Author Archives: Richard Denison

EPA releases final risk assessment for TCE: One down, 84,999 to go*

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

EPA achieved a rather significant milestone today in releasing a final risk assessment for the solvent trichloroethylene (TCE).  This document is for the first of a group of 83 “work plan chemicals” EPA identified in 2012 as needing risk assessments and, where warranted, risk management.

Why do we call it a milestone?  It is the first final risk assessment issued by EPA using its authority under the Toxic Substances Control Act (TSCA) in – wait for it – 28 years.

The last time EPA issued a final risk assessment for a chemical under TSCA was in 1986, for asbestos.  (EPA has developed a few draft assessments under TSCA over the years, but today marks the first time since 1986 that one of them has been finalized.)

So, kudos to EPA for finally getting this risk assessment to the finish line.  Now what’s next?  Read More »

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

Imbalanced act: An EPA IRIS agenda that speaks 1000 words

Richard Denison, Ph.D., is a Lead Senior Scientist.  Rachel Shaffer is a research assistant.

[UPDATE 6/24/14:  Perhaps in response to this post of last week, an updated agenda for this week's IRIS meeting was posted by EPA today that reflects a somewhat more balanced set of speakers.  Industry interests appear to have consolidated their number of slots, down from a high of 8 to a high of 6 per issue, and down from a high of 6 to a high of 4 individuals per issue from the same consulting firm.  In addition, several additional slots are assigned to non-industry speakers.  If you wish to see the changes, here is the agenda we linked to that was current as of last week, and here's the updated agenda posted today.]

In comments EDF made at a November 2012 stakeholder meeting held by EPA’s Integrated Risk Information System (IRIS) program, we warned that the tendency of the IRIS program to respond to criticism by expanding opportunities for “public” input would serve to increase rather than decrease the imbalance in stakeholder input.

We noted that providing more opportunities for participation not only lengthens the timeline for completing assessments; it also virtually ensures the input received by EPA is imbalanced and badly skewed toward the regulated community. That’s because companies that produce and use each chemical to be assessed – and the trade associations and myriad hired consultants that represent them – have a clear vested financial interest in the outcome of the assessment.  They can and will take advantage of each and every opportunity for input, and they will be better represented than other stakeholders each and every time.

IRIS recently began holding bimonthly meetings focused on “key science issues” relating to upcoming assessments.  And guess what?  An army of industry representatives, including staff for trade associations and paid consultants, are overwhelming the agendas.

Exhibit A:  Have a quick look at the list of speakers in the agenda for this month’s bimonthly meeting.  A striking imbalance, no?  As many as 8 industry representatives are set to speak on a given issue, including 6 from the same consulting firm!  [UPDATE 6/24/14:  See the top of this post for a description of the updated, slightly more balanced agenda; here is the agenda we had linked to that was current as of last week, and here's the updated agenda posted today.] Read More »

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

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 | Tagged , | 2 Responses, comments now closed

Better late than never: EPA finally takes first step to collect safety data on fracking chemicals

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

Nearly two-and-a-half years after the U.S. Environmental Protection Agency  partially granted a petition filed under the Toxic Substances Control Act (TSCA) by EDF, Earthjustice, and 114 other groups calling for a rulemaking to require companies that make or process chemicals used in oil and gas production, the agency finally responded today.

This morning EPA issued what’s known as an Advanced Notice of Proposed Rulemaking (ANPRM) seeking public input on “the information that should be reported or disclosed for hydraulic fracturing chemical substances and mixtures and the mechanism for obtaining this information.” A 90-day comment period will start once the notice is published in the Federal Register next week.

What Today’s Announcement Means

The process that begins with today’s announcement is directed to manufacturers and processors of fracking chemicals and would call on them to report to EPA health- and safety-related data they have on those chemicals. Notably, it would apply not only to the presently undisclosed chemicals used in these operations, but also to hundreds of substances whose use in fracking is already widely reported, but for which little or no health or environmental safety data are available.

This effort is distinct from others aimed at drilling companies and well operators, which seek to reveal what materials are going down a well, but don’t indicate what their potential effects might be.

While much of the health and environmental effects data EPA would receive could become public and hence would complement and add valuable information to disclosure efforts, the main aim is to ensure EPA has information sufficient to understand the potential risks of the subject chemicals at an aggregate, national level.

It’s also worth noting that not all of the data reported to EPA would necessarily become available to the public; under the Toxic Substances Control Act, companies can claim certain information constitutes confidential business information, in which case EPA cannot disclose it to the public. That is, the agency would know but we would not.

A Long Road Ahead

This is only the first baby step toward initiating the rulemaking process EPA said it would undertake. EPA intends to use input it receives during the comment period to decide both how and what information should be reported.

The original petition asked the agency to require companies that make or process chemicals used in oil and gas production to: a) report basic production, processing and available health and safety information on those chemicals, and b) conduct testing to fill data gaps in the available information. In November, 2011, EPA granted the first part but denied the second, and limited the scope to just chemicals used in hydraulic fracturing. EPA said it would issue the ANPRM, and begin a stakeholder process – both of which would be used to solicit input as to the scope of the reporting rules.

It’s unfortunate that this process has taken so long, as it addresses a critical need to ensure the safety of chemicals used in fracking. It will be essential that the public engage in the development of EPA’s reporting system to ensure it delivers the needed information to EPA and maximizes public access to that information.

   

Posted in Health Policy, Regulation | Tagged | Comments 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 | Tagged , , , , | Comments closed

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 , , | Comments closed

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 »

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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
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