Growing up in the 1970s, Mischief Night was a big deal for me.  When I was in grade school, hoards of us kids took to our neighborhood just after dark to wreak innocent havoc.  More fun than Halloween, I recall soaping up car windows and decorating neighbors' trees with toilet paper.  (What were our parents thinking?)

When a wonder toy called Silly String hit the stores, Mischief Night turned psychedelic with crazy vibrant colors issuing in long streams from an aerosol can!  And what was the harm?  Silly String simply dried up and blew away.  Who knew that we might actually be spewing a brew of toxic chemicals? 

Polyisobutyl methacrylate, hexabromobenzene, dibutyl phthalate, dimethyl siloxane, dichloromethane and sorbitan trioleate.  While the current formulation of Silly String is claimed to be confidential business information, these are some of the ingredients in the product's original formula.  This, according to a fun little fluff piece that ran in a recent issue of Chemical & Engineering News titled “Silly String: It’s a party for polymer chemistry, all in a can.”

Some of these chemicals — hexabromobenzene (a brominated flame retardant), dibutyl phthalate (an endocrine disruptor) and dichloromethane (also known as methylene chloride, a carcinogen) — ought to rank high on anyone's list of chemicals of concern.

But am I just being a killjoy when I ask why we should be letting our kids play with this stuff?

I don’t think so, and here is why:  While thousands of synthetic chemicals are integral parts of our modern lives, this does not mean that any chemical can and should be used in any product.  In particular, how chemicals like the ones I just noted are used should get intense scrutiny, to say the least.

It may be that some of the offending chemicals are no longer used in the current Silly String formula – but that's something we don't know because its maker is allowed to claim such information proprietary.  It may be that some of the toxic chemicals used to make the polymer fully react, so that they aren't present in the Silly String itself, at least in normal use – but we can’t know this either, because no one requires such testing for residuals.

Whatever the risk, I would still assert the following:

• Chemicals with such clear toxicity should not be used in children’s toys.  Period. 
• Workers should not have to risk being exposed to such chemicals for the purpose of making toys.
• Society should not have to risk having such chemicals released into the environment as a consequence of making toys, whether during the chemicals' or product's manufacture or transport or after disposal of the product itself.

The C&E News article highlights an unplanned and highly novel use of Silly String:  Soldiers in combat zones have learned to spray it ahead of themselves when in confined spaces to help detect the presence of deadly trip wires.  Another possible future use is as an adhesive for medical use. 

Those potentially life-saving applications for this admittedly nifty polymer technology certainly call for a different calculus, where the outcome could be quite different than for its use as a children’s toy.  (I'm not suggesting, however, that the hazards of such uses should not also be scrutinized, or that safer alternatives not be identified or sought.) 

But the problem is that, at this point, no one is even bothering to do the calculation.  It is telling that the obvious questions as to whether this use of these kinds of chemicals might pose a risk to kids, or whether it is worth taking any such risk, were not even raised by the article's author.  Nor does our current chemicals management system effectively raise them, let alone demand they be answered.

This "silly" example is yet another reminder of why EDF believes we must fundamentally reform the law that governs how we manage these kinds of chemicals.

The Safer Chemicals, Healthy Families campaign today released the results of a nationwide poll conducted in August by renowned pollster Celinda Lake of Lake Research Partners.  The most striking finding:  Majorities of Republicans and Independents as well as Democrats strongly support adoption of new legislation that would give EPA the power to immediately restrict the use of dangerous chemicals.

It seems that all that's left is for Congress to act … 

The poll reached a demographically and geographically representative group of 1,000 registered voters across the country.  It found that voters across political affiliations are seriously concerned about the limitations of the Toxic Substances Control Act (TSCA), including that:

• TSCA did not require testing and a demonstration of safety of the tens of thousands of chemicals in commerce in 1976 (87% of voters are concerned);
• EPA is unable to take dangerous chemicals off the market, even ones as dangerous as asbestos (80% concerned); and
• TSCA has allowed EPA to require testing for only a small fraction of chemicals on the market (84% concerned).

When various proposals for TSCA reform were described, large majorities of voters expressed strong support:

• "If a chemical is detected in babies at birth or in infants, it will be taken off the market"
  • 84% of voters support
  • 60% strongly support:
    • 66% of Democrats
    • 52% of Independents
    • 59% of Republicans
• "Exposure to other toxic chemicals, such as formaldehyde, that have been extensively studied, will be reduced to the maximum extent possible"
  • 85% of voters support
  • 59% strongly support:
    • 69% of Democrats
    • 51% of Independents
    • 57% of Republicans

Voters also express strong support for a systematic overhaul of TSCA that requires the safety of all chemicals to be demonstrated:

• "A process will be created so that all chemicals in use must be tested and shown to be safe over the next 15 years"
  • 81% of voters support
  • 57% strongly support (breakdown  by political affiliation not available to me)

It seems that all that's left is for Congress to act!  Click here to help make sure they get the message:  EDF Action Alert: Help Strengthen America's Toxic Chemicals Standards

 And to learn more about this issue, visit our website and blog.

It's got pictures of kids and families.  People of all colors.  Gentle hands cradling our fragile planet.  A hard hat resting on a pair of worn work gloves and a hammer.  It says the coalition is "people like you."  It bears an uncanny resemblance to the website of the Safer Chemicals, Healthy Families campaign, of which EDF is a founding member.  But dig deeper and you'll discover that the website of the "Coalition for Chemical Safety" is actually created and run by industry.

It actually takes quite a bit of digging to ferret out who's behind this group.  Click on "About Us" and you'll be told the coalition is "a non-profit social welfare organization."  Click on "Contact Us" and you'll get only a nondescript form to fill out to have more information sent to your email address.

Nowhere does the website reveal who runs or is behind it.  But clues begin to emerge when you are invited to "Click here to make your business the latest member of the Coalition for Chemical Safety," and when you find that, to do so, you must check a box to avow "I agree to support balanced chemical safety reform that protects public health, innovation, and economic growth" and to identify yourself as "an advocate supporting reasonable reform of the Toxic Substances Control Act (TSCA)." (emphases added)

A clickable map suggests there are coalition chapters in 13 states, although only eight of them list any members.  But the members are hardly the promised "people like you."  Heading the list is the Chemical Industry Council of California.  While the list of members is quite a hodge-podge, others include the Louisiana Propane Gas Association, the Montana Agribusiness Association and the Virginia Biotechnology Association.

[10/27 UPDATE:  I see that, apparently in response to my post and to my comment below, at least a couple of changes have been made to the coalition's website.  First, the "Click here" statement I described above has been changed to remove the reference to "business."  It now reads:  "Click here to become the latest member of the Coalition for Chemical Safety."

Second, a new link on the map has been added for Washington, DC, which now lists the American Chemistry Council as a coalition member.

Still no indication anywhere on the website as to what company or organization is behind or running the coalition, although a Mr. Joe Householder has come forward and identified himself as its Executive Director, via comments on this post (see below) and at the bottom of  the "Contact Us" webpage.]

By searching for who registered the domain name of the coalition's website, we have learned that the website is developed and run by DDC Advocacy, one of several arms of The DDC Companies (short for Democracy Data & Communications, LLC).  The companies "provide comprehensive public affairs services for corporate, trade association, and non-profit clients," specializing in so-called "issues management" – industry-speak for product and corporate reputation defense and protection.

You can read more about DDC Advocacy and its parent, the Alfred Street Partners, at SourceWatch.  DDC Advocacy boasts having nine of the Fortune 10 among its clients.  DDC Advocacy's CEO is B.R. McConnon III, who also serves as a key spokesperson for the National Federation of Independent Business and is a former analyst at the anti-regulatory think tank, Citizens for a Sound Economy.  Its Senior Vice President of Strategic Development is Julie Cram, former Director of Public Affairs for Burson-Marsteller.

Now, far be it from me to suggest industry isn't a key stakeholder in the debate over TSCA reform, or that it doesn't have a right to organize and advocate for its views.

But surely it can do all of that without wrapping itself in a "people like you" cloak of deception!

All this leaves me with two questions: 

First, who is paying DDC Advocacy to set up and run the website and organize the coalition?

And second, why are they so afraid of showing themselves?

Real engagement demands transparency.  A good first step would be for the company or organization that started the new coalition to step out from behind the curtain and identify itself.

_________________

Below is the list of companies and organizations identified as members of the Coalition for Chemical Safety, current as of October 25, 2009.

California

Chemical Industry Council of California

Gallade Chemical Inc.

Ross Organic Specialty Inc.

Illinois

Chemical Industry Council of Illinois

Indiana

C.M. Hobbs, Inc.

Calvin Landscape

Dorfman Design Builders

Louisiana

Louisiana Propane Gas Association

Maryland

Cytherian Solutions

Eastern Scientific, Inc.

Golden, Inc.

Maryland Biotechnology Entrepreneurs Coalition

Sequella, Inc.

Marlin Steel Wire

Systems Consulting Group

Intelect Corporation

Medical Supplies Corporation

Regional Manufacturing Institute

Fraley Corporation

Minnesota

Denny C’s Produce

G&G Property Maintenance

Montana

Montana Agribusiness Association

Montana Contractors Association

United Property Owners of Montana

Virginia

Virginia Retail Merchant Association

Virginia State Police Association

Virginia Biotechnology Association

In an opinion piece titled "Chemical regulators have overreached" in the August 27, 2009 issue of Nature, two prominent animal welfare advocates claim that vastly larger numbers of chemicals will have to be tested under the European Union's REACH regulation than previously estimated, and hence that 20 times more laboratory animals will be sacrificed.  They call for a moratorium on some animal tests.  Well, a closer look reveals that it's the opiners themselves that have greatly overreached.

[Update 8/28:  The European Chemicals Agency (ECHA) has just issued this press release also disputing the findings of this new study.]

The authors of the Nature opinion piece are Thomas Hartung and Costanza Rovida.  Hartung is the director of the Center for Alternatives to Animal Testing (CAAT), while Rovida is identified as a private consultant, but was formerly affiliated with the European Centre for the Validation of Alternative Methods (ECVAM), as was Hartung. 

The Nature piece cites a longer, 22-page report by the same authors released by the Trans-Atlantic Think Tank for Toxicology (t4).  t4 is a creation of CAAT.

The report is laid out to look like a peer-reviewed journal article but is self-published (more later on what the authors claim to be the expert review conducted of the report).  [Note added 8/27: The report is to be published in a journal called ALTEX.  According to its website, ALTEX is "the official journal of CAAT ... and t4, the transatlantic think tank of toxicology."  According to an article appearing in today's BNA Daily Environment Report (p. A-4):  "The study was prepared with funding from the Transatlantic Think Tank for Toxicology, which works with [CAAT]."  Hence my characterization of the report as "self-published" is quite appropriate.]

This study has used numerous demonstrably false or highly questionable assumptions, one piled on another, to grossly inflate the number of chemicals requiring testing under REACH, and the number of animals involved.

Both the opinion piece and the accompanying report reflect a fundamental misunderstanding of the basics of REACH and an apparent willingness to inflate every number in long chains of calculations to yield the largest possible estimates for the number of animals to be sacrificed under REACH. 

In this post, I will address in detail some of the more egregious claims.  They include:

• Vastly overstating the number of chemicals in commerce, to be registered and required to tested under REACH.
• Vastly overstating the number of high-production-volume chemicals in the EU.
• Overstating the number of animals required for at least certain tests.
• Claiming expert review of its report, when 7 of the 8 reviewers are either close colleagues of the authors or representatives of the chemical industry.  Not a single representative of the European Commission or the European Chemicals Agency reviewed the report.

Prepare for a fairly deep dive, with lots of numbers, because that's what the authors have based their claims on.

Some context

But first, some context.  During the nearly decade-long debate over the final text of REACH, animal welfare advocates extracted major concessions from the EU.  In addition to peppering REACH with statements to the effect that animal testing would be done only as a "last resort," the changes forced by animal welfare advocates included elimination of all animal testing for existing chemicals produced below 10 tons per year per manufacturer, and a requirement that only testing proposals, not test data, be submitted at the time of registration for any tests involving laboratory animals. 

Most notably, an entire Title of REACH is devoted to "Data Sharing and Avoidance of Unnecessary Testing," setting in motion the mandatory formation of so-called Substance Information Exchange Forums (SIEFs) among makers and users of a chemical that have become the latest poster child for the chemical industry's ongoing gripes about REACH.

Let me be clear:  I personally, and EDF organizationally, strongly support taking all possible measures consistent with good science and sound chemicals safety policy to reduce unnecessary animal testing.  That includes unearthing and utilizing all available data, allowing and facilitating the appropriate use of alternatives to animal testing, including in vitro methods, read-across within chemical categories, and estimation models based on structure-activity relationships (SARs).  It also means aggressively developing more alternatives, including high-throughput screening methods and computational toxicology – approaches that form the core of the long-term vision embodied in the National Academy of Sciences' seminal report Toxicity Testing in the 21^st Century.

But we also need to address the fact that tens of thousands of chemicals are in active use today that have never been sufficiently tested or assessed for safety, due to policies put in place decades ago that simply presumed them to be safe.  That is a very deep hole to dig ourselves out of.

But it's not nearly as deep as Hartung and Rovida would have us believe.  Let's examine some of their claims:

Claim #1:  "More than 100,000 synthetic chemicals are used in consumer products."

That's the very first sentence in the Nature opinion piece, and it's flat wrong.  This number is derived from the number of chemicals listed in the EU's inventory of all chemicals that were in commerce in the EU at the time the inventory was developed in 1981.  It is not an accurate count of chemicals currently in commerce.

In the US, about 84,000 chemicals are listed on the cumulative TSCA Inventory, first set in 1979, but again not all of those are currently in commerce.  EPA's latest count of those manufactured or imported above 25,000 pounds/year is less than 7,000 chemicals.  While that is clearly an underestimate as there are many chemicals below this threshold, and the reporting system has a number of exemptions, nowhere near 84,000 chemicals are in active commerce in the U.S.  Given the global nature of the chemicals market, it seems highly unlikely that the situation is radically different in the EU.

Claim #2.  "Our report … is based on the pre-registration of chemicals [under REACH]."

The authors' primary analysis is based on the gross number of substances that were pre-registered under REACH last year.  However, as the European Chemicals Agency (ECHA), which administers and oversees REACH, has made clear, pre-registration is not an accurate representation of the number of chemicals to be registered under REACH. 

ECHA's press release from March of this year states:

• "ECHA does not expect all of these [preregistered] substances to be registered."
• "In ECHA’s opinion the list contains many preparations and substances that did not require registration."

ECHA has already found that the list of pre-registered substances contains many substances (as well as items such as articles) that are duplicates or are entirely exempt from or inapplicable under REACH and will not need to be registered at all.  Pre-registrations were filed not only by chemical makers and importers, but by downstream users, as well as contract testing labs, consultants and others, mining for business opportunities.

Bizarrely, Hartung and Rovida acknowledge "a large abuse of preregistration" as well as significant duplicative entries.  Yet they proceed unfazed to base much of their analysis on the inflated pre-registration numbers.

Claim #3.  "The latest published list of REACH chemicals contains 143,835 substances that are supposed to be fully registered, each requiring a chemical safety report."

     AND

There are a total of "140,008 substances that may require extensive testing for registration."

These sentences contain several significant errors.  First, they reflect the gross number of pre-registered substances.  It is true that ECHA's pre-registration list contains more than 140,000 entries.  But as noted above, that number is highly inflated and the number of substances to be registered under REACH is expected by ECHA to be far lower. 

In a statement sent to Nature by ECHA in response to Hartung and Rovida's study (referred to in NatureNews here), ECHA reiterates that, based on its review of the pre-registration lists, it still believes its original estimates for the number of unique substances to be registered under REACH (about 30,000) is quite close to accurate.

Second, only those registered substances above 10 tonnes/year are required to have chemical safety reports (CSRs).  The EU estimates that the large majority (about two-thirds) of all registered substances will fall under this threshold and not require CSRs.  For these chemicals, no animal testing is to be required under REACH.

Claim #4.  We estimate "68,000 chemicals falling under REACH, and this is the lower (optimistic) estimate in our study."

The authors characterize the estimate they derived from pre-registration lists as "worst-case," yet they use it as the primary basis for their analysis.

But even their "best case" number of 68,000 chemicals is also highly inflated.  Its derivation is frankly, laughable:

• They start with the EU's own estimate that about 30,000 chemicals will be registered under REACH.  That number was derived by data collected by the EU in the mid-1990s, compelling the authors to seek to "update" it.
• First they note that chemical production as measured by sales volume has increased substantially in the EU, nearly doubling between the mid-1990s and today.  I have no reason to doubt this.
• Second, they point out that the EU itself has grown by accepting into its ranks a number of new countries.  They put that growth at about 20%.  Again, all fine.
• But then, astoundingly, they assume that the number of chemicals produced in the EU has increased in direct proportion to these growth factors.  That leads them to multiply the 30,000 EU estimate by about 2 and then again by about 1.2, to yield the 68,000.

The notion that recent growth in the sales and volumes of chemicals in the EU was derived entirely by introduction of new chemicals, and not primarily by increases in production of existing chemicals, is contradicted by all empirical evidence – including the statistics cited by the authors themselves in the very first paragraph of the Nature opinion piece. 

They point out that "existing 'old' chemicals represent about 97% of those in use today and 99% of the production volume."  I'll let you do the math to conclude that there is simply no way that 38,000 new REACH-eligible chemicals have been introduced in the EU since the mid-1990s.  OK, I'll do the math:  That would mean, among other things, that the "old" chemicals would account for well under half of those in use today, not 97%!

Indeed, the actual number of new chemicals registered in the EU since 1981 (which is cited by the authors elsewhere but ignored here!) is about 4,400.

Claim #5.  After going through more arcane calculations, the authors finally arrive at the following numbers of chemicals that they claim will require extensive animal testing:

• 47,858 chemicals marketed above 1000 tonnes/year, to which a 2010 registration deadline applies
• 53,040 chemicals marketed above 100 tonnes/year, to which a 2013 registration deadline applies

The former of these numbers represents what the EU calls high-production-volume (HPV) chemicals.  The authors claim there are nearly 48,000 such HPV chemicals.  The EU estimates there are only a few thousand.  Who's right?

The Organization for Economic Cooperation and Development (OECD) maintains a list of HPV chemicals produced in its 33 member countries.  OECD includes not only all of the EU, but also the U.S., Japan, Australia, Canada, Korea and all of the rest of the developed world.

How many HPV chemicals does the OECD list?  About 5,000.

So yet again, Hartung and Rovida grossly overstate reality:  They are off by at least an order of magnitude.

Claim #6.  "The two-generation study for reproductive toxicity … consumes an average of 3,200 rats per chemical."

The authors zero in on this particular test as a primary culprit, calling for a moratorium on such testing under REACH.  Let's look at the claim.

The authors claim this "average" number was calculated in a paper by Höfer et al (2004).  That paper, however, merely asserts the number and provides no calculation.  It does, however, characterize the number as a "maximum" number, and includes it in a table of "theoretical extrapolation of a maximum number of animals to be used."

The authors allude to a second paper by Cooper et al. (2006) that estimates only 2,600 rats per test, but doggedly stick with the higher number for all of their calculations.  Even that number seems high to experts we have contacted.  The Cooper et al. estimate assumed an average of 15 offspring per mated pair of rats; Hartung and Rovida themselves cited data that the average litter size for rats is only 8.2 offspring, while others put it at around 10.  Yet the authors appear unaware of and certainly never flag this major discrepancy.

There are, of course, many reasons why understanding a chemical's effects on reproduction is critical, and there is a large number of chemicals for which we are already finding such effects.  ECHA's statement summarizes the need for this test as follows:

     "The two generation study is the only study where functional fertility (including mating, fertility, number of implantations and litter size) is investigated in parental animals exposed during vulnerable life stages from conception, in utero up to puberty. Such an exposure design may be of special importance, e.g., for endocrine disrupting chemicals. This is not covered by any other reproductive study, including one-generation study protocols, as long as mating of the F1 generation [offspring of the exposed parents] is not performed."

Claim #7.  "The plausibility of our assumptions and calculations was checked by eight experts from industry, academia and regulatory authorities."

This paper has not been peer-reviewed in any normal sense of the term. 

A footnote on the first page identifies two reviewers.  One is the current Chair of the Board and former director of CAAT, the organization Hartung now directs.  The other is a colleague of Hartung's at the University of Konstanz in Germany, where Hartung has a joint appointment.

Six other expert reviewers are cited in the Acknowledgement section of the paper.  Five of the six work for the chemical industry or its trade associations:  ECETOC (a trade association "financed by its membership, which comprises 50 of the leading companies with interests in the manufacture and use of chemicals"), Dupont, Shell, Exxon-Mobil and BASF.  CAAT's advisory board is also well-stocked with industry representatives.

This is no accident:  There is, shall we say, a strongly shared interest between the chemical industry and animal welfare advocates in undercutting chemical testing programs.  This isn't the first instance of such close cooperation, and I very much doubt it will be the last.

A single reviewer was drawn from government (a German federal agency). 

The paper received no review whatsoever from anyone from the European Commission or ECHA.  Perhaps had that occurred, some of the huge errors might have been caught before publication.

Conclusion

As noted at the start, this study has used numerous demonstrably false or highly questionable assumptions, one piled on another, to grossly inflate the number of chemicals requiring testing under REACH, and the number of animals involved.

Why?  One need only look at the last concluding sentence of the author's study for what I think is at least part of the answer:

     "It is be­yond dispute that the primary aim of REACH is protecting hu­man health and the environment from unwanted consequences of exposure to chemicals.  The challenge will be to do it sensibly within the context of REACH while using all the information and experience we have and recognizing that most chemicals have been produced and used safely for many years without ex­tensive testing on animals.  (emphasis added)

That naïve assumption – that what we haven't tested can't hurt us – is what got us into this mess in the first place.  I cited many sources of information that demolish that argument  in the Introduction to my 2007 report, Not That Innocent.

There is a near-total absence in either the Nature piece or the accompanying study of mention of concern for the need to protect human health from the effects of toxic chemicals.  More striking, given the animal welfare orientation of the authors, is their utter failure to recognize or acknowledge that gaining a better understanding of chemical hazards is essential to protecting animals in the wild from toxic chemicals. 

Our knowledge of the endocrine-disrupting effects of chemicals originated with studies of animals in the wild.  DDT's devastating effects first came to light through witnessing the dramatic declines in reproductive success of ospreys and eagles in the wild.  Growing evidence indicates that the widespread and increasing deformations and gender-bending effects seen in wild fish and amphibians are the result of chemical exposures.  We now know that wildlife in the remotest parts of the Earth carry dangerous levels of persistent substances in their bodies.

All of these impacts of untested and under-assessed chemicals affect untold billions or trillions of animals in the wild.

Doesn't that matter?

[My EDF colleague and toxicologist, Dr. Cal Baier-Anderson, helped with some aspects of the content of this post.]

I hate to say it, but Friends of the Earth, Consumers Union, and the International Center for Technology Assessment (ICTA) have done a disservice to good science and policy with their new superficial report Manufactured Nanomaterials and Sunscreens: Top Reasons for Precaution. There are all kinds of legitimate safety questions yet to be answered about the use of nanoscale ingredients in sunscreens, a few of which are briefly discussed in the report.  But virtually all of them apply equally to the alternative chemicals used in other sunscreens as well, a fact that the report's authors conveniently duck.

Instead, the authors cite the usual litany of effects seen in various studies of nanomaterials, most of them associated with inhalation or ingestion – exposure pathways the relevance of which they never question in their apparent haste to warn consumers off of applying nano-containing sunscreens to their skin.  They cite the "small size" of nanomaterials as the driving concern, failing to recognize that the organic molecules used in other sunscreens are typically far smaller – not to mention specifically designed to be absorbed into the skin.

Like the authors, I'm all for thorough testing, labeling and demonstration of safety of nanoscale ingredients in sunscreens and other consumer products.  But those needs extend well beyond nanoscale materials to all ingredients.  A less selective rendition of the facts about the safety of sunscreens would better serve these causes – and consumer protection.

[Note:  This post was originally posted as a comment on Gina Solomon's blog post on Huffington Post.  The context is a pending budget proposal from the Governor's office in California to eliminate the State's Office of Environmental Health Hazard Assessment (OEHHA) under CalEPA and disperse some but not all of its functions to other agencies.  This proposal, if implemented, would in my view be truly tragic.  If you agree, make your voice heard!] 

As someone intimately involved in chemical assessment and policy both in California and nationally, I find the budget proposal to eliminate or atomize OEHHA to be both deeply disturbing and ironic.

Disturbing, because it would dissolve a world-class group of scientists who for decades have delivered scientifically sound, objective assessments of chemical risks. Losing that top-notch expertise would deprive not just the State, but the globe, of a vital resource.

Ironic, because California is poised to lead the nation in advancing a greener and more sustainable chemicals economy through the Governor's signature Green Chemistry Initiative. Losing OEHHA would rip the heart out of that effort, at the very moment the State most needs an objective source of sound information and expertise to guide critical decisions about chemicals.

Governor Schwarzenegger has expressed understandable reluctance to have the Legislature make risk decisions about chemicals, arguing that a systematic approach driven by agency expertise is needed — hence the Green Chemistry Initiative. While DTSC (lead agency for the Initiative) and other agencies within CalEPA bring much to the table, OEHHA houses the core competency needed to objectively and consistently assess chemicals of concern and potential alternatives.

While California clearly faces major budgetary challenges, the huge return on investment that OEHHA (a tiny agency by any standard) provides to the people of California — by anticipating and reducing the health and environmental impacts of chemicals and their enormous associated costs — more than justifies retaining OEHHA intact within Cal EPA.

Some months ago, my colleague John Balbus posted here about studies finding that when multi-walled carbon nanotubes (MWCNTs) are injected into the abdominal cavities of mice, they induce inflammation and mesothelioma-like reactions similar to those caused by asbestos.  He appropriately cautioned that – among other critical questions – these studies had not demonstrated that inhaled MWCNTs could actually move out of the lung and into the tissues where asbestos gives rise to its effects.  Well, that particular dot now appears to have been connected.

We learned about the new findings via a blog post by Liz Borkowski at The Pump Handle.  She noted a disturbing item on the NIOSH blog posted by Vince Castranova and his colleagues late last week, in which they are seeking to share more broadly results they first presented at the recently-concluded Society of Toxicology meeting in Baltimore.

The NIOSH researchers reported new data showing for the first time that MWCNTs can migrate intact from the alveoli out of the lungs of mice and into the pleura, the tissue surrounding the lungs.  And it is in the pleura (as well as the abdominal cavity) where asbestos induces its signature form of cancer, mesothelioma.

In this case, the MWCNTs were introduced into the lungs using pharyngeal aspiration, a procedure by which mice are induced to inhale a droplet of liquid in which the MWCNTs are suspended.  While this procedure is thought to mimic direct inhalation, the NIOSH researchers note this and other limitations of the study, and caution that the results are preliminary and have not yet been peer-reviewed.

They also note that it's possible that the mice used in the study are unique and may not accurately portray what would happen in people, say, workers exposed to MWCNTs.  And, as my colleague pointed out in his earlier post, whether sufficient material could or would be suspended in the air to result in inhalation exposure also remains an open question.

Nonetheless, these new findings strongly suggest that, like asbestos, MWCNTs behave as stable fibers capable of penetrating and migrating through the lung.  And together with the earlier studies showing that introducing MWCNTs into the tissues surrounding the lung induces mesothelioma-like reactions, it's fair to say the alert level on MWCNTs just went up significantly.

It's been nearly a year since EPA launched its voluntary Nanoscale Materials Stewardship Program (NMSP) – and over three years since EPA was urged, by a diverse group of stakeholders, to do so only in conjunction with the development of mandatory reporting rules as a backstop and to limit the duration of the basic part of the program to at most six months.

EPA ignored that advice, and proceeded with an open-ended voluntary program and no development of backstop rules.  Now EPA has issued its first evaluation of the NMSP.  So what did EPA find?

Despite a major arm-twisting effort by EPA to get companies to sign up, only 29 have made submissions to EPA under the basic program, and only four have said they're willing to discuss the possibility of doing any testing under the in-depth program.

Perhaps not surprisingly, few of the submissions contain any health and environmental data – confirming that few if any nanomaterials have been sufficiently studied, despite their rapid commercialization.  Also in the category of "not surprising:"  Large amounts of the data that were submitted were claimed to be confidential business information – despite EPA's plea that companies disclose as much information as possible.

More surprising, but welcome, is EPA's forthright acknowledgment that the submissions cover only a small fraction of both:  a) those nanomaterials likely to be already commercially available, and b) the underlying chemical structures on which they are based.  EPA's report provides a rather extensive analysis that reveals the following:

• Fewer than 10% – 123 out of the more than 1,600 unique nanomaterials EPA estimates are already commercially available – were addressed in the basic program submissions.
• The submissions encompass only one-seventh (28 of 200) of the unique chemical structures on which nanomaterials in use or development are based.

[Update:  In my haste to get this post up, while I got the "fewer than 10%" and "only one-seventh" right, I mis-stated the underlying numbers: The first bullet above should read "123 out of the more than 1,800 ... ."  And the ratio in the second bullet should be 34 out of 238 unique existing chemicals.]

EPA also acknowledged it cannot determine whether participants submitted information on all or only a subset of nanomaterials they produce, and whether information submitted for a given nanomaterial was complete or selective.  EDF had predicted precisely this problem because of EPA's failure to include these metrics in the design of the Nanoscale Material Stewardship Program.

And given that only four companies have agreed to consider conducting any testing, EPA concluded that "most companies are not inclined to voluntarily test their nanoscale materials."

The good news is that, given the poor showing for the NMSP, EPA now says it is finally "considering how to best use testing and information gathering authorities under the Toxic Substances Control Act" to address the remaining gaps in information. 

Reading between the lines a bit, this is the first time EPA has been willing publicly to state that mandatory reporting and testing rules will be needed to provide the Agency with the information it needs to craft a regulatory approach to nanomaterials. 

Let's hope EPA is serious about refocusing its energies on these critical tasks.

In 2004, Gunter Oberdorster and colleagues demonstrated that upon inhalation, ultrafine particles, the dimensions of which are measured in nanometers, can move from the nasal passages of rodents to the brain via a specialized nerve called the olfactory bulb.  The evolutionary purpose of the olfactory bulb is to relay information about odors directly and rapidly from the nose to the brain. 

The extent to which rapid transit via the olfactory bulb is a significant potential route of exposure to engineered nanomaterials is still an open question.  But two new papers add support for the relevance of this intriguing exposure pathway, raising important questions regarding the safety of inhaled nanoparticles. 

The first paper, by Jiangxue Wang and colleagues, followed the movement of nanoscale titanium dioxide (TiO₂) particles placed directly in the nasal passages of mice to the brain via the olfactory bulb.  When they looked to see where in the brain the TiO₂ went, they found it went pretty much everywhere, although after 30 days the highest concentrations were found in the olfactory bulb and hippocampus.  Moreover, the brain tissue of the exposed mice exhibited changes in structure and biochemistry consistent with damage from reactive oxygen compounds.

Nanoscale silver was the subject of the second paper by Jae Hyuck Sung and colleagues.  Instead of a single exposure, rats were exposed to nanosilver in the air for 13 weeks.  Like an earlier 28-day inhalation study, this one also found widespread distribution of nanosilver in the rats. 

This study also sought to determine if there were any health effects associated with longer-term exposures.  And they did find effects:  inflammation in the lungs, and subtle cellular changes in the livers that are sometimes indicative of pre-cancerous conditions. 

Nanosilver was detected in both the olfactory bulb and the brain but unfortunately the paper did not report on any effects that might have been associated with the presence of nanosilver.  It is not clear from the description provided if the extent of examination of the brain would have been able to identify subtle effects if they were present.

So what should the next steps be?  Elucidating the possible impacts of nanoscale materials on the brain is tricky, in part because the effects could be very diverse, requiring lots of different types of tests to capture them.  While damage to brain cells may be relatively easy to discern, other effects, such as those altering brain development or biochemistry, may require more sophisticated testing. 

While it is often assumed that inhalation exposure to nanomaterials will be limited primarily to workplaces, such materials are also being used in consumer products that can be widely dispersed.  This is particularly true of nanosilver, which can be found in sprays that release nanosilver into the air.  This is why we have repeatedly advocated that such dispersive uses be avoided until more is known about the potential adverse effects that could come with these kinds of exposures. 

John Balbus, M.D., M.P.H., is Chief Health Scientist.

Some 216 delegates representing 26 countries converged on the largest city in China last week for the 7^th meeting of the International Standards Organization (ISO) Technical Committee (TC 229) on Nanotechnologies.

In China, the turtle symbolizes cosmic order, strength, endurance and wisdom.  In the US, the turtle has come to symbolize slow progress and not keeping up with the times.  Which representation better captures what's going on in ISO's TC 229?   Maybe a little of both.

ISO is an international voluntary standard-setting organization comprised of national delegations (each country has one vote) that are dominated by government and industry interests.  Most of ISO's work is devoted to harmonizing and standardizing industrial processes and products to facilitate commerce and global trade.  But a significant portion entails the development of environmental, health and safety (EHS) standards, like the ISO 14000 series.  For better or worse, these standards tend to emphasize implementing corporate management systems and procedures over achieving specific measureable results. 

There are three levels of documents that come out of ISO.  The first is a technical report, which does not carry the force of a standard or require broad consensus, making it the easiest to adopt.  Next is a technical specification, which again is short of a standard but represents a stronger consensus of the countries participating.  Getting a full standard passed is the hardest and usually takes years.

Countries are starting to put forward a number of documents addressing EHS for nanotechnology.  But given the early state of the science, most of these documents are technical reports or technical specifications.  The expectation is that it will take a few years for the science and practice to evolve to the point where developing full standards will be practical.  In the meantime, technical reports and technical specifications can provide useful guidance now, and potentially serve as the basis for standards development later. 

It's all pretty bureaucratic, but ISO is one of very few ways to influence corporate behavior on a global basis.

As I reported in my last post, the US delegation brought to ISO a proposal to use the EDF-DuPont Nano Risk Framework (NRF) as a basis for an ISO Technical Report.  The Shanghai meeting marked the first international discussion of this proposal.  Former EDF staffer (now consultant) Scott Walsh and I went to Shanghai as US experts on the project group for this document.

The Nanomaterial Risk Evaluation Framework (NMREF), as the ISO version is provisionally titled, was generally well-received by the international delegates.  While some concerns were raised about how OECD guidelines and the European Union's REACH Regulation might conflict with elements of the starting document, there was no opposition to some of the most important elements of the Framework, such as taking a lifecycle approach, information-driven decision-making, and emphasis on transparency.  And the mood for moving forward was very positive.

There are other projects underway within the EHS workgroup.  These range from detailed testing methods to general guidelines for workplace handling of nanomaterials.   In addition, the committee created a new group on nanotechnology and sustainability.  And the groups working on material specifications are including guidelines for incorporating EHS information in every specification.

Is ISO the global key to ensuring safe development of nanomaterials?  Probably not.  For starters, all ISO standards are voluntary — they don't carry the force of law.  Ensuring that all nanomaterials are carefully assessed and that all companies take the necessary precautions to limit uses and releases of potentially harmful materials will require sound regulations. 

But there are a couple of reasons to ride the turtle for now.  First, there are enormous gaps in regulatory frameworks in most if not all countries.  Until those gaps are filled, many companies will look to ISO documents for operational guidance.  And second, as countries around the world decide how to adapt or extend current regulations to the special case of nanomaterials, ISO will play a role in validating and disseminating concepts to be used in the development of regulations.

So while the turtle moves slowly, it has set out on its way, and we're doing what we can to make sure it gets steered in the right direction.