Monthly Archives: June 2011

Waiting for Godot: 405 days and counting at OMB on EPA’s modest proposal to identify chemicals of concern under TSCA

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

Yesterday, three legal scholars from the Center for Progressive Reform (CPR) sent a letter to Cass Sunstein, Administrator of the Office of Information and Regulatory Affairs (OIRA) in the White House Office of Management and Budget (OMB).  That letter rebutted on legal grounds the call made by the U.S. Chamber of Commerce in its own letter to Mr. Sunstein for OMB to force EPA to withdraw its proposal to use its authority under the Toxic Substances Control Act (TSCA) to list chemicals of concern.

EPA’s proposal, which entails use of its clear authority under Section 5(b)(4) of TSCA, has been stalled at OIRA for 405 days as of today, with OIRA refusing even to allow the proposal out for public comment.  I wrote an extensive blog post earlier about all of the reasons why EPA’s proposal is legally sound and makes good market sense.  That post – titled “Why is OMB blocking EPA from using even its limited authority under TSCA?” – went up way back in December, and there’s been no movement on the proposal since then.

CPR’s letter rebuts the Chamber’s claims, noting that it plain and simply “Gets the Law Wrong.”  EDF, too, has developed a legal analysis of EPA’s authority under TSCA to identify and list chemicals of concern, which is fully consistent with CPR’s analysis but goes further to address a few other legal aspects of the issue.  That’s why I’ve decided to post it here.

I’ll leave you to read our memo for the details, but provide its conclusion here as a teaser:

“EPA has clear authority under Section 5(b)(4) to list chemicals of concern and is not required to establish criteria in advance of the issuance of a proposed rule listing specific chemicals.  EPA’s authority also extends to the listing of categories of chemicals.  The legal threshold for action under Section 5(b)(4) should be interpreted as identical to that in Section 4(a), which requires only a “more than theoretical” basis for concluding that a chemical “may present” an unreasonable risk.  Even if Section 5(b)(4) is interpreted to mean something different from that in Section 4(a), it should be interpreted to be far less restrictive than the standard in Section 6.  In addition, Section 5(b)(4) does not require consideration of economic impact in the decision to list a chemical.  Finally, the statute is clear that listing of a chemical in a proposed rule under Section 5(b)(4) triggers export notification under Section 12, and may require the issuance of a SNUR [Significant New Use Rule] with respect to significant new uses of the chemical.”

It’s a sad state of affairs when even this modest step proposed by EPA to use its clear authority under TSCA is not even being allowed by OMB to see the light of day and benefit from public review and comment.

Samuel Beckett’s play, which I borrowed for the title of this post, is described as an absurdist play.  That pretty much sums up the endless review by OMB of EPA’s modest proposal.

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More progress under REACH: 13 more chemicals en route to the Authorization list

Allison Tracy is a Chemicals Policy Fellow.

The European Chemicals Agency (ECHA), the agency responsible for implementation of the EU’s REACH Regulation, posted a press release last week listing 13 chemicals it proposes to advance from its list of “Substances of Very High Concern” (SVHCs), also known as the Candidate List for Authorization, to its list of chemicals subject to Authorization, also known as Annex XIV.

Authorization is one of the main pillars of REACH, via which use of designated SVHCs is limited to those uses specifically authorized by EU authorities. Following the public consultation period that is now underway, some or all of the 13 chemicals will move to the Authorization list.   Read More »

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Chemical safety evaluation: Limitations of emerging test methods

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

Parts in this series:      Part 1     Part 2     Part 3     Part 4

This is the fourth in a series of blog posts on new approaches that federal agencies are exploring to improve how chemicals are evaluated for safety.  In this post, we’ll discuss a number of current limitations and challenges that must be overcome if the new approaches are to fulfill their promise of transforming the current chemical safety testing paradigm.  Read More »

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ACC resorts to smear tactics to defend its cash cows, formaldehyde and styrene

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

An increasingly common tactic in modern bare-knuckle politics is to divert attention away from your own weakness or vulnerability by loudly – and falsely – accusing your opponent of having that very defect you possess but won’t admit to.

That Rovian tactic was on display last week, with the American Chemistry Council (ACC) as the accuser, and the National Toxicology Program (NTP) as its “opponent.”  Mind you, NTP is the nation’s leading authoritative body on cancer-causing chemicals.

The precipitating event?  NTP’s long-overdue release of its 12th Report on Carcinogens (RoC).  Among other additions NTP made since its last report was published way back in 2005, it had the audacity – according to ACC – to:

  • upgrade its classification of formaldehyde to “Known to be a human carcinogen,” from its earlier classification (dating back to 1981) as “Reasonably anticipated to be a human carcinogen,” and
  • for the first time include styrene on its list of chemicals linked to cancer, classifying it as “reasonably anticipated to be a human carcinogen.”

The accusation hurled at NTP was this gem from ACC President and CEO, Cal Dooley:

“We are extremely concerned that politics may have hijacked the scientific process and believe this report by HHS is an egregious contradiction to what the President said early in his administration, ‘…That science and the scientific process must inform and guide decisions of my administration…’.”

Talk about the pot calling the kettle black (per the “second, subtler interpretation” of that phrase).

Read More »

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ECHA adds seven more Substances of Very High Concern to REACH Candidate List

Allison Tracy is a Chemicals Policy Fellow. Richard Denison, Ph.D., is a Senior Scientist.

The European Chemicals Agency (ECHA) issued a press release on Tuesday announcing the addition of seven chemicals to the Candidate List of Substances of Very High Concern (SVHC) under the European Union’s REACH Regulation.  [Update 6/20/11:  The formal addition of these substances to the candidate list, the initial announcement of which this post addressed, happened today.  See ECHA’s press release, which also contains some additional information about the uses of these chemicals.  The full candidate list including these seven substances is available here.]

All of the chemicals are officially classified as Carcinogenic, Mutagenic or Reproductive toxicants (CMRs).  Their addition brings the total number of chemicals on the Candidate List to 53.  Adding a chemical to REACH’s Candidate List is the first step toward subjecting it to REACH’s Authorization process, whereby the chemical can be used only if specifically authorized by EU authorities.

In this brief post we present a bit more information on these latest seven SVHCs, including the extent of their presence in U.S. commerce and their main uses.  Read More »

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