Richard Denison, Ph.D., is a Senior Scientist.

As a Washington policy geek, it’s sometimes hard not to let the ups and downs of political prospects for achieving real improvements in public health protections from toxic chemicals get me down.  The tenacity with which some stakeholders insist on throwing wrenches into the works to block efforts to reach middle ground is indeed depressing.

But through it all, there is one constant that continually restores my optimism that we’ll eventually get where we need to get to:  Science keeps moving forward and inexorably points toward the need for reform.  I will use this post to briefly highlight four recent studies that demonstrate the changing landscape of our knowledge of how environmental factors, including toxic chemical exposures, are affecting our health.  What’s noteworthy about these studies is that they all identified adverse health effects in human populations, and linked those effects to early-life exposures.  They all also illustrate the complex interplay between chemical exposures and social or other environmental factors that directly challenges the overly simplistic and non-scientific approach to causation that our chemicals policies have taken for decades. 

Below are summaries of and links to the new studies. 

• Early-life exposure to PCE is associated with later-life risky behaviors. 

It is well-established that acute and chronic exposures to solvents like perchloroethylene (PCE) can affect one’s cognitive abilities as well as mental disposition and behavior.  So it should probably not come as a great surprise that epidemiologists are finding links between such exposures and problematic social behaviors such as alcohol and drug abuse and smoking. 

A major new retrospective cohort study (Aschengrau et al. 2011) published in Environmental Health compared a group of more than 800 people who had been exposed either prenatally or in early childhood to PCE in contaminated drinking water to an unexposed group of more than 500 people.  These researchers at Boston University School of Public Health found a 50-60% increase in the extent of drug use as teenagers or adults in those individuals who were highly exposed to PCE early in life, and a 30-60% increase in risky drinking and smoking behaviors.  The study employed extensive statistical analysis to identify and control for many other potentially confounding factors, including the subjects’ mothers’ behaviors and health status and a history of learning disabilities or mental illness.  While the authors appropriately note that “These findings should be confirmed in follow-up investigations of other exposed populations,” this study ought to be a real wake-up call.

• Phthalate exposure is associated with excess weight in New York City children.  

We’ve blogged here before about the increasing evidence that certain chemicals may act as “obesogens,” in some cases interacting with dietary, lifestyle and other environmental factors to increase the proclivity toward obesity.  Of particular concern are studies in laboratory animal that indicate prenatal and early-life exposures to such chemicals appear to increase life-long susceptibility. 

A new study (Teitelbaum et al., 2011) just published in Environmental Research lends greater weight to these findings.  The authors, who work at the Centers for Disease Control and at Mt. Sinai School of Medicine, measured body mass index (BMI) and weight circumference of 387 Hispanic and Black New York City children who were between six and eight years old.  They also measured the concentrations in the children’s urine of nine breakdown products (“metabolites”) of phthalates, including both high- and low-molecular-weight phthalates.  Of these, the urinary concentration of one of the metabolites – that of monoethyl phthalate – as well as the sum of all of the low-molecular-weight phthalate metabolites showed a strong dose-response relationship with both measures of body size in overweight children among the cohort. While such associative studies do not prove causality, the results are wholly consistent with other laboratory animal and human epidemiological studies.  All of this research increasingly points to the anti-androgenic effects of certain phthalates as the biological basis for physiological changes leading to increased body size (among other effects such as interference with normal reproductive development).

• Exposure to perfluorinated chemicals may interfere with childhood vaccine effectiveness.

Perfluorinated chemicals (PFCs) are widely used as surfactants and as water, grease and stain repellants in everything from upholstery textiles and clothing to paper food packaging.  As a class they are environmentally persistent and in some cases bioaccumulative, which has led to contamination of water and food.  Two of the most infamous PFCs are perfluorooctanoic acid (PFOA, now being phased out), the basis for the Teflon brand of products; and perfluorooctane sulfonic acid (PFOS), the former basis for the Scotchgard brand of products.  Both chemicals have been routinely detected in people through biomonitoring. 

A new study (Grandjean et al., 2012) just published in the Journal of the American Medical Association followed a group of about 600 babies born in the Faroe Islands (part of Denmark) through early childhood.  This location was selected because a high fish diet was expected to lead to higher levels of PFC exposure.  The children had received routine tetanus and diphtheria vaccines, and then at 5 and 7 years old were tested for associated antibody levels, which are correlated with the ability to fight off the disease if a child becomes infected.  The study found that the level of PFCs in the children’s blood was inversely correlated with the level of antibodies produced and maintained in response to the two vaccines:  the higher the levels of PFCs, the lower the antibody count.  In addition, the expectation that these children would carry higher levels of PFCs in their bodies due to higher fish consumption was not borne out; their levels were the same as or even slightly lower than those of children living in the U.S.

• Epigenetic changes are associated with socio-economic status and biomarkers for cardiovascular disease.

A growing body of research is identifying changes in epigenetic patterns in our DNA as a key mechanism that mediates the effects of exposure to a wide array of environmental factors, leading to changes in gene expression.  We’ve blogged here before about evidence suggesting that such epigenetic perturbations may explain how early-life exposures to toxic chemicals can lead to adverse health outcomes later in life.

Now, a new study (McGuinness et al., 2012) from British researchers published in the International Journal of Epidemiology adds to evidence that socio-economic status can lead to alterations in epigenetic programming that are in turn tied to potential adverse health outcomes.  In this study, a key type of epigenetic marking – methylation of DNA – was measured in about 240 people in Glasgow, Scotland.  What was measured was not the methylation of specific genes but rather the total level of methylation of DNA (termed global DNA methylation).  The authors note that “Changes in global DNA methylation may be some of the earliest cellular events in disease onset,” citing evidence linking decreases in DNA methylation to aging as well as various diseases, including cardiovascular and neuronal disorders and cancer.  The Glasgow cohort used in the study was established originally to investigate “the associated variation in mortality, morbidity and the extreme socio-economic (SE) gradient of health inequality in this city which is not fully explained by conventional risk factors for disease.”  What the authors found is startling:  A 17% reduction in global DNA methylation in the most socio-economically deprived group within the cohort compared with the least deprived group, and a 24% decrease in manual workers compared to non-manual workers that could not be explained by differences in age, gender or other factors beyond income level.  These reductions also correlated with an increase in certain biomarkers of cardiovascular disease, indicating higher risk.

The authors note that “Such global hypomethylation could be reflective of environmental exposures and/or diet during life, or a direct consequence of developmental programming in utero, or a combination of both.”  While noting that a larger study would be needed to distinguish among these options, they note that in utero epigenetic reprogramming has been associated in other studies with development of obesity, arteriosclerosis and diabetes.  In any event, it should be very disturbing that low socioeconomic status has now been shown to lead to readily measurable epigenetic changes associated with adverse health outcomes, potentially not only in individuals directly exposed but also in their children.

So there you have it:  Four studies that happened to come across my desk over just the last couple of weeks.  While no single such study is ever definitive, the results support and add to the import of many other studies in both laboratory animals and people.  Taken together, this growing body of research simply must move us to re-examine the impacts on our health arising from our shockingly laissez-faire approach to environmental exposures, especially those that disproportionately affect the most vulnerable among us. 

Richard Denison, Ph.D., is a Senior Scientist.  Allison Tracy is a Chemicals Policy Fellow.

Environmental Defense Fund today submitted comments along with 15 other health, environmental justice and state and national environmental organizations, in support of EPA’s proposed rule to address the final batch of 45 “orphan” chemicals that were never sponsored under the agency’s earlier High Production Volume (HPV) Challenge Program. 

An earlier post to this blog highlighted and applauded the novel, innovative and efficient approach EPA has proposed, which actually entails the coupling of two rules:

(1) a test rule for 23 of these HPV chemicals for which EPA can make the requisite exposure findings to require testing, combined with:

(2) a Significant New Use Rule (SNUR) for the other 22 HPV chemicals for which EPA cannot presently make such findings, which requires companies to notify EPA if their production or use of those chemicals changes so as to increase the potential for exposure and then warrant testing.

The comments we filed today reiterate our strong support for this approach – and propose that the same approach be extended to several additional batches of HPV chemicals that still lack a basic set of hazard data.

Background on the HPV Challenge Program

The HPV Challenge Program was initiated in 1998 to develop and make public a base set of hazard information on HPV chemicals:  those produced or imported in amounts of one million pounds or more per year. 

The starting list for the program was the roughly 2,800 chemicals reported at HPV levels in the 1990 Inventory Update Reporting (IUR) cycle.  Although the HPV Challenge Program ultimately led to the sponsoring of approximately 2,200 chemicals, it by no means successfully addressed all HPV chemicals.  In addition to sponsored chemicals that have yet to be tested or for which incomplete data sets were provided (see our report card on the program here), hundreds of chemicals were never sponsored and came to be known as “orphan chemicals.” 

EPA has slowly progressed in addressing those orphan chemicals that have continued to be produced at HPV levels, through this and three previous test rules published in the Federal Register.  When this fourth rule is finalized (hopefully including both a test rule and an accompanying Significant New Use Rule (SNUR)), EPA indicates that will conclude its efforts to address these orphan chemicals.  EPA has also indicated it may use this same paired-rule approach to address HPV chemicals reported in future cycles of the Chemical Data Reporting (CDR) rule for which a base set of hazard information is not publicly available.

Why we support the proposed rule

The final versions of previous test rules for earlier batches of HPV orphan chemicals were issued without an accompanying SNUR, and hence did not address those orphan HPV chemicals initially included in the proposed rule, but for which EPA was unable to make the exposure findings needed to justify issuance of a test rule under the Toxic Substances Control Act (TSCA).  That approach leaves open the possibility that production or use of such chemicals could expand in the future, perhaps presenting significant exposure potential, without EPA learning of such expansion in a timely manner and having the ability to require development of basic hazard information on those chemicals.  EPA needs sufficient information to screen such chemicals to determine if they may pose risks to human health or the environment. 

Given that HPV chemicals are, by definition, produced in aggregate volumes equal to or greater than one million pounds per year, we strongly support the proposal that EPA – when unable at present to require testing – at least be able to review the risks associated with a significant new use of such a chemical before that new use is initiated.  Using the combination of a test rule and a SNUR is a more thorough approach to getting the information needed to identify the potential risks posed by these 45 chemicals, and will better allow EPA to fulfill its responsibility to protect human and environmental health from hazardous chemicals.

Suggested improvements to the proposed rule

While we strongly support the current proposed rule, we believe this same approach needs to be expanded to all other groups of chemicals that were originally included in the HPV Challenge Program, but for which a base set of hazard data has yet to be developed and made public.  While not all the chemicals in these groups are “orphans” under the program, the data gaps that remain for them even many years after the HPV Challenge Program has run its course are unacceptable and warrant urgent action.

In our comments, we argue that EPA should issue paired SNURs and test rules for each of the following additional groups of HPV chemicals that either were removed from, or have yet to be adequately tested under, the HPV Challenge Program:

• A SNUR should be issued to require EPA notification of significant changes in production or use of those chemicals included in previous proposed rules on HPV orphan chemicals, but not retained in the corresponding final rules, due to a lack of sufficient evidence of substantial human exposure or environmental release.
• A SNUR should also be issued for chemicals that were initially identified as being HPV, but were designated no longer HPV based on production volume data that emerged later through Inventory Update Rule (IUR) reporting; our concern with relying on those data is the infrequent, spotty nature of the reporting that compromises EPA’s ability to accurately capture their actual production volume.
• A test rule should be issued for chemicals that were sponsored through the HPV Challenge Program (or a sister OECD program), but for which a base set of hazard information is still lacking; where EPA cannot make the requisite exposure findings to justify a test rule, a SNUR should be issued as EPA has proposed for the last batch of orphan HPV chemicals. 

See our comments for all the details!

Richard Denison, Ph.D., is a Senior Scientist.

Last August, Earthjustice, Environmental Defense Fund (EDF) and over one hundred other groups recently filed a petition under the Toxic Substances Control Act (TSCA) calling on the Environmental Protection Agency (EPA) to require manufacturers and processors of chemicals used in oil and gas exploration and production (E&P chemicals) – including those used in hydraulic fracturing fluids – both to conduct testing and submit to EPA health and environmental data they already have on hand..  The aim of the petition was to ensure EPA obtains better information on the identity, production, use and health/environmental effects of these chemicals in order to evaluate their health and environmental risks.  Late last month, EPA announced its decision. 

EPA Decision on the Petition

In November, EPA partially granted the petition.  It granted the petitioners’ request that EPA develop rules requiring makers of chemicals used in hydraulic fracturing fluids to submit existing information to EPA identifying the chemicals, their intended uses, quantities produced and health or environmental exposure to or effects of the chemicals.

While this is a positive step forward, EPA denied two other aspects of our petition. EPA rejected the request to issue a rule requiring testing of these chemicals to fill data gaps because the agency lacks sufficient information to make the potential risk or high-exposure findings it is required to make under TSCA to justify a test rule.  (The high evidentiary burden EPA must meet to require testing is of course a serious limitation of TSCA and a major reason why TSCA reform is so badly needed.)  It also limited the scope of the reporting rules only to chemicals used in hydraulic fracturing, and did not include other E&P chemicals, such as those used in drilling muds, or fluids.

An Important Clarification

It is important to note that the actions called for under the TSCA petition are different from the disclosure efforts EDF and others have been pushing for on a state-by-state basis, in three respects.  First, the reporting rules will apply to manufacturers and processors of the chemicals themselves, whereas the disclosure initiatives focus on oil and gas drillers to publically disclose chemicals they add to hydraulic fracturing fluid.  Second, the EPA rules are intended to provide EPA with information sufficient to understand the potential risks of the subject chemicals at an aggregate, national level, whereas the disclosure initiatives are aimed at a local, even well-by-well scale.  Third, the EPA rules encompass information beyond just the identity of the subject chemicals to include other information about their production, use and potential health/environmental effects.  While much of the information reported to EPA under the rules can and should be made public, increasing disclosure per se is not the primary focus of our petition nor of the rules.

Next Steps

EPA’s decision is in sum welcome as an advancement of efforts to identify and reduce environmental and public health impacts from oil and gas exploration and production.  EPA plans to solicit input on the design and scope of reporting requirements as well as the process by which information is “aggregated and disclosed to maximize transparency and public understanding.”  Through these processes, EDF, Earthjustice and other petitioners can argue for EPA to make enhancements “to ensure that the health and environmental risks posed by E&P chemicals are fully understood,” as we stated in the TSCA petition.

Richard Denison, Ph.D., is a Senior Scientist.

One thing I’ve learned in observing EPA try to operate under the Toxic Substances Control Act (TSCA) over the years is that – faced with limited authority and significant evidentiary and resource burdens – the Agency often has to resort to a workaround to get something it needs to do done.

Can’t ban a nasty chemical?  Wait until it’s voluntarily withdrawn and then pounce on it with a Significant New Use Rule (SNUR) to try to wedge the door closed.  Witness PFOS and penta and octaBDE.  (Under TSCA, without a SNUR in place on a chemical, a new producer or importer could start up without even letting EPA know; where EPA has issued a SNUR for a chemical, advance notification is required and EPA least has a chance to weigh in before production or import proceeds.)

Can’t require an up-front minimum data set for new chemicals?  Recommend to companies that for certain chemicals they submit such a data set along with the pre-manufacturing notice (PMN) they’re required to file, or risk having EPA extend the review of their new chemical or negotiate with them to do the testing.  EPA has made such “recommendations” for those relatively few new chemicals where the company “anticipates” at the outset producing it in large amounts in the first three years or where significant release or exposure is projected. 

The latest such workaround?  EPA’s simultaneous issuance of a proposed test rule and a proposed SNUR for a batch of high production volume (HPV) “orphan” chemicals that no company agreed to sponsor under the Agency’s voluntary HPV Challenge Program.

Necessity is the mother of invention, they say, and these creative new proposals are a case in point.  But, my oh my, there’s gotta be a better way….

EPA bears a heavy cross to require testing 

Now, to justify requiring testing under TSCA, EPA has a number of substantial burdens it must meet.  First, EPA must first make one of the following statutory findings:

1.  The substance “may present an unreasonable risk of injury to health or the environment” and the probability of exposure to it is more than just theoretical. 

OR

2.  The substance is produced in “substantial quantities” and either enters the environment in “substantial quantities” or there is “substantial or significant” human exposure.

In practice, EPA is rarely able to make the first, “risk-based finding” because it lacks the very data that testing would provide.  In virtually all cases where it has issued test rules, EPA has relied on making the second “exposure-based finding.”   

Here are the criteria EPA uses to define “substantial” production and environmental release:

• substantial production/importation is one million or more pounds per year; and
• substantial release is one million or more pounds per year, or 10% of the total amount produced or imported.  

EPA defines “substantial or significant” human exposure as that affecting 1,000 workers, 10,000 consumers, or 100,000 members of the general population.  Here again, however, EPA has to have sufficient information to document that these thresholds are met. 

Finally, there are two other, non-trivial findings EPA must make in order to issue a test rule.  EPA must show that:

3.  existing data are inadequate for risk assessment,

AND

4.  testing is needed to develop the data.

Issuing a SNUR is not as difficult as is a test rule; while EPA has a list of factors it must consider, it doesn’t have specific findings it must make.  However, there are two significant limitations:

• A SNUR cannot reach any activities associated with a chemical that are already underway, because by definition they are not "new."
• 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.  To regulate, EPA would have to negotiate a Section 5(e) consent orderwith the notifier or demonstrate "unreasonable risk" to justify a restriction under Section 6 (a task that has proven virtually impossible in practice). 

So how has EPA met these burdens in the present case?

All 45 of the chemicals that are the subject of the latest proposed rules are HPVs, i.e., produced at or above one million pounds per year.  So they meet the substantial production threshold.  But, as just noted, that’s not enough for EPA to be able to justify testing. 

The 45 HPV chemicals that are the subject of the latest proposed rules fall into two classes: 

• For 23 of them, EPA is proposing to require testing because it indicates it has sufficient information to meet the burden of showing “substantial or significant” human exposure.  In the current context, EPA has based these findings on evidence that:  (1) the chemicals are present in consumer products used by large numbers of the general population, and (2) more than 1,000 workers are reasonably expected to be exposed within one or more corporate entities producing the chemical.
• For the other 22, EPA is proposing a SNUR, because it lacks such information; the SNUR would require that EPA be notified before a company begins producing, importing or processing one of these chemicals for use in a consumer product or in a manner that would potentially expose more than 1,000 workers within a corporate entity.

Now, here’s the creative part: 

• If EPA receives reliable evidence in comments it receives on the proposed rules indicating that a chemical in the first group is not produced or used in the manner it believes to be the case that justifies requiring testing, it will instead issue a SNUR for that chemical that would require notification should such production or use be pursued by a company.
• If EPA receives reliable evidence in comments it receives on the proposed rules indicating that a chemical in the second group is currently being produced or used in the manner that would trigger the SNUR – and hence that it should not be included in the SNUR because such production or use is in fact not new – EPA intends to issue a test rule for that chemical because such production and use would now meet the additional triggers needed to require testing.

Lest you’re thinking this paired-rule approach proposed by EPA is too clever by half, it’s good to remember that, way back in 1998 when it launched the HPV Challenge Program, EPA said its expectation wasthat all HPV chemicals would have, as a condition for being on the market, a minimum set of screening-level hazard data:   

“EPA expects that, over time, the testing of new HPV chemicals will become routine, and companies may wish to test new HPV chemicals as they appear.”

Industry agreed, after considerable pressure was applied, and the American Chemistry Council (ACC) unilaterally launched in 2005 its short-lived voluntary Extended HPV Program that was intended to spur testing of the many hundreds of chemicals that have reached HPV production levels after the HPV Challenge was launched and hence were not included in it.  But the Extended HPV Program was flawed from the outset, never attracting more than a small number of volunteer companies and delivering little new data.   

In writing this post, I had planned to link to ACC’s webpages for the Extended HPV Program, but alas, they’ve disappeared from ACC’s website, and I could only find a single mention of it anywhere on the site, buried on this brief page on the HPV Challenge.  That speaks volumes (pun intended).

At any rate, given the industry’s acknowledgment that at least all HPV chemicals ought to have a base set of hazard information publicly available, one would hope they will support EPA’s modest workaround.  Even EPA’s proposed approach falls well short of ensuring all HPV’s have such data.  That’s because under TSCA, the fact that a chemical is produced in volumes of one million pounds or more is not sufficient to trigger testing. 

What does all this mean for TSCA reform?

The machinations EPA must go through to try to get basic safety data even for those chemicals produced in the highest volumes are pretty sad, in my view.  What should be done?   

First, a basic set of safety data ought to be mandated, not only for HPV chemicals, but for all chemicals in commerce.  That straightforward notion is embodied in the preamble to TSCA itself and bears repeating: 

“It is the policy of the United States that … adequate data should be developed with respect to the effect of chemical substances and mixtures on health and the environment and that the development of such data should be the responsibility of those who manufacture and those who process such chemical substances and mixtures.”  

Second, EPA shouldn’t have to go through a case-by-case rulemaking, as required to issue a SNUR, just to be able to learn about and keep up with significant changes to the production and use of a chemical.  Here again, there ought to be an ongoing, universal requirement that companies notify EPA when such changes occur.  And EPA should have authority to look at, or re-look at, a chemical when that information warrants.

Those modest asks, it seems to me, are common- sense underpinnings of a sound chemicals management system in which the public can have confidence. 

The Wikipedia entry for “workaround” notes:  “Workarounds can also be a useful source of ideas for improvement of products or services.” 

In this context, “improvement of products and services” ought to serve as code for legislative reform of TSCA.

Richard Denison, Ph.D., is a Senior Scientist.

I want to clarify and expand on the discussion in my last post on ACC’s selection of criteria for persistence (P) and bioaccumulation (B).  The bottom line remains the same:  ACC selected the least conservative values proposed by any authoritative body for these parameters. 

I want here to give a fuller picture of available P and B criteria.  It should be noted that there can be multiple types of measures of both P and B, but so as not to overly complicate the discussion, and for comparative purposes, I’m focusing here on:

• Values for transformation half-lives for P
• Values for fish bioaccumulation factors (BAF) or fish bioconcentration factors (BCF) for B

As a reminder, here’s what ACC proposed for these values:

• Half-life < 180 days = non-persistent
• BAF/BCF > 5,000 = bioaccumulative

So how do those compare to cut-offs established by authoritative bodies?

Globally Harmonized System (GHS):

• For P, GHS doesn’t use transformation half-life values.
• For B, GHS indicates that a fish BCF < 500 is “considered as indicative of a low level of bioconcentration.”

EPA’s New Chemicals Program (policy for PBTs) and Toxics Release Inventory (TRI) PBT definitions:

• For P:
  • a half-life > 60 days in water is deemed persistent and triggers imposition of testing requirements and controls via a consent order (if B and T criteria are also met)
  • a half-life > 180 days is deemed highly persistent and triggers a presumptive ban unless demonstrated to be incorrect (if B and T criteria are also met)
• For B:
• a fish BAF/BCF > 1,000 is deemed bioaccumulative and triggers imposition of testing requirements and controls via a consent order (if P and T criteria are also met)
• a fish BAF/BCF > 5,000 is deemed highly bioaccumulative and triggers a presumptive ban unless demonstrated to be incorrect (if P and T criteria are also met)

EPA’s Design for Environment (DfE) Program:  These are the values that I cited in my last post; they were developed by DfE staff in consultation with other EPA experts and consideration of relevant literature.  They were designed to provide greater granularity in P and B rankings to reflect the continuous nature of these chemical properties.

EU REACH Regulation Annex XIII:

• For P:
  • a half-life > 40 days in fresh water is deemed persistent
  • a half-life > 60 days in fresh water is deemed very persistent (vP)
• For B:
• a fish BAF/BCF > 2,000 is deemed bioaccumulative
• a fish BAF/BCF > 5,000 is deemed very bioaccumulative (vB)

Finally, it’s worth noting that the Stockholm Convention on Persistent Organic Pollutants (POPs) also has criteria to identify P and B for chemicals for which international bans on production and use are warranted (when they also meet toxicity criteria) – which of course goes far beyond mere criteria for prioritizing chemicals for further scrutiny.  Here are the POPs criteria:

• For P:  a half-life > 60 days in fresh water
• For B:  a fish BAF/BCF > 5,000

It’s clear that ACC’s P and B cut-off values are those representing the most extreme level of concern for these parameters across a range of authoritative U.S. and international bodies.

Richard Denison, Ph.D., is a Senior Scientist.

As I noted in my last post, the American Chemistry Council (ACC) issued its own “prioritization tool” in anticipation of the Environmental Protection Agency’s (EPA) public meetings  to get input on the approach it will use to identify additional chemicals of concern under its Enhanced Chemicals Management Program.

In the context of TSCA reform, various actors in the industry have long called for prioritization, often saying they support EPA’s ability to get off to a quick start on identifying chemicals for further work – only to propose schemes that are more likely to do the opposite.

ACC itself has over time come off as a bit schizophrenic on prioritization, apparently being for it before they were against it.  ACC’s release of its tool puts it squarely back in the pro-prioritization camp, but just what is it proposing?  My sense is it’s after something quite different from what EPA proposes, and frankly, different from what EPA is currently capable of deploying, given its limited authority and resources under TSCA.  In this sense, ACC’s proposal is more relevant in the context of TSCA reform, where we presumably would have an EPA with a mandate to review all chemicals in commerce, the authority to readily get the data it needs, and the resources required to execute the kind of comprehensive prioritization scheme ACC proposes.

But setting that disconnect aside for the moment, let’s delve a bit deeper into the ACC proposal on its own merits. 

ACC’s proposal is welcome in several ways:  First, it’s substantive and specific (which I haven’t always been able to say about what ACC has offered in the past).  It’s so much easier to start working toward common ground when you know where the other guy is coming from.

Second, there are some refreshing elements and acknowledgments:

• ACC at least implicitly notes (p. 2) that there are gaps in available hazard data for many chemicals – and that a chemical with such gaps should be elevated in priority to a high ranking.  (Unfortunately, ACC makes no such provision for what is arguably an even larger knowledge gap for chemicals:  data on use and exposure.  This is one of several ways in which ACC’s tool over-relies on limited exposure information.)
• Chemicals with multiple uses would be assigned the overall exposure ranking corresponding to the use with the greatest potential exposure (p. 5) – an appropriately conservative approach.  (Unfortunately, this is not the approach ACC uses in other cases; more below).
• ACC rightly criticizes at some length (p. 9) EPA’s reliance on presence in children’s products as insufficiently indicative of kids’ exposure – noting, for example, that products used in the home but not by children may well lead to higher exposures.  (Unfortunately, it relegates children’s exposure potential to a second-tier consideration in prioritization.)
• ACC appropriately proposes using production volume (p. 6) as one of several surrogate measures of exposure – a bit ironic, given how much the industry railed against the European Union’s REACH Regulation for doing the same.  (Unfortunately, ACC reserves its “high” ranking for those few chemicals annually produced at the staggeringly high level of 100 million pounds per year – that’s 100 times higher than the level EPA has designated as a high production volume (HPV) chemical.)
• ACC proposes that EPA be able to use its professional judgment (p. 1) in certain aspects of prioritization – though it then appears to limit that allowance to hazard ranking (not exposure ranking!) and second-tier considerations.  (And as we’ll see below, little evidence of such flexibility is evident in the details of ACC’s proposal.)

There are also a number of quite problematic aspects of ACC’s proposal:

Overly rigid rules applied in lockstep

For an organization that has frequently asserted that the greatest strength of TSCA has been its flexibility, ACC has produced a remarkably rigid tool for prioritization.  With calculator-like precision, neatly-assigned little numbers get tallied up in the ACC tool:  Each element gets a numeric score, which are then added up and banded to yield crisp overall scores, which are finally assigned to high-, medium- and low- priority status.  But the real world is not quite so reducible to simple arithmetic.

ACC’s tool demands EPA use certain “rules” in the name of sound science and consistency:

The “equal basis” rule:  Most prominent among these rules is that “the hazard and exposure elements should be applicable across all substances being evaluated” (p. 10), “rather than just those information elements available only for subsets of chemicals” (p. 1).

By this sleight of hand, ACC manages to rule out any types of information that may indicate a hazard or exposure of high concern unless it has been measured across basically all chemicals subject to prioritization.  This rule may well help to explain ACC’s relegation to a second-tier consideration any direct evidence of human or environmental exposure – e.g., biomonitoring and environmental release and media monitoring data – because such data aren’t collected for all chemicals.  ACC instead would have EPA resort to extremely narrow and rigid definitions and measurements of persistence and bioaccumulation potential even where direct real-world exposure data exist (more on this below).

The lockstep application of this rule would have EPA ignore a chemical like perfluorooctanoic acid (PFOA) because it accumulates in blood rather than in fat tissue – the latter being the only kind of data that are available for many if not most chemicals and to which ACC restricts its bioaccumulation criterion.

ACC’s rule would also have EPA ignore other chemicals with unique or uncommon properties simply because either most chemicals haven’t been examined for those properties or because those properties actually distinguish certain chemicals from most others.  An example of the former might be a chemical deemed of concern because it is known to disrupt expression of a particular gene, while an example of the latter would be virtually all nanomaterials with unique size-dependent behavior that only shows up at the nanoscale.

High hazard and high exposure:  A second such rigid rule in ACC’s tool is that only chemicals for which high hazard and high exposure can be demonstrated warrant high priority.  While such chemicals certainly merit prioritization, applying this as a hard-and-fast rule is overly limiting of professional judgment.

I noted in my last post that ACC invokes the Canadian approach to categorization to support its tool.  But ACC fails to point out that the criteria Canada used to screen its inventory included separate criteria for hazard and exposure, and any chemical meeting either advanced to the next stage.

Given the large gaps in hazard and exposure data for many chemicals, it’s simply shortsighted to automatically set aside as low priority any chemical for which evidence of both high hazard and high exposure is lacking – without any regard for how high the hazard or exposure might be.  A potent developmental toxicant for which there is uncertainty about the extent to which pregnant women or infants are exposed may well warrant prioritization; likewise for a chemical released to the environment that is highly bioaccumulative and where there is suggestive but not definitive evidence of serious hazard.

This need is especially acute given that one of the key actions to be taken on chemicals that are prioritized is to get more information on their hazards, uses and exposures – a step that would be forgone if a high-hazard or high-exposure chemical were set aside indefinitely.

Over-relying on exposure information – appropriately called the “weakest link” in risk assessment – to relegate high-hazard chemicals to low priority is especially problematic – a topic on which I have blogged at some length earlier.

Persistent and bioaccumulative:  A third rigid rule relates both to how ACC defines these P and B properties, and how ACC would only assign high priority to chemicals that are both P and B.  Here again, ACC’s invoking of Canada as the ideal approach fails to acknowledge that that country’s criteria included chemicals that, in addition to being toxic, were found to be persistent or bioaccumulative.

ACC’s tool uses extremely narrow definitions of P and B, presumably due in part to the “equal basis” rationale that more data exist from tests based on the narrow definitions.  The B definition, for example, assumes that the only means by which chemicals bioaccumulate is by being taken up from water into the fat tissue of aquatic organisms.  Yet bioaccumulation can occur in other tissues (e.g., blood, bone) and by other routes, for example, through food-web uptake and accumulation by air-breathing animals.

Many chemicals that may not qualify as P or B using ACC’s narrow definitions are for all intents and purposes persistent or bioaccumulative.  This is often the case for chemicals that are frequently or even continuously released into the environment or to which people are routinely exposed.  Bisphenol A is not P or B, yet shows up in the bodies of more than 90% of the American population.  Why?  Because exposure to it is ubiquitous and ongoing, it’s being replaced as fast as it’s being eliminated.  It makes no sense for EPA to be required to ignore that fact.

There’s every reason to consider the data on P and B that ACC proposes be used – but there’s also every reason not to stop there.  Especially if data from biomonitoring and monitoring of environmental releases and media reveal direct evidence of persistence, EPA can and should consider this information in making prioritization decisions.  Yet ACC’s tool would relegate such data to at best second-class status.

Consistent use of the least conservative classification values

For toxicity, ACC proposes that EPA rely on classification criteria developed under the Globally Harmonized System (GHS) for Classification and Labeling (p. 1). 

(Now, I simply must stop here for a moment to flag a statement in ACC’s document (p. 2) that I can only hope is an inadvertent – if gross –misstatement.  ACC claims that “GHS classification information is readily available for all substances, as U.S. manufacturers have developed GHS classifications for their products to meet international requirements.”  But GHS does not require any company to generate any data where it doesn’t already exist; it simply provides a means of classifying already available data.  Because GHS provides criteria for dozens of different endpoints, I can imagine that most chemicals will have some data for some endpoints for which GHS provides classification criteria.  But it is simply untrue that companies have data for all such endpoints.  A very small number of chemicals have been tested for carcinogenicity, for example, yet GHS provides criteria for this endpoint.)

But back to ACC’s tool:  I generally support ACC’s proposal that EPA rely on GHS criteria, but with two caveats:  First, GHS does not include every endpoint of concern, and its use should not limit EPA’s ability to consider other health or environmental endpoints.

Second, GHS’ cutoff values must be used faithfully – and here, ACC fails badly.

ACC’s Table 2 (p. 3) lists what it says are cutoff values for repeat dose toxicity test data.  But the table neglects to specify the corresponding test duration or to note that the cutoff values depend on the duration of the repeat dose test.  Instead, ACC uses the least conservative values – those corresponding to the less commonly used 90-day test duration.  Applying ACC’s cutoff values to data from the much more commonly used 28-day repeat dose test would relegate what GHS would classify as a high-toxicity chemical to a lower ranking.  See Table 6, p. 17, in this EPA document summarizing the GHS repeat dose criteria.

This is not the only case in which ACC has selected the least conservative cutoff values:

• Persistence:  ACC’s tool would designate any chemical with a degradation half-life in water, soil or sediment of less than 180 days as “non-persistent” (p. 7).  Yet EPA’s own PBT criteria, also used in the New Chemicals Program, would classify chemicals with half-lives all the way down to 16 days as at least moderately persistent!  Here are EPA’s criteria (from Table 12, p. 23 in this EPA document):
  • > 180 days half-life = Very highly persistent
  • 60-180 days half-life = Highly persistent
  • 16-59 days half-life = Moderately persistent
• Bioaccumulation:  ACC’s tool would only designate a chemical as bioaccumulative if its fish bioaccumulation factor (BAF) or bioconcentration factor (BCF) exceeded 5,000 (p. 7).  Yet here again, EPA’s own PBT criteria, also used in the New Chemicals Program, would classify chemicals with BAF or BCF values all the way down to 100 to be at least moderately bioaccumulative!  Here are EPA’s criteria (from Table 13, p. 24 in this EPA document):
  • >5000 BAF/BCF = Very highly bioaccumulative
  • 1,000-5,000 BAF/BCF = Highly bioaccumulative
  • 100-1,000 BAF/BCF = Moderately bioaccumulative

ACC’s tool fails on two counts:  Not only does it use the least conservative values, which would relegate many P and B chemicals to low priority.  It also takes two critical chemical properties that manifest themselves along a broad continuum, and assigns a single bright line – when all authoritative bodies have explicitly acknowledged the continuous nature of such properties by designating multiple classification categories, ranging from very high to low or very low.

Over-relying on limited exposure information and discounting evidence of hazard

In several subtle ways, ACC’s tool reflects its longstanding tendencies to over-rely on limited exposure information and discount evidence of hazard:

• The tool collapses its health hazard and environmental hazard rankings into a single score (albeit the higher of the two), whereas it combines scores for its three exposure elements.  This means that a chemical that harms both people and other organisms only gets counted once, while a chemical that is low-volume and used only as an intermediate and is not P or B gets credit for being of low concern for all three attributes.
• The tool’s scale for hazard runs from only 1-4, whereas its exposure scale runs from 1-5.  Because these scores ultimately get combined, it’s that much harder for a high-hazard chemical to get a high overall ranking than it is for a low-exposure ranking to get a low overall ranking.
• High-exposure scenarios that occur in industrial and commercial settings get discounted (Table 3, p. 5).  Only chemicals with consumer exposure get a high ranking; this means that even if large numbers of workers are exposed to a very high-hazard chemical, that chemical automatically gets assigned a lower exposure priority.  Again, this approach is too rigid:  EPA needs to be able to elevate in priority a chemical where the risk to a subset of the population is disproportionately high.

Conclusion

While ACC’s tool has some serious flaws and is not something that EPA has the authority or resources to utilize under current TSCA, ACC has put forth a serious proposal for prioritization that should help to raise the level of debate over this critical issue in TSCA reform. 

Richard Denison, Ph.D., is a Senior Scientist.  Thanks to my colleagues Jennifer McPartland and Allison Tracy for their analysis of the EPA proposal discussed in this post.

Last week, the Environmental Protection Agency (EPA) held stakeholder meetings to get public input into the criteria it will use to identify additional chemicals of concern beyond the 11 chemicals or chemical classes it has already identified.  EPA used these meetings (as well as an online forum open until September 14) as an opportunity for the public to respond to a “discussion guide” it issued in August that sets forth draft criteria and identifies data sources it intends to use to look for chemicals that meet the criteria.

The day before the EPA meetings, the American Chemistry Council (ACC) issued its own “prioritization tool” which lays out its own criteria and ranking system for identifying chemicals of concern.  This post will make a few observations about EPA’s proposal.  My next post will provide a critique of ACC’s proposed tool.

EDF and the Safer Chemicals Healthy Families coalition strongly support EPA in this endeavor – both for what it is, and for what it is not.   

The word “action” was for many years virtually missing from the EPA chemicals program’s vocabulary.  (I guess you could say the program was kinda “missing in action.”)  Of the more than 60,000 chemicals on the market at the time TSCA was adopted in 1976, fewer than two percent have received any substantive, data-informed review.  So it is a welcome development that EPA is actually looking at chemicals in commerce – despite the lack of a mandate to do so under the Toxic Substances Control Act (TSCA) – and, for those posing concerns, initiating at least those limited actions allowed by TSCA.

For the chemicals of concern EPA identifies, it expects to develop “chemical action plans” similar to those it has developed for the first 11 noted above.  These plans identify “a range of actions … from voluntary phase-outs and alternatives assessments in cooperation with industry and other stakeholders, to the development of test rules to require the development of additional data under section 4 of TSCA, to controls or use restrictions under sections 5 or 6 of TSCA.”

What EPA’s proposal is not

That’s the purpose of the criteria EPA is now proposing to formalize.  Equally important is what EPA’s purpose is not.  As EPA states on its website:

“EPA’s goal is to identify priority chemicals for near-term evaluation, not to screen and prioritize the entire TSCA Inventory of approximately 84,000 chemicals.”  (emphasis added) 

EPA has been clear that the latter task – a comprehensive review and ranking of all chemicals in commerce – is beyond its current authority and resources, and that any such effort – to the extent it is desired – must await TSCA reform.

Clarity as to the more limited purpose of EPA’s current initiative is important to note for two reasons.  First, it means that EPA is not claiming that chemicals it identifies as priorities are necessarily those that have somehow been shown to pose the greatest risk in comparison to all other chemicals.  Rather, they are chemicals for which there is sufficient evidence or reason for concern that they warrant further scrutiny.  And, of course, in order to actually regulate the production or use of such chemicals, EPA would have to meet the very high burdensimposed on it under TSCA. 

Second, some in industry have been arguing that EPA cannot even name a chemical of concern unless it first shows it is at the top of the list, identified through some kind of comprehensive ranking system that is applied to all chemicals in commerce.  That approach is indeed awfully close to what ACC has proposed as its “comprehensive” prioritization tool, about which I’ll have more to say in my next post. 

This impression is amplified by ACC’s invoking of the Canadian approach to prioritization to support its tool.  What ACC fails to mention is that Canada’s approach – which entailed a review of all 23,000 chemicals on Canada’s equivalent to the TSCA Inventory – was mandated by statutein amendments to the Canadian Environmental Protection Act (CEPA) adopted in 1999.   

Moreover, Canadian agencies were given seven years and a major infusion of new resources to complete just the first phase of its process.  With 84,000 chemicals on the TSCA Inventory … well, I’ll let you do the math to guesstimate how long and how many resources it would take for EPA to carry out the same approach.  Without the authority and the resources, well, that’s just a recipe for paralysis by analysis.

So, what is EPA’s proposal? 

While the EPA description of its proposal is merely a “discussion guide” and more detail will be needed to fully comprehend it, the agency proposes to utilize a basic set of criteria about which there is little controversy at least at the 30,000-foot level.  We are pleased to see an emphasis on chemicals that can adversely affect children’s health, on PBTs (persistent, bioaccumulative and toxic chemicals), and on chemicals detected in biomonitoring.

EPA also identifies a list of sources of information it would use initially to identify chemicals meeting each of the criteria, and then additional sources it would use to refine the list, conduct reviews of the selected chemicals and initiate risk assessment and risk management actions as warranted.  Again, the sources EPA identifies are pretty straightforward.   

The idea, according to EPA, is to generate and make public an additional list of chemicals of concern this fall, and then to proceed on to identify more chemicals over time using the same criteria.  Release of that list would provide all parties with an opportunity to provide more information to the agency.

What else is needed? 

We generally support EPA’s approach and believe it strikes the right balance between clarity and transparency and avoiding paralysis by analysis.  Nonetheless, we offer the following 10 additional suggestions for improvement:

1.      Cast a wide net in Step 1:  EPA need not and should not limit the sources it relies on in Step 1 to a small number, as it suggests it will do, especially if those sources are intended to identify the longer list from which a subset will be selected for further review and action.

• Many of the sources EPA plans to use in Step 2 could identify chemicals that might otherwise be missed in Step 1.  For example, databases of chemical releases to or presence in air, water, fish, sediment, etc. should supplement the human biomonitoring data sources identified for use in Step 1.
• While an exhaustive search of all possible data sources is not warranted especially to develop a “starter list,” EPA should be able to efficiently conduct searches of multiple data sources by relying on its own and others’ integrated databases and portals, such as:
  • ToxRefDB:  EPA’s own Toxicity Reference Database captures thousands of in vivo animal toxicity studies on hundreds of chemicals.
  • ExpoCastDB:  EPA’s Exposure Database includes studies where chemicals were measured in environmental and biological media, including air, house dust and food, and human biological fluids and tissues.
  • The OECD’s eChem Portal:  The Portal consolidates chemical data from many different international and national programs across OECD member countries.
  • European Union classification databases and lists, including ESIS (the European chemical Substances Information System), which includes lists of chemicals classified using criteria developed under the Globally Harmonized System (GHS) for Classification and Labeling as carcinogens, mutagens, reproductive toxicants, aquatic toxicants, PBTs, etc.

 2.      EPA should not preclude using published, peer-reviewed literature as a primary source of information to identify priority chemicals:  While reliability and data quality always need to be considered in any weight-of-the-evidence approach, there is no a priori reason to exclude such information, any more than to exclude industry-generated data that populate many of the databases just noted.

 3.      Add criteria for environmental hazard and exposure:  EPA’s proposed criteria are heavily weighted toward human health and need to be balanced by adding criteria that address both hazards to wildlife and ecosystems and environmental release and exposures.

 4.      Expand health effects of prenatal and postnatal concern for children’s health:  Reproductive and developmental toxicity are appropriate focuses, but need to be supplemented with an additional explicit focus on neurodevelopmental effects, a major concern for many chemicals for which early life exposure may occur.

5.      Expand the scope of exposure considerations for children:  While EPA articulates a broad concern for children’s health, its main focus on products intended for use by children is far too limited.  Children may be directly exposed to products used in the home whether or not they use them.  And exposures that occur in utero via transfer of chemicals from pregnant women or through breast feeding may be just as or more important than children’s product exposures.

6.      Consider a broader range of vulnerable subpopulations:  While a focus on children’s health is warranted, EPA also needs to consider chemical exposures of workers and other subpopulations (e.g., environmental justice communities) who may be more susceptible or disproportionately exposed relative to the general population.  For workers, this focus should extend beyond chemical or product manufacturing workplaces to include exposures to chemicals in industrial or commercial products or materials they use (e.g., building materials, automotive products) or manage after their use (e.g., product and material recycling, disposal).

7.      Consider aggregate exposure to chemicals:  In making prioritization decisions, EPA should factor in the range of sources and uses of a chemical that contribute to overall exposure, not just those uses that fall under its TSCA jurisdiction.  While legal issues would need to be addressed if and when EPA decided that regulatory action would be needed, it makes no sense for EPA to ignore at this stage uses or sources of a chemical that may contribute substantially to overall exposure.  Just as EPA’s proposed reliance on biomonitoring data represents a measure of exposure integrated across all sources, so too should its consideration of other exposure information sources.

8.      Don’t exclude chemicals with high hazard or high exposure for which data gaps leave uncertainty as to risk:  Where strong evidence of high hazard or pervasive or high exposures exists, EPA should be able to prioritize such a chemical.  This is critical if the limited data gaps are to be addressed – otherwise, EPA will simply continue to look at the same data-rich chemicals over and over again.  Chemicals with high hazard or high exposure for which there is concern about the other parameter need to be prioritized at a minimum for data development to determine the level of risk they pose.  (I’ll have more to say about ACC’s insistence that only chemicals with affirmative evidence of both high hazard and high exposure should be identified as priorities.)

9.      Go beyond the TSCA Inventory Update Reporting (IUR) data on use and exposure wherever possible:  As we’ve blogged about repeatedly in the past, and as EPA has forthrightly acknowledged in finalizing major enhancements to its chemical information reporting system, chemical use information available to EPA through the IUR  are woefully incomplete and limited.  To the extent possible, EPA should look for other sources of such information to identify priority chemicals, and certainly should not exclude high hazard chemicals on the basis of such information.  That was a common mistake EPA made in its earlier, ill-fated ChAMP initiative.

10.   Provide more clarity as to how EPA intends to proceed from Step 1 to Step 2:  This is an area where EPA discussion guide is particularly lacking in detail and needs to be clarified.

As noted, my next post will provide a critique of the ACC prioritization tool it released last week, so stay tuned!

Richard Denison, Ph.D., is a Senior Scientist.

I’ve often been amazed when watching sports games on TV how quickly commentators can dig up the most obscure statistic about a player or team in real time, truly on the fly.  It’s not uncommon to be watching a game when a batter comes to the plate and I am immediately provided with his on-base percentage when batting left, facing that specific pitcher in the 9^th inning when there’s a runner on second and his team is trailing by two or fewer runs.

I was reminded of all that this morning when perusing the New York Times sports page, which had this incredible graphic.  It depicts the exact location of every ball put in play this season by Yankee first baseman Mark Teixeira, who’s having a bad year, comparing how well (or in this case, poorly) he does when he bats left- vs. right-handed. 

In the accompanying article, there is a link to Teixeira’s BaseballReference.com page showing batting stats for his entire career.  These include his batting stats for home vs. away games, games before vs. after the All-Star Game break, stats broken down by month of the season, by whether his team won or lost, by whether he was a starter or a substitute, by what position he was playing, by his position in the batting order, by inning, by what the ball-strike count was when he got a hit, by what bases were occupied at the time – this list represents only half of the slices and dices of the data provided on this one player’s page.

One player out of hundreds active this year, all with such stats available at the flick of a mouse.  Comparable stats on past players for decades past.  And this is just major league baseball.  There’s football, soccer, tennis, horse racing.

So, just one question:  Would somebody tell me why can’t I find out how many chemicals are produced in the U.S. and how they’re used?  Or what their hazards or risks are?

Speaking of the Toxic Substances Control Act (TSCA) and baseball, I can’t help but point to this recent quote (subscription required) that, believe it or not, links the two.  It was delivered by Fisk Johnson, CEO of S.C. Johnson & Son, at the American Chemical Society's 15th annual Green Chemistry & Engineering Conference in Washington, DC on June 21:

Your child has a better chance of becoming a Major League Baseball player than a chemical has of being regulated by EPA.

Now there’s a  statistic!

Richard Denison, Ph.D., is a Senior Scientist.  Allison Tracy is a Chemicals Policy Fellow.

A major initiative of EPA’s toxics office finally made it across the finish line yesterday when EPA posted a pre-publication copy of the final rule upgrading its chemical reporting system under the Toxic Substances Control Act (TSCA).  The process took over 16 months just to get from the draft of the proposed rule to yesterday’s final rule, with EPA having to endure not one but two nearly six-month regulatory reviews by the Office of Management and Budget.

The wait was largely worth it:  EPA’s new program – renamed the Chemical Data Reporting (CDR) rule – significantly advances chemical production and use reporting relative to its predecessor, the more arcane-sounding Inventory Update Reporting (IUR) rule.  Most, though not all, of the critical elements EPA proposed last year made it through to the final rule.  The catch is we’ll have to wait until 2016 for the program to reach its full potential. 

The significance of this reporting program is under-appreciated:  It is the only systematic means by which the federal government – and by extension the American public – gets any picture of which chemicals are produced in or imported into this country, by what companies, in what amounts and for what uses.  This kind of information is crucial to EPA’s efforts to carry out its mission to assess and manage the risks that chemicals may pose to human health and the environment.

Given the obvious need for such information, it is astounding that this program to collect it, in place since 1986, was so flawed as to yield not only an incomplete, but actually an inaccurate, picture of chemical production and use.  Changes made to the program in the mid-2000s in many ways made matters even worse, by reducing the frequency of reporting from one out of every four to one out of every five years, and by dramatically scaling back the number of chemicals reported by raising the reporting threshold from 10,000 to 25,000 pounds per year per site of production.

The new leadership at EPA undertook to change this situation to the extent it could.  While the final rule fails to reverse the threshold increase made in the mid-2000s, the reporting frequency has been returned to every four years – AND the rule will require reporting of production volume for every year in each cycle if the threshold is triggered for any year in the cycle. 

As we noted in comments we filed on the proposed rule, the previous system of reporting volume data for only a single year in each five-year cycle yielded a very inaccurate picture of which chemicals are actually in commerce.  We’ll have to wait until the 2016 reporting cycle for that to kick in, unfortunately, although in the 2012 cycle at least we’ll get production volume data for both 2010 and 2011.  Production volumes have been shown to fluctuate enormously from year to year, so having a system that provides year-to-year production data is essential to providing a reliable picture of the magnitude of chemical commerce.

One of the few positive aspects of the mid-2000s changes – in principle – was the addition of a requirement for companies to report processing and use information – a critical gap in both government’s and the public’s knowledge base on chemicals that has severely limited our ability to understand the potential risks posed by a chemical.  But the intent was stymied by three conditions placed on such reporting.  First, it only applied to chemicals produced above a whopping 300,000 pounds per year per site – a small minority of the chemicals subject to any reporting.  Second, such information could be claimed confidential without providing any justification.  And third, a company could claim the requested information to be “not readily obtainable” and get out of having to report it at all.

EPA’s final rule addresses all three of these flaws:

• The threshold for reporting processing and use information is being lowered, to 100,000 pounds per year per site in the reporting to be done next year, and to 25,000 pounds per year per site in the 2016 cycle. 
• Any confidentiality claim must be accompanied by up-front substantiation, which acts both to reduce the number of claims made and ensure those that are made are warranted. 
• Finally, the “not readily obtainable” loophole – very heavily used in the last reporting cycle – has been eliminated, replaced with the more conventional “not reasonably ascertainable” standard – which means you actually have to put some effort into trying to find the requested information.

Two other positive changes to note: 

• While the overall reporting threshold remains at 25,000 pounds per year per site, that threshold has been lowered to 2,500 pounds per year per site for those chemicals for which EPA has undertaken certain actions based on concerns about their risks.  These include chemicals for which EPA has issued Significant New Use Rules (SNURs), has listed as chemicals of concern (assuming OMB ever allows EPA to propose such a list), or has regulated under Section 6 of TSCA (the latter has rarely been used due to the high burden of proof EPA must carry, though EPA is considering trying to do so again).  Importantly, EPA need only have proposed, as opposed to finalized, such an action in order for the lower reporting threshold to apply.
• EPA will now require electronic reporting under the new rule.  Believe it or not, this was controversial even in 2011.  The lack of such a requirement in the last reporting cycle led to both major delays in EPA’s release of the data it collected and inaccuracies introduced by EPA being forced to manually translate information from hard copy to electronic form.

The final rule is not perfect:  the reporting threshold remains too high, wide latitude remains for industry to claim its submissions to be confidential business information (CBI), and most unfortunately, some of the key improvements made by EPA won’t hit the road until 5 years from now.

But given what the Agency had to navigate in the way of industry opposition, OMB meddling and delay and complaints from some in Congress, all in all, not a bad day’s (well, actually a couple years’) work.

Allison Tracy is a Chemicals Policy Fellow. Richard Denison, Ph.D., is a Senior Scientist.

EPA today proposed a Significant New Use Rule (SNUR) that, once finalized, would mandate that companies notify EPA prior to engaging in any “significant new use” of any of the 14 chemicals EPA has identified collectively as glymes.  Among other concerns, EPA has identified their use in various consumer products and their potential to cause reproductive and developmental toxicity.  For most of the glymes, the significant new use would be any use in a consumer product beyond those that are already ongoing.  For two of these chemicals, the significant new use would be any use.  

This proposed SNUR, which was mired at the Office of Management and Budget (OMB) for more than six months, is now out for a 60-day public comment period.  A SNUR is essentially the only means available to EPA under the Toxic Substances Control Act (TSCA) by which it can try to limit the use of an existing chemical of concern.  It is far from a perfect means of doing so. 

Nonetheless, within its limited authority under TSCA, today’s step by EPA brings at least some degree of scrutiny over a quite nasty group of chemicals. 

What the heck is a SNUR?

Section 5(a) of TSCA authorizes EPA to designate by rule certain uses of a chemical to be “significant new uses” and require any company to notify EPA at least 90 days prior to producing, importing or processing such a chemical for such a use.  Such a Significant New Use Rule affords EPA the opportunity to review the designated use of chemical (in a manner virtually identical to the way it reviews a new chemical), and decide whether more information is needed to assess its risk or conditions should be placed on it.  Sounds good, right?  Not so fast:

• Even to require notification of a significant new use via a SNUR, EPA must generally go through 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(e) (via a consent order) or Section 6 (a task that has proven virtually impossible in practice).

Nonetheless, a SNUR is better than nothing; in its absence, 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.

EPA’s Federal Register notice announcing the proposed SNUR identifies known uses for some of the glymes, as well as unconfirmed uses for which it seeks more information.  It cites specific toxicity concerns for the three glymes for which data exist – but notes its concern extends to all 14 chemicals because of their structural similarity to those that have been tested.

The SNUR for the glymes arose from “risk-based prioritizations” done under EPA’s ChAMP program on two glymes – monoglyme and diglyme.  These documents relied on hazard data from the High Production Volume (HPV) Chemical Challenge and use and exposure-relevant data from the Inventory Update Reporting (IUR) rule.   EPA’s assessments found these chemicals to be of high concern to workers, consumers and children due to potential risks from known uses.  They are both high production volume (HPV) chemicals, produced in amounts exceeding one million pounds annually.

As to the scope of the "significant new use" designations for the group of chemicals, EPA notes:

"Of the 14 glymes, 12 have industrial or consumer uses of some kind and two have no current uses. EPA has preliminarily determined that the manufacture, import, or processing of 12 of the glymes for “any use in a consumer product” is a significant new use, although some ongoing uses are excluded from the SNUR. In addition, EPA has primarily determined that the manufacture, import, or processing of the remaining two glymes for “any use” is a significant new use."

Health concerns raised by two glymes that have been tested

Monoglyme

The risk-based prioritization of monoglyme (CAS number 110-71-4) summarizes the available information on its production, uses, hazards and exposure potential.  Data from animal studies led EPA to conclude:  “The potential health hazard is considered high based on the results of repeated-dose studies using a major metabolite, 2-methoxyethanol (CAS No. 109-86-4) (effects on blood, thymus, and adrenal gland), and on reproductive/developmental toxicity found in studies on monoglyme (effects on sperm production, fetal body weight, and fetal skeletal defects).”

Monoglyme is used as a solvent in industrial products and can also be found in lithium batteries and certain industrial coatings. EPA classified the risk to workers as “high concern” because they are more likely to be exposed than the general population due to the many industrial uses. The known uses of monoglyme also establish the possibility of exposure for commercial workers and consumers (including children), for whom EPA also found the risk to be of “high concern.”

Diglyme

 As is the case for monoglyme, EPA’s risk-based prioritization for diglyme (CAS number 111-96-6) classified the chemical as “High Priority, Special Concern.”  The health risks associated with diglyme include lower sperm counts, toxicity to bone marrow, anemia, and damage to tissues of the immune system.  Studies also link diglyme to reproductive toxicity manifested in pregnancy loss, poor fetal growth and survival, and abnormal development.  The health effects are severe and run the gamut of toxicity-induced outcomes.

Diglyme is a solvent used in printing inks, automotive care products, paints and coatings, brake fluid and adhesives and sealants.  EPA’s designations of potential risks for workers and consumers (including children) from such uses were again “high concern.”