Eye on OIRA: Meddling with IRIS Again, Now on Arsenic

by Matt Shudtz

February 25, 2010

Add arsenic to the list of carcinogenic chemicals that will see delayed regulation from EPA as a result of OMB’s meddling. Last week, after almost seven years’ work, EPA released a draft assessment of the bladder and lung cancer risks posed by arsenic in drinking water. But the release of the final arsenic risk assessment is being delayed while EPA’s Science Advisory Board is asked to take yet another look at agency scientists’ work. As Jonathan Strong wrote in InsideEPA (sub. req'd) last week, the recursive review by SAB is “emboldening” activists who want to delay any potential new drinking water regulations.

Demanding external peer review of EPA scientists’ work on just about anything is a standard tactic industry uses to bide time before they have to shell out the money to clean up the messes they’ve made. Witness Sen. David Vitter’s hold on President Obama’s nominee for the head of EPA’s Office of Research and Development (the people responsible for IRIS assessments). Senator Vitter kept the hold on Dr. Anastas for months, until Administrator Jackson agreed to send the long-delayed formaldehyde IRIS assessment to the National Academy of Sciences for Review. That guaranteed Sen. Vitter’s constituents in the formaldehyde industry at least another 18 months of regulatory delay – more, if they can pull a few choice words from NAS’s eventual report and claim that they undermine the draft assessment.

A Senate hold on a presidential nominee isn’t the only way to ensure delay, though. Strong encouragement from people within the Executive Office of the President is another, and that’s just what the opponents of arsenic regulation got. In October 2008, EPA released an early draft of the arsenic IRIS reassessment for “interagency” review. OMB weighed in, as usual, with a set of comments that ask some highly scientific questions. As we’ve noted many times before in this space, OIRA’s small staff, with their expertise in economics and general regulatory policy and responsibility for overseeing the entire Executive Branch, should not be delving deep into the pre-regulatory science at one agency.

(Comments on IRIS assessments labeled as being from OMB often are actually an amalgamation of comments from other federal agencies that want to remain anonymous. Indeed, the varied tone of the OMB arsenic comments might lead to that conclusion here. OIRA does not further President Obama’s goal of transparent governance by encouraging anonymous comments on EPA’s scientific work, but I digress.)

Scientific comments from OMB are a problem in themselves, but the new trend we’re seeing – with EPA’s arsenic assessment, perc assessment, and others – is OMB pressing EPA to send draft assessments out for external peer review. When Administrator Jackson announced a new process for updating IRIS assessments as one of her first acts, she promised that recursive external peer reviews of the assessments would no longer be the norm because they result in unnecessary delay. Yet, OMB continues to pressure her staff to get SAB or NAS to double- and triple-check the work of EPA’s highly qualified scientists. As is increasingly becoming the case, they’ve capitulated on the arsenic assessment.

According to Strong’s InsideEPA article, on Friday, a coalition of 17 industry groups is scheduled to meet with Dr. Anastas of ORD to discuss the arsenic assessment. No doubt they are annoyed that EPA sent the draft assessment to SAB without asking for industry’s input on the charge to the peer reviewers, an opportunity they were hoping to use to turn this new review into a broad ranging and time consuming excursion into every area of arsenic science. Given President Obama’s promises of regulatory transparency and scientific integrity, and given that we’re now in the public comment stage of arsenic’s IRIS revision process, the materials presented to Dr. Anastas and notes from Friday’s meeting should be posted in the public docket.

Interesting post. As a practising environmental engineer, I would like to comment on how difficult it will be to achieve a lower standard (if it survives peer review and promulgation). a)The current MCL of 10 ppb is almost at the detection limits of most lab instruments; b)the EPA RA cites a Taiwan study as the basis for its increased dose-response. These are two different populations with different physiological characteristics. Even EPA staff probably have questioned this; c)dose response is not linear at parts per billion concentrations, it probably follows a curve. Peer review is there for a reason: your conclusions are supported by your methodology and are technically defensible.
— J. R. Caspary
Thanks for the comment. Three very good points. With respect to the MCL, the Safe Drinking Water Act requires EPA to start its regulatory process with maximum contaminant level goals (MCLGs) that are purely health-based, set at the level where "no known or anticipated adverse effects on the health of persons occur and which allows an adequate margin of safety." That's the point of the IRIS assessment. Later, other program staff will set an MCL as close to the MCLG as is feasible, given the technical and cost factors to which you've alluded. That process will involve many opportunities for stakeholder involvement. I don't know the science of arsenic toxicity well enough to comment on your other two points, except to say that EPA staff seem to have followed standard procedures, as defined in their various (peer-reviewed) guideline documents arising from NAS/NRC reports. To deal with population-level variability they've applied a standard safety factor, and to deal with the extreme end of the dose-response curve they determined they didn't have adequate data to characterize any non-linearity, so they've maintained the conservative, linear default. As EPA considers further regulation of arsenic, there will be many opportunities for stakeholder involvement. Another round of peer review on the IRIS assessment will only further delay those opportunities.
— Matt Shudtz
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Matthew Shudtz, J.D., is the Executive Director of the Center for Progressive Reform. He joined CPR in 2006 as policy analyst, after graduating law school with a certificate in environmental law.

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