Policymakers, several public-interest advocates, and business groups are greeting the Office of Management and Budget's new risk assessment memorandum released Sept. 19 with a surprisingly muted reaction, according to recent interviews by BNA.

The mild response is in sharp contrast to the disagreement between opponents and supporters of OMB's original risk assessment bulletin, as expressed in public comments after it was released in draft form in January 2006 (121 DER A-40, 6/21/06).

On Sept. 19, OMB withdrew its controversial 2006 draft risk-assessment bulletin, which was described as "fundamentally flawed" by the National Academy of Sciences in a January 2007 review.

OMB replaced the draft bulletin with an updated memorandum based on earlier risk-assessment principles set forth in 1995 by Sally Katzen, then-director of OMB's Office of Information and Regulatory Affairs during the Clinton administration.

The updated memorandum restates the 1995 principles and adds references to more recent OMB guidance--including OMB's Information Quality Guidelines, Peer Review Bulletin, and Final Bulletin for Agency Good Guidance Practices--which OMB says are intended to "reinforce" the 1995 principles (182 DER A-24, 9/20/07). The new memo was released jointly by OMB and the White House Office of Science and Technology Policy.

'Modest Step,' Says Former OIRA Head

"The memo is a modest, constructive step in the right direction," John Graham, who served as administrator of OIRA from 2001-2006, said in an e-mail message to BNA. "Given the concerns of the National Academy of Sciences, OMB was wise to withdraw the draft bulletin."

Echoing Graham, Donald Arbuckle, OIRA's deputy director from 1996-2006, called the new memo "a pretty modest gesture," in a telephone interview with BNA. "I was surprised OMB was able to get it out," added Arbuckle, who now teaches public policy at the University of Texas-Dallas. "It's not really a final bulletin but more of an amplification of the 1995 Katzen standards."

Describing the memo as "unfinished business" from earlier in Graham's tenure as OIRA administrator, Arbuckle said OIRA knew "the scientific community would go bananas" if it released the risk assessment bulletin in final form.

Instead, Arbuckle said "OIRA hit upon the idea of taking advantage of what we do know and what most people agree on" and placed it in the updated memo.

Arbuckle said both Graham and Katzen "shared the same general philosophy that you somehow need to manage this huge set of federal agencies by establishing some organizing principles [for risk assessments]."

Katzen, who now teaches law at George Mason University School of Law, told BNA: "I think it is significant that OMB withdrew the Bulletin, which was very heavy handed. They are replacing it with a document that is not written in those terms. In this respect, I think the memo is responsive to the NAS critique."

She added: "I also think it's significant that OSTP co-signed the document. That seems to suggest that the memo is not a power grab by OIRA."

Interest Groups Have Mixed Response

Responding to the memo on the public interest side, Rena Steinzor, who is on the board of the Center for Progressive Regulation and teaches risk assessment at the University of Maryland School of law, told BNA, "With this memo, OMB is not doing what they originally set out to do--not anything close." She added: "They backed down. Even in this administration there are limits to how obstreperous OMB can become."

Rick Melberth, director of regulatory policy at OMB Watch, which opposed OMB's original risk assessment bulletin, called the new memo "not very significant" in a statement issued when the memo was released. "Agencies will probably stick this in a desk drawer because this doesn't change much in the way that agencies conduct their regulatory analyses," Melberth added.

On the other hand, Robert Shull, deputy director for auto safety and regulatory policy at Public Citizen, views the new policy as an attempt to bootstrap more recent OMB policies onto the 1995 principles, potentially subjecting agency risk assessments to political interference by OMB as well as objections by industry.

"If the memo in fact adds no new requirements to agency risk assessments, then this is an opportunity to look back in horror at what the Bush administration has wrought," said Shull. He noted that OMB's Information Quality Guidelines, Peer Review Bulletin, and Final Bulletin for Agency Good Guidance Practices impose public notice and comment requirements, potentially subjecting risk assessments to court challenges by industry.

Low Key Response From Industry Groups

Industry groups offered mild praise for the new policy. "We think the memo was framed in the right way," said Rosario Palmieri, vice president for regulatory affairs at the National Association of Manufacturers. "It's not a dramatically new restatement of policies that should be guiding sound risk assessments in all agencies."

Speaking on behalf of the American Chemistry Council, Dr. Richard Becker, ACC's senior toxicologist, said, "the risk analysis memorandum outlines the goals and general principles for risk analysis that will enhance scientific objectivity and promote efficiency and consistency government-wide."

The U.S. Chamber of Commerce, which was outspoken in its praise for OMB's original 2006 risk assessment bulletin, declined to comment on the new memo. "We're still studying it," said a spokesman for the Chamber.

OMB Implementation is Key

How aggressively OMB intends to enforce various aspects of the memo will be the key to its importance, said several policymakers and analysts.

"OMB should enforce the memo as strongly as their resources permit," said Graham, the former OIRA head. "But much will depend on the good will and professionalism in the agencies."

Arbuckle, the former OIRA deputy said, "What likely will happen is that this will be part of an informal list of principles that OIRA's desk officers will discuss with the agencies."

He added, "It will be pretty obvious when the principles need to be applied--more likely with a major regulation from [the Environmental Protection Agency] or [Food and Drug Administration] than a run of the mill rule from the Department of Transportation."

Katzen said, "When the 1995 principles were sent to the agencies, there was a cover letter that said the risk assessment principles are aspirational, not prescriptive." She added, "Their application requires flexibility and practical judgment. That kind of language is not present in the current version. At the same time, however, the current version doesn't include words like mandatory or prescriptive. The issue will be how the memo is implemented."

Katzen continued: "I've seen quotes from [certain outside groups] claiming victory and saying that this memo gives OMB a huge foot in the door for controlling agency risk assessments, that OMB will require strict compliance with the principles, that OMB will be using all the authority under the Data Quality Act, etc. I don't read that in the document."

James Tozzi, a former OIRA deputy director during the Reagan administration who currently heads the industry-supported Center for Regulatory Effectiveness, viewed as "very important" the fact that OMB, in its introduction to the new memo, said it "would follow through and make sure that agencies are following the procedures set forth in the memorandum."

Tozzi added, "the linkage with the Data Quality Act and their plan to follow through with enforcement are very important things."

Steinzor, at the University of Maryland, discounted notions that the memo exposes risk assessments to industry court challenges. "That's not to say people won't try but there is nothing enforceable in the memo," she said. "It's completely vague. There isn't a shadow of a glimpse of a possibility this will ever end up in court."

Taking a broader view, Steinzor said that ultimately it was "pointless" to speculate about what will or will not happen with the memo. "We know there's going to be a change in administration's next year. It's kind of hard to imagine that OMB will get very fussy about this. We all have bigger fish to fry."

By Ralph Lindeman Bureau of National Affairs _____________________________________________________________________