EDF Health

Selected tag(s): Data requirements

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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Not just kids’ play any more: TSCA reform gets serious

By / Published: April 15, 2010

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

Today, at long last, legislation to reform the Toxic Substances Control Act (TSCA) hit the streets.  A bill, the Safe Chemicals Act of 2010, was introduced by Senator Lautenberg in the U.S. Senate.  And just to keep things interesting and all of us on our toes, Congressmen Rush and Waxman today released the Toxic Chemicals Safety Act of 2010 that is similar but not identical and is in the form of a discussion draft, rather than a bill.

It’s been a long road to get here, but of course this is only the end of the beginning.

EDF and the Safer Chemicals Healthy Families coalition support the new legislative language and believe it includes most of the elements needed to move our outdated and broken chemical safety system into the 21st century.  We also will be seeking improvements in several areas as the bill moves forward.

For our coalition’s initial perspective on the positive aspects as well as some of the shortcomings of the legislative proposals, see the news release we issued today.  We will also soon be posting an analysis that aligns the bill’s and discussion draft’s provisions with the planks of our platform, and I’ll provide an update with a link here. Read More »

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EPA IG report: New Chemicals Program fails to assure protection

By / Published: February 20, 2010

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

In a post to this blog nearly a year ago, I noted that many voices in the chemical industry were claiming that EPA’s New Chemicals Program (NCP) was robust and served as an excellent model for TSCA reform.  My post took considerable issue with that point of view, noting the many structural constraints TSCA imposes on EPA in its effort to review new chemicals:

  • No data, no problem: No up-front testing requirement or minimum data set applies to new chemicals.
  • Guessing game: EPA is forced to heavily rely on limited models and methods to predict the toxicity or behavior of a new chemical.
  • Catch-22: While EPA can require testing of a new chemical on a case-by-case basis, it must first show the chemical may pose a risk – not an easy task without any data in the first place!
  • One bite at the apple: EPA typically gets only a single opportunity to review a new chemical.
  • Crystal-ball gazing: EPA has to try to anticipate a new chemical’s for-all-time future production and use.
  • Black box: New chemical reviews lack transparency.
  • Anti-precaution: In deciding whether to require testing or controls for a new chemical, EPA equates lack of evidence of harm with evidence of no harm.

Lately, I’ve been hearing chemical industry representatives trying to resuscitate the NCP-as-model-for-TSCA-reform mantra.  So it is especially timely that a new report from EPA’s Office of Inspector General (OIG) has just been released that again thoroughly dismantles that notion.  The new report’s critique of the NCP closely mirrors the appraisal I provided earlier.  And adding weight to its analysis is the fact that EPA’s senior management has fully concurred with the report’s conclusions and recommendations. Read More »

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