Before Christine Todd Whitman can issue a new standard protecting against arsenic in drinking water, she must get his approval. Ditto if Tommy Thompson wants to collect information on nursing home performance. Or if Ann Veneman wants to require new testing for listeria in meat products. In fact, no health, safety, or environmental standard is beyond his reach. The man behind the curtain is John Graham, administrator of an obscure but powerful office within OMB -- the Office of Information and Regulatory Affairs (OIRA) -- which has the authority to review, and possibly reject or amend, any agency regulation or collection of information. Such far-reaching authority is naturally open for abuse. During the Reagan and Bush I administrations, OIRA emerged as an ideological tool to limit government's reach. Agency proposals would go to OIRA for review and languish there -- sometimes for years -- with little or no explanation to the public. This changed somewhat during the Clinton administration, as agencies were afforded a greater degree of deference, but Graham has started to return OIRA to its more activist roots. Graham's nomination was widely opposed by health and safety advocates -- and ultimately, by 37 senators -- for precisely this fear. As head of the Harvard Center for Risk Analysis, which is heavily funded by industry groups, Graham was a frequent and vocal opponent of new government regulation, as well as a vociferous proponent of regulatory "reform" legislation that sought to constrain agencies from acting. Like his predecessors from OIRA's activist years, Graham has been aggressive in the regulatory review process. In his first six months, Graham has already rejected 17 regulations submitted to OIRA. With each rejected regulation, Graham has sent a "return letter" -- made public through OMB's web site -- summarizing the reasons for the rejection, which inevitably have focused on cost considerations. Most recently, Graham turned away an auto safety proposal from the National Highway Traffic Safety Administration (NHTSA). Developed as a response to problems with Firestone tires that resulted in 271 deaths and a massive recall, NHTSA's proposal would have required automakers to install a system in all cars by 2007 that would alert drivers if their tires are underinflated. In rejecting the standard, Graham advised NHTSA of his preferred way to regulate, which involved a less costly yet less reliable system preferred by the automakers, discussed in detail here. Yet Graham is moving OIRA beyond its traditional review function. Rather than focusing exclusively on reviews of specific agency actions, and acting as an ideological block, Graham has moved to affect the decision-making process upfront -- to change the nature of regulations before they are even received by OIRA for review. He has started to do this through "prompt letters" directing agencies to examine a problem identified by OIRA. But more significantly, Graham has pressed greater agency reliance on certain decision-making tools, such as cost-benefit analysis, risk assessment, and peer review, using OIRA's ultimate review authority as a powerful stick. On the surface, this may not seem such a big deal. These tools have been used by agencies for years in regulatory decisions and can be very useful. Yet such subtle questions of emphasis, and the manner in which they are used, can have powerful implications for the outcome of regulatory decisions -- potentially leading to less protective health, safety, and environmental protections. Graham's Actions In his first six months as OIRA administrator, Graham has begun to implement his vision by exerting more centralized control of the regulatory process across agencies, at all stages of the process. Specifically: Graham issued a memo to agency heads signaling a more active role for OIRA, emphasizing cost-benefit analysis, risk assessment and peer review. In one of his first moves as OIRA administrator, Graham put agencies on notice with HREF="http://www.whitehouse.gov/omb/inforeg/oira_review-process.html">a memo outlining his regulatory review priorities at OIRA. On the surface, the memo may seem rather benign -- not much more than a restatement of OIRA's current responsibilities. But in a number of ways, it signals a new aggressiveness, which may not bode well for health, safety, and environmental protections. In particular, Graham signals that he will exercise increased oversight over agency cost-benefit analysis, risk assessment, and other various executive orders, including those requiring assessments of affects on our energy supply and federalism. OIRA has always exercised authority in these areas, but with varying degrees of diligence (and in the Clinton administration, at least, provided the agencies a degree of deference). For instance, the federalism executive order, which has its roots in the Reagan administration, served more as a general statement of policy and has been only modestly enforced by OIRA. Graham, however, makes clear that his OIRA will be more demanding of agencies than ever before (at least in this respect). "As OMB Director Daniels has pledged to Congress," he says in the memo, "rulemaking proposals that were not subjected to adequate State and local consultation will be returned to agencies for reconsideration." Interestingly, Graham's memo makes no mention of enforcing an executive order, signed by President Clinton, requiring that agencies give special attention to children's health. The memo's clear that emphasis should be on burdens to regulated industry. On this point, Graham's effort to elevate cost-benefit analysis in the rulemaking process is particularly troubling. Graham's memo indicates that rules will be returned if OIRA deems the agency has performed inadequate analysis, noting this has already happened in several cases. Frequently, laws designed to protect public health or safety -- such as the Clean Air Act or the Occupational Safety and Health Act -- forbid agencies from basing decisions on cost-benefit analysis (even though E.O. 12866 still instructs them to do it); instead, saving human life is preeminent. In these cases, Congress has rightly recognized that such analysis is unreliable and frequently biased in favor of costs because of analytical limitations, which can lead agencies to be hyper-cautious, leaving the public with insufficient protection. Graham has advocated a different position; once he was part of an amicus brief before the Supreme Court arguing that costs should be considered for clean air rules. The danger is Graham will enforce his vision despite congressional restrictions and the fact that agencies, not OIRA, are statutorily charged with carrying out regulation. OIRA's power over regulation flows only from executive order. As part of his effort to elevate cost-benefit analysis -- also referred to as Regulatory Impact Analysis (RIA) -- Graham's memo advises agencies to subject each RIA to peer review by "qualified specialists." Currently, agencies frequently engage in some sort of peer review -- such as EPA's Science Advisory Board -- to assess the science and whether regulation is necessary. But RIAs are not subject to peer review. This idea has been a key component of regulatory "reform" legislation -- never enacted, but energetically supported by Graham -- that has been a mainstay since the Contract with America. Currently, anyone can comment on an RIA following publication of a proposed rule in the Federal Register, and the agency has a chance to respond and incorporate suggestions as it moves to finalize the regulation. The problem with the sort of peer review advocated by Graham is that it is a closed process, conducted before notice is even given to the public. Moreover, on a more practical level, "qualified specialists" will be difficult to find, particularly given limited resources with which to compensate peer reviewers. The danger is that peer review panels would become a stacked deck of those with the time, money, and incentive to serve -- namely regulated industry (and indeed, this has even become a problem for EPA's Science Advisory Board, as documented in this GAO report). Nonetheless, Graham serves up a nice carrot to get agencies to comply: "OIRA will be giving a measure of deference to agency analysis that has been developed in conjunction with such peer review procedures." Consistent with this desire to impose his vision on the rulemaking process, Graham also advises agencies on his preferred method of risk assessment, quoting at length the risk assessment provisions of the Safe Drinking Water Act. Graham was closely involved in writing the Safe Drinking Water Act, and it's understandable that he holds the act in high regard. Yet its provisions for assessing risk may not be appropriate for assessing risk in all cases, across the whole range of government activities. Indeed, in many cases, agencies methods for assessing risk will be governed first by its statutory obligations laid out by Congress. Graham has begun issuing return letters for rejected agency regulations. During the first six months of Graham's tenure, OIRA has delivered a slew of return letters, as well as post-review letters, which are sent to an agency after OIRA completes a review of a draft rule. Most of Graham's 17 return letters and each of the three post-review letters claim inadequacies in the agency's cost-benefit analysis -- making good on the promise to elevate cost-benefit analysis outlined in the memo discussed above. In no case does OIRA return a rule for being insufficiently protective of public health, safety, or the environment. OIRA's clear overriding concern is cost. For instance, in returning a rule from the Department of Transportation on hazardous materials -- specifically, safety requirements for cargo tanks transporting flammable liquid -- OIRA suggested exempting tanks older than 15 years, questioning the "cost-effectiveness" of the rule, and indicating it feels that DOT is overstating benefits. To satisfy OIRA and "prove" cost-effectiveness, monetization of benefits becomes crucial. This emphasis on cost-benefit analysis, and in particular the monetization of benefits, is very troubling to health, safety, and environmental advocates. Cost considerations are frequently easier to monetize than benefits. For a company, they may involve purchases of new equipment or the hiring of additional personnel. Benefits on the other hand frequently do not involve goods or services traded on the open market; they may involve the saving of human life, prevention of environmental degradation, or the reduction of injury or disease. Monetizing such benefits involves severe limitations and a host of questionable analytical assumptions. Under the monetization methods favored by Graham, this process is likely to deflate benefits relative to costs, which can be used to justify a decision not to act. Rhetorically at least, Graham has recognized the difficulty in monetizing certain benefits and the necessity of incorporating qualitative factors in cost-benefit analysis. Yet through his letters to agencies, as well as his memo, it is clear Graham believes agencies are not doing enough to monetize benefits. For instance, in a post-review letter on an EPA proposal to control emissions of certain recreational engines, OIRA objects that EPA failed to monetize the environmental benefits associated with the rule. Besides affecting the rule in question, such a public letter also serves to send a message across government, affecting the way other agencies operate - which Graham has stated is his intent. This emphasis on monetization does not bode well for health, safety, and environmental protections. Graham has put agencies on alert by detailing in the president’s budget proposal his preferred methods for assessing costs and benefits. Besides simply demanding monetization, as described above, Graham is pressing agencies to adopt particular analytical methods to achieve monetization. If employed, these methods will rig the result and undoubtedly lead to less protective health, safety, and environmental standards. Graham points to his preferences in the president’s recent budget submission to Congress, noting that new formal guidance to agencies on how to conduct monetization is forthcoming: “OMB has committed to update periodically its guidelines for regulatory analysis, which are used when OMB reviews agency rulemakings.” In particular, Graham stresses the importance of “league tables” for setting regulatory priorities. These tables are intended to compare the costs and benefits of one type of regulation, such as auto safety, to another, such as environmental protection. As an example, Graham presents his own league table of rules already on the books, which includes four rules from EPA, four from the Department of Transportation, and two from OSHA. From this table, Graham notes “the tendency for safety rules to be more cost-effective than health rules.” For instance, DOT’s rule on head impact protection scores well while EPA’s NOx SIP Call rule on air quality and OSHA’s rule on methylene chloride (to prevent against cancer) do not. Ideally, according to Graham, league tables should be used to compare programs across agencies at the beginning of the regulatory process for proposed rules (rather than rules that have already been adopted). This “is more useful for synoptic purposes or for decision making by governmental entities with inter-agency responsibility (e.g., appropriations committees and OMB),” Graham writes. Based on Graham’s presentation, this seems to suggest a trimming of agency budgets that deal primarily with health or the environment, such as EPA, and perhaps redistributing the savings to safety agencies, such as DOT, that deliver more “cost-effective” rules. As Graham points out, “The table suggests that we need to do a better job at both refining estimates of the cost-effectiveness of regulatory proposals and setting priorities for the use of the nation’s limited resources to protect citizens from health, safety, and environmental risks.” Yet this policy position is a direct result of Graham’s analytical choices, which are open to question. In formulating the league table, Graham employs his favored method to monetize the costs and benefits of each rule. As explained above, the mere process of monetization, regardless of method, inevitably fails to capture crucial benefits. In the case of Graham’s league table, the benefit estimates are derived almost exclusively from avoided fatalities. They exclude or devalue other impacts, such as morbidity, effects on ecosystems, and equity considerations. Moreover, even for measures of avoided fatalities, which Graham has included, benefits are greatly understated as a result of Graham’s analytical preferences. Specifically, Graham monetizes benefits by focusing on life-years saved (as opposed to the number of individual lives saved, as commonly practiced), assuming no benefit until the first life-year is saved. Already, this method of computing benefits will inevitably bias the system against regulation such as cancer prevention -- which has a long latency period -- that primarily benefits the elderly (who have fewer “life-years” remaining) and people in the future. Yet on top of this, Graham then discounts the value of life-years saved in the future by 5 percent for EPA rules (7 percent for other rules) from the point that the first life-year is expected to be saved. To use an example from Georgetown Law Professor Lisa Heinzerling, a regulation that, on average, prevents fatality at the age of 35 would save 42 life-years assuming a life expectancy of 77 years. Discounting 5 percent from each life-year starting at age 36, the present value of the 42nd life-year saved would be approximately 1/8 of a year. Not surprisingly, no such discounting takes place on the cost side of the equation -- to account for inevitable economic growth -- which produces more resources to be spent on regulation over time or well-documented adaptive effects, such as technological advances or “learning by doing.” As a result, cost estimates frequently prove overblown in the real world. For instance, EPA estimated in 1990 that acid rain controls would cost electrical utilities about $750 per ton of sulfur dioxide emissions; yet the actual cost today is less than $100 per ton, billions of dollars less than what was initially anticipated. With overblown cost estimates, combined with Graham’s approach to discounting and use of life-years, it’s hard to see how the government would ever again produce a regulation that primarily is directed against diseases of old age. From these value-laden analytical choices, Graham suggests the emphasis should be on safety regulation, which can save young people today, while we should curtail health and environmental regulation, which do not fare well under his “cost-effectiveness” test. Yet why do we even need to pose such a tradeoff? Certainly, safety regulations are important (although so far, Graham seems weak even here, as evidenced by his recent rejection of DOT’s tire safety standard). But should that preclude regulation to protect public health and the environment? Graham has previously accused the government of “statistical murder” for failing to pose such tradeoffs, and his promotion of league tables is clearly an attempt to move in that direction. This formulation assumes a fixed national budget for risk reduction, where a dollar spent on Risk A means a dollar less to spend on Risk B. Yet the United States has a $9 trillion economy, of which only a tiny fraction is devoted to risk reduction. Of course, agencies and decision-makers must prioritize activity within fiscal constraints. But frequently the hard tradeoffs posed by Graham pitting one life-saving measure against another are unnecessary and lead you down the path to inaction. In the end, the effort to monetize benefits is just a distraction that masks the true policy choices that must be made. Because of all the assumptions and analytical games that go on to arrive at a dollarized figure -- which only the practitioner can sort out and truly understand -- it would be more useful to decision-makers and more transparent to the public if non-monetary benefits were simply described (quantitatively to the extent feasible) by stating, for example, the expected number of lives saved over a given period of time. As it stands now, numbers are thrown around like rhetorical grenades and no one really knows what they mean. Graham has moved to hire scientists at OIRA for the first time, implying a new role for the office. OIRA has come under criticism in the past for involving itself in a very substantive way in scientific questions for which it has little or no expertise. Executive Order 12866 gives OIRA review authority over agency cost-benefit analysis, and the Paperwork Reduction Act gives review authority over information collection requests, both of which involve economic considerations and analysis. But questions of science that go to the need for a regulation should be the chief purview of the regulatory agencies, such as EPA, DOT, or OSHA. After all, agencies not only have a statutory obligation to address these scientific questions (which OIRA lacks), they have the built-in expertise to do it. OIRA on the other hand has no scientists on staff, and never has; instead, virtually all OIRA staff have backgrounds in economics or public policy. Graham is set to change this, however. Recently, Graham announced his intent to hire five new analysts "aimed at expanding the Office's scientific capabilities." This includes a risk assessor, a public health scientist, a health economist/decision scientist, and an engineer. Undoubtedly, such a move gives chills to agencies that regulate in the areas of health, safety, and the environment. What it seems to signal is a centralizing of control and regulatory functions at OIRA. Not only will OIRA be performing its traditional review functions, it may begin to more aggressively assert itself in agenda setting at the agency level, which Graham has stated is his intent from the beginning. Indeed, that has already started in a modest way through the prompt letters discussed below. Likely, this is only the beginning. In turning back NHTSA's tire pressure standard mentioned above, Graham indicated he had other plans for auto safety. "The question of whether anti-lock braking systems should be made standard equipment in all cars -- and through a regulation -- is worthy of a regulatory proceeding," Graham told the Washington Post. "We at OMB have been thinking about that issue for the last several months." What's so startling about this statement is that it implies OIRA spearheading action in an area that is clearly in NHTSA's statutory jurisdiction. Undoubtedly, the hiring of scientists is part of a larger effort by Graham to exert greater control over the flow and direction of federal regulation. Graham has begun issuing "prompt letters" asking that agencies direct their attention to specific regulation. Graham has issued a number of prompt letters. One asks FDA to give priority to a proposed rule on trans fatty acid; the other asks OSHA to look into requiring defibrillators in the workplace; and most recently, another asks EPA to look at new research methods for fine particulate matter, emphasizing public-private partnerships. By themselves, none of these letters is truly harmful, and in fact, may be helpful. However, it raises the question of the proper role for OIRA. OIRA has -- for good reason -- never before attempted to prioritize regulatory issues for agencies, which unlike OIRA, are statutorily charged with carrying out regulation. OIRA has little scientific expertise on staff (and as explained above, had none until recently) and lacks the resources and procedural mechanisms to guarantee public involvement in such important decisions. Indeed, the letter to OSHA seems to have been sent because Graham happened to have read a couple of journal articles. This hardly seems a sound foundation on which to base agency priority setting. The case of the FDA rule, however, is less clear-cut. In this case, the agency had already initiated a rulemaking, making it a priority on its own; the Graham letter simply asked the agency why it had not completed the rulemaking. The public interest community has long complained that agency rulemakings take too long, sometimes more than a decade. It might be an appropriate role for OIRA to provide the occasional whip to make sure that rules are being completed in a timely fashion, and examine the possible sources of ossification (such as budgetary constraints) where it exists. A cynic might observe that Graham picked his first two prompt letters because they advocate regulation -- something his critics, including OMB Watch, have argued he's predisposed against. This may not be true, but to be sure, the prompt letters will be something to keep an eye on, to see if future letters seek to roll back health, safety, and environmental protections. In a report to Congress, Graham recommended regulations to rescind or revise, many of which were health, safety, and environmental protections. As part of its annual report to Congress on the costs and benefits of federal regulation, released in December of 2001, the Office of Management and Budget (OMB) published a list of 23 "high priority" regulations it believes should be rescinded or revised. Many of these regulations are health, safety, and environmental standards, including major clean air and water standards (i.e., ">New Source Review and Total Maximum Daily Loads). EPA has the most rules on the list with eight, while the Department of Labor is second with five, including one under the Fair Labor Standards Act and another under the Family and Medical Leave Act. This target list is another sign that Graham, who as OIRA administrator has responsibility for carrying out the report, intends to make his office an aggressive player in setting the regulatory agenda across agencies, likely at the expense of strong health, safety and environmental protections. It also marks a departure from the Clinton-era OIRA, which gave agencies greater deference to define their own objectives and priorities; agencies, after all, have the statutory authority delegated by Congress, the technical and scientific expertise, and the proximity to affected parties -- including regulated interests and the intended beneficiaries of regulation -- that OIRA lacks. Under the statute mandating the report, OMB is to provide Congress "recommendations for reform." Not suprisingly, Graham used this language as an opportunity to address specific rules. In its draft report published last May, OMB asked for suggestions from the public on specific regulations that could be rescinded or changed to increase benefits to the public. OMB received 71 such suggestions -- 44 of which were from George Mason's conservative ">Mercatus Center -- and after its initial review of the comments, placed the suggestions into three categories: "high priority," "medium priority," and "low priority." There were 23 rules rated "high priority," which, OIRA explained, it is inclined to agree with and will examine further. There were 30 rules listed as "medium priority," about which OIRA decided it needs more information, and 24 other suggestions were listed as "low priority," the merits of which OIRA was not convinced. As for the cumulative cost-benefit analysis, OMB's report estimated that the costs of complying with environmental, health, and safety regulations range from about $150 billion to $230 billion annually, while benefits range from $250 billion to more than $1 trillion. These estimates -- which OMB Watch has argued contain enormous analytical limitations -- are similar to estimates made by the Clinton administration in last year's report. Regulations are being altered at OIRA at a very high rate. If you have any question over the influence of OIRA, all you need to do is look at the rate rules are altered once they are sent to OIRA for review. For instance, as shown by the chart on the front page of the Executive Report, 33 out of 61 EPA rules (54 percent) were changed while under review at OIRA; 9 out of 10 DOL rules were changed; and 52 out of 94 HHS rules (55 percent) were changed. These figures are similar to those of the Clinton administration (and in fact are slightly lower than 2000) and do not represent anything new or earth shattering. Rather, they reinforce the immense reach of OIRA in shaping regulation of all types. Of course, the nature and scope of these changes is what's most important. Unfortunately, this is impossible to assess from data reported by OIRA; a change for clarity, such as the insertion of a comma, is reported in the same manner as a change in substance that affects the very nature of the regulation. In other words, Bush's OIRA may be playing a more substantive role than Clinton's even though changes are made at close to the same rate, but it's difficult to know. At OIRA's docket library, you are supposed to be able to look at changes made to a specific regulation after OIRA takes action, and evidence may be built on an anecdotal basis. Yet for years, OIRA has done a poor job of managing and reporting such information in a way that's easily accessible and understandable. To his credit, Graham has initiated reforms to the docket library to correct this problem. Yet in the meantime, as reorganization takes place, such docket information is unavailable. For more on transparency issues at OIRA, click here. OMB Watch has strongly supported Graham's efforts to improve transparency at OIRA and in the regulatory review process. The length of regulatory reviews has sometimes exceeded the limit established under executive order. As stated earlier, OIRA frequently operated as a regulatory black hole during the Bush I and Reagan administrations. Rules would go there for review and sit, sometimes for years, with little or no explanation to the public. President Clinton sought to bring accountability to this process through his Executive Order 12866, signed at the beginning of his administration and still observed by the Bush administration. E.O. 12866 established a 90-day timeframe for OIRA reviews, with a possible 30-day extension upon agreement of the relevant agency head. So far, Graham's OIRA hasn't been as bad as it once was in terms of sitting on regulations, but it hasn't always lived within the time limits either. For instance, OIRA exceeded 90 days in reviews of 17 EPA regulations this past year, five of which exceeded 120 days. Reviews of 10 HHS regulations exceeded 90 days, six of which lasted more than 120 days. Two DOJ rules and one DOT rule also exceeded 120 days. At present, however, there are no pending regulatory reviews that exceed even 90 days. On average, it has taken OIRA 93 days to review each EPA regulation it has received during the Bush administration; 53 days for both DOJ and HHS; and 20 days for Interior. For a complete breakdown of all regulatory review data, see these charts. A Washington Post story highlighted Graham's role in compiling a hit list of regulatory paperwork. Barbara Kahlow, a Republican congressional aide for Rep. Doug Ose (R-CA), who chairs the House Subcommittee on Regulatory Affairs (which has oversight over OIRA), convened key lobbyists in December to identify and rank regulations with associated paperwork that business groups find overly burdensome, as reported in the Dec. 4, 2001, Washington Post. According to Kahlow, this happened at the request of John Graham. The target list, obtained by OMB Watch and provided here, includes the most paperwork intensive rules, most dealing with health, safety, and environmental protections. Under the Paperwork Reduction Act, OIRA is responsible for reviewing agency information collections, which often serve as the foundation for monitoring compliance and enforcing regulation. Approval by OIRA of such collections of information can only be given for up to three years under the PRA. Once approval is about to expire, agencies must seek a renewal of their information collection requests from OIRA. This renewal process is what the target list deals with. Potentially OIRA could disapprove or revise an information collection request, leaving the regulation unenforceable, even if that regulation has been on the books for years. (Technically, the regulation is still enforceable, but practically without the government forms to implement the rule, it is not.) Of the list of 57, 2 information collection requests have already expired and 9 will be expiring in the next 6 months. The paperwork review process was frequently used as a tool during the Bush I and Reagan administrations to block regulation. As Jim Tozzi, who worked as Kahlow's boss when she was at OIRA during the 1980s, told the Post, "I have to plead guilty to that. The paperwork is a way in, you know?" One of the strange legacies of this historical bend against health, safety, and environmental regulation is the number of OIRA staff, called desk officers, assigned to the various agencies. Agencies such as EPA, USDA, DOL, HHS, DOT, and Dept. of Education have a disproportionate number of OIRA desk officers overseeing their work compared to the amount of paperwork they actually produce. For instance, USDA's paperwork burdens account for 0.9 percent of the total burden imposed by government paperwork, yet six of 34 desk officers at OIRA are (18 percent of OIRA's desk officers) assigned to the agency. Similarly, EPA's paperwork burden consists of 1.7 of the total government paperwork, yet it also has six desk officers overseeing its work. In contrast, the Treasury Department, which constitutes over 82 percent of government paperwork burden, has only one assigned desk officer. (based on GAO FY 1999 estimates and the list of OIRA desk officers' assignments as of October 15, 2001.) The meeting between Kahlow and industry groups was held behind closed doors. A business lobbyist first leaked information to the Washington Post, and OMB Watch later obtained a copy of the list of 57, which we have now posted with expiration dates for each information collection request. OIRA has also provided OMB Watch with a copy of the original list of information collection requests that OIRA sent to Barbara Kahlow, which was then whittled down to the 57. This original list was separated into two documents -- one excluding IRS and one of IRS only. OMB Watch, along with a coalition of other organizations, responded by sending a letter to Sen. Joseph Lieberman (D-CT), who chairs the Senate Governmental Affairs Committee, asking that he exercise oversight in this matter. In the House, such oversight is not likely to take place given that Kahlow's boss chairs the relevant oversight subcommittee. Graham's OIRA has been slow approving paperwork associated with regulation. Using the database of paperwork requests on OIRA's web site, OMB Watch calculated the length of time agency paperwork requests have been sitting at OIRA. As of September 30, 2001, EPA had 75 paperwork requests that had been at OIRA for more than 60 days, 50 of which had been there for more than 120 days - more than double the time limit that OIRA is allowed under the Paperwork Reduction Act. Agencies are allowed to move ahead without OIRA approval if a review lasts over 60 days, but only if that request is a renewal, which must be sought at least every three years. However, if the request is new, the agency cannot proceed even if OIRA has exceeded its legal time limit under the PRA. Eighteen of EPA's 75 ICR requests (almost 25 percent) fell into this latter category, and were in effect blocked. Other agencies also experienced similar problems with OIRA paperwork reviews. The Department of Health and Human Services (HHS) had 40 information collection requests sitting at OIRA for over 60 days; the Department of Labor (DOL) had 19; the Nuclear Regulatory Commission (NRC) had 14 over 60 days; Treasury had 34; the United States Department of Agriculture (USDA) had 33 over 60 days; the Department of Housing and Urban Development (HUD) had nine; and Veteran's Affairs (VA) had 12 over 60 days. Shortly after finding this problem, OMB Watch called OIRA to ask about the EPA paperwork reviews in particular, since 17 of them were over 300 days old, and 12 of them had actually been at OIRA for more than a year. A desk officer told us that he would look into it, and a couple weeks later, Donald Arbuckle, Deputy Administrator, responded to OMB Watch, thanking us for highlighting this problem and assuring us that he would take care of it. Needless to say, October was a busy month for OIRA. For instance, by the end of the month, EPA had 59 requests over 60 days, down from 75 in September. OIRA approved 43 of EPA's requests in October, compared to 0 approvals in September. It's still unclear why so many paperwork requests sat for so long, but it's encouraging to see that the log jam was broken. Currently, there are still some information collection requests that have been pending for more than 60 days. For instance, four EPA requests are still pending after 60 days, including one that has exceeded 90 days and another that has exceeded 120 days; 15 requests from Treasury have exceeded 60 days, one more than 90 days; and 13 requests from Justice have exceeded 60 days, one more than 90 days. OIRA issued agency-wide "data quality" guidelines that could be used to block the free flow of important regulatory information. There is a commonsense part to the guidelines (which were a statutory requirement) -- dissemination should be predicated on good data quality. But the definition of what is good can be a shifting target, thereby limiting public access. Moreover, for those who believe in regulatory protections, this is a prescription for disaster. John Graham added that even if research funded by the agency is peer reviewed for scientific journals (independent, external peer review) it might not be adequate to meet the standard for good data quality and, hence, dissemination. Since regulation is predicated on research -- cost-benefit analysis and risk assessment -- these data quality rules -- and the administrative mechanism for complaints -- can greatly constrain the use/dissemination of such research. The result will be a further slowdown in rulemakings. OMB creates a convoluted message to agencies regarding "influential scientific, financial, or statistical information." Such information faces different types of "reproducibility" tests based on what type of information it is. For example, for "original and supporting data," reproducibility means transparency about research design and methods, not replication. Yet for "analytic results," reproducibility may mean "that an independent reanalysis could be undertaken by a qualified member of the public." And another standard is set for "analysis of risks" to human health, safety and environment. The distinctions between these types of data are very confusing. Each agency must now produce its own data quality rules based on OMB's guidelines that include "administrative mechanisms allowing affected persons to seek and obtain correction of information maintained and disseminated by the agency." On an annual fiscal year basis, starting in Jan. 1, 2004, each agency must report to OMB on the number and nature of complaints it receives regarding data quality and how such complaints were resolved. This seems dangerously close to treating information dissemination in the same manner as regulation. If that's the case, this truly could be a major blow for dissemination. Back to Executive Report