Scientific Review of the Proposed Risk Assessment Bulletin from the Office of Management and Budget (2007) / Chapter Skim
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Appendix E: Questions for Federal Agencies from the Committee and Agency Responses to Questions
Appendix E: Questions for Federal Agencies from the Committee and Agency Responses to Questions
Pages 155-286
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Appendix E Questions for Federal Agencies from the Committee and Agency Responses to Questions
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To address its charge, the committee is hoping that the agencies will assist it by responding to the questions below. QUESTIONS FOR ALL AGENCIES POTENTIALLY AFFECTED BY THE OMB BULLETIN General questions about current risk assessment practices • Please provide a brief overview of your current risk assessment practices.
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• If applicable, please specify provisions in the Bulletin that can be expected to have a substantial negative effect on the quality, conduct, and use of risk assessments undertaken by your agency. • If your agency followed the procedures described in the Bulletin, would it affect the time course for production of the risk assessment (that is, the time required from initiation of the risk assessment to delivery to the regulatory decision maker)
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. How will the OMB Bulletin impact the quality, conduct, and use of risk assessments in these cases?
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, each typically based on a number of separate studies and analyses. The OMB Bulletin defines "risk assessment" to apply to "any document" that "could be used for risk assessment purposes, such as an exposure or hazard assessment that might not constitute a complete risk assessment as defined by the National Research Council." What is the advantage of defining risk assessment in this way?
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Appendix E Agency Responses to Questions* • Consumer Product Safety Commission • Department of Defense • Department of Energy • Department of Health and Human Services • Department of Housing and Urban Development • Department of Interior • Department of Labor • Department of Transportation • Environmental Protection Agency • National Aeronautics and Space Administration • Office of Management and Budget *
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General questions about current risk assessment practices • Question: Please provide a brief overview of your current risk assessment practices. Specifically, do you conduct probabilistic risk assessment?
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The simplest assessments may be completed in a matter of days, while more involved analyses take months or years, especially if the agency must perform extensive studies to assess exposure or convene a CHAP. Questions about OMB's definition of risk assessment and applicability • Question: Using the definition of risk assessment described in the OMB Bulletin, are there work products that would now be considered risk assessments that were not previously considered risk assessments?
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Questions about type of risk assessment (tiered structure) • Question: In your agency, is there currently a clear demarcation between risk assessments used for regulatory analysis and those not used for regulatory analysis?
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Questions about impact of the Bulletin on agency risk assessment practices • Question: If applicable, please specify provisions in the Bulletin that can be expected to have a substantial positive effect on the quality, conduct, and use of risk assessments undertaken by your agency. CPSC Staff Response It is unclear whether the provisions of the Bulletin will have a substantial positive effect.
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CPSC staff agrees that some risk assessments remain a source of information years after they are conducted, and such important assessments should be updated as information becomes available. However, many CPSC risk assessments are conducted for specific purposes, e.g., preliminary assessments conducted to support decisions on the disposition of petitions, and may never again be used for informational or regulatory purposes.
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This would be especially applicable to many routine work products, such as screening level risk assessments and other tasks not normally considered risk assessments. • Question: One of the Bulletin's reporting standards states the need to be scientifically objective by "giving weight to both positive and negative studies in light of each study's technical quality." Please give an example of how this would be implemented by your agency or department.
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appreciates the opportunity to respond to the questions posed by the National Research Council's Committee chartered to review the Office of Management and Budget's (OMB's) proposed Risk Assessment Bulletin.
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. The ma jority of the human health assessments conducted by DoD follow the methodology outlined in the Environmental Protection Agency's (EPA's)
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Probabilistic risk assessments may be performed within DoD for past or predictive effects on health, although rarely in support of baseline risk assessments conducted for the Defense Environmental Restoration Program. Probabilistic techniques have been explored but dismissed in a number of cases because of lack of scientifically defensible technical information; lack of acceptance by the regulatory community; difficulty in communicating the results to the public; and/or significant time, resource, and cost restraints.
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d. Please identify any substantial scientific or technical challenges that you may encounter when conducting risk assessments for your agency.
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Likewise, fate and transport data are often unavailable, as are scientifically defensible exposure inputs and statistical distributions for these exposure inputs. Consequently, this absence of information has hindered the use and performance of probabilistic risk assessments.
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Today, many health risk assessors believe that multiplying default uncertainty factors overestimates risk. When coupled with the use of non peer reviewed toxicity values, the approach may lead to significantly overesti mated risk values and thus overly conservative cleanup levels.
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Health Hazard Assessment Program: Risk assessment is an organized process used to describe and estimate the likelihood of adverse health outcomes from occupational or environmental exposures to hazards. It consists of four steps: hazard identification, toxicity assessment, exposure assessment and risk characterization.
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It may be used to support a regulatory program or policy position and meet one or more of the following criteria: - Focus on significant emerging issues - Support major regulatory decisions or policy/guidance of major impact - Establish a significant precedent, model, or methodology - Support major regulatory decisions or policy/guidance of major impact - Have significant inter-agency implications - Consider an innovative approach for a previously defined problem, process, or methodology - Satisfy a statutory or other legal mandate for peer review Civil Works The COE does not have risk "terms of reference" nor overall risk assessment standards. As the COE explores an appropriate approach to implementing the OMB bulletin, the necessary Engineering Regulations will be revised in accordance with the requirements of Section IV of the bulletin.
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Is this clear at the outset of the risk assessment? There is no clear demarcation between "influential risk assessment" used for regulatory purposes and other risk assessments used for regulatory purposes.
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However, it would be beneficial if the OMB Bulletin provided examples of when it may be appropriate to regulate using the expected effect vice the most conservative estimate. • A more comprehensive characterization of the sources of uncertainty via use of quantitative approaches will be included in risk assessments performed.
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The adherence to the provisions listed in Section V: "Special Standards for Influential Risk Assessment" and in Section IV: "General Risk Assessment and Reporting Standards", the performance of risk assessments will be more labor and resource intensive. Additional labor will be required to: • Collect the necessary information and data to characterize risk as outlined in the OMB Bulletin.
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Would it be helpful to you if risk assessments submitted to your agency by external groups, such as consultants and private industry, met the requirements proposed in the OMB Bulletin? Products produced by external groups are occasionally used and frequently reviewed by DoD.
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, • Increased transparency when using products prepared by others, and • Better information on which a risk manager can base a decision. The use by federal agencies of risk assessments submitted by external organizations, such as consultants and private industry, may increase the pace of such risk assessments and increase the number of toxicity benchmarks available by removing the burden for all toxicity benchmark development from EPA.
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• Please identify any substantial scientific or technical challenges that you may encounter when conducting risk assessments for your agency. • What is your current definition of risk assessment, and what types of prod ucts are covered by that definition?
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We note that most of the risk assessments conducted by DOE would likely not be "influential risk assessments" as defined in OMB's proposed Bulletin. Regarding the first bullet -- Please provide a brief overview of your current risk assessment practices.
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In addition, consistent with the proposed OMB Bulletin, DOE recommends that the resources expended for a risk or dose assessment be commensurate with the importance of the risk assessment, taking into consideration the nature of the potential hazard, the available data, and the decision's needs. DOE is currently drafting a policy and guidance on risk methodology consistent with OMB Information Quality Guidelines in response to a request from the Defense Nuclear Facilities Safety Board.
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National Research Council questions about OMB's definition of risk assessment and applicability: • Using the definition of risk assessment described in the OMB Bulletin, are there work products that would now be considered risk assessments that were not previously considered risk assessments? If so, what are they?
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National Research Council questions about impact of the Bulletin on agency risk assessment practices: • If applicable, please specify provisions in the Bulletin that can be expected to have a substantial positive effect on the quality, conduct, and use of risk assessments undertaken by your agency. • If applicable, please specify provisions in the Bulletin that can be expected to have a substantial negative effect on the quality, conduct, and use of risk assessments undertaken by your agency.
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Would it be helpful to you if risk assessments submitted to your agency by external groups, such as consultants and private industry, met the requirements proposed in the OMB Bulletin? DOE Response: As noted in the responses to other questions, DOE depends almost exclusively on the risk assessments prepared by others (primarily other Federal agencies or national and international standards organizations)
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. How will the OMB Bulletin impact the quality, conduct, and use of risk assessments in these cases?
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from the release point add little to the comparison of alternatives but greatly increase uncertainty and complexity of the analyses. A Yucca Mountain total system performance assessment is part of an important decision process, so would qualify as an "influential risk assessment," but given the explicit exemption suggested above, the "special standards" for influential risk assessments would not apply to either its pre-licensing or licensing assessments.
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• Assessments related to the performance of high-level radioactive waste repository and management of HLW (http://www.ocrwm.doe.gov/index.shtml) • Assessments related to performance of the Waste Isolation Pilot Plant for tran suranic waste (http://www.wipp.energy.gov/)
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192 Review of the Proposed OMB Risk Assessment Bulletin HHS-A
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Appendix E 193 HHS-1
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194 Review of the Proposed OMB Risk Assessment Bulletin HHS-2
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Appendix E 195 HHS-3
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196 Review of the Proposed OMB Risk Assessment Bulletin HHS-4
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Appendix E 197 HHS-5
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198 Review of the Proposed OMB Risk Assessment Bulletin HHS-6
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Appendix E 199 HHS-7
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200 Review of the Proposed OMB Risk Assessment Bulletin HHS-8
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Appendix E 201 HHS-9
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202 Review of the Proposed OMB Risk Assessment Bulletin HHS-10
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Appendix E 203 HHS-11
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204 Review of the Proposed OMB Risk Assessment Bulletin HHS-12
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Appendix E 205 HHS-13
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206 Review of the Proposed OMB Risk Assessment Bulletin HHS-14
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Appendix E 207 HHS-15
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208 Review of the Proposed OMB Risk Assessment Bulletin HHS-16
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Appendix E 209 HHS-17
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210 Review of the Proposed OMB Risk Assessment Bulletin HHS-18
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Appendix E 211 HHS-19
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212 Review of the Proposed OMB Risk Assessment Bulletin HHS-20
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Appendix E 213 HHS-21
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214 Review of the Proposed OMB Risk Assessment Bulletin HHS-22
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Appendix E 215 HHS-23
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216 Review of the Proposed OMB Risk Assessment Bulletin HHS-24
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Appendix E 217 HHS-25
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This is largely due to the fact that the data are not amena ble to aggressive statistical data manipulation ○ HUD addresses uncertainty analysis where the data are amenable to the re quired statistical analysis. ○ HUD currently addresses uncertainty and variability in risk assessments by describing the confidence level of the mean (either arithmetic or geometric)
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Questions about OMB's definition of risk assessment and applicability • New risk assessment not previously considered if HUD uses the proposed OMB Bulletin definition. ○ Because inspections and adjudications are explicitly not covered by the proposed bulletin, HUD believes that no additional programs will require risk assessments.
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○ HUD believes the cost and time effects will not have substantial nega tive effects. • Effect on the time course for production of the risk assessment (that is, the time required from initiation of the risk assessment to delivery to the regulatory decision maker)
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222 Review of the Proposed OMB Risk Assessment Bulletin HUD Response to National Research Council Questions Review of the OMB Risk Assessment Bulletin ADDITIONAL ISSUES FOR HUD • Consideration of baseline conditions when evaluating alternative mitigation op tions for regulatory analysis may be inappropriate where there is a statutory re quirement. • The definition or guidelines for the determination of what constitutes a signifi cant comment would be useful for consistency.
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Office of Information and Regulatory Affairs (OIRA) proposed risk assessment bulletin, along with the accompanying set of questions developed by the National Research Council (NRC)
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The failure analysis of physical structures is addressed to a limited extent. Consider expanding discussion of aspects of risk assessments for physical structures to include the integration of scientific data, simulations and analysis data, failure analysis, and expert elicitation (where expert elicitation provides probabilistic valuation integrating data, analysis, experience, and professional judgment when statistical data is not readily available)
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describe this bulletin as "technical guidance" yet some sections of the Bulletin, including the critical implementation section at the end (the formally titled "Risk Assessment Bulletin" section) create an impression that these are requirements.
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This is clear in the first paragraph: "When determining whether a potential hazard exists, weight should be given to both positive and negative studies." In the second paragraph, there are references to peer-reviewed science and data collected by accepted or best available methods. In reality, risk is seldom directly measured and objectivity standards are difficult to apply to the risk characterization.
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However, since the Bulletin focuses on health, safety, and the environment, its impact on risk assessment practices is minimal (or none) for MRM, and unclear for OMM.
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Agency Responses to the NRC Questions -- Questions and Agency Responses General questions about current risk assessment practices • Please provide a brief overview of your current risk assessment practices. Specifically, do you conduct probabilistic risk assessment?
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Reviews and analyses of offshore operational data are also done in-house to support reviews of Outer Continental Shelf operations. MMS also conducts probabilistic risk assessment for meeting or failing to meet the fair market value requirement for Royalty-in-Kind.
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BOR: For Reclamation, risk assessment activities include identification of potential risks, data collection and information analysis for computing risks, assembling a team of technical experts to develop risk models and report estimated risks, and decision-making regarding Reclamation actions to be taken to address the risk. Reclamation work products include risk analysis reports, decision documents, and workload priorities.
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BOR: Based on the OMB Bulletin, there are no work products in the Dam Safety Program that would now be considered a risk assessment that were not previously considered risk assessments. FWS: OMB's definition appears to more broadly define risk assessment, or risk assessment-like processes, than what the Service has historically called risk assessment.
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MMS: No. Questions about impact of the Bulletin on agency risk assessment practices • If applicable, please specify provisions in the Bulletin that can be expected to have a substantial positive effect on the quality, conduct, and use of risk as sessments undertaken by your agency.
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In other MMS areas, the Bulletin's procedures may extend the timeline for the risk assessments conducted by MMS staff. • One of the Bulletin's reporting standards states the need to be scientifically objective by "giving weight to both positive and negative studies in light of each study's technical quality." Please give an example of how this would be implemented by your agency or department.
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Reclamation requires these risk assessments to meet the same standards as risk assessments performed internally by Reclamation staff. Therefore the benefits of an OMB risk assessment bulletin would be only those addressed by previous questions.
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appreciates the opportunity to respond to questions from the National Research Council's Committee to review the proposed OMB Risk Assessment Bulletin. Within DOL, analyses of safety and health risks are performed by both the Occupational Safety and Health Administration (OSHA)
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Most often, OSHA bases its regulatory decisions on a range of central estimates of risk derived from the best supported models. The key assumptions and uncertainties in the assessment are identified and their impact discussed.
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Census to develop estimates of the size of the population at risk. OSHA does not typically conduct probabilistic uncertainty analysis as part of its exposure assessment and risk characterization, but does conduct sensitivity analysis to describe the effect of uncertainties in estimates of exposure or population-at-risk on benefits estimates.
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Analysis of safety risks generally take less time, ranging from weeks for an assessment of risks that are already characterized by BLS, to a year or more for risks that have not been so classified. Questions about OMB's definition of risk assessment and applicability • Using the definition of risk assessment described in the OMB Bulletin, are there work products that would now be considered risk assessments that were not previ ously considered risk assessments?
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The actual impact of a regulation is usually determined well after a risk assessment has been initiated since the results of the assessment in part are necessary to make regulatory decisions that can affect the size of the impacts. Questions about impact of the Bulletin on agency risk assessment practices • If applicable, please specify provisions in the Bulletin that can be expected to have a substantial positive effect on the quality, conduct, and use of risk assessments undertaken by your agency.
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Provision IV.6 of the proposed Bulletin would require that an executive summary of the risk assessment include information that would place the risk estimates in context with other risks that might be familiar to the target audience. OSHA does not generally engage in such comparative risk analyses for decision making purposes since OSHA's regulatory decisions must be based on consideration of the significance of risk and the extent to which those risks would be reduced by the regulatory action (as well as other factors such as technologic and economic feasibility)
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OSHA believes that the Bulletin's provisions to develop quantitative distributions of model uncertainty and variability, wherever feasible, could add significant time to some risk assessments without necessarily increasing the utility of the risk assessment for Agency decision makers. • One of the Bulletin's reporting standards states the need to be scientifically objec tive by "giving weight to both positive and negative studies in light of each study's technical quality." Please give an example of how this would be implemented by your agency or department.
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Response: The DOT does not provide written guidance as to how the DOT operating administrations should conduct risk assessments1 so there is no common approach to risk assessments and uncertainty analyses within the DOT operating administrations. As a result, the operating administrations employ varied risk assessment practices that range from informed judgment to probabilistic risk assessments.
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, typically conducts risk assessments, including probabilistic risk analyses, for regulatory analysis, investment analysis and procurement. The FAA conducts risk assessments to evaluate the effects of proposed industry-wide mitigations against broad categories of aviation accidents.
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The FAA applies the risk assessment process to products including regulatory analyses and investment analyses of air traffic control services and airport infrastructure to support procurement decision-making. PHMSA defines risk assessment as a determination of risk context and acceptability, often relative to similar risks.
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Questions about OMB's Definition of Risk Assessment and Applicability Question 5: Using the definition of risk assessment described in the OMB Bulletin, are there work products that would now be considered risk assessments that were not previously considered risk assessments? If so, what are they?
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The FAA explains that as the scope of a risk assessment does not necessarily vary based on whether or not the assessment is for regulatory or non-regulatory analysis, a clear demarcation would serve no practical purpose. Another operating administration, NHTSA, gave a similar explanation, noting that its analysts are well aware of when risk assessments are used for regulatory purposes because the assessments are developed in the context of, and included within, the regulatory document.
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In such cases, NHTSA will include in its analysis a variation in estimates of the population at risk. Questions about Impact of the Bulletin on Agency Risk Assessment Practices Question 8: If applicable, please specify provisions in the Bulletin that can be expected to have a substantial positive effect on the quality, conduct, and use of risk assessments undertaken by your agency.
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Thus, this could cause an unnecessary negative effect; a remedy would be to make many of the requirements discretionary for safety decisions, depending on the particular circumstances of each assessment. Despite the above-referenced concerns, the DOT understands that many of the negative effects of the Bulletin could be minimized through the application of the Bulletin's "rule of reason," which could provide the DOT operating administrations with sufficient discretion and flexibility to apply the guidelines when they are appropriate.
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Question 11: One of the Bulletin's reporting standards states the need to be scientifically objective by "giving weight to both positive and negative studies in light of each study's technical quality." Please give an example of how this would be implemented by your agency or department. Response: Currently, the DOT operating administrations are generally scientifically objective when evaluating studies, even though the method by which the studies are evaluated may vary.
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Question 12: Does your agency use risk assessments conducted by external groups? Would it be helpful to you if risk assessments submitted to your agency by external groups, such as consultants and private industry, met the requirements proposed in the OMB Bulletin?
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NRC Questions and EPA Responses QUESTIONS FOR ALL AGENCIES POTENTIALLY AFFECTED BY THE OMB BULLETIN General questions about current risk assessment practices NRC Question 1.
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, and the December 2001 Superfund document Risk Assessment Guidance for Superfund: Volume III -- Part A, Process for Conducting Probabilistic Risk Assessment (USEPA, 2001a) " Section 3.4.3 of Chapter 3 of the Staff Paper described generally how EPA uses probabilistic analyses with respect to hazard assessment.
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. Risk assessment guidance for Superfund: Volume III - Part A, Process for conducting probabilistic risk assessment.
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How will the uncertainty analysis affect the regulatory decision?
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" NRC Question 2. Please identify any substantial scientific or technical challenges that you may encounter when conducting risk assessments for your agency.
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reporting results as population risks; • the need for clear definitions, an understanding of the needs for the decision, the statutory environment, and the specific context, in distinguishing between central estimates and expected risks; • limited or no data to support a quantitative measure of the relative plausibility of alternative risk estimates; and • the need for caution (See NRC, 1994) in treating fundamentally different pre dictions as quantities that should be averaged.
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For most Agency exposure assessments programs typically use a single preferred exposure model to develop exposure estimates. Such models have been peer reviewed and their performance and limitations are well documented.
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National Research Council (NRC) : Risk assessment is a process in which information is analyzed to determine if an environmental hazard might cause harm to exposed persons and ecosystems." EPA has long embraced the idea that a risk assessment consists of analyses that embrace the four steps described in NRC 1983: hazard identification, dose response assessment, exposure assessment, and risk characterization.
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Using the definition of risk assessment described in the OMB Bulletin, are there work products that would now be considered risk assessments that were not previously considered risk assessments? If so, what are they?
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EPA interprets influential risk assessment to mean any risk assessment (or component) , as defined above, that meets the OMB Peer Review Bulletin's definition of "influential scientific information," which is, "scientific information the agency reasonably can EPA-10
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Considers an innovative approach for a previously defined prob lem/process/methodology; h) Satisfies a statutory or other legal mandate for peer review." Questions about impact of the Bulletin on agency risk assessment practices EPA-11
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have already been adopted by EPA: • in our quality system which includes our implementation of the OMB Information Quality Guidelines and OMB Peer Review Bulletin; • in the EPA Risk Characterization Handbook (www.epa.gov/osa/spc/2polprog.htm ) • in the EPA Staff Paper on Risk Assessment Principles and Practices; and • in other EPA guidance, guidelines, and policies.
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NRC Question 9. If applicable, please specify provisions in the Bulletin that can be expected to have a substantial negative effect on the quality, conduct, and use of risk assessments undertaken by your agency.
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Scientific "defaults" or "inference guidelines" play an important role for EPA in providing a consistent and peer reviewed means of addressing recurring, fundamental issues of science policy in its risk assessments. The proposed Bulletin does not address this aspect of risk assessment practice that is discussed in the 1983 NRC "redbook" and specifically described for different areas in the EPA Risk Assessment Guidelines.
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EPA conducts its peer reviews and public involvement in line with its defined policies in these areas and consistent with the OMB Peer Review Bulletin, which provides for different processes for influential scientific information and highly influential scientific assessments. This section goes beyond those guidelines by calling for a response to comment package for all influential risk assessments, and also in its call not only to explain the basis for the agency position, but also to explain why other approaches were not taken, and why.
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Regarding pesticides specifically, what risk-assessment activities will be covered by the Bulletin and what risk-assessment activities will be exempted? The Agency agrees with the OMB bulletin that risk assessments for permitting or licensing programs should be exempt.
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. Consistent with EPA's current practices, application of these principles involves a "weight-of-evidence" approach that considers all relevant information and its quality, consistent with the level of effort and complexity of detail appropriate to a particular risk assessment." EPA committed to ensure, to the extent practicable and consistent with Agency statutes and existing legislative regulations, the objectivity of our dissemination of influential scientific information regarding human health, safety or environmental risk assessments by applying an adaptation of the SDWA principles.
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The Bulletin should clarify that it does not modify or supersede OMB-approved agency adaptations of the SDWA risk assessment principles in their Information Quality Guidelines. NRC Question 15.
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Is there a common approach to both risk assessments and uncertainty analysis? How do you currently address uncertainty and variability in your agency's risk assessments?
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Application of Probabilistic Techniques for the Assessment of Technical Risks NASA uses the scenario-based modeling framework for probabilistic risk assessment (PRA) of space systems.
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• Probabilistic Risk Assessment Procedures Guide for NASA Managers and Prac titioners, August 2002 (http://www.hq.nasa.gov/office/codeq/doctree/praguide.
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Similarly, the standard method for propagating uncertainties through a risk model is to use simulation techniques. In the context of managing risk of space systems, it is important to separate the epistemic from aleatory uncertainty.
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• Representative reliability and failure data presents a challenge to conducting risk as sessment of space systems. There is limited experience data with respect to the op eration of systems and components in space.6 In addition, as technology advances, improved space systems and hardware are fielded that increase energy efficiency and reduce weight.
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which is required by all programs and projects that provide aerospace products or capabilities -- i.e., flight and ground systems, technologies, and operations for space and aeronautics. Question 4: About how long (that is, from initiation of the risk assessment to delivery to the regulatory decision maker)
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These types of risk assessments are typically conducted at a high level. Questions about OMB's definition of risk assessment and applicability Question 5: Using the definition of risk assessment described in the OMB Bulletin, are there work products that would now be considered risk assessments that were not previously considered risk assessments?
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Questions about impact of the Bulletin on agency risk assessment practices Question 8: If applicable, please specify provisions in the Bulletin that can be expected to have a substantial positive effect on the quality, conduct, and use of risk assessments undertaken by your agency.
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requirement provides. Implementation of risk assessment, particularly probabilistic risk assessment, to analyze technical risks is a relatively new activity.
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The results of those risk assessments then are to be used to identify control activities that can be implemented to ensure agency objectives are met. The OMB Bulletin indicates that influential risk assessments are those that the agency reasonably can determine will have a clear impact on private sector decisions.
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REFERENCES 1 Space Shuttle Probabilistic Risk Assessment, Volume II, Rev. 1: Model Integration Report, Johnson Space Flight Center, January 2005.
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10 Report of the Independent Peer Review Panel on the Probabilistic Risk Assessment of the International Space Station Phase II – Stage 7A Configuration, Prepared for NASA Headquarters Office of Safety and Mission Assurance, June 2002. 11 Space Shuttle Flight Readiness Review.
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Appendix E 283 OMB-1
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284 Review of the Proposed OMB Risk Assessment Bulletin OMB-2
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Appendix E 285 OMB-3
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286 Review of the Proposed OMB Risk Assessment Bulletin OMB-4
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