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

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

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

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

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

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

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

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

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

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

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  It reads:  "The Chemical Assessment and Management Program (ChAMP) has been superseded by the comprehensive approach to enhancing the Agency’s current chemicals management program announced by Administrator Lisa Jackson on September 29, 2009."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.

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

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

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

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

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

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

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

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

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

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

Some context

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

     AND

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Conclusion

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

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

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

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

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

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

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

Doesn't that matter?

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

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

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

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

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.

Many of the screening-level hazard data being collected and analyzed under ChAMP that pertain to human health are derived from traditional laboratory animal studies.  The National Academy of Sciences (NAS) recently offered a "new paradigm for toxicity testing" in its 2008 report Toxicity Testing in the 21^st Century: a Vision and a Strategy.  Can ChAMP hazard data be used to facilitate the development of new testing strategies? 

First, more about the new toxicity testing paradigm envisioned by NAS:  Instead of exposing whole animals to chemicals to examine their effects, which takes a lot of time, costs a lot of money and may not always be a good model for how humans can be affected, might we use human cells or tissues (e.g., liver, kidney) to determine how chemicals act biologically?  Where chemicals interact with the cells and alter (e.g., inhibit or over-stimulate) critical biochemical pathways, such perturbations may well represent early events or signals that can eventually lead to an adverse effect.

ToxCast

There is an EPA initiative called ToxCast that is exploring the use of high-throughput screening (HTS) test methods to predict hazard, characterize so-called "toxicity pathways," and prioritize among large numbers of chemicals.  According to the ToxCast website:  "In its first phase, ToxCast^TM is profiling over 300 well-characterized chemicals (primarily pesticides) in over 400 HTS endpoints."  The endpoints include tests that measure DNA and protein synthesis activities, multi-cell interactions and developmental assays in zebrafish.  These methods are among those being developed to realize the vision described in NAS' report. 

The results of the first set of ToxCast assays are still being validated – meaning that they are being analyzed to determine how similar the outcomes are to those of standard laboratory animal tests.  This is one important step in determining whether the ToxCast testing array can actually substitute for some standard laboratory animal testing.

But we would suggest there are already two timely and useful applications of the data that ToxCast can generate in aiding EPA's effort to evaluate hazard information under ChAMP.

Supporting alternatives analysis

The first idea would be to compare the relative capacity for chemicals in the same functional use class (e.g., solvent, chelator, fragrance) or chemical category (e.g., fatty nitrogen derived cationics) to effect biological changes detectable by the ToxCast HTS methods.  In doing so, we would be testing the hypothesis that chemicals that demonstrate less capacity for effecting changes in the HTS tests are more likely to have lower hazard profiles. 

As we described in a previous post, alternatives analysis is a tool that compares hazard assessments of chemicals that are used to perform similar functions, in order to identify those that have a lower hazard profile.  Using ChAMP hazard data and characterizations for this purpose would start by comparing the results of laboratory animal study data.  By running some of the ChAMP chemicals through the ToxCast HTS system and comparing the results of the HTS tests with the ChAMP hazard data, EPA could both support the identification of safer chemicals and test how well the HTS methods predict in vivo effects – a true win-win.

Validating (or refuting) chemical categories

About 80% of the chemicals sponsored under EPA's HPV Challenge Program are members of proposed chemical categories.  Within these categories, sponsors and EPA propose that hazard data for tested category members can be "read across" to untested members, as an alternative to direct testing of each chemical.

Grouping chemicals into a category starts with an hypothesis that distinct chemicals that show similarity or regularity in their physical-chemical properties and chemical structures actually possess similar or predictably regular patterns of biological activity.  Establishing a valid category requires that the hypothesis actually be demonstrated to be true, once the available data on physical-chemical properties, environmental fate and toxicity/ecotoxicity for the proposed category members are assembled.  Then, some degree of read-across among category members can be justified.

However, as our comments on the several ChAMP assessments we've analyzed in recent posts make clear (see here, here and here), both industry sponsors under the Challenge and EPA under ChAMP appear frequently to be over-relying on category approaches, lumping together chemicals that are insufficiently related or similar to warrant read-across.

HTS data could play a very useful role, therefore, in helping either to demonstrate – or to negate – an hypothesis that members of a proposed category of chemicals actually exhibit similar biological activity.  If category members in fact exhibit similar or regular patterns of activity across an array of different cellular and subcellular assays, then the case for grouping them for purposes of read-across would be much stronger than a case based solely on similarity or regularity in their physical-chemical properties and chemical structures.  Alternatively, if HTS data do not show such patterns, the category should not be utilized and either it should be broken up into smaller groupings or its putative members should be tested individually.

Both of these uses of ChAMP hazard data and characterizations side-by-side with HTS data developed under ToxCast – in supporting alternatives analysis and in category validation – would offer the added benefit of helping to advance the transition to the "new paradigm for toxicity testing."

This new post serves as a response to Charlie Auer's most recent comment responding to our critique of ChAMP.  (To see the whole exchange, start here, then go here, here and here.)  So far, this exchange has focused mainly on our disagreement over whether or not EPA is somehow required to do risk assessments under ChAMP.  At some point, I hope Charlie and others will engage on the substance of our critique – the serious concerns we've raised about the quality and validity of the ChAMP assessments.
 

Risk-based at all costs?

In Charlie's latest comment, his main interest seems to be to lock in EPA's current approach under ChAMP.  He steadfastly maintains that EPA now has no choice but to turn out risk decisions for HPV chemicals under ChAMP, given its 2007 commitment under the Security and Prosperity Partnership (SPP) signed by President Bush. 

For all the reasons I've stated earlier, I strongly dispute that conclusion.  Indeed, it is striking how the chemical section of the SPP agreement – including the very language Charlie cites ("the three countries [are] to enhance appropriate coordination in areas including testing, research, information gathering, assessment, and risk management actions") – seems to go out of its way to avoid linking the words "risk" and "assessment."  That term never appears.

I don't dispute, as Charlie says, that "US and Canadian [regulatory] actions are risk-based."  Indeed, EDF supports the view that, in most cases, chemical regulatory actions ought to be risk-based, or certainly ought to take into account both hazard and exposure.

Now, if ChAMP were actually proposing any actions to mitigate risk, e.g., to restrict production or use of any HPV chemicals through regulation, Charlie's argument might be germane.  But as we've noted, ChAMP's not doing that, even for the few chemicals it has designated to be of high risk and high priority.

So the fact that EPA will only consider regulating a chemical based on risk in no way requires that EPA must do risk assessments under ChAMP – regardless of whether the data available to the agency are sufficient to support such assessments. 

Indeed, the SPP agreement was signed well before the use and exposure information EPA has collected under the Inventory Update Rule (IUR) were made public and its major deficiencies were realized.  I disagree with Charlie that the mere fact that EPA collected such data compels it to use them regardless of their adequacy.

As we noted in our last two posts on ChAMP, in cases where hazard concerns warrant action, there are lots of steps the agency could be taking to manage or reduce potential risks – without having to wait for the emergence of use and exposure data of sufficient quality to carry out a risk assessment.  EPA itself has taken such actions occasionally, for example in launching the 2010/2015 PFOA Stewardship Program.

Sacrificing the public's chemical right-to-know on the altar of risk

Add to this the fact that EPA's insistence on pursuing the "rush to risk" under ChAMP is delaying the public's right-to-know about the hazards of HPV chemicals, and I have to strongly question the wisdom of EPA's devoting most of its limited chemical program resources to doggedly pursuing this course.

I also am disturbed by Charlie's conclusion that his and EPA's interpretation of the SPP commitments "are superior to and overtake informal EPA commitments made to pursue the NPPTAC recommendation."   Recall that NPPTAC recommended, and EPA agreed, that the agency issue hazard characterizations and identify remaining data gaps for some 1,200 HPV chemicals by the end of 2009, which it's nowhere closing to meeting.

What NPPTAC called for did not come out of thin air:  It reflected the core purpose of the HPV Challenge, which was in turn the cornerstone of EPA's much-touted chemical right-to-know initiative:  It would be tragic indeed if EPA chooses to negate its public right-to-know commitments by saying they've been trumped by a political decision made by the last administration.

Under ChAMP, the minimum data set has become wholly optional

Charlie cites OECD guidance calling for integrating exposure considerations into assessment activities.  We have no quarrel with that, as long as the exposure information is sufficient; but as our examples amply demonstrate, that is not the case with the IUR data.

Nor does consideration of exposure in any way obviate the need for a complete Screening Information Data Set (SIDS).  International experts convened by the OECD, including from the U.S., devised the SIDS to be the minimum amount of hazard data needed on which to base a screening-level assessment.  EPA itself has repeatedly acknowledged this fact; see, for example, p. 15 of this EPA report on the HPV Challenge.  Outside of some very limited derogations (e.g., for closed-system intermediates) from certain endpoints, full SIDS data sets are to be provided – wholly independent of exposure considerations.

The need for such complete screening data sets is all the more critical given that EPA is intent on making low-priority designations that preclude, for the foreseeable future, any further data development.  Yet under ChAMP, EPA is routinely making such designations for chemicals that lack the basic SIDS data set.

Acknowledging the limitations

It's very helpful and refreshing that Charlie, as former head of EPA's toxics office, acknowledges that EPA faces high hurdles in trying to mandate testing through issuing TSCA test rules.  That's what many of us have been saying for years, and it's among the strongest arguments for why we so badly need fundamental reform of TSCA.

But even without issuing test rules, EPA could help this situation enormously by forthrightly and transparently identifying and acknowledging the significant gaps and deficiencies in the quality of data remaining for HPV chemicals sponsored under the Challenge.  Instead, Charlie and EPA are papering over the problems through their rhetorical sleight-of-hand of substituting "data gap" with "data need."

Interestingly, Charlie argues that instead of our pressing EPA to pursue test rules, we should just wait for the European Union's REACH Regulation to provide most of the data we need.  As tempting as that sounds, some notes of caution are warranted.  First, for all tests involving laboratory animals, REACH requires only that test proposals, not test results, be submitted at the time of registration.  So even in the best of circumstances, much of the data we need for HPV chemicals likely won't be available for some time after the registration deadline of December 2010.  Second, as I've discussed at length elsewhere, it remains to be seen just how much testing will be required under REACH.

I also appreciate that Charlie has acknowledged the need for major changes in EPA's Inventory Update Rule, given the hugely disappointing results of the latest data collection effort.  I agree with many of his thoughtful proposals for needed fixes.  I'd add another:  Require annual reporting of production and use data.  The current reporting requirement is limited to only a single year once every five years – yielding a highly distorted view of actual chemical production (for more on this, see p. 38 of this paper).

But given the rate at which ChAMP is churning out risk decisions using the current IUR data, I must heartily disagree with his notion that we should set aside concerns about those data and only focus on making improvements for the next IUR collection cycle.  That collection won't even begin until 2011, and if this last round is any guide, data won't be released until 2013 or 2014.  On EPA's current trajectory, ChAMP will have already cranked through all of the HPV chemicals by then.

Bottom line:  ChAMP embodies a blatant double standard

Charlie's responses to date (and the lack of any response from current EPA staff) suggest an unwillingness to engage on the substance of our critique of EPA's ChAMP assessments – its systematic reliance on incomplete and/or poor-quality data, a problem further compounded not only by EPA's refusal to reject such data and identify them as gaps, but its use of such flawed data as a basis to claim no or low toxicity, and thence to draw unwarranted low-risk conclusions about hundreds of HPV chemicals.

All of this brings me to the crux of the problem:  Under ChAMP, EPA appears more than willing to rely on limited hazard, use and exposure data to effectively exonerate scores of chemicals, by relegating them to the low-priority dustbin.  Yet in the few cases where EPA has had to conclude, using the same quality of data, that a chemical poses a high level of concern, no action to control such chemicals is even proposed.

Charlie's characterization of such high-priority chemicals as being only "putative positives" is quite telling.  It's a clear illustration of just how high a bar EPA has set to initiate action to reduce use of or exposure to (or even mandate testing of) a problematic chemical – in contrast to the remarkably low bar it must clear to dismiss a chemical altogether.

That's a double standard I just can't abide.

[Earlier posts in this series can be found here and here.]

Over the past decade, the Environmental Protection Agency (EPA) has pursued a voluntary program, the High Production Volume (HPV) Chemical Challenge, as a means to fill the enormous gaps in publicly available data on the hazards of the most widely used chemicals in the U.S. Using the Challenge data, EPA has recently begun assessing HPV chemicals under its Chemical Assessment and Management Program (ChAMP). But is ChAMP up to the job?

While the HPV Challenge has fallen well short of its promise to ensure timely development and public access to high-quality hazard data on HPV chemicals, it has provided EPA with a greater ability to screen such chemicals for potential hazards than was previously possible. That's where ChAMP enters.

ChAMP grew out of an overly-ambitious U.S. commitment made in August 2007 under the North American Security and Prosperity Partnership (SPP). ChAMP commits EPA to assess about 2,750 HPV chemicals as well as about 4,000 medium production volume (MPV) chemicals by 2012.

Last year, EDF provided to EPA a critique of ChAMP, raising numerous serious concerns about the direction it was taking. Among them was a lack of transparency about the extent of data and methodology it was using in its assessments.

The good news is that EPA recently issued several documents that significantly enhance the transparency of its assessment process.

The bad news, unfortunately, is that these documents make clear that EPA is intent on pursuing – now at breakneck speed – a scientifically flawed approach to assessing HPV chemicals under ChAMP.

In this and subsequent posts, we will update and expand our critique and provide a series of specific examples that illustrate the unsupportable risk decisions EPA is making under ChAMP.

What does EPA do under ChAMP?

To provide a good understanding of ChAMP, I need to walk through some background and introduce some arcane terminology:

Hazard characterizations

EPA began issuing so-called "hazard characterizations," or HCs, starting in September 2007, and has now posted HCs covering several hundred HPV chemicals. This step was called for by a federal advisory committee (on which EDF sat) that EPA convened to assist it in deciding what to do with the HPV Challenge hazard data it was compiling. As the committee requested, EPA agreed to do the following for each HPV chemical:

• conduct an objective evaluation of the quality and completeness of the data set in the HPV Challenge Program submission;
• independently assess the submitted data for each endpoint to determine the level of hazard of the substance; and
• develop and make public a hazard characterization of the substance(s).

As EPA's HCs have been made public, serious concerns have emerged over both the quality and completeness of data for many HPV chemicals. EPA's own accounting indicates that data gaps remain in about 30% of the supposedly final HPV submissions it has reviewed, and our analysis has identified even more.

The very foundation of the HPV Challenge was that companies were to provide a hazard data set specified through an international consensus process as the minimum amount of data needed to conduct even a screening-level hazard assessment for a chemical. The fact that serious data gaps remain calls into question, therefore, EPA's ability to characterize hazards of these chemicals even at a screening level.

So how has EPA responded to these data gaps?

• To date, EPA has not initiated any regulatory action to require that these gaps be filled, despite a promise to do so when it launched the HPV Challenge.
• EPA has frequently obscured or glossed over the extent of missing data, although more recent postings have been more transparent in this regard.
• In the few high-priority cases it has identified (more on this below), EPA's only response to data gaps has been to "encourage companies to provide available information on a voluntary and non-confidential basis."
• Moreover, even for chemicals with data gaps, EPA is routinely characterizing almost all of them as of low or moderate hazard – an unsupportable conclusion on policy and scientific grounds.

It would be one thing for EPA to identify as high-hazard those chemicals where, despite the data gaps, available data demonstrate high toxicity. It's quite another for EPA to effectively exonerate chemicals as low-hazard when not even a bare-minimum data set is available for them.

Risk-Based Prioritizations

Although not required by the SPP agreement or called for by its advisory committee, EPA has on its own expanded its commitment to assess the risk, not just the hazard, of all HPV chemicals by 2012.

As will be explained below and in subsequent posts, this rash decision further strains the credibility of ChAMP. EPA is quite literally rushing to crank out what it calls "risk-based prioritizations," or RBPs, for hundreds of HPV chemicals. These documents rank the chemicals as being of low-, medium- or high-priority from a risk perspective. But once again, EPA is basing its rankings on data that fall far short of what would be needed to do a credible screening-level assessment of risk.

To assess risk, one needs to have information about the use of and exposure to a chemical, as well about its hazards. Remember the old equation:

hazard x exposure = risk

EPA had high hopes – I would say unrealistically high – that it would get good use and exposure information through something called the Inventory Update Rule, or IUR. Starting in 2006, manufacturers of HPV chemicals were required to report certain information about the downstream processing and uses of their chemicals, which is relevant to ascertaining the potential for exposure of the public, workers, consumers and children, as well as the environment (see Section VI of this paper for details).

EPA's idea was that it could combine the HPV Challenge hazard data with the 2006 IUR processing and use data, and draw conclusions about how risky HPV chemicals are.

Reliance on poor chemical use information

I've already summarized some of the many limitations of EPA's hazard data. The situation with the quality and completeness of the IUR processing and use information is far worse.

Consider the limitations to the IUR reporting program itself:

• IUR reporting is limited to only a single year in each 5-year reporting cycle, so currently EPA is relying only on data reported for 2005.
• Only manufacturers are required to report under the IUR, not downstream processors, distributors or users of the chemicals.
• Manufacturers can claim any and all of the information they submit to be confidential business information (CBI); while EPA can see the CBI, the public cannot. According to EPA, about a third of the processing and use data were claimed to be CBI; see Exhibit 3 in this report.
• When EPA developed the reporting requirements, it required manufacturers to report processing and use information only to the extent it was readily obtainable. So how often did the companies maintain such data were not readily obtainable? Often enough that EPA actually coined a new acronym – NRO – for such situations. EPA's summary IUR report indicates that manufacturers made NRO claims:
  • about 10-15% of the time, for the processing data elements (e.g., type of process applied to the chemical or in which it is used, industrial function of the chemical),
  • about 20% of the time, for information about the commercial or consumer product categories in which their chemicals were used, and
  • a whopping 40% of the time, when indicating whether the chemical was known to be used in products intended for use by children.

It is widely acknowledged that manufacturers are often in a very poor position to know much about the downstream processing and use of the chemicals they produce. See, for example, here and here. Even chemical manufacturers agree: the Society of Chemical Manufacturers and Affiliates (SOCMA), a chemical industry trade association, cited this concern when it filed comments vigorously opposing EPA's addition of processing and use information to the IUR in the first place. No doubt that helped them to get what has turned about to be a huge loophole in the reporting requirements.

So it's not surprising that EPA received only limited data on HPV chemicals through its IUR reporting. The real question is why does EPA think such incomplete data derived solely from chemical manufacturers is sufficient to draw definitive exposure and risk conclusions about HPV chemicals?

Here again, it would be defensible for EPA to use incomplete use data to identify chemicals posing a high exposure potential, if the available data so demonstrate. It's quite another for EPA to set aside chemicals as low-exposure (and hence low-risk) based on such sketchy data.

What does it take to get flagged under ChAMP as a chemical of concern?

So we have established that EPA is using often-incomplete data to rank HPV chemicals as:

• high/moderate/low hazard and
• high/medium/low exposure,

and then it combines these to rank the chemicals as high/medium/low risk.

One might reasonably assume that – given the decidedly mixed quality and completeness of the data EPA is using – it would err on the side of caution so as not to prematurely eliminate potentially risky chemicals. After all, this whole exercise is a "screening" process, designed to flag chemicals for further scrutiny: Including "false positives" – chemicals initially thought to be of concern that turn out not to be – is of far less concern than excluding "false negatives" – chemicals that actually are of concern. That's because any false positives will be detected later upon further examination, whereas false negatives set aside won't be looked at further and hence won't be discovered to have been incorrectly classified.

Here's what EPA is actually doing, however:

A prudent approach to screening would be to acknowledge that a high-hazard chemical ought to have awfully strong evidence of low exposure before relegating it to the low-risk dustbin. Likewise, one ought to have a pretty high degree of confidence that a chemical to which exposure is expected to be high is low-hazard before deciding it can be set aside.

The decision matrix for a prudent screening system would look like this:

or at least like this:

But no: EPA acts as if the information it's using is complete and perfect. How else could it possibly support a screening approach that says: no matter how hazardous a chemical is, we'll only consider it high-risk if we are quite certain exposure to it will occur.

At this point, it probably won't surprise you to learn that, of 212 chemicals for which EPA has issued RBPs, 6 chemicals were ranked high-risk, 56 medium-risk, and 150 low-risk. (To its credit, EPA has also ranked eight more chemicals as high-priority, because their sponsors never followed through on their HPV Challenge commitments, and hence the chemicals lack hazard data altogether.)

EDF is not alone in flagging the fact that EPA's approach to risk ranking is the opposite of health-protective. EPA's own Children's Health Protection Advisory Committee (CHPAC) raised very similar concerns about ChAMP in a letter sent to the EPA Administrator last year.

EPA will at least aggressively seek better information, right?

Well, no. The irony and real tragedy of EPA's decision logic under ChAMP are that the hundreds of chemicals it relegates to low-priority status will likely never be targeted for development of better information on which to more accurately assess their risks. That's because EPA clearly states there is to be "no follow-up action at this time." See, for example, here and here.

Even for medium- and high-priority chemicals, the most EPA can muster in the way of any action to address data limitations is to say that "companies are encouraged to provide available information on a voluntary and non-confidential basis." See, for example, here and here.

Conclusion

I'll sum up this post as follows: Under ChAMP, EPA has constructed a house of cards, piling marginal data on top of questionable assumptions on top of a decision logic that is the antithesis of a prudent screening approach. The result is a system that is so rigged against identifying a chemical to be of high potential risk that – voila! – virtually none are being found!

It's getting harder and harder to believe that this is all an accident. The chemical industry has for years pleaded with EPA not to publicize chemical hazards without "putting the information into a risk context," lest it scare the public. ChAMP seems to be fulfilling industry's every wish, supplying the risk context in a manner that bends over backward to argue that even high-hazard high-volume chemicals are of low priority for further scrutiny – and in the process preclude even getting better information about such chemicals.

ChAMP is a holdover from the last Administration. Will it become EPA's "gift that keeps on giving" to the chemical industry?

Many of the shortcomings of the ChAMP initiative – most notably its reliance on incomplete and often questionable data to "prioritize" chemicals (see my earlier post on the debate over what prioritization means) – can be directly traced to structural limitations in the authority EPA has under the Toxic Substances Control Act (TSCA), which restrict EPA's ability both to identify and act to control dangerous chemicals. This is especially ironic, since ChAMP is being actively positioned as either obviating the need – or providing a model – for TSCA reform. See examples here, here and here.

So going forward, we'll also put the direction EPA has chosen for ChAMP and the wholesale chemical industry endorsement of it into the context of the broader debate around TSCA reform.

Coming next: This is the first of several posts that aim to expose the enormous problems with the direction EPA has taken ChAMP. Over the coming weeks, we'll provide a more specific critique and analysis of ChAMP's RBPs, and we'll start posting individual case examples of chemicals that directly illustrate the manner in which EPA has managed to prematurely exonerate hundreds of HPV chemicals.

Come back soon.

[The first post in this series can be found here.] 

Some in the chemical industry point to EPA's New Chemicals Program as a robust program, one that could serve as a model for reform of the Toxic Substances Control Act (TSCA).  Most recently, the National Petrochemical & Refiners Association (NPRA) did so in its testimony at a recent House of Representatives subcommittee's TSCA oversight hearing.  So just how robust is EPA's program on new chemicals? 

When it was enacted in 1976, TSCA drew a clear line between "new" and "existing" chemicals.  Existing chemicals – those in commerce in the mid-late 1970s when the TSCA Inventory was established – did not have to be reviewed by EPA in order to remain on the market.  In contrast, new chemicals – defined as those not on the TSCA Inventory – cannot enter commerce without such an EPA review.  Once that review is completed and manufacture commences, a new chemical is placed on the Inventory and essentially becomes an existing chemical. 

Of the roughly 84,000 chemicals now listed on the Inventory, 62,000 were in commerce when TSCA was enacted, and about 22,000 new chemicals have since entered commerce.  EPA reviews about 1,500 new chemicals every year, about half of which go on to enter commerce and be listed on the Inventory.

So right off the bat, it's important to recognize that the great majority of chemicals in commerce are not and will not be addressed by EPA's New Chemicals Program (NCP).  Rather, advocates for NCP as a model chemicals policy argue that TSCA reform could consist of simply applying the program's basic approach and review processes to chemicals already on the market.

Unfortunately, while it makes a lot of sense to mandate that new chemicals be reviewed before their commercialization, Congress dealt EPA an exceedingly poor hand to use in conducting such assessments.  Below I'll explore the following limitations, each of which illustrate why the NCP is not a good model for TSCA reform:

• No data, no problem: No up-front testing requirement or minimum data set applies to new chemicals.
• Guessing game: EPA is forced to heavily rely on limited models and methods to predict the toxicity or behavior of a new chemical.
• Catch-22: While EPA can require testing of a new chemical on a case-by-case basis, it must first show the chemical may pose a risk – not an easy task without any data in the first place!
• One bite at the apple: EPA typically gets only a single opportunity to review a new chemical.
• Crystal-ball gazing: EPA has to try to anticipate a new chemical's for-all-time future production and use.
• Black box: New chemical reviews lack transparency.
• Anti-precaution: In deciding whether to require testing or controls for a new chemical, EPA equates lack of evidence of harm with evidence of no harm.

The bottom line is that – precisely because it suffers from TSCA's major structural flaws – the NCP falls far short of serving as a model for the statute's reform.

No data, no problem:  No up-front testing requirement or minimum data set applies to new chemicals.

TSCA requires any company planning to produce or import a new chemical to notify EPA at least 90 days before commencing manufacture.  The notification typically takes the form of a Premanufacture Notification (PMN), unless the company seeks any of several exemptions EPA provides (for more on the available exemptions, see here).

PMNs must include basic information on anticipated use, production volume, exposure and release – to the extent such information is known or reasonably foreseeable by the submitter at the premanufacture stage. 

However, TSCA does not require companies to submit a minimum base set of data on a chemical's toxicity or ecotoxicity or its environmental fate and behavior.  This oddity of TSCA stands in contrast to the policies of virtually every other developed country in the world.  Although EPA encourages such data to be included in the PMN, the great majority of PMNs do not:  67% of PMNs contain no test data, and 85% of PMNs contain no health data; and more than 95% of PMNs contain no ecotoxicity data. 

TSCA actually precludes EPA from requiring up-front development and submission of a minimum set of data on a new chemical's hazards, by limiting the data required to be submitted in a PMN to that which is either already "in the possession and control" or is already known to, or "reasonably ascertainable" by, the notifier.  See TSCA Section 5(d).

Despite this lack of even basic data on a chemical's hazards, TSCA typically requires that EPA complete its review of a new chemical within 90 days and decide whether a chemical needs more data or any restrictions placed on its manufacture or use; if EPA fails to act, manufacture can commence. 

What's an agency to do?

Guessing game:  EPA is forced to heavily rely on limited models and methods to predict the toxicity or behavior of a new chemical.

To make the best of the bum hand it was dealt, over the last several decades, EPA's New Chemicals Program has pioneered the development of – and relies heavily on the use of – predictive methods and models, most notably structure-activity relationships (SARs).  SARs attempt to predict the behavior or toxicity of an untested chemical based on how similar its chemical structure is to those of other tested chemicals.  SARs include both mathematical models and algorithms that yield quantitative estimates, and more qualitative approaches that group chemicals into categories based on structural similarities and "read across" from tested to untested chemicals within the category.

EPA's efforts to develop ways to predict the hazards of new chemicals in the face of the constraints under which it must operate under TSCA have been admirable.  But they hardly represent an ideal or model approach to data development. 

Among other things, SARs themselves have severe limitations:

• SARs are only available and reasonably robust for a subset of even basic hazard endpoints of concern, and are best for predicting properties like persistence and bioaccumulation potential. In particular, with the notable exception of genotoxic carcinogenicity, validated SARs are lacking for most human health-relevant endpoints, especially for chronic concerns such as reproductive and developmental effects.
  A good illustration of this limitation is the fact that EPA's otherwise-useful online SAR tool, the PBT Profiler, includes only one toxicity endpoint – a value for chronic toxicity to fish.
• SARs don't work or haven't been developed for many major classes of chemicals, including highly fluorinated compounds, inorganic chemicals, salts of organic chemicals, even moderately reactive chemicals, surfactants, and any multi-component process stream or mixture.
• Even for covered endpoints and chemicals, SARs can provide estimates that differ dramatically from measured data. For example, EPA has found that its SARs predicted that the acute aquatic toxicity of dichloroacetyl chloride would be three orders of magnitude lower than found when directly measured in aquatic organisms.

Catch-22:  While EPA can require testing of a new chemical on a case-by-case basis, it must first show the chemical may pose a risk – not an easy task without any data in the first place!

TSCA does give EPA authority to require, on a case-by-case basis, testing or data development for new (as well as existing) chemicals.  And, for a small fraction of new chemicals, EPA has done so.  These are cases where EPA can meet the statutory burdens to require testing:

• In a classic Catch-22, EPA must already have substantial information about a chemical – enough to demonstrate that it "may present an unreasonable risk" or that it will be produced in large quantities and result in significant environmental releases or human exposures.
• EPA must also demonstrate that insufficient information exists to determine the effects of the chemical on health or the environment, and that testing is necessary to develop such information.

Arguably EPA has somewhat more leverage to compel testing of a new chemical relative to a chemical already in commerce.  Depending on the case, EPA can suspend its review of the PMN pending development of the data, or complete its review but include conditions that require testing prior to manufacture or impose controls pending completion of testing.  It can also negotiate a Consent Order (more on this below) or a Voluntary Testing Action in cases where PMN submitters agree on the need for testing.

Where EPA imposes a prohibition or limitation on a new chemical while testing is done, TSCA requires that any such controls be temporary and no longer apply upon submission of the specified information (see TSCA Section 5(e)).  Any permanent regulation of a new chemical would still require EPA to find that it "presents or will present an unreasonable risk" – the same near-impossible burden that applies to existing chemicals under Section 6 of TSCA (see TSCA Section 5(f)).

Just how often EPA has compelled or negotiated testing is unclear, as EPA has never publicly reported such data without lumping them together with other actions it has taken on new chemicals.  What is known is that EPA has taken action of some sort on fewer than 10% of the PMNs it has reviewed, only a fraction of which entail testing obligations.

One bite at the apple:  EPA typically gets only a single opportunity to review a new chemical.

TSCA grants EPA typically only one bite at the apple for new chemicals – a one-time, 90-day review opportunity at the premanufacture stage that takes place well before the full picture of the actual production, use and exposure, and lifecycle impacts of a chemical has emerged.

Once that review is completed and manufacture commences, the new chemical is placed on the TSCA Inventory, becomes an "existing" chemical, and any company can manufacture and use it without even having to notify EPA it is doing so.

In the relatively rare cases that EPA imposes any conditions or testing requirements on a new chemical, they apply only to the original notifier – unless EPA decides to go through a wholly separate rulemaking process to promulgate what is called a Significant New Use Rule (SNUR) specific to that chemical. 

EPA has issued SNURs for about 7% of new chemicals.  They typically specify the same conditions imposed on the original notifier, and extend them to any other manufacturer that wants to begin producing the chemical.  If – and only if – such a company wants to produce or use the chemical in a manner that falls outside of the conditions specified in the SNUR, it must first notify EPA.

SNURs themselves only require notification so that EPA can review the new use, and do not themselves impose new regulatory controls.  To do that, EPA would have to either promulgate yet another regulation or negotiate a Consent Order with the new company. 

All that just to ensure proper use of one new chemical.

Here again, TSCA is out of step with the laws of other developed countries.  Both Canada and the European Union have tiered notification and assessment processes for new chemicals.  As a chemical enters commerce and its production volume increases, these countries require additional notifications, impose additional data requirements and provide for renewed scrutiny by government.

Crystal-ball gazing:  EPA has to try to anticipate a new chemical's for-all-time future production and use.

The lack of up-front hazard data requirements for new chemicals under TSCA reflects in part the fact that notification takes place at a relatively early point in the course of developing, manufacturing, and marketing a new chemical, when it may not be realistic to expect a company to have conducted much testing.  Government intervention at this stage has the advantage of flagging overt potential concerns before manufacturing has commenced and before significant financial investment has been made by the producer.  It also has the potential to allow redesign of the manufacturing process or the chemical itself to eliminate or reduce the concern in advance of commercialization.

However, the lack of data on a chemical's hazards and other properties, combined with the rather speculative nature of information a company provides in its PMN on the chemical's potential uses, releases, and exposures, severely limits the robustness of any risk evaluation conducted at this stage.  And for the vast majority of new chemicals, no matter how significant a change in production or use occurs subsequently, a company is not even required to let EPA know it's happened.

Essentially, EPA has a single, highly time- and data-constrained opportunity to gaze into a crystal ball to predict the for-all-time trajectory of a chemical's production, use and disposal – and if it guesses wrong, EPA's only remaining regulatory recourse is under Section 6 of TSCA.  And recall that EPA has almost never succeeded in using its Section 6 authority to control dangerous substances, failing even to ban asbestos.

Black box:  New chemical reviews lack transparency.

I often hear from EPA staff that its new chemical reviews really are well-done and protective – they just can't reveal enough of the details to convince me of that fact.

Three major factors render EPA's review of new chemicals largely opaque to the public.

First, and perhaps most understandable, TSCA highly constrains how EPA can handle any information it receives that the submitter claims to be confidential business information (CBI).  CBI designations for new chemicals are the absolute norm: about 95% of PMNs contain information, including chemical identity, designated by the submitter as CBI.  As I have discussed elsewhere, both the latitude with which CBI claims can be asserted under TSCA and the constraints that apply to EPA in handling such information (including risking criminal charges and imprisonment for its wrongful disclosure; see TSCA Section 14(d)) have yielded a culture and practice at EPA that bends over backwards to prevent disclosure at all costs.

Second, because TSCA's requirements for developing test rules or regulatory controls are so onerous with regard to time, resources and evidentiary burdens, EPA instead resorts to using Section 5(e) Consent Orders to impose such requirements on new chemicals.  Over the course of TSCA's life, EPA has issued well over 1,000 such Consent Orders, compared to 4 – that's right, 4 – regulatory restrictions on new chemicals under its Section 5(f) authority.

However, although it is not prohibited from doing so, EPA rarely makes its Consent Orders public, even in redacted form to remove CBI.  This is because, according to EPA staff, these documents need not be made public because they are considered products of adjudication.  (In contrast, if EPA follows up a Consent Order with a SNUR, the latter is a regulation subject to full notice and comment, and hence, disclosure.)

Finally, it is exceedingly difficult to assemble even a rough, let alone accurate, picture of the number and nature of EPA decisions on new chemicals.  EPA does not publicly track such data even in the aggregate.  And on the few occasions it has published statistics on how often it has used various authorities or instruments to review or control new chemicals, the data lump together or obscure important facts – such as for how many new chemicals EPA has imposed a testing requirement.

Even within TSCA's constraints, EPA could certainly be far more transparent about – and engender more public confidence in – its review of new chemicals.  The fact that it has failed to do so says much about the need for statutory reform to shift the prevailing culture at EPA from one that errs on the side of keeping chemical information within its four walls, to one that affirmatively drives more and better information into the public domain.

Anti-precaution:  In deciding whether to require testing or controls for a new chemical, EPA equates absence of evidence of harm with evidence of no harm.

One of the best peeks into the black box I've had of late is when EPA took the unusual step of leaking a "sanitized" or CBI-redacted copy of a TSCA Section 5(e) Consent Order it negotiated with the manufacturer of a carbon nanotube.  I have already blogged at some length about this, here and here.  My angle here is to highlight again the decision logic EPA used, which staff tell me is not at all unusual in new chemical reviews at EPA.

In order to take action to control a new chemical – whether to impose conditions on use, restrict workplace exposures or disposal, anything – EPA must first find as a matter of law that the chemical "may present an unreasonable risk."  (To require testing only, EPA can alternatively find that a chemical will be produced in substantial quantities and may be result in significant release or exposure.)

EPA can and typically does make separate findings for human health and for the environment.  In the case of the carbon nanotubes, its basis for these different findings is telling:

• Human health: The Consent Order notes that this PMN was like most others in that no test data were submitted. EPA's actual finding, it would seem, logically follows: "EPA is unable to determine the potential for human health effects" from exposure to this nanomaterial, and hence it "may present an unreasonable risk of injury to human health." But the basis for this finding is not actually the absence of any test data for the nanotubes that are the subject of the PMN review. Rather, it is based on the existence of other affirmative evidence that certain carbon nanotubes act like asbestos. As a result, EPA is requiring one test to be performed, and imposing some modest restrictions on use and workplace exposures.
• Environment: One might think the wholesale absence of test data would be enough for EPA to conclude that it is also "unable to determine the potential for environmental effects as well." One would be wrong: The Consent Order actually affirmatively states that EPA has determined that "no significant environmental effects are expected." As a result, EPA is not requiring any testing for environmental effects and is not imposing any controls on environmental releases.

Given how little environmental data exist on nanomaterials in general, let alone this particular carbon nanotube, how could EPA have reached this conclusion? 

I'll repeat here what I said in my earlier post, because it bears repeating:  In reviewing a new chemical, EPA's decision logic is as follows:  Only if EPA already has evidence of a potential effect can it conclude that it is unable to determine whether there is an effect and call for testing.  If EPA doesn't have evidence of a potential effect – even if it has no data at all – it's ready to conclude that no significant effects are expected.

The precautionary principle, which the U.S. chemical industry so loves to malign, calls for initiation of proportionate action on a chemical where there is evidence of potentially dangerous impacts, even where that evidence is still incomplete or uncertain. 

That principle also underpins the European Union's REACH Regulation, which calls for the development of sufficient data on both new chemicals and those already in commerce, so as to be able to prioritize among them and act to control those that pose significant risks on an intelligent and well-informed basis

Some maintain that the New Chemicals Program is TSCA's version of precaution, arguing that it seeks to prevent harm before it happens.  But the example I've just provided suggests that, if anything, TSCA forces the New Chemicals Program to employ an anti-precautionary principle.

Next up:  I'll dissect the argument that EPA's Chemical Assessment and Management Program (ChAMP) is a model for TSCA reform.

As one who has closely followed the emergence of nanotechnology, I am sure I was not alone several years ago in welcoming what appeared to be a refreshingly new attitude among a broad range of stakeholders toward the introduction of this new set of technologies and materials.  Calls from my organization to "get nanotech right the first time" were echoed widely.  Perhaps the most frequently used metaphor, though, was that a "window of opportunity" had opened to do things differently this time.  But I increasingly fear that the window is closing.

Not long ago, the debate over nanotechnology seemed to reflect a willingness to learn from past failures in how our society had approached the introduction of other novel technologies like genetically modified organisms.  Many called for an inclusiveness that provided a seat at the table for all stakeholders.  And all parties, the industry included, tacitly if not always overtly agreed that a more cautious approach was needed, one that would identify and forthrightly address potential risks alongside the development – that is to say, the responsible development – of nanotechnology.

Perhaps the first sign of trouble came about 18 months ago, when officials charged with overseeing the National Nanotechnology Initiative testified before Congress to the effect that all the hoopla about nano risks was overblown and the result of shoddy science.  Then a year ago February, the White House felt obliged to issue its so-called "Principles for Nanotechnology Environmental, Health, and Safety Oversight," addressed to all federal departments and agencies, that seemed primarily intended to rein in any renegade federal officials hell-bent on over-regulating nanotechnology.

The latest signs that the window of opportunity is closing fast are coming from some among the legions of lawyers whose business it is to protect nano-enabled companies from legal actions.  As Rick Weiss reported last week in a piece titled "The Big Business of Nano Litigation," industry lawyers are sending mixed messages to their clients, some of them now apparently advising their clients to forget all the warm fuzzy stuff.  The latter group's messages:

• Don't rush to line up to work voluntarily with government agencies.
• Don't volunteer to turn over your data to government.
• Don't do any testing that you aren't required to do. (Rick Weiss quotes George Burdock, president of the Burdock Group, as advising clients not to overdo it: "Don't test yourself out of a product.")

That kind of advice might help to explain the low level of participation in both the basic and in-depth components of EPA's voluntary Nanoscale Materials Stewardship Program.

I certainly don't want to imply this is the only or even the predominant message reaching or emanating from nano companies, but these kinds of statements seem to signal an unfortunate shift toward a more defensive strategy and away from one that would keep that window of opportunity open at least a while longer.