Selected tags: prioritization

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 »

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

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

ACC’s chemical prioritization tool: Helpful, but flawed and off the mark for EPA to use without TSCA reform

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

As I noted in my last post, the American Chemistry Council (ACC) issued its own “prioritization tool” in anticipation of the Environmental Protection Agency’s (EPA) public meetings  to get input on the approach it will use to identify additional chemicals of concern under its Enhanced Chemicals Management Program.

In the context of TSCA reform, various actors in the industry have long called for prioritization, often saying they support EPA’s ability to get off to a quick start on identifying chemicals for further work – only to propose schemes that are more likely to do the opposite.

ACC itself has over time come off as a bit schizophrenic on prioritization, apparently being for it before they were against it.  ACC’s release of its tool puts it squarely back in the pro-prioritization camp, but just what is it proposing?  My sense is it’s after something quite different from what EPA proposes, and frankly, different from what EPA is currently capable of deploying, given its limited authority and resources under TSCA.  In this sense, ACC’s proposal is more relevant in the context of TSCA reform, where we presumably would have an EPA with a mandate to review all chemicals in commerce, the authority to readily get the data it needs, and the resources required to execute the kind of comprehensive prioritization scheme ACC proposes.

But setting that disconnect aside for the moment, let’s delve a bit deeper into the ACC proposal on its own merits.  Read More »

Posted in Health Policy, Regulation, TSCA Reform | Also tagged , , , , , , | 1 Response, comments now closed

Avoiding paralysis by analysis: EPA proposes a sensible approach to identifying chemicals of concern

Richard Denison, Ph.D., is a Senior Scientist.  Thanks to my colleagues Jennifer McPartland and Allison Tracy for their analysis of the EPA proposal discussed in this post.

Last week, the Environmental Protection Agency (EPA) held stakeholder meetings to get public input into the criteria it will use to identify additional chemicals of concern beyond the 11 chemicals or chemical classes it has already identified.  EPA used these meetings (as well as an online forum open until September 14) as an opportunity for the public to respond to a “discussion guide” it issued in August that sets forth draft criteria and identifies data sources it intends to use to look for chemicals that meet the criteria.

The day before the EPA meetings, the American Chemistry Council (ACC) issued its own “prioritization tool” which lays out its own criteria and ranking system for identifying chemicals of concern.  This post will make a few observations about EPA’s proposal.  My next post will provide a critique of ACC’s proposed tool.

EDF and the Safer Chemicals Healthy Families coalition strongly support EPA in this endeavor – both for what it is, and for what it is not.    Read More »

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