Selected tags: Confidential Business Information (CBI)

Chemical Safety Reform: Will the Center Hold?

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

Copyright © 2014, Environmental Law Institute®, Washington, D.C. www.eli.org
Reprinted by permission from The Environmental Forum®, May/June 2014

Compromise is tough. It can be thankless and unsatisfying, and, by definition, you don’t get everything you want. But it’s the only way reform of the Toxic Substances Control Act will happen. Nearly everyone, from environmentalists to industry honchos, agrees TSCA is badly broken. But start talking about how to fix the problems and you’ll find there are legitimate core principles held by different stakeholders that are difficult to reconcile. Here are just three examples:

New chemicals. The common-sense notion that new chemicals should be shown safe before entering the market, versus the desire not to hinder innovation or U.S. companies’ ability to compete globally by getting chemicals to market quickly;

Preemption. The appeal of a single federal oversight system that does not impede interstate commerce, versus the view that states have the right to act to protect their residents; and

Confidential business information. The right of citizens, consumers, and the market to information on potential risks of chemicals they may use or be exposed to, versus assurance that legitimate trade secrets submitted to regulators will not generally be disclosed.

As an active participant in the past decade’s debate, I’ve seen firsthand how such conflicting principles complicate — politically and substantively — prospects for achieving reform. I’ve also learned that progress comes only when both sides accept they have to give something to get something. Conversely, progress stalls when stakeholders get greedy. The past year has seen both tendencies.

The late Senator Frank Lautenberg (D-NJ) assessed the landscape last year and saw the need for compromise. He took the political risk of working on legislation with Senator David Vitter (R-LA), who had been about to introduce his own legislation. The result was the first-ever bipartisan legislation to reform TSCA, the Chemical Safety Improvement Act.

Sadly, Senator Lautenberg died shortly after CSIA was introduced. But the legislation remains very much alive, and although it was (and is) far from perfect, there has been major progress thanks to the continuing work of Senator Vitter and Senator Tom Udall (D-NM) to address major concerns raised about the bill and strengthen its health protections.

Additional progress is endangered, however, as some players have fallen back to their core principles and hardened their positions. And after holding a promising series of constructive, balanced hearings on TSCA, the House majority floated reform legislation — albeit a discussion draft rather than a bill — that tilts heavily in industry’s favor.

These challenges have led some stakeholders to consider forgoing the present opportunity and either opt to retreat to the status quo or try to forestall action and wait for more political advantage in the future. In my view, this notion of an easier path any time in the foreseeable future is illusory. The conflicting needs of stakeholders are so fundamental, and the political climate so polarized, that counting on them to change appreciably is wishful at best.

The only recourse is to do the hard work of negotiating to forge a legitimate and fair compromise that delivers an efficient and effective chemicals management system. Let me use my earlier three examples to illustrate what common ground looks like:

New chemicals. EPA should make an affirmative determination of safety before market entry, but using a standard that allows prompt review based on the limited information available for a new chemical. Where that information is insufficient, EPA should be able to require more — or impose conditions sufficient to address potential risks even in its absence;

Preemption. States should be able to act to address a chemical’s risks wherever EPA has not, or when they can make the case for going further. Preemption should apply prospectively, and when, but only when, the agency has all the information it needs to make a definitive safety decision and takes final action on a chemical. Requirements that do not directly restrict a chemical’s manufacture or use — such as for reporting, warnings, monitoring or assessment, which do not unduly impede interstate commerce — should remain available to states; and

Confidential business information. Legitimate trade secrets should be protected, but not information on health and environmental effects or general information on a chemical’s use. Identities of chemicals should generally be available once they enter commerce. Up-front substantiation and EPA approval of claims should be required. Claims should generally be time-limited but renewable upon resubstantiation. State and local governments, medical personnel, first responders, and health and environmental officials should have access to confidential business information.

The opportunity before us is apparent: Our best chance to fix an outdated law that serves nobody’s interests. The alternative — sticking with a piecemeal system that undermines consumer confidence and puts our health at risk — is no alternative at all. All it takes to seize this opportunity is to agree that compromise doesn’t have to be a dirty word.

Posted in Health Policy, TSCA Reform | Also tagged | 2 Responses, comments now closed

New Draft of House Chemical Safety Bill Falls Short; EDF Calls on All Sides to Redouble Effort

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

Release in response to today's House Environment and Economy Subcommittee hearing on a revised discussion draft of the Chemicals in Commerce Act (CICA)

Today’s hearing makes clear that the discussion draft has made progress but still falls far short of legislation that will fix the fundamental flaws of the current law, according to Dr. Richard Denison, Lead Senior Scientist at Environmental Defense Fund. He urged all sides to keep the bipartisan process moving forward in both houses of Congress.

“While bipartisan discussions have yielded a number of substantial improvements to address serious concerns with the original draft, the most problematic provisions remain virtually untouched,” Denison said. “The goal now should be to keep the conversations going.”

Examples of progress include giving the Environmental Protection Agency (EPA) authority to require testing where data are insufficient for prioritization purposes; incorporation of deadlines for agency action to assess and address risks of high-priority chemicals; and less prescriptive and onerous information quality and evaluation requirements.

Sections of the draft pose major concerns and fail to strike a fair and reasonable balance. Examples include the sweeping preemption of state authority for chemicals never subject to a thorough EPA safety review; overly broad allowances for companies to mask the identity of chemicals even long after market entry; and a failure to ensure that conditions placed on new chemicals apply to all companies making or using them.

“We’re optimistic that solutions are at hand that address the needs of all stakeholders, but it is going to take a redoubling of effort by all sides to get there,” he said.

 

Posted in Health Policy, TSCA Reform | Also tagged , , , | Comments closed

Report: Staggering amounts of toxic chemicals produced across America

Alissa Sasso is a Chemicals Policy FellowRichard Denison, Ph.D., is a Lead Senior Scientist.

[Cross-posted from EDFVoices blog]

Recent spills in West Virginia and North Carolina cast a spotlight on toxic hazards in our midst. But as bad as they are, these acute incidents pale in scope compared to the chronic flow of hazardous chemicals coursing through our lives each day with little notice and minimal regulation. A new report by EDF, Toxics Across America, tallies billions of pounds of chemicals in the American marketplace that are known or strongly suspected to cause increasingly common disorders, including certain cancers, developmental disabilities, and infertility.

While it’s no secret that modern society consumes huge amounts of chemicals, many of them dangerous, it is surprisingly difficult to get a handle on the actual numbers. And under current law it’s harder still to find out where and how these substances are used, though we know enough to establish that a sizeable share of them end up in one form or another in the places where we live and work.

Our new report looks at 120 chemicals that have been identified by multiple federal, state and international officials as known or suspected health hazards. Using the latest, albeit limited, data collected by the U.S. Environmental Protection Agency, we identify which of these chemicals are in commerce in the U.S.; in what amounts they are being made; which companies are producing or importing them; where they are being produced or imported; and how they are being used. An interactive online map accompanying the report lets the user access the report’s data and search by chemical, by company, by state, and by site location.

Among our findings:  Read More »

Posted in EPA, Health Policy, TSCA Reform | Also tagged , , | Comments closed

A REACH milestone: First authorisation application passes the European Chemicals Agency

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.  Read More »

Posted in EU REACH, Health Policy | Also tagged , | Comments 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 | Also 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 | Also 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.

 

Posted in Environment, Health Policy, Regulation | Also tagged , , | Comments closed

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 | Also tagged , , | 2 Responses, comments now closed

West Virginia officials trust shaky science in rush to restore water service: One-part-per-million “safe” threshold has questionable basis

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

[SEE NOTE ADDED 1/15/14 BELOW]

In a press conference today outlining plans to restart the water system serving 300,000 people, West Virginia state officials and executives from the West Virginia American Water utility company stressed that levels of the toxic chemical that contaminated the supply after last week’s spill had reached a “safe” level of one part per million (1 ppm), the threshold agreed upon by state and federal officials on Saturday.

Unfortunately, the science behind this standard remains unclear.  Based on what we do know, there are good reasons to believe that officials are overlooking significant health risks.  Read More »

Posted in Environment, Health Policy, Regulation | Also tagged , , , | 36 Responses, comments now closed

Failed TSCA collides with the real world in West Virginia chemical spill this week

Richard Denison, Ph.D., is a Senior Scientist.  Jennifer McPartland, Ph.D., is a Health Scientist.

[CORRECTION ADDED BELOW 1/12/14]

If the protracted debate over reform of the Toxic Substances Control Act (TSCA) sometimes seems esoteric or abstract, the epic failure of this law could not be better illustrated than by what’s unfolding in Charleston, WV this week.

There, a major spill into the Elk River of an obscure chemical used to wash coal has disrupted the lives of hundreds of thousands of residents of the state for what is likely to be days if not weeks or longer.  The storage tank from which the chemical has leaked lies upstream from the intake for one of the city’s drinking water treatment plants.  Even before the leak had been detected or reported, the chemical was sucked into the plant and distributed through thousands of miles of pipe to homes and businesses.  Residents have been told not to drink, bathe or otherwise come into contact with the water – although some exposure clearly did occur before the warnings were issued.  Massive amounts of water are being trucked into the area.  President Obama declared the situation a national emergency.

What is particularly maddening and outrageous is that no one – not local or state officials, not the company that owns the storage tank, not the federal government – can say anything even close to definitive about what risk the chemical poses to people, even in the short-term, let alone over time.  And that’s where the failures of TSCA come into sharp focus.  Read More »

Posted in Health Policy, Regulation, TSCA Reform | Also tagged , , | 10 Responses, comments now closed
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