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.

Growing up in the 1970s, Mischief Night was a big deal for me.  When I was in grade school, hoards of us kids took to our neighborhood just after dark to wreak innocent havoc.  More fun than Halloween, I recall soaping up car windows and decorating neighbors' trees with toilet paper.  (What were our parents thinking?)

When a wonder toy called Silly String hit the stores, Mischief Night turned psychedelic with crazy vibrant colors issuing in long streams from an aerosol can!  And what was the harm?  Silly String simply dried up and blew away.  Who knew that we might actually be spewing a brew of toxic chemicals? 

Polyisobutyl methacrylate, hexabromobenzene, dibutyl phthalate, dimethyl siloxane, dichloromethane and sorbitan trioleate.  While the current formulation of Silly String is claimed to be confidential business information, these are some of the ingredients in the product's original formula.  This, according to a fun little fluff piece that ran in a recent issue of Chemical & Engineering News titled “Silly String: It’s a party for polymer chemistry, all in a can.”

Some of these chemicals — hexabromobenzene (a brominated flame retardant), dibutyl phthalate (an endocrine disruptor) and dichloromethane (also known as methylene chloride, a carcinogen) — ought to rank high on anyone's list of chemicals of concern.

But am I just being a killjoy when I ask why we should be letting our kids play with this stuff?

I don’t think so, and here is why:  While thousands of synthetic chemicals are integral parts of our modern lives, this does not mean that any chemical can and should be used in any product.  In particular, how chemicals like the ones I just noted are used should get intense scrutiny, to say the least.

It may be that some of the offending chemicals are no longer used in the current Silly String formula – but that's something we don't know because its maker is allowed to claim such information proprietary.  It may be that some of the toxic chemicals used to make the polymer fully react, so that they aren't present in the Silly String itself, at least in normal use – but we can’t know this either, because no one requires such testing for residuals.

Whatever the risk, I would still assert the following:

• Chemicals with such clear toxicity should not be used in children’s toys.  Period. 
• Workers should not have to risk being exposed to such chemicals for the purpose of making toys.
• Society should not have to risk having such chemicals released into the environment as a consequence of making toys, whether during the chemicals' or product's manufacture or transport or after disposal of the product itself.

The C&E News article highlights an unplanned and highly novel use of Silly String:  Soldiers in combat zones have learned to spray it ahead of themselves when in confined spaces to help detect the presence of deadly trip wires.  Another possible future use is as an adhesive for medical use. 

Those potentially life-saving applications for this admittedly nifty polymer technology certainly call for a different calculus, where the outcome could be quite different than for its use as a children’s toy.  (I'm not suggesting, however, that the hazards of such uses should not also be scrutinized, or that safer alternatives not be identified or sought.) 

But the problem is that, at this point, no one is even bothering to do the calculation.  It is telling that the obvious questions as to whether this use of these kinds of chemicals might pose a risk to kids, or whether it is worth taking any such risk, were not even raised by the article's author.  Nor does our current chemicals management system effectively raise them, let alone demand they be answered.

This "silly" example is yet another reminder of why EDF believes we must fundamentally reform the law that governs how we manage these kinds of chemicals.

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.

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.

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

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

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

Who would know better than EPA?

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

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

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

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

Not a bad start for the new leadership at EPA.

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

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

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

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

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

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

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

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

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

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

Some context

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

     AND

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Conclusion

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

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

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

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

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

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

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

Doesn't that matter?

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

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

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

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

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

What's EPA's next move?

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

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

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

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

Still with me?

A red herring

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

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

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

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

The bigger problem

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

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

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

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

Solutions

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

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

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

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

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

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