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

A new entry showed up sometime in the last day on EPA’s webpage for its ChAMP initiative.  It reads:  “The Chemical Assessment and Management Program (ChAMP) has been superseded by the comprehensive approach to enhancing the Agency’s current chemicals management program announced by Administrator Lisa Jackson on September 29, 2009.” 

Don’t miss this bit at the top of the page:

Yes, that image is a cobweb, which EPA uses to designate archived web content.  What’s happening here?

Lost in the buzz surrounding EPA Administrator Jackson’s speech on Tuesday unveiling EPA’s new TSCA reform principles was the fact that EPA simultaneously announced a rather sweeping set of changes to its current existing chemicals work aimed at “Enhancing EPA’s Chemical Management Program.”

Now, as regular readers of this blog know, EDF has for some time been raising serious concerns with ChAMP.  To review:

• We noted that, about 18 months ago, EPA had made an abrupt shift from developing hazard characterizations based on the hazard data sets submitted under the HPV Challenge, to cranking out “risk-based prioritizations” that were frequently designating high-hazard chemicals as being low-risk, based on poor and incomplete use and exposure information. 
• We also said EPA was, in the process, obscuring the significance of the data gaps and data quality problems remaining even in supposedly “final” industry data submissions. 
• Finally, we lamented the fact that the only “action” EPA was proposing to take even for the high-concern chemicals it identified under ChAMP was yet more testing and assessment – never getting to any risk mitigation.

So it ’s quite heartening to see that EPA’s enhancements directly address all of these problems:

• EPA has returned the focus of its assessment activities to developing hazard characterizations for HPV chemicals, and just posted 100 of them in September.
• EPA is to publish TSCA Section 4 test rules to tackle HPV Challenge chemical data gaps, not only for unsponsored “orphan” chemicals, but for “sponsored but unfulfilled chemicals.”
• In 2010, EPA will propose a significant revamping of its Inventory Update Reporting (IUR) rule to “make the reporting of chemical use information more transparent, more current, more useful, and more useable by the public.”
• And last but certainly not least, EPA will be taking on a slew of new “regulatory risk management actions” for old enemies like lead and mercury, and developing “chemical action plans” for some of the more recent arrivals on the toxic chemicals scene.  The initial list contains some bold entries:
  • Benzidine dyes and pigments
  • Bisphenol A (BPA)
  • Penta, octa, and decabromodiphenyl ethers (PBDEs) in products
  • Perfluorinated chemicals
  • Phthalates
  • Short-chain chlorinated paraffins

EPA says it “intends to utilize the full array of regulatory tools under TSCA to address risks, including authority to label, restrict, or ban chemicals under Section 6 of TSCA.”

Now, I can just hear you saying, “But wait, how will this EPA overcome all of TSCA’s hurdles, which you’ve prattled on about ad nauseum, Richard?”

Well, let me say two things to that.  First, bless their hearts for being willing to try.  Second, in addition to the inherent burdens imposed by TSCA, EPA has been stymied over the years by two other forces: 

• a massively burdensome executive branch process for regulatory development, and
• a virtual guarantee that industry will challenge EPA’s regulations at every opportunity.

So, this new EPA effort will be an interesting test, both for the new Administration’s regulatory review process and for industry’s new-found religion under which it has acknowledged that EPA needs to be able to exercise greater authority under TSCA.

One image immediately comes to mind; click here.

I can also hear you saying, “Gee, if EPA manages to pull this off, what’s the need for TSCA reform?”

Again, two responses.  First, I’m in favor of any action EPA can take to reduce chemical risk, and the sooner the better, especially given it’ll be some time before:  a) TSCA reform is adopted, and b) TSCA reform is implemented.

Second, as welcome as all this new stuff is, it’s hardly the comprehensive approach that’s needed.  That looks much more like this and this.

Today, EPA Administrator Lisa Jackson unveiled the Obama Administration’s “Essential Principles for Reform of Chemicals Management Legislation.”  The principles’ significance lies not so much in the words they contain, but rather in what they symbolize:  A clear confirmation that this Administration understands that the Toxic Substances Control Act (TSCA) needs fundamental reform and that it is ready and willing to engage in making it happen.

There’s no shortage of principles and platforms for TSCA reform, of course.  See my earlier post comparing and contrasting the platform of the Safer Chemicals, Healthy Families coalition – of which EDF is a member – with the American Chemistry Council (ACC) “principles for modernizing TSCA.”

So what does EPA’s entrance into the fray mean?   It is a real sea change to have the very agency charged with implementing TSCA be willing to say the law isn’t working, that it doesn’t provide EPA with the tools it need to do its job.

Who would know better than EPA?

For the first time EPA is publicly affirming it needs substantially greater authority if it is to protect human health and the environment from dangerous chemicals.  And the preamble to the principles makes clear that EPA stands ready to engage, to work for TSCA reform, and that such reform should happen “quickly.”  That’s great news, and a major reversal from the last EPA’s view that TSCA was working just fine as is.

It’s also noteworthy that Ms. Jackson identified the principles as those of the Obama Administration, not just EPA.  That reflects the fact that they went through a thorough interagency review process – and it also means they have the backing of the White House.

I’m not going to attempt to dissect or parse in detail the new Administration principles here.  I’ll only say they encompass most of the elements EDF and others have for years been arguing are essential to TSCA reform, including:

• a requirement that industry develop and provide to EPA the data needed to determine whether chemicals – both new and existing – are safe;
• far greater and easier authority for EPA to require additional testing of chemicals;
• assessment of chemical safety against a health-based standard, rather than the cost-benefit “unreasonable risk” standard that has been the downfall of the current TSCA;
• an obligation to address the higher risks to sensitive subpopulations, including children, workers and communities suffering disproportionate impacts from chemicals;
• authority to reassess safety when a chemical’s production or use changes or new information emerges;
• authority to require use and exposure information from downstream users as well as chemical makers;
• narrowing the ability of industry to claim its submissions as confidential business information, and requiring an up-front justification for any such claims; and
• the need for a dedicated source of funding to support EPA’s implementation of TSCA, derived from chemical manufacturers.

Not a bad start for the new leadership at EPA.

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.]

In June, EPA published a Federal Register notice that included Significant New Use Rules (SNURs) for two carbon nanotubes (as well as 21 other chemicals).  That notice certainly got the attention of lawyers in town (see here, here and here).  The nanotube SNURs would require anyone planning to produce or process either of the two substances to notify EPA if the person intended not to comply with the (rather limited) risk management conditions specified by EPA.  Well, as reported yesterday by Sara Goodman of E&E News, EPA is now withdrawing the SNURs, at least temporarily.   

[Note:  Since first posting this Friday, I have made a few changes.  In first writing this post, I let show too much my frustration over the fact that even the smallest of steps taken by EPA to ensure some review of nanomaterials prior to their commercialization appears to have engendered an industry challenge.  In a few places, I got too personal and took some gratuitous swipes I shouldn't have.  I apologize for that, and have taken those out.]

The withdrawal notice is posted here.  On one level, the withdrawal is based on a technicality.  EPA had issued the SNURs as part of what is called a “direct final rule,” a mechanism EPA can and typically does use as a short-cut to get around having to go through lengthy full notice-and-comment rulemaking (see p. 31299 of this 1989 Federal Register notice).  Such a rule applies immediately upon issuance – unless someone files, within 30 days, a notice of intent to submit “adverse or critical comments.”

Surprise, surprise, someone did just that.  One of those DC lawyers, James Votaw of the firm Wilmer, Hale, had the notice hand-delivered to EPA just 2 days before the deadline, “on behalf of one or more clients.”  (Hey, this is a regulation, after all, so it’s just begging to be challenged.  Besides, things are kinda slow in DC during the dog days of August.) 

Votaw’s notice of intent is posted in an EPA docket you can access here.

What’s EPA’s next move?

Based on EPA’s withdrawal notice, EPA “intends to publish in the Federal Register, under separate notice and comment rulemaking procedures, proposed SNURs” for the two nanotubes.  It would then presumably proceed to issue a final rule containing the SNURs at some point.

It’s unclear from this whether EPA intends now to proceed via full notice-and-comment rulemaking, or to reissue the SNURs via an “interim final rule” (again, see p. 31299 of this 1989 Federal Register notice).  The latter takes effect on the date of publication, even as public comment is taken and considered.  As long as EPA promulgates a final rule within 180 days, the SNUR remains in effect during the interim.

The “interim final rule” approach may well be more advisable in this case.  Otherwise, some devious DC lawyer could advise his or her clients that, if they hurry, they could engage in the very activity for which EPA intended to require notification – but without ever having to tell EPA – simply by starting the activity identified as a “significant new use” in the proposed rule before the rule goes final.  Such a client could be a downstream processor or another manufacturer of the nanotubes, as the SNURs would apply to both.

This loophole speaks more generally to the major limitations facing EPA in trying to use SNURs to regulate new chemicals or new uses of existing chemicals.  By definition, any activity already ongoing at the time a SNUR is issued cannot be considered a “new use” and hence is beyond the reach of a SNUR – it can only require notification for activities not already occurring.

Still with me?

A red herring

What Sara Goodman reports as Mr. Votaw’s main problem with the nanotube SNURs is that EPA did not sufficiently identify the specific carbon nanotubes to which they apply.  Indeed, the SNURs themselves refer only to a “generic” name for each nanomaterial. 

Well, that’s standard practice under the Toxic Substances Control Act (TSCA).  The specific identities of the nanotubes are claimed as confidential business information (CBI) by the original submitters of the corresponding pre-manufacturing notifications (PMNs), so EPA is barred from revealing them publicly and must use a generic name.  (EPA’s use of the generic name apparently confused enough folks that EPA felt obliged to email around a clarification that the SNURs do indeed apply only to the very specific nanotubes made by the companies that submitted the original PMNs.  Makers of any other nanotubes would still need to file their own PMNs.)

Mr. Votaw and his clients surely know this.  They also surely know that, if his clients really want to know whether the SNURs in question apply to a nanotube they intend to produce, there’s an app for that:  They are to submit to EPA what’s called a “Bona Fide Intent to Manufacture or Import Notice.”  EPA then determines whether the specific nanotube the client proposes to make is or is not the same as that to which the SNUR applies, and informs them of the determination.

All of that so as not to reveal the confidential identity of the nanotubes that started all this.  (In case you’re wondering, as ordinary folk, you and I can’t file a bona fide request, so there’s no way for the public to participate in this ritual.)

The bigger problem

Notwithstanding the unfounded basis for Mr. Votaw’s concern, in light of the standard remedy EPA has provided, the fact remains that EPA lacks a nomenclature system that can distinguish between different nanotubes (or any other classes of nanomaterials, for that matter).  For now, EPA has indicated it will identify nanotubes based on what company produced them (among other factors).  So it may consider even two apparently identical nanotubes made by different companies to be different. 

That means that future SNUR development and any evaluation of potential risks will be done on a case-by-case basis for each nanotube.  That’s good on one level, in that their properties may well be quite specific; bad on another level, in that any SNUR will apply only to a very specific nanotube and hence does not provide a viable avenue to require notification or to regulate nanotubes more generally.

This episode also vividly illustrates how cumbersome chemical regulation is under TSCA:

• Even to require notification via a SNUR, EPA must go through a rulemaking – and if anyone objects, a notice-and-comment rulemaking – for each and every case.
• A SNUR cannot require notification by any companies who maintain they are complying with the conditions of the SNUR, naturally raising compliance questions.
• A SNUR cannot reach any activities associated with a chemical that are already underway, because by definition they are not a “new use.”
• A SNUR does not regulate a chemical’s production or use; it only requires notification of EPA and provides an opportunity for an EPA review.  Any regulation would require EPA to demonstrate “unreasonable risk” and promulgate a separate rule under TSCA’s Section 5(f) (for a new chemical) or Section 6 (for an existing chemical), a task that has proven virtually impossible in practice.
• In the absence of a SNUR, any company can produce and use any chemical on the TSCA Inventory under any conditions it chooses, without having to notify EPA it is doing so.

Solutions

This convoluted situation is one of many aspects of current chemical regulatory practices in the U.S. that is motivating calls for major reform of TSCA.  EDF is working within the Safer Chemicals, Healthy Families coalition to achieve this aim. 

Among the changes we propose that are relevant in the current context are:

• Requiring that all producers of a chemical (including a nanomaterial) – whether new or existing – identify themselves to EPA and provide basic safety information.
• Requiring that any significant change in a company’s production or use of a chemical automatically trigger both EPA notification and an update safety review.
• Extending the definition of specific chemical identity to include physical as well as chemical characteristics of a substance, to ensure EPA can distinguish among nanomaterials based on more than just their underlying chemical structures.
• Limiting the ability of companies to claim a chemical’s identity to be confidential in association with any information regarding that chemical’s safety.

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.

Today, the American Chemistry Council (ACC) unveiled its “10 Principles for Modernizing TSCA.”  Also today, the Safer Chemicals, Healthy Families coalition – of which EDF is a member – issued a news release and unveiled its 9-point “Platform for Reform of TSCA.”  How do they line up?

I’ll leave to you readers to decide just how much alignment (or lack thereof) there is between these dueling manifestos.  To get the ball rolling, I’ll use this post to single out three key differences.

First, however, let me say I welcome the fact that ACC is finally moving beyond rhetorical flourishes about “modernization” and “the need to restore public confidence in its products.”  At last ACC has begun to provide something that could become something that one can sink one’s teeth into.

Equally refreshing is that ACC is now acknowledging a number of deep problems with TSCA that it has traditionally denied – problems that many of us having been raising for years.  To be specific:

• TSCA does not require that chemicals be shown to be safe in order to be on the market.
• TSCA’s reliance on a cost-benefit rather than a health-based standard to determine safety was ill-advised.
• EPA should be required to complete safety assessments expeditiously and within clear deadlines.
• Companies throughout the supply chain, not just manufacturers, should be required to provide information on chemical use and exposure, as well as hazards.
• Children are at particular risk from chemical exposures and merit special protection.
• EPA lacks but should be given authority it can actually exercise to regulate chemicals.
• EPA shouldn’t have to prove risk to require testing of chemicals.
• The public should have access to chemical use and exposure, as well as hazard, information.

That’s all good and welcome news.  ACC has come a long way, baby.

But let’s scratch below the surface a bit, and we’ll see some fundamental differences quickly begin to emerge.

1.  What ACC wants:  ACC clearly wants the focus to be on only a few “priority” chemicals, and seeks to set aside the rest.  Indeed, ACC’s principles go even further to say we should skip over all but the “most significant uses and exposures” of the priority chemicals, and then narrow things even more to consider only their “intended” uses.

What we actually need:  Robust data on all chemicals, not just the few we already know are bad actors.  A full understanding of all chemical uses, not just those chemical producers have knowledge of and consider most significant.  Authority for EPA to act promptly to control chemicals we already know are high-priority.

As readers of this blog know full well, the problem with ACC’s approach is that it puts the cart before the horse:  The state of knowledge about chemical hazards, uses and exposures remains poor despite more than three decades of life under TSCA – so poor that we can’t begin intelligently to prioritize most chemicals.

One particularly huge gap in knowledge is about the full range of uses of chemicals.  As I’ve discussed before, companies that make chemicals often don’t know how and by whom their own chemicals are used – not even for the uses they intend for them, let alone those they may never have anticipated.  That yields a very spotty picture of real-world exposures – which may help to explain why time and again government and industry have failed to predict which chemicals we’re all exposed to, let alone how or to what extent.

Hazard information about a chemical is of value regardless of its use, and can help enormously to guide selections among alternatives when considering a new or revisiting a current use.  Yet, in the name of prioritization, ACC would have us utilize various imperfect surrogates for exposure – production volume, known uses, etc. – to severely limit the number of chemicals whose hazards we would ever test for.

The evident gaps in hazard, use and exposure data add up to an inability both to prioritize and to decide a priori what’s safe or not.  What’s needed instead is a systematic and thorough – not piecemeal – approach, both to getting better information about chemicals, and to assessing their safety.  That’s why we call for the development of at least basic information for all chemicals, and a requirement that all chemicals be shown to be safe, not just those we think might be problems based largely on supposition.

     Prioritization is a means, not an end

We fully recognize that undertaking the extent of information development and assessment needed to ensure chemical safety cannot happen overnight, given the depth of the hole that TSCA dug by grandfathering in tens of thousands of untested and unassessed chemicals – which still today account for the great majority of chemicals in use.  We welcome a legitimate debate over how fast and how best we can do all of what’s needed, but not one over whether we need to.

It’s one thing to prioritize chemicals to determine the order in which their safety should be determined, as long as we ultimately reach all chemicals; it’s quite another to place such false confidence in priority-setting as to, as ACC proposes, sweep away most chemicals from ever being tested or assessed.

Now, none of this is to say we have to wait to control those chemicals we already know will rise to the top of anyone’s priority list, such as chemicals possessing that deadly trifecta of properties of persistence, bioaccumulation potential and toxicity – the so-called PBTs – to which we know people are being exposed.  That’s why we support moving expeditiously to phase such chemicals out of commerce, retaining them only for the most critical uses where no viable alternatives exist.  And we can and should be immediately taking steps to reduce exposure to other dangerous, well-studied chemicals, such as formaldehyde.

2.  What ACC wants:  ACC wants any requirements for testing or monitoring to be imposed by EPA strictly on a case-by-case basis.

What we actually need:  Minimum hazard, use and exposure data sets on all chemicals, delivered up-front, not upon request.  A major expansion in biomonitoring to encompass all chemicals with the potential for human exposure.

While ACC would free EPA at last from the Catch-22 of first having to prove risk to require testing, it would still retain significant evidentiary burdens on EPA to show that having access to data is “reasonably necessary to make safe use determinations.”  Huh?

ACC remains intent on avoiding the development of robust, consistent information across chemicals in commerce.  As we’ve argued before, there’s an inherent contradiction here, given that ACC is among the first to cry “regrettable substitution” when insufficient attention is given to what will replace a chemical targeted for restrictions.  How are we ever to compare alternatives and select safer ones with confidence without good information about them?

EDF and the Safer Chemicals, Healthy Families coalition believe that prioritization must be based, not on the current state of data gaps and supposition, but on a firm foundation of public knowledge that will only come by requiring a minimum data set for all chemicals as a condition for entering or remaining on the market.

3.  What ACC wants:  ACC wants to continue to pretend that people and the environment are somehow able to distinguish between multiple exposures to the same chemical just because they’re regulated under different laws or by different agencies.

What we actually need:  An agency (EPA) charged with conducting a holistic assessment across the aggregate of all uses and sources of exposure to chemicals.  And for chemicals that cannot be shown to be safe, the authority and responsibility to ensure that appropriate action is taken regardless of which agency or law has primary jurisdiction.

A major failing of our chemicals policies is that no one is charged with assembling a full picture of exposure to a given chemical, let alone regulating it on that basis.

Name a chemical in the headlines over the last few years – phthalates, bisphenol A, PFOA – and you’re looking at a chemical with uses that span agency jurisdictions.  Phthalates in cosmetics fall on FDA’s turf, while those in toys fall to the Consumer Product Safety Commission.  ACC would have us continue that atomized approach, where different agencies look at one product at a time, using inconsistent methodologies to measure and assess risk.

And people are exposed to a given chemical not just through its use in products, but through their workplaces, in air and water, and in some cases because of past uses that have yielded “legacies” of exposure, for example from contaminated dump sites or brownfields.  Different offices at EPA are in charge of each of these areas and operate under different statutory authorities.

TSCA need not be the “statute of last resort”

It is with good reason that TSCA is often called the “statute of last resort,” because under it EPA must defer to any other statute that could potentially address a problem.  This is an ironic shame, but TSCA is unique among statutes in its intent (at least on paper) to address the full lifecycle of chemicals.  This feature offered the hope – unrealized – that TSCA would break down the silos that artificially divide chemical exposures into neat little, unrealistic bits.

We seek to restore that latent promise of TSCA, by requiring EPA to assess aggregate exposures and risks, across all uses of and sources of exposures to a chemical.  And if a chemical is found unsafe due to uses or exposure sources, some of which fall under another law or agency’s jurisdiction, then TSCA should ensure that EPA has the authority and responsibility to ensure either that the other agency or office within EPA takes actions needed to restore safety – or, if it doesn’t, that EPA acts under TSCA.

___ 

So, we welcome ACC in at last joining a serious debate over the future of TSCA.  But it still has a long way to go to help the rest of us bring TSCA into the 21^st century.

Some time back, I promised a look at whether Canada’s Chemical Management Plan provides a model for TSCA reform.  This post will provide that look.  Bottom line:  While our neighbor to the north has undertaken and accomplished a great deal over the past decade, it has done so with one hand tied behind its back. 

Canada’s activism on chemical safety issues is remarkable, given that Canada has only about 2% of the global chemicals market, and that a large fraction of the chemicals used there is imported.  Population-wise, it’s also much smaller than the US.  Yet Canada was the first country in the world to tackle the huge legacy of un- and under-assessed chemicals that were – as with TSCA in the US – grandfathered into its regulatory system decades ago.

What did Canada do?

In the 1990’s, concern was mounting among the Canadian public in response to increasing evidence of widespread exposure to hazardous chemicals, especially those that are persistent or bioaccumulative, as well as toxic (PBT) chemicals, which were accumulating in wildlife and people even in remote regions of the Arctic.  That concern culminated in amendments to the Canadian Environmental Protection Act (CEPA), adopted by Parliament in 1999. 

CEPA 1999 mandated a novel approach to identifying and initiating government action on chemicals of concern.  It called for two government agencies – Health Canada and Environment Canada – to review all 23,000 previously unassessed chemicals listed on its Domestic Substances List (DSL), Canada’s counterpart to the US TSCA Inventory.

Relying on existing information, government was to “categorize” all of these chemicals, by developing and applying specific criteria to identify those that:

• may present, to individuals in Canada, the greatest potential for exposure; or
• are persistent or bioaccumulative and inherently toxic to human beings or to nonhuman organisms.

CEPA 1999 also mandated that this large task be done within seven years of enactment.  Given that legislative mandate and a strict deadline, it not only got done – it got done on time.

This effort remains the most ambitious initiative undertaken to date by any region of the world to examine large numbers of existing chemicals to identify those requiring further data development, assessment and management.

What was the outcome?

Going into the DSL Categorization, most observers expected at most a few hundred chemicals would be “categorized in,” i.e., meet one or more of the hazard or exposure criteria noted above.  Instead, more than 4,000 chemicals were found to have one or more of the characteristics of concern.  That, in my view, puts to rest any notion that only a small number of chemicals possess properties of potential concern.

The Canadian government then prioritized among these, identifying about 500 as high priority for action.  Most of these are PBTs, though some showed evidence of high human toxicity without being persistent or bioaccumulative.

CEPA 1999 also mandated that screening-level risk assessments be done on all chemicals that were “categorized in.”  It also required that:

• affirmative decisions be made, based on such assessments, to take no further action, to place the chemical on the Priority Substance List, or to place it on the List of Toxic Substances;
• for chemicals placed on the Priority Substance List, to decide based on a more detailed assessment whether or not to place it on the List of Toxic Substances, and to do so within at most five years; and
• for chemicals placed on the List of Toxic Substances, to develop and propose a management strategy within two years, and finalize and begin implementing that strategy within another 18 months.

Canada has been plugging away at these tasks since completing the DSL categorization in September, 2006.

Mandatory assessments?  Affirmative decisions?  Mandatory management strategies?  And deadlines for all of the above?

I must be dreaming – none of this is required for existing chemicals under TSCA!

So, what’s not to like about Canada’s system?

Here’s the hand that was tied behind Canada’s back:  It was forced to rely on already available information, however limited it was.  And it was indeed limited.

Hazard data:  Overshadowed by how many chemicals Canada “categorized in” is the fact that there were also thousands of chemicals for which sufficient data did not exist to allow categorization.  For example, for the more than 11,000 organic substances examined, database searches found:

• experimental bioaccumulation data for 410 substances, and one-quarter of these data was of acceptable quality;
• experimental persistence data for 850 substances, and one-third of these data was of acceptable quality; and
• experimental data on inherent toxicity to nonhuman organisms for 1,051 substances, and three-quarters of these data were of acceptable quality.

To try to make some headway in the face of these huge data gaps, and given its lack of a mandate to compel testing, Environment Canada had to rely heavily on estimation models.  And while it managed to cobble together enough data and estimates to categorize most chemicals, thousands were not categorized or were done so at less than a high-confidence level.

Health Canada, in seeking evidence of toxicity to humans, employed a different approach, in which it ranked health endpoints in a hierarchy of more to less serious.  Failure to identify data for a high-concern endpoint simply bounced the chemical down the hierarchy.  Unlike Environment Canada, Health Canada did not reveal the extent of data gaps, but surely they were large as well.

Unfortunately, given the large number of chemicals that were categorized in and the limited resources of the agencies (remember, Canada has a population one-tenth that of the US), scant attention has been paid to filling data gaps.

Exposure data:  Under CEPA 1999, Health Canada was to identify DSL chemicals posing the Greatest Potential for Exposure (GPE) to Humans.  But the data gap was even worse for production, use and exposure information than for hazard data.  The information available to Canada was exceedingly old, dating back to when the DSL was first developed, between 1984 and 1986.

Because of this, and the lack of a routine reporting requirement, Canada is finding that many of the chemicals it categorized in based on their hazards or high exposure potential are no longer manufactured or used in Canada.  Unfortunately, the same data gap raises the converse critical question: How many chemicals that were not manufactured or used in significant quantities in the mid-1980s are today, and hence pose a risk of significant exposure not captured through the DSL Categorization?

At least TSCA has an updating mechanism, called the TSCA Inventory Update Rule (IUR).  But that system is infrequent, incomplete and riddled with exemptions, too-high-reporting thresholds, and other loopholes; see here and here.

Conclusion

While much can be learned from the Canadian experience, it is not a sufficient model for US reform.  Industry likes it (see here, for example) – I suspect in large part because it puts very little burden on them, and a lot on government.  That’s one thing when you’re dealing primarily with imports, quite another when you’re dealing with producers – and the biggest market for chemicals of any country in the world.  We can and should do better.

When it comes to prioritization, the basic choice is between:

• muddling through with whatever data can be cobbled together and then addressing whatever happens to rise to the top; OR
• acknowledging that available data are insufficient to effectively prioritize among chemicals, and therefore first collecting a good baseline of data, and then using that to prioritize.

In addition to relying on incomplete and insufficient hazard data for the great majority of chemicals and employing questionable, ill-informed assumptions about use and exposure (that sounds a lot like EPA’s ChAMP initiative before it was suspended), the former approach risks focusing only on those chemicals about which we already know enough to know they’re problems, while ignoring the rest – the proverbial looking for car keys lost somewhere in the parking lot at night only under the streetlights because the light is better there. 

That approach also fails to allow us to identify with confidence what could be safer chemicals and avoid so-called “regrettable substitutions,” because even if limited available data don’t show a problem, what we don’t know about such chemicals could still hurt us.

In earlier posts (here and here), I discussed a notice EPA had received in July of 2008 from BASF reporting toxic effects at very low doses of a carbon nanotube (CNT) observed in a 90-day rat inhalation study.  In that notice, BASF had declared the specific identity of its CNT to be confidential business information, hence denying that information to the public.  Now, in a setting more to its liking, it appears the company has decided to reveal the identity after all.

The original notice was submitted by BASF as required under Section 8(e) of the Toxic Substances Control Act (TSCA).  That provision requires a company that makes a chemical to notify EPA within 30 days if it obtains new information that “reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to health or the environment.”

Identity hidden

BASF complied – but in doing so, claimed the identity of the nanomaterial in question to be confidential business information (CBI), requesting that it be identified only generically as “Carbon Nano Tube.”  No way, therefore, for the public to tell whether it was single- or multi-walled or much of anything else about its actual identity or structure.

Identity revealed

Now, just last week BASF published a paper in the journal Toxicological Sciences that is almost certainly based on the same study.  (The abstract is publicly available, but the full paper requires a subscription.)  All of the details – the doses, number and type of animals, exposure conditions, and observed effects – match those reported in the Section 8(e) notice.

But in this setting BASF chose to fully describe the identity of its CNT, disclosing for the first time that it is multi-walled and describing other structural features in detail.

As I reported before, the study found this nanomaterial to be highly toxic, causing lung inflammation and granulomas at doses 200-fold lower than the high-concern level identified under EPA and international standards.  That makes it at least an order of magnitude more toxic than crystalline silica and – as BASF itself describes in the published paper – also at least 10-fold more toxic than nano-structured carbon black.

A major effort has been mounted in the nanotechnology community to demand that researchers fully identify and characterize their nanomaterials when publishing papers in the peer-reviewed literature, and that journals accept only such papers.  See, for example, the “Minimum Information for Nanomaterial Characterization Initiative, or Characterization Matters for short.

That likely explains why BASF provides such a full identification and characterization in its recent paper.

So why, then, did BASF claim the identity of its nanomaterial to be confidential when submitting the same study to EPA?

The answer is simple:  Because it could.

Right-to-know under TSCA:  Health impacts - yes; chemical identity - no

EPA routinely posts notices it receives under Section 8(e) in which the chemical identity, and often the submitter’s identity, are claimed confidential and hence not publicly disclosed.  It’s hard to imagine a less useful – and more frustrating – public disclosure system:  Some chemical is found to cause serious health or environmental effects, serious enough for TSCA to require immediate submission to EPA.  As a member of the public, you get to see just how bad the effects are – but are left to guess just what chemical causes the effects!

The ultimate insult is that, under TSCA, EPA actually should be prohibiting companies from declaring confidential the identity of a chemical that is the subject of a submitted health and safety study. 

Consider:

• TSCA itself does not preclude – and hence requires – disclosure of health and safety studies; see TSCA Section 2613(b).
• EPA regulations clearly define chemical identity to be an integral part of a health and safety study; see the definition of a health and safety study at 40 CFR §716.3 and §720.3(k).
• EPA regulations then do provide certain conditions under which a company may assert a confidentiality claim for the identity of a new chemical even when associated with a health and safety study. However, the regulations further state that EPA will deny such a claim unless the claimant demonstrates that “the specific chemical identity is not necessary to interpret a health and safety study.” See 40 CFR §720.90(c)(3).

How could anyone reasonably argue that knowing the specific identity of a carbon nanotube is not critical to interpreting a health and safety study?  Given, for example, recent findings that multi-walled CNTs of certain lengths, but apparently not single-walled CNTs of any length, behave like asbestos, knowing a nanomaterial’s identity is central to interpreting health and safety data.

Yet EPA has taken no apparent action to preclude such claims for nanomaterials.  Indeed, four of the eight TSCA Section 8(e) notices EPA has received for nanomaterials that I discussed in my earlier post had masked the materials’ identities.

One possible reason why EPA hasn’t acted?  Lack of EPA resources to review and challenge the thousands of CBI claims asserted annually by industry. 

Given the ease with which TSCA allows CBI claims to be asserted, there is every reason to expect that many such claims wouldn’t pass muster if actually examined.  A 1992 EPA study identified extensive problems with respect to the extent of inappropriate CBI claims; see pp. 32-33 of this 2005 report from the Government Accountability Office.

EPA can, of course, challenge CBI designations on a case-by-case basis, but it rarely does so because of the extensive resources required.  In the absence of a successful challenge by EPA, the information must be held as confidential.

This is a nano problem that requires a macro solution:  Fundamental reform of the CBI provisions of TSCA.  That’s one of ten essential elements in TSCA reform that I discuss at length in this recent paper I published in Environmental Law Reporter.

It probably goes without saying that EDF welcomes EPA’s decision to suspend the development and posting of risk-based prioritizations under its Chemical Assessment and Mangement Program (ChAMP).  EDF has been arguing (see our earlier posts) that ChAMP’s “rush to risk” has taken EPA badly off-track.  But we have also identified many useful things that EPA’s existing chemicals program can and should be doing with the data it obtained through the HPV Challenge (whether called ChAMP or not) .

We look forward to working with EPA to craft a new approach, grounded in a return to developing scientifically defensible hazard, not risk, characterizations and transparently identifying and addressing data gaps and data quality problems.