Author Archives: Richard Denison

The perverting of prioritization: How a good idea for TSCA reform went bad – and how to save it

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

For years, the concept of prioritization as an element of TSCA reform has enjoyed support from a broad array of stakeholders.  The number of chemicals in active commerce is large, if uncertain:  surely less than the 85,000 listed on the TSCA Inventory, but still in the tens of thousands. That sheer number demands that EPA develop and apply a process to decide where to start and how to sequence the enormous task of reviewing the safety of those chemicals. 

There has also been widespread agreement that EPA should make an initial pass using available information to identify three groups of chemicals:  a) those that present significant hazard or exposure potential or both; b) those for which existing information doesn’t raise such concerns; and c) those that need more information to determine their level of concern.

As conceived, prioritization was to be a low-stakes proposition for the various stakeholders, simply the means to get the new system up and running.  Prioritization decisions would not be final actions; rather, they were expressly designed to minimize dispute, and would be barred from legal challenge.  Chemicals identified as high priority and in need of immediate scrutiny would get a more thorough assessment before any decision as to whether they posed significant risk and required a regulatory response.  Chemicals identified as low-priority would be so designated provisionally based on less than a thorough assessment, and could be revisited if and when new information arose.  And chemicals lacking sufficient information to be prioritized would be subject to further data collection and generation, and then funneled back into the prioritization process.

These concepts are well-established both in the outcomes of industry-NGO negotiations and in heavily negotiated provisions of the more recent incarnations of the Safe Chemicals Act.

But then some folks got greedy.  Read More »

Posted in Health Policy, TSCA Reform | Tagged , , | Leave a comment

Conflicted West Virginia chemical spill panel is repeating many of CDC’s mistakes

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

Yesterday, the chair of a “Health Effects Expert Panel” convened by the West Virginia Testing Assessment Project (WV TAP) held a press conference to present the panel’s preliminary findings from its review of the “safe” level set by the Centers for Disease Control (CDC) for MCHM and other chemicals that spilled into the Elk River in early January and contaminated the drinking water of 300,000 West Virginia residents.

A final report from the panel apparently won’t be released until May, but a press release issued yesterday sounds far from preliminary in saying the panel supports CDC’s methods, assumptions, toxicity data and “safety factors.”  While providing no details, the release indicates the panel is using the same flawed and incomplete summary of a toxicity study used by CDC in its rush to set a safe level for MCHM.  And it parrots CDC’s erroneous use of the term “safety factors,” which is at odds with the National Academy of Sciences’ strong recommendation that such term should be avoided as it is highly misleading.

In addition to choosing to rely on the same summary CDC used of a 1990 study conducted by MCHM’s manufacturer, Eastman Chemical, the panel accepted at face value Eastman’s interpretation that the study identified a no-effect level.  That conclusion has been questioned and cannot be independently assessed because Eastman has not provided the actual quantitative data from the study.  Moreover, the study used a protocol dating from 1981 that has been extensively revised at least twice since then.  These are among the many problems identified with this study.

It appears the panel’s main departure from CDC was to assume the most highly exposed population would have been formula-fed infants instead of older children.  The panel’s “safe” level is 120 parts per billion (ppb), a value about 8-fold lower than CDC’s level of 1 part per million (ppm).  That seems an improvement over the CDC’s methodology.

The panel’s conflict of interest

However, the process by which the panel itself was formed and the clear conflict of interest (COI) involved – a conflict that only came to light in response to a reporter’s questions at yesterday’s press conference – are deeply concerning.

The company selected by WV TAP to convene the Health Effects Expert Panel is named Toxicology Excellence in Risk Assessment (TERA), founded by Dr. Michael Dourson.  TERA has a long history of working with the petrochemical and related industries.  Acknowledged sources of industry funding noted on its website include the American Petroleum Institute, PPG Industries, Eli Lilly, the American Cleaning Institute (formerly called the Soap and Detergent Association), Procter & Gamble, and the Nickel Producers Environmental Research Association.

While TERA was chosen by WV TAP to convene the Health Effects Expert Panel, TERA’s role is far more substantial.  TERA appointed its own founder, Dr. Dourson, as chair of the panel, and Dourson was the only one of the panel’s members to speak at yesterday’s press conference.

At the press conference, a reporter asked Dourson whether he or TERA had worked for Eastman Chemical, Dow Chemical (the maker of the other chemicals that spilled on January 9) or trade associations that represent their interests.  Dourson’s response to this question was apparently the first public disclosure of his affiliations with these companies.  According to the Charleston Daily Mail:

During the event, Dourson acknowledged his nonprofit organization TERA had conducted some work for Dow Chemical, one of the makers of a chemical believed to have been involved in the spill. He said they’ve also done work for Eastman Chemical, the maker of crude MCHM, but not recently. TERA has done work for the state of West Virginia in the past as well, he said.

On its website, TERA says it’s received between 31 and 40 percent of its funding since 2008 from industry and industry related work. The rest comes from “government and other nonprofit work.”

The fact that an individual and company that have done work directly for the companies that make the spilled chemicals were selected not only to convene the expert panel, but to chair it and serve as its spokesperson, points to a clear conflict of interest.  And the fact that the conflict was only revealed because a reporter happened to ask the right question is even more troubling.

A quick search for recent work done by Dourson and TERA funded by Dow turned up the following:

TERA also convenes and manages several other projects that are heavily funded by the chemical industry and promote its agenda.  These include:

Anyone else see a problem here?

 

Posted in Health Science, Industry Influence, States | Tagged , , | Comments closed

House TSCA reform discussion draft: Major problem #2 – Preemption of State authority

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

The House’s discussion draft of the Chemicals in Commerce Act (CICA) issued last week was accompanied by statements from both its sponsor and the American Chemistry Council (ACC) claiming that it represents a “balanced” approached to reform of the Toxic Substances Control ACT (TSCA).

Despite the rhetoric, however, the draft is anything but balanced, and instead pegs the needle far to one side of the dial.  My earlier post describes the massive requirements EPA must meet in order to regulate a dangerous chemical and how far out of kilter those requirements are compared both to current TSCA and to the Chemical Safety Improvement Act (CSIA), especially as the latter is being revised via ongoing negotiations.

This post focuses on another area in which the CICA draft takes an extreme position:  its preemption of state authority, which is far more sweeping than under current TSCA or even CSIA as introduced.  But first let me start by arguing that any preemption needs to follow – not precede – final EPA actions that are based on robust information.  Read More »

Posted in Health Policy, TSCA Reform | Tagged , , , | Comments closed

House TSCA reform discussion draft: Major problem #1 – EPA regulatory hoops

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

Imagine the following scenario under a new TSCA based on the House discussion draft issued last week:  A major consumer products company decides to expand its line of air fresheners with a new peppermint flavor.  After introducing the new product, information surfaces indicating that one of the product’s ingredients that imparts that aroma causes mutations in a standard genetic toxicity test.

Based on the high hazard and exposure potential, EPA designates the chemical as high priority, requires additional data to be generated, and conducts its safety assessment, concluding the chemical is very likely to be a human carcinogen and poses significant risk when inhaled at levels associated with normal use of the air freshener.

EPA’s safety determination concludes the chemical “will result in an unreasonable risk of harm to human health,” and so EPA initiates the requisite rulemaking to restrict use of the chemical.  Under the House discussion draft (section 6(f)(4)), here’s what EPA would have to prove in order to take any regulatory action:

  • its restriction is “proportional” to the risk involved;
  • the restriction “will result in net benefits;”
  • the restriction is “cost-effective” compared to all alternative restrictions;

AND, here’s the real kicker:

  • there are “technically and economically feasible alternatives that materially reduce risk to human health or the environment compared to the use proposed to be prohibited.”

In other words, before it could act, EPA would have to find a safer, ready-off-the-shelf alternative peppermint flavor for the consumer products company to use instead of the human carcinogen.  And all of the burden of proof – of proportionality, net benefits, cost-effectiveness, technical feasibility, economic feasibility and comparative safety – would rest entirely on EPA and none of it on the company that markets the product or makes the chemical for that intended use.

Something just doesn’t smell right, wouldn’t you say?

These provisions of the House discussion draft would take what is arguably the most fatal flaw in current TSCA – EPA’s inability to regulate dangerous chemicals due to an onerous and paralyzing cost-benefit analysis requirement – and actually make it worse.  While the draft would strike TSCA’s requirement that EPA show any restriction it proposes is the “least burdensome,” it would replace it with evidentiary and analytic burdens that are even more onerous and paralyzing.

There’s a far better and fairer way to deal with the scenario I’ve outlined:  Give EPA the authority to grant exemptions for certain uses of an unsafe chemical – but only for uses that are critical or essential.  That would ensure EPA can effectively restrict non-critical or essential uses of dangerous chemicals.

The seeds of this exemption approach are planted in the Senate’s Chemical Safety Improvement Act (in section 6(c)(10)), although there are other major problems with those provisions of CSIA as introduced (happily, considerable progress toward resolving those problems has been made in the ongoing negotiations on CSIA).

Here’s how an exemption process should work:  EPA would have authority to grant exemptions for uses of an unsafe chemical it finds to be critical or essential.  And companies who believe their use of a chemical is critical or essential could seek such an exemption – but the burden would be on them to show there are no safer, viable alternatives.  The exemptions would be time-limited, and renewable if the need for the exemption is demonstrated to remain.  And EPA would have full authority to impose conditions on such uses needed to protect human health and the environment.

But to force EPA – as the House discussion draft would do – to have to find for a company viable, safer alternatives to a dangerous chemical for each and every use of that chemical it proposes to restrict is simply preposterous.

 

Posted in Health Policy, TSCA Reform | Tagged , , , , | Comments closed

A full month after West Virginia spill, many questions linger … along with the chemical’s distinctive odor

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.  Read More »

Posted in Environment, Health Policy, Health Science | Tagged , , | 2 Responses, comments now closed

Should we be holding our breath waiting for more information on risks of the chemical spilled in West Virginia?

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 ingestionAbsolutely 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.

Posted in Environment, Health Policy, Health Science | Tagged , , , | 3 Responses, comments now closed

"Epic fail" in West Virginia chemical spill: Poor information, poor communications, poor decisions

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:

  1. State and federal officials appear to have initially relied on Eastman Chemical Company’s incomplete and out-of-date Material Safety Data Sheet (MSDS) on “crude MCHM,” and as a result sowed confusion from the outset that has led to widespread public mistrust.
  2. Those same officials appear to have accepted without scrutiny the adequacy, accuracy and relevance of Eastman’s additional toxicity studies of MCHM, based only on summaries of those studies when they were finally provided by Eastman.

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.  Read More »

Posted in Environment, Health Policy, Regulation | Tagged , , , | 3 Responses, comments now closed

Another new wrinkle on the “new” mystery chemical in West Virginia spill

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

Well, this story is rapidly evolving!  Even since my last blog post this morning, new information has come to light as to the identity of the “new” chemical that was present in the leaking tank that led to contamination of the drinking water in Charleston, WV.

The Charleston Gazette has now reported that Freedom Industries, the owner of the leaking tank, has told government officials that the “new” chemical is actually a mixture of two chemical products, both of them made by The Dow Chemical Company.  One of those is in fact the “DOWANOLTM PPh Glycol Ether” I discussed in my last post.  The second is a closely related Dow product called “DOWANOLTM DiPPh Glycol Ether.”   (These links are to Dow’s Material Safety Data Sheets (MSDSs) for the two products.)

The first product consists almost entirely (>99.5%) of propylene glycol phenyl ether (CAS no. 770-35-4).  The second is a mixture (see its MSDS), the main component of which (≥60%) is di-propylene glycol phenyl ether (CAS no. 51730-94-0) – a closely related chemical.

My earlier post indicated that a Dow contact had told me this morning it does not make a “stripped” version of its PPh product, and hence did not believe it was the supplier of the material to Freedom Industries.  As I noted in that post, use of the “stripped” designation to describe the “proprietary” chemical listed in the MSDS supplied yesterday by Freedom Industries for the “new” chemical had suggested the substance had somehow been further distilled.

But the latest article in the Charleston Gazette helps to clarify the situation.  It cites State officials indicating that Freedom Industries’ “PPH, stripped” is in fact a mixture of the two Dow products.

Interestingly, the MSDSs for the two Dow products reference a considerably larger amount of toxicity data than does Freedom Industries’ MSDS.  It appears, therefore, that there may be more data for officials to go on to assess potential risks associated with this “new” chemical.

Dow’s Technical Data Sheet and Product Safety Assessment for DOWANOLTM PPh Glycol Ether” list several uses for the product, none of which appear to explain why Freedom Industries would have added the product to the tank of MCHM, which is used to wash coal.

There appear to be some disconnects between Dow’s knowledge of how its own chemicals are being used and by whom, and also between the intended uses of such chemicals and their actual use.  These disconnects point to flaws in our current chemical safety policies:  chemical manufacturers often don’t have a full picture of how their chemicals are actually used, and downstream users may not have a clear picture of which uses of a chemical are appropriate or not.

The number of lessons to be drawn from this West Virginia chemical spill appears to be growing by the day.

 

Posted in Environment, Health Policy, Regulation | Tagged , , , | 1 Response, comments now closed

Is this the mystery chemical in the WV spill?

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

[PLEASE SEE UPDATE TO THE INFORMATION BELOW IN MY MORE RECENT BLOG POST.]

I blogged last night that the Charleston Gazette had reported that a “new” chemical that was revealed to have been present in the tank in Charleston, WV, that began leaking into the Elk River on January 9 and contaminated the drinking water supply for 300,000 residents.

Two alert readers recognized the acronym “PPH” and the description of the chemical in Freedom Industries’ Material Safety Data Sheet (MSDS) for “PPH, stripped”, to which I had linked, and suggested the identity of the chemical might be a grade or form of propylene glycol phenyl ether (CAS no. 770-35-4).

I’ve not been able to find further references to or information on “PPH, stripped,” but with the help of those alert readers I have found information on what appears to be a similar but not identical product made by The Dow Chemical Company, under the trade name “DOWANOLTM PPh Glycol Ether” – see Dow’s Technical Data Sheet and its Product Safety Assessment.  Among the names Dow lists for its product are both “propylene glycol phenyl ether” and “PPh.” 

I’ve compared information available on the Dow and Freedom Industries products.  Physical-chemical properties are similar but not identical for the two materials.  For example, the boiling point for “PPH, stripped” is 247°C, and for DOWANOLTM it’s 241°C.  (This is consistent with the process of “stripping,” by which more volatile components of a mixture are distilled out, which would raise the boiling point of the remaining more concentrated higher molecular weight components of the mixture.)  The liquid densities of the two products also match:  1.06 grams per cubic centimeter.

Both products are indicated as being eye and skin irritants, but of low acute oral toxicity.

I contacted Dow this morning, and asked if the Freedom Industries’ “PPH, stripped” material was supplied by Dow or is the same material.  My Dow contact answered no to each question.  There are quite a few suppliers of this chemical globally.

[PLEASE SEE UPDATE TO THE ABOVE INFORMATION IN MY MORE RECENT BLOG POST.]

It thus appears likely that the “new” chemical in the West Virginia spill is a form of propylene glycol phenyl ether.  But questions remain as to who made the “stripped” version, who supplied it to Freedom Industries, why its specific chemical identity is being claimed proprietary, and what information beyond that in the company’s MSDS is available regarding its hazard properties.

 

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Yet another chemical identified as present in West Virginia chemical spill

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

Just when you thought this story couldn’t get any weirder or worse, it has just been revealed that another chemical substance was present alongside the crude MCHM mixture that leaked into the Elk River and contaminated the drinking water of 300,000 West Virginia residents.

A story published late today in the Charleston Gazette by Ken Ward, Jr., reports that the U.S. Environmental Protection Agency (EPA) has told officials that a chemical identified as “PPH, stripped” was present in the leaking tank at a level of 5.6%.  A Material Safety Data Sheet (MSDS) for the substance, provided by the Gazette, describes the substance as consisting of 100% “polyglycol ethers” – but withholds the substance’s specific chemical identity as “proprietary.”

And while the scant toxicity data provided on the substance in the MSDS suggest it has lower acute oral toxicity than the crude MCHM mixture – at least for what is called the “majority component” (suggesting that this substance, too, is a mixture) – the MSDS notes that “PPH, stripped” is a “serious eye irritant” and a skin irritant.

It has already been reported by the Charleston Gazette that some residents making hospital visits did so because of rashes or other skin irritation; other reports indicate eye irritation among residents as well.  It should be noted that the MSDS for crude MCHM reports that it is also a skin and eye irritant.

Some quick searches I’ve done tonight for “PPH” and “PPH, stripped” – including one using ChemIDPlus, a large chemical database maintained by the National Library of Medicine, have not yielded further information.

All this means yet more questions and more uncertainty for West Virginia residents.  A few:

- How did EPA learn of the presence of this new chemical in the spilled material?  So far, EPA’s not talking.

- Why did it take 12 days for this information to come out?  And then, not from the company, Freedom Industries, that owns and operates the leaking tank?

- Has this chemical been monitored for in the river and drinking water samples?  (Presumably not, since its presence was just revealed.)

- Who makes PPH, and will they now reveal its identity given the massive human exposure that has occurred?

- Or will EPA exercise its rarely used authority under the Toxic Substances Control Act (TSCA) to compel disclosure of the identity of PPH?  Section 14(a)(3) of TSCA provides that confidential business information “shall be disclosed if the [EPA] Administrator determines it necessary to protect health or the environment against an unreasonable risk of injury to health or the environment.”

Surely, this is such a case.

 

Posted in Environment, Health Policy, Regulation | Tagged , , , | 2 Responses, comments now closed
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