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Rachel Shaffer is a research assistant.
Seven years ago, leading children’s environmental health experts Philippe Grandjean and Philip Landrigan published a groundbreaking review that identified five chemicals prevalent in the environment—lead, methylmercury, polychlorinated biphenyls (PCBs), arsenic, and toluene—as developmental neurotoxicants. In their follow-up review released last week, they have added six more chemicals—manganese, fluoride, polybrominated diphenyl ethers (PBDEs), chlorpyrifos, DDT, and tetrachloroethylene (PERC)—to this list. The implications of early-life exposures to these common compounds, say the authors? A “global silent pandemic of neurodevelopmental toxicity.” (more…)
Richard Denison, Ph.D., is a Senior Scientist.
Today marks exactly a month since what is now said to be 10,000 gallons of “crude MCHM” – mixed with what was later found to have included other chemicals – spilled into West Virginia’s Elk River, contaminated 1,700 miles of piping in the water distribution system for nine counties, and disrupted the lives of hundreds of thousands of the state’s residents.
Despite declining levels of the chemical in the water being fed into the distribution system, late this past week five area schools were closed due to detection of the distinctive licorice-like odor of MCHM and multiple reports of symptoms such as eye irritation, nausea and dizziness among students and staff.
The latest sampling data (for February 7 and 8) at locations such as area fire hydrants and hospitals and at schools shows that MCHM is at non-detect levels (<10 parts per billion) in most samples, but the chemical is still being detected in a minority of the samples despite extensive flushing. Despite repeated calls to do so, officials appear to have yet to conduct any sampling of taps in residents’ homes.
This past week also featured a press conference by state and federal officials seeking to explain their response to the spill (a video of the entire press conference is available in four parts here; it’s worth watching). [UPDATE 3/29/14: As this link no longer works, here are updated links to Part 1, Part 2, Part 3 and Part 4 of the press conference.]
Today’s Charleston Gazette features the latest in a long series of outstanding front-line reports by Ken Ward, Jr., and his colleagues, who have closely followed every twist and turn of both the spill and the government’s response to it. Today’s article makes clear the extent to which federal officials were winging it in the hours and days after the spill was discovered as they rushed to set a “safe” level for MCHM in tap water.
In this post I’ll delve a little deeper into CDC’s rush to set the “safe” level and the many ways in which CDC inadequately accounted for major data gaps and uncertainties. I’ll end by saying what I think CDC should have done instead. (more…)
Alissa Sasso is a Chemicals Policy Fellow.
It’s been a while since we’ve posted an update on ongoing activities under the European Union’s Regulation on the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH). The European Chemicals Agency (ECHA) has been quite busy in recent months.
The first application for authorisation (we’ll be using the English spelling of this term, as it is spelled in REACH) to use a Substance of Very High Concern (SVHC) cleared ECHA’s Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) on January 3rd. This is a significant step in the implementation of REACH in the EU. The authorisation process is intended both to manage the risks posed by SVHCs and to drive the replacement of these hazardous substances with safer alternatives. And, as the final step in the process laid out under REACH for managing chemical substances, its execution is central to the success of REACH as a whole. This first application for authorisation was therefore a kind of test-run for ECHA, as well as the chemical industry, and sets the stage for the submission and review of future authorisation applications.
As we run through the details of this particular authorisation application, keep in mind that ECHA received seven other applications for authorisation last year, and will see even more activity in the coming year.
A reminder on what is involved in applying for an authorisation
We’ve laid out the process of authorisation on this blog before (see here and here), but here’s a quick refresher course. The process begins when a chemical is added to the Candidate List of Substances of Very High Concern for Authorisation, which means that the chemical meets certain high levels of concern for potential risks to human health or the environment. Once a chemical is on the SVHC list, ECHA then prioritizes which SVHCs should actually be subject to authorisation, with greater consideration given for PBTs, vPvBs or chemicals with the potential for high exposure due to their use or volume.
The European Commission ultimately decides which chemicals are added to the authorisation list, and the published list provides two dates: the date by which applications for authorisations must be filed, and the date by which any unauthorised or non-exempted use is to be phased out (the sunset date). (Currently, the only exempted uses for any substances on the authorisation list include their use in immediate packaging of medical devices.) You can view the Authorisation List here.
Authorisations are use-specific and apply to the entire supply chain of a chemical; therefore, both manufacturers/importers and downstream users of a chemical must decide whether to apply for an authorisation. The Commission may grant an authorisation by either of two routes, which determines what kind of application needs to be prepared:
The application must include a report on chemical safety, an analysis of alternatives, and a plan for substitution if alternatives are available. In the case of the socioeconomic route to authorisation, a socioeconomic analysis must also be provided.
The current status of authorisation applications is available here. Within 10 months of receiving the application, the RAC and SEAC hold a public consultation on alternatives, and then draft opinions on the application that are presented to the European Commission. The European Commission then prepares a draft decision within three months and subsequently adopts a final decision granting or refusing the authorisation. A summary of the final decision is then made publicly available through ECHA and the Official Journal of the European Union. For more information, see this useful factsheet prepared by ECHA.
What was the chemical? And for what use was an authorisation applied for?
The chemical for which REACH’s first authorisation has been recommended by ECHA is Bis(2-ethylhexyl)phthalate or DEHP (CAS # 117-81-7). Applications for authorisations for this chemical were due by August, 2013, and only a single application was received: It was prepared for Rolls-Royce, a UK company which uses DEHP to manufacture fan blades for plane engines. The sunset date for the unauthorised uses of DEHP is February 21, 2015.
The RAC and SEAC issued a positive opinion of the application, deciding that the risks associated with DEHP for this specific use were demonstrated to be “adequately controlled.” The RAC opinion stated that the application demonstrated the safety of this use of DEHP because the use is limited, DEHP is used in very small quantities, consumer and indirect environmental exposure are negligible, and the health risk to workers is “adequately controlled.”
Interestingly, four possible alternatives to DEHP for this use were identified, and two of these suggestions were made during the public comment period (Chemical Watch, subscription required). While Rolls-Royce tested two of the alternatives (which were suggested by a research institute) and determined them to be ineffective, the other two alternatives still could be found to be feasible. Due to the time it will take to assess them and implement a substitution plan, the committees proposed that the application be reviewed again in seven years.
The opinions adopted by the RAC and SEAC will now be passed onto the European Commission to draft a decision on whether or not to grant the authorisation. The final decision is expected to take about six months from the time the Commission received the Committee opinions (Chemical Watch, subscription required).
That seems simple… is there a catch?
It is unlikely that future authorisation applications will be this simple. This use identified for an SVHC is a very specific one, only one company was involved, and at the time that the committees began assessing the application, they had yet to receive any other authorisation applications. In the future, applications will likely involve more complex supply chains and potentially broader uses, and the committees may well be looking at multiple applications for a variety of chemicals simultaneously. So while the process ran relatively smoothly this time, ECHA is definitely still in the learning phase of dealing with authorisation.
The NGO community is not pleased about this one proceeding to completion. In December, 2013, a group of European environmental NGOs sent a letter to Geert Dancet, the Executive Director of ECHA, accusing ECHA of making decisions that “are not in line with the aims of REACH” because the process does not sufficiently promote substitution with safer alternatives, one of the main goals of authorisation. The NGO community is also concerned with the degree of confidential information masked in the public application, which they argue compromises the utility of the public consultation period.
The upcoming year will likely be a busy time for REACH authorisation, and it will be important to see how ECHA addresses the current concerns with the process, particularly as the applications get more complicated.
Stay tuned for an upcoming blog post looking at other authorisation applications that have been submitted, as well as chemicals for which application deadlines fall during this year. It’s worth noting that some of these chemicals are among the U.S. EPA’s TSCA Work Plan Chemicals, which should be of interest to those of us here in the U.S.
Richard Denison, Ph.D., is a Senior Scientist.
A hearing held yesterday by the West Virginia Legislature’s Joint Legislative Oversight Commission on State Water Resources created quite a stir, when a witness – West Virginia Environmental Quality Board vice-chairman Scott Simonton – said that the human carcinogen formaldehyde had been detected in several water samples drawn from a Charleston, WV, restaurant, and that people in the area affected by the January 9 spill could be expected to have inhaled the chemical, which he identified as a likely breakdown product of the spilled material, crude MCHM. See stories in the Charleston Gazette and USA Today.
State officials and the West Virginia American Water company were quick to call Simonton’s claims “unfounded” and “misleading and irresponsible,” respectively. The controversy led even the American Chemistry Council – which has laid low ever since the spill – to quickly issue its first statement related to the spill through its Formaldehyde Panel.
While experts are noting that data are insufficient to identify the spill as the source of any formaldehyde detected in the water samples, this new kerfuffle does point to yet another major data gap on crude MCHM.
The one part-per-million (1 ppm) “safe” level state and federal officials set was based on limited data from studies in which rats were exposed to crude or pure MCHM through oral ingestion. Absolutely no data are available on the chemical with respect to exposure through inhalation. Yet officials did not hesitate to tell residents the 1 ppm level would be safe not only for drinking the water, but also for bathing and showering.
(It’s curious that the Eastman Chemical Company apparently performed no inhalation studies on crude or pure MCHM, given that Eastman said its motivation for the studies it did perform was to understand risks to workers in industrial settings, and its safety data sheet for crude MCHM prominently notes the potential for health concerns for workers from inhalation.)
[UPDATE 1/31/14: This morning, Eastman posted an updated version of its Q&A document on its website (linked to in the above paragraph), and took down the earlier version. Here is the original version, the updated version dated 1/31/14, and a redline comparison of the two versions.]
Clearly the material that spilled is volatile – that’s why people can smell it. Taking a hot shower in such water means that people would clearly be exposed via inhalation of the vapor; how much exposure would occur has not been ascertained. But in the absence of any data as to toxicity of the chemical via inhalation, there is simply no scientific basis on which to say or imply that showering in water contaminated at 1 ppm level was OK.
Chemicals can be more or less toxic by inhalation than by ingestion, with one study finding inhalation to be the more toxic route for half of the chemicals examined and oral ingestion to be the more toxic route for the other half. Benzene, for example, is estimated to be several hundred times more toxic by inhalation than by ingestion, while inhalation of chloroform is estimated to be about 25-fold lower in toxicity than it is by ingestion.
What such comparisons indicate is that extrapolating from data on oral toxicity to predict inhalation toxicity – which is effectively what government officials did in this case – is about as accurate as flipping a coin.
Jennifer McPartland, Ph.D., is a Health Scientist.
Common sense tells us it’s impossible to evaluate the safety of a chemical without any data. We’ve repeatedly highlighted the scarcity of information available on the safety of chemicals found all around us (see for example, here and here). Much of this problem can be attributed to our broken chemicals law, the Toxic Substances Control Act of 1976 (TSCA).
But even for those chemicals that have been studied, sometimes for decades, like formaldehyde and phthalates, debate persists about what the scientific data tell us about their specific hazards and risks. Obtaining data on a chemical is clearly a necessary step for its evaluation, but interpreting and drawing conclusions from the data are equally critical steps – and arguably even more complicated and controversial.
How should we evaluate the quality of data in a study? How should we compare data from one study relative to other studies? How should we handle discordant results across similar studies? How should we integrate data across different study designs (e.g., a human epidemiological study and a fruit fly study)? These are just a few examples of key questions that must be grappled with when determining the toxicity or risks of a chemical. And they lie at the heart of the controversy and criticism surrounding chemical assessment programs such as EPA’s Integrated Risk Information System (IRIS).
Recently, a number of efforts have been made to systematize the process of study evaluation, with the goal of creating a standardized approach for unbiased and objective identification, evaluation, and integration of available data on a chemical. These approaches go by the name of systematic review.
Groups like the National Toxicology Program’s Office of Health Assessment and Translation (OHAT) and the UCSF-led Navigation Guide collaboration have been working to adapt systematic review methodologies from the medical field for application to environmental chemicals. IRIS has also begun an effort to integrate systematic review into its human health assessments.
Recently a paper in Environmental Health Perspectives (EHP) by Krauth et al. systematically identified and reviewed tools currently in use to evaluate the quality of toxicology studies conducted in laboratory animals. The authors found significant variability across the tools; this finding has significant consequences when reviewing the evidence for chemical hazard or risk, as we pointed out in our subsequent commentary (“A Valuable Contribution toward Adopting Systematic Review in Environmental Health,” Dec 2013).
EDF applauds these and other efforts to adopt systematic review in the evaluation of chemical safety. Further elaboration of EDF’s perspective on systematic review can be found here.
Richard Denison, Ph.D., is a Senior Scientist.
[UPDATE 1/28/14: See updates at several places in this post regarding a 2011 Eastman safety data sheet on crude MCHM – which, though more recent than the 2005 version initally circulated, still does not reference the additional oral toxicity studies conducted by Eastman in the 1990s.]
Little more than two weeks after the January 9, 2014, spill of multiple chemicals into West Virginia’s Elk River, it’s becoming increasingly clear that the private and public sectors at all levels failed miserably with regard to protecting the public’s health. There is plenty of blame to go around.
Our focus in the blogging we’ve done about this terrible incident has been and remains on the lack of reliable information available on the chemicals involved in the spill, the failure to promptly share what was available with the public, and the shaky science upon which decisions and public communications as to the critical safety questions were based. In this post, I revisit several aspects of the initial and ongoing information gaps to add some additional perspective.
I discuss in some detail below two major problems that I believe demand close examination in the Chemical Safety Board’s and others’ investigations into the causes and consequences of the spill:
I end by briefly describing some of the implications of this tragic incident that need to be addressed going forward.
One caveat: Because information on this incident has emerged in a piecemeal and haphazard manner, I cannot vouch for the accuracy of every detail provided in this post. I have strived to the best of my ability to accurately describe the sequence and nature of events based on the available information. (more…)
