Selected tags: prioritization

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

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| Also 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| Also 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| Also tagged , , , | Comments closed

Why can’t ACC tell the truth about the Safe Chemicals Act?

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

It’s very disheartening to see just how far the American Chemistry Council (ACC) has moved away from anything resembling a good-faith effort to debate and advance meaningful reform of the Toxic Substances Control Act (TSCA).  There’s more than enough in TSCA reform for stakeholders to debate and disagree about without adding distortions and outright falsehoods to the mix, yet ACC seems intent on doing just that.

The latest indication?  An April 16, 2013 post to ACC’s blog titled “A new year, but the same unworkable Safe Chemicals Act.”  The post purports to identify four fatal flaws in the Safe Chemicals Act of 2013, which was introduced on April 10 and is cosponsored by 29 Senators.  The first two utterly ignore or fault the legislation for major changes made to it to address industry concerns, while the latter two once again restate outright falsehoods ACC has made about the Act – claims that ACC knows are false.  Read More »

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

Variety is the spice of … accurate chemical testing

Rachel Shaffer is a research assistant.  Jennifer McPartland, Ph.D., is a Health Scientist.

There has been a lot of buzz in recent years about the federal government’s new chemical testing initiatives, ToxCast and Tox21 (see, for example, these articles in Scientific American and the New York Times).  These programs are developing high-throughput (HT) in-vitro testing to evaluate—and ultimately predict—the biological effects of chemicals.  In contrast to the relatively slow pace of traditional animal testing, ToxCast and Tox21 use sophisticated robots to rapidly test thousands of chemicals at a time. As a result, they hold the potential to more efficiently fill enormous gaps in available health data, predict adverse effects, and shed light on exactly how chemicals interact and interfere with our biology. (For more on these potential benefits, see Section 5 of EDF’s Chemical Testing Primer).

Yet, among the key challenges that these new methods must address is one that traditional, animal-based methods have faced for decades: how can laboratory testing adequately account for the high degree of variability in the human population? The latest research suggests the exciting possibility that genetic diversity, at least, may be able to be incorporated into emerging HT in vitro approaches.   Read More »

Posted in Emerging Testing Methods, Health Science| Also tagged , , , | 2 Responses, comments now closed

Despite TSCA-like law, there is movement down under on chemical safety

Alissa Sasso is a Chemicals Policy Fellow.

Australia’s chemical law, dating back to 1989, in many ways resembles the U.S. Toxic Substances Control Act of 1976 (TSCA).   Australia, however, has begun taking steps to address tens of thousands of existing chemicals at a scale that has not been taken in the U.S.  These steps come in the wake of government and stakeholder recognition that Australia’s TSCA-like approach to chemicals management is inadequate and in need of revision.  Read More »

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

Repost: The new Safe Chemicals Act fulfills every detail of ACC’s 10 “Principles for Modernizing TSCA”

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

[NOTE:  I am reposting this piece, given that it was first posted during the dog days of August and I don't want those interested to have missed it in digging out from time away from the office.  If you have an interest in understanding just how much the Safe Chemicals Act has changed to account for earlier industry concerns, please take the time to look at the analysis I've done comparing the bill to ACC's TSCA Principles.]

You wouldn’t know it from listening to the American Chemistry Council (ACC) talk about the Safe Chemicals Act, but the new and improved version of the bill that was passed out of the Senate Environment & Public Works Committee on July 25 closely mirrors every detail of ACC’s 10 “Principles for Modernizing TSCA.”.

Those principles, issued in August of 2009, represent a key reference point given that they are virtually the only somewhat detailed public articulation by ACC of its substantive position on TSCA reform, one to which ACC continues to refer today.  In describing its principles, ACC says they “create a roadmap to a modern chemical regulatory system that will protect public health and the environment, while preserving the ability of American chemical companies to drive innovation, grow jobs, and compete in the global marketplace.”

ACC indicated in its statement on the revised bill that it only conducted a “cursory review” of the bill language, which perhaps explains why it got even some basics wrong.  One example:  ACC claims “[t]he bill would also dramatically increase the time it would take for the Environmental Protection Agency (EPA) to review new chemicals.”  In fact, the revised bill retains the 90-day review period for new chemicals operable under current TSCA.

So how does the bill stack up against ACC’s 10 Principles for TSCA Modernization?  Read More »

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Onwards and upwards: South Korea and Turkey advance their REACH-like policies

Alissa Sasso is a Chemicals Policy Fellow. Richard Denison, Ph.D., is a Senior Scientist.

This summer we saw a flurry of activity surrounding our own chemical safety legislation, the Toxic Substances Control Act (TSCA); international reform efforts have been just as busy. In this blog post, we’ll discuss recent developments in toxic chemicals management in South Korea and Turkey. As apparent in our recent post on new Chinese regulations, these developments are notable because of their alignment with the EU’s REACH legislation.  Read More »

Posted in Health Policy, International| Also tagged , , | Comments closed

The new Safe Chemicals Act fulfills every detail of ACC’s 10 “Principles for Modernizing TSCA”

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

You wouldn’t know it from listening to the American Chemistry Council (ACC) talk about the Safe Chemicals Act, but the new and improved version of the bill that was passed out of the Senate Environment & Public Works Committee on July 25 closely mirrors every detail of ACC’s 10 “Principles for Modernizing TSCA.”.

Those principles, issued in August of 2009, represent a key reference point given that they are virtually the only somewhat detailed public articulation by ACC of its substantive position on TSCA reform, one to which ACC continues to refer today.  In describing its principles, ACC says they “create a roadmap to a modern chemical regulatory system that will protect public health and the environment, while preserving the ability of American chemical companies to drive innovation, grow jobs, and compete in the global marketplace.”

ACC indicated in its statement on the revised bill that it only conducted a “cursory review” of the bill language, which perhaps explains why it got even some basics wrong.  One example:  ACC claims “[t]he bill would also dramatically increase the time it would take for the Environmental Protection Agency (EPA) to review new chemicals.”  In fact, the revised bill retains the 90-day review period for new chemicals operable under current TSCA.

So how does the bill stack up against ACC’s 10 Principles for TSCA Modernization?  Read More »

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