EDF Health

Selected tag(s): Risk assessment

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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EPA IG report: New Chemicals Program fails to assure protection

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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Won’t we ever stop playing whack-a-mole with “regrettable chemical substitutions”?

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

In recent days, two compelling cases have surfaced of so-called “regrettable substitutions” – industry responding to concerns about the use of one dangerous chemical by replacing it with another that is less well-studied, or at least not currently in the crosshairs.

Case 1:  Chinese manufacturers of children’s jewelry, responding to concerns and restrictions on the use of lead in such products produced for export to the U.S., have replaced it with cadmium, a known human carcinogen and developmental toxicant that, if anything is even more toxic to kids than lead – but is not subject to any restrictions in such kids’ products.

Case 2:  American food product manufacturers, responding to concerns about the devastating effects on the lungs of workers exposed to diacetyl – an artificial butter flavoring used in many products, most notably microwave popcorn – have begun to replace it with closely related chemicals likely to break down into diacetyl or otherwise have similar effects.

Are we destined forever to play this dangerous variant on the game of whack-a-mole, or can something be done? Read More »

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EPA deserves an “A for Effort” for its new Chemical Action Plans

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

Just squeaking in under its self-imposed deadline, late on December 30 EPA issued the first batch of chemical action plans it has promised under its enhanced chemical management program.  In doing so, EPA has signaled its intention to do all it can using its existing authority under the Toxic Substances Control Act (TSCA) – even as it also makes clear that authority is “both outdated and in need of reform.”  To my ear, that strikes just the right balance. Read More »

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Over-Exposed: Why relying on exposure to prioritize chemicals is dangerous

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

When the chemical industry talks about prioritization – a central question in the debate over TSCA reform – more often than not it quickly reduces the question down to the argument that we should focus only on those chemicals, however hazardous or untested they may be, to which we know people are exposed.  In a perfect world, that might suffice.  But, as this post will explore, the world of exposure assessment is anything but perfect.  Read More »

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ChAMP “superseded”: EPA shifts into action mode

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

A new entry showed up sometime in the last day on EPA’s webpage for its ChAMP initiative.  It reads:  “The Chemical Assessment and Management Program (ChAMP) has been superseded by the comprehensive approach to enhancing the Agency’s current chemicals management program announced by Administrator Lisa Jackson on September 29, 2009.”

Don’t miss this bit at the top of the page:cobweb

Yes, that image is a cobweb, which EPA uses to designate archived web content.  What’s happening here? Read More »

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