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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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).
Read More »

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

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.

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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 »

Posted in Health policy, Regulation, TSCA reform / Tagged , , , , , , , , , , , , | Read 5 Responses