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

A peer-reviewed paper released today documents that nonwhite toddlers in North Carolina carry nearly twice as much of certain toxic flame retardant chemicals in their blood compared with white toddlers.  The finding adds to a growing body of evidence that exposures to toxic chemicals are higher in communities of lower socioeconomic status.

Numerous other studies have found higher levels of the flame retardants known as polybrominated diphenyl ethers, or PBDEs, in children and adolescents relative to adults.  The current study – authored by Stapleton et al., and appearing in Environmental Health Perspectives – may be the first, however, to demonstrate differential exposure based on socioeconomic status.

The authors studied a group of about 80 toddlers 1-3 years old living in North Carolina.  PBDEs were detected in 100% of the blood samples drawn from the toddlers, as well as in all samples of house dust and 98% of hand wipes tested by the authors.

The authors note that children’s exposure to PBDEs is especially concerning “due to their known endocrine disrupting and neurodevelopmental properties as observed in animal studies.”  They also note recent human studies reporting correlations between blood levels of PBDEs and motor, cognitive and behavioral performance in children.  PBDEs were the primary focus of a scathing expose of chemical industry deception and manipulation of science that ran recently in the Chicago Tribune, about which I blogged earlier.

Time Magazine has an excellent article on the new research and the larger context.

Interestingly, the higher levels of PBDEs found in the blood of nonwhite toddlers could not be explained by higher levels in house dust in the homes in which those toddlers reside, as the authors found no statistically significant difference in the concentrations of the PBDEs the measured in house dust samples across their cohort.  House dust is known to be a major, but not the only source of PBDE exposure.  The authors note that in this study they did not take into account dietary differences or variability over time or other differences in exposure patterns that may help explain the differential blood serum levels they observed.

Other important conclusions of the authors about PBDE exposure:

• Exposure via the indoor environment is substantial, and much of that exposure in toddlers is likely occurring via hand-to-mouth activity.
• These factors likely explain the higher levels seen in toddlers than adults, because toddlers engaged in more hand-to-mouth activity and spend longer amounts of time at home.
• One particular PBDE congener was an exception and showed higher levels in toddlers of higher socioeconomic status; the authors postulate that exposure via breastfeeding – the duration of which studies indicate is higher in women of higher socioeconomic status – may be a more important pathway for this particular PBDE.

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

After my long post this morning, I’ll keep this one brief:  The United Steelworkers, one of the nation’s top occupational physicians and EDF, represented by Earthjustice, have filed a motion to intervene in D.C. District Court, seeking to help defend the U.S. Department of Health and Human Services’ listing of styrene as "reasonably anticipated to be a human carcinogen."  The motion is in response to a chemical industry lawsuit attempting to force the agency's National Toxicology Program to withdraw the styrene warning, which was published in the 12th edition of the Congressionally mandated Report on Carcinogens. 

• See this earlier post for some background.
• Here’s our groups’ press release with more details.
• And here’s the motion itself.

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

This post is longer than usual and starts with a rather esoteric topic, but I urge you to read it through, as it vividly shows there is no limit to the lengths to which the American Chemistry Council (ACC) will go to squirm out of a regulatory requirement, even if it means violating rules by which ACC had agreed to abide.

But that’s far from the worst of it.  Going farther than even I could imagine when I blogged earlier about its tactics, ACC is sparing no effort to deny your right to know about the health impacts of chemicals, by mustering every argument it can invent – however far-fetched – to  keep health and safety studies from being shared with the public. 

ACC insists that the U.S. Environmental Protection Agency (EPA) should hassle the European Union (EU) instead of its members for the health and safety data ACC promised to provide – despite the fact that the chemical industry itself has thrown up major roadblocks to such sharing.  And reaching a new low in tortured logic, ACC argues that, should EPA succeed in getting its hands on the health and safety data submitted to the EU, EPA can and should deny the public access to those data – despite the fact that the Toxic Substances Control Act (TSCA) clearly prohibits EPA from withholding such information. 

First, some needed background.  Last week, EPA held a meeting to take public comments on a so-called “test rule” it proposed last October using its authority under TSCA.  The proposed rule, which we support, is the fourth in a series of test rules EPA has issued to make good on a promise it made over a decade ago, when it launched the voluntary High Production Volume (HPV) Chemical Challenge. 

The entire premise of the Challenge was that the public should have access to basic health and safety information on all high-volume chemicals.  Part of the agreement reached between EPA, ACC and EDF that established the Challenge was that EPA would impose testing requirements by rule on manufacturers that did not step up voluntarily to provide a base set of hazard data HPV chemicals they made.  Such unsponsored chemicals are commonly known as “orphan” HPV chemicals.

The proposed test rule would require testing of 23 orphan HPV chemicals, the fourth batch of such chemicals for which EPA has issued test rules.  Let me repeat:  These are chemicals actively being made and marketed in the U.S. at levels exceeding one million pounds every year.  Yet not one of the manufacturers of those chemicals was willing to make good on the industry’s commitment to honor the Challenge and voluntarily develop and make public a base set of hazard information. 

That has forced EPA to go through the laborious, multi-year (12 years and counting) process of rulemaking just to ensure the public gains access to the most basic of safety information on those chemicals produced in the largest amounts.  (This is but one of many shortcomings of the HPV Challenge; for more, see the EDF report High Hopes, Low Marks: A final report card on the HPV Challenge.)

Enter ACC, which is now opposing most aspects of EPA’s proposal and making two specious demands of EPA as to why it should not require ACC member companies to comply with the test rule.  These demands were delivered with a straight face by an ACC spokesperson at this week’s meeting, and they’re also included in the comments ACC filed on the proposed rule. 

I discuss those two demands next.  But the real clincher is where ACC goes after that, so be sure to read to the end of this post.

Demand #1:  EPA shouldn’t require our members to submit full copies of the required studies.

In launching the Challenge way back in 1988, EPA tried to offer incentives to companies to get them to volunteer.  One small incentive was that those who volunteered up front need only submit a so-called “robust summary” of each study reporting results of new testing, rather than a full copy of the study.  (EPA could subsequently request the full study on a case-by case basis.)  In contrast, companies who “volunteered” only after their HPV chemical was subjected to a test rule, and companies who decided not to volunteer at all and simply wait for the test rule, had to submit full copies of the studies reporting the new test data.

ACC agreed to all of these ground rules, as they were part of the original Challenge framework; see here and here.

Moreover, EPA test rules, including the newly proposed one, always require that companies submit full copies of studies developed to comply with the rule.  EPA’s proposed test rule states this explicitly:  “Data submitted to EPA to meet the requirements of testing under the proposed rule must be in the form of full copies of unpublished studies or full citations of published studies, and may be accompanied by a robust summary.” (p. 65597, emphasis added)

Why?  EPA has indicated that full copies of studies are needed because they are “relied upon to demonstrate data adequacy.”  While robust summaries can be useful for some purposes, access to full studies by the public as well as EPA is important.  In addition to providing important detail, without such access one must simply trust that the company that prepared the robust summary did so accurately and without bias.  Providing access both to robust summaries and to full studies embodies the maxim “trust, but [be able to] verify.”

Despite all this and ACC’s prior agreement that full studies should be provided, it now seeks to nickel-and-dime EPA.  In its written comments on the proposed test rule, echoed in this week’s oral presentation, ACC states:  “While full studies are preferable if available, EPA should accept a robust summary as sufficient for its data needs if a full study is not available.”

“… if a full study is not available.”  Hmm, that’s interesting.  Why wouldn’t the full study be available?  Why would an ACC member be submitting a robust summary of someone else’s study?  And how would they know it was accurate if they didn’t have access to the full study?

To recap, here we have ACC arguing that EPA and the public should make do with a robust summary, and that EPA should accept it no questions asked – even if it was prepared by someone other than the company subject to the test rule and that company lacks access to the underlying study.

What’s especially bizarre about this argument is that, in another context, ACC and its members are so adamant about preventing any “unauthorized” use by one company of chemical safety data developed by another company that they are mounting obstacles that threaten to preclude governments from sharing chemical studies with each other at all.

It’s ironic, because a requirement to provide full copies of studies would go some distance toward assuring that submitting parties not only have access to and an understanding of the full studies – but that they also have the right to submit the studies if they did not themselves develop them.

Which brings us to ACC’s second specious demand.

Demand #2:  EPA should just ask the European Chemicals Agency for the data.

It turns out that’s not so easy, and it’s the chemical industry that’s to blame.

ACC notes that “the test rule proposal would require the development and submission of studies which, for certain substances, the European Chemicals Agency (ECHA) likely already has in its possession or will receive in the near future under the EU’s regulation on the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH).”  ACC goes on to say:

“EPA should work for an agreement that would allow ECHA to share those studies and others to be submitted under REACH with EPA in confidence.”

Why couldn’t companies subject to the test rule provide those data directly to EPA?  According to ACC:  “It is often not feasible for persons subject to EPA test rules to obtain data from the Substance Information Exchange Forums (SIEFs) or consortia which own the studies submitted or to be submitted to ECHA under REACH, even by offering to pay data compensation.  SIEF or consortia agreements may specifically limit the use of data to REACH compliance, thus precluding authorization for use under TSCA.”   

What ACC fails to mention are two salient facts:

1.  Those “SIEF or consortia agreements” were not dictated by ECHA; they were negotiated by the chemical industry itself, so any data sharing problems are of the industry’s own making.

2.  Those same barriers to data sharing are hampering EPA’s ability to obtain REACH data from ECHA just as much if not more than they hinder companies from doing so. 

It’s not ECHA or EPA that is at fault; it’s the chemical industry.  That’s because the chemical industry, including ACC, is demanding that there be no sharing of REACH data even between governments without two conditions being met: 

The first demand is reasonable:  There should be a system that ensures the company that paid to conduct a study is compensated by any other company that seeks to use those data to meet a regulatory requirement.  (REACH has such a system, by the way.  TSCA does too, though it’s been used rarely in part because so few testing requirements have been imposed under TSCA.)

The second demand is outrageous:  That public access to such data must be denied.

Now for ACC’s attempted coup de grace

Did you notice how, several paragraphs up, I had italicized “in confidence” at the end of that first indented excerpt from ACC’s comments?  Take a moment to re-read that sentence.

Lest there be any doubt that what ACC means by that phrase is that the public should be denied access, here is what else ACC writes in its comments on the proposed rule (emphases added):

“It should be clear that section 14(b) of TSCA does not preclude EPA from keeping data and information obtained from other agencies confidential.”

[For a refresher on what TSCA Section 14(b) actually says, scroll down in this post to the header that reads “What TSCA says about your right to know.”  In brief, section 14(b) says that, with very limited exceptions, health and safety data received by EPA cannot be claimed confidential and withheld from the public – something that section 14(a) does allow for other kinds of data submitted under TSCA.]

Here comes ACC’s really tortured (nay, water-boarded) logic:

“Section 14(b)(1)(A) excludes from the reverse-FOIA provision of section 14(a) “any health and safety study which is submitted under this Act ….” The phrase “submitted under this Act” clearly refers to submissions by persons required by EPA under TSCA to submit information. It may also include submissions by members of the public who submit information under TSCA voluntarily. There is no reason to believe, however, that studies submitted to ECHA under REACH, and then provided by ECHA to EPA for the purpose of inter-governmental cooperation, would necessarily be “submitted under” TSCA.”

Know that whenever ACC says, in discussing the language of TSCA, that something is “clear” or “clearly means X,” it’s a “tell” that the opposite is far more likely to be the case.

ACC goes on:

“Section 14(b)(1)(B) also excludes from the scope of section 14(a) “any data reported to, or otherwise obtained by, the Administrator from a health and safety study which relates to a chemical substance or mixture described in clause (i) or (ii) of subparagraph (A).” This provision should similarly be read to be limited to data from health and safety studies obtained by EPA from private parties in connection with TSCA. “Reported to” is synonymous with “submitted.” “Or otherwise obtained by” refers to information that EPA may obtain from private parties under TSCA by request, from discovery, through subpoenas, or by other means. The phrase is clearly not intended to address confidential data received from other governments.

There’s that “clearly” again.  You don’t have to be a lawyer to see ACC’s blatant attempt to recreate TSCA in its own image, adding words that don’t exist in the statute or twisting those that do to serve their own twisted ends.

Here, in sum, is the sleight of hand that ACC is trying to pull off, telling EPA:

1. Don’t require our companies to provide data under the test rule if there’s a possibility now or any time in the future that similar data might be submitted under REACH.
2. Instead, negotiate an agreement with the Europeans to get the data from them, even though we’ve erected huge barriers to your doing so.
3. Should you nevertheless succeed, you must deny the public access to those health and safety data – something you could never do under TSCA if we submitted them to you directly – because what Congress meant when it required public access to any health and safety information “obtained by” EPA is only data we deign to agree to give you, which we won't do.

A new low, indeed.

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

Every day in my email I get the American Chemistry Council’s (ACC’s) “SmartBrief,” a digest of the day’s news related to the chemical industry.  Here’s its self-description:

Designed specifically for American chemistry professionals, ACC SmartBrief is a FREE, daily e-mail news briefing. It provides the latest news and information on the American chemistry industry.

As I noted in my last blog post, all this week the Chicago Tribune has been running one of the biggest stories relating to the chemical industry published in a long, long time.  Titled “Playing with Fire,” it documents in meticulous detail the campaign of deception that producers of chemical flame retardants have foisted on the American public for decades.

One might expect, therefore, that ACC’s SmartBrief this week would be directing its readers – who sign up to keep up with what they need to know that affects the chemical industry – to the Tribune’s series.  One would be wrong.  Nary a mention of this blockbuster story managed to find its way into SmartBrief this week.

It appears that only certain news relevant to SmartBrief’s audience of American chemistry professionals is deemed essential enough to make the cut over at ACC.  SmartBrief readers might need to look elsewhere if they want to know what’s really affecting their industry.

In fact, the only response to be found anywhere on ACC’s website to this week’s major news is this highly oblique press release posted there yesterday.  It makes no mention of the Tribune series, but does affirm the industry’s commitment to safety as a general matter.  And it includes this tidbit: 

ACC always strives to conduct its advocacy work in an open and transparent manner.

Oh really?

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

It’s hard not to get cynical in Washington, DC these days.  Just this past week, the American Chemistry Council (ACC) hosted an ice cream social on Capitol Hill – I kid you not.  ACC’s beckoning slogan:  “Join and learn about the benefits of chlorine chemistry and enjoy a tasty treat.”  I’m told hundreds of House staffers partook of this propaganda fest, at least the tasty treat part.  My initial reaction?  How can health and environmental advocates hope to compete?  Especially if one can successfully curry favor merely by offering a scoop of a staffer’s favorite flavor.

But just as I began to despair, Part I of a major exposé on a far more serious campaign of deception by the chemical industry ran on the front page of the Sunday Chicago Tribune.  (Actually, the article occupies virtually the entire front page of today’s edition.)  

The Chicago Tribune story is the first in a series titled Playing with Fire, and Part I will be followed by additional stories on Tuesday, Wednesday and Thursday.  The investigative reporters who deserve the credit:  Patricia Callahan, Sam Roe and Michael Hawthorne.

The chemicals in question are brominated flame retardants, chemicals produced in huge volumes and added to everything from furniture foam to TV and computer casings to myriad children’s products.  The chemicals are persistent, bioaccumulative and toxic (PBTs) and have been detected in marine and terrestrial mammals, birds, fish, and invertebrates – not to mention people.  They are strongly linked to a range of health and environmental impacts.

Here’s the title of today’s story in the Tribune:

Fear fans flames for chemical makers
Manufacturers of fire retardants rely on questionable testimony, front groups to push standards that boost demand for their toxic — and ineffective — products

And here’s a small excerpt that sets the stage:

These powerful industries distorted science in ways that overstated the benefits of the chemicals, created a phony consumer watchdog group that stoked the public's fear of fire and helped organize and steer an association of top fire officials that spent more than a decade campaigning for their cause.

The deceptions of the chemical industry in this matter are multiple.  They include the creation of a “citizen” front group called Citizens for Fire Safety – eerily reminiscent of the “Coalition for Chemical Safety,” the front group that ACC set up in 2009 to create the impression of strong support for its version of reform of the Toxic Substances Control Act (TSCA).  After it was exposed as a front group, CCS's existence was scrubbed from the Internet. 

Despite its warm and fuzzy name, Citizens for Fire Safety is the creation of the three main producers of brominated flame retardant chemicals – Chemtura, Albemarle and ICL Industrial Products, which the Tribune reports control 40% of the global flame retardant market.

Another key deception?  That the chemicals actually work.  In a companion piece to the front page story, the Tribune reports that testing, including by the Consumer Product Safety Commission, found that the chemicals don’t appreciably reduce the risk or slow the progression of fire.  And they are far less effective than ready alternatives such as wrapping foam in naturally fire-resistant wool or other barrier materials, as shown in testing by Underwriters Laboratory.  See also this 2010 paper in Reviews on Environmental Health, co-authored by the current Director of the National Institute of Environmental Health Sciences.)

I’ll leave you to read the Tribune series for more details.  I’ll close by simply quoting Launcelot from Shakespeare’s Merchant of Venice:  The truth will out.

Allison Tracy is a Chemicals Policy Fellow.

After many months of increasing the quantity but not the quality of dossiers available to the public for chemicals registered under REACH, the European Chemicals Agency (ECHA) has recently announced two improvements.  (REACH is the European Union’s regulation for the Registration, Evaluation, Authorization and Restriction of Chemicals.)  According to the agency, the public will soon have access to more data from the dossiers that were submitted by companies as part of the first wave of REACH’s Registration process.  

In a press release issued a couple of weeks ago, ECHA announced that it will publish information from registered chemicals’ Safety Data Sheets – including the identity of the registrant and whether the chemical was found to be Persistent, Bioaccumulative and Toxic (PBT).  And last week, ECHA said it will also publish (by June) the aggregate production volume ranges (called “tonnage bands”) for chemicals registered under REACH.  These decisions will improve ECHA’s record on disclosure and transparency by increasing the amount of both hazard and exposure data available to the public on chemicals in use. 

In ECHA’s most recent newsletter, it notes that 92% of the more than 27,000 registration dossiers received have been disseminated so far.  The disseminated dossiers cover more than 4,300 chemicals, while the dossiers yet to be published cover another 1,190 chemicals.  Dossiers are being posted as they are released on ECHA’s website.  

While ECHA has continued to publish dossiers on a regular basis, and they provide some helpful data, ECHA has repeatedly faced complaints that the dossiers do not tell consumers what they want to know (Chemical Watch, subscription required).  Indeed, European NGOs have filed lawsuits (Chemical Watch, subscription required) against ECHA as a result of its refusal to release company identities and production volume data for a particular group of hazardous chemicals.  Even with these two new proposals for greater disclosure, European NGOs have expressed skepticism about the completeness and timeliness of information that will become available.

Although some of the problems with the dossiers have more to do with ease of access than with the information itself, improving the quantity and quality of information is essential.  In this respect, ECHA’s decision to publish information on the registrant identity, PBT status, and production volume will go a long way towards improving utility.  Frankly, the dossiers have been lacking this crucial information since they began to be made available online more than a year ago. 

Confidentiality and public disclosure under REACH

The lack of basic information in the dossiers is particularly puzzling, given the rather clear specifications in REACH as to what information received from companies is to be disclosed.  Articles 118 and 119 of REACH delineate three categories into which data submitted in dossiers can fall:

• Information that is always confidential;
• Information that is never confidential and can be publicly disseminated;
• Information that shall be publicly disseminated unless the registrant has submitted a confidentiality claim and ECHA has accepted that claim.

Until recently, there was ambiguity as to where ECHA would place the registrant name, registration number, and the results of the PBT assessment (all of which are contained in Safety Data Sheets).  A Q&A document that ECHA released with its first proposal clarifies that these data elements are to be publicly disseminated unless ECHA has received and approved a CBI claim.  Hence, they are now squarely in the third category.

The subject of ECHA’s second proposal, the total tonnage band, is listed in the third category in the original text of REACH.  I touch on the controversy surrounding the interpretation of this placement later in this post.

The first announcement: Welcome, if overdue  

To date, the public has been unable even to find out which companies have registered which chemicals under REACH.  As part of a larger effort to improve the flow of information between companies as well as to the agency and the public, ECHA is finally embarking on a project to add the registrant name, registration number, and the outcome of the required PBT assessment to the publicly available versions of the dossiers.

ECHA will derive this information from the Safety Data Sheets that are required to be submitted with the majority of chemicals registered to date.  For chemicals without Safety Data Sheets, ECHA will still disseminate registrant identities (unless they have been claimed and approved as confidential).  ECHA is in the process of refreshing its data dissemination portal to facilitate this process. 

Of course, companies are allowed to claim some data as confidential business information (CBI) where they believe that dissemination would divulge a trade secret; ECHA must review and approve such claims for them to stand. 

From the perspective of some in industry, namely the European Chemical Industry Council (Cefic), companies are becoming more amenable to being identified as a participant in REACH registration (Chemical Watch, subscription required).  They may well perceive that evidence of their good-faith participation in making more information about chemicals available will improve their reputation in the eyes of customers and the public. 

However, the degree to which CBI claims will impede ECHA’s efforts remains to be seen.  There are relatively few claims thus far, which may be due in part to the fact that, unlike EPA under the Toxic Substances Control Act, ECHA imposes a fee for making confidentiality claims.  Of course, that hasn’t solved the problem of invalid claims being asserted:  In an article in Chemical Watch (subscription required), ECHA is quoted stating the following about the 1,750 claims it has received:  “We have assessed more than half of these claims so far, and about half of the [reviewed] claims have had a positive outcome for the registrant and about half a negative outcome.”

Hopefully, ECHA will be able to deliver much more information through this first proposal.  The agency has not yet published all of the expected guidance documents on confidentiality claims, so some uncertainty remains.  And although the intention is to launch the project by July, it is unlikely that the public will actually see the information until the fall.

The second announcement: What is the public really getting?

Add to this first effort ECHA’s new proposal also to disseminate tonnage band information, and it seems like the public will be much closer to getting what it was supposed to get under REACH.  ECHA has stated that the promised tonnage band information will be out by June.  However, there are several caveats.  For example, ECHA has provided a table of the tonnage bands that it will use, which are actually quite broad.

Additionally, European NGOs had requested that ECHA disseminate tonnage band information from the dossiers as reported by each registrant (Chemical Watch, subscription required).  The agency has instead decided, for a given chemical, to report aggregate data for each joint submission, as well as to separately report the data for any other individual submissions.  Hence, for joint submissions, the “tonnage band” for the dossier cannot be broken down by registrant.

The public will soon see the total tonnage band for each dossier – unless the tonnage band was claimed CBI.  If companies wish to claim the tonnage band CBI in light of ECHA’s proposal, they may do so by providing the agency with a justification and the requisite fee; ECHA must review and approve the claims for them to hold.  Hopefully these requirements will result in ECHA receiving and granting CBI claims only for data that warrant confidential status.

ECHA plans to deal with the “mosaic effect” (the concept that disclosing non-confidential information may inadvertently disclose CBI) in a novel manner.  The agency has said it will disseminate the tonnage band information in a jointly submitted dossier even if some registrants have claimed the tonnage CBI.  However, this will be done only if there are four or more registrants for a chemical.  The agency reasons:  “This is because the aggregation of tonnages of four or more registrants cannot reveal the individual tonnage of a specific registrant and as such will allow a fuller set of information on tonnages to be published without compromising commercially sensitive information.”  

ECHA’s proposals seek to satisfy longstanding requests for access to more information from the registration dossiers, but there are several remaining problems and uncertainties.  Despite the fact that the REACH regulation clearly identifies data that must be publicly disseminated, it clearly did not resolve all ambiguities and ECHA’s current efforts may still fall short.

Jennifer McPartland, Ph.D., is a Health Scientist.

Earlier this month Dr. David Bellinger at Boston Children’s Hospital published a very interesting paper in Environmental Health Perspectives offering a new way to consider the importance of various risk factors for child neurodevelopment—such as pre-existing medical conditions, poor nutritional status or harmful chemical exposures—at the population level.  “A Strategy for Comparing the Contributions of Environmental Chemicals and Other Risk Factors to Neurodevelopment of Children” argues that, in evaluating the contribution of a risk factor to a health outcome, it is critical to consider not only the magnitude of its effect on the health outcome, but also the prevalence of that risk factor in the population.

Dr. Bellinger argues: “Although a factor associated with a large impact would be a significant burden to a patient, it might not be a major contributor to the population if it occurs rarely.  Conversely, a factor associated with a modest but frequently occurring impact could contribute significantly to population burden.”  The former “disease-oriented” approach has generally been used to estimate the burden of harmful chemical exposures to population health, rather than the latter “population-oriented” approach.  Relying solely on the former approach, he contends, may result in an underestimation of the impact of a chemical exposure or other risk factor on public health. 

Dr. Bellinger illustrates his point by examining the impact of various risk factors on neurodevelopment in U.S. children.  He first estimates the drop in full-scale IQ (FSIQ) score (the size of the risk factor’s effect) associated with various risk factors, ranging from congenital heart disease to lead exposure.  He then multiplies the effect size of each risk factor by the prevalence at which that risk factor occurs in U.S. children aged 0 to 5 years (a total of 25.5 million children), to determine the total cumulative impact of each risk factor on FSIQ loss in these children. 

The eye-opening results are shown in the table below.

Dr. Bellinger notes that the cumulative population burdens associated with chemical exposures (methylmercury, organophosphate pesticides and lead) are “surprisingly” large—due not so much to their effect sizes (degree of FSIQ loss), but rather to the prevalence at which children in the U.S. experience these exposures. 

Dr. Bellinger emphasizes that the estimates of FSIQ loss associated with the various risk factors should not be over-interpreted, pointing to several limitations in his calculations.  For example, some of the effect-size estimates for the risk factors were derived from studies conducted on non-U.S. samples.  There could be regional differences that modify effect size in these populations versus U.S. populations. 

Nevertheless, the take-home message stands:  Population burden needs to be considered just as much individual burden when evaluating the impact of a risk factor to a health outcome.

In EDF's chemicals policy work, we emphasize that the effects of chemical exposures on human health can vary across individuals and sub-populations, and hence, we need policies that protect the most vulnerable among us, such as children and pregnant women.  Such vulnerabilities can be considered to represent the “depth” of a chemical exposure.  This paper points out the other side of the same coin, namely that the “breadth”—or prevalence at which a chemical exposure occurs—is just as important in judging its significance to public health.

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

There is clearly a need to balance the legitimate claims of companies to protect certain confidential business information (CBI) from public disclosure with the legitimate need for the market, consumers and the public to have access to information they need to make sound decisions about chemicals that are in commerce.  Unfortunately, most of TSCA’s provisions and their implementation by EPA have skewed this balance radically in the direction of denying the public’s right to know and creating an ill-informed chemicals marketplace.

The core problem is two-fold, constituting a vicious circle:  Too many CBI claims are made, and each of the infrequent examinations of such claims done by EPA has found a large fraction to be illegitimate, i.e., not meeting the well-established criteria for what constitutes a legitimate trade secret.  And because of the large number of claims made, EPA has lost the ability to review claims to ensure they are in fact legitimate and remain so over time; this lack of review has led directly to more claims being made, thereby completing the vicious circle. 

Under TSCA companies are free – literally, at no cost – to claim any information they submit to EPA to be CBI, often without providing any justification, thereby denying access to the public and even to state and local governments.  Even the identities of chemicals that are the subject of health and safety studies – which TSCA expressly forbids from being claimed CBI except in very limited circumstances – have been routinely masked under policies in place at EPA until recently.  CBI claims remain in place until and unless challenged by EPA, yet EPA is not required to review the claims, and they never expire.     

The Safe Chemicals Act of 2011 (S. 847), would go far to restore the right balance.  All CBI claims would have to be justified up front.  EPA would be required to review them, and only approved claims would stand.  Approved claims would expire after no more than five years, except for types of claims for which EPA determines the five-year term would not apply.  Other levels of government would have access to CBI.

Many in industry have acknowledged the need for substantial reform of TSCA’s policies toward information disclosure.  There is widespread agreement, for example, on the need for up-front substantiation both to reduce the number of claims asserted and better ensure the legitimacy of those claims that are made.  And some in industry have been receptive to the concept of a fee to cover the costs of EPA review of CBI claims, which also could help to reduce the number of claims.

One key to striking the right balance is to recognize that it is often information that links a specific chemical to a specific company or product that is most sensitive.  Many disclosures, for example of a health and safety study on a chemical, which in my view is information for which the public has a right to know, can be done in a manner that does not disclose such linkages and hence avoids or lessens the concern.

The most difficult area is with new chemicals, where companies understandably have a greater need to protect the identity of the chemicals in which they’ve invested.  Here, I think a viable approach may be to provide a time-limited allowance for some types of protections on information concerning new chemicals, but with clear exceptions made for such chemicals where a potential hazard has been identified.

One specific improvement to S. 847 would be to amend the provision limiting CBI claims to a single five- year period, to allow such claims to be extended upon a showing by the claimant that the conditions for granting CBI status in the first place remain.  Another would be to specify up front certain types of information that are always eligible for CBI protection, such as a company’s list of customers or detailed information about the precise process it uses to make a chemical.

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

The primary means by which chemical risks are to be judged under current legislative proposals for reform of the Toxic Substances Control Act (TSCA), including the Safe Chemicals Act of 2011 (S. 847), is through risk assessment – a key demand of industry.  Yet traditional risk assessments have often fallen short of protecting public health and have sometimes taken decades to identify a “safe” level of exposure to certain chemicals.  As a result, public and health and environmental community confidence in risk assessment is very low.  There are also major technical deficiencies in current risk assessment methodologies that must be addressed if it is to serve as a credible basis for determining chemical risks.  For example, we now know that there are many chemicals for which any level of exposure poses some risk, yet traditional risk assessment assumes a safe level exists for nearly all chemicals.

The Safe Chemicals Act includes provisions to ensure that EPA’s use of risk assessment incorporates the best available science, initially by requiring EPA to rely on the recent recommendations of the nation’s foremost scientific body, the National Academy of Sciences, as to how EPA can improve its practice of risk assessment. Implementing the recommendations is critical to restoring the credibility of and public confidence in risk assessment.

A key recommendation of Science and Decisions, the NAS’ so-called “Silver Book” of risk assessment released in 2009, is to reverse the common practice used by EPA of assuming that there is a level of exposure – a “threshold” – to a chemical below which there is no risk.  Science tells us that many chemicals have effects even at very low doses; moreover, even where such a threshold may be seen for a chemical in a highly controlled study conducted using genetically homogeneous laboratory animals, the extent of variability in the human population as a whole often effectively erases such a threshold.  Hence, NAS recommends that only if EPA has strong affirmative evidence for a threshold in the human population should it assume there is a wholly "safe" level of exposure.

A second key NAS recommendation is that EPA needs to assess risk so as to ensure protection of vulnerable populations, including developing fetuses and children that are typically more susceptible to the effects of chemical exposures. Third, EPA needs to assess “aggregate” exposures to a chemical, accounting for the often multiple sources of exposure to a given chemical. 

Finally, a second NAS report urges that, where science allows, EPA risk assessments should identify groups of chemicals to which people may be exposed that act similarly or produce the same or similar health effects, and assess the “cumulative” exposures to all of those chemicals.

Moving the practice of risk assessment into the 21st century through adoption of these recommendations simply must be at the core of any proposal to rely on risk assessment as the primary means to address chemicals under a reformed TSCA.

Allison Tracy is a Chemicals Policy Fellow.

Posts to this blog concerning REACH – the European Union’s regulation for the Registration, Evaluation, Authorization and Restriction of Chemicals – have dealt mainly with the “R” and “A”.  A few weeks ago, the European Chemicals Agency (ECHA) took a first big step to capitalize on the “E” (Evaluation).

Specifically, the final 2012-2014 Community Rolling Action Plan (CoRAP) was published on February 29th (see ECHA’s press release).  After many months of consultation with the Member States, ECHA has released the list of 90 chemicals that will be the first to undergo REACH’s substance evaluation process in 2012, 2013, and 2014. 

Existing data guided the prioritization process that led to the production of this list, but REACH’s authorities granted for substance evaluation will allow ECHA and the Member States to gather new information to fill data gaps.  This new information will help to improve both governmental and public knowledge about the risks these chemicals may pose to human health and the environment. 

Where does the CoRAP come from?

The text of REACH calls for the development of the CoRAP to identify “substances for which there is a suspicion that their manufacture and/or use could pose risks to human health or the environment.”  Working together, ECHA and the Member States used the guidelines in REACH to develop the 2011 CoRAP Criteria.

Hazard criteria: The 2011 criteria require ECHA and the Member States to consider the following types of chemicals when prioritizing hazard characteristics in the selection process:

• Suspected Persistent, Bioaccumulative and Toxic substances (PBTs), very Persistent and very Bioaccumulative substances (vPvBs) and PBT-like substances
• Known PBTs/vPvBs
• Suspected endocrine disruptors
• Suspected Carcinogenic, Mutagenenic and Reprotoxic substances (CMRs) (e.g. based on structural similarities)
• Known CMRs (Category 1A , 1B and 2 according to the Regulation on Classification, Labeling, and Packaging)
• Suspected sensitizers (e.g. based on structural similarities)
• Known sensitizers (skin and especially respiratory sensitizers)

Exposure criteria: The 2011 criteria require ECHA and the Member States to consider the following exposure characteristics in the selection process:

•  Wide dispersive use (number of sites of use, use in mixtures or articles used by the public, etc.)
• Number of using sites if emission due to industrial use
• Consumer use and exposure of sensitive subpopulations such as children
• Aggregated tonnage

Risk criteria: The 2011 criteria require ECHA and the Member States to consider the following risk characteristics in the selection process:

• Whether the estimate of exposure is below the threshold at which the substance is considered hazardous
• Whether individuals may be exposed to the chemical in combination with structurally similar chemicals that could compound the effects

What does the CoRAP do?

The 90 CoRAP chemicals that ECHA and the Member States selected using the 2011 criteria are those that were deemed to warrant the most suspicion as to their risk, based on existing information.  As such, the EU is driving relatively rapid evaluation on these chemicals.  Member States will submit draft substance evaluations for the 2012 batch of CoRAP substances (36 chemicals) by February 28^th, 2013.  The registration dossiers submitted under REACH thus far will be valuable sources of information for evaluation of these substances.  Thirty of the 36 substances for 2012 and 79 of the total 90 chemicals have registration dossiers.

Once Member States submit their drafts, ECHA will forward them to the registrants of the chemicals in question to provide them with an opportunity to comment.  (It is not clear whether other stakeholders will have access to these draft evaluations in order to provide their input, although any decisions to require development of more information and the final evaluations will be made public.)  The final conclusion of evaluation may be that no further action is needed, but evaluation may also lead to the introduction of new risk management measures if the suspected risks are supported by new information.

The numbers game

The draft CoRAP from October listed 91 substances, one of which (1,1-bis(tertbutyldioxy)-3,3,5-trimethylcyclohexane) has been removed in the final list because existing information was deemed to be sufficient (Chemical Watch, subscription required).  However, according to an earlier Chemical Watch article on the draft CoRAP, ECHA and the Member States had planned to evaluate 50 substances in 2012 and 100 substances per year from there on out.  The limited resources of Member States convinced ECHA that a list of 250 chemicals was too ambitious for the first CoRAP, leaving only 90.  Still, the Agency has noted that it is possible that the CoRAP for 2012-2014 will be expanded in February of 2013.  The final CoRAP lists 36 chemicals for 2012, 23 for 2013, and 31 for 2014. 

Chemicals of concern

ECHA notes that “in many cases the initial concerns are related to PBT-properties, suspected endocrine disruption, or carcinogenic, mutagenic and reprotoxic properties in combination with wide dispersive use or consumer uses.”  Some of the noteworthy chemicals included in the CoRAP are:

• triclosan (part of the 2012 batch),
• tetrachloroethylene (part of the 2013 batch),
• formaldehyde (part of the 2013 batch), and
• three phthalates (part of the 2014 batch). 

Each of these chemicals or group of chemicals already has earned a degree of notoriety based on associated adverse effects on human health.

The forest through the trees

The big-picture message is that the CoRAP is a powerful supplement to ECHA’s Candidate List of Substances of Very High Concern (SVHCs).  The Candidate list puts SVHCs on a track towards Authorization, which is likely to lead to elimination or significant reduction in use, but it can only address chemicals for which there is sufficient information.

That’s where the CoRAP comes in.  ECHA does not assume that  a chemical with insufficient information does not pose a risk.  In fact, ECHA states in the 2011 CoRAP criteria that:  “In general, a suspected property is considered by default to be more important criterion than a known property [as a trigger for evaluation], as it is more obvious that some further information is needed to confirm the existence of the property in case of suspicion.”  As is evident from this statement, substance evaluation is essential to living up to REACH’s “no data, no market” motto because it allows ECHA and the Member States to fill data gaps about chemicals.  Substance evaluation also informs the market, which can itself lead to improvements in the safety of chemicals and bolster consumer confidence in the products of the chemical industry – a win-win situation.   

Many of the chemicals listed in the CoRAP are in commerce in the United States:

• 84 of the 90 CoRAP chemicals are present on the public version of EPA's Toxic Substances Control Act (TSCA) Inventory, which lists approximately 67,000 chemicals that have been in commerce in the U.S at some point since 1979.  That includes 34 of the 36 chemicals in the 2012 batch, 19 of the 23 chemicals in the 2013 batch, and all 31 of the chemicals in the 2014 batch.
• 75 of the 90 CoRAP chemicals were publicly reported in the 2006 cycle of the Inventory Update Reporting rule (IUR), which required companies to report information on chemicals manufactured or imported in amounts exceeding 25,000 pounds per year.  This includes 29 of the 36 2012 chemicals, 19 of the 23 2013 chemicals, and 27 of the 31 2014 chemicals.

As with the comparisons we’ve done with REACH’s Candidate and Authorization lists, this comparison again shows that there is no shortage of chemicals in U.S. commerce that are being flagged for potential or actual concerns under REACH.