previous decades that the placenta does not adequately protect the fetus from toxicants and that, due to their rapid development and immature defense systems, the developing fetus, infant and child are especially susceptible to environmental toxicants."

After sharing some of the Center's research in this area, she noted that the research demonstrates "the link between fetal and child exposures to phthalates, BPA, and PBDEs, and adverse developmental and neurodevelopment effects."  She suggested that "a preventive approach is clearly needed," and offered the example of the case of lead removal from gasoline as an illustration of the effectiveness of such an approach. She acknowledged that there were still many uncertainties in cause and effect, but suggested that:

"given the widespread exposure to chemicals such as those I have discussed, these uncertainties do not outweigh the need for a preventative approach to children’s health. The public health and economic benefits of prevention are clearly great. Our data and those of many others support a preventative chemical policy to protect our youngest and most susceptible population."

More on the hearing can be found on the subcommittee web site.

Head of Poison Information and Education System Testifies at Toxic Chemicals and Children's Environmental Health Hearing

As noted in my other posts this week, on Tuesday there was a Senate subcommittee hearing on "Toxic Chemicals and Children's Environmental Health" in New Jersey.  In addition to testimony by EPA Administrator Lisa Jackson and CNN's Medical Correspondent Dr. Sanjay Gupta, there was testimony by Dr. Steven Marcus, Executive and Medical Director, New Jersey Poison Information and Education System, Professor, Department of Preventive Medicine and Community Health, Associate Professor of Pediatrics
New Jersey Medical School of The University of Medicine & Dentistry of New Jersey.

Dr. Marcus emphasized the importance of poison control centers around the country.  He noted that "poison centers respond to the needs of the US citizens in every state and territory of the country 24 hrs a day, 7 days a week, 365 days a year."  He noted that, nationally, "there are over 4 million exposures reported to poison centers with over 50% of the victims of these exposures occurring in children under 5 years of age."

"To put that into perspective, once every 15 seconds a child in this country is reported to be exposed to some potential toxin."

His take home message at the end of his testimony was that there "are actions which can and should be taken now" that "will help respond to the risk of exposure to chemical substances of all nature, medications, spoiled food, etc."  He listed:

1. Find a way to “shore up” the funding of existing poison centers

2. Supply funds to allow enhanced surveillance activities of poison centers

3. Supply funds to train medical toxicologists outside of the Medicare cap and encourage
pediatricians to seek such training.

More information at the subcommittee web site.

CNN's Dr. Sanjay Gupta Testifies at "Toxic Chemicals and Children's Environmental Health" Hearing

Continuing with the news of the last two days, Dr. Sanjay Gupta, the highly visible physician and medical correspondent for CNN testified at the Senate subcommittee hearing on "Toxic Chemicals and Children's Environmental Health" in New Jersey on Tuesday. 

Gupta had looked at the potential for reproductive and developmental effects related to chemical exposure in a CNN special program called "Toxic America" first aired several months ago.  In his testimony, Gupta noted that "children are especially vulnerable to toxic chemicals. Children are not simply small adults. For one thing, children have a faster metabolism. They take in – pound for pound --- more air, water and food than adults."  Further, "infants and toddlers also spend a lot of time close to the ground, where dust accumulates. And we know from research this dust can contain toxic chemicals like flame retardants, shed from our televisions and other appliances. Young children can breathe in this dust. As a father, I also know first-hand how little kids like to put their hands in their mouths. That’s another potential route of exposure."

While in the CNN article Gupta acknowledges that "there is no science that demonstrates a conclusive cause-and-effect relationship between chemicals children are born with and particular health problems," he argues that "studies are finding associations between elevated levels of chemicals in a baby's body and their development."  In his testimony he notes that "children are also more susceptible because their immune systems are still developing. Kids are simply not as good at getting rid of toxic chemicals. That means toxic chemicals stay in their bodies longer. Also, their growing bodies are not as good at repairing damage from exposures to toxic chemicals."

And that is the take home message on which Gupta ended his testimony:

Finally, we know our exposure to many chemicals accumulates over time – what’s known as body burden. So what children are exposed to now can build as they age, and their risks of harm from these chemicals could rise with their body burden. So we need to take into account the long-term risks of chemical. After all, children – and the rest of us – are still being exposed to PCBs, which the government calls “probable carcinogens,” and PCBs have been banned for more than 30 years.

More testimony and an archived web cast can be found on the subcommittee web page.

EPA Administrator Jackson Addresses "Toxic Chemicals and Children's Health"

As noted yesterday, today was a subcommittee hearing called "Toxic Chemicals and Children's Environmental Health" in Newark, New Jersey and chaired by New Jersey Senator Frank Lautenberg.  The lead testimony was from EPA Administrator Lisa Jackson.

Jackson noted that "[w]hile chemicals have improved our lives in many ways, there are still significant scientific gaps in our understanding of the health risks of many chemicals."  She called out the special nature of protecting children from chemical exposure, and that there are cultural and socioeconomic differences as well:

Ensuring that our children are protected from exposure to environmental threats is central to EPA’s work. Children face greater threats from environmental pollutants than adults due to differences in their physiology, activity patterns and development. And not all children are the same: we continue to see disparities in exposures and health outcomes among the poor, African American, Latino, Native American and other ethnic minorities.

She also reminded us all that children have differences in metabolism, eating habits, and motor behavior that significantly increase their chances of exposure as well as the potential ramifications of such exposure on physiological, morphological, and immunological systems that are not fully developed.

Jackson reiterated the six principles that she had introduced just over a year ago and called again for Congress to take action to reform the 34 year old Toxic Substances Control Act.  And finished by noting:

Further, legislative reform of TSCA should address a number of other areas the Administration believers are important in modernizing this nation’s chemicals management efforts, such as encouraging the development and use of green chemistry and adoption of safer alternatives. It should impose stricter requirements for assertion of confidentiality claims while allowing the sharing of critical data – with appropriate safeguards – with state governments also regulating chemicals.

Her full testimony and that of the other witnesses can be found here.

Senate Hearing on Toxic Chemicals and Children's Environmental Health - Tuesday (Oct. 26th)

In a subcommittee event to be held away from Washington DC, the Senate Subcommittee on Superfund, Toxics, and Environmental Health will hold a hearing in Newark, New Jersey called "Toxic Chemicals and Children’s Environmental Health."  Headlining the event will be EPA Administrator Lisa Jackson, who is returning to her old turf (she was previously head of the New Jersey Department of Environmental Protection).  

The meeting will be held tomorrow, October 26th, in the Oral Health Pavilion Multi-purpose room at the University of Medicine and Dentistry of New Jersey in Newark. The hearing starts at 10:30 am EDT.

While Jackson will provide the sole remarks in the first panel, many will recognize the name of Sanjay Gupta, CNN Chief Medical Correspondent and once floated as a possible Surgeon General, who will lead off the second panel.  Also testifying in the second panel will be Lisa Huguenin (a New Jersey mother of child with autism and an immune system disorder), Steven Marcus (Executive and Medical Director of the New Jersey Poison Information and Education System and Professor at the New Jersey Medical School of The University of Medicine & Dentistry of New Jersey), and Frederica Perera (Director of the Columbia Center for Children's Environmental Health and Professor at the Columbia University Mailman School of Public Health).  

The subcommittee chair is New Jersey Senator Frank Lautenberg, who introduced the Kid Safe Chemical Acts of 2005 and 2008 (neither of which made it out of committee) and the Safe Chemicals Act of 2010 (which is likely also to sit largely untouched for the rest of this legislative term).  


More information and copies of testimony will be available at the subcommittee web site.

Japan Chemical Association Highlights Japanese Business Trends

The Japan Chemical Industry Association (JCIA) has released a powerpoint presentation highlighting business trends in the chemical industry.  After posting significant decreases in production and shipment from early 2008 through early 2009, both started recovering by the end of the first quarter 2009 and have now reached levels consistent with inventories.

A series of powerpoints can be downloaded here.

The JCIA has about 180 member companies and about 80 organizations engaged in the manufacturing and handling of chemical products and related services. "Under the basic idea of "coexistence and co-prosperity with society," JCIA has continued to undertake activities for almost half a century to fulfill its mission of promoting the stable development of the chemical industry and thus contributing to the economic prosperity of Japan and elevation of its living standards."