EDF Health

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

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.
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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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Yes, Virginia (and all 49 other states), chemicals do cause cancer

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

Please help me welcome to the true mainstream of scientific and medical thought the seemingly radical yet commonsense notion that chemical exposures are a significant contributor to cancer, many types of which are rising in incidence even as overall rates decline.

This morning, the President’s Cancer Panel released its 2010 report [available here].  The report is remarkable not so much for its core finding that chemical exposures are a major factor in human cancer, but rather because of its source — an authoritative and bipartisan body — and because of the strong linkages it makes to our failed chemicals policies.

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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