UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460	.
OFFICE OF THE
ADMINISTRATOR
Recommended Procedures for Involving the Clean Air Scientific
Advisory Committee (CASAC) in the Review Process for National
Ambient Air Quality Standards
Lester D. Grant, Ph.D.
Director, Environment Criteria and Assessment Office
Office of Research and Development
Mr. Joseph Padgett
Director, Strategies and Air Standards Division
Office of Air Quality Planning and Standards
Mr. Terry F. Yosie
Staff Officer, Clean Air Scientific Advisory Committee
Science Advisory Board
Introduction
EPA staff have held several discussions as a follow-up to the January
SAB/CASAC meeting concerning possible ways for CASAC to become involved in
the review process for National Ambient Air Quality Standards (NAAQS).
This memorandum contains a list of proposals and procedures arrived at
during these discussions. We are hopeful that agreement can be reached with
committee members on the content of these proposals at the forthcoming
meeting of CASAC.
p £% \
ussy
PRCflt&
SUBJECT:
FROM:
EPA is required to review and revise, if necessary, each NAAQS every
five years. The current schedule for proposal of a revised standard, or
reaffirmation of an existing one, is as follows:
CO	August 1979
NO2	November 1979
Particulates	May 1980
S02	May 1980
Promulgation would occur six months after proposal. These schedules
include time for SAB/CASAC to review the criteria document in a public meeting,
with a contingency allowed for a second meeting, if needed. According to
the Clean Air Act Amendments of 1977, the reviews must be completed, i.e.
a revised standard promulgated (if needed), by December 31, 1980.
The Science Advisory Board has played a key role for some time in
ensuring that the criteria document is scientifically adequate for standard
setting. However, the SAB has not participated in the remainder of the

-------
standards development process. With the establishment of the Clean Air
Scientific Advisory Committee, mandated by Congress, we need to develop
with CASAC procedures to define what CASAC should review, the type of
output to result from such reviews, and how these reviews can be accomplished
consistent with Congressionally mandated time schedules.
For the purposes of discussion, the NAAQS standards development process
can be divided into the following components, each of which we suggest be
considered for CASAC review:
1.	Criteria document
2.	Implications for standard setting of critical health studies
3.	Risk assessment
4.	Regulatory analysis—economic, environmental, energy, urban and
community impacts
5.	Overall standards development methodology
Involvement of CASAC in each of these components is discussed below.
Criteria Document
The review of criteria documents is a traditional function of the
Science Advisory Board (now the SAB/CASAC) and already has been integrated
into the standards development schedule. One significant issue that
remains to be resolved, however, is the approach by which the Environment
Criteria Assessment Office receives some written assessment from CASAC
concerning the content and quality of a criteria document for its use in
standards development. This issue can be termed "closure". Closure
represents a "sense of the committee" determination upon the scientific
adequacy of a criteria document for regulatory purposes at a specific point
in time, based upon the information currently available. Closure is intended
to supplement other forms of channeling advice such as transcripts, individual
notes, and official committee minutes. The overall purpose of closure,
therefore, is to ensure that the committee has given explicit written advice
concerning a criteria document so that in the future the committee's position
will not be misunderstood. Embodied within the concept of closure is that,
when necessary, individual committee members can submit written minority
reports if they disagree with all or part of the full committee report. A
sense of the committee report would be signed by the chairman and staff
officer.
Some additional suggestions for how the closure process might be
accomplished are included among the appended materials which summarize
the six phases now typically involved in the preparation and review of
criteria documents. The last three phases outlined in the appended
summary concern steps involved in the external review of the documents.
This includes, as indicated under Phase IV, SAB/CASAC review of any
initial external draft of a document. Also, as indicated there, it would
be useful to have from the SAB/CASAC, or one of its subcommittees charged
with the review, a formal staff report which details the extent to which
the Committee-of-the-whole or subcommittee concurs with the contents and
conclusions of the document and which also points out any specific objections
or problems regarding the external draft. Phase V, following the initial
SAB/CASAC meeting, would involve: (1) revision of the document by EPA/ECAO
- 2 -

-------
in response to the points or issues """^^^^submntal of*the document to
in commenting on the exte™L^a pha"e vi, it is suggested, should involve:
SAB/CASAC for further evaluation. Phase •	*nq their impressions of
(1) individual SAB/CASAC committee members convey 9	0„ detera1ning
the revised document to the chairman and 2 the cn	Hate further
the overall sense of the c0™j"e|lB^sAcn™Jlic review meeting or prepara-
irof"9HnCarci-1t0teeanrepori^	ra^^bTfJcSSTon'l-
sra.Bs:v«;
Please note the time Pe<"i«js that we estinate ^™^t|eth|Sprocess of
tK^e suggest that agree^be reached
between EPA and SAB/CASAC regari	public review meeting on
committee reports would be r®	* their final committee reports
inn al external draft of	Submitted at the end of
regarding later, revi|ed versions of	documents re m ^ wnhi(1 a
Phase V. Provision of the SAB/CASAC	CMmittee .n orde(. t ?nsure
relatively short, but reasonable	Sory gr0up and yet still
that the Agency can be responsive t	cuhseauent steps in the standards
complete the criteria	on so as to meet Congressionally-mandated
development process in timely fashion
or court-ordered deadlines.
for S--"* ^t.ino of Critical Health Studies
Following	completion	of	the	critena	docurentvJPA^mus^^.^^
rationale for a proposed standard. Factors^ ^	quaiity, serious-
the rationale are the rel^*!Lficat-jon 0f sensitive populations, risk
ness of health effects,exceedances of the standard,
public health, averaging time,	These factors are evaluated by the
and margin 0^-!afe)Lnp?rin arriving at a final recommendation to the
regulatory office (OAQPS) m arm g	evaluate, prior to proposal,
Administrator. "	in setting a standard,
as^ell^another factors which will influence the final standard.
p-uk Assessment
A risk assessment technique for	o^AI/quality
development has been	K'r^years^Ozone was the
develop ambient standards.
- 3 -

-------
The OAQPS risk assessment technique was reviewed on April 19-20,
1979 by an SAB subcommittee on risk assessment. The committee felt that
this technique was not yet ready for use in setting ambient standards
but strongly encouraged us to continue development. EPA also was urged
to structure an expanded program which would develop, evaluate, and
possibly test alternative techniques applicable to the standard setting
process.
The risk assessment committee had no objections to our performing a
risk assessment for CO as a means of continued development of risk
assessment methodology. However, we have concluded that the potential
difficulty we would have in assuring the public that the results of a
risk assessment would have no impact on selecting a CO standard argues
for delaying this assessment until at least after proposal.
Although there is a separate SAB committee on risk assessment, we
recommend that CASAC be briefed on the OAQPS methodology and future
development plans since we do expect to use risk assessment at some
point to help us set standards. A report on the April SAB risk assessment
subcommittee meeting is on the agenda for the June CASAC meeting. We
recommend that CASAC be more fully briefed in future meetings on risk
assessment, future plans, and issues related to use in setting NAAQS.
Regulatory Analysis
* The regulatory analysis includes economic, environmental, energy,
and urban and community impact analyses. These are required for all
major regulatory actions and are released in draft at the time of proposal.
The results are not to be considered in setting the standard, however,
and therefore should not influence SAB/CASAC in developing the advice
and/or recommendations discussed in prior sections. It is planned that
these documents will be made available to the CASAC at the time of
proposal. It is recommended that the CASAC review a set of regulatory
analysis documents for at least one standard, after which the committee
can decide whether these documents should be routinely reviewed.
Overall Standard Setting Methodology
It is recommended that the CASAC consider, from time to time, the
overall standard setting methodology. Of particular interest to EPA is
the identification of additional analyses and research which might be
needed to improve the quality of the final decision on a standard.
- 4 -

-------
APPENDIX
1. PREPARATION AND INTERNAL REVIEW OF ECAO AIR CRITERIA
AND HEALTH EFFECTS/RISK ASSESSMENT DOCUMENTS
PHASE I: DOCUMENT PLANNING AND INITIATION (30 DAYS)
Assignment of Project Manager and other ECAO staff members to
document preparation team
Recruitment of internal EPA Task Force and outside contributing
consultants
Development of work plan and time-table for document preparation
Initiation of literature search and article procurement procedures
PHASE II: PREPARATION OF IN-HOUSE DRAFT (60-90 DAYS)
Accumulation and analysis of pertinent literature
Writing of rough drafts of document sections
Preliminary meetings of authors and polishing of initial draft
Typing and circulation of preliminary review draft to internal
task force and three to five outside reviewing consultants
PHASE III: INTERNAL REVIEW OF IN-HOUSE DRAFT (30 DAYS)
Convening of ECAO Team, document authors, EPA internal task force
and reviewing consultants at 1-day in-house review workshop
Follow-up meetings of ECAO staff, reviewers and authors as necessary
Post-workshop revision of document
Typing, editing, and printing of external review draft

-------
2. EXTERNAL REVIEW OF ECAO AIR CRITERIA AND
HEALTH EFFECTS/RISK ASSESSMENT DOCUMENTS
PHASE IV: PUBLIC REVIEW OF EXTERNAL DRAFT (60 - 90 days)
Publication of Federal Register Notice announcing availability of
external review draft of document
Circulation of external draft to other government agencies, (SAB/CASAC)
and the general public
°f ECA0 sJaff» other EPA personnel, and contributing consultants
to analyze comments and prepare for SAB/CASAC meeting
Presentation and review of external draft at public SAB/CASAC meeting
SAB/CASAC committee staff report summarizing major concerns or
problems
PHASE V: POST SAB/CASAC MEETING DOCUMENT REVISION (60 DAYS)
Debriefing of ECAO staff, other EPA personnel and consultants
In-depth cataloging, review, and analysis of SAB/CASAC and public
comments from before, during, and after the SAB/CASAC meeting
Assignment of specific revision responsibilities to ECAO staff
members and contributing consultants
SAR/rflsSr mLh8V1Sl0n aSj1*Hn!I!ents and consultation with individual
SAB/CASAC members as needed to resolve clarity and content issues
Typing, editing, and reproduction of revised draft and resubmittal
of document to the SAB/CASAC
PHASE VI: SAB/CASAC CLOSURE ON DOCUMENT STATUS (45-60 DAYS)
Report of individual SAB/CASAC committee members to chairman of group
Determination by chairman of overall sense of the committee and
implementation of appropriate options based on following criteria:
Major objections/Problems remaining — Hold public review meeting
Minor objsctions/Problems reniaininQ Hold conferencs call
No substantive problems remaining — Prepare sense of committee report
If latter, proceed with final editing, printing, and release of document

-------
3. PROPOSED FORMAT FOR SAB/CASAC
REVIEW COMMITTEE REPORTS
Chairman's summary of overall concensus or majority view regarding
committee's evaluation
Focus on evaluation of document in terms of:
Completeness of literature review—coverage up-to-date, key
references properly considered or noted?
Adequacy of review and evaluation of studies—data accurately
described, interpreted, reanalyzed?
Clarity of presentation of data and conclusions—effective
presentation of text, tables, figures, summaries?
Accuracy of overall interpretation of data base—main conclusions
well-founded and extrapolations justified?
Signed concurrence of committee chairman and_staff officer on
report—specifics of individual dissent or minority report appended.

-------