EDF Health

Selected tag(s): Risk assessment

EPA seeks to improve TSCA data reporting; a real litmus test looms for the chemical industry

By / Published: August 20, 2010

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

While I was on vacation last week, EPA’s proposed rule to improve chemical information reporting under its so-called Inventory Update Rule (IUR) was finally published in the Federal Register.  (I say “finally” because the proposal languished for almost 6 months over at OMB, nearly double the 90 days such mandatory reviews are supposed to take.  That unfortunate delay is curious given the relatively modest changes that appear to have been made by OMB – mostly limited to compelling EPA to shift a few elements from proposals to options open to comment, and requiring EPA to expand the range of issues on which it now seeks comment.)

I won’t summarize the EPA proposals here; EPA’s factsheet does a good job of that, and Daniel Rosenberg at NRDC has also nicely recapped the proposal on his blog.  Suffice it to say that the proposed changes would go far to address the many failings of the current IUR, which amply manifested themselves in the last reporting cycle and severely hampered EPA’s ability to assess high production volume (HPV) chemicals under its ill-fated ChAMP Initiative.

So how will the chemical industry react?  Here’s why I’ll be watching intently.  Read More »

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EPA clarifies it wants more information on those dispersants made public

By / Published: June 9, 2010

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

EPA issued a statement today drawing attention to its posting on its website late last week of the ingredients in NALCO’s Corexit® dispersants, more than one million gallons of which have now been released into the Gulf of Mexico.  The statement appears to have been issued in response to queries from myself and others as to why the posting was not more prominently flagged by EPA.  It indicates that the most recent disclosure “was possible because NALCO waived their claim” that the ingredient identities are proprietary.  It also makes clear EPA doesn’t consider Nalco’s disclosure to be the end of the story, and that EPA will continue to seek to provide the public with more information about the dispersants than their producers have produced to date.

I’ve posted EPA’s statement just beyond this jump. Read More »

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

By / Published: June 5, 2010

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

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

By / Published: January 12, 2010

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

By / Published: January 4, 2010

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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