EDF Health

Selected tag(s): Data requirements

Does dispersant toxicity count? No toxicity standard limits EPA’s listing of oil spill dispersants

By / Published: June 24, 2010

Richard Denison, Ph.D., is a Senior Scientist.  EDF’s Health Program Intern Shannon O’Shea provided valuable assistance in the research for this post.

The more I have looked into the question of how dispersants get listed and selected under the country’s National Oil and Hazardous Substances Pollution Contingency Plan (NCP), the more disturbing it gets.

It turns out EPA regulations impose no maximum toxicity limits on dispersants allowed to be listed on the NCP Product Schedule.  Nor is such a listing deemed by EPA to be an approval or authorization for use of a dispersant on a spill – it merely signifies (with one exception) that required data have been submitted to EPA.  Yet, once listed, a dispersant is effectively “pre-authorized” for use, and the guidance provided to officials charged with deciding whether to allow use of a dispersant, and if so which one and in what quantities and settings, makes scant mention of toxicity as a factor to be considered in the selection decision.

No wonder there’s little incentive to do the research needed to understand the full scope of impacts associated with dispersant use, let alone to develop and shift to safer and more effective dispersants.

This post examines the following questions:

  • How does a dispersant get listed on the NCP Product Schedule?
  • Is listing of a dispersant considered approval for use on a spill?
  • How is a dispersant approved for use in a spill?
  • How are decisions made about dispersant use?
  • How is toxicity information considered in making decisions about dispersant use?

Read More »

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Side-by-sides of TSCA, Senate bill and House discussion draft

By / Published: June 5, 2010

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

I have updated and made some minor corrections to the summary chart I posted earlier comparing current TSCA to the proposed TSCA reform legislation (Senate bill and House discussion draft) at the 10,000 foot level. It’s displayed below.

In addition, I have prepared a much more detailed side-by-side of the Senate bill and House discussion draft, which I’m posting here as a PDF.

Currently under TSCA Under the Senate and House proposals
DATA:  Few data call-ins are issued, even fewer chemicals are required to be tested and no minimum data set is required even for new chemicals. Up-front data call-ins for all chemicals would be required.  A minimum data set (MDS) on all new and existing chemicals sufficient to determine safety would be required to be developed and made public.
BURDEN OF PROOF:  EPA is required to prove harm before it can regulate a chemical. Industry would bear the legal burden of proving their chemicals are safe.
SAFETY ASSESSMENT:  No mandate exists to assess the safety of existing chemicals.  New chemicals undergo a severely time-limited and highly data-constrained review. All chemicals, new and existing, would be subject to safety determinations (in the case of certain new chemicals, at some point after entry into commerce).
SCOPE OF ASSESSMENT:  Where the rare chemical assessment is undertaken, there is no requirement to assess exposure to all sources of exposure to a chemical, or to assess risk to vulnerable populations. The safety standard would require the assessment of a chemical to account for aggregate and cumulative exposures to all uses and sources, and to ensure protection of vulnerable populations that may be especially susceptible to chemical effects (e.g., children, the developing fetus) or subject to disproportionately high exposure (e.g., low-income communities living near contaminated site or chemical production facilities).  “Hot spots” would be specifically identified and addressed.
REGULATORY ACTION:  Even chemicals of highest concern, such as asbestos, have not been able to be regulated under TSCA’s “unreasonable risk” cost-benefit standard.  Instead, assessments often drag on indefinitely without conclusion or decision. Chemicals would be assessed against a health-based standard, and deadlines for decisions would be specified.  Chemicals of highest concern would be subject to expedited safety determinations and/or actions to reduce use or exposure to them.
INFORMATION ACCESS:  Companies are free to claim, often without providing any justification, most information they submit to EPA to be confidential business information (CBI), denying access to the public and even to state and local government.  EPA is not required to review such claims, and the claims never expire. All CBI claims would have to be justified up front.  EPA would be required to review them, and only approved claims would stand.  Approved claims would expire after a period of time.  Other levels of government would have access to CBI.
RULEMAKING REQUIREMENTS: To require testing or take other actions, EPA must promulgate regulations that take many years and resources to develop. In addition to the MDS requirement, EPA would have authority to issue an order rather than a regulation to require reporting of existing data or additional testing.
Posted in Health policy, TSCA reform / Also tagged , | Comments are closed

Just what the doctor ordered: EPA tells BP to use less toxic oil dispersants in the Gulf

By / Published: May 20, 2010

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

This just out:  The Washington Post is reporting that EPA has given BP 24 hours to identify and locate a supply of a less toxic dispersant to be applied to the Gulf oil spill, and to begin using it within an additional 72 hours.

As noted in my last post, EPA has identified numerous alternative dispersants that are both less toxic and more effective than those on which BP has been relying to date — more than 600,000 gallons of which have already been released into Gulf waters.  The Post also notes that some forms of the initial dispersants, sold by Nalco under the trade name Corexit®, were banned by the British government more than a decade ago.

Posted in Environment, Health science / Also tagged , | Comments are closed

Raising the bar for chemical safety will spur, not stifle, innovation

By / Published: May 9, 2010

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

An emerging chemical industry talking point in TSCA reform is the claim that imposing new requirements on new chemicals will somehow stifle innovation.  The milder manifestation of this perspective emanates from those who oppose requiring a safety determination for new chemicals unless they raise major red flags in an initial review.

But some in the industry go further, arguing that even requiring safety data for new chemicals would put the big chill on development of new chemicals.

I beg to differ with both arguments.  This post will make the opposite case, and will also argue that true innovation embraces rather than shuns safety, and demands the information needed to demonstrate it. Read More »

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A minimum data set: Why, what, how much and when?

By / Published: April 21, 2010

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

As I noted in my last post, EDF and the Safer Chemicals Healthy Families coalition believe TSCA needs to ensure that basic safety data are developed and made available for all chemicals in commerce.  Such information is:

  • a core element of the public’s right-to-know;
  • embodied in the “no data, no market” concept already in place under the EU’s REACH; and
  • most importantly, critical for identifying BOTH:
    •  chemicals of concern we have not yet identified, due to data gaps; and
    • chemicals  presenting little or no concern, which may serve as safer alternatives to chemicals of concern but we need to be able to identify with greater confidence.

The chemical industry’s opposition to comprehensive data requirements is an inherent contradiction:  It is often the first to claim “regrettable substitution” when a chemical is restricted, asking: “How do we know the substitute is any better?”  The answer is we often won’t – UNLESS we take a comprehensive approach to data development

So what types of data, and how much, should comprise a minimum safety data set?  And when should it be submitted? Read More »

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A minimum data set: Who needs it?

By / Published: April 18, 2010

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

Sound chemicals management and control demands sound information.  The Safer Chemicals Healthy Families coalition believes information sufficient to determine a chemical’s safety needs to be provided for all chemicals, as a condition for them to enter (for new chemicals) or remain (for existing chemicals) on the market.

Needed chemical information is not limited to test data, and even for types of data that can be derived from testing, alternative sources and approaches may be appropriately used.  Given the large number of chemicals for which information is needed, the availability of various sources of information, and the desirability of minimizing cost and use of laboratory animals, all reasonable efforts should be made to use existing information and data derived from the use of validated alternative methods – as long as the information they provide is current and scientifically reliable.

But who needs such information? Read More »

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