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.

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

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

Critical differences between assessing hazard and exposure

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Conclusion

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

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

_____

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

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

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

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

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

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

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

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

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

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

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

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

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

All this leaves me with two questions: 

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

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

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

_________________

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

California

Chemical Industry Council of California

Gallade Chemical Inc.

Ross Organic Specialty Inc.

Illinois

Chemical Industry Council of Illinois

Indiana

C.M. Hobbs, Inc.

Calvin Landscape

Dorfman Design Builders

Louisiana

Louisiana Propane Gas Association

Maryland

Cytherian Solutions

Eastern Scientific, Inc.

Golden, Inc.

Maryland Biotechnology Entrepreneurs Coalition

Sequella, Inc.

Marlin Steel Wire

Systems Consulting Group

Intelect Corporation

Medical Supplies Corporation

Regional Manufacturing Institute

Fraley Corporation

Minnesota

Denny C’s Produce

G&G Property Maintenance

Montana

Montana Agribusiness Association

Montana Contractors Association

United Property Owners of Montana

Virginia

Virginia Retail Merchant Association

Virginia State Police Association

Virginia Biotechnology Association

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

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

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

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

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

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

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

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

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

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

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

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

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

One image immediately comes to mind; click here.

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

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

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

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.

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.

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.

It had to happen sooner or later. After several years spent by the UK and US governments conceptualizing, vetting, proposing, again vetting, developing, yet again vetting, and finally launching and reporting on their voluntary reporting programs for engineered nanoscale materials – only to have them largely spurned by the intended targets – other governments observing all this have decided that mandatory approaches are needed.

The UK was the first to try the voluntary approach.  Its Voluntary Reporting Scheme was launched in September 2006 and ran for two years.  It closed out in September 2008 after attracting only 11 submissions. 

It took the US another 16 months to follow suit with its voluntary Nanoscale Materials Stewardship Program (NMSP), launched in January 2008 and also intended to run for at least two years.  EPA's interim report, which evaluated the submissions it received from 21 companies in the first seven months, was released last month.  That count has increased now to 29 companies, more than the UK program attracted but still a small fraction of the companies engaged in nanomaterial activities in the US (I blogged about the report's findings earlier).

With many more companies and nanomaterials in or about to enter commerce than have been captured by these voluntary efforts, and the inability of government to judge how complete or selective the data it is receiving actually are, it appears other governments are opting for mandatory reporting.

First comes France, which, as reported by SafeNano, proposed new legislative amendments in early January that would require that "those who manufacture, import or place on the market nanoparticulate substances periodically report to the administrative authorities the identity, quantity and uses of these substances.  In addition, a further note declares that information on identity and use of substances should be made available to the public, except if doing so would be potentially damaging to national defense."

Then comes California (which is not at all unaccustomed to acting as if it were a national government!).  Its Department of Toxic Substances Control (DTSC) posted a notice on its website and sent a letter on January 22 to several dozen companies, universities and research facilities that produce in or import into the state carbon nanotubes (CNTs).  DTSC's "information call-in" for CNTs requires submission, within one year, of data regarding "analytical test methods [for sampling, detection and measurement of CNTs in workplaces and the environment], fate and transport in the environment, and other relevant information."

And now it appears Canada is poised to issue in mid-February a Ministerial Notice requiring mandatory reporting of information relating to nanoscale materials.  Canada has been planning to issue such a notice for some time, based on information it submitted for inclusion in a June 2008 Tour de Table document (see Canada section) recently made public.  That document summarizes nanotechnology safety-related activities of various OECD countries participating in the Working Party on Manufactured Nanomaterials (WPMN) of the Organisation for Economic Cooperation and Development (OECD). 

As reported in the Daily Environment Report on January 26 (subscription required), a spokeswoman for Environment Canada said companies would have to report "basic information on the quantity of the substance that is manufactured or imported, details about the use of the substance, and any data on physical and chemical properties, toxicity data currently available to respondents, and information on the procedures, policies and technological solutions that have been put in place to prevent or minimize releases of the substance to the environment and exposure to individuals."  The reporting requirement will apply to nanomaterials produced or imported in amounts exceeding one kilogram in 2008, and the requested information is to be submitted within four months.

With even EPA having hinted in its interim report on the NMSP that it will now look seriously into developing mandatory reporting and testing rules, it appears that the "voluntary phase" of government policy toward nanomaterials may have run its course.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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