Monday, June 18, 2007

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OIRA Chief Dudley Unsure On Timing Of Risk Assessment Bulletin

Susan Dudley, the administrator of the White House Office of Information & Regulatory Affairs (OIRA), says she is unsure when the office will issue a final risk assessment bulletin for EPA and other agencies to follow.

Dudley's statement, which she made in a June 8 interview with Inside EPA , follows pressure from lawmakers and the National Academy of Sciences (NAS) to change or withdraw the bulletin. The proposed bulletin, put forward by Dudley’s predecessor, John Graham, in January 2006 has faced multiple hurdles, including an NAS review that called it “fundamentally flawed” and a recent letter from Sens. Jeff Bingaman (D-NM) and Joe Lieberman (I-CT) asking the White House Office of Management & Budget (OMB), of which OIRA is a part, not to release it.

The proposed bulletin aims to revamp risk assessment practices for all federal agencies, including EPA, by requiring extensive new regulatory analyses to accompany chemical risk assessments. The bulletin would also require regulators to detail a risk range and communicate risks to the public in terms comparable with other known risks.

Dudley’s statement suggests a new version of the proposal, based on public and interagency comments, may not be available for some time.

She also said agencies are currently preparing lists of guidance documents for OMB review to determine which documents constitute “significant” guidance under a new good guidance bulletin released to complement Executive Order (E.O.) 13422. President Bush signed the order Jan. 18, amending E.O. 12866 to give OMB authority to review any significant guidance documents developed by federal agencies. The amendment is nearly identical to OMB’s Bulletin on Good Guidance, which was finalized on the same day.

Dudley spoke with Inside EPA about the bulletin, the E.O. and several other issues during the interview, which is reproduced below.

Q: John Graham was here for a while, and people have been talking about what his legacy will be. How do you think you’ll distinguish yourself? What are your priorities?

A: What OIRA does is very much reacting to other agencies. Agency rulemakings come in, and agencies are very much in turn reacting to what Congress, through statutes, has told them to do. EPA may have a set of priorities, may say “I want to make sure this set of rules gets out.” OIRA’s [priority] is a lot more making sure other agencies’ priorities are implemented as effectively as possible. So that would be one of my prime priorities, to make sure we do our job well and make sure regulations are as effective as possible, that we understand what their consequences will be.

Q: Graham’s legacy in large part will be the risk assessment bulletin that he put out.

A: I’m not sure I’d put that as his legacy because that wasn’t final.

Q: But how much will you be supporting that, or how much will that be a part of what you do?

A: He did the information quality guidelines. He formalized the regulatory analysis guidelines, which were patterned after guidelines [Graham predecessor] Sally Katzen had done. John put them out for public comment. . . . He took those and sent them out for public notice and comment and made them into a circular.

Q: But on the bulletin, how much will you be supporting that, or where does that stand?

A: It went out for public notice, it went for interagency review and it went to NAS for peer review. The academy came back with what I call very constructive suggestions for improving the bulletin. They supported the overall goal, they said in a lot of ways the draft didn’t get you there, and they had a lot of constructive suggestions for how to get you there.

Q: So you don’t interpret them as recommending that it be withdrawn?

A: I guess what I would say is the academy supported the goals and gave constructive suggestions on how to meet those goals better. I think we can follow those recommendations and issue an improved set of guidelines for risk assessment, and I do plan to do that.

Q: Do you know when?

A: No.

Q: [Bingaman and Lieberman] have asked that it be withdrawn completely. Do you not intend to follow that?

A: I’d have to look at the language of their letter. I didn’t look specifically at that.

Q: There has been a lot of what some people have called unexpected congressional oversight of [E.O. 13422] and the risk assessment bulletin going forward. How will you respond when Congress asks you, “Why is this new order necessary? Why all this new administrative review of regulations?” What is your strategy for responding to that?

A: I think I have a strategy for how we will implement [the order]. I wasn’t here when it was developed, so I can’t comment on it, but I can talk about going forward. OMB has been reviewing guidance documents since we’ve been reviewing regulations. . . . What the [good guidance] bulletin does is focuses more on what are good practices for issuing guidance documents. How do you make sure you get public input? It’s a transparency, accountability notion. It requires them to be posted on the Web so people subject to guidance know what they are.

Q: I understand what their mechanisms are, but there’s been political resistance to implementing them. How will you overcome that?

A: I think what the E.O. does is it involves interagency coordination. It’s not something that will need new resources on the part of OMB or the agencies. It’s something that we’ve been doing for some [agency guidances], and there will be other guidelines that will be part of this interagency review.

Q: Like what?

A: Agencies are now working on lists of what their guidelines are, and these are things that are coming in the future, so I don’t know what they are. Agencies are working on . . . identifying whether [their guidances] are “significant” or not, working with OMB on what constitutes whether they’re significant or not.

Q: Essentially you intend to go forward as the E.O. and the risk bulletin describe now?

A: Yes, the agencies and I plan to implement the order. The risk bulletin is separate, it’s not final. I don’t plan to go forward with the way the risk assessment bulletin is written now.

Q: Can you describe how you would change it? What’s your thinking so far?

A: We are going to follow the public comments, interagency review and NAS. That’s what we’re going to do.

Q: But you don’t have any plan for which changes you’re going to make?

A: I have not made any plans public to anyone. We are working on this internally at the moment.

Q: There’s a proposed [risk assessment] guidance that was sent to OMB from the Center for Regulatory Effectiveness [June 5], which is staffed by a lot of former OMB people. Whether or not you’ve seen this draft proposal, I’m curious to know whether you’ve discussed the ideas that are in it. Among them are separating out portions of risk assessments to discuss researchers’ confidence in the data, and whether that should lead to regulatory standards or not. Are those at least the kinds of things you’ve talked about with other agencies?

A: I didn’t see the draft. I can tell you our internal discussions of the risk assessment [bulletin] and where we should go with that have not been influenced by the draft. I don’t know what’s in the draft, so I can’t comment on whether there are any similarities or not. We’re being guided by the NAS review and public comments.

Q: What are some of the ideas you’re discussing?

A: We’re not ready to discuss that externally yet. These are internal deliberations, and there’s nothing more I can tell you except we’re following the public comments and the peer review we’ve gotten.

Q: There was a meeting on Monday [June 4] between the Office of the Vice President and industry and OIRA on the [new] ozone standard. Your name is on the list of attendees. Were you there?

A: I was there.

Q: I just want to ask why EPA wasn’t present.

At this point Ms. Dudley went off the record.

Date: June 18, 2007