United States Regulation and Information June 1984 Environmental Protection Management Division Agency Office of Standards & Regs. Washington.DC 20460 Regulation Management Series A Decision System For Regulatory Development ------- A DECISION SYSTEM FOR REGULATORY DEVELOPMENT INTRODUCTION Over the last several months, we have adopted a number of innovations in our internal procedures for developing and review- ing regulations and other policy documents. We adopted these changes with several objectives in mind—to improve the oppor- tunity for top management to direct Agency policy, promote more systematic assessment of policy options, establish standards for decision documents and support analyses, and use the Agency's management and analytic resources more efficiently. I have approved three principal documents that establish these changes: ' 1. The Options Selection/Rejection Process. This decision procedure gives the Administrator, the Deputy Administrator, Assistant Administrators, and Regional Administrators the oppor- tunity to participate in a rulemaking before the rule's decision package undergoes' Steering Committee Review. Under this process, these senior Agency officials meet to consider an array of options for the rulemaking--presented by the lead program office—early in the development of' the' rule. These options meetings are" chaired either by jthe Deputy' Administrator or the lead office.'s Assistant Administrator (depending on the scope and complexity of the rulemaking). At these meetings, the participants discuss the options that:'are presented, and attempt to reach a consensus of the best approach '£6''take. f Issues not resolved at the first meeting are addressed at subsequent options meetings. 2. The Criteria and Guidelines Memorandum. This document sets forth general criteria that all Agency rules and other policy- setting actions must satisfy before they can be approved by the Administrator. The Document also sets out specific substantive guidelines for developing and reviewing a rulemaking action-- explicitly relating each guideline to a given stage'in the regu- latory development process. Taken as a whole, the document sets the Agency's standards for acceptable policy products. 3. The Memorandum on Procedures for Regulation Development and Review. This document provides a comprehensive statement of the required procedures for developing a rule, taking into account the innovations introduced by the Options Selection/ Rejection Process and the Criteria and Guidelines memorandum. The document also spells out the internal review processes (Steering Committee' and Red Border reviews), and adapts them to recent Agency organizational changes. ------- -2- Taken together, these three documents give the Agency a comprehensive system for making decisions on regulatory poli- cies. I urge you to become familiar with them and rely on them in planning and carrying out your rulemaking responsibilities. Alvin L. Aim Deputy Administrator JUNE 7, 1984 ------- UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON. D.C. 20460 NOV 41983 OFFICE OF THE ADMINISTRATOR MEMORANDUM TO: Assistant Administrators General Counsel FROM: Alvin L. Aim Deputy Administrator SUBJECT: Options Selection/Rejection Process Attached is a description of the regulatory options selection/rejection process which was approved at our meeting on November 1. As we agreed, incorporated into the description of the Level II process are statements designed to clarify the circumstances under which Steering Committee options meetings would be convened. cc: Regional Administrators S. Schulhof Attachment ------- PROCESS FOR LEVEL I REGULATIONS Deputy Administrator selects the rules from nominations by the lead office AA, OPPE, OGC and other interested parties Purpose of the quarterly planning meetings (chaired by DA) is to: —Give status overview of Level I rules —Provide advance notice of rules that will be ripe for an options review during the quarter* —Decide which AAs and RAs in addition to the lead office, OPPE, OGC and ORD should participate in options review meetings and whether DA chooses to chair the meeting or designate the lead AA as chairman. Options review meetings for each regulation will occur whenever a decision point is reached and will be sche- duled through the quarterly planning meetings or independently if necessary. They will be called by the chairman on the advice of the lead office or other affected parties. The initial meeting will be held very early in the development process—typically as part of the process of approving a development plan— to serve as a guide in the basic research and analysis. —Lead AA circulates options paper to all participants 10 days before meeting —Lead AA briefs, with reactions from other participants —If resolution is not reached on which options should be retained for further analysis and which might be rejected, each AA presents recommendations in writing during week following options meeting —OPPE serves as secretariat to DA, documents results of meeting and options rejected or selected, and issues closure memo (which will be a vehicle for raising disagreements to the DA for resolution when necessary). Would cover about 20-30 rules each year * Perhaps a specific day each month would be set aside so that the options reviews could be slipped easily into AA's schedules. ------- PROCESS FOR LEVEL II REGULATIONS Level II covers all other rules under development, including a large number of routine, non-controversial rules for which a formal options selection process would not be appropriate. The options selection review for Level II rules would normally apply only to rules that are of sufficient importance to undergo a Steering Committee review. Approximately 40-50 Level II rules a year would be subject to options selection review. o Options selection will be under the direction of the lead program Assistant Administrator with participa- tion of other affected program offices, Office of Research and Development, Office of the General Counsel, and Office of Policy, Planning and Evaluation. This process will typically be performed through the work group, and initial selections will be incorporated in the development plan. Subsequent options selection meetings, as required to further refine and limit options for development, will also be the responsi- bility of the lead program Assistant Administrator. o OPPE lead analysts will be responsible for periodic reports to the Steering Committee Chairman. These reports will outline work group progress, including options under consideration and those rejected. o Each participating office will be responsible for raising to the Steering Committee Chairman—through its Steering Committee representative—those options with merit which, in" its judgment, are not being investigated, or which have been rejected wrongly or prematurely. Before raising the issue to the Steering Committee Chairman, reasonable attempts should be made to resolve concerns by working with the lead program Assistant Administrator. o If these attempts to resolve the issue prove unsuc- cessful, Steering Committee options meetings would be convened at the request of Steering Committee representatives or by decision of the Steering Committee Chairman. The AA's representative must be able to speak for and bind the AA when such meetings have been called. o In such cases, the Steering Committee determines options for consideration; when the Steering Committee is unable to achieve closure, it iden- tifies disagreements to be raised to the affected AAs and DA. ------- -2- o OSR documents results of such meetings and options selected or rejected. o OD/OSR signs and circulates closure memo to participants and AA/OPPE. o Lead office will include as part of the Steering Committee and Red Border packages a summary of options considered and rejected, as well as why and when each was rejected. ------- UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 JAN 3 1 1984 OFFICE OF MEMORANDUM THE ADM.NISTRATOR SUBJECT: Criteria and Guidelines for Review of Agency Actions FROM: Alvin L. Aim Deputy Administrator TO: Assistant Administrators General Counsel Inspector General Associate Administrators Regional Administrators Agency Office Directors To assure that Agency regulations and other policy-setting actions are of high quality, present defensible options, and meet the Administrator's policy goals, I have established general criteria that regulations and other general statements of policy must meet to be deemed acceptable for the Administrator's consid- eration. I expect you to do your best to ensure that each of your decision packages satisfies these criteria. For each rule- making, I will solicit the independent advice of OPPE on whether these criteria — and the associated guidelines — have been appropri- ately taken into account. However, I will hold the program offices accountable for consistency wit-h these criteria, as well as for timeliness and policy. This memorandum will set out: o in section I, general criteria that regulatory actions must satisfy to be considered acceptable; and o in section II, guidelines for developing Agency regulatory actions. The guidelines in section II are divided into units corresponding to the main stages in developing an Agency action. The intention is to bring into focus those considerations that should be para- mount for you at each stage in the regulatory development process. I should add at the outset, that I am well aware of the enormous differences among rulemakings, and even, for a given rule, between its proposal and the final promulgation. In offering the criteria and guidelines that follow, therefore, it is with the understanding ------- -2- that not all will be equally relevant or appropriate to any given individual case. For example, in the case of minor rules, emergency actions, or purely administrative rulemakings, many of the criteria will apply very loosely or not at all. I. POLICY CRITERIA FOR ACCEPTABLE AGENCY ACTIONS The Agency's primary goal is to develop standards and regulations that protect human health and the environment. Ultimately, the most important criterion for evaluating any of our actions is the extent to which they achieve this goal. Given this responsibility, and within the limits of time, resources, and statutory authority, any Agency standard, regulation, or other policy-setting action should achieve high levels of environ- mental protection and the best possible combination of the following criteria: A. Compared with the feasible alternative options, the action produces the greatest net benefit to society. B. As a means of achieving efficient outcomes, compared with all the alternative options, the action allows maximum flexibility in compliance with standards or rules—for instance, where possible, specifying perfor- mance or end-results rather than means. C. To the extent possible, the action encourages environ- mentally acceptable innovation in the regulated community— for example, by encouraging the development and use of better or more efficient control technology, or providing incentives for the development of safer products. D. The action is consistent with other regulatory programs— EPA's, the States' and those of other Federal agencies— and complements them where possible, especially when they affect the same regulated community. E. Consistent with meeting the other criteria, the action places the least possible burden on the public and : regulated parties with respect to reporting, record- keeping, and information collection requirements. F. The action avoids disrupting competitive markets, or is the least disruptive of the alternative options with similar levels of net benefits. G. The action can be smoothly implemented and adequately enforced by those responsible for doing so, within likely budget/resource constraints. ------- -3- Often no one action consistent with our primary goal of protecting the public dominates all others with respect to these criteria. In that case, unless an explicit choice has been made by the Administrator at a previous stage, alternatives must be presented for his consideration accompanied by the recommendations of all the offices that have participated in developing the action. II. GUIDELINES FOR INTERNAL DEVELOPMENT AND REVIEW OF DECISION PACKAGES The process of developing a regulatory action can be divided-- in terms of work products—into four stages: o submission of start action request (SAR), o preparation of the development plan, o development of options in conjunction with the options selection process, and o drafting of the regulatory decision package. The guidelines for each of these stages are the following: A. The Start Action Request (SAR) Before you submit a SAR, you should determine that, to the best of your knowledge: 1. The action responds to a clearly defined problem that requires regulatory action. 2. The action will be consistent with, and adequate to, the statutory mandate. 3. The action is not likely to duplicate or conflict with other regulatory programs, either at EPA or at other Federal agencies, without adequate justification. 4. The action will coordinate its approach with that of other relevant Federal and State programs that affect the same prospective regulated community. 5. This is the appropriate time to develop the action, and the effort will make the best use of our resources in view of competing priorities. B. The Development Plan The development plan (where required) sets forth the basic policy and management framework for developing the regulation. You should ensure that: ------- -4- 1. The plan states the need for the regulation and identifies its goals and objectives. 2. The plan discusses the prima facie reasonable, legal, and technically feasible options, including; - no action; - alternatives to Federal regulation, including market, judicial, or State or local regulatory mechanisms; - alternatives within the scope of the action's legislative provision, including degree of control, effective compliance dates, and methods of ensuring compliance. 3. The plan identifies any alternatives that may be environmentally or administratively preferable, or more cost-effective, but that currently cannot be considered because they are precluded under existing law. 4. The plan specifies any generic decision rules drawn from current or historical Agency policy that will be used to choose among the options. (For example, certain generic forms of regulations are compared on the basis of the cost of pounds of pollutants reduced.) 5. The plan presents a work plan for developing the regulation that outlines, as appropriate; - the areas that projected analyses will cover, including, as applicable: health and environ- mental risks, benefits, economic impacts, effects on small entities, paperwork and record- keeping burdens, potential for fraud, waste, or mismanagement; - the major areas of technical uncertainty, and how we plan to resolve them; - the major tasks that will be performed—from the first work group meeting to the final promulgation of the regulation—and milestones for each task; - the Agency offices—including EPA Regional Offices- that will participate in developing the rule, and the choice of the work group chairperson; - other agencies, States, and others that will be involved in developing the regulation, and the nature of their involvement; ------- the mechanisms for communicating with participants external to the Agency, other affected parties, and the general public during the regulatory development process; and - the Agency personnel and contract resources that will be necessary to develop the regulation. C. The Options Selection Process The options selection process involves the formulation of, and selection among, feasible options, connected with one or a series of decision points that successively narrows the range of alternatives for the Administrator's final consideration. At each of the decision points the process is supported by the analyses anticipated in the development plan, performed with respect to the options that still remain under active consideration. For each of these options, you should ensure that to the extent possible: 1. The analyses are based on the best data available within the constraints of the decision schedules, taking into consideration; uncertainties in the data; other technically sound scientific studies based on adequate peer review; - anticipated requirements for further research; and - adequate and appropriate statistical data. 2. The analyses consider all relevant health and environ- mental impacts, including primary and secondary impacts, cumulative impacts, .and short and long term impacts. Especially for major rules, the analyses should consider these impacts not only in qualitative terms, but—where possible—in quantitative and monetized terms as well. 3. The analyses consider the relevant economic impacts, such as; the effect on product prices, and overall economic output; the impact on foreign trade and competition; - potentially disproportionate effects on small businesses; and - potential effects on plant closures or employment. 4. The analyses take account of the reporting and record- keeping burdens that the option entails. ------- -6- The analyses consider the following issues related to implementation; - the resources required for implementation and enforcement; - the enforceability of the option; - the degree to which the option allows for flexibility in achieving compliance; and - the potential inherent in the option for fraud, waste, or mismanagement in practice. The analyses assess impacts on other regulatory programs— both within and beyond the Agency—and overall consistency with Agency policy and regulatory strategy. D. The Decision Package The decision package provides the Agency's brief for the option(s) it presents, based on the supporting analyses. You should ensure that the package clearly presents the results of these analyses. Specifically, you should ensure that to the extent appropriate: 1. The package includes a neutral discussion of the major options that were considered at the most recent decision point in the options selection process,including; - the comments of any Assistant Administrators who were involved in the decision, reflecting their preference among the options; - the pros and cons of each of these options. 2. The package very briefly summarizes the major options considered and rejected at earlier decision points, indicating (again, very briefly) the point at which each option was rejected and why. 3. The package very briefly summarizes any legally proscribed alternatives that were identified as environmentally or administratively preferable, or more cost-effective—explaining in each case the legal restrictions that operate. 4. The package clearly presents; - as appropriate, the comparable costs, risks and benefits of the options considered based on com- parable assumptions; and ------- -7- a comparison of the action's cost-effectiveness with that of any similar regulatory actions. 5. The package adequately analyzes reporting and recordkeeping burdens, including: - the uses of the required information; and effective means to control the quality of the information and data processing. 6. The package assesses resources for implementing the ruler including; - plans for enforcement, implementation, and fpllpw-up actions; and resource needs, particularly for regional requirements. You should also ensure that the package satisfies the applicable procedural requirements, specifically that: 1. The package has met the requirements of E.O. 12291, the Paperwork Reduction Act, the Regulatory Flexibility Act, and EPA's "functional equivalency" requirements for compliance with the National Environmental Policy Act, including; analytical requirements; public participation requirements; OMB review requirements; and preamble requirements for appropriate statements and certifications. 2. The package has met Federal Register requirementsi including vocabulary and format constraints. 3. The package complies with Agency procedures for Steering Committee and Red Border review, and incorporates a "communication plan" for the the proposed action. Finally, you should ensure that: 1. The presentation of the action is adequate, both in internal documents and in the published rule and preamble, and includes; a clear statement of the problem; ------- -8 - clear conclusions flowing logically from the basic information; - a clear, consistent, and logical rationale for the proposed or final Agency position; - clear justification for any departures from the environmentally preferable option; and - presentation of any risk analysis information in a clear and consistent format. The action includes a mechanism for decision follow through, including plans for; - evaluating the effectiveness of the regulation; - correcting data gaps identified during the rule development process; - analyzing statutory restrictions against alternatives that may be environmentally or administratively preferable, or more cost-effective, for possible corrective action; and - preventing fraud, waste, or mismanagement in implementing the action. The criteria and guidelines set forth in this memorandum are necessary to establish adequate policy oversight and quality control over the Agency's policy-setting actions. I expect you to treat them as standards for acceptable regulatory development in your offices. They will be the measure I will use — with the advice of OPPE — to assess your recommendations. Of course, I expect that we will all treat these criteria and guidelines intelligently — recog- nizing both that not all will apply, or apply equally, in every case, and that sometimes the press of deadlines or the limitations on resources will dictate flexibility. I should add that while some of the guidelines as set out in this memorandum are rather general, more specific guidance exists in a number of instances. Attached to this memorandum is a list of review guidelines, along with references to relevant guidance documents. The list includes both currently available and forth- coming documents, as well as their estimated completion dates. I welcome suggestions of additional areas where more detailed regula- tory development guidance is needed. Attachment ------- GIJIDANCK FOR DEVELOPMENT AND REVIEW OF REGULATORY ACTIONS Tlie chart below lists the questions to be addressed during the four-stage process of developing a regulatory action, together with sources of official guidance on how to consider such issues. A. The Start Action Request (SAR) A Start Action Request represents the judgment of the lead program office that a prob- lem requires some action by the Agency. Currently Available Guidance Forthcoming Guidance o Does the SAR clearly define the problem? o Does it justify a regulatory approach to the problem, as opposed to other approaches? o Does the proposed action fulfill the statu- tory mandate? o Will the action conflict with or duplicate other regulatory programs, particularly those covering the same prospective regulated com- mun ity? o Will the proposed action make the best use of the Agency's resources, in view of com- peting priorities? Is this the best time to develop the action? Procedures for Regulation Develop- ment and Review (Office of Stan- dards and Regulations, OPPE, 4/82) UNDER REVISION Checklist of Regulatory Alternatives (Office of Planning and Management, 7/80) Managing the Process (Office of Standards and Regulations,OPPE,8/82) EPA Chemical Activities Status Re- port (Chemical Coordination Staff, OPTS, 6782 and CIS) Overview of the Industry File Index System (Chemical Coordination Staff, OPTS, 6/83) ------- R. The Development Plan Currently Available Guidance Forthcoming Guidance The development plan sets forth the basic policy and management framework for developing the regulation by presenting a preliminary set of options and their projected analytical needs. o noes the plan state the need for the regula- tion? o Does it present all reasonable and technical- ly feasible options, including: o alternatives to Federal regulation, in- ding market, judicial, or State or local regulatory mechanisms; and o alternatives within the scope of the ac- tion's legislative provision, including degree of control, effective compliance dates, and methods of ensuring compli- ance? o Does the plan identify any generic Agency de- cision rules that will dictate a choice among the options? o noes the plan outline projected analytical requirements, including (as applicable): o health and environmental risks; o benefits; o economic impacts; o effects on small entities; and o paperwork and recordkeeping burdens. o Does the plan identify major technical un- certainties and their possible resolution? o Does the plan identify major tasks and pro- vide milestones for them? Checklist of Regulatory Alternatives (op. cit.) Managing the Process (op.cit.) Procedures for Regulation Develop- ment and Review (op. cit.) Procedural Requirements of Executive Order 12291(President Reagan,2/81) Regulatory Options Selection/Rejec- tion Process (Memo from Alvin Aim, 11/83) Compliance with the Regulatory Flexibility Act (Memo from Ron Smith to Steering Committee Repre- sentatives, 4/83) Guidelines for Performing Regula- tory Impact Analyses (Office of Policy Analysis, OPPE, 11/83) Chemical Substances Designation (Chemical Coordination Staff, OPTS, 12/81) Checklist for Regional Review (Of- fice of Standards and Regulations, OPPE Feasibility Study Guidance Document (Office of Policy and Program Management,OSWER, 1/84) Planning and Budgeting Manual (Office of the Comptroller, ARM, 3/84) ------- Development Plan (Continued) Currently Available Guidance Forthcoming Guidance Does the plan identify participating Agency offices and a work group chairperson? Does the plan identify how and why other Fed- eral and non-Federal institutions will be in- volved? Does the plan anticipate needed personnel and contract resources? Does the plan present a mechanism for commu- nicating with participants external to the Agency, other affected parties, and the gen- eral public during the development of the regulation? Background Information for Develop- ment of Communication Strategies (Memo from Josephine Cooper, 8/83) Federal Activities in Toxic Sub- stances (Chemical Coordination Staff, OPTS, 5/80) UNDER REVISION ------- C. Options Selection Process Currently Available Guidance Forthcoming Guidance The goal of the options selection process is to present the Administrator with decision pack- ages which clearly present and analyze realistic alternatives. The analytical support for these alternatives, which was anticipated in the de- velopment plan, is further developed during the options selection process. Are the analyses based on the best data a- vailable within the constraints of decision schedules, taking into consideration: o uncertainties in the data; o other technically sound scientific stud- ies based on adequate peer review; o anticipated requirements for further re- search; and o adequate and appropriate statistical data? Do the analyses consider all relevant health and environmental impacts, not only in quali- tative terms, but — where possible — in quantitative and monetized terms as well? Do the analyses consider all relevant econom- ic impacts, including: o the effect on product prices, output (i.e.,demand and response); O the impact on foreign trade (e.g., GATT); o potentially disproportionate effects on small businesses; and o potential effects on plant closures or employment Do the analyses take account of the reporting and recordkeeping burdens entailed by each of the options under consideration? Survey Management Handbook; Guide- lines for Planning and Managing a Statistical Survey (Office of Stan- dards and Regulations, Vol.I,11/83) EPA Chemical Activities Status Re- port (op.cit.) Interim procedures and Guidelines for Health Risk and Economic Im- pact Assessments of Suspected Car- cinogens (Office of Health and En- vironmental Assessment,ORD,5/76: Appendix I: Interim Guideline for Carcinogen Risk As- sessment Appendix II: lnterim~Guideline for Economic Impact Ana- lysis of Proposed Reg- ulatory Actions to Control Carcinogenic Pesticides Method for Determining the Unit Risk Estimate for Air Pollutants DRAFT (Office of Health and Environmental Assessment, ORD, fi/80) Water Quality Criteria Documents (Criteria and Standards Division, OW, 11/80): Appendix A: Summary of Water Qual- ity Criteria Survey Management Handbook; Guidelines for Planning and Managing a Statistical Sur- vey (Office of Standards and Regulations, Vol.II, 1/84) Quality Assurance Manual (Of- fice of Monitoring and Qual- ity Assurance, ORD, Chapter I, 10/84) Procurement and Grants Data Base (EPA Information Clear- inghouse, ARM, 4/84) Report of the Administrator's Task Force on Toxics Integra- tion; Guidelines for Risk Assess- ment Guidelines for Risk Manage- ment Uniform Reporting Format for Risk Management Information Risk Assessment for RCRA Reg- ulations (Office of Policy Analysis, OPPE, 12/83) Risk Evaluation and Management Procedure Manual (office of Policy and Program Management, OSWER, 7/84) ------- C. The Options Selection Process (Continued) o Do the analyses consider all relevant econom- ic impacts, including: o the effect on product prices, output (i.e., demand and response); o the impact on foreign trade (e.g., GATT); o potentially disproportionate effects on small businesses; and o potential effects on plant closures or employment? o Do the analyses take account of the reporting and recordkeeping burdens entailed by each of the options under consideration? o Do the analyses assess the resources required for implementation and enforcement, and the degree to which the options allow for flexi- bility in achieving compliance? o Do the analyses assess impacts on other regu- latory programs — both within and beyond • the Agency — and overall consistency with Agency policy and regulatory strategy? Currently Available Guidance Appendix B: Appendix C: Guidelines for Deriving Water Quality Criteria for the protection of Aquatic Life and Its Uses Guidelines and Methodo- logy Used in the Prepa- ration of Health Effect Assessment Chapters of the Consent Decree Wa- ter Criteria Documents Proposed Guidelines for Mutagenicity Risk Assessments (Office of Health and Environmental Assessment, ORD, 10/80) Assessment of Risks to Human Repro- duction and to the Development of the Human Conceptus from Exposure to Environmental Substances (Office of Health and Environmental Assess- ment, ORD, 10/80) Guidance for the Preparation of Ex- posure Assessments DRAFT (Office of Health and Environmental Assess- ment, ORD, 9/83) Water Quality Criteria for the Protection of Aquatic Life and Its~ Uses Guidelines and Method- Appendix C; ology Used in the Pre- paration of Health Ef- fect Assessment Chap- ters of the Consent De- cree Water Criteria Documents Guidelines for Performing Regulatory Impact Analyses (op.cit.) Forthcoming Guidance Risk Evaluation and Manage- ment Procedure Manual (Of- fice of Policy and Program Management, OSWER, 7/84) Draft Policy on Small Business, (OPPE, 2/84) Agency Guidelines for Imple- menting the Paperwork Reduc- tion Act Requirements (Office of Standards and Regulations, OPPE, /84) Guidelines for Evaluation Planning (Office of Standards and Regulations, OPPE, /84) Guidance on Meeting the Func- tional Equivalency Require- ments of the National Environ- mental Policy Act (NEPA~j (Office of Federal Activities, OEA, 2/84) ------- D. The Decision Package Currently Available Guidance Forthcoming Guidance The decision package is the Agency brief for the options it presents, and is based on the suppporting documents. To be effective, the package must clearly present the results of these analyses. o Does the package neutrally present the most recently considered major options from the selection process, including: o the pros and cons of each of these op- tions; and o the comments of the AAs who were involved in the decision, along with their prefer- ence among the options? o Does the package briefly summarize when and why major options were rejected earlier in the process? o Does the package clearly present: o the costs, risks, and benefits of the'op- tions considered; o comparable costs and benefits based on comparaole assumptions (e.g., comparable baselines, or interest and inflation rates); and o a comparison of the options' cost-effec- tiveness with that of any similar regula- tory actions? o Does the package adequately analyze reporting and recordkeeping burdens, including: o the uses of required information; and o effective means to control the quality of the information and data processing? o Does the package assess resources required for implementing and enforcing the rule, i nclucl iny : o plans for enforcement, implementation, and follow-up actions; and o resource needs, particularly regional requ i rements? Procedures for Regulation and De- velopment and Review (op.cit.) Regulatory Options Selection/Rejec- tion Process (op.cit.) Guidelines for Performing Regulatory Impact Analyses (op.cit.) Survey Management Handbook, Vol.1. (op.cit.) Appendices to the Guidelines for Performing Regulatory Im- pact Analyses; A. Analysis of Benefits B. Analysis of Costs C. Analysis of the Discount Rate D. Analysis of Economic Im- pacts (Office of Policy Analysis, OPPE, 1/84) Agency Guidelines for Imple- menting Paperwork Reduction Act Requirements (op.cit.) Survey Management Handbook, Vol.11 (op.cit.) Quality Assurance Manual (op.c i t.) Guidelines for Evaluation Planning (op.cit.) ------- 0. Decision Package (Continued) Currently Available Guidance Forthcoming Guidance Has the package met the requirements of Exe- cutive Order 12291, the Paperwork Reduction Act, the Regulatory Flexibility Act, and EPA's "functional equivalency" requirements for compliance with the National Environmen- tal policy Act (NEPA), including: o analytical requirements; o public participation requirements; o OMB review requirements; and o preamble requirements for appropriate statements and certifications? Has the package met Federal Register require- ments, including vocabulary and format con- straints? Does the package comply with Agency procedure for Steering Committee and Red Border review? Does it incorporate a "communication plan" for the action? Is the action presented adequately, both in internal documents and in the published rule and preamble? Does it include: o a clear statement of the problem; o clear conclusions flowing logically from the basic information; o a clear, consistent, and logical ration- ale for the Agency action; o clear justification for any departures from the environmentally preferable option; and o a clear and consistent presentation of any risk analysis information? Procedural Requirements of Execu- tive Order 12291 (op.cit.) Regulatory Options Selection/Rejec- tion Process (op.cit.) Compliance with the Regulatory Flexibility Act (op.cit.) Guidance on Information Clearance Requirements (Memo from Ron Smith, 5/83) Procedures for Regulation Develop- ment and Review (op.cit.) Document Development Handbook (Of- fice of the Federal Register) Federal Register Thesaurus Guidance (Office of Standards and Regula- tions, OPPE, 11/81). Background Information for Develop- ment of Communications Strategy (op.cit.) Guidance on Meeting the Func- tional Equivalency Require- ments of the National Environ- mental Policy Act (NEPA) (op.cit.) ------- n. Decision Package (Continued) Currently Available Guidance Forthcoming Guidance Does the action include a mechanism for de- cision follow-through, including plans for: o evaluating the effectiveness of the action; o correcting data gaps identified during the rule development process; o identifying statutory restrictions against various actions and analyzing these restrictions for possible correc- tive action? Guidelines for Evaluation Planning (op.cit.) ------- UNITED STATES ENVIRONMENTAL PROTECTION AGENCY • WASHINGTON, D.C. 20460 FEB 2 1 1984 MEMORANDUM OFFICE OF THE ADMINISTRATOR SUBJECT: Procedures for Regulation Development and Review FROM: Alvin L. Aim Deputy Administrator TO: Assistant Administrators General Counsel Inspector General Associate Administrators Regional Administrators Staff Office Directors This memorandum revises a number of the Agency's current rulemaking procedures set out in the April 30, 1982 memorandum on this same subject. The purposes are: o to incorporate the options selection/rejection process announced in my memorandum of November 4, 1983; o to provide the mechanisms for ensuring that Agency rulemaking conforms to the criteria and guidelines set out in my memorandum of January 30, 1984. o to make the rulemaking process as consistent, predic- table, efficient, and accountable as it can be given its inherent complexity. This memorandum — taken together with those setting out the options selection/rejection process, and the criteria and guidelines-- replaces the April 30, 1982 memorandum referenced above. In presenting the revised procedures, this memorandum will: 1. Set out the classification scheme that will apply to regulatory actions; 2. Describe the primary participants in regulatory development and review; 3. Outline the procedures themselves; and 4. Explain the mechanisms for making the process accountable, including the Action Tracking System (ATS) . ------- -2- The memorandum will devote a section to each of these, and then append: (i) a matrix relating the classification scheme to elements of the procedures, (ii) a matrix diagram summarizing the structure of formal reviews associated with regulatory development, and (iii) a table listing the specific changes that this memorandum makes in current Agency practice. I. Classification of Agency Regulations The Agency must establish priorities among its regulations that allow us to allocate our program, analytical, and management resources efficiently. Regulations that have major program im- plications, that involve especially significant effects on the environment or the economy, or that are the subject of contro- versy or widespread public concern deserve a proportionately greater share of the Agency's time and resources. I therefore want to continue the three-level classification scheme of major, significant, and minor rules. Major rules are those meeting the definition of "major" in section one of Executive Order. 12291. A rule is significant if it is not major but nonetheless will have important effects on the environment, public health, or the economy, will present intermedia issues, or will affect th£ administration or operation of several Agency offices. Minor rules are those that are neither major nor significant. They include the more specialized and routine rules that affect only one program or sector of the economy, or that simply implement established Agency policy. This classification bears on major elements of the procedures outlined in this memorandum, including the process for options reviews. All major or significant regulations will be covered by either the Level I or the Level II options review process, while minor rules will be subject to neither. Attachment (i) summarizes the relation between the classification scheme and elements of the procedures. II. Participants and Role This section describes the Agency participants who play important roles in preparing or reviewing the regulation packages that reach me and the Administrator for our decision. A. Lead Office The lead office for a regulation initiates, and has program responsibility for, the rulemaking. The four environ- mental program offices—OAR, OPTS, OSWER, and OW—have lead responsibility for nearly all of the regulations covered by these procedures. ------- -3- The Assistant Administrator (AA) of the lead office and his/her designee (the project officer) manage the development of the regulation. The lead office organizes the Agency-wide work group and notifies the designated representatives, and the project officer chairs the work group sessions. The lead office is the primary source of technical expertise, drawing on other offices to complement its analytical resources. In addition, the lead office sets the schedule for the rulemaking and elicits the participation of other Agency offices and the public. B. Assistant Administrators and the General Counsel 1. Program Assistant Administrators In addition to heading the lead offices for regulatory development, the program AAs review other regulations to offer their views and expertise, and to assure the neces- sary integration of our programs. They are represented in all Steering Committee reviews. In addition, they participate in options selection reviews, and in Red Border reviews that are of interest to them. 2. Assistant Administrator for Policy, Planning and Evaluation The Assistant Administrator for the Office of Policy, Planning and Evaluation (AA/OPPE) manages the process outlined in this memorandum, supported by his staff in the Office of Standards and Regulations (OSR). As part of this, he oversees the Agency's compliance with such external requirements as Executive Order 12291, the Paper- work Reduction Act, and the Regulatory Flexibility Act. In addition, the AA/OPPE heads the policy review of Agency regulations, both directing the Steering Commit- tee process, and participating in each Red Border review. Supported by a lead OPPE analyst assigned to each regu- lation and work group, the AA/OPPE focuses especially on analytical quality, program integration, cost- effectiveness, and scientific and statistical validity. I also rely on the AA/OPPE to promote thorough consider- ation of options and to provide an independent assessment of proposed rules for me and the Administrator. 3. General Counsel The Office of General Counsel (OGC) reviews regulatory packages to advise the Administrator, Deputy, and Assistant Administrators on the legal aspects of each rulemaking. OGC lawyers help draft the regulations and their preambles, working closely with the lead offices. The General Counsel is represented in Steering Committee reviews, and partici- pates in all Red Border reviews. ------- -4- 4. Other Assistant Administrators and the Regional Administrators The Assistant Administrators for Enforcement and Compliance Monitoring, Research and Development, Exter- nal Affairs, and Administration and Resources Management have lead office responsibility for a select number of rulemakings generated by their offices. In addition, these AAs, and the Regional Administrators (RAs), are represented in all Steering Committee reviews and parti- cipate in Red Border reviews of packages that are of specific interest to them. C. Work Group The lead office first convenes the work group shortly after the SAR is approved, to draft the development plan. The AA for OPPE and the General Counsel always send a representative. Almost all work groups also include repre- sentatives of at least one RA and of the AAs for Research and Development, Enforcement and Compliance Monitoring, and External Affairs. Other offices participate when there are issues involved that concern them. The work group continues to meet throughout the regulatory development process, until the final decision package is submitted for Agency-wide review. These meetings provide a forum for sharing expertise on the regulation under development. Full work group participation helps resolve conflicts at the start, thus enhancing the quality of Steering Committee review. Full participation also helps ensure that all necessary analyses are integrated and that resources are efficiently allocated. D. Steering Committee The core Steering Committee membership includes a representative for each of the nine Assistant Administra- tors (AAs), for the General Counsel, and for each of the Associate Administrators for Regional Operations and Inter- national Liaison. These representatives should: {1) be at or above the Office Director's level, (2) be located in the immediate office of their AAs (or General Counsel) or report directly to their AAs, and (3) have general respon- sibilities covering the entire range of regulatory issues within the offices that they represent. Ideally, these representatives are either Deputy AAs or persons of similarly senior status. They speak for their AAs or General Counsel and are directly accountable to them. Regional Adminis- trators are included in all Steering Committee Reviews and are encouraged to attend meetings on regulations in which they have sufficient interest. The Director of OSR chairs the Steering Committee. ------- -b- III. Procedures for Developing a Regulatory Action In terms of work products, the process of developing a regulatory action can be divided into four stages: o submission of a start action request (SAR); o preparation of the development plan; o review and selection of options; o submission of the proposed/final regulatory decision package. For each of these stages, the procedures consist of certain requirements that the lead program office must satisfy together with an associated review process. The following sections describe the requirements and review processes at each stage, and their applicability. If you are unsure whether a particular requirement applies in a given case, check with the Chief of the Regulation Management Staff, in the Office of Standards and Regulations (OSR). A. Submission of Start Action Request (SAR) Applicability. SAR requirements apply to ail rulemaking subject to OMB review under Executive Order 12291* — except for approvals of State plans in the various programs (including State Implementation Plans), pesticide tolerances, Significant New Use Rules and other routine; high-volume categories of actions. Requirements. Before starting work on a regulation, the lead office must submit a Start Action Request (SAR) to OSR for the approval of the AA/OPPE. No action can enter internal Agency review without an approved SAR. The SAR must: o describe the proposed action and its purpose; o state the statutory authority for the action and propose its classification as either major, signi- ficant, or minor; o explain the reason(s) for proposing to initiate the action, and the consequences of not doing so; o certify that the action's relation to other relevant programs has been investigated,- and justify any pro- jected conflict, duplication, or failure to pursue possibilities for integration; o explain why developing the action now will be an appropriate use of our time and resources. See Attachment fi) ------- -6- The Review. OPPE review normally takes at most three weeks, which includes a week for review by Steering Committee members. An approval will bear the signature of the AA/OPPE. In reviewing the SAR, OPPE will determine, in consultation with the lead office, whether the action is major, significant, or minor. B. Preparation of the Development Plan Applicability. Development plan requirements apply to all rulemakings that are classified as major or significant. However, for some significant rulemakings, OPPE may waive the development plan requirements when it approves the SAR. The Requirements. The lead office must submit the development plan to the Steering Committee within 60 days after OPPE approves the SAR. Typically, the lead office prepares the plan in consul- tation with the work group. As appropriate, the plan must cover the points spelled out under the heading "The Development Plan" in my Criteria and Guidelines memorandum. It is especially important that the plan present a broad array of options for management to co'nsider in determining the most effec- tive way to meet our regulatory obligations. Where the rulemaking is subject to the options selection process, the lead program office must begin this process as a part of preparing the development plan. Other affected programs, ORD, OGC, and OPPE all participate. The Review. Development Plans are reviewed by the Steering Committee; this normally takes two weeks. The Chairman of the Steering Committee must approve all required development plans. In the case of major regulations, the AA/OPPE must also approve the plans. In addition, where the plan is for a Level I rule, it will normally be reviewed by the first formal options review meeting on that rule, which I or the lead program AA will chair. Where there is an accompanying ANPRM, it receives Steering Committee review together with the Development Plan. The ANPRM must also undergo Red Border review, and normally must be signed by the Administrator. C. Review and Selection of Options 1. Level I Process Applicability. All Level I rules. The Requirements. At least 10 days before a scheduled options review meeting, the lead office must circulate an options paper for the rule in question. The options paper should be based on the analyses specified under the heading "The Options Selection Process" in my Criteria and Guidelines memorandum. ------- -7- The Review. The options review meetings are chaired by me (or, if I so choose, the lead program AA). At these meetings, the lead AA briefs the participants on the options, and the parti- cipants attempt to agree on which options to retain for further development and which to reject. If no agreement can be reached on specific options, the participating AAs and RAs present their recommendations in writing within a week after the meeting. OPPE documents results of options review meetings, and issues closure memos (which serve as vehicles for raising disagreements to me for resolution when necessary). 2. Level II Process Applicability. All Level II rules. Requirements. Typically, the work group serves as the forum for the Level II options selection process — beginning with its first meeting, which is convened after the SAR is approved, to draft the development plan. The lead program office calls this meeting, as well as subsequent meetings at which the options are refined and selected/rejected for further development. When it submits the decision package for Steering Committee and Red Border reviews, the lead office must include a summary of the options considered and rejected, stating why and when each was rejected. Where participating offices believe that options with merit are not being investigated, or have been wrongly or prematurely rejected, they must make reasonable attempts to resolve their concerns by working with the lead program AA. If differences persist, they must then communicate their concerns to the Steering Committee Chairman. The Review. The OPPE lead- analyst for the rule in question reports periodically to the Steering Committee Chairman, outlin- ing work group progress and the options considered and retained or rejected. Where work group participants are unable to resolve differences over options with the lead program AA, Steering Committee options meetings are convened — either at the request of the Steering Committee representatives or by decision of the Steering Committee Chairman. In such cases, the Steering Committee determines the options for consideration—or, if i.t is unable to achieve closure, it identifies disagreements to be raised to me and to the affected AAs. OPPE documents the results of such meetings and the options selected or rejected, the Steering Committee Chairman signing the closure memo and circulating it to the participants and the AA/OPPE. D. The Decision Package Applicability. All rules, with qualifications as noted. The Requirements. The lead office must prepare a decision package to be submitted for Steering Committee and Red Border reviews. The package must satisfy the applicable guidelines under ------- -8- the heading "The Decision Package" in my Criteria and Guidelines memorandum. Before it is submitted for Steering Committee review (or Red Border review, in the case of minor rules), the package must be circulated to all members of the work group for review and comment, and then approved by the lead program AA. In addition to the preamble and the rule itself, the decision package must include: o an action memorandum signed by the lead office AA; o for Level I and II rules, a summary of: (1) the options considered and rejected, and (2) why and when each was rejected; o for Level I and II rules, the written comments of any Assistant Administrators or Regional Administrators who were involved in the options selection process, reflecting their preference among the options; o any Information Collection Requests (ICRs) associated with the rule. This must be submitted at the time of Steering Committee review unless the requirement is waived. In the case of a waiver, the ICR must be sub- mitted at the time of Red Border review; and o any other important support documents. The Chairman of the Steering Committee may refuse to schedule a Steering Committee review for any package that does not satisfy the above requirements. OPPE may correspondingly refuse to begin Red Border review. The Reviews. Both proposed and final decision packages undergo the following sequence of reviews: o Steering Committee Review. All major and significant rules undergo Steering Committee review, which normally requires two weeks. For major and many significant rules, a meeting of Steering Committee representatives is scheduled. However, some significant rules undergo Consent Calendar review.in lieu of a meeting. In these cases, OPPE circulates the package to the Steering Com- mittee for comments in writing, normally due in two weeks. The Steering Committee determines whether the package is ready to go on to Red Border review. This includes identifying the issues that require resolution by the AAs, me, or the Administrator. The Steering Committee recommends resolutions for those of the issues on which the representatives can reach agreement. The ------- -9- Steering Committee Chairman, the lead office represen- tative, and representatives from the affected offices then present at least the more important of the issues— together with any Committee recommendations—to their AAs and to me for decision. Especially where there are disagreements arising from the Steering Committee review, the Steering Committee Chairman must ensure that I have the views of all the offices concerned. OPPE prepares a summary of important issues, comments, and agreements arising from Steering Committee review. In addition, before the package enters Red Border review, the lead office must prepare a summary of important changes in the package since Steering Committee review. The lead office summary must address Steering Committee comments. Both the OPPE and the lead office summaries accompany the package through Red Border review. o Red Border Review. This is the formal senior management review of all decision packages, normally limited to the AA/OPPE and the General Counsel. Other non-lead AAs and RAs may be included if they have identified issues or concerns at the Steering Committee stage and ask to par- ticipate in the Red Border review. The normal period for a Red Border review is three weeks. If a reviewing office fails to respond by the review deadline, i may ask that the review be terminated without their comments. o OMB Review. Executive Order 12291 requires that all proposed and final rules (except those that OMB has exempted) be sent to the Office of Management and Budget (OMB) for review under the Order. Minor and significant rules are submitted to OMB for a 10-day review. Proposals of major rules and a draft regulatory impact analysis are submitted to OMB for a 60-day review. Final major rules and a final regulatory impact analysis are submitted for a 30-day review prior to signature. The AA/OPPE must approve Agency documents (except SIPs) for transmittal to OMB before they are sent for OMB review under the Executive Order. Normally OPPE will grant this approval only for documents that have completed Red Border review. However, Red Border and OMB reviews may sometimes proceed at the same time if OPPE determines that no significant unresolved issues remain. OPPE will continue to have complete responsibi- lity for managing the OMB review, including that for SIP actions. ------- -10- In the course of its review, OMB may comment on the rule, or deem it to be "inconsistent with the Executive Order." In either of these cases, the action memo must be revised to explain the issues involved and detail any resulting changes to the package. OMB also reviews any information collection requests (ICRs) associated with a rule, under the authority of the Paperwork Reduction Act. This review begins when the proposed rule is sent to the Federal Register, and generally takes 60-90 days. If OMB has problems with an ICR, or if there are changes, the ICR may have to be resubmitted when the final decision package is prepared. Consult OPPE's memorandum entitled "Integrating Paperwork Review into the Agency's Regulation Review Procedures" for details on timing in this case. o Administrator and Deputy Administrator Review The Office of Standards and Regulations in OPPE presents the decision package to the Office of the Admin- istrator through AX once the Red Border and OMB reviews are complete. My staff or the Administrator's staff may raise questions or issues before the decision package is presented for final approval and signature. The Administrator and I will often have reviewed a regulation before it reaches us at this stage, through either the options selection process or special briefings or decision memoranda. This means that—especially for significant and major regulations—we will probably be aware of important policy choices and issues before the package is presented to us in the form of a final draft. Once the Administrator signs a rule it is returned through AX to the Office of Standards and Regulations, which arranges for publication in the Federal Register. IV. Scheduling and Accountability I have established an Agency-wide Action Tracking System (ATS) that allows me to monitor the progress of many of the rules covered by these procedures. The biweekly ATS reports inform me regularly of problems or delays and are designed to ensure that there is ade- quate review time in the development process for each regulation. Each lead AA must allow adequate time for analysis and review of each regulation within his or her program. This must include time for the procedures in this memorandum, including the options selection/rejection process, and for products specified in my Criteria and Guidelines memorandum. Lead AAs must also allow suf- ficient time for final review by me and by the Administrator. In turn, OPPE, OGC, and other reviewing offices have an obligation to complete reviews in a timely manner. ------- Attachment (i) SAR Development Plan Options Review Analytical Requirements Steering Committee Review Red Border OMB Review MAJOR SIGNIFICANT MINOR Yes Yes Yes ( unless specifi- cally exempted Yes, with approval by AA/OPPE , Yes, with approval by Steering Committee Chairman No 1 Covered by Level I or Level II process. Covered by Level I or Level II process. Not covered by the formal options process RIA No RIA, but usually sub- stantial analytical support. Minimal or generic analytical support. Yes Yes No Yes Yes Yes (unless specifically delegated or exempted ) Yes — for 60-day (proposal) or 30-day (final) period. Yes — for 10-day period. Yes — for 10-day period, unless exempt. ------- Attachment (ii): Required Documents and Formal Reviews at the Four Stages of Regulatory Development Symbols "o" = review and approval required REQUIRED DOCUMENTS I. Start Action Request (SAR)* (Required for all rulemakings and policy documents subject to OMB review under Executive Order 12291) I la. Development Plan [Required for (a) all major rules, (b) all significant rules not specifically exempted by the AA/OPPE, and (c) some policy documents] lib. Accompanying ANPRM [Optional] I I I. Opt ions Papers [Require for all major and significant rules] IV. Proposed and Final Decision Packages Vtork Group o [all Level II rules] o Steering Committee (SO o o [approval of chairman required] o [Level II rules, if there are unresolved issues in the work group] o [all major and significant rules] AA/OPPE o o [required for major rules] Deputy Adminis- trator/AA Options Review Meeting . o [all Level I rules] 1. In sane cases OPPE will send documents for OMB review before Red Border review fonr 2. Time periods for CMS review are: proposed major; 60 days; proposed non-major; 10 da final non-major: 10 days. AA/OPPE, General Counsel and other participating AAs ("Red Border") 3 weeks max. o [required for ANPRM] o OMB l'»,^) 10-60 days o Deputy Administrator o [normally required for ANRPM] o [if there are unresolved issues in SC or Options Review Com- mittee] o [except delegated actions] Administrator o [normally required for ANRPM] o [except delegated actions] ally ends. ys; final major: 30 days; . ------- Changes from the April 30, 1983 Procedures Memorandum to the New Procedures Memorandum PAST PRESENT SAR two-week review period, SAR three-week review period; new SAR form (presently being prepared) covers additional points. Red Border standard two-week review. Red Border standard three-week review; Deputy Administrator can terminate at deadline. Enforcement review of all Red Border packages as part of OLEC. Office of Enforcement and Compliance Monitoring review of selected Red Border packages with enforcement issues. No specific requirements on submission of Information Collection Requests associated with rules. Requirement that ICR's associated with rules be submitted at Steering Committee entry point. Occurrence of OMB review after completion of Red Border Allowance for parallel OMB/Red Border review under prescribed circumstances. Participation of the AA External Affairs, and the Associate Admin- strators for Regional Operations and International Liaison in the review process through Steering Committee representations and selected Red Border reviews. Incorporation of options selection/rejection process. Incorporation of Criteria and Guidelines Document. ------- 1/9/84 PROGRAM OFFICE COMMENTS AND RESPONSES I. Steering Committee 1. Comment; The Steering Committee should be chaired by a disinterested party - not an advocate like OPPE. As an alternative, the Steering Committee chair could be rotated among the program offices. Response: Rotating the Steering Committee chair would badly compromise its responsibilities for managing the ongoing process of Agency-wide review of regulatory actions, Since the chair must reside with one office, then, OPPE is the most appropriate choice—for at least two reasons: First, OPPE is more likely to be detached from the actions under review than any of the program offices, since OPPE very rarely has lead responsibility for such actions. This helps ensure that the independence and integrity of the review process will be maintained. (Of course, OPPE does also play an advocate's role.) Second, OPPE is, after all, the office charged with the responsibility for managing both Agency-wide review and the regulatory development process generally. 2. Comment; Steering Committee representation should be at a higher level, possibly including the Assistant Administrators. Response; The document provides for representation by "Qeputy Assistant Administrators or persons of similarly senior status." Assistant Administrators are welcome to par- ticipate in any Steering Committee activities. 3. Comment; The document should define in more detail the role of the Steering Committee. Response; Page 8 gives a brief explanation of the Steering Committee's role; specific aspects of this role are discussed elsewhere in the document. If addi- tional description would be useful, we would welcome specific suggestions. 4. Comment: OPPE should circulate more Steering Committee consent calendars and conduct fewer meetings. ------- -2- Response: Currently about three=fourths of the Steering Committee's reviews are consent calendar. We try to limit meetings to those cases where a meeting is needed to help resolve outstanding issues. In view of this practice, we don't think we can make the proportion of reviews that involve a meeting any smaller than it already is. In fact, on previous occasions program offices have suggested that we hold more meetings. 5. Comment: If the Steering Committee decides that the work group has not done a thorough job, OPPE should send the regulation back. Response; In some cases, regulations have been sent back to the work group for substantial revision or addi- tional analysis. That practice would continue under the new document. 6. Commenti OPPE should assume automatic concurrence when the two-week Steering Committee review period is over on routine regulations and "a reviewing office has not responded. Response: We do assume concurrence unless we have been informed that an office intends to submit comments. Even in those cases, we agree that a program should not delay its work to respond to comments submitted well past the deadline. II. Work Group 1. Comment; OPPE analysts should issue reports on work group effectiveness. Response; OPPE now assigns a lead analyst to each regu- lation, and part of that lead analyst's responsibilities is to report periodically on work group effectiveness. 2. Comment; Who is responsible for work group effectiveness? Specifically what role should OPPE, OECM, and the lead office play in regulation development? Response; Each office is responsible for ensuring the effectiveness of its representation on work groups. The work group chairman from the lead office should contact the Steering Committee representative from any other office that does not provide effective representation. This draft includes more detail on the work group and on the role of various offices, including reviewing and lead offices. ------- -3- 3. Comment; Work group members should have an appropriate policy or technical background and should be able to represent management's viewpoint. Response: Agreed. This is not a matter we thought should be addressed in the document itself. However, each office has a clear responsibility for seeing that it is appropri- ately represented on the work group. III. General 1. Commentt How does the options selection/rejection process relate to or differ from the Development Plan? Response; The development plan is the initial specifica- tion of options that will be considered, and of analyses the Agency will conduct to assess and compare those options. Under the options selection/rejection process, formal options reviews normally would begin when the development plan enters Agency review, and would continue as necessary beyond that point. The options process would not replace the develop- ment plan. Pages 5-7 of" the procedures document describe this in more detail. 2. Comment; There should be less stringent review require- ments for minor actions. Response; Minor rules do not require a formal development plan, do not receive a Steering Committee review, and are not covered by the formal options selection process. In addition, OPPE has adopted streamlined internal procedures for Red Border reviews of many minor rules. 3. Comment; There should be more flexibility in how the pro- cedures are applied. There should also be clear criteria for exceptions from standard requirements. Response; The document provides for waivers from or excep- tions to many requirements. In practice, exceptions to the rules have always been available when there has been good reason not to follow standard procedures. It is difficult to specify criteria for exceptions, because we cannot always anticipate the special circumstances that make exceptions appropriate. IV. QPPE Management 1. Comment; Delegate responsibility for signing Red Borders to the OPPE Office Directors on more routine actions. ------- -4- Response; Agreed. OPPE has adopted this practice for several categories of actions. 2. Comment; Prompt and high-quality Red Border reviews should be an element of OPPE performance standards. Response; Agreed. This is an element for most OPPE managers, 3. Comment; OPPE should streamline its review chain. Response; OPPE has taken steps to streamline its reviews. Several classes of regulations are delegated to office directors for approval and formal memoranda have been eliminated for many such actions. 4. Comment; OPPE should reallocate its assignments, taking resources from Air and Water to sufficiently cover OSWER and OPTS. Response; OPPE has increased the resources available for review of OPTS rules, and for regulation review generally. 5. Comment; OPPE should aggressively manage the review process. It should provide regular feedback on status of regulations. Response; OPPE monitors Red Border performances care- fully, and will continue to do so. In addition, OPPE has designated a lead analyst for each regulation under development to provide a source of information on issues, problems, or delays. The list of lead analysts will be sent to program offices. By way of feedback, OPPE pre- pares a Red Border Status Report, updated every day and sent through electronic mail, as well as a comprehensive monthly report on all regulations under review. ------- |