UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON D.C. 20460
OFFICE OF THE ADMINISTRATOR
SCIENCE ADVISORY BOARD
January 23, 2008
EPA-CASAC-08-008
Honorable Stephen L. Johnson
Administrator
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue, NW
Washington, DC 20460
Subject: Clean Air Scientific Advisory Committee Recommendations Concerning the
Implementation of EPA's Revised NAAQS Review Process
Dear Administrator Johnson:
We, the seven members of the Clean Air Scientific Advisory Committee (CAS AC or
Committee), are writing to express our serious concerns regarding the implementation of the
Agency's revised process for reviewing the National Ambient Air Quality Standards (NAAQS)
for criteria air pollutants, as described in a series of memoranda written by EPA Deputy Admin-
istrator Marcus Peacock dated December 15, 2005, December 7, 2006, and April 17, 2007. The
CASAC's mandate under the Clean Air Act is to provide its independent scientific advice and
recommendations on the adequacy and basis of existing, new, or revised NAAQS that are requi-
site to protect both public health and public welfare, and, in the case of the protection of public
health, to do so with "an adequate margin of safety." This letter is also written in reply to the
Deputy Administrator's memo of January 3, 2008 to Dr. Rogene Henderson, CASAC Chair, in
which he requested more information regarding the Committee's specific concerns about the
Agency's new NAAQS review process.
EPA's Revised NAAQS Review Process
The Agency announced the results of its "top-to-bottom review of the NAAQS process"
in the Deputy Administrator's memo of December 2006. The revised EPA NAAQS review
process would include: (1) a science workshop convened by the Agency at the beginning of each
NAAQS review cycle to discuss the new scientific evidence acquired since the last review of
each pollutant, and to receive CASAC and public input concerning policy-relevant questions
and/or science issues, as the basis for the development of an integrated planning document (as
recommended by the Committee); (2) the replacement of the voluminous air quality criteria
document (AQCD) with an integrated science assessment (ISA) — a more concise, integrated
assessment of the policy-relevant science (as also recommended by the CASAC) — which will
enable the Committee to more efficiently review the underlying scientific criteria for each air
pollutant and thus be able to devote more time to assessing the technical analyses of the criteria
as these pertain to rulemaking; (3) the publication of a stand-alone risk/exposure assessment
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document that is "focused on key results, observations, and uncertainties"; and (4) the replace-
ment of the Staff Paper with a, policy assessment that reflects the views of EPA management, to
be published in the Federal Register as an advance notice of proposed rulemaking (ANPR). This
policy assessment would "describe a range of options for standard setting, in terms of indicators,
averaging times, [statistical] form, and ranges of levels for any alternative standards," along with
the underlying scientific justification and supporting data and analyses for each of these, to "help
... 'bridge the gap' between the Agency's scientific assessment and the judgments required of
the Administrator in determining whether it is appropriate to retain or revise the standards."
CASAC's Evaluation of the Implementation of EPA's Revised NAAQS Review Process
The Committee has now had the opportunity to participate in each of the steps in EPA's
new review process — albeit not sequentially, for a single air pollutant. The CASAC's experi-
ence with the early phases in the new NAAQS review process has been favorable. The Agency's
science workshop to kick-off the review of the particulate matter (PM) NAAQS was excellent.
The integrated planning documents reviewed by the Committee have been appropriate. While
there were no dedicated science workshops for the NOX and SOX primary NAAQS reviews —
and the associated ISAs are still undergoing development — these documents seem to be moving
in the right direction and show promise of becoming much more efficient and useful than were
the previous AQCDs in providing the scientific background information for NAAQS reviews.
However, EPA chose to implement its revised process in the middle of the current review
cycle of the lead standards — thus resulting in a "hybrid" process that combined elements of the
old and the new NAAQS processes — which revealed significant problems that exist in the latter
steps of this new review process. To begin with, an Agency Staff Paper is conspicuously absent
from this revised NAAQS process. The Staff Paper is a document that has been highly-valued
by CAS AC for its thorough analysis of the new scientific evidence in the AQCD, its presentation
of the possible alternatives for the standards to be considered by the Administrator and, most im-
portantly, its provision of the scientific evidence undergirding those alternatives. Under the re-
vised NAAQS process, as noted above, the Staff Paper would be replaced by ^policy assessment
to be published as an ANPR. Nevertheless, on the basis of how the policy assessment was de-
scribed in the Deputy Administrator's December 2006 memo, the Committee was reassured that
it would be functionally identical io the former Staff Paper in terms of presenting the information
and supporting analyses describing the range of options for setting the NAAQS, along with a
complete and robust explanation of "the alternative underlying interpretations of the [associated]
scientific evidence and risk/exposure information that might support such alternative standards."
Unfortunately, as discussed extensively in the Committee's recent letter to the Adminis-
trator concerning the CASAC Lead Review Panel's review of the ANPR for the NAAQS for
Lead (EPA-CASAC-08-007, dated January 15, 2008), this was not the case. The ANPR for the
Lead NAAQS did not contain any such "policy assessment" of scientific and technical informa-
tion as described in the Deputy Administrator's December 2006 memo. Rather, this document
simply laid out all NAAQS policy options for consideration by the Committee and the public
while omitting the fundamental scientific rationale for many of them, or even the relative scien-
tific merits of the different alternatives. Accordingly, the CASAC found the ANPR for the Lead
NAAQS to be both unsuitable and inadequate as a basis for rulemaking.
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Thus, in EPA's recent, partial implementation of its revised process in the Lead NAAQS
review, there is a stark contrast between the empty and regressive nature of the ANPR — which
is not a true policy assessment — and the scholarly and complete scientific analyses presented in
EPA's Staff Paper. Indeed, if such an ANPR were to be the benchmark for subsequent NAAQS
reviews, the Agency would have failed in its responsibility to "ensure that the best available sci-
ence [will] guide and inform Agency decision making" while adhering to the "highest scientific
standards" so that NAAQS-related decisions "would be informed by the best available science
without compromising the scientific integrity [i.e., soundness and transparency] of the process,"
as stated in the Deputy Administrator's previously-cited memoranda.
The ostensible purpose of replacing the Staff Paper with an ANPR was to permit Agency
policymakers to influence the options that were presented for CASAC and public review. How-
ever, the ANPR for the Lead NAAQS offered no scientifically-justified alternatives. Instead, the
ANPR solicited public comment on options for lead standard-setting that had already been con-
sidered in public advisory meetings and "settled" (that is, dismissed on scientific grounds by
both the CASAC and EPA staff) — which serves only to undermine the scientific foundation of
the NAAQS reviews. Moreover, far from inducing greater efficiencies, the Agency's ANPR —
by its illogical contemplation of a greater number of options as time progresses — unavoidably
slows-down the NAAQS review process.
What Needs to be Modified in EPA's Revised NAAQS Review Process
Fortunately, the new NAAQS review process is still "a work in progress" — and it can be
modified to the mutual benefit of all concerned. First, an advance notice of proposed rulemaking
belongs at the beginning of this review process, not at the end. The CASAC has become aware
that, in other parts of the Agency, an ANPR (which EPA had not previously used in its NAAQS
rulemaking activities) is employed to initiate a rulemaking process — and so is wide-ranging to
take into account all possible options that might be considered. Such a broad ANPR is an inap-
propriate tool to utilize at the conclusion of a comprehensive NAAQS review, since it essentially
puts the whole process in reverse. Therefore, the CASAC recommends that EPA issue an ANPR
at the start of a NAAQS review cycle, either prior to or immediately after the science workshop.
Toward the end of the NAAQS review cycle — that is, after the CASAC's review of the
integrated planning document, the ISA, and the risk/exposure assessment — the Agency should
issue a policy assessment document as stated in the Deputy Administrator's December 2006
memo that will, in fact, describe the range of specific policy options under consideration for set-
ting the standard (including all four elements of a NAAQS), accompanied by supporting scientif-
ic data and rigorous analyses. Furthermore, it is essential that this policy assessment document
be furnished to the CASAC for peer-review in public advisory meetings, in the same manner as
multiple drafts of the Staff Paper were provided to the Committee for review under the previous
process. It cannot be overstated that, in order to fulfill its Congressionally-mandated and thus
legal role, the Committee needs to conduct a thorough and open evaluation of this "best available
science," i.e., the scientific justification and underlying analyses of the various options for stand-
ard-setting that the Agency formerly presented in the Staff Paper — which of course will now in-
clude the viewpoints of EPA management. Obscuring or weakening such an independent scien-
tific review would subvert both the vital interests of the CASAC and the public's confidence in
this NAAQS review process — a result that the Agency surely neither intends nor desires.
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In closing, the CASAC reiterates its request that the Agency modify its revised NAAQS
review process to put the ANPR at the beginning of the process, rather than at the end, and pro-
vide the Committee and the public with a genuine policy assessment of scientific and technical
information., as was formerly contained in the Staff Paper. Such a change is required to allow the
CASAC to maintain the transparency and the scientific soundness of the NAAQS review process
— and thus fulfill its statutory mandate under the Clean Air Act to make scientifically-informed
recommendations to the EPA Administrator concerning the adequacy and basis of the NAAQS.
Sincerely,
/Signed/
Rogene Henderson, Ph.D.
Chair, Clean Air Scientific Advisory Committee
Scientist Emeritus
Lovelace Respiratory Research Institute
/Signed/
Donna Kenski, Ph.D.
Director of Data Analysis
Lake Michigan Air Directors Consortium
(LADCO)
/Signed/
Ellis Cowling, Ph.D.
University Distinguished Professor At-Large, Emeritus
North Carolina State University
/Signed/
Armistead (Ted) Russell, Ph.D.
Georgia Power Distinguished Professor of
Environmental Engineering
Georgia Institute of Technology
/Signed/
James D. Crapo, M.D.
Professor, Department of Medicine
National lewish Medical and Research Center
/Signed/
Douglas Crawford-Brown, Ph.D.
Director, Institute for the Environment; and
Professor, Department of Environmental Sciences and
Engineering,
University of North Carolina at Chapel Hill
/Signed/
Jonathan M. Samet, M.D.
Professor and Chairman,
Department of Epidemiology
Bloomberg School of Public Health,
Johns Hopkins University
cc: Marcus C. Peacock, Deputy Administrator
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