Potentially Regulated Parties, White House Trying to Inject the Data Quality Act and Other Distractions Into EPA's IRIS Assessment Process

by Matt Shudtz

In the year since EPA Administrator Lisa Jackson announced a new process (pdf) for updating chemical risk assessments in EPA's IRIS database, agency scientists have succeeded in getting some stalled assessments moving through the system. Since the May 21, 2009 announcement, EPA staff have competed nine new and updated assessments. Two others are in the final stages of review and 20 more are at the external peer review stage.

But just as EPA staff are getting geared up, industry, potentially regulated federal agencies, and the White House are trying to throw a monkey wrench into the works.

First, Inside EPA reports (subs. required, "Industry, Agencies Struggle To Revise EPA's Risk Assessment Process") that anti-regulatory advocate Jim Tozzi's Center for Regulatory Effectiveness is making the claim that external peer review must be "Data Quality Act compliant." That's a great way to strike fear in the minds of an embattled office like the IRIS office, but it lacks any real basis. The purpose of a Science Advisory Board SAB (SAB) review is to get outside scientists' opinion on specific science-policy decisions made by EPA staff in the process of developing the IRIS assessment. By definition, opinions are not "information" covered by EPA’s DQA guidelines (pdf, p.16), so the DQA doesn't apply. And even if it did apply, there's no checklist to make sure a document is DQA compliant. The DQA simply creates a (not-judicially-reviewable) administrative mechanism for outside parties to request that an agency correct information that they disseminate that does not meet the agency's DQA guidelines. At its core, the DQA respects the fact that agencies are staffed by dedicated and highly competent individuals who do high quality work. The burden is on an outside party to prove that disseminated information does not conform to an agency's DQA guidelines. There is no burden for EPA to perform any sort of DQA-specific analysis of a piece of information before disseminating it.

Second, the White House's Office of Management and Budget has recently filed comments on several draft IRIS assessments asking EPA to take language from its DQA guidelines and insert the language into the charge questions for SAB reviewers looking at the IRIS assessments. Specifically, OMB has asked that EPA charge SAB reviewers with assessing whether the risk assessment is accurate, clear, complete, transparently and objectively described, and scientifically justified. (See, e.g., OMB’s comments on hexachloroethane (pdf, p.3).) In essence, OMB is asking EPA to deputize SAB as DQA a pre-clearance screening committee.

Using SAB in that way is unnecessary at best. The DQA put the burden on the public, not the government, to find faulty information disseminated by agencies and prove that it doesn't meet the relevant DQA guidelines. SAB exists to help EPA untangle particular and difficult science-policy questions, not engage in protracted and unfocused quality reviews. At worst, asking SAB volunteers to be DQA pre-clearance reviewers will create a massive disincentive to participation on SAB panels, detracting from the number and quality of experts who want to serve.

To be clear, I don't foster any illusions that OMB actually cares about DQA enforcement in the IRIS process. This is just an attempt to give certain peer reviewers an opening to attack pieces of the risk assessment that IRIS staff have not identified as needing outside review. One of EPA Administrator Lisa Jackson's goals in devising the new IRIS process was to speed the completion of new assessments. To that end, EPA staff are asking for focused external review that will enable them to finish IRIS profiles quickly and move on to new assessments. Potentially regulated parties benefit from each day of delay, though, and inserting DQA-themed review into the IRIS process would significantly slow the external review stage.

Finally, someone within NASA has apparently requested a meeting with EPA to air grievances about not having sufficient opportunities to critique draft IRIS assessments, according to the Inside EPA article. But unlike other regulated parties who are limited to one public comment period, NASA gets three opportunities to nitpick each IRIS assessment. Check out this chart. A potentially regulated agency can comment first at Step 3, the interagency science consultation on the initial draft; second at Step 4, the standard public comment period; and third at Step 6B, the final round of interagency review. That's three opportunities to comment on a document that doesn't even have direct regulatory impact. When the IRIS assessment is eventually used to set a cleanup standard or other regulatory action, NASA (and other regulated parties) will have many other opportunities to critique the science. 

Talk about looking a gift horse in the mouth. When EPA adopted the new IRIS process last May, it might very well have eliminated interagency review or treated potentially regulated agencies like any other stakeholder and restricted their input to comments filed during the public comment period. But instead, EPA gave other agencies two additional passes through the back door. And NASA doesn't think that's enough. I'm shocked. Shocked. Of course, this is exactly the reason we argued that EPA eliminate the interagency review process -- it's a waste of resources considering the immense backlog of chemicals for which we have insufficient risk analyses. Again, delay is the name of the game.

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