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.

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

This past November, EPA scientists published a sobering paper, “The exposure data landscape for manufactured chemicals,” in the journal Science of the Total Environment.  The paper reveals how little systematic information we have about human and environmental exposures to the thousands of chemicals in use today. 

The aim of the study was “to define important aspects of the [chemical] exposure space and to catalog the available exposure information for chemicals being considered for analysis as part of the U.S. EPA ToxCast screening and prioritization program.”  Its conclusion:  “The results suggest that currently available exposure data are insufficient to provide the evidence base required to inform risk assessment and public health decision making.”  Not good, but not surprising.  Read on for more detail.

As I’ve described in a series of earlier blog posts, EPA has been investing in new toxicology platforms like ToxCast and Tox21 to better evaluate the potential hazards of the thousands of chemicals for which we have little or no data.  On the exposure side of the risk equation, EPA is developing complementary programs like ExpoCast, which seeks to “ensure that the required exposure science and [relevant] computational tools are developed.”  An early goal of ExpoCast is to improve publicly available information on chemical exposures.  The “gap analysis” presented in this recent paper is a necessary step toward realizing that goal.   

The authors focused their analysis of exposure data availability to chemicals in EPA’s Aggregated Computational Toxicology Resource (ACToR) database.  This is likely EPA’s most comprehensive chemicals database, containing varying – and I do mean varying! – levels of information on 547,088 chemicals.  EPA notes that the ACToR database, which aggregates information from several data repositories, holds “essentially all publicly available information on chemical identity, structure, physical-chemical properties, in vitro assay results and in vivo toxicology data.” 

The researchers classified the available types and sources of exposure data into the following categories:  production/import volumes and processes; consumer product ingredients and usage; environmental release; environmental media concentrations; and human exposure/biological monitoring. 

I won’t attempt to describe here all of the findings of this paper, but here are some highlights:

• 8 million chemicals are “commercially available” world-wide.
• 100,000 chemicals have been inventoried as available in U.S. Commerce:  82,000 chemicals regulated under the Toxic Substances Control Act (TSCA), 8,600 food additive chemicals, 3,400 cosmetic ingredients, 1,800 pharmaceuticals, and 1,000 pesticide active ingredients.
• Fewer than 22,000 of the total nearly 550,000 ACToR chemicals – a minuscule 4% – have anysort of exposure-related data.  These include:
  • the roughly 15,000 chemicals reported under EPA’s periodic TSCA reporting system (formerly, the Inventory Update Reporting (IUR) rule, now the Chemical Data Reporting rule) at least once since 1986;
  • 2,485 food additive chemicals; and
  • 203 additional chemicals identified as chemicals of concern for children by various authoritative bodies.
• Of the 100,000 ACToR chemicals having at least some toxicity data, fewer than 20% have any exposure-related information, and even for these chemicals, that information is extremely limited (e.g., production volume).
• Even production volume information is available for fewer than 15,000 (less than 3%), of the ACToR chemicals.
• Use information is available for only about 7,500 (1.4%) of the ACToR chemicals, and for only 2,400 (17%) of the IUR-reported chemicals.
• Truly minuscule numbers of the ACToR chemicals have any data on their concentrations in environmental media: 1,153 chemicals in water, 788 chemicals in soil, 720 chemicals in food, 670 chemicals in air, and 390 chemicals in people (through biomonitoring).
• The vast majority (nearly 90%) of ACToR chemicals that have any type of exposure-related information have only one type of such information (i.e., only production volume or use information or presence in food or water concentration, etc.).
• Of the 700 ACToR chemicals that have so far been identified as of concern for children, exposure-related information is available for only 185 of them.

If we are serious about basing decisions about chemicals on risk, then we need adequate information on both hazard and exposure.  This paper shows just how far away from that goal we are. 

So where does EPA plan to go from here?  On the hazard side of the equation, the ToxCast and Tox21 programs hold the promise of quickly generating useful toxicity data on many thousands of chemicals.  Given the high-throughput nature of these assays—automated small-volume tests done in multi-well plates—such an endeavor is possible. 

But the possibility of developing useful exposure information on a comparable scale and pace is far more limited.  This is especially true for critical information such as understanding the exposures resulting from the use of products.  For this, among other things EPA will need to charge chemical manufacturers, importers, and processors of chemicals with providing far more exposure-relevant data. 

To achieve this, we will need enhanced policies that give EPA the authority and resources it needs to systematically collect and process the necessary information.   For industrial chemicals, that clearly means we need reform of the Toxic Substances Control Act (TSCA).  The authors of the paper I’ve reviewed here make this clear:

[I]f enacted, proposed reform of U.S. legislation regulating potentially toxic chemicals would likely require chemical manufacturers to provide a minimum set of data, including more detailed data on exposure potential, for large numbers of chemicals. Such data requirements hold the promise of greatly expanding the universe of chemicals for which useful exposure-related information exists.

EPA has made some positive steps recently to gather more exposure (as well hazard) information on chemicals even while awaiting more authority from Congress to develop a truly effective system.  For example, as noted earlier, EPA has revamped the Inventory Update Rule (IUR) to create what is now called the Chemical Data Reporting (CDR) system (see this blog post for more information on the CDR).  The agency is also is moving ahead on prioritizing chemicals for risk assessment.  Just this month, using a process explained here, EPA identified eighty-three “work plan” chemicals for which it intends to complete risk assessments.  EPA selected these chemicals in part because they are among the few chemicals that have sufficient hazard and exposure information to allow for risk assessment.  EPA will develop risk assessments for seven of these chemicals in fiscal year 2012.

Admittedly relatively small-scale efforts, given the magnitude of the overall task, but important and much more than the Agency has attempted in the past.

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

Today's New York Times logs a passing this past weekend that should be noted by any of us who consider ourselves to be a friend of science and the environment:  Dr. Sherwood Rowland, a modest but persistent chemist who, together with his colleague, Mario Molina, discovered that a class of synthetic chemicals — chlorofluorocarbons (CFCs) — widely used at the time as propellants in aerosol cans and as refrigerants were tearing a hole in the ozone layer.

That discovery, reported in a seminal paper published in Nature in 1974, ultimately earned him the Nobel Prize in Chemistry in 1995.  In addition to the import of the discovery itself, however, there are several other aspects of this story that for me have considerable resonance in the current debate over chemicals policy. 

Rowland found that even minute releases from consumer products of chemicals widely asserted to be wholly "inert" could persist and accumulate so as to cause potentially catastrophic effects at a global scale.  It is a case study of the ability of humans, through literally millions of individual decisions and events, to transform the health of the global environment – a huge wake-up call. 

Yet this science was treated as virtual heresy at the time.  Major efforts were mounted by the chemical and affected consumer products industries to discredit his work; today's New York Times obituary reports:  "One article, in the trade publication Aerosol Age, accused him and Dr. Molina of being K.G.B. agents out to destroy capitalism."  And he was largely shunned by other academic chemists, reportedly receiving not a single invitation to lecture in a university chemistry department for a decade after the Nature paper was published.

Dr. Rowland also believed that the implications of his scientific discovery were so profound as to warrant his advocating for changes in policy.  A 1988 article about him in the Los Angeles Times reported that: 

Rowland's wife, Joan, recalls one night in the fall of 1973 when her husband got home late from work. "How'd it go?" she had asked drowsily.  "It's going very well," he said. "It just means, I think, the end of the world."

It may well have, had not Rowland and many others taken that science and pressed for national and global action, an effort that led ulitmately to global adoption in 1987 of the Montreal Protocol, which bans virtually all uses of CFCs.

A good and timely reminder that, collectively, human activity even on a small individual scale, can both create health and environmental problems at a global scale, and — with sufficient political will backed by a conviction that science will ultimately prevail —  find and implement global solutions.

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

I’ve blogged here frequently about EPA’s efforts over the past couple of years to make more chemical information available to the public, especially health and safety information.  A key part of this, believe it or not, is simply making sure that when EPA shares a health study with the public – as required by law – you get to know the identity of the chemical that is the subject of that study.

EPA’s initial steps (see below) were met with a little grumbling on the part of the chemical industry, but not a whole lot.  After all, the industry says it wants the public to have more information about chemicals.  At #7 on the American Chemistry Council’s (ACC) top 10 principles for TSCA reform is:  “Companies and EPA should work together to enhance public access to chemical health and safety information.”

Times, apparently, have changed.  In recent weeks, ACC has launched a broadside attack on the EPA’s efforts to compel its member companies ever to name a chemical when submitting health and safety information to EPA.  My evidence?  A 36-page White Paper delivered by ACC to the office of the regulatory czar at the Office of Management and Budget, at a meeting held there on January 20.  The ACC document is a wonder of tortured logic, obfuscation and selective renditions of the history of TSCA.

Today, a response was mounted.  EDF and Earthjustice staff, as well as representatives of health-affected individuals, environmental justice communities and workers, held their own meeting with OMB officials.  And we delivered our own letter to OMB that thoroughly rebuts ACC’s White Paper.  It also points out that, way back in 1976, the drafters of TSCA actually wanted you to have access to health and safety information on chemicals – and they darn well didn’t expect you to have to guess at the identity of those chemicals. 

Duh, you say?  How can this not have been the case all along?  And yet EPA has spent the last couple years seeking to undo three decades of practice at the Agency that has allowed companies routinely to hide the identity of the chemical in a health study they’re required to submit.  That has meant the public gets to learn that a chemical, let’s say, causes mice to sprout a second head, but you haven’t been allowed to know just which chemical it is that has that particular effect.  I’m not lying (well, OK, I am about the second head).

EPA’s recent efforts to ensure public access to health and safety information

EPA has been working to address this obvious problem in increments.  In January 2010, it announced it would: (a) begin reviewing confidential business information (CBI) claims seeking to mask the identity of chemicals in notices companies are required to submit under TSCA when they develop or obtain evidence indicating that a chemical “presents a substantial risk,” and (b) generally deny such claims if the chemical is already listed on the publicly available version of the TSCA Inventory (Duh, you say again; and, yes, there is also a top-secret version of the Inventory with some 17,000 entries.)

Then in May 2010, EPA expanded on its first step to announce that: (a) it will now review all confidentiality claims for the identity of both new and existing chemicals in health and safety studies, and (b) companies making such claims should expect EPA to deny such claims except where the chemical identity would expressly reveal the process by which the chemical is made or the portion of a mixture the chemical comprises, as designated under Section 14(b) of TSCA.

Pursuant to the new policy, EPA has been reviewing and declassifying hundreds of previously submitted health and safety studies, disclosing the identities of the underlying chemicals in the process.

To operationalize aspects of the May policy for new chemicals, EPA has been developing a proposed rule that would make the needed changes to its premanufacture notification (PMN) regulations, which date all the way back to 1983.  That proposal, which has not yet been made public, was sent by EPA to OMB for it 90-day review on December 27 of last year.  The precipitating event for ACC’s broadside is that pending proposal.

But it is critical to understand that ACC is mounting a much wider assault on all parts of what EPA has done to address this problem, not just this latest proposal, details of which are not yet even known.  It is asserting that companies should have the ability to hide from the public the identity of any chemical for which a company is submitting a health and safety study – whether for a new or existing chemical, and whether that chemical is already known to the world or not.

To put it bluntly:  Your right to know what industry knows about chemical risks is under direct, frontal attack.

What TSCA says about your right to know

Section 14(b) of TSCA carves out an exception for health and safety information from the general allowance in Section 14(a) for companies to claim any information they submit to EPA to be CBI.  The only exceptions to that exception (still with me?) are the ones just mentioned:  where the disclosure would reveal either (a) how a chemical is made or processed, or (b) in the case of a mixture, the portion of that mixture a chemical comprises.

Notably, Section 14(b) also expressly applies to health and safety studies submitted for both existing and new chemicals – it treats them the same.  Here’s the provision, with the italicized phrases referring to existing chemicals and new chemicals (those subject to TSCA’s Section 5), respectively:

(b)  Data from health and safety studies

(1) Subsection (a) does not prohibit the disclosure of –

(A) any health and safety study which is submitted under this chapter with respect to –

(i) any chemical substance or mixture which, on the date on which such study is to be disclosed has been offered for commercial distribution, or

(ii) any chemical substance or mixture for which testing is required under section 4 of this title or for which notification is required under section 5 of this title, and

(B) 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).

ACC would have you believe that even though Congress expressed its intent for you to have access to health and safety information about chemicals – it did not intend that you know the identities of the chemicals in question.  That’s ludicrous on its face.

What EPA’s regulations say about your right to know

Moreover, EPA regulations clearly define chemical identity to be an integral part of a health and safety study; see the definition of a health and safety study at 40 CFR §716.3 and §720.3(k).

Now, EPA’s regulations do go on to say that confidentiality of chemical identity might be granted if “[t]he specific chemical identity is not necessary to interpret a health and safety study.”  40 C.F.R. §720.90(c)(3).  This additional exception appears nowhere in TSCA and, frankly, is in direct conflict with the law.  That is likely among the reasons EPA needs to change the regulations, as it is proposing to do. 

In any event, EPA’s own reports indicate that it would be highly unusual for the agency to conclude that the specific chemical identity is not necessary to interpret a health and safety study.  In particular, a 1992 report commissioned by EPA’s Office of Pollution Prevention and Toxics (OPPT) summarized the low likelihood that chemical identity would not be necessary to interpret a health and safety study as follows:

OPPT attorneys have argued that it is rarely the case that chemical identity information could legitimately be covered by such an exemption. It is unlikely that any reputable health or environmental scientist could be found who would argue that it is ever the case that chemical identity is unnecessary to interpret health and safety data. (emphases in original). 

Likewise, the CBI Final Action Plan developed by OPPT in 1994 declares that:

[t]he utility of a health and safety study, particularly for chemicals in commercial distribution, is greatly enhanced by connection to a specific chemical identity.  … This connection allows for risk analysis by all segments of the interested public, including the chemical industry.  … Such actions cannot take place when a hazard cannot be associated with a specific chemical.

Despite all of this, until recently EPA’s practice has been wholly inconsistent, in no small part because it has lacked the resources needed to review and challenge even the most bogus CBI claims.  Companies in the chemical industry quickly figured out that the best way to avoid a challenge from EPA of a CBI claim was to flood the agency with such claims; see this blog post for details.  One result:  Some 22,000 case files of industry submissions of health and safety studies in which the chemical identity was claimed CBI.  EPA has the ambitious plan to review all of these claims by 2015.

ACC’s proposed solution:  Let the public eat generic names in place of specific chemical names

Instead of providing specific chemical identities, ACC proposes that you make do with a “generic name” – which, of course, is specifically designed not to let you identify the chemical in question.  Our letter to OMB provides a thorough critique laying bare the many inadequacies of this approach.  In 1985, EPA developed guidance for the selection of such generic names; as illustrated in our OMB letter, some of these generic names would “narrow” the universe to literally hundreds or thousands of possible chemicals.  How useful would that be to you?

ACC’s proposal to rely on generic names is particularly galling coming from an industry that has for decades allowed its members to openly flaunt even EPA’s permissive guidance for the selection of generic names.  Consider these generic names provided by companies in notices they’re required to submit to EPA disclosing health and safety studies that indicate their chemicals present “substantial risk.”  These do not reflect some stale past practice; they’re taken from the most recent monthly batch of such notices posted by EPA in January 2012:

• four notices for chemicals whose identities have been masked and instead identified as “Confidential *2”,
• four notices for chemicals whose identities have been masked and instead identified as “Substance A *2”,
• four notices for chemicals whose identities have been masked and instead identified as “Substance B *2”, and
• a notice for a chemical merely identified by the generic name “hydrofluorocarbon.”

I could go on, but to wrap up this long post, I’ll just ask you to peruse our letter to OMB to discover the many other smoke-and-mirrors tactics being employed by ACC in its effort to rein in your right to know.