Category Archives: TSCA Reform

Only a 2-month wait, down from 28 years: New EPA risk assessments find paint stripper chemicals pose significant health risks

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

In June, I blogged about the first final risk assessment EPA had issued in 28 years using its authority under the Toxic Substances Control Act (TSCA), for the solvent trichloroethylene (TCE).  Happily, we only had to wait two months for EPA’s TSCA office to issue final risk assessments for three more chemicals.

One of the three is dichloromethane (DCM), also known as methylene chloride.  DCM is a common ingredient of paint strippers, the use on which EPA’s risk assessment focused.  As with TCE, EPA found DCM-laden paint strippers pose significant health risks to workers, consumers and the general public.  Here’s what EPA said in its press release:

The risk assessment for Dichloromethane (DCM), which is widely used in paint stripping products, indicates health risks to both workers and consumers who use these products, and to bystanders in workplaces and residences where DCM is used.  EPA estimates that more than 230,000 workers nationwide are directly exposed to DCM from DCM-containing paint strippers.

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Nothing is forever – and chemical industry trade secret claims shouldn’t be an exception

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

A coalition of health, labor, environmental and environmental justice groups (including EDF), represented by Earthjustice, filed a petition today with the Environmental Protection Agency (EPA) that requests EPA establish a limit on how long information on chemicals submitted and claimed confidential by the chemical industry under the Toxic Substances Control Act (TSCA) can be protected from disclosure.

The petition asks EPA to close a loophole in its current regulations that by default grants indefinite protection for nearly all chemical information claimed confidential.  Because EPA’s only option under its current regulations is to challenge these claims on a case-by-case basis, industry bears no responsibility to ensure that its claims remain valid over time.  The lack of any expiration date for such claims has contributed to a large backlog of excessive and often unwarranted claims – the protection of which imposes large costs on EPA and the American taxpayer and denies public and market access to information that could lead to better-informed decisions about chemicals.

The petition filed today offers a simple solution, one called for in virtually every internal and external review of EPA trade secret policy conducted over the last several decades (see list at the end of this post):  EPA should alter its regulations to create a “sunset” for confidential business information (CBI) claims, which would expire after a set period of time (5 years is proposed) unless the claimant shows that continued protection is warranted.  This approach would allow true trade secrets to continue to be protected while providing public access to information that no longer warrants trade secret protection.  Read More »

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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 »

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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.

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A gift for mothers (and daughters, and all of us): New tools for breast cancer monitoring and prevention

Rachel Shaffer is a research assistant.

Our mothers are no doubt on our minds right now, after Mother’s Day weekend. And I am no exception, especially since, as I blogged about last year, this month is the anniversary of my own mother’s breast cancer diagnosis.

This year though, in addition to celebrating my mother’s recovery, I can find hope in a new report from researchers at the Silent Spring Institute that provides guidance to improve our ability to screen for and study potential breast carcinogens — thereby enhancing efforts to prevent this widespread disease. Good news, certainly… and a timely gift for all of the women in our lives.

This new report describes biomonitoring methods for 102 breast carcinogens with high exposure potential and identifies existing cohort studies into which these methods could be integrated immediately. These chemicals are among the 216 previously identified by the authors as chemicals linked to mammary gland tumors in rodents. By testing for exposure markers of these priority breast carcinogens in the population, researchers should be able to better identify and study high-risk groups, and regulators will be better able both to limit dangerous exposures and to demonstrate the public health benefits of these exposure reductions.

The full report is available online, but I want to highlight a few key themes that are particularly relevant to current scientific and political debates.  Read More »

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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.

 

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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 »

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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 »

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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.

 

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