UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                     WASHINGTON, D.C  20460
                                       0$ £006
MEMORANDUM

FROM:      George Gray
             Assistant Administrator
             Office of Research and Development

             William Wehrum
             Acting Assistant Administrator
             Office of Air and Radiation

TO:          Marcus Peacock
             Deputy Administrator

RE:          Review of Process for Setting National Ambient Air Quality Standards

       On December 15,2005, you requested that we form an Agency workgroup to review the
process the Agency uses in setting the National Ambient Air Quality Standards (NAAQS) and to
provide specific recommendations by April 3, 2006. We are pleased to present you with the
attached workgroup report that reflects extensive and excellent work done by staff from several
offices. In particular, we would like to recognize Lydia Wegman and Kevin Teichman for their
leadership and Karen Martin with much help from Robert Fegley for primary authorship of the
attached report. We also would like to thank the number of current and former Clean Air
Scientific Advisory Committee (CASAC) members and stakeholders who provided their detailed
comments on what works well and what can be improved in terms of the NAAQS review
process. In addition to carefully considering these comments, we have attached meeting
summaries and all written comments.

       The workgroup report summarizes the current NAAQS review process, presents various
options for improving the process, and makes conclusions and recommendations on how to
improve the process.  To organize the internal deliberations and stakeholder comments, we have
focused on answering the four key issues that we identified in our follow-up discussions with
you:
           1. Timeliness of the NAAQS review process;
          2. Consideration of the most recent available science;
          3. Distinctions between science and policy judgments; and,
          4.  Identifying, characterizing, quantifying, and communicating uncertainties in
             scientific information.

       Importantly, this document identifies some of the key tradeoffs and resource implications
that should be considered when reviewing the recommendations and identifies further work that
can be done should you elect to pursue these recommendations.
                  Internet Address (URL) • http://www epa.gov
Recycled/Recyclable • Printed with Vegetable OH Based Inks en Recycled Paper (Minimum 25% Postconsumer)

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       After carefully considering the recommendations put forward by the workgroup, we are
forwarding them on for your consideration with our endorsement. We also recommend the
overall NAAQS criteria and standards review process be considered in the context of four
activities: planning, science assessment, risk/exposure assessment, and rulemaking initiated by
the policy assessment document. These activities are interrelated and in some cases overlap and
proceed on a parallel track. This process will promote the timeliness for setting air quality
standards, provide increased consistency with other Agency rulemakings, and enable a more
thorough review of the latest science on air quality. Our specific recommendations fall into these
four activities:

   •   Planning: The preparation of an integrated, policy-relevant plan as described in the
       workgroup report should immediately follow the completion of the prior NAAQS review.
   •   Science Assessment: The science assessment document should be a more concise
       evaluation, integration, and synthesis of the most policy-relevant science, including key
       science judgments that will be used in conducting the risk and exposure assessments. In
       addition, the Agency should also provide for a more continuous process of identifying
       and evaluating new scientific studies. We recognize that this recommendation is
       potentially resource-intensive and we request additional time to explore how best to
       implement it.
   •   Risk/Exposure Assessment: The risk/exposure assessment document should be more
       concise and include supporting materials in comprehensive annexes. We recommend that
       you ask the Science Advisory Board (SAB) Staff Office to form a CASAC subcommittee
       on  risk/exposure assessments to provide more focused feedback and advice on the
       planning, methodology, and characterization of uncertainties in the risk/exposure
       assessments.
   •   Policy Assessment/Rulemaking: We agree with the workgroup that, provided other
       recommendations are followed, the Staff Paper should be replaced with a more narrowly
       focused policy assessment document. We have concluded that it is appropriate for the
       policy assessment document to reflect the Agency's views, consistent with EPA practice
       in other rulemakings. We believe that serious consideration should be given to furthering
       the public involvement in the rulemaking process by publishing the policy assessment
       document as an Advanced Notice of Proposed Rulemaking, which would also receive
       review by CASAC. It  is important to note that the workgroup report does not make
       recommendations on these two issues.

   If you agree with these recommendations, we can take immediate actions to begin
implementing them.  However, individual components of these recommendations would benefit
from additional consideration, including resource evaluation and further consultation with
CASAC members and the public.

   In closing, we would like  to note that  the NAAQS review process has evolved  over the
course of three decades, and the recommendations presented today represent the most recent
potential refinements to that process. We  thank you for an opportunity to offer these
recommendations.

Attachment

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     Review of the Process for Setting
National Ambient Air Quality Standards
       Prepared by the NAAQS Process Review Workgroup

            for the Assistant Administrators of the
    Offices of Air and Radiation and Research and Development
           U.S. Environmental Protection Agency
                     March 2006

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                             ACKNOWLEDGMENTS

      This report was prepared by the NAAQS Process Review Workgroup, which was formed
at the request of Deputy Administrator Marcus Peacock, U.S. Environmental Protection Agency
(EPA), for the purpose of providing recommendations on the process used by the Agency for
setting National Ambient Air Quality Standards (NAAQS).  Workgroup efforts have been led by
Lydia Wegman, Office of Air Quality Planning and Standards (OAQPS) in EPA's Office of Air
and Radiation (OAR), and Kevin Teichman, Office of Science Policy (OSP) in EPA's Office of
Research and Development (ORD).  Workgroup members include John Bachmann, Karen
Martin, and  Harvey Richmond in OAQPS/OAR; Jason Burnett and Carl Mazza in OAR; John
Vandenberg in the National Center for Environmental Assessment (NCEA)/ORD; Bob Fegley in
OSP/ORD; Gerry Gleason, John Hannon, and Steve Silverman in EPA's Office of General
Counsel (OGC); and Al McGartland in EPA's Office of Policy, Economics, and Innovation
(OPEI).  The workgroup's recommendations presented in this report were prepared for Bill
Wehrum, Acting Assistant Administrator for OAR, and George Gray, Assistant Administrator
for ORD, to help inform their recommendations to the Deputy Administrator.

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                              Table of Contents


List of Figures 	 ii

EXECUTIVE SUMMARY	E-l

1.   INTRODUCTION	1
      1.1    Scope and Approach 	1
      1.2    Statutory requirements for NAAQS reviews	2
      1.3    Historical perspective and previous NAAQS process reviews	3

2.   CURRENTNAAQS PROCESS 	6
      2.1    Key Elements of the NAAQS Process	7
            2.
            2.
            2.
            2.
            2.
            2.
            2.
               . 1  Planning	9
               .2  Science Assessment	9
               .3  Risk/Exposure Assessment 	11
               .4  Policy Assessment	11
               .5  Rulcmaking 	12
               .6  CASAC Review	13
               .7  Public Participation 	14
      2.2    Comments on the NAAQS Process from Outside Parties	15
            2.2.1  Views of Current and Former CASAC Members	15
            2.2.2  Views of Various Stakeholders	17

3.   OPTIONS FOR CHANGES TO THE NAAQS PROCESS 	21
      3.1    Framework for Consideration of Options  	21
      3.2    Options for Changes to the Key Elements	24
            3.2.1  Planning	24
            3.2.2  Science Assessment	25
            3.2.3  Risk/Exposure Assessment  	26
            3.2.4  Policy Assessment	27
            3.2.5  Rulemaking 	28
            3.2.6  CASAC Review	29
            3.2.7  Public Participation 	29

4.   WORKGROUP CONCLUSIONS AND RECOMMENDATIONS	30
Attachment 1: Memorandum from Marcus Peacock to Dr. George Gray and Bill Wehrum
            (December 15,2005)

Attachment 2: Key Questions for the Review of the Process for Setting NAAQS

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Attachments 3-A to 3-E:
             Clean Air Scientific Advisory Committee Members' Comments on the Agency's
             Process for Establishing National Ambient Air Quality Standards

Attachments 4-A to 4-E:
             Summary of Stakeholder Discussions and Individual Stakeholder Comments
                                  List of Figures


Figure 1.     History of NAAQS Reviews: 1970 - present	4

Figure 2.     Current NAAQS Review Process 	7

Figure 3.     Key Functional Elements of Current NAAQS Review Process  	8

Figure 4.     Key Functional Elements in Alternative NAAQS Review Framework 	22

Figure 5.     Timeline for Alternative NAAQS Review Framework	23

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                              EXECUTIVE SUMMARY
       In response to a request from the Deputy Administrator of the Environmental Protection
Agency (EPA), the Assistant Administrators for the Offices of Air and Radiation and Research
and Development formed this intra-agency workgroup to conduct a "top-to-bottom" review of
the process used by the Agency to periodically review and, as appropriate, revise the air quality
criteria and national ambient air quality standards (NAAQS) as required by the Clean Air Act
(CAA). This NAAQS review process has evolved since it was instituted in 1970, with many of
the current features having been in place for over 20 years. The present review is aimed at
examining whether and, if so, how the process can be further strengthened, and at identifying
ways of streamlining the process so that EPA can achieve more timely NAAQS reviews.  We
have concluded that the process can be strengthened and have identified specific
recommendations as summarized below.

       Past reviews of the process have addressed a number of issues, including the difficulty
EPA has had historically in completing NAAQS reviews at 5-year intervals as required by the
CAA, resulting in litigation-driven review schedules; the statutory role of the Clean Air
Scientific Advisory Committee (CASAC) in providing scientific and policy-relevant advice to
the Administrator; concerns about the "encyclopedic" nature of EPA's science assessment
documents (referred to as "Criteria Documents") and support for a more integrative synthesis of
the science; and general support for the introduction and subsequent evolution of a policy-
oriented "Staff Paper" to help bridge  the gap between the  science presented in the Criteria
Document and the policy judgments required of the Administrator in reaching decisions on the
NAAQS.  While many improvements have come about as a result of these past reviews, some of
the same issues remain relevant today, and are addressed again in this process review.

       Consistent with meeting the April 3, 2006 deadline for this report, we focused on the
following  key issues identified as being of most interest to the Deputy Administrator:  timeliness
of the NAAQS review process; consideration of the most  recent available science; distinctions
between science and policy judgments; and addressing uncertainties in scientific information.
To help inform our review, we solicited input from a number of outside parties who have been
actively engaged in the process over time, including all current and former CASAC members,
who were asked to provide their individual views.  While the time frame for this report precluded
broad solicitation of public comments, we did engage  in a limited set of consultations with
representatives of various stakeholder groups, including representatives of industry groups,
environmental and public health groups, States, and the chairs of National Academy of Sciences
(NAS) committees that have addressed NAAQS-related issues.

       For purposes of this review, we have focused on the basic functional elements of the
NAAQS process and on the nature of and linkages between the contents of documents that are
currently prepared as part of the NAAQS review. These key functional elements include
planning, science assessment, risk/exposure assessment, policy assessment, and rulemaking.
Overlaid on these functional elements throughout the process are the involvement of CASAC in
                                          E-l

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providing review and advice on the air quality criteria and the standards and numerous
opportunities for public participation.

       In considering the questions that framed this process review, and taking into account the
views expressed by individual CASAC members and other outside parties, the workgroup
identified a number of options for changing the NAAQS review process. Options were
identified for each of the key functional elements and also addressed CASAC involvement and
public participation in the process. On the basis of our examination of the NAAQS review
process, and considering the resulting options for change, we have reached several key
conclusions, as summarized below:

       »•     Past NAAQS reviews demonstrate that, in the absence of unusual developments,
             it is possible to complete the current process for reviewing a NAAQS within the
             statutory 5-year review cycle.  However, the likelihood that the process will be
             completed in that time frame, in the absence of court-imposed schedules, can be
             increased by making changes that generally create a more policy-relevant focus
             and a more internally coordinated, consultative approach to each of the process
             elements.

       >     NAAQS decisions could be based on more recent science than has historically
             been available for consideration by adopting changes that provide a continual
             compilation/evaluation of science, enhance linkages between science and risk/
             exposure assessments, facilitate reaching proposed policy decisions as quickly as
             possible after the completion of those assessments, and expedite provisional
             assessment of "new" science, when appropriate, during the rulemaking process.

       ••     Distinctions between science and policy judgments made by EPA and by CASAC
             throughout the NAAQS review process can be clarified and made more
             transparent, in part, by adopting changes that facilitate the preparation and review
             of a policy assessment document that is based on, but separate from, the science
             and risk/exposure assessments.

       »•     Changes that enhance the linkages between the preparation of the science
             assessment and risk/exposure assessment, which in turn would enhance the
             linkages between CASAC reviews of these two documents, can also help to
             ensure that more complete, policy-relevant characterizations of uncertainties are
             incorporated into these assessments.

       To effect these improvements, we recommend implementing changes to the NAAQS
process, as summarized below. The extent to which the projected improvements are likely to be
realized depends not only on which changes and related options are adopted, but also on the
extent to which adequate resources and continued management support are provided for the
effective and ongoing implementation of any such changes.
                                         E-2

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Combine the current separate planning activities into the preparation of one
integrated planning document that focuses the science, risk/exposure, and policy
assessments on a set of policy-relevant issues.  This plan should maximize the
amount of time allotted to the science and risk/exposure assessments; more
closely link these assessments through a more coordinated, consultative process;
minimize the time between the completion of these assessments and reaching
proposed decisions on the NAAQS; and allow for provisional assessment of
"new" science, as appropriate, during the rulemaking process.

Restructure the science assessment document to be a more concise evaluation,
integration, and synthesis of the most policy-relevant science (with
comprehensive annexes with generally descriptive information), and to include
key science judgments that are integral to the risk/exposure assessments.  This
document should present the synthesis of policy-relevant science not only for a
scientific audience, but also in language that will be understood and meaningful
to policy makers, perhaps in the form of a "plain-English" executive summary.

Develop and implement a continuous process to identify, compile, characterize,
and prioritize new scientific studies with the assistance of state-of-the-art
electronic databases developed by the Office of Research and Development.
Recognizing that the development of such a system is complex and potentially
resource-intensive, we believe that additional time is needed to explore various
approaches, options, and resource requirements for its development.

Develop a more concise risk/exposure assessment document focused on key
results, observations, and uncertainties (similar to the risk/exposure chapter(s)
that are now included  in Staff Papers), with comprehensive annexes that include
all relevant information, assumptions, results, and assessments  of variability and
uncertainty (similar to the information now included in contractor reports).

To the extent that the changes recommended above are adopted and effectively
implemented, replace  the Staff Paper with a more narrowly focused policy
assessment document, based on the science and risk/exposure assessments and
including policy-relevant air quality analyses.  This document could focus on
identifying approaches for reaching policy judgments; considering the adequacy
of the current standards and whether alternative standards should be assessed for
consideration; and identifying a range of options for alternative standards (in
terms of indicators, averaging times, forms, and ranges of levels) that might be
considered by the Administrator in making policy choices.  We recognize that
important and complex issues are involved in deciding the scope of such a
document; whether such a document would continue to reflect  staff views, EPA
senior management views, or both; and how that choice  may affect the process by
which such a document would be reviewed by CASAC and the public.
                             E-3

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       ••      Work with the Science Advisory Board (SAB) Staff Office to consider the
             formation of a CASAC subcommittees on risk/exposure assessment, when
             appropriate; to examine additional measures that can be taken to orient new
             CASAC panel members; and to give further consideration to the issue of CASAC
             "closure" in its review of key documents.

       We also offer additional recommendations for continuing this examination of the
NAAQS process beyond April 3, 2006, as summarized below:

       »•      Continue a dialogue with the public in the coming months on the issues addressed
             in this review of the NAAQS process.

       »      Continue to examine more specific options for implementing those changes that
             are adopted, or that remain under consideration, as well as their organizational,
             staffing, and resources implications.

       »      More broadly, consider the organizational and resource implications for EPA of
             coordinating and conducting reviews of all NAAQS on 5-year cycles, and work
             with the SAB Staff Office to consider the implications of constituting CASAC
             Panels and managing the CASAC review process for all such NAAQS reviews.
                                        E-4

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                                1.   INTRODUCTION
      On December 15, 2005, the Deputy Administrator of the Environmental Protection
Agency (EPA) asked the Assistant Administrators for the Offices of Air and Radiation (OAR)
and Research and Development (ORD) to conduct a "top-to-bottom" review of the process used
to periodically review and, as appropriate, revise the air quality criteria and national ambient air
quality standards (NAAQS), as required by sections 108 and 109 of the Clean Air Act
(Attachment 1). The principal purpose of this review was to ensure that the best available
science guides and informs decision making within EPA. Although previous reviews of the
NAAQS process have led to significant changes and improvements, many of its current features
have been generally  followed for over 20 years. The present review is aimed at examining
whether and, if so, how the process can be further strengthened, and at identifying ways of
streamlining the process so that EPA can achieve more timely NAAQS reviews.

1.1    Scope and Approach

      To carry out this review, an intra-agency workgroup was formed and charged with
preparing a report on the NAAQS process to include specific recommendations for possible
changes to that process. Our workgroup recommendations are intended to help inform the
recommendations to be made by the Assistant Administrators for OAR and ORD to the Deputy
Administrator, as requested, by April 3, 2006.  In defining the scope for this review, consistent
with meeting this deadline, we prepared a set of key questions to focus the review on those
issues identified by the Deputy Administrator as being of particular interest (Attachment 2).

      To help inform our workgroup's examination of the current NAAQS process, we have
solicited input from a number of outside parties who have been actively engaged in the process
over time. In recognition of the statutory role that the Clean Air Scientific Advisory Committee
(CASAC) plays in the NAAQS review process, and the unique perspective that members of
CASAC have on the process, we invited all current and former CASAC members to provide
their individual views on the current process. Using the set of key questions to help focus their
responses, we asked them to identify what is currently working well and what recommendations
they might have to improve the process for achieving a  comprehensive and timely review of the
NAAQS.  While the time frame initially allotted for this review precluded the solicitation of
broad public comments at this time, we engaged in a limited set of consultations with
representatives of various stakeholder groups that have  been actively involved in NAAQS
reviews.  We invited representatives of industry groups, environmental and public health groups,
States, and the chairs of National Academy of Sciences (NAS) committees that have addressed
NAAQS-related issues to participate in teleconference meetings with us that focused on the set
of key questions and to provide written comments.

       While our workgroup defined the scope and approach used to conduct this review so as to
meet the immediate goals and deadline set by the Deputy Administrator, we also recognized that
efforts to review the NAAQS process beyond that date could well be worthwhile. This report
presents a set of general conclusions and recommendations for possible changes to the NAAQS

                                           1

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process, but additional time would be needed to more fully explore the implications of various
options that have been identified. In addition, we recognize the potential value in extending the
scope of this effort beyond looking at the process for conducting the review of the NAAQS for
any individual pollutant to more broadly considering the implications of a process that would
ensure meeting the statutory 5-year review cycle for all of the NAAQS pollutants. Further, we
note that continuing this effort beyond April 3, 2006 would allow time for broader input from
interested parties and for examining processes used by other organizations to conduct complex
science-based assessments.

1.2    Statutory requirements for NAAQS reviews

       The Clean Air Act (CAA) calls for EPA to issue and periodically review air quality
criteria (AQC) and NAAQS for the "criteria" pollutants that now include particulate matter
(PM), ozone (O3), carbon monoxide (CO), sulfur dioxide (SO2), nitrogen dioxide (NO2), and lead
(Pb).  Section 108 of the CAA requires that EPA issue AQC for each criteria pollutant and that
the AQC "accurately reflect the latest scientific knowledge useful in indicating the kind and
extent of all identifiable effects on public health or welfare which may be expected from the
presence of such pollutant  in the ambient air, in varying quantities." The AQC are to include
information on:
       »      "those variable factors (including atmospheric conditions) which of themselves or
              in combination with other factors may alter the effects on public health or welfare
              of such air pollutant;"
       »      "the types of air pollutant which, when present in the atmosphere, may interact
              with such pollutant to produce an adverse effect on public health or welfare;" and
       »•      "any known or anticipated adverse effects on welfare."

       Section 109 of the CAA requires that EPA issue  primary and secondary NAAQS for each
criteria pollutant, as appropriate.  Primary (health-based) NAAQS are to be ambient air quality
standards which in the judgment of the Administrator, based on the AQC and allowing an
adequate margin of safety, are requisite to protect public health.  The courts have ruled that such
primary standards are not intended to be  "risk free," nor are they to be based on the cost
associated with their implementation. The standards must be requisite to protect public health,
allowing for an adequate margin of safety. They must be sufficient but not more than necessary
to meet this criterion, requiring the Administrator to make judgments of degree.  Making this
determination requires public health policy judgments as to what level of air quality is required
to protect sensitive groups  within the population, although not the most sensitive individual
within that group, from adverse health effects.  The approach to providing an adequate margin of
safety is a public health policy choice left to the Administrator's judgment.  Secondary (welfare-
based) NAAQS are to specify a level of air quality which in the judgment of the Administrator,
based on the AQC, is requisite to protect the public welfare from any known or anticipated
adverse effects. Welfare effects as defined by the CAA  include effects on vegetation, crops,
soils, water, wildlife, man-made materials, and visibility, among others.

       Section 109 of the CAA also requires EPA to review the AQC and NAAQS at 5-year
intervals, and to make such revisions in the AQC and NAAQS and promulgate such new

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NAAQS as may be appropriate. Section 109 further requires that EPA appoint an independent
scientific review committee to be composed of seven members that include at least one member
of the NAS, one physician, and one person representing State air pollution control agencies.
This committee, the Clean Air Scientific Advisory Committee (CASAC), is required to complete
a review of the AQC and NAAQS at 5-year intervals and to recommend to the Administrator any
new NAAQS and revisions of existing AQC and NAAQS as may be appropriate.  Section 307 of
the CAA requires that EPA explain in the rulemaking the reasons for any differences between
proposed or final NAAQS and CASAC recommendations.

       Another statute, the Environmental Research, Development, and Demonstration
Authorization Act of 1978 (ERDDAA), which established EPA's Science Advisory Board
(SAB), applies to the review of the NAAQS under the CAA as well as more broadly to standards
set under several other EPA statutes. Under ERDDAA, the Administrator is to make available to
the  SAB any proposed criteria document or standard  at the time it is provided to any other
Federal agency for formal review and comment. Further, the SAB may make available to the
Administrator, within the time specified by the Administrator, its advice  and comments on the
adequacy of the scientific and technical basis for any proposed criteria document or standard.
The EPA has historically relied upon the review process conducted by CASAC, which is
administered by EPA's SAB Staff Office, to address these ERDDAA provisions.

1.3     Historical perspective and previous NAAQS process reviews

       A general overview of the history of setting and reviewing NAAQS is shown in Figure 1.
The initial NAAQS were set in 1971, as required by CAA amendments in 1970, for O3, PM, SO2,
NO2, CO, and hydrocarbons (HC), based on air quality criteria completed in 1969. The original
requirement for periodic reviews of the air quality criteria and NAAQS was modified to specify
5-year intervals by the CAA amendments of 1977. In 1976, EPA laid out a schedule to review
all of the NAAQS, with review of O3 first (1976-79), followed by NO2, HC. and CO (1977-
1985). The PM and SO2 reviews, initiated in 1979, were linked through  an integrated review of
the PM/SO2 air quality criteria, although decisions on the PM and SO2 standards were made
separately. New PM standards were promulgated in  1987, even as review of the primary SO2
standards continued. An initial review of Pb was started in 1975, and lead standards were first
set  in 1978.

       In the 1980s, EPA initiated new reviews of the O3, NO2, CO, and Pb standards within
about 1 to 2 years of the previous decisions. Ozone and Pb reviews began in the early 1980's.
The O3 review concluded in 1993 (under court order) with a decision not to revise the NAAQS,
but to accelerate the next review as much as possible to consider new scientific studies that had
become available  since completion of the revised air quality criteria for O3.  The Pb review
ended in 1991  without a published rulemaking decision, but with the Agency's announcement
and implementation of an integrated lead strategy that focused on other sources of lead
exposures, reflecting the dramatic decrease in airborne lead resulting from the phaseout of leaded
gasoline. The CO and NO2 reviews began in the late 1980s and were completed in the mid-
1990s with decisions to reaffirm the standards.

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1970 1980 1990 2000 2010
Ozone
PM
SO2: Primary
Secondary
N02
CO
Pb
HC
1
1
1 1 1 1 1 1 1 1 1
Revise
__4 _
•^ •
»4 •
•^ •
Revoke
Annual

New
1 1 1 1 1 1 1 1 1
1 1 1 1 1 1 1 1 1

Revise


Reaffirm
Revoke'
Secondary

Revoke
1 1 1 1 1 1 1 1 1
1 1 1 1 1 1 1 1 1
Reaffirm Revise
Revise
Reaffirm
p LILTr . .
Keattirm
Reaffirm
p T|» 	
Keanirm
No change
1 1 1 1 1 1 1 1 1
1 1 1 1 1 1 1 1 1
^_ ^w
	 >
	 >
— -->
On hold
1 1 1 1 1 1 1 1 1

• | Notice of Final Decision • > Court-ordered Deadline — — >Deadlme litigation
for Future Final Decision ongoing
Figure 1.     History of NAAQS Reviews: 1970 - Present
       EPA initiated new reviews of the standards for O3, PM, and CO in the 1990s, and the
ongoing reviews of the SO2 primary and secondary standards were completed in the mid-1990s
(although the Agency is continuing to consider the primary SO2 standard in response to a remand
of that decision). The new O3 and PM reviews began in  1993 and the review schedules were
linked in the expectation that if the standards for both pollutants were revised, promulgating
those revisions at the same time could facilitate the development of integrated implementation
strategies. New O3 and PM standards were promulgated on the same day in 1997 (pursuant to a
court-ordered schedule).  The CO review was put on hold  in 2000 while a Congressionally
mandated NAS study of CO-related issues was conducted, and that review has not yet been
completed.

       Following the 1997 O3 and PM decisions, EPA initiated a new PM review within months,
and started a new O3 review  in  2000. These staggered PM and O3 schedules were established so
that the ozone review could benefit from the review of new epidemiologic studies that addressed
both PM and O3 in the context of the PM criteria review, and also  reflected EPA resource
limitations that precluded starting both reviews at the same time. Both reviews  have been
substantially extended due in part to protracted litigation involving the 1997 decisions (final
resolution of which did not occur until 2002 when the U.S. Court of Appeals for the D.C.
Circuit, on remand from the Supreme Court, upheld both standards), and in part to the need to
account for new findings regarding statistical methodology, which required reanalysis of a

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number of epidemiological studies in 2002. In addition, there has been an unprecedented
volume of new scientific studies on PM due in large part to the substantial increase in PM
research funding mandated by Congress during this time. The schedules for the PM and O3
reviews are now governed by a court order, calling for completion of the PM review by
September 2006 and of the O3 review by the end of 2007.  A new Pb review was initiated in
2004 in response to litigation, and a court order calls for completion of that review in 2008. The
schedules for the NO2 and SO2 reviews are now the subject of litigation.

       Over the last 25 years, many reviews of the NAAQS process have been undertaken both
by EPA and CASAC, leading to a number of changes and significant improvements. A former
CASAC chair published an article in 1987 that presented an overview of reviews done to that
date, discussed how the NAAQS process had evolved in part in response to those reviews, and
offered additional recommendations for further changes to improve the process.1 These past
reviews of the process have addressed a number of issues, including the difficulty EPA has had
historically in completing NAAQS reviews at 5-year intervals, resulting in litigation-driven
review schedules; clarification of the role of CASAC in reviewing the AQC and the NAAQS and
in providing scientific and policy-relevant advice to the Administrator; concerns about the
"encyclopedic"  nature of EPA's science assessment document (referred to as "Criteria
Documents") and support for a more integrative synthesis of the  science; and general support for
the introduction in the early  1980s and subsequent evolution of a policy-oriented "Staff Paper" to
help bridge the  gap between the science presented in the Criteria Document and the policy
judgments required of the Administrator in reaching decisions on the NAAQS.  While many
improvements have come about as a result of these past reviews, some of the same issues remain
relevant today, and are addressed again in this process review.
       'Lippmann, Morton (1987) Role of Science Advisory Groups in Establishing Standards
for Ambient Air Pollutants.  Atmospheric Science and Technology 6:93-114.

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                          2.  CURRENT NAAQS PROCESS
       The current process for periodic review of the AQC and NAAQS, as it has evolved over
the years, is typically described by reference to a series of sequential activities that starts with the
publication of scientific studies in peer reviewed journals and ends with final EPA decisions on
the standards. A frequently used flow chart (Figure 2) highlights key steps and products in the
process, including the preparation and review of two documents: (I) an ORD Criteria
Document, a comprehensive characterization and integrative assessment of relevant scientific
studies; and (2) an OAQPS Staff Paper, which identifies the most policy-relevant science drawn
from the Criteria Document, presents results from quantitative risk and/or exposure assessments,
describes how the science and risk/exposure assessment results can be considered as a basis for
making decisions on whether to retain or revise the standards, and includes staff conclusions and
recommendations  regarding the key components of an air quality standard - indicator, averaging
time, statistical form, and level. Since 1980, these recommendations have been in the form of
ranges of alternative standard options for the Administrator's consideration. Early steps in the
preparation of the  Criteria Document broadly involve the scientific community, including
workshops with scientific experts that are open to the public, and reviews by CASAC and the
public are part of the development of the Criteria Document, Staff Paper, and related risk and/or
exposure assessment reports.  In conducting these reviews, the seven-member CASAC is
supplemented with additional subject-matter experts, as appropriate, forming a CASAC Review
Panel, to address the range of scientific information and issues that are expected to be important
in any given review. The Agency then initiates notice-and-comment rulemaking, based on the
information in the Criteria Document, Staff Paper, and quantitative risk and/or exposure
assessments, after an interagency review process. The rulemaking  includes both a public
comment period and public hearings. EPA takes the comments received through this process
into consideration in reaching final decisions on the NAAQS.

       In the current process, the information presented in the Criteria Document, as well as the
related risk and/or exposure assessments and some of the information included in the Staff Paper
address the statutory provisions requiring EPA review and, as appropriate, revision of AQC.
The statutory provisions requiring CASAC review and recommendations to the Administrator
concerning appropriate revisions of existing AQC and NAAQS are addressed through CASAC's
reviews of drafts of the Criteria Document and Staff Paper.  The final documents, taken together,
present an updated assessment of the science as well as a policy assessment leading to staff and
CASAC recommendations on alternative standards for consideration by the Administrator.

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  Scientific studies
  related to health and
  environmental effects
  Scientific peer review
  of published studies
EPA Criteria Document
mtegrative assessment of
scientific studies
                              1L
EPA Staff Paper policy-relevant
science and nsk assessments,
staff recommendations on ranges
of standards for consideration
 Workshops involving
 scientific community
 and reviews by
 CASAC and the public
    Reviews by CASAC
    and the public
                                                                              EPA
                                                                            proposed
                                                                           decision on
                                                                            standards
Figure 2.     Current NAAQS Review Process
2.1    Key Elements of the NAAQS Process

       For proposes of this review, we have prepared a somewhat different chart that focuses on
the basic functional elements of the NAAQS process and on the nature of and linkages between
the contents of documents that are currently prepared as part of the NAAQS review (Figure 3).
The time frames typically allotted to each of these elements within a generic 5-year review cycle,
and the extent to which work on these documents is done concurrently or sequentially, can vary
substantially from one review to another. Differing time frames for these elements and
documents come about, for example, as a result of differences in the volume and nature of the
new science available in any given review,  differences in the nature and complexity of the issues
that must be addressed, and differences in the scope and nature of any risk and/or exposure
assessments conducted, as well as from constraints arising from litigation and agency staffing
and budget limitations.

       As discussed below, the key functional elements are identified as planning, science
assessment, risk/exposure assessment, policy assessment, and rulemaking.  Overlaid on these
functional elements throughout the process are the involvement of CASAC in providing review
and advice on the AQC and standards and numerous opportunities for public participation.

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       Planning
       Science
    Assessment
   Risk/exposure
    Assessment
       Policy
    Assessment
    Rulemaking
  CD Development Plan
 • Comprehensive set of
 topics
 • CASAC/public review
> Criteria Document (CD)
• "Encyclopedic" iterative
drafts [or more evaluative
chapters with detailed
descnptive annexes]
• CASAC/public reviews until
CASAC "closure" [or EPA
decides to close, potentially
with additional CASAC
advice on final document]
• Final document
     NAAQS Review Plan
 • Process and schedule for
 entire review
 • Projected scope or air quail
 and nsk/exposure assessment!
 • Outline of SP contents
 • CASAC/public review
     Risk/exposure
  Assessment Reports
• Detailed scope/methods
plan based on studies in CD
• CASAC/public review
• Sequential drafts of phases
of assessment (and
supporting staff memos)
• CASAC/public review
• Final assessment reports


  Staff Paper (SP)
 • Policy-relevant air quality
 analyses building upon CD
 (anasupportng staff memos)
 • Synthesis of policy-relevant
 science drawn from CD
 • Summary and key results
 from nsk/exposure
 assessments
• Approach to evidence- and
risk-based policy assessment
• Staff policy assessment
and recommendations for
ranges of alternative
standards
                                          • Iterative drafts with addition of final phase of risk/exposure
                                          assessments and staff recommendations
                                          • CASAC/public reviews until CASAC "closure" with advice on
                                          standards Tor EPA decides to close, potentially with additional
                                          CASAC advise on final document]  .
                                          • Final document                I	
      Proposal Notice
• Substantially drawn from SP
text and CASAC advice
• Interagency review
• Administrator's rationale for
proposed decisions,
• Reasons for any differences
from CASAC recommendations

   Post-Proposal Actions
• Public heanngs and comments
• Potential for additional CASAC
advice
• Ad hoc provisional assessment
of "new" science
• Document responding to all
significant comments

      Final Notice
• Summary of responses to
significant comments
• Consideration of "new"
science assessment
• Interagency review
• Administrator's rationale for
any changes to proposal
Figure 3.     Key Functional Elements of Current NAAQS Review Process

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       2.1.1  Planning

       At the beginning of a NAAQS review, under the current process the first planning
document, prepared by NCEA/ORD, is a Development Plan for the Criteria Document. This
plan is a comprehensive set of scientific topics and issues that are likely to be relevant for a
review of the AQC for the pollutant in question. The plan also discusses the organization of the
prospective Criteria Document, identifies key authors for each of the subject-specific chapters,
and provides a projected schedule that includes iterative reviews of draft documents by CASAC
and the public. A draft of this plan is the subject of a public consultative meeting with CASAC
that generally occurs before the full CASAC Review Panel is formed, such that the broader
group of experts who will be reviewing the draft Criteria Document generally do not have an
opportunity to comment on the development plan.

       A second planning document is prepared generally around the time that the first draft of
the Criteria Document is being developed. This NAAQS Review Plan, prepared by
OAQPS/OAR, discusses the overall process and schedule for the review of the AQC and the
NAAQS.  It discusses in general terms initial plans for various quantitative assessments,
including air quality analyses, human health exposure and risk assessments, and any
environmental assessments that may be done, and focuses on the policy-relevant issues that the
Staff Paper will address. These policy-relevant  issues are related most generally to the choices
that need to be made in deciding whether to retain or revise the current NAAQS, including
choices about the indicators, averaging times, forms, and levels of the primary and secondary
NAAQS.  This plan is typically the subject of a consultation with the CASAC Review Panel and
public comments are solicited.

       2.1.2   Science Assessment

       In  this report, the term "science assessment"  refers to a range of activities that includes
the identification of peer-reviewed publications  related to the pollutant  in question in the
scientific literature, the description and evaluation of these studies' methods and findings, and
the synthesis of the entire body of evidence to develop an integrated, generally qualitative
assessment designed to inform the central policy-relevant issues. The results of the science
assessment serve as the foundation for the subsequent quantitative risk/exposure and policy
assessments.

       In the current process, the bulk of the science assessment activities are undertaken by
NCEA in the development of the Criteria Document. Using the Criteria Document Development
Plan as a guide, EPA convenes a series of technical workshops to bring together experts from
throughout the scientific community to discuss important scientific and technical issues
identified in that plan. These public workshops are designed to help focus the presentation of
each subject-specific chapter in the Criteria Document on the key issues.  Before the workshops,
lead authors (typically academics under contract to EPA) are identified for each of these chapters
and asked to prepare initial draft materials to frame the workshop discussions. These chapters are
generally organized by academic discipline, such as air quality, epidemiology or toxicology, and

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have typically been comprehensive and "encyclopedic" in nature.2 In addition to these subject-
specific chapters, EPA staff also prepares an integrative synthesis chapter that brings together
information from the various disciplines to reach conclusions that are central to the review, for
example, about the extent to which the weight of the evidence supports inferences  of causality in
the relationships between various health-related endpoints and exposures to the pollutant in
question and about the subpopulations that are likely at increased risks for various  health effects.

       After initial chapters are drafted by lead authors and reviewed by EPA staff, they are
released for CASAC and public review.  Under the current process, this first External Review
Draft of the Criteria  Document may not contain an integrative synthesis chapter. After receiving
CASAC and public comments, lead authors, working with NCEA staff, revise the draft chapters
as appropriate. In addition, NCEA staff develop an integrative synthesis chapter based on the
conclusions from the individual chapters and the comments received to date. Following internal
review, the resultant Second External Review Draft of the Criteria Document is released for
CASAC and public review, following which final changes are made to the document to address
comments received.  In some cases, NCEA has prepared additional drafts (e.g., four drafts of the
most recent PM Criteria Document, with further iterations on certain chapters, including the
integrative synthesis), or, if significant time has elapsed since the cut-off date for studies to be
included in the Criteria Document, EPA has sometimes prepared a Supplement or Addendum
that evaluates new science (e.g, as was done in the mid-1980s for the PM/SO2 and CO Criteria
Documents).

       While the science assessment is primarily presented in the Criteria Document, that
document has generally been written for a scientific audience rather than being oriented toward
policy makers. To help bridge the gap between the scientific information, as conveyed in the
Criteria Document, and the judgments required in making policy decisions on the NAAQS, an
integrated presentation of the most policy-relevant scientific information is included in the Staff
Paper in terms that are intended to be understandable and meaningful for policy makers and a
broad public audience. This activity essentially winnows down the voluminous material in the
Criteria Document to address the critical needs of decision makers in addressing issues central to
promulgating a NAAQS, including in particular issues related to choosing the indicator,
averaging time, statistical form, and numerical level for each standard. This policy-oriented
presentation of scientific information is distinct from the other two major functions of the Staff
Paper:  (1) reporting the major findings of the risk/exposure assessment and (2) the integration of
scientific evidence and quantitative risk-based information into a policy assessment upon which
staff-recommended ranges of specific policy options and alternative standards, as appropriate,
are based. These latter two functions are described in  the following sections.
       Consistent with recommendations from past NAAQS process reviews, NCEA departed
from preparing an "encyclopedic" set of chapters with its most recent Ozone Criteria Document,
in which comprehensive descriptive materials were presented in a series of annexes, with the
main body of the document being much more concise and evaluative in nature.

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       2.1.3   Risk/Exposure Assessment

       Based on the information in the science assessment, OAQPS typically conducts
quantitative assessments of public health risks, human exposures, and/or risks, exposures, and
impacts on the environment.  Together with the information in the Criteria Document, an issue-
oriented discussion in the Staff Paper presents the foundation and criteria for decisions about the
scope and methods to be used in the assessments.  To obtain input on the scope and methods
prior to conducting the assessments, OAQPS prepares a detailed Scope and Methods Plan for
each assessment that builds upon the general plan included in the initial NAAQS Review Plan.
This detailed plan is the subject of consultation with CASAC and is made available for public
review and comment.

       The Scope and Methods Plan addresses various aspects of the assessment design,
including the selection of categories of effects, geographic study areas, and sensitive populations
for which EPA will do a quantitative assessment.  This plan also addresses key methodological
issues related to: developing estimates of background air quality levels; approaches to
simulating air quality levels that would meet the current standard and an appropriate range of
possible alternative standards; various aspects of selecting appropriate concentration- and/or
exposure-response functions;  quantifying relevant baseline incidence rates and sensitive
populations; and approaches to characterizing uncertainty and variability across all the elements
of the assessment.

       Taking into account CASAC advice and public comments on the plan, OAQPS directs
work on the assessments, typically using contractors to carry out the main components and to
prepare complete documentation in the form of contractor-authored reports. OAQPS staff then
prepares for inclusion in the Staff Paper an overview of the assessment, a discussion of the
criteria and assumptions that led to the assessment design and selection of scope and methods,
and a presentation of the results and key observations with a focus on the uncertainties and
variability in the assessment results. The contractor reports serve as technical support
documents for the presentation of the risk/exposure assessments in the  Staff Paper

       The risk/exposure assessments  are reviewed  by CASAC and the public through review of
iterative drafts of both the Staff Paper and the technical support documents. The first drafts
typically contain the first phase of the assessment results which include risk/exposure estimates
associated with recent ambient air quality levels and estimated risk/exposure reductions
associated with just meeting the current NAAQS. The second drafts typically also contain  the
second phase results which include risk/exposure estimates associated with just meeting
alternative standards identified by OAQPS staff based on the information in the science
assessment and the results of the first phase of the risk/exposure assessment.

        2.1.4  Policy Assessment

        The primary purpose of the OAQPS Staff Paper (subtitled: Policy Assessment of
Scientific and Technical Information) is to evaluate  the policy implications of the scientific
information contained in the Criteria Document and the results of the quantitative risk/exposure

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assessments.  In addition to the sections of the Staff Paper that discuss the science and
risk/exposure information, there is also a section that presents air quality analyses conducted by
staff that help to interpret that information in a policy-relevant context.  These sections serve as
the basis for subsequent sections that discuss approaches to evaluating whether the current
NAAQS are adequate or whether any revisions are appropriate, and to developing staff
recommendations on the elements of possible alternative standard options (in terms of the
indicator, averaging time, form, and ranges of levels) for consideration by the Administrator.
This policy assessment seeks to identify a broad range of reasonable approaches for taking into
account both evidence-based (e.g., epidemiologic evidence in the form of short- and long-term
exposure studies)  and quantitative risk-based considerations in reaching policy judgments about
the current and possible alternative standards. Public health policy judgments about standards
that are requisite to protect public health with an adequate margin of safety generally involve
consideration of a number of factors, such as the nature and severity of the health effects
involved, the degree to which those effects are judged  to be adverse, the nature and size of the
sensitive population(s) at risk, and the kind and degree of uncertainties that must be addressed.
Characterization and consideration of the various types of uncertainties that are inherent in any
such assessment are highlighted, including both qualitative uncertainties about the likelihood
that reported associations are causal in nature and quantitative uncertainties in estimated risks
that reflect not only statistical confidence intervals but also the sensitivity of results to different
modeling approaches and to underlying  assumptions.

       Under the  current process, this policy assessment includes staff recommendations, and
the associated rationales, as to whether the Administrator should consider retaining or revising
the current NAAQS, and if appropriate,  what alternative standard options and ranges of levels he
might consider. Such recommendations are based on various types  of judgments about the
scientific evidence, quantitative risk and/or exposure estimates, and alternative ways  to weigh
uncertainties in making policy choices.  A summary of key uncertainties and research
recommendations related to setting NAAQS are included at the end of the policy assessment to
help inform the next review.  Iterative drafts of this policy assessment are reviewed by CASAC
and the public as part of their review of the Staff Paper, providing an opportunity for input on the
range of policy-relevant judgments that  will need to be made by the Administrator in reaching
his proposed NAAQS decisions.

       2.1.5  Rulemaking

       The rulemaking process begins with the preparation of a notice of proposed rulemaking
(NPR), which is based on the information in the Criteria Document  and Staff Paper and on
CASAC advice and recommendations, with consideration also given to input received from
stakeholders and through an interagency review process. Interagency review is a mechanism
that provides other federal agencies, including the Office of Management and Budget (OMB), an
opportunity to review and comment on a draft proposal notice, with comments received during
this process being placed in the public docket for the rulemaking. The preamble discussion in
the NPR draws heavily from text in the final Staff Paper and  further articulates the
Administrator's rationale for his proposed decisions on the NAAQS. These decisions include
whether the standards should be retained or revised, and if the proposal is to revise them, what

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revised standards are requisite to protect public health with an adequate margin of safety and
what secondary standards are requisite to protect public welfare from known or anticipated
adverse effects. To the extent that any of these decisions differ from advice received from
CASAC, the reasons for the differences are clearly explained in the preamble. In addition to
soliciting comment on all aspects of the Administrator's proposed decisions, the proposal notice
often solicits comments more broadly on a range of alternative standards that may have been
recommended by CASAC or advocated by other parties, or on alternative interpretations of the
underlying scientific information that may have been advanced by other parties.

       Following publication of the NPR in the Federal Register, a public comment period is
provided that typically extends for at least 90 days.  During this time, public hearings are
generally held to provide opportunities for interested parties  to present their comments on the
proposed rule in person to agency officials as well as in written comments.  There have been
instances in which CASAC has met during this period to review the proposed decisions and
provide further advice to the Administrator. All comments received during this comment period
are placed in the public docket, including transcripts of public hearings, and are considered by
the Agency in reaching final decisions.  If relevant "new" scientific studies (i.e , studies not
published in time to be included in the Criteria Document) are identified by the Agency or
submitted in public comments, EPA may provisionally assess them, as appropriate, so that the
Administrator is aware of the latest scientific information before reaching a final decision.

       Based on a consideration of all significant comments received during  the comment
period, and with an awareness of the latest scientific information, the Administrator reaches final
decisions on the NAAQS. The preamble to the notice of final rulemaking (NFR) articulates the
Administrator's rationale for his final decisions and summarizes the most significant comments
on the proposed rule and the Agency's responses to them. All significant comments and
responses are documented more fully in a separate document that is placed in the public docket.
These responses may draw upon any provisional assessment of "new" science that may have
been done to provide a more up-to-date context for considering  specific comments, although the
provisional assessment has not been relied upon as a basis for the final decisions.  The draft NFR
also goes through interagency review. Upon completion of this process, the final rule is
promulgated and the NFR is published in the Federal Register.

       2.1.6   CASAC Review

       As is clear from the above discussions of each NAAQS review element, CASAC plays a
central role throughout the review of the AQC and NAAQS. Through its public consultations
with EPA staff on draft review and assessment plans, and its review and advice and
recommendations on iterative drafts of the Criteria Document, Staff Paper and related
risk/exposure assessments, CASAC fulfils its statutory responsibilities to review the AQC and
NAAQS and to provide advice to the Administrator on any revisions to the AQC and NAAQS as
may be appropriate.

       The process by which CASAC reviews these documents and provides its final advice to
the Administrator has for many years included the step of CASAC reaching "closure" on both

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the Criteria Document and Staff Paper, as reflected in a "closure" letter to the Administrator.
That is, CAS AC "closes" its review of each of these documents when it deems that the document
is adequate for use as a basis for reaching decisions on the NAAQS.  By continuing to revise and
make additional drafts of these documents available for CASAC and public review until CASAC
reaches "closure," EPA has sought to implement a process that produces high quality
assessments and that makes CASAC's advice and recommendations clear and transparent. On
the other hand, this CASAC "closure" step can lengthen the time to complete the review, in some
instances beyond court-ordered deadlines. In such instances, EPA has at times requested from
the court an extension in the schedule to allow for additional review. However,  in the case of the
most recent Staff Paper for PM, for example, EPA determined that it was appropriate to publish
a final document that reflected CASAC input on the second draft of the document by the court-
ordered deadline, even though CASAC felt that the necessary changes were substantial enough
to warrant  its reviewing an additional draft.  Both to allow EPA to meet the deadline and to
ensure that the Administrator had the benefit of whatever further advice CASAC wanted to
provide, EPA's SAB Staff Office convened a meeting of the CASAC Review Panel after the final
Staff Paper was published and facilitated the preparation of a letter to the Administrator that
conveyed CASAC's views on the final Staff Paper.  This additional advice from  CASAC was
then considered by the Administrator in reaching his recently proposed decisions on the PM
NAAQS.

      The CASAC and its NAAQS Review Panels are administered by EPA's SAB Staff Office
and are subject to the provisions of the Federal Advisory Committee Act (FACA), which
requires that advisory panels be fairly balanced  in terms of the points of view represented and the
functions to be performed. EPA's SAB has  a formal process for forming advisory panels and
making decisions about conflict of interest and balance among panelists.  All CASAC meetings
to discuss the NAAQS reviews are public meetings, and include public comment periods to
provide CASAC Panel members an opportunity to hear comments from the public on the
documents under review during their deliberations.

      2.1.7  Public Participation

      Opportunities for public participation are provide throughout the NAAQS review
process, including opportunities coincident with CASAC reviews and consultations on EPA draft
documents. Prior to rulemaking, the public can participate by providing written  comments to
EPA and CASAC on all draft documents and can also provide oral comments at CASAC
meetings.  As  noted above, the public comment periods during CASAC meetings provide an
opportunity for CASAC to hear the views of interested parties on the documents under review,
as  supplemented by whatever written comments are provided, and to question the commenters
for clarification of their views.  During rulemaking, the public can provide comments during the
public comment period, both in writing and orally at public hearings.
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2.2     Comments on the NAAQS Process from Outside Parties

       2.2.1  Views of Current and Former CASAC Members

       Individual views of current and former CASAC members who provided comments on the
current process are summarized below and included as Attachments 3-A to 3-D.  Areas in which
several of the individual commenters expressed similar views are summarized first, followed by
a listing of issues that were raised by one or another of the CASAC members who commented.

       All individual comments received were consistent with the view that EPA should take
actions that would improve the timeliness and efficiency of the process. The CASAC
commenters generally felt that EPA could bring about these improvements in part by ensuring
that adequate time and resources are devoted to producing initial draft documents that are of high
quality. With regard to the Criteria Document, virtually all CASAC commenters expressed
strong support for restructuring the document to make it far more concise and focused on
evaluation and synthesis of the science. Several CASAC commenters expressed the view that
the synthesis of scientific information in the Criteria Document should be focused on policy-
relevant issues to better inform EPA's policy decisions. A number of comments addressed the
importance of ensuring that uncertainties are fully characterized in a balanced way, both in the
more qualitative discussions of scientific evidence in the Criteria Document and in the
quantitative risk/exposure assessments. The CASAC commenters generally supported the
preparation of the type of policy assessment currently presented in the Staff Paper, which
provides a framework for CASAC to provide advice on ranges of alternative standards.

       Most of the CASAC  commenters expressed strong support for reinstating the "closure"
process that CASAC has historically used to advise the Administrator when the document under
review is judged to be adequate to be used as a basis for regulatory decision making. Some
individuals expressed the view that CASAC's ability to fulfil its statutory responsibilities as  an
independent committee charged with providing its advice directly to the Administrator is
compromised by a discontinuation of the "closure" process.

       Several CASAC commenters addressed the issue of distinguishing science and policy
judgments throughout the process.  Some expressed the view that EPA should more clearly
articulate the policy  considerations central to its decision making, both early in the review
process (e.g., through charge questions to CASAC) and as part of its regulatory decision  making.

       With regard  to consideration of the most recent science, some individual CASAC
commenters expressed the view that "new" studies rarely have major impacts on an  integrated
interpretation of the entire body of scientific evidence. In those cases where circumstances
warrant consideration of exceptionally important new studies,  several commenters felt that
CASAC should review any such studies and that CASAC could accomplish that review quickly
without unduly delaying the review process.
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       Individual CASAC members offered a number of additional comments, including the
following:

       >•      EPA should give more careful consideration to secondary standards.

       »      NCEA should enlist workshops and/or CASAC consultations to identify
             important issue at the beginning of the process to help frame the integrative
             science assessment.

       *      The basic compilation of scientific literature should be reviewed by CASAC
             subcommittees (by teleconferences) so as to allow more time for CASAC to focus
             its review on the integrative synthesis of the science in the Criteria Document and
             the policy assessment in the Staff Paper.

       »•      EPA could use a process more similar to that used by the National Research
             Council (NRC) to produce the science assessment; alternatively, EPA might
             consider asking NRC to conduct the science assessment.

       »      EPA should more fully incorporate modern information tools and processes into
             the review process.

       »      EPA should more clearly and consistently define key policy-relevant concepts
             (e.g., adequate margin of safety, sensitive populations, adverse health effects,
             susceptible individuals, population-based thresholds, acceptable level of
             population risk).

       ••      OAQPS should not issue the first draft of the Staff Paper until the Criteria
             Document is final.

       »      The Staff Paper should be incorporated into a restructured Criteria Document, and
             that single document should focus only on policy-relevant studies.

       »      CASAC  should focus its advice on ranges of alternative standards that are
             supported by the science and not recommend specific policy choices.

       »      EPA's risk assessments tend to  under-state scientific uncertainty; EPA should
             consider expanding the risk assessments (e.g., by having multiple parties,
             including EPA staff, produce potentially "dueling" assessments) so as to more
             thoroughly characterize uncertainties; comparative risk information should be
             presented to put air pollution risks into a broader context.

       »      Uncertainties in epidemiological estimates of effect are not adequately reflected
             in the current risk assessment; a formal probabilistic risk assessment is needed.
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       »      Public comments on draft documents should be made available to CASAC earlier
             to allow time for members to review the comments in advance of the CASAC
             meetings; EPA should formally respond to these comments.

       >      CASAC procedures should be modified in a number of ways; for example,
             provide transcripts of all CASAC meetings; minimize or eliminate
             teleconferences; invite CASAC members to participate in legal negotiations to
             ensure that regulatory schedules are consistent with a full science review.

       >      The Administrator should work with Congress to lengthen the NAAQS review
             cycle from five to ten years.

       2.2.2  Views of Various Stakeholders

       Views of various stakeholder groups on the current process are summarized below and
more fully in Attachment 4, which includes all written comments submitted by commenters. A
number of overarching comments were received from the stakeholder groups that were consulted
with in the preparation of this report. In particular:

       »•      There was broad recognition among all the outside parties consulted that there are
             problems with the process taking too long, which generally led to questions about
             the adequacy of the resources being allocated. Many commenters expressed the
             view that EPA presently allocates insufficient resources to consistently produce
             documents, especially science assessments, that are both timely and of optimal
             quality.

       »•      Aside from the issue of timeliness, some commenters believe that the process
             generally works well and is not structurally "broken," and would not want to see
             major structural changes.  Virtually all of these commenters nonetheless
             recognize that some changes in the process would be beneficial,  with different
             commenters focusing on changes to different elements of the process, as
             discussed below.

       »      Some other commenters believe that there are several areas where the process
             could and should be structurally improved to address the key questions that frame
             this review, as discussed below.

       »•      Varying views were expressed with regard to the distinctions made throughout
             the review between science and  policy, with some feeling that such distinctions
             were currently being made to the extent necessary. Others expressed the view
             that such distinctions are somewhat artificial, whereas still others felt that the
             distinctions could and should be made more transparent.

       »•      More generally, one commenter expressed the view that a statutory change is
             warranted to allow for a longer than 5-year NAAQS review cycle.  Another

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             commenter felt that this review of the NAAQS process should be extended
             beyond April 3, 2006, allowing for a more transparent review and for more
             informed and inclusive involvement of the scientific community and the public.

       With regard to the planning element, commenters expressed the following views:

       »•      Some felt that the process would be improved by identifying key policy-relevant
             issues at the beginning of the process and using those issues to frame the science
             assessment and the quantitative risk/exposure assessment.

       >      Some expressed the view that criteria should be presented at the beginning of the
             process for how key studies will be selected for "policy-relevance" and for how
             those studies, and the entire body of evidence, will be evaluated and integrated in
             the Criteria Document.

       Views on the science assessment took the form of comments on the Criteria Document.
and included the following:

       ••      There was broad recognition that the Criteria Document is typically
             "encyclopedic" in nature, which is seen by many as contributing to an
             unnecessarily lengthy process for preparing document drafts and for reviews by
             CASAC and the public, and obscuring a focus on the most policy-relevant
             scientific information.

       »      Very broad support was expressed for moving to a more continuous process for
             identifying and characterizing new scientific studies.  Some commenters provided
             detailed suggestions for the development and  use of an electronic database that
             would catalogue descriptive documentation of scientific studies. Some
             commenters noted that such a database would facilitate the development of a
             more focused evaluative and integrative assessment document for each S-year
             NAAQS  review cycle, and that it could also be used to facilitate the preparation
             of more frequent periodic updates of the new science for the full set of criteria air
             pollutants. These periodic updates could, in turn, facilitate the development of
             pollutant-specific documents to support specific NAAQS reviews.

       >      Some commenters expressed the view that the contrast between what was known
             in the previous review, and the key uncertainties at that  time, and what is now
             known, and what are now the key uncertainties, should be a major focus of the
             Criteria Document.

       »      Some commenters felt that the evaluation of the science should be made more
             transparent by more clearly defining and following sets  of criteria for identifying
             and evaluating individual studies and for synthesizing scientific  information
             across disciplines in the Criteria Document.
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       With regard to the risk/exposure assessment, commenters expressed the following views:

       »      Several commenters viewed the assessments as being thorough and transparent,
             and as serving as a bridge between science and policy, whereas others saw a need
             for more transparency with respect to some of the analytical choices made in the
             assessments.

       »•      Some viewed the current assessments as generally being well done and
             transparent in addressing uncertainties, while others expressed the view that
             transparency should be improved and uncertainty analyses should be broadened.

       Views on the policy assessment element took the form of comments on the Staff Paper.
and included the following:

       »•      Some commenters expressed the view that the Staff Paper was generally well
             done and was an appropriate mechanism to lay out policy options.

       »      Some commenters expressed the view that the discussions of health and welfare
             effects in the Staff Paper are duplicative of material that is or could be covered in
             the Criteria Document.

       >      Some commenters felt that the first draft of the Staff Paper was often incomplete
             and thus prematurely offered for CAS AC and public comment.

       »      Several commenters expressed the view that it was desirable to have a document
             that reflects staff views (to avoid the perception of political influences) made
             available for CASAC and public review. In sharp contrast, others felt that it
             would be desirable to have a document that represented EPA senior management
             views made available for CASAC and public review earlier in the process, before
             Agency decisions are proposed. One commenter suggested that this could be
             accomplished  by eliminating the Staff Paper and placing its contents into an
             advance notice of proposed rulemaking (ANPR).

       Some views were expressed that related to the rulemaking stage of the process, including
the following:

       »      There was broad recognition that regulatory decisions are necessarily made
             without the very latest science having been integrated into the science assessment.
             Some commenters felt that this was not generally a problem in NAAQS reviews,
             in that a small number of new studies rarely have a large impact on the overall
             weight of evidence. Others felt that this concern could be addressed through
             some type of provisional assessment during the rulemaking phase. It was noted
             that any such provisional assessment would be facilitated by a continuous process
             for identifying, compiling, and characterizing new emerging scientific studies.
                                           19

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       >      Concern was expressed by some commenters that the interagency review process
             that occurs before proposed and final decisions are published allows for
             potentially inappropriate changes to EPA's assessment of the science that
             reflected CASAC's review and advice.

       With regard to CASAC's role in the process, commenters expressed the following views:

       »      Some felt that CASAC Panel members could be better guided with regard to their
             statutory responsibilities and important distinctions between providing policy-
             relevant advice and making specific policy recommendations. Some commenters
             expressed the view that it was appropriate for CASAC to offer advice as to the
             adequacy of the current standard or a range of alternative standards, but that it
             was important that the rationale for its advice be based on scientific evidence and
             judgments, not policy preferences.

       *•      Concern was expressed by some commenters that EPA may be too deferential in
             instances when individual CASAC Panel members press EPA to do more work or
             analyses on particular issues, especially when the  issue in question is not
             important from a policy perspective.  This concern was cited as an issue that can
             add to problems with the timeliness of the review.

       »      Sharply contrasting views have been expressed on the issue of allowing the
             review process to continue until CASAC reaches "closure" on a document under
             review. As noted above, many CASAC members expressed strong views about
             the importance of their reaching "closure" before EPA finalizes documents,
             whereas some stakeholders see "closure" as a means by which CASAC Panel
             members can inappropriately extend the length of (and their influence upon) the
             NAAQS review.

       »•      One commenter raised questions about real or perceived bias with regard to issues
             such as the choice of CASAC/Panel members; members reviewing chapters that
             include their own studies; members coming  in with their own policy goals;
             inappropriate conduct or contact between EPA staff and CASAC/Panel members;
             and inadequate time for CASAC/Panel members to hear and give appropriate
             consideration to public comments.

       With regard to public participation in the NAAQS review process, there was broad
recognition that there are frequent opportunities for public participation and comment throughout
the process. Nonetheless, some stakeholders expressed the view that in some instances the time
allotted to review documents has not been sufficient. Some commenters felt that it would be
desirable to have more time to present public comments during CASAC meetings and  that EPA
should fully respond to public comments provided on draft documents that are made available
for public review.
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              3.   OPTIONS FOR CHANGES TO THE NAAQS PROCESS
3.1     Framework for Consideration of Options

       In considering potential options for changes to the current NAAQS process, the
workgroup has examined each of the functional elements and the nature and linkages among the
key documents, as described above.  Our examination has focused on the key questions that
frame this review, and has taken  into consideration the comments and recommendations received
from current and former CASAC members and from stakeholder groups. As a first step, we
derived an alternative framework for addressing each of the key functional elements through the
preparation of somewhat differently structured documents that would be less overlapping in
content and could be developed through more efficient approaches. This alternative framework
is shown in Figure 4, which highlights changes from the current process as depicted in Figure 3
above.

       The time  frames that might reasonably be allotted to each of the elements within this
alternative framework, and the extent to which work on the significant documents could be done
concurrently or sequentially, are  shown in Figure 5.  While recognizing that the relative timing
of the elements of a review will inevitably vary somewhat from one review to another, and
depend in  part on what options may be adopted for changes to the NAAQS process, we judged
that this general time  line provided a useful mechanism for examining potential efficiencies to be
gained from the changes contemplated by this alternative framework.

       A range of options for each of the key elements is discussed below in the context of the
alternative framework presented  in Figures 4 and 5.  We believe that many of the options
discussed  below  have the potential to bring about increased efficiency and other improvements
to the process and are responsive to the key questions that frame this review. It is important to
note that the time frames described in Figures 4 and 5 are such that a review of the NAAQS
would typically take a full five years.  The increased timeliness and efficiency expected under
the alternative framework derive from making it more likely that a coordinated, comprehensive,
and policy-relevant review can be conducted in that time frame, while reducing the likely
amount of time between the science assessment and the issuance of the proposal, increasing the
likelihood that the proposed decision will be based on the most recent science.
                                          21

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        Planning
        Science
     Assessment
   Risk/exposure
    Assessment
       Policy
    Assessment
    Rulemaking
    Plan for Review of
   Criteria and NAAQS
  Combine plans into one
  policy-relevant review plan
  • Process and schedule for
  entire review
  • Policy-relevant issues to
  frame assessments
  • Projected scope of
  risk/exposure assessments
  • Overview of approach to
  policy assessment
  • CASAC/public review
!   Science Assessment
j        Document
j Continuous compilation/
\ characterization of new
i science in conjunction with
\ periodic NAAQS-relevant
i science assessments
\ • Continuous compilation/
: characterization of relevant
: new science in electronic
i database
i           AND
i • Iterative drafts of concise,
i policy-relevant evaluation/
; synthesis of new science with
i comprehensive descriptive
! annexes of information drawn
: from database [obviating the
: need for the synthesis or
i science now in a Staff Paper]
i • Allow for CASAC/public
| reviews of two drafts, with
: expectation of CASAC
1 "closure"
 • Final document
     Risk/exposure
 Assessment Reports
Include risk/exposure
content that is now in a
Staff Paper
•Detailed scope/methods
plan clearly built on issues/
conclusions in science
assessment document
• CASAC/public review
• Sequential drafts of
phases of assessment in
concise reports with
comprehensive annexes
(and supporting staff
memos)
• CASAC/public review
• Final assessment reports
   Policy Assessment
       Document
Include policy assessment
content that is now in a Staff
Paper
•Approach to evidence- and
risk-based policy assessment
• Policy-relevant air quality
analyses (and supporting
staffmemos)
• Draft policy assessment
drawn from science and
nsk/exposure assessment
documents, including
recommended ranges of
alternative standards
• CASAC/public review, with
CASAC advice on standards
• Final document
• Potentially additional
CASAC advice on final
document    I
      Proposal Notice
• Substantially drawn from
science, nsk, and policy
assessment text and CASAC
advice
• Interagency review
• Administrator's rationale for
proposed decisions,
• Reasons for any differences
from CASAC recommendations

   Post-Proposal Actions
• Public hearings and comments
• Potential for additional CASAC
advice
• Planned assessment of "new"
science drawn from ongoing
compilation of studies in database
• Document responding to all
significant comments

      Final Notice
• Summary of responses to
significant comments
• Consideration of "new"
science assessment
• Interagency review
• Administrator's rationale for
any changes to proposal
Figure 4.     Key Functional Elements in Alternative NAAQS Review Framework
                                                                    22

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              |RA)





  CASAO!Maca»w«HW
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3.2    Options for Changes to the Key Elements

       3.2.1  Planning

       The implementation of some or all of the following options for changing the nature of the
current planning process could enhance the efficiency and timeliness of the process for preparing
each of the assessment documents and for CASAC and public review of those documents.  These
options could also facilitate early input from EPA senior management and outside parties on
important policy issues that could then serve as a basic  integrative framework for the science,
risk/exposure, and policy assessments to be prepared in the course of the NAAQS review.

       >      ORD and OAR could collaborate on combining the current Criteria Document
             Development Plan (prepared by ORD/NCEA) and the NAAQS Review Plan
             (prepared by OAR/OAQPS) into one integrated plan for the review of both the
             AQC and the standards.

       »      The focus of such an integrated planning document could change from (1)
             identifying a comprehensive set of scientific topics to be addressed in a science
             assessment document to (2) identifying key policy-relevant issues that would
             generally be used to frame the science assessment, risk/exposure assessment, and
             policy assessment documents. These policy-relevant issues would  reflect the key
             uncertainties, gaps in knowledge, and research needs identified at the end of the
             previous NAAQS review. It would also be appropriate to recognize in the plan
             that new issues could arise and would need to be addressed during the course of
             the current  review.

       »      In discussing  policy-relevant issues, this plan could help clarify appropriate
             distinctions between science and policy judgments and/or elaborate on important
             concepts and terms that have both science and policy components.

       »•      The set of policy-relevant issues identified in this plan could include those science
             judgments that are an integral part of the projected risk/exposure assessment.
             Such a plan would link the preparation of a draft science assessment document
             with the development of methodologies for the risk/exposure assessments.

       »•      The plan could include criteria for the identification and selection of policy-
             relevant scientific studies as well as criteria for how the science assessment will
             evaluate the weight of the evidence for purposes of drawing inferences about
             causal relationships.

       >      The plan could allow for provisional assessment of "new" science (i.e., new
             studies that have appeared in the peer-reviewed literature after the presumptive
             cut-off date for the science assessment document), as appropriate, to be  prepared
             following proposed rulemaking.  Such an assessment would serve to make the
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             Administrator aware of the most recent science beyond that which is incorporated
             into the science assessment document prior to his reaching final decisions.

       3.2.2  Science Assessment

       The implementation of some or all of the following options for changing the nature of the
assessment of the science done by ORD, as typically documented in a Criteria Document,  could
enhance the efficiency and timeliness of the preparation of the document and of its review by
CASAC and the public.  These options could further streamline the overall NAAQS review by
obviating the need for some of the work that is now done as part of the development of a Staff
Paper.

       >•     The Criteria Document could be substantially restructured in a number of ways.
             For example, the material included in the main body of a science assessment
             document could be much more concise and evaluative and integrative in nature,
             and focus more clearly on characterizing the strengths and uncertainties of the
             available scientific evidence.  Such a document would appropriately be supported
             with comprehensive annexes that include generally descriptive information, the
             preparation of which would require judgments about study selection,
             characterization, and prioritization consistent with the criteria laid out in the
             planning document.  We note that the current Ozone Criteria Document generally
             reflects this type of restructuring.  Further, the presentation and final synthesis of
             information could be organized to more directly address key policy-relevant
             issues, as identified in an initial integrative plan. To the extent that a restructured
             document identified and focused on the most policy-relevant science, there would
             not be a need for the type of synthesis of the science that is now included in a
             Staff Paper.

       >     The timely development of such a science assessment document would be
             facilitated by the use of a continuous process (including the use of up-to-date
             electronic methods and searchable databases) for identifying, compiling,
             characterizing, and prioritizing relevant new scientific studies. In developing and
              implementing such a continuous process, several factors would need to evaluated
             and addressed, including:  the scope of information to be included in such a
              database(s); whether pollutant-specific databases or one multi-pollutant database
              should be developed; the range of descriptive information to be included (e.g.,
              key elements of the study design; environmental variables such as air quality
              statistics or dose levels; relevant results and authors' conclusions); whether any
              evaluative judgments about each study should be included, and if so, the nature of
              such information; approaches that might be used for the development of such a
              database(s), taking into account resource considerations and the use of EPA staff
              and/or consultants/contractors; and the extent to which CASAC and the public
              would be asked to play a role in the development of such a process.
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             Consideration would also need to be given to options for staffing the ongoing
             maintenance of such a process. In addition, the desired output of information
             from the database(s) would need to be determined in terms of what is needed to
             support the science assessment done as part of 5-year NAAQS review cycles, and
             whether more frequent periodic (e.g., annual) updates on emerging new science
             across all criteria pollutants would be useful and appropriate and with what type
             of peer review.  Periodic updates on emerging science have the potential to raise
             new policy-relevant issues that could be factored into the review and to facilitate
             the development of pollutant-specific science assessments.

       >      The breadth of conclusions reached  in the science assessment document could be
             extended beyond what is currently done in the Criteria Document to explicitly
             address many of the types of science judgments that are integral to the planned
             quantitative risk/exposure assessments. To the extent that this is done, there
             would be less need for these types of judgments to be made separately in
             conjunction with the development of methods for risk/exposure assessments.

       »      ORD could produce the science assessment document through a more
             coordinated, consultative internal process, consulting with subject experts across
             ORD, OAR, and other offices, as appropriate, across the Agency. This approach
             would help to ensure the policy-relevance of the assessment and would facilitate
             consideration of the newest scientific data and methods.

       »•      Consider changing the name of the document (e.g., "Assessment of Scientific
             Information") to emphasize the restructured and  refocused content.  Avoiding the
             use of the word "criteria" in the name of the document could help to clarify that
             the "air quality criteria" called for in the CAA may include  information beyond
             that which is presented in the science assessment document (e.g., the
             risk/exposure assessments).

       3.2.3  Risk/Exposure Assessment

       The implementation of some or all of the following options for changing the
risk/exposure assessments conducted by OAR/OAQPS (including both human health and
environmental assessments) could enhance the efficiency and timeliness of the overall NAAQS
review process.  Structuring the process to facilitate the completion of the risk/exposure
assessments closer in time to the completion of the science assessment would also allow the
policy assessment to be done closer in time to the science assessment. Thus, such changes
would help to minimize the time between completion of the science assessment and reaching
proposed decisions on  the standards.

       »      The detailed scope and methods plan for the risk/exposure assessments, which
             builds upon the more general discussion in the initial NAAQS Review Plan, could
             be developed through a more coordinated, consultative process with ORD, in
             conjunction with the preparation of relevant sections of the  science assessment

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             document.  This approach would facilitate concurrent peer and public review of
             (1) the underlying science judgments and assessment models presented in the
             science assessment document and (2) the 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.  This approach would be expected to improve the quality
             of the reviews of these documents and, hence, the quality of the documents
             themselves.

       >      The risk/exposure assessment report could be restructured to be a more concise
             assessment focused on key results, observations, and uncertainties (similar to the
             risk/exposure chapter(s) that are now included in a Staff Paper).  Such a document
             would be supported with comprehensive annexes that included all relevant
             technical information and results to make the assessment methods, results, and
             uncertainties transparent. The annexes would include all the information that is
             now presented in the comprehensive risk/exposure report(s) that are prepared in
             conjunction with a Staff Paper.  We note that this change would parallel the
             restructuring of the Criteria Document discussed above, and would obviate the
             need for this material to be separately summarized as part of a Staff Paper.

       >      A Risk/Exposure Subcommittee of the CASAC NAAQS Review Panel could be
             established, when appropriate, to provide broader and more focused expertise on
             the risk/exposure assessment. This approach would help to ensure that the latest
             assessment methodologies and approaches to characterizing uncertainties are
             incorporated into the assessments.

       3.2.4  Policy Assessment

       The implementation of some or all of the following options for changing the policy
assessment developed by OAR/OAQPS, as currently documented  in a Staff Paper, could
potentially enhance the efficiency and timeliness of the review.  These changes could also
include providing for input from OAR and/or EPA senior management to be reflected in a policy
assessment that is made available for CASAC and public review, prior to the selection of policy
choices as presented in a proposed rulemaking.

       »      To the extent that science assessment and risk/exposure assessment documents
             are restructured as discussed above, the Staff Paper as currently structured could
             be replaced with a more concise policy assessment document. This document
             would not need to include the synthesis of policy-relevant science and the key
             observations from the risk/exposure assessment that are now included in Staff
             Papers; instead, it would include only the policy-relevant air quality analyses and
             policy assessment content.  This content includes discussion of evidence-based
             and quantitative risk-based approaches for making policy choices and the
             identification of ranges of alternative standards that reflect alternative policy
             judgments.  Such ranges of alternative standards would continue to provide a

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             framework for CASAC advice and recommendations and for public comment.
             This document would be based primarily and directly on the information in the
             final synthesis chapter of the science assessment and in the risk/exposure
             assessment report. This document could further elaborate on important concepts
             and terms that have both science and policy components,  building upon a
             discussion of these concepts in the initial planning document. To the extent that
             such a document included research recommendations, as are included in current
             Staff Papers, it could provide important input to the identification of policy-
             relevant issues for incorporation in the integrated plan for the next review.

       »      Since all the relevant science and risk/exposure assessment information would
             already have been reviewed by CASAC and the public by the time such a policy
             assessment document would be prepared, it might be reasonable to make only one
             draft of the policy assessment document available for CASAC and public review.
             This approach would shorten the time between the completion of the science and
             risk/exposure assessments and publication of a NPR. Following review,
             comments received could be incorporated into a final policy assessment
             document, or alternatively could be addressed directly in the NPR, without taking
             time to prepare a separate final policy assessment document.

       »      Such a policy assessment document could reflect staff views, as does the current
             Staff Paper, EPA senior management views, or  both. Ranges of alternative
             standards could continue to reflect staff recommendations for the Administrator's
             consideration, or alternatively could be presented as a set of options defined by
             staff and/or senior management for the purpose of eliciting more  focused
             comments on alternative standards.  To the extent that the policy  assessment
             reflects senior management views, consideration could also be given to the option
             of publishing the document in the form of an ANPR, which would solicit
             comment from CASAC and the public, rather than as a report.

       3.2.5  Ruletnaking

       The following options would help  improve the Agency's ability to use the most recent
science and to ensure that the assessment of the science that forms the basis for the
Administrator's decisions is appropriately  transparent.

       »•      Prior to  initiating an interagency review, the role of the interagency review
             process  in reviewing the science, risk/exposure, and policy assessments upon
             which EPA's proposed decisions are based could be more clearly defined for all
             participants in the review.  The transparency of whose views are being expressed
             in the preamble to the rulemaking notices could be enhanced, in part through a
             more clearly defined interagency review process.

       *•      Both an improvement in the timeliness of the other components of the review, as
             well as development of an ongoing survey of scientific information, would serve

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             to reduce the amount of new science that might need to be examined during the
             public comment period. A survey and provisional assessment of "new" science
             could be prepared, as appropriate, following proposed rulemaking.

      3.2.6  CASAC Review

      We believe that the effectiveness of the CASAC review process would be enhanced if
many of the options identified above for changes to the science, risk/exposure, and policy
assessments were adopted. Many of these options are consistent with the comments offered by
individual CASAC members for ways to improve the NAAQS review process.  In addition, we
believe that the following options would also serve to enhance the effectiveness of CASAC
reviews:

       >      EPA could prepare more comprehensive information and guidance on CASAC's
             statutory roles and responsibilities to enhance the orientation of CASAC panel
             members to the NAAQS review process. Among other things, this information
             and guidance could serve to increase awareness of the importance of maintaining
             the distinction between science and policy judgments in the advice and
             recommendations prepared by CASAC.

       "      With regard to the issue of "closure," we believe that this is an important issue
             that warrants further consideration by EPA and perhaps communication with
             CASAC so it can be addressed in a manner that meets both CASAC's and EPA's
             needs.

       »•      The SAB Staff Office could consider issues raised by some commenters during
             this process review with regard to the selection and  management of CASAC
             NAAQS review panels to identify any areas where changes are warranted or
             where current procedures could be made more transparent.
       3.2.7  Public Participation

       We make the following observations about public participation in the context of an
alternative framework for the NAAQS process:

       »     Opportunities for public participation are available throughout the current process
             and such opportunities would remain in the alternative framework and with any of
             the options for change discussed above.

       »•     While responses to public comments received on draft documents prior to
             publication of the NPR could be more clearly documented, which could serve to
             enhance the transparency of the process, such an effort would add to the time for
             the review and would require additional resources.
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          4.   WORKGROUP CONCLUSIONS AND RECOMMENDATIONS
       In considering the questions that framed this process review, and the options for changing
the NAAQS review process discussed above, we have reached the following conclusions:

       »      Past reviews demonstrate that, in the absence of unusual developments, it  is
             possible to complete the current process for reviewing a NAAQS within the
             statutory 5-year review cycle.  However, the likelihood that the process will be
             completed in that time frame, in the absence of court-imposed schedules, can be
             increased by making changes that generally create a more policy-relevant  focus
             and a more internally coordinated, consultative approach to each of the elements
             of the process. While this conclusion applies to the process for reviewing the
             NAAQS for any one pollutant, it does not address important resource-related
             issues that would arise in considering the likelihood that all of the NAAQS can
             regularly be reviewed within 5-year review cycles (as noted below under
             recommendations for continuing work).

       >      Within the review cycle, NAAQS decisions could be based on more recent
             science than has historically been available for consideration by adopting changes
             that provide a continual compilation/evaluation of science, enhance the linkages
             between the science and risk/exposure assessments, facilitate reaching proposed
             policy decisions as quickly as  possible after the completion of those assessments,
             and expedite provisional assessment of "new" science, when appropriate, during
             the rulemaking process (as noted below under recommendations for continuing
             work).

       >      Distinctions between science and policy judgments made by EPA and by CASAC
             throughout the NAAQS review process can be clarified and made more
             transparent, in part, by adopting changes that facilitate the preparation  and review
             of a policy assessment document that is based on, but separate from, the science
             and risk/exposure assessments. This can also be done by increasing the
             awareness of CASAC Review Panel members of the importance of this
             distinction and the  need for a science-based review of policy issues.  Additionally,
             this can be done by clarifying  to the public the role of the interagency review
             process in reviewing  EPA's discussion and views on science and policy issues in
             the rulemaking notices.

       »      Changes that enhance the linkages between the preparation of the science
             assessment and risk/exposure assessment, which in turn would enhance the
             linkages between CASAC reviews of these two documents, can also help to
             ensure that more complete, policy-relevant characterizations of uncertainties are
             incorporated into these assessments.
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       To effect these improvements, we recommend implementing the general changes to the
NAAQS process identified below. The extent to which the projected improvements are likely to
be realized depends not only on which changes and related options are adopted, but also on the
extent to which adequate resources and continued management support are provided for the
effective and ongoing implementation of any such changes.

       »      Combine the current separate planning activities into the preparation of one
              integrated planning document that focuses the science, risk/exposure, and policy
              assessments on a set of policy-relevant issues, which reflect key uncertainties and
              gaps in knowledge identified at the end of the last review, and that includes
              criteria for identifying key policy-relevant studies and for assessing the weight of
              the evidence for important scientific issues. Include in this plan a schedule for the
              review that maximizes the amount of time allotted to the science and
              risk/exposure assessments; that more closely links these assessments through a
              more coordinated, consultative process; that minimizes the time between the
              completion of these assessments and reaching proposed decisions on the NAAQS;
              and that allows for provisional assessment of "new"  science, as appropriate,
              during the rulemaking process. The preparation of such an integrated, policy-
              relevant plan would provide an opportunity for early involvement of EPA senior
              management and/or outside parties in  the framing of policy-relevant issues.

       ••      Restructure the science assessment document to be a more concise evaluation,
              integration, and synthesis of the most  policy-relevant science (with
              comprehensive annexes that include generally descriptive information), and to
              include key science judgments that are integral to the risk/exposure assessments.
              This document should include a presentation of the synthesis of policy-relevant
              science not only for a scientific audience, but also in language that will be
              understood and meaningful to policy makers, perhaps in the form of a "plain-
              English"  executive summary.

       »      Develop  and implement a continuous  process to identify, compile, characterize,
              and prioritize new scientific studies with the assistance of state-of-the-art
              electronic databases developed by ORD. We recognize that the development of
              such a system is complex and potentially resource-intensive, and believe that
              additional time is  needed  to explore various approaches, options, and resource
              requirements for its development. Consideration of the extent to which such a
              system would facilitate a  survey of "new" science during the rulemaking and/or
              preparation of more frequent periodic updates should be done in conjunction with
              efforts to develop such  a system.

       »      Develop  a more concise risk/exposure assessment document focused on key
              results, observations, and uncertainties (similar to the risk/exposure chapter(s)
              that are now included in Staff Papers). This document would be supported with
              comprehensive annexes that include all relevant background information,
              assumptions, results, and  assessments of variability and uncertainty to ensure the

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             transparency of the assessment (similar to the information now included in
             contractor reports).

       »      To the extent that the changes recommended above are adopted and effectively
             implemented, replace the Staff Paper as currently structured with a more narrowly
             focused policy assessment document. This document would be based on the
             information contained in the science and risk/exposure assessments, and would
             also include the results of policy-relevant air quality analyses.  This document
             could focus on identification of a set of evidence- and risk-based approaches for
             reaching policy judgments; consideration of the adequacy of the current standards
             and whether alternative standards should be assessed for consideration; and
             identification of a range of options for alternative standards (in terms of
             indicators, averaging times, forms, and ranges of levels) that might be considered
             by the Administrator in making policy choices.  We recognize that important and
             complex issues are involved in deciding the scope of such a document, as well as
             deciding whether such  a document would continue to reflect staff views, EPA
             senior management views, or both, and how that choice may affect the process by
             which such a document would be reviewed by CASAC and the public.

       >      Work with the Science Advisory Board (SAB) Staff Office to consider the
             formation of a CASAC subcommittees on risk/exposure assessment, when
             appropriate;  to examine the extent to which additional measures can be taken to
             orient new CASAC panel members to the NAAQS review process and to increase
             awareness of the importance of maintaining the distinction between science and
             policy judgments in the Committee's advice and recommendations; and to give
             further consideration to the issue of "closure." Request that the SAB Staff Office
             consider issues raised by some commenters during this process review with
             regard to the selection and management of the CASAC NAAQS review panels.

       We also offer the  following  additional recommendations for continuing this examination
of the NAAQS process beyond April 3, 2006:

       »•      Continue a dialogue  with the public in the coming months on the issues addressed
             in this review of the NAAQS process. As indicated above, we consulted with a
             limited set of stakeholder groups that have been actively involved in NAAQS
             reviews to solicit the views of knowledgeable individuals  on how the NAAQS
             process might be improved. However, time constraints for this initial report
             precluded  the broader involvement of many other parties who may also have
             valuable insights as to how the NAAQS process might be  improved and a strong
             interest in  providing  comments on it.

       »•      Continue to examine more specific options for implementing those changes that
             are adopted, or that remain under consideration, as well as their organizational,
             staffing, and resources implications. In particular, as noted above, continue to
             explore various approaches, options, and resource requirements for the

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development of a state-of-the-art electronic database system to facilitate the
continuous identification, compilation, characterization, and prioritization of
relevant published scientific studies.  With regard to assessing "new" science
during rulemaking, continue to examine the questions of when and how
assessment of "new" science could appropriately be performed and used during
the rulemaking.

More broadly, consider the organizational and resource implications for EPA of
coordinating and conducting reviews of all NAAQS on 5-year cycles, and work
with the SAB Staff Office to consider the implications of constituting CASAC
Panels and managing the CASAC review process for all such  NAAQS reviews.
This broader examination of how EPA plans for and implements reviews of all
the NAAQS might include consideration of some or all of the following issues:

»      The variable nature of the amount and complexity of the work involved in
       reviewing the NAAQS for the different criteria pollutants,  based in part on
       the volume and nature of available new science, beyond that  included in
       the last science assessment, and how these factors relate to the amount of
       time and resources needed to conduct each review.

»•      The value of conducting various NAAQS reviews on somewhat different
       schedules, within the statutory 5-year review cycle,  taking into account the
       factors identified above.

••      The desirability of building more flexibility into the planning of NAAQS
       reviews to allow for integration across pollutants when the nature of the
       available science suggests that some degree of integration could result in a
       more scientifically sound and/or efficient review process.

To the extent that any recommendations for continuing this examination of the
NAAQS process beyond April 3, 2006 are accepted, we will prepare a plan for
the development and implementation of the continuing actions,  including target
dates and organizational responsibilities for interim progress reports and for the
phase-in and implementation of the actions.
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