When the chemical industry talks about prioritization – a central question in the debate over TSCA reform – more often than not it quickly reduces the question down to the argument that we should focus only on those chemicals, however hazardous or untested they may be, to which we know people are exposed.  In a perfect world, that might suffice.  But, as this post will explore, the world of exposure assessment is anything but perfect. 

While both hazard and exposure are clearly relevant in determining chemical risks, there are critical differences between our ability to assess hazard and exposure that have implications for the development and application of chemicals policies.  And real-world experience in chemical assessment programs that have attempted to rely on exposure information to prioritize chemicals also offers lessons for exposure assessment.

Critical differences between assessing hazard and exposure

Approaches that seek to rely on exposure to prioritize or assess chemicals need to acknowledge and account for a number of critical differences between the nature of hazard and exposure information and their relative extent of availability.  Certain characteristics of exposure information pose serious challenges to sound decision-making.  Here are several reasons why.

1.  Hazard is largely inherent to a chemical and (aside from degradation or metabolism) doesn’t fundamentally change over space or time, whereas any exposure information necessarily represents only a “snapshot” in both space and time.

A chemical’s hazard is an intrinsic property, one that is directly related to the chemical's composition.  While manifestation of a hazard can of course vary by route of exposure, it otherwise exists largely independent of how the chemical is used, where or how it enters the environment, or other factors that vary with time and place.  Hazard data are therefore relevant and needed regardless of how the chemical is used.  That is, such data are useful in understanding any actual or potential use or release of a chemical – and in deciding what kind of exposure-reducing efforts may need to be taken.

Just the opposite is true for exposure, which can change dramatically depending on how a chemical is produced, used, transported and discarded or released.  The consequences of exposure depend on who or what might be exposed, and the level, frequency and duration of the exposure. 

Conditions that determine exposure can and often do differ enormously for every setting and point in time that a chemical is present.  Basic physiological differences (including those associated with age and life stage) as well as cultural factors (e.g., extent of fish consumption) and activity patterns also amplify the variability in exposure to a chemical.  And even if a “snapshot” of current exposure is able to be assembled, the next new use or activity leading to a release alters the exposure picture.

The highly variable nature of exposure poses a major challenge to exposure (and risk) assessment:  It means that exposure assessment must be an ongoing activity, with the scope and frequency of its measurement sufficient to characterize the variation (spatial and temporal) in, as well as magnitude of, exposure. 

That's but one reason why exposure assessment is often called the "weakest link" in risk assessment.

2.  Mechanisms for generating and collecting exposure information are undeveloped relative to those for hazard information.

An extensive body of methods developed through international consensus specifies how to test a chemical for most hazardous properties.  And while new hazard concerns and new test methods emerge over time and must be incorporated, the infrastructure for doing so is largely in place:  detailed government-sanctioned procedures, guidelines, criteria and standards have been specified for conducting hazard tests, for assuring the quality and reliability of the results, and for determining whether the results constitute evidence of a particular hazard.  Moreover, these measures allow that results are reproducible and can be independently verified.

In contrast, virtually none of these mechanisms are in place or established to assure that exposure information is complete and accurate.  Debates over what constitutes adequate exposure assessment and how to address the “moving target” nature of such information are far from resolved.  Government-sanctioned procedures for generating, evaluating the adequacy of and interpreting exposure data have yet to be developed or validated, including testing and measurement standards, guidance, methods and tools.

Use and exposure information is rarely systematically collected and even less often made public in any useful form.  For the first time, beginning in 2006, the Environmental Protection Agency (EPA) began to require the reporting of basic information relevant to understanding uses of and exposure to chemicals.  But that program is fraught with limitations, as I've described in detail in earlier posts here and here.

Because of these and other factors, estimates of chemical exposures typically depend on severely limited sources of information.  In many instances, little or no information is publicly available on how chemicals are manufactured, processed, used, or discarded; the numbers of workers and consumers exposed; quantities released to the environment; how chemicals are distributed and transformed in the environment; and other parameters necessary for estimating exposures. 

3.  Assumptions and modeling used to characterize exposure are notoriously inaccurate.

As a result of the information constraints just discussed, exposure-driven prioritization initiatives and exposure modeling exercises may well utilize incorrect exposure assumptions.  Biomonitoring has revealed such instances by “ground-truthing” exposure assumptions – providing objective, incontrovertible evidence of the extent to which chemicals end up in people.  Recent biomonitoring data on both phthalates and poly-brominated diphenyl ethers amply illustrate this point. 

Phthalates are very widely used in products ranging from plastics to cosmetics and other personal care products.  They exhibit a range of toxicity, including to the liver, kidney, and male reproductive system.  The first CDC National Report demonstrated surprisingly high levels of di-butyl phthalate (DBP) and di-ethyl phthalate (DEP) in U.S. residents in general, and for DBP, in women of child-bearing age in particular (see the first two letters here).  Indeed, these data demonstrated high-end levels of DBP that were an order of magnitude higher than a prior estimate that had been developed based on industry-provided use data and expert judgment.

Polybrominated diphenyl ethers (PBDEs) are widely used flame retardants.  Different species of PBDEs are used in products ranging from plastics (such as computer cases) to upholstery foam.  Toxicological studies indicate that they can disrupt thyroid metabolism and may have effects on other organs, including the liver.  Because PBDEs are not very volatile or water soluble, they were assumed to more or less stay in place in products, and were not believed to have a high potential for exposure.  However, biomonitoring studies from around the world have demonstrated that levels of PBDEs in peoples’ bodies have been dramatically increasing over the past two decades, with the highest levels currently reported in the United States; see, for example, this paper).

4.  Differential access to both exposure data and the means to generate them severely limit the “reproducibility” of such data.

In addition to the variability and absence of agreed-upon procedures noted above, other factors limit “reproducibility,” that is, the ability to readily and independently measure or verify exposure data.  Most exposure data and the means to generate them reside virtually exclusively with industry.  It simply must be acknowledged that industry has a strong interest in maintaining that exposure to its chemicals is low, so the ability to independently measure and verify exposure data is critical.  Yet physical access to many exposure “settings” (e.g., workplaces) is very limited and infrequent at best, even for government officials. 

Broader access to exposure-relevant information is even more restricted:  Wide latitude is typically provided to claim chemical use and exposure information as CBI, preventing even its review outside government; this situation is often in contrast to that applying to hazard data, which is more likely to be deemed ineligible from designation as CBI. 

Finally, even chemical manufacturers have incomplete access to and information on their customers and how their chemicals are used.  Intermediaries (vendors, brokers, distributors) are a formidable information flow bottleneck, as is the often-proprietary nature of information concerning downstream use and competition among suppliers.  These factors serve to impede information-sharing even within supply chains, which in turn affects the extent and accuracy of exposure-relevant information that any one entity in a supply chain can provide if asked or required to do so; see this paper and Modules 1 and 2 of this report for more discussion of these limitations.

Conclusion

For all of these reasons, we cannot continue to rely on assumptions about chemical exposure or on the industry-supplied or otherwise-limited exposure information that is currently available.   That is simply too uncertain and unreliable a basis on which to set aside hazardous or untested chemicals as low-priority, or to decide for which chemicals hazard data should be developed. 

Of course, where affirmative evidence indicates exposure to a chemical is occurring, for example as revealed through biomonitoring, this should clearly suffice to prioritize such a chemical at a minimum for further testing, assessment or control.  But the converse cannot be said:  that in the absence of reliable information about exposure we can simply drop a chemical from further consideration.

_____

There is actually considerable real-world experience that documents the adverse consequences of an over-reliance on exposure to prioritize chemicals.  For more detail, see our analyses of:

• EPA's recently replaced ChAMP Initiative;
• Canada's Chemical Categorization; and
• the Existing Chemicals Program of the Organization for Economic Cooperation and Development (OECD) – see the paper included as pages 109-114 of this OECD report, which I wrote several years ago and from which this post is derived.

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 a previous post, I argued that the European Union's REACH Regulation for chemicals goes a long way to address the regulatory needs for nanomaterials – despite the fact that REACH never mentions nano and was not developed with nano in mind.  I also noted, however, that REACH will clearly need more than fine-tuning to ensure adequate nano oversight.  Apparently at least some in the European Parliament agree. 

Just this week, the Environment Committee of the European Parliament approved a report calling for a nano-specific review and updating of REACH.  (See the amendments that were adopted this week to the January draft report.) 

Most notable is the report's call to extend the "no data, no market" cornerstone of REACH to nanomaterials – meaning that nanomaterials could not enter or remain on the market absent provision by their producers of at least basic information to assess their safety.

The report also calls for the development under REACH of nano-specific definitions, testing and assessment protocols, and data requirements.  And it argues for labeling of products containing nanomaterials.

The report comes not long after the European Commission issued its own recommendations for how to address nanomaterials under REACH.  While the Commission noted numerous challenges – most notably, the dearth of safety data and the difficulty of applying current risk assessment methodology – it argued that REACH addresses the potential risks of nanomaterials "in principle."  Looking at the same basic problems, the Parliament report reaches the opposite conclusion:  that REACH cannot in its current form adequately address nanomaterials.

Changes to REACH that the Parliament committee recommends include requiring:

• a simplified registration for nanomaterials manufactured or imported (with a threshold based on e.g. surface activity instead of tonnage), providing core data on physico-chemical properties as well as toxicological and ecotoxicological effects,
• a chemical safety report with exposure assessment for all registered nanomaterials, irrespective of hazard identification, and
• notification for all nanomaterials placed on the market on their own, in preparations or in articles irrespective of tonnage and concentration thresholds.

See these articles from Euractiv, ENDSEurope and ChemicalWatch for more detail and document links (the last two require subscriptions).

A growing number of observers of nanotechnology policy in the U.S. – at least those outside the U.S. government! – recognize that the Toxic Substances Control Act (TSCA) is poorly suited both to spur the generation of sufficient information about nanomaterials, and to ensure that information indicating potential risks will trigger meaningful action.  So why not just tweak TSCA to make it work better for nano?

In earlier posts, I have explored in some detail the challenges that arise in trying to apply TSCA to nanomaterials.  Others have done so as well:  the Environmental Law Institute, NRDC, the Project on Emerging Nanotechnologies, and the American Bar Association, to name a few.

On July 23, former EPA official Terry Davies released an excellent report prepared for the Project on Emerging Nanotechnologies, titled Nanotech: A Regulatory Blueprint for the Next Administration.  In it, he usefully proposes a number of surgical strikes to fix key provisions of TSCA (see his Appendix C). 

What is notable about these fixes is that all but one would affect and apply to all chemicals under TSCA, not just nanomaterials.  That leads me to ask:  Do we need a nano-fix to TSCA – or do we simply need to fix TSCA?  I will argue here that the latter approach is where we need to start, for two main reasons.

We should avoid inadvertently setting a double standard

First, fixing TSCA for all chemicals avoids setting up a double standard, whereby nanomaterials would be subjected to greater scrutiny merely because they're nanomaterials, which amounts to an implicit assumption that, a priori, they're more dangerous or less well-studied than conventional chemicals. 

One example:  I've always been bothered by the call from some groups to selectively require the labeling of products containing nanomaterials.  I share their motivation – to flag the fact that a product contains ingredients that have not been tested sufficiently or shown to be safe.  But using those criteria, many if not most product ingredients warrant labeling!  (I personally support the growing calls for companies to disclose the identity of all of the ingredients in their products, nano or not.)

Fixing TSCA for all chemicals will give us most of what we need for nanomaterials

The second reason I think we need to focus on a broad fix to TSCA is that making TSCA "safe" for all chemicals will get us 90% of the way to where we need to go to ensure the safety of nanomaterials.  How would an improved U.S. chemicals policy – in and of itself – help with nanomaterials?

Consider the European Union's sweeping new REACH Regulation, which was developed without nanomaterials in mind at all.  I absolutely agree there is a need to further tailor REACH to ensure it is adequate for nanomaterials, as most recently called for by the European Trade Union Confederation (ETUC) and the subject of a current European Commission consultation.  But – even if REACH were left untouched – it will cover nanomaterials far better than TSCA ever could.  Here are a few reasons:

First, EU officials are taking the same position that I blasted EPA for taking: maintaining that nano forms of substances already in commerce are existing, not new, substances.  Yet I am far less concerned about such a decision in the context of REACH.  That's because REACH, unlike TSCA, largely eliminates the distinction between new and existing chemicals – it requires that both types of chemicals be registered, tested, their uses identified and assessed.  None of that will happen for nanomaterials deemed existing substances under TSCA, so EPA's decision has far more dire implications. 

Second, REACH obligates a company to update its registration, datasets and assessments whenever the composition, use or knowledge of the risks of a chemical change – changes that would very likely be triggered by introduction of a new nano form of an existing chemical.  This provision is essentially an automatic Significant New Use Rule (SNUR), in EPA jargon – except that it applies to all chemicals all of the time.  In contrast, under TSCA, EPA would have to first determine that the nano form of a chemical represents a truly "new" use.  If not, EPA could not issue a SNUR because, by definition, the use would not be "new"!  Then EPA would have to go through a full notice-and-comment rulemaking process.  Even then, only notification would be required, not development of new data or a robust assessment.

Finally, the threshold triggering registration requirements under REACH is set at one metric ton (2,200 pounds) of production or import per company per year.  That threshold is far lower than the various exemption and threshold levels that apply under TSCA (discussed in parts 2, 3 and 4 of my earlier series of posts).  These range from:

• 22,000 pounds per year to qualify for a low-volume exemption from new chemical notification requirements, to
• 25,000 pounds per year for TSCA Inventory Update Reporting, to
• 100,000 pounds per year that defines an exempted "small manufacturer," to
• a whopping 1,000,000 pounds per year, which is the "substantial production" threshold that is but one of several conditions that must be met for a chemical to be subject to mandatory testing.

I share the concerns of ETUC and others that some nanomaterials will be missed by the one-metric ton threshold for REACH registration, and that data requirements for low-volume substances under REACH are insufficient for nanomaterials.  But even before REACH is more appropriately fitted to nanomaterials (something the EU appears intent to do), it is a vast improvement over the status quo in the U.S.

Bottom line:  We need to reform TSCA for all chemicals, keeping nanomaterials squarely in mind as we do so.  A good start:  The Kid-Safe Chemicals Act of 2008, identical versions of which were introduced in May in both the U.S. House of Representatives by Representatives Solis and Waxman (H.R. 6100) and in the U.S. Senate by Senators Lautenberg, Boxer, Clinton, Kerry, Menendez and Whitehouse (S. 3040).