New NAAQS Review Process

1. New NAAQS Review Process Briefing for EPA Staff Kevin Teichman, ORD and Lydia Wegman, OAQPS April 5, 2007

2. Overview of Today’s Discussion • Purpose of today’s briefing • EPA’s review of the NAAQS review process • Key steps in new NAAQS review process • Role of CASAC in new NAAQS review process • Plans for transition to new NAAQS review process

3. Review of the NAAQS review process • “Top-to-bottom” review of the process by which NAAQS are reviewed and revised was requested by EPA Deputy Administrator Marcus Peacock in Dec. 15, 2005 memo to Bill Wehrum and George Gray • Internal EPA workgroup formed to address key issues and make recommendations on the standard-setting process • Timeliness (i.e., how to complete NAAQS reviews on a 5-year cycle as required by Clean Air Act) • Consideration of the most up-to-date scientific information • Distinctions between scientific and policy judgments • Characterization of uncertainties in scientific and technical information • Meetings held with CASAC, stakeholders, and congressional staff • April 3, 2006 Workgroup report and cover memo from Bill Wehrum and George Gray (http://www.epa.gov/ttn/naaqs/naaqs_process_report_march2006.pdf) • Additional meetings with CASAC and the public in June 2006 • Peacock memo outlining revised process on December 7, 2006 (http://www.epa.gov/ttn/naaqs/memo_process_for_reviewing_naaqs.pdf) • Further modifications to address CASAC concerns outlined in March 2007 Peacock memo

4. New NAAQS review process: Key steps • Planning: Early in the process, NCEA/OAQPS will develop one integrated plan to guide the entire review • Plan will outline schedule, process, and key policy-relevant science issues • Science Assessment: The Criteria Document will be replaced by a more concise evaluation and synthesis of the most policy-relevant science • Science Assessment Support Document (SASD): NCEA’s compilation and characterization of new scientific studies • Integrated Science Assessment (ISA): Drawing from detailed SASD, provides concise evaluation and synthesis of the most policy-relevant science • ORD working to develop and implement process (state-of-the-art electronic database) to identify, compile, characterize, and prioritize new studies • Risk/Exposure Assessment: OAQPS will develop a more concise document, informed by the ISA, that focuses on key results, observations and uncertainties • Policy Assessment/Rulemaking: The Staff Paper will be replaced with an advance notice of proposed rulemaking (ANPR) containing a policy assessment that reflects Agency views, rather than staff views • ANPR will present a range of policy options for standard setting, and will include a description of the underlying interpretation of the scientific evidence and risk/exposure information that might support each option

5. New NAAQS review process Peer-reviewed scientific studies Science Assessment Support Document Integrated Science Assessment: concise evaluation and synthesis of most policy-relevant studies Integrated Plan: timeline and key policy-relevant scientific questions CASAC review and public comment Workshop on science-policy issues Draft ANPR: policy assessment reflecting Agency views on range of policy options and rationales Risk/Exposure Assessment: concise, quantitative assessment focused on key results, observations and uncertainties Review by CASAC and the public EPA advance notice of proposed rulemaking Agency decision making and draft proposal notice Interagency review Public comment period and CASAC review Interagency review EPA final decision on standards Public hearings and comments on proposal Agency decision making and draft final notice EPA proposed decision on standards Interagency review

6. Planning Phase • Historically, NCEA prepared an Air Quality Criteria Document development plan early in the process and OAQPS prepared a NAAQS review development plan later in process (including development plans for the Staff Paper and risk/exposure assessment) • Under the new process, NCEA/OAQPS will begin joint planning for next review immediately following completion of each NAAQS review • NCEA/OAQPS will hold early “kickoff” workshop with external scientists and the public to discuss key policy-relevant science issues (either remaining from last review or newly emerging) that should be the focus of the current review • Following this workshop, NCEA/OAQPS will develop a draft integrated plan to guide the entire review process: • Schedule for review that links the components to ensure effective coordination between NCEA/OAQPS • Key policy-relevant science issues to be focused on in science assessment, risk/exposure assessment, and policy assessment • Criteria for identifying key policy-relevant studies and approach for assessing the weight of the evidence • Approach for considering the evidence and risk/exposure information as basis for assessing policy options • Final integrated plan will reflect input from Agency management, consultation with CASAC, and consideration of public comment

7. Science Assessment • Historically, NCEA prepared a very extensive Air Quality Criteria Document (AQCD), including discipline-specific chapters and an integrative synthesis chapter; OAQPS drew from AQCD to prepare summary of most policy-relevant science in Staff Paper chapters on air quality and health and environmental effects • Under the new process, NCEA will prepare an Integrated Science Assessment (ISA) to provide a more concise evaluation, integration, and interpretation of the most policy-relevant science, including key science judgments that will be used in the risk assessment • ISA will focus on more clearly characterizing the strengths and uncertainties of the available scientific evidence • CASAC will review and the public will have opportunity to comment on two drafts of the ISA • ISA will be supported by comprehensive Science Assessment Support Document (SASD), which will eventually be linked to an electronic database of key studies • Independent panels will review chapters of the SASD • ORD is working toward a continuous process of identifying, compiling and evaluating new scientific studies, supported by this comprehensive database, to ensure that policy decisions are informed by the best and most up-to-date science possible • As appropriate, NCEA may conduct a provisional assessment of new science following publication by OAR of a NAAQS proposal notice

8. Risk/Exposure Assessment • Historically, OAQPS conducted risk and/or exposure assessments based on science in AQCD, consulting with CASAC on a scope/methods plan, presenting key results and uncertainties in Staff Paper chapter(s), with comprehensive documentation in separate technical support document(s) • Under the new process, OAQPS will develop a more concise risk/exposure assessment report focused on key results, observations, and uncertainties • Detailed scope/methods plan will be developed by OAQPS through a coordinated, consultative process with ORD in conjunction with ORD’s preparation of the first draft of the ISA • This approach facilitates concurrent CASAC and public review of: • Underlying scientific judgments and assessment models presented in the first draft ISA • Scope and methods plan that projects how such science judgments would be incorporated into the risk/exposure assessment, how the assessment models would be applied, and how uncertainties would be characterized • Second draft risk/exposure assessment report, including assessment of alternative standard levels, will be informed by and concurrently reviewed with second draft ISA; final assessment will be informed by final ISA • To ensure transparency, risk/exposure assessment report will be supported by comprehensive annexes that include all relevant background information, assumptions, results, and assessments of variability and uncertainty • EPA’s Science Advisory Board staff will strengthen the risk/exposure expertise on CASAC panels

9. Policy Assessment/Rulemaking • Historically, OAQPS prepared policy assessment, reflecting staff views, based on air quality analyses, scientific evidence, and risk/exposure assessments, as Staff Paper chapters on primary and secondary standards • Under the new process, based on final ISA and risk/exposure assessment report, OAQPS will prepare a policy assessment that reflects the Agency’s views, and publish that assessment as an ANPR, which will: • “Bridge the gap” between the Agency’s scientific assessment and the judgments required of the Administrator in determining whether it is appropriate to retain or revise the standards • Identify evidence- and risk-based considerations for reaching policy judgments about the adequacy of current standards, and a range of potential alternative standards that may be appropriate to consider • Describe range of options for standard setting -- including indicator, averaging time, form, and range of levels for any alternative standards -- along with description of alternative underlying interpretations of the scientific evidence and risk/exposure information that could support such alternative standards • CASAC review and advice and public comment on ANPR will inform Agency decision making for proposed rulemaking • Final decision will reflect public comments and any additional CASAC comment/advice on proposed rule

11. Key Collaborative Elements: OAR and ORD • Planning and facilitating kickoff workshop on key policy-relevant scientific issues • Preparing integrated plan • Coordinating risk/exposure assessment scope/methods plan with first draft ISA • Coordinating deliverables to ensure simultaneous CASAC review of overlapping components (ISA drafts and risk/exposure assessment drafts) • Characterizing most policy-relevant science in draft ANPR based on information in ISA • If needed, structuring provisional assessment of new science following notice of proposed NAAQS decision

12. Role of CASAC in new NAAQS review process • CASAC will continue to advise the Administrator on all key elements of the NAAQS review: planning, integrated science assessment, risk/exposure assessment, and policy assessment • In addition, at CASAC’s recommendation, NCEA/OAQPS will hold initial “kickoff” workshop to receive input from experts, including CASAC members, to help the Agency formulate the draft integrated plan which will guide the entire NAAQS review • Each NAAQS review will continue to involve a number of CASAC consultations and reviews, with these reviews involving evaluation of overlapping elements of the review (rather than a somewhat more sequential approach taken in past): • CASAC consultation on draft integrated NAAQS review plan • CASAC review of 1st draft ISA and draft risk/exposure assessment scope/methods plan • CASAC review of 2nd draft ISA and 1st draft risk/exposure assessment • CASAC review and comment on 2nd draft risk/exposure assessment • CASAC review and comment on ANPR • CASAC may also choose to provide additional comments/advice on final documents and on the proposed NAAQS decision

13. Transition to New NAAQS Review Process • Current ozone NAAQS review will not be affected by the new process • Final Staff Paper released January 31, 2007, with staff recommendations • Proposal: June 20, 2007 • Final Rule: March 12, 2008 • Transition to new process has begun with Pb NAAQS review • Final Pb Criteria Document issued September 2006 • 1st draft Staff Paper and Health/Environmental Assessment issued December 2006 • No 2nd draft SP: instead, ANPR to be issued late November 2007 • Proposal: March 2008 • Final Rule: September 1, 2008 • NOx/SOx reviews: workshops in Feb. 2007 (health effects/primary standards) and June 2007 (environmental effects/secondary standards) to discuss key issues and initial draft SASD chapters; followed by ISA, risk/exposure assessment report, policy assessment/ANPR (2009), notice of proposed rule (2009-2010) and notice of final rule (2010) • Next PM NAAQS review: first to fully implement new process (workshop to be held July 2007 to inform development of draft plan)