Over the last few months, I was heartened to hear a number of industry stakeholders in the debate over TSCA reform embrace the idea of designating in TSCA reform legislation a "jump-start" or "quick-start" list of chemicals of high concern or priority.  The idea was to allow EPA to hit the ground running, by having an agreed-to list of chemicals on which it could immediately initiate action.  Well, it now appears many in industry actually have something far slower and far more cumbersome in mind.

The Subcommittee on Commerce, Trade and Consumer Protection of the U.S House of Representatives' Energy and Commerce Committee held a hearing yesterday on the question of "prioritization":  How a new law could best spur prompt identification of and action on the chemicals of highest concern.  Mr. Bill Greggs testified on behalf of three trade associations prominent in the debate over TSCA reform:  The Consumer Specialty Products Association, the Soap and Detergent Association, and the Grocery Manufacturers of America.

In Mr. Greggs' testimony and answers to questions from subcommittee members, what industry has in mind when it talks about a quick start became much clearer:

• There would be no list of chemicals in the bill.  Nor would there even be a process laid out by which EPA would identify chemicals of highest concern for the purpose of promptly taking action to reduce exposure to them.
• Instead, the bill would merely contain some potential hazard and exposure triggers for EPA to consider. 
• The legislation would then impose a risk-finding requirement on EPA (sound familiar?), by restricting any further effort to only those chemicals that are found – on the basis of existing information, however incomplete – to pose BOTH the highest hazard and the highest exposure.
• Once the legislation passed, EPA would first have to develop specific high-hazard and high-exposure criteria, and then apply the criteria through a review of all chemicals it knows to be in commerce and for which such hazard and exposure data exist.
• Then EPA would have to provide industry with a robust process by which industry could – and surely would – challenge each and every designation of such a chemical by EPA.
• Assuming any chemical made it through that process, such highest-of the-high-priority chemicals would then merely enter a further limbo:  a review and risk assessment process as a prelude to a "safe use" determination by EPA.

Hardly the quick start I had hoped for. 

If the last decade of voluntary programs and ChAMP has taught us anything, it's that it's time to move beyond the endless cycle of having one round of assessment to identify chemicals of highest concern lead to nothing more than a further round of assessment.

The re-energized new leadership at EPA recently took upon itself to identify an initial handful of bad-actor chemicals, for which it is developing action plans to reduce the harm those chemicals are causing.  EPA didn't ask for industry's blessing before listing those chemicals.  Can you imagine what would have transpired had it done so?

Nor should EPA have to provide an opportunity for industry to challenge such listing decisions:  Under Greggs' scheme, any listing of chemicals is pre-regulatory –  indeed, it's arguably pre-pre-regulatory or even pre-pre-pre-regulatory.  The notion that EPA's mere identification of a chemical through such a process should be eligible for challenge by the very companies that make or use the chemical is preposterous – not to mention a recipe for endless delay and fights.

And hey:  Wasn't avoiding all that the motivation behind having a quick-start list in the first place?

Lest you think I'm reading too much into a 5-minute statement at a hearing, I'll point you to a detailed proposal these same three trade associations (joined by a dozen others) gave to California earlier this year, as a "model" for regulations under the state's Green Chemistry Initiative.  By my count, that proposal would provide no fewer than six – 6 – opportunities for industry input into and challenge of the state agency's process for designating and prioritizing a chemical of concern.

Talk about greedy:  In addition to requiring formal notice and comment on any proposed listing of chemicals, that proposal would require another round of notice and comment on the "final" list.  And it would repeat that dual-intervention opportunity at each of several steps in a process that would precede any regulatory action to restrict the use of the chemical.

That makes the federal rulemaking process under the Administrative Procedures Act look like a cakewalk in comparison, even after factoring in the interventions by the Office of Management and Budget called for under Executive Orders and such.

A prominent refrain in the industry's new TSCA hymn book has been to say that EPA needs more authority.  I, for one, would like to hear that tune sung more than just in Sunday choir and have it enter the actual work week.

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.

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

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

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

Who would know better than EPA?

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

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

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

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

Not a bad start for the new leadership at EPA.

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

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

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

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

What's EPA's next move?

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

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

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

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

Still with me?

A red herring

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

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

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

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

The bigger problem

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

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

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

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

Solutions

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

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

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

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.

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

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

Identity hidden

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

Identity revealed

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

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

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

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

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

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

The answer is simple:  Because it could.

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

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

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

Consider:

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

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

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

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

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

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

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

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.

This example raises some new issues as well as some we discussed in the earlier examples:  EPA relies on a highly flawed "category approach" that ignores major differences in the properties and structures of the 13 members of this category.  It compounds this problem by unquestioningly accepting data from inadequate studies to assert low toxicity, rather than demanding that sufficient studies be provided.  As a result, it fails to identify, let alone require to be filled, the enormous gaps in the data available for many of the category members.  EPA ignores or dismisses without explanation its own earlier comments raising serious concerns about the quality and completeness of data provided by the sponsor of these chemicals under the HPV Challenge.  Finally, this example once again shows how EPA's heavy reliance on self-reported use information from manufacturers paints an incomplete and potentially very misleading picture of the actual uses of industrial chemicals. 

The Fatty Nitrogen Derived Cationics category includes 13 chemicals that are used in industrial and consumer detergents and cleaners, as well as hair care products (conditioners or softeners), disinfectants, textile softening and antistatic agents, deodorizers, emulsifiers, dispersants, coagulants, industrial lubricants and corrosion inhibitors, among other uses.  Two supporting chemicals are registered with EPA as antimicrobial pesticides.  Annual production volumes ranged from <1 million pounds for two of the category members to 50-100 million pounds for one of the chemicals.  The sponsor of this group of chemicals under the HPV Challenge was the American Chemistry Council's Fatty Nitrogen Derivatives Panel's Cationics Task Group.

Is this a legitimate category?

EPA and international protocols provide for the grouping of chemicals into categories for data development and assessment purposes.  However, that approach starts with a hypothesis that chemicals that have structural similarities actually possess similar or predictable patterns of biological activity.  These protocols require 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, and that a full and compelling rationale be provided.

Neither the sponsor of this category nor EPA has done any such thing in the present case.  Indeed, the sparse available data do not support the category:

• Few measured physical-chemical and environmental fate data have been provided, which is essential to demonstrate similarity in properties and behavior. Instead, estimated values are provided that are either eerily identical for all category members (e.g., bioconcentration factor, or BCF) or actually vary dramatically across category members (e.g., Henry's Law Constant, which is a measure of the distribution of a chemical between water and the air above it). These findings hardly support the hypothesis that all category members will behave similarly.
• The spotty measured biodegradation data that have been provided also differ significantly (ranging from 0% degradation in 28 days, to 12% in 182 days, to 98% in 2 days). EPA acknowledges this huge range, but fails to discuss how it comports – or doesn't – with the category rationale.
• The aquatic toxicity data vary across category members by orders of magnitude. For example, acute fish toxicity values (96-hour LC50s) vary from 0.07 to 24 milligrams per liter (mg/L) – more than spanning EPA's high-moderate-low hazard classifications.
• Acute oral mammalian toxicity values (LD50s) are available for most category members – but they also vary, from 238 to >16,300 milligrams per kilogram of body weight (mg/kg-bw). And while the sponsor and EPA argue these data are similar enough to support the category (they only span EPA's moderate and low hazard classifications), there is no reason to expect that the mechanisms that impart acute toxicity are at all related to those that lead to other toxicities, such as reproductive or developmental toxicity (these endpoints are discussed further below). So how exactly do similar data for one endpoint support a conclusion that data for entirely unrelated endpoints will be comparably similar? EPA never bothers to explain this.
• As discussed below, far fewer data are available for the other human health endpoints, and what data are available do not support the category.

Despite these findings, EPA states that it agrees with the sponsor's category justification, asserting that the category members possess "similar physicochemical properties, biodegradability, aquatic toxicity, mammalian toxicity and environmental disposition patterns."  The differences in the actual data noted above are neatly set aside.

In comments EPA provided to the sponsor in 2002, EPA itself clearly considered the chemicals in this category to be sufficiently different from each other structurally that it broke them into three subcategories and argued for the need for more data to be provided within the subcategories in order to bolster the overall category.  (As we'll discuss below, the sponsor refused to provide the additional data, and EPA capitulated with nary a word as to why).  These subcategories are:  a) four chemicals that have a single alkyl chain; b) seven that have two alkyl chains; and c) a third subcategory that includes one chemical with three alkyl chains and one that has a dimeric structure.

EPA's rankings 

Now let's look at how EPA ranks the category, and some of the many reasons why we disagree.

Hazard rankings:  EPA ranks the entire chemical category as moderate for human health hazard, apparently due to the results of repeated dose testing.  While EPA maintains that none of the chemicals are expected to bioaccumulate, it expects most (9) of the category members to exhibit moderate persistence.  The hazard for aquatic organisms – fish, invertebrates and algae – is ranked high, based on the results of both acute and chronic testing using multiple test species. 

Exposure rankings:  Exposures to workers, consumers and children are expected by EPA to be high, due to the uses of these chemicals in common household and personal care products.  Releases to the environment are not known, so EPA estimated that exposures to the general public and the environment resulting from such releases would likely be moderate. 

Risk rankings:  EPA judged the risk ranking for this group of chemicals to be medium for all possible receptors. 

Prioritization ranking:  EPA assigned this chemical category a medium priority and identified a list of "possible next steps" to get additional information that would "assist EPA" to develop a better understanding of use and exposures.  These include just about everything you can imagine EPA would have needed to make any findings about exposure in the first place:  potential releases to water from manufacturing, use and disposal; information concerning worker exposures; and information concerning potential exposures to these chemicals in consumer products, such as presence and concentration and consumer use patterns.

Why We Disagree:

1.  As discussed above, the grouping of chemicals into categories can in some cases be justified, but it requires a sufficient amount of measured data to demonstrate that the chemicals within the category actually behave in a similar or predictable manner reflective of their structural similarity. In this case, the available data are grossly insufficient to support the category. Yet EPA still manages to conclude there are no data gaps for any endpoints for this entire category.

     Here is the actual extent of data for the mammalian endpoints:

Endpoint                            # Chemicals with measured data
                                            (includes 2 supporting chemicals)

Acute Oral                                                      11 of 15
Acute Dermal                                                   5 of 15
Acute Inhalation                                              2 of 15
Repeated Dose Oral                                        4 of 15
Repeated Dose Dermal                                    4 of 15
Repeated Dose Inhalation                               0 of 15
Reproductive Toxicity                                       1 of 15
Developmental Toxicity                                    5 of 15

2.  As noted earlier, EPA broke this category into three subcategories, based on structural differences. Let's examine in more detail the nature and extent of mammalian toxicity data provided for the first of these subcategories, the mono alkyl quaternary ammonium chlorides:

a. Repeated dose toxicity. None of the members of this subcategory has a reliable repeated dose toxicity study (a test that is used to evaluate health effects from more than single-dose exposures and serves as a screen for possible effects from chronic exposure). No oral studies are available, and the single dermal study provided used only a single dose. That dose yielded no adverse effects – but the dose was very low, below the dose where if an effect were seen EPA would rank the hazard as high.

Tests that use only a single dose and tests that fail to find an effect level because they use doses that are too low are insufficient to support any hazard assessment.  Yet EPA doesn't even discuss the matter.  It doesn't acknowledge the test is insufficient, nor does it identify this endpoint as a data gap, nor does it adopt a reasonable default assumption in the absence of valid data that developmental toxicity could be high.  Instead, it proceeds merrily to "read across" this negative result to the untested members of the subcategory.  And worst of all, it actually concludes in its hazard characterization summary that "no treatment-related systemic toxicity was evident at the doses tested" – completely burying critical information about data quality and reaching a scientifically unjustified conclusion.

b. Reproductive toxicity. This same subcategory lacks any reproductive toxicity data whatsoever. In comments EPA provided back in 2002 on the test plan submitted by the sponsor of this category, EPA requested that a combined reproductive/ developmental toxicity test be conducted to address this glaring gap (as well as the corresponding gap in data for developmental toxicity). The sponsor responded in 2003, stating that in its view the requested additional testing "will not further the understanding of potential human health hazards…" of these chemicals. The sponsor provided no rationale to support its claim, failing even to acknowledge EPA's point that there were no data available for any of the monoalkyls.

In EPA's current ChAMP assessment, issued in March 2009, EPA now states merely that it accepts this response, and provides absolutely no explanation for its change of heart.  Instead, EPA – without any stated justification – is now content to "read across" to all four members of this subcategory the data from a "supporting" chemical that is actually a di-alkyl, not a mono-alkyl, compound.  Indeed, this supporting chemical serves as the ONLY source of reproductive toxicity test data for all 13 category members!  On this basis, EPA then blithely claims there is no reproductive toxicity – and no data gap for reproductive toxicity – for all 13 members of this category.

c. Developmental toxicity. Data are available for one of the four members of the mono alkyl subcategory for the oral route of exposure, and for two other members for dermal exposure. EPA "reads across" these data to the untested members of the subcategory. That might normally be sufficient, but again in this case neither test yielded any adverse effects at the highest doses tested, and again those doses were very low, below the dose where if an effect were seen EPA would rank the hazard as high.

Remember, tests that fail to find an effect level because they use doses that are too low are insufficient to satisfy an endpoint and support hazard assessment.  But once again, instead of acknowledging this inadequacy, identifying this as a data gap, and using a reasonable default assumption that developmental toxicity could be high, what does EPA do?  It claims "no signs of developmental toxicity were observed"!

In its hazard characterization summary, EPA downplays or omits the results of the developmental toxicity studies it reviewed.  It ignores without explanation evidence of adverse effects that are at least equivocal, and may be significant:

• EPA claims that a test done on the di-alkyl supporting chemical "resulted in no developmental toxicity," despite the fact that increased fetal mortality and decreased fetal body weight were observed – and at doses that warrant a high hazard ranking using EPA's criteria.
• Similarly, with respect to tests done on two dialkyl category chemicals, EPA claims the studies did not produce an effect at the highest doses tested. Yet both chemicals were actually found to have increased fetal resorptions, albeit at doses that EPA would rank as low-hazard.

In each of these cases, we are forced to infer a rationale because EPA never clearly explains its decisions.  But the apparent rationales – effects seen only at doses that are also toxic to the mother, effects within the range historically observed for controls in the laboratory (though with no supporting data provided by the laboratory) – are not sufficient to conclude there are no adverse developmental effects, even if they are also insufficient to conclude there are such effects.  Indeed, in a screening-level hazard characterization based on scant or equivocal data, the default should be either to assume an effect exists or at the very least to call for further testing.

Finally, even if one were to accept these studies as definitively negative for the dialkyl subcategory, EPA has no basis either to extrapolate that finding to the other subcategories or to paper over the enormous data gap that exists for this endpoint.

3. We also disagree with EPA's risk ranking for this chemical category. Even assuming EPA's moderate ranking of the human health hazard of this group is appropriate, given that there remain important data gaps, and exposures to humans are ranked high, and the chemicals are likely to be washed down the drain into the environment, we don't see how this category should be ranked as anything but both high risk and high priority.

4. The two supporting chemicals used to provide hazard data for this category are both antimicrobials, and given EPA's readiness to treat all of the chemicals together, it is reasonable to assume that the category chemicals may also have antimicrobial properties. Add to this the facts that the chemicals in this category are used in a widespread and dispersive manner, and that they may well end up in wastewater treatment plants and surface waters, there is every reason to be concerned that they could adversely affect beneficial microbes used in wastewater treatment and found in the environment.

Antimicrobials used and marketed as such are exempted from TSCA, and are instead regulated under the Federal Insecticide, Fungicide and Rodenticide Act.  However, the chemicals in this category are used in applications where such a function and associated claims are not operative. That is, we have a group of chemicals that EPA considers similar to known antimicrobial pesticides that are disposed of down the drain, into sewage treatment systems that may not effectively remove these chemicals, potentially resulting in distribution through the ecosystem.

EPA is wholly silent on this issue.  In addition to collecting more data, we would strongly recommend that these chemicals be evaluated to determine if inherent antimicrobial properties warrant regulation as antimicrobial pesticides.

5. EPA ranks most (9) of the category members as exhibiting moderate persistence, and the remaining four as of low persistence. Yet it barely discusses the available data and ignores the following:

• Using EPA's own criteria, 3 of the 4 chemicals EPA ranked low actually exhibit moderate photodegradation rates (based on estimated data, as no measured data were provided).
• 3 of the 4 chemicals EPA ranked low for biodegradation appear to exceed EPA's criterion for a low ranking, and several of those ranked moderate show little if any biodegradation.
• EPA ranks as moderate one chemical that showed 0% degradation in 28 days. This obviously should be ranked high.
• EPA also ranks as moderate another chemical that has a half-life in soil of a whopping 1,048 days – nearly 3 years! EPA's criteria rank any half-life in soil that exceeds 180 days as high – yet EPA's ranking of this chemical is, inexplicably, moderate.
• 6 of the category members have no biodegradation data, and any rationale for EPA's implied read-across from the other members is absent.

In comments EPA provided earlier to the sponsor, EPA raised several serious concerns about the extent and nature of data provided for, and the sponsor's claims made about, biodegradation.  In the sponsor's response, it refused to do the testing EPA called for or to revise its claims that all category members are biodegradable. 

In its current ChAMP assessment, EPA seems once again to have fully capitulated:  no data gaps identified, no flagging of the enormous range in biodegradation values that calls into question the viability of the category, and a failure in contradiction of its own criteria to identify any of the category members as having high persistence.

6. EPA claims that none of the category members are expected to bioaccumulate. This is based, however, entirely on estimated data using an EPA model that yields the exact same result – a bioconcentration factor estimate of 71 – for all 13 category members. Doesn't this bear some explanation? Why can't this parameter be measured? EPA's silence is deafening.

7. Last, but not least, this ChAMP assessment amply illustrates the huge shortcomings of the use information EPA has sought to collect under its Inventory Update Rule (IUR). As we've discussed at length before, these data are of questionable value because they are self-reported by manufacturers, often incomplete because of major reporting loopholes EPA has provided, and often kept removed from any public access because EPA provides wide latitude for submitters to claim the information to be confidential. This category is a great example of these problems.

IUR submissions were received for 11 of the 13 category members.  Here's a summary of the extent of data EPA did and did not receive, and what it has not made public because of confidential business information (CBI) claims:

Types of responses in IUR submissions
Number of chemicals

*  Submitter did not submit because information is "not readily obtainable"
** Number represents CBI submissions identified as such by EPA.  EPA notes the number could be higher.

In this case, EPA has ready access to other public sources of use information for these chemicals – including, ironically, the HPV Challenge submission for this category that was provided by the same companies that under the IUR claimed such information CBI!  But in other cases, such information may not be available, as reliable and current chemical use information is very limited in general.

Given the poor performance of manufacturers reporting under the IUR, and the often very limited availability of information from other sources, how comfortable are you in EPA using these data to assess chemicals' risks to workers, the public, the environment, consumers and children?

Conclusion

In an earlier post, we characterized EPA as constructing "houses of cards" in its ChAMP assessments.  Some of you might have considered that to be awfully harsh.

But here's a classic house of cards:  EPA uses very spotty, variable, misclassified or entirely estimated data on degradation or bioconcentration to claim that this questionable category of chemicals has only low or moderate environmental persistence and bioaccumulation potential.  It then uses those findings to downgrade use information that clearly indicates these chemicals are used in a manner that culminates in down-the-drain disposal or similar release, and hence significant, ubiquitous releases to the environment – in order to claim that exposures to aquatic organisms and the general population via such releases will only be "medium."  Finally, it uses that finding to downgrade its finding of high aquatic hazard to a medium risk ranking, and to further downplay its (flawed) moderate human health hazard by finding only a medium risk to the general population.

Any questions?

Our analysis of EPA's risk decision under ChAMP for this category of toxic chemicals vividly illustrates how EPA has failed to adopt a health-protective approach to its screening of HPV chemicals.  Rather, it misclassifies or understates these chemicals' hazards, asserts that existing regulations are sufficient even when they are quite old or do not cover identified exposures, and naively assumes that children will not be as exposed as adults to consumer products used in the home unless they are intended for their use.  Finally, this case demonstrates that manufacturers are not reporting to EPA even readily available information on their chemicals' uses. 

The chlorobenzenes category is comprised of four chemicals: monochlorobenzene (CAS# 108-90-7), 1,2-dichlorobenzene (CAS# 95-50-1), 1,3-dichlorobenzene (CAS# 541-73-1) and 1,2,3-trichlorobenzene (CAS# 87-61-6).  The first three of these chemicals are on the Toxics Release Inventory (TRI).  Reported production volumes under the Inventory Update Rule and TRI emissions for 2005 and reporting manufacturers (other companies may have claimed their identity to be confidential business information) for these chemicals are as follows:

Industrial uses reported by manufacturers include use as intermediates and solvents for plastics manufacturing and basic organic chemicals manufacturing, and pesticide and other agricultural chemical manufacturing.  EPA notes other uses cited in the Hazardous Substances Data Bank (HSDB):  "pesticides, solvents, heat transfer medium, and chemical intermediates, as well as many other uses."

All members of this category were included in test rules issued under TSCA Section 4, in use and exposure-related information reporting rules issued under TSCA section 8(a), and health and safety data reporting rules issued under TSCA section 8(d).  Additionally, these chemicals are regulated under the Clean Air Act and Clean Water Act, and the Occupational Safety and Health Administration (OSHA) has set Permissible Exposure Limits (PELs) for two of the chemicals (1,2-dichlorobenzene and monochlorobenzene).

EPA considers 1,3-dichlorobenzene to be a high-priority chemical, a decision with which we agree (but see point 8 below).  It considers the other chemicals to be low-priority, and this review primarily focuses on that decision.

Hazard rankings:  EPA ranks monochlorobenzene, 1,2-dichlorobenzene and 1,2,3-trichlorobenzene as having moderate human health hazard, based on the results of repeated dose toxicity tests and developmental toxicity tests.  All three of these chemicals (as well as 1,3-dichlorobenzene and one of the supporting chemicals for the category) exhibited evidence of genotoxicity in vivo. One of the chemicals (monochlorobenzene) exhibited some, though not clear, evidence of carcinogenicity, and one of the supporting chemicals showed clear evidence of carcinogenicity.

Exposure rankings:  EPA indicates that there is a high potential for exposure to these chemicals of the general public via environmental releases, based on their reported TRI releases, environmental persistence, detection in environmental monitoring and their myriad uses.  EPA ranks worker exposures high (for two chemicals) and moderate (for the third).  Based on the use of these chemicals in consumer products, EPA ranks exposures to consumers as high and exposures to children as medium.  Interestingly, EPA reports that the IUR data – submitted by manufacturers – do not indicate uses in consumer products, but that several other sources, including the HSDB, the NIH Household Products Database, and EPA's Source Ranking Database, do indicate uses in consumer products.

Risk rankings:  EPA ranks the risks of these three chemicals to the environment to be moderate to fish and high to invertebrates and aquatic plants.  It ranks risks to the general public, consumer and children as moderate, despite their high exposure potential, based on ranking human health hazard as moderate.  EPA ranks risks to workers as low for the two chemicals with OSHA PELs (1,2-dichlorobenzene and monochlorobenzene) and moderate for 1,2,3-trichlorobenzene.

Prioritization rankings:  EPA considers all three chemicals to be low-priority because it expects existing regulations and ongoing reporting to be sufficient to mitigate risk and to alert EPA to the presence of chemicals in workplaces, environmental releases from facilities, and drinking water.

Why we disagree:

1. Given the high exposure potential to these chemicals, which EPA found to pose moderate human health hazards, even a modestly health-protective decision would rank their risks to the general public, consumers and children as high, not moderate. The potentially large number of uses, the large production volumes and TRI releases for two of the three chemicals and the substantial uncertainty regarding the magnitude, frequency, and duration of possible exposures, would support such a ranking.
        In this way, at least the development of better hazard, use and exposure information and further scrutiny of the magnitude of risks would be spurred.  Instead, EPA concludes that "No follow-up action is suggested at this time on [these three] chemicals in this category.
2. The conclusion that these chemicals are low-priority due to the existence of Clean Air Act and Clean Water Act regulations is unjustified. Despite those regulations, substantial TRI releases to air and some releases to water are being reported – sufficient for EPA to rank exposure potential as high. Yet EPA then invokes those same regulations as being adequate to prevent the very exposures it just characterized as potentially high!
3. The main reason EPA ranked consumers' and children's exposure potential high and medium, respectively, is because of expected exposures through consumer products. However, the cited CAA and CWA regulations do not address these exposures at all.
4. EPA provides no real basis for ranking children's risks lower than consumers'. EPA implies this is because it lacks evidence that these chemicals are used in products specifically intended for use by children. But EPA notes it sources of use information indicate "many other uses" for these chemicals that are not identified, and EPA provides no basis on which to conclude that uses in products not intended for use by children would not expose them. Indeed, EPA acknowledges: "Exposures to children, however, may be expected to occur through the household use of some consumer products" (p. 48 here).
5. Positive results for all of the chemicals in this category in in vivo genotoxicity studies, and for monochlorobenzene and one of the supporting chemicals in two-year carcinogenicity bioassays, clearly warrant follow-on testing to clarify the carcinogenic potential of at least the untested chemicals in this category. Yet EPA proposes no such testing; indeed it barely discusses the findings other than to repeatedly emphasize the one chemical for which negative carcinogenicity results were found.
6. In its risk rationale for children, EPA misclassifies the level of developmental toxicity for two of the three chemicals. On p. 3 here, EPA claims "available data with postnatal exposures in animals suggest a low hazard for two category members (CASRNs 95-50-1 and 108-90-7)." Yet the results of developmental toxicity tests in rats via inhalation exposure to vapors of these two chemicals actually showed moderate and high developmental toxicity, respectively, based on EPA's own criteria:
   • CAS# 95-50-1:  LOAEL ~ 2.4 mg/L/day vs. EPA range for moderate developmental toxicity of 1-2.5 mg/L/day (see pp. 27 and 38 here vs. the table on p. 12 of EPA's Methodology for Risk-Based Prioritizations under ChAMP.
   • CAS# 108-90-7:  LOAEL ~ 0.35 mg/L/day vs. EPA cutoff for high developmental toxicity of <1.0 mg/L/day (see pp. 26 and 38 here vs. the table on p. 12 of EPA's Methodology for Risk-Based Prioritizations under ChAMP
     High exposure and high or moderate developmental toxicity – surely even EPA will acknowledge these chemicals merit a high-risk and high-priority ranking?
7. EPA invokes the existence of OSHA PELs for two of these chemicals to argue that worker risk is low. Both of these PELs were promulgated in 1989 (see here and here), and at least for one of them, monochlorobenzene, NIOSH has found that "[t]he 1989 OSHA PEL may not be protective to workers."
        Were these PELs developed in consideration of and are they adequate to protect against the toxicities EPA presents herein?  While some of the test data (ca. 1984, 1987) predate the year the PELs were adopted, given the long process required to develop a PEL, the timing cannot be taken as evidence that such data were considered by OSHA.  EPA cannot merely assert that the PELs are adequate to protect workers without demonstrating that the permissible levels were set after evaluation of these data, and are still adequate in light of any other more recent toxicity data. 
        At the very least, EPA needs to engage in a meaningful referral of these data to OSHA, using its TSCA Section 9 authority, including follow-up to ensure the data have been fully considered and acted upon appropriately at OSHA.
8. Despite its high-priority finding for one of the chemicals in this category, 1,3-dichlorobenzene, EPA's only response is to state that "in order to confirm or refute the high potential risk … companies are encouraged to provide available information on a voluntary and non-confidential basis." This is clearly inadequate for such a high-risk chemical. It begs the question: what would it take for EPA to be willing to actually impose risk management on such a chemical?
9. Last but not least, EPA's finding that there are myriad product uses of these chemicals – none of which were reported by any of their manufacturers under the Inventory Update Rule (IUR) – vividly illustrates why EPA's frequent sole or primary reliance on the IUR as its source of use and exposure data for ChAMP assessments is wholly inadequate as a basis for making exposure and risk decisions for high production volume chemicals.