EDF Health

A thing of beauty: EPA restores a good chunk of the public’s right to know under TSCA

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

One rarely gets to use the words “elegant” and “Federal Register notice” in the same sentence.  But that’s the best way to describe the notice EPA published yesterday.  The notice states EPA will now review all confidentiality claims for chemical identity in health and safety studies, and announces to companies making such claims that they should expect soon thereafter to get a letter from EPA denying the claim.

In a concise and clearly reasoned notice, EPA sweeps away decades of poor policy and practice at the agency that was at odds with the clear intent of Congress under the Toxic Substances Control Act (TSCA).
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Oil spill dispersants: What part of “contingency plan” did we not understand?

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

Now more than a month into the mammoth, out-of-control, no-end-in-sight oil spill at Deepwater Horizon, the unanswered questions, data gaps and withheld information surrounding BP’s use of dispersants are flowing in seemingly as fast as the oil is leaking.

With each passing day, it seems we know less and less about the composition and safety of these dispersants, other available dispersants, and even whether the use of dispersants– especially on this unprecedented scale – is to be advised at all.

It begs the question:  Isn’t having ready answers to such questions the reason why the federal government was required to develop a contingency plan in the first place?  Read More »

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Compounding the problem: Why aren’t we using the safest and most effective dispersants in the Gulf?

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

Imagine learning you have a serious disease.  Your doctor decides to treat you with a drug, noting it could have some bad side effects.  He also plans to inject you with the drug, even though it’s only been used orally before now.  That makes you nervous enough to ask for the name of the drug. “Sorry, I can’t tell you,” he says.  “It’s proprietary.”  Even if you trust your doctor, you’re now left with no way to investigate the risks and tradeoffs you’re facing.

Imagine how mad you’d be if you learned your doctor hadn’t told you there were other drugs that not only had fewer side effects, but were more effective in treating your condition.  And then you learn he’s on the Board of Directors of the company that makes the drug he prescribed.

Now consider that the patient is the Gulf of Mexico, the doctor is BP, and the drug is the oil dispersants, sold by Nalco under the trade name Corexit®, more than 500,000 gallons of which have been applied to date, with no end in sight.  Read More »

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

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?

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?

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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