"*• t
Setting Mibient Mr Duality Standards:
Improving the Process
A Report of the Clean Air Scientific Advisory Committee
Science Advisory Board
U.S. Environmental Protection Agency
September 19B1
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EPA NOTICE
This report has been written as a part of the activities of
the Agency's Science Advisory Board, a public advisory group
providing extramural scientific information to the Administrator
and other officials of the Environmental Protection Agency. The
Board is structured to provide a balanced expert assessment of
scientific matters related to problems facing the Agency. This
report has not been reviewed for approval by the Agency and hence
its contents do not represent the views and policies of the
Environmental Protection Agency, nor does mention of trade names
or commercial products constitute endorsement or recommendation
for use.
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TABLE OP CONTENTS
Page
Roster of CASAC Members and Core Consultants...,....,..».....,,... iv
Introduction , ..................................... 1
Conclusions and Recommendations....».,..»,».....,.......»,.,....». 1
Development of Ambient Air Quality Standards ................. 4
A. Legislative Requirements 4
B. Development Process for Air Quality Criteria............. 7
C. Criteria Document Closure Process........I...,.*.....*... 8
D. Staff paper. 11
CASAC Role and Responsibilities 11
Findings, Recommendations, and Comments of the Clean Air
Scientific Advisory Committee ..........*.............*.. IB
1. National Ambient Air Duality Standards 18
2. Current Limitations on the Role of CASAC in Reviewing
Ambient Air Quality standards. ...,.....,«»,.*...,.*...,»..... 19
3. Need for Long-term Commitment to Research in Support
of Air Quality Standards Development..»...*.,............... 21
4. Strengthening of Improved Procedures for the Preparation of
the Next Five-Year Cycle of Criteria Documents 24
5. Form and Content of Ambient Air Quality Criteria Documents
and Staff Papers. ......... 27
6. Risk Analysis and Air Quality standards..................... 27
7. Public Participation in Scientific Reviews.................. 28
8. Working Relationship Between EPA and CASAC. 29
Appendix of Major CASAC Documents*...........,......,......*...... A-l
LIST OP FIGURES
Figure 1: 1970 Clean Air Acti Key Air Quality Criteria and
Standards Provisions 5
Figure 2; 1977 Clean Air Act Amendments* Key Additional
Provisions Beyond 1970 Act.....,...........*.........*. 6
Figure 3t Summary of Criteria Document Preparation Process....... 9
Figure 4; Format for SAB/CASAC Closure Memorandum for Criteria
Documents .,.....,,................*...«..*. 10
Figure 5t Chronology of CASAC Meetings, Agendas, and Major
Recommendations 14
Figure 6: National Ambient Air Quality Standards'
Setting Process 2(1
Figure 7: CASAC Recommendations for Establishing a Long-term
Ongoing Research Program in Support of the Development
of Ambient Air Quality Standards. 25
iii
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Hosier of Members and Core Consultants of the
Clean Air Scientific Advisory Committee
Chairman
Dr, Sheldon K, Friedlander
Dept. of Chemical, Nuclear and
"Thermal Engineering
School of Engineering and Applied
Science
UCLA
Los Angeles, Calif, 90024
Staff Officer
Dr. Terry P. Yosie
Science Advisory Board (A-101)
EPA
401 M. Street, s.W*
Washington, D.C. 20460
Members
Dr. Mary Aradur
Dept, of Nutrition and Food
Science
MIT
Cambridge, Mass, 02139
Dr. Judy A, Bean
College of Medicine
Dept, of Preventive Medicine
and Environmental Health
University of Iowa
Iowa City, IA 52242
Mr. Harry Hovey
New York Dept. of Environmental
Conservation
50 Wolf Road
Albany, New York 12233
Dr. Vaun Pewill
Associate Medical Director
Exxon Corporation
1251 Avenue of the Americas
New York, NBW York 10020
Mr. Donald Pack
Consulting Meteorologist
1826 Opalocka Drive
Mcliean, VA. 22101
Core Consultants
Dr. Robert Dorfman
Dept. of Economics
Harvard University
Cambridge, Mass. 02138
Dr. Bernard Goldstein
Dept. of Environmental and
Community Medicine
Rutgers Univ. Medical School
Piscataway, N.J. 08854
Dr. Herschel Griffin
Graduate School of Public Health
San Diego State University
San Diego, Calif, 92182
Dr. Morton Lippmann
Institute of Environmental
Medicine
New York University
New York, N.Y. 10016
Dr. Michael Treshow
Department of Biology
University of Utah
Salt Lake City, Utah 84112
IV
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INTRODUCTION
Among the provisions of the 1977 Clean Air Act Amendments
was a requirement that the Administrator of the 0.S. Environmental
Protection Agency appoint an "independent scientific review
committee" to undertake a number of review functions associated
with EPA's development, promulgation, and implementation of
National Ambient Air Quality Standards (NAAQS), Since its
original meeting in November 1978 this committee, known as the
Clean Air Scientific Advisory Committee (CASAC), has held a number
of public meetings with EPA staff from various program offices as
well as members of the public. The Committee has directly
participated in the process of developing NAAQS through its
scientific review of air quality criteria documents and
supplementary documents prepared by the Agency in the course of
proposing and promulgating NAAQS, Due to the time constraints
encountered during the review of such documents, the Committee has
not had the opportunity to thoroughly investigate issues such as
the role of economics in setting NAAQS, alternative strategies for
attainment of air quality standards, and regulatory analysis of
proposed standards. Future meetings and reports of the Committee
will address these and other issues associated with NAAQS.
Based upon its experience in the scientific review process,
the Committee has prepared a report, with recommendations
concerning the standard-setting process, which it hopes will prove
useful to the Agency in improving methods of setting
scientifically supportable ambient air quality standards.
Committee members have also prepared this report to supplement the
discussions they have carried out in CASAC's public meetings. We
believe the report will be useful to EPA and to the Congress as
amendments to the Clean Air Act are considered during the coming
months.
CONCLUSIONS AND RECOMMENDATIONS
* National Ambient Air Quality Standards (NAAQS) are an
effective way of controlling atmospheric levels of pollutants such
as carbon monoxide which are directly emitted from a variety of
sources of different types. Conventional emission standards,
alone, would not be sufficient for the control of atmospheric
levels of such pollutants whose concentrations are superimposed in
the atmosphere.
National Ambient Air Quality Standards are also a
reasonable way of controlling pollutants formed in the atmosphere,
such as ozone and other photochemical oxidants and nitrogen
dioxide. In principle, the control of emissions of the precursors
of such pollutants should be sufficient to limit atmospheric
levels of the reaction products to any prescribed level. However,
the available models relating air quality to emission sources are
not good enough to use emission standards by themselves to protect
air quality for pollutants formed in the atmosphere.
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Ambient Air Standards need to be periodically reviewed
to determine whether they are adequate in form or numerical values
to protect the public health and welfare. The five-year review
cycle established by the 1977 Clean Air Act Amendments is an
appropriate time frame in relation to the rate of advance of the
pertinent scientific data bases.
• CASAC's role in the standard-setting process should be
expanded to include th£ opportunity to comment on the Begulatory
Decision Package (RDP) sent to the Administrator prior to
selection and publication of proposed ambient air quality
standards in the Federal Register* CASAC's current
responsibilities have included the scientific reviews of criteria
documents and Office of Air Duality Planning and Standards'
(OAQPS) staff papers, which identify key studies and evaluate
other factors which are critical in setting or revising an ambient
standard, CASAC's role has not included review of the Regulatory
Decision Package. Since neither the criteria document nor the
staff paper has specifically addressed the numerical value(s) for
the standard, CASAC has not had an opportunity to advise the
Administrator on the scientific aspects of the standard. *•
In seeking to comment on the RDP, CASAC does not wish to set the
standard; that should remain the responsibility of the
Administrator. However, the Committee believes that the
Administrator can make better use of its advice on the
implications of alternative forms and values of the standards for
public health and environmental quality and on the implications
for monitoring and pollution controls, prior to publishing a
proposal.
* Research in support of standards development should be
conducted on a continuing basis and for project periods
appropriate to the complexity of the issues being investigated,
rather than be tied to current budgetary restrictions or the
timetable of a particular standard-setting cycle. Our key
recommendation for improvement in the support of research for
standards development is the creation of a Council for Besearch on
Ambient Standards Development to be composed of senior scientists
from outside the Agency.Council members should have scientific
stature and broad perspectives of the needs of the standards
program. The Council should guide the Agency's decisions on which
of its peer reviewed approved grants to fund from a specific line
appropriation in the Agency's budget. The Council could also
periodically identify research needs to the Agency, the Office of
Management and Budget, and the Congress to aid in budgetary
planning.
* EPA should continue to strengthen its procedures for
development of the next five-year cycle of air quality criteria
documents. These procedures should continue to include early
identification of critical scientific issues; assignment of
An exception to this practice was the CASAC review? in
July 1981 of the recent draft staff paper for particulate matter
in which the Agency, as an experiment, included ranges of numbers
for a twenty-four hour and an annual standard.
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responsibility to a Criteria Document Manager for producing a
scientifically supportable criteria document? and extensile use of
workshops and public comments in the review and revision of
criteria documents.
* Current criteria documents, while massive, lack many
kinds of informed commentary and critical interpretation which the
Administrator needs to set standards. CASAC recognizes that all
pertinent studies dealing with specific pollutant effects must at
least be identified in the criteria documents. However/ these
documents should contain a more judicious selection of studies for
discussion with an emphasis on significant studies or studies of a
high scientific quality. EPA has agreed in principle with this
recommendation for development of the next five-year cycle of
criteria documents. If the criteria document were so
restructured, there would be less need for interpretation of the
scientific data base in the staff paper; the staff paper could
then be expanded to include a discussion of the possible forms and
ranges of numerical values for the standard and the implications
of each of these alternative values for the protection of the
public health and welfare,
* The scientific basis for several of the NAAQS remains
uncertain. Dose-response relationships, particularly at low
concentration levels, are difficult to establish and are likely to
remain controversial. To deal with these uncertainties, EPA
should increase its efforts to develop risk assessment
methodologies for quantifying the range of public health effects
produced by exposure to individual or combined class(es) of air
pollutants. By asking different sets of questions of available
scientific data, risk assessments could assist the Administrator
and the general public in evaluating the uncertainties in the
medical evidence and would indicate more explicitly the health
risks associated with alternative standards,
* CASAC reaffirms its policy of liberal participation at
its meetings by interested members of the public. CASAC has
invited individuals and groups from the public to make formal
presentations before the Committee as well as to engage in the
more informal question and answer sessions with Committee members
and EPA staff. This process has improved the quality of the
scientific dialogue on issues of national concern and has provided
a forum for the exchange of sometimes differing views. By
engaging in these discussions, EPA staff has had to defend their
scientific assumptions and views prior to reaching decisions on
standards. The result has, we believe, enhanced the
decisionmaking process.
* An effective working relationship has developed between
EPA and CASAC. Through the closure statement the Agency depends,
upon CASAC to advise it on the scientific adequacy of criteria
documents and staff papers. Closure thus provides a strong
incentive for cooperation between the Agency and the Committee. A
similar incentive is needed for the Agency to seek CASAC advice on
the scientific adequacy of standards.
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DEVELOPMENT OF AMBIENT AIR QUALITY STANDARDS
A. Legislative Requirements
The Clean Air Act Amendments gave the Environmental
Protection Agency the responsibility to establish nationwide
ambient air quality standards requisite to protect the public
health and welfare with an adequate margin of safety. Key
provisions of the present Act are included in Figure 1.
In order to establish an ambient air quality standard, the
Act requires a determination that a particular pollutant, which
arises from diverse mobile or stationary sources, causes or
contributes to air pollution which in the Administrator's judgment
"may reasonably be anticipated to endanger public health or
welfare," Within 12 months of the listing of a pollutant under
section 108(a) of the Clean Air Act, the Administrator must
publish an air quality criteria document which assesses the
scientific data base underlying the ambient air quality standard.
The criteria document must contain the "latest scientific
knowledge useful in indicating the kind and extent of all
identifiable effects on public health or welfare."
Simultaneous with the publication of a criteria document,
the Administrator must propose p_rimary_ and secondary national
ambient air quality standards, as appropriate. A primary standard
must be one that, in the Administrator's judgment, is requisite to
protect the public health with an adequate margin of safety, A
secondary standard must be adequate to protect the public welfare
fromknown or anticipated adverse effects. Following the proposal
of any primary or secondary standard, a public comment period
ensues, including the holding of a public hearing. Taking into
account the public comments, the Administrator then promulgates
the final standard.
The 1977 Clean Air Act Amendments retained most of the
legislative requirements of the 1970 Act for the development of
ambient air quality standards and specified certain additional
requirements (Figure 2). For example, the 1977 Amendments require
that all existing criteria documents be periodically reviewed by a
newly created "independent scientific review committee." Itiis
directive was in addition to the already existing practice of
having EpA's Science Advisory Board (SAB) review draft criteria
documents. The SAB's authority to comment on draft criteria
documents was statutorily established by the Environmental
Research, Development and Demonstration Authorization Act (ERDDAA)
of 1978, The CASAC, as an SAB committee, therefore retains
authority to provide advice to EPA on both draft and existing
criteria documents. The CASAC, like all SAB committees, is an
independent body made up of scientists and other experts from
outside the Agency who have substantial scientific and technical
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FIGURE 1
CLEAN AIR ACT;
SI MS QQ&LITY CRITERIA AND STANDARDS PROVISIONS
o LIST UBIQUITOUS POLLUTANTS WHICH IN ADMINISTRATOR'S
JUDGMENT MAY ENDANGER PUBLIC HEALTH OR WELFARE
O ISSUE CRITERIA DOCUMENTS CONTAINING LATEST
SCIENTIFIC KNOWLEDGE ON IDENTIFIABLE EFFECTS
OF POLLUTANT ON PUBLIC HEALTH/WELFARE
O PROPOSE NATIONAL AIR QUALITY STANDARDS WHEN CRITERIA
DOCUMENTS ARE ISSUED
O PERIODICALLY REVIEW, AND WHERE APPROPRIATE, REVISE
CRITERIA DOCUMENTS AND AIR STANDARDS
CLEAN AIR ACT STANDARDS PROVISIONS
o PRIMARY NATIONAL AMBIENT AIR QUALITY STANDARDS
PROTECT THE PUBLIC AGAINST ADVERSE HEALTH EFFECTS
WITH AN ADEQUATE MARGIN OF SAFETY
0 SECONDARY NATIONAL AMBIENT AIR QUALITY STANDARDS
PROTECT PUBLIC WELFARE FROM KNOWN OR ANTICIPATED
ADVERSE EFFECTS
PUBLIC WELFARE DEFINED TO INCLUDE EFFECTS ONs
SOILS O WATER O CROPS O VEGETATION o ANIMALS
WILDLIFE O WEATHER o VISIBILITY o CLIMATE
MAN-MADE MATERIALS O ECONOMIC VALUES
PERSONAL COMFORT/WELL BEING
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FIGURE 2
1977 CLEAN AIR ACT AMENDMENTS:
KEY ADDITIONAL PROVISIONS BEYOND 1970 ACT
O REVIEW AND REVISE ALL EXISTING CRITERIA AND
STANDARDS AS APPROPRIATE BY DECEMBER 31, 1980
o THEREAFTER REVIEW AIR QUALITY CRITERIA AT S-YEAR
INTERVALS AND REVISE STANDARDS AS NECESSARY
o ISSUE, N02 CRITERIA {FOR UNDER 3-HOURS) AND PROMULGATE
SHORT-TERM N02 STANDARD IF NECESSARY
O ESTABLISH A SCIENTIFIC REVIEW COMMITTEE TO REVIEW AIR
QUALITY CRITERIA AND STANDARDS
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expertise relevant to the mission of the Agency. The SAB is
' chartered by the Administrator to provide independent advice and
critical review on scientific matters before the Agency.
In addition to the establishment of the CASAC, section
109(d) of the 1977 Clean Mr Act further directs the Administrator
to complete a review of all existing criteria and standards before
the end of 1980 and at five year intervals thereafter, and to
revise the criteria and standards as appropriate. The
Administrator is also required to issue NOj criteria (for under
three hours}.and promulgate a short-term NOj standard, if
necessary to protect the public health.
Turning to Clean Air Act provisions for the implementation
of ambient air standards, once an ambient standard is promulgated,
primary responsibility under the Clean Air Act shifts from the
federal government to the states, within nine months after
promulgation, each state is required to prepare and submit a State
Implementation Plan (SIP) to EPA for approval. This plan must
identify emission limitations and other measures to attain the
primary standard "as expeditiously as practicable" but not later
than three years after EPA approval, and to attain the secondary
standard within a reasonable time. EPA has established primary
standards solely on the basis of adequately protecting public
health. Both the Agency and the courts have interpreted the clean
Air Act as forbidding the consideration of costs and feasibility
of attainment in setting either the primary or the secondary
standards, although such considerations are relevant in the
development of State Implementation Plans.
B. The Development Process for Air Quality Criteria
During the past few years considerable change has taken
place in the approach by which the Agency reviews and revises air
quality criteria. These changes include reorganizations within
the Office of Research and Development and alterations in the
process of preparing criteria documents7 more formalized review of
criteria documents by the Clean Air Scientific Advisory Committee;
and the development of a critical issues "staff paper" by the
Office of Air duality Planning and Standards.
An administrative decision was made by EPA to house the
CASAC within the Science Advisory Board. This decision stemmed
from a recognition that the activities of CASAC would necessarily
overlap those areas of scientific review carried out by the
Science Advisory Board in such areas as ecological effects,
pollutant transport and transformation, and health effects of
ambient air pollutants. By making the Committee a part of the
Board, the Agency hoped to reduce administrative duplication and
make optimal use of other Board committees and members. Like the
Science Advisory Board, the CASAC is organizationally placed
within the Office of the Administrator and reports directly to the
Administrator*
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The first major step in the process of formulating or
revising ambient air standards is the development or a revision
of a criteria document. Figure 3 summarises six key phases or
steps involved in the Agency's preparation of a criteria
document. The minimum amount of time necessary to accomplish
each step is indicated in parentheses.
Primary responsibility for the preparation of criteria
documents rests with the Environmental Criteria and Assessment
Office (ECAQ), a subdivision within the Office of Research and
Development (QRD), The establishment of this office in early
1978, as a successor to ORD's Criteria and Special Studies Office
(CSSO), resulted front ORD's recognition of the need for a more
formalized preparation of air quality criteria. This awareness
stemmedr in part, from major criticisms leveled by the Science
Advisory Board during its review of the lead criteria document and
from 1977 Clean Air Act Amendment requirements to revise all
existing criteria documents. At least four managerial changes
distinguish ECAO from its predecessor office. These include 1)
recruitment of a multidisciplinary staff with expertise in a range
of health and ecologically-related disciplines? 2} establishment
of formalized workgroups drawn from a number of Agency program
offices to assist in the preparation of criteria documents; 3}
extensive use of consultants to assist in the writing and review
of working drafts of criteria documents both prior and subsequent
to public review? and 4) use of public workshops in which Agency
and non-Agency scientists debate and discuss the merits of
specific studies and attempt to resolve scientific controversies
over their interpretations before such matters are addressed as
part of the public comment period and CASAC review of external
review drafts.
C. Criteria Document Closure Process
The main features of the CASAC review of a criteria document
are embodied in the process known as "closure." (See Figure 4.}
Closure can be characterized in the following manner:
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. 3
4 Letter from L. Grant, J. Padgett, T. Yosie to CASAC,
June 14, 1979. See Appendix,
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FIGURE 3 SIMMY OP CRITERIA DOCUMENT PREPARATION PHDCBSS
PREPARATION AND REVIEW
OP ECW AIR QUALITY CRITERIA
DOCUMENTS
o FjjASB It DOCUMENT PLAtWIMO AND INITIATION [60_DAYS)*
INITIATION OF LITERATtlRB AND ARTICLE PRO-
CUREMENT PBOCEDURES - NOTICE IN FEDERAL REGISTER
OP jw OTHER STAFF
MEMBERS TO DOCUMENT PREPARATION TEAM
RECRUITMENT OF INTilWAL BPA TASK FORCE AND OUTSIDE
CONTRIBUTING CONSULTANTS
OP WORK PLAN AMI TIffiTABLE FOR DOCUMENT
PREPARATION - DEFINITION OF DOOMWf QQOTENTS
BRIEFING OF EPA SCIENCE ADVISORY BOARD (SAB/CASAC)
ON DOCUMENT PUN AMD CONTENTS
o PHASE II; PREPARATIpN OF IClRKIHG DRAFT [60-90 DAYS)
ACCUMULATION AND ANALYSIS OP PERTINENT LITEMTOHE
WRITING OP ROUGH DRAFTS OP DOCUMENT SECTIONS - MAINLY
SUMMARIZING RELEVANT PUBLISflED STUDIES
PRELIMINARY OP AimJDRS TO INITIAL-
DRAFTS - INITIATE CRITICAL ASSESSMENT OF STUDIES
TYPING AND CIRCULATION OP WORKING DRAFT TO INTERNAL
TASK FORCE AND OUTSIDE REVIEWING CONSULTANTS
o PHftSB III: BEVIBW AND REVISION OF WORKING DRAFT (60 DAYS)
CONVENING OP ECA0 TOW, DOaMEMT AOTKMS, EPA IHTERNAL
TASK FOflCE, AND REVIEWING ODNSULTANTS AT 1-3 DAY HJBLIC
WQWKSIIOP
FOLU3W-UP tffiBTINGS OF ECAO STAFF, REVIEWERS, AND
AUT1I3RS AS NECESSA1Y TO 1U5SOLVB REVISION ISSUSS
POST -WORKSHOP REVISION OP DOCUMENT WORKING DRAFT
CRITICAL READING AMD EDITING OF DRAFT BY ECAO STAFF
TYPING, GRAPHICS, AMD PilHTINe OF EXTERNAL REVIEW DfiAFT
* Minimum time necessary to complete phase shown in parentheses.
o HIA5E IV: PUBLIC REVIEW OF EMffiRIW DRAFT (60JMS)
POBLICATION OP REGISTER NOTICE ANNOUNCING
AVAILABILITY OF EXTERNAL REVIEW DRAFT OF DOCUMENT
CIRCULATION OF EOTRMAL DRAFT TO OTHER GOVEWWENT
AGENCIES, EPA'S SCIENCE ADVISORY BOARD {SAB/CASAC},
AMD THi PUBLIC
BCAO REVIEW OP PUBLIC COMMENTS
FOR POSSIBLE REVISION OF TSIB CRITERIA DOCWCNT
PRIOR TO REVIEW BY T1IB CASAC
MBETING OF BCAO STAFF, OTHER EPA PERSCTWEl,, AND
CONSULTANTS TO FOR SAB HEFTING
PRESENTATION AND REVIEW OF EXTERNAL DRAFT AT PUBLIC
SAB
o PHASE V: POST SftB DOCUMaff REVISION
DEBRIEFING OF EC/tO STAFF, OTIER PERSONNEL, AND
CONSULTAHTS ' -
IN-DEPTH CATALOGING, REVIEW, AND ANALYSIS OF SAB/
CASAC AND PUBLIC COMMENTS DELrVERED AT CASAC MEETING
ASSIO*EHT OF SPECIFIC REVISION RESPONSIBILITIES TO
ECAO STAFF HEMBERS AND CONTRIBUTING CONSULTANTS
EXECUTION OP REVISION ASSIOMEOTS AND CONSULTATION
HII11I INDIVIDUAL SAB/CASAC MMJERS AS NEEDED
TYPING, EDITING, AND REPRODUCTION COP REVISED PRAFT
AMD RESUBMITTAL OF DOCUMENT TO 11 IE SAB/CASAC
o PilASB VI; PIMM. SAB CLOSUBE AND PUBLICATION (60 DAYS)
HECIR0JLATION OF EXTERNAL REVIEW DRAFT FOR PUBLIC
COMMENT AND SAB REVIEW
BCAO REVIEW OF PUBLIC FOR POSSIBLE
OF CRITERIA DOCLWENT PRIOR TO REVIEW BY CASAC
PRESENTATION AND REVIEW OP EXTERNAL DRAFT AT
PUBLIC SAB/CASAC MEETING
SUBMITTAL OF WRITTEN SAB/CASAC COMMITTEE
REPORT ON DOOftKNT TO OPA ADMINISTRATOR
TYPING, EDITING ANH PRINTING OF PREPRINT
AMI PUBLICATION OF Hi [TIM A DOCUMENT
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FIGURE 4
FORMAT FOR SAB/CASAC CLOSURE MEMORANDUM FOR CRITERIA DOCUMENTS
o CHAIRMAN'S SUMMARY OF OVERALL CONSENSUS OR MAJORITY VIEW
REGARDING COMMITTEE'S EVALUATION
O 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?
O SIGNED CONCURRENCE OF COMMITTEE MEMBERS OR CHAIRMAN ON
REPORT—SPECIFICS OF INDIVIDUAL DISSENT OR MINORITY REPORT
APPENDED
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The practice of closure represents a marked improvement in
the review of criteria documents compared to previous reviews
conducted prior to the establishment of CASAC. For example, it
avoids the confusion that surrounded the review of the oxidant
criteria document by the Science Advisory Board. In the review
of that document, charges that the Agency ignored its scientific
advisors have surfaced in litigation brought against EPA on the
ozone standard. This controversy wight have been avoided had
the Agency and the review committee employed present reporting
procedures.
D. Staff Paper
Once the criteria document has been reviewed by the public
and the CASAC, the staff of the Office of Air Quality Planning
and Standards prepares a paper which evaluates the key studies
in the criteria document and identifies critical elements to be
considered in the development of the standard. In addition, the
paper provides a discussion of uncertainties in the medical
evidence and other factors which the staff believes should be
considered in selecting an adequate margin of safety and a final
standard level. The staff paper also evaluates studies which
should be used in making scientific judgments on the level at
which there are effects on public welfare. Previous staff
papers for carbon monoxide and nitrogen dioxide did not present
a judgment on what concentration level(s) should be established
for the standard, although the recent draft staff paper for
particulate matter did discuss possible ranges for a revised
standard* The paper does help to bridge the gap between the
science contained in the criteria documents and the judgment
required of the Administrator in setting ambient air quality
standards.
Although not required by statute, the staff paper is
reviewed externally by the public and the CASAC. CASAC holds a
public meeting to provide its comments and to solicit comments
from the public. Once the paper has been reviewed by the CASAC,
the scientific judgments made in the paper form the basis for
the OAQPS staff's recommendation to the Administrator for a
proposed standard.
CASAC POLE AND RESPONSIBILITIES
Section 109(d)(25 of the Clean Air Act, as amended,
provides CASAC with a broad mandate to conduct scientific reviews
in a number of areas related to EPA's development of air quality
criteria and the promulgation and implementation of primary and
secondary ambient air quality standards* Quoting from the
statute, the Committee's duties include the following!
"Not later than January 1, 1980, and at five-year
intervals thereafter, the committee...shall complete a
review of the criteria published under section 108 and the
national primary and secondary ambient air quality standards
promulgated under this section and shall recommend to the
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Administrator any new national ambient air quality standards
and revisions of existing criteria and standards as may be
appropriate *. * *
Such committee shall also (i) advise the Administrator
of areas in which additional knowledge is required to
appraise the adequacy and basis of existing, new, or revised
national ambient air quality standards, (ii) describe the
research efforts necessary to provide the required
information, (iii) advise the Administrator on the relative
contribution to air pollution concentrations of natural as
well as anthropogenic activity, and (iv) advise the
• , Administrator of any adverse public health, welfare, social,
economic, or energy effects which may result from various
strategies for attainment and maintenance of such national
ambient air quality standards.1*
In addition to these statutory requirements, CASAC's
desianation by EPA as a standing committee of the Science Advisory
Board has conferred other responsibilities. Quoting from CASAC's
Science Advisory Board charter, the Committee
"shall hold meetings, perform studies, make necessary
site visits and undertake other activities necessary to meet
its responsibilities. The Committee will coordinate its
activities with other committees of the Science Advisory
Board and may, as it deems appropriate, utilize the
expertise of other committees and members of the Science
Advisory Board. Establishment of subcommittees is
authorized for any purpose consistent with this charter.
The Committee will report to the Administrator of the D.S.
Environmental Protection Agency....
Members shall be persons who have demonstrated high
levels of competence, knowledge, and expertise in
scientific/technical fields relevant to air pollution and
air quality issues. Members of the Committee become members
of the Science Advisory Board, and the Chairman of the
Committee, or his designee, shall serve as a member of the
Executive Committee of the Science Advisory Board. The
Committee will meet three to six times per year. Support
shall be provided by EPA through the offices of the Science
Advisory Board. The annual operating cost will not exceed
3150,000 and three man-years."
And, as previously noted, as a committee of the Science
Advisory Board, CASAC, pursuant to section 8{e) of the
Environmental Research, Development and Demonstration Authorization
Act of 1978, may make available to the Administrator its advice
and comments on the scientific and technical basis of proposed
criteria documents and standards.
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How has the Committee addressed these responsibilities? The
Clean Air Act requires that the Committee review all of the air
quality criteria documents published under section 108 of the Act.
Since the Agency had already announced its plans to revise
existing criteria documents, the Committee decided that the most
useful approach was to review the scientific and technical
adequacy of new criteria documents. This course of action has
provided the Committee with greater opportunity to exercise its
influence in reviewing the scientific basis for new criteria
documents. Discussion of this and other issues pertaining to the
Committee's role occurred in public meetings with participation by
EPA's Office of Air Quality Planning and Standards, Office of
Research and Development, Office of General Counsel, and
interested members of the public. To date, CASAC has reviewed
four sets of criteria documents. These include carbon monoxide
(CO), hydrocarbons (HC), nitrogen oxides (NQX), and sulfur
oxides/particulate matter (SO /PM). A summary of CASAC meetings,
agendas, and major recommendations is provided in Figure 5.
Throughout its review of a variety of scientific issues,
CASAC has stressed the need for EPA to address effects on public
health or welfare produced by exposures to a mix of air
pollutants. Examples include the following:
o At the first meeting of CASAC in November 1978,
Committee members recommended that the Agency issue
a combined sulfur oxides/particulate matter criteria
document. The Committee reaffirmed this advice in
August 1980.
o CASAC has noted the significance of health effects
produced by combined SO.J/PM exposures or with
pollutants combined with NOX or O3.
o The Committee has recommended to the Administrator
that EPA prepare an integrated and interpretive
scientific document that reviews the causes and
effects of acidic deposition. Such a document
should evaluate the state of scientific knowledge
with regard to precursor emissions, transport of
acidic compounds, pollutant deposition (both wet and
dry), and the effects (both measured and potential)
of acidic deposition. The Administrator has
reviewed this recommendation and has directed Agency
staff to prepare such a document, which will be
reviewed by the Committee.
o CASAC has suggested the incorporation of information,
in various criteria documents, on the role of
hydrocarbons in ozone formation and their role as
generators of chemical species that also affect
other atmospheric processes, so that control
strategies are formulated with the several impacts
of hydrocarbons in mind.
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FIGURE 5
Chronology of CflSAC Meetinga, flgendaa, and Major Recommendationa
Date
Agenda
Major CAS.RC Conclusiona/Recommendations
November 1-2, 1978
January 23-30, 1979
January 30-31, 1979
(CO Subcommittee)
Process of Setting HAAQS and Standards
Currently Using Developed
Schedule and Procedures for Preparing
Criteria Documents
Development Plan tor SOX/PM Criteria
Document
fieview of NOX criteria document
Review of CO criteria document
CASAC endorses joint criteria document approach
CASAC recommends substantial revisions in assess-
ments of scientific studies of health and welfare
effects from NOjj, EPA agrees to revise and! resubmit
criteria document for GASAC review.
CO Subcommittee advises reviaion. of'Criteria
document to amplify comments on certain. Issues and
stucilea t but Subcommittee Is In general agreement
with criteria document conclusions.
June 14-15, 1979
Revised CO criteria document
CO Staff Paper
CO Subcommittee concluctes revised CO criteria
document ia scientifically adequate for standard
setting.
1, Critical COHb level reached at 2.7-3,0%.
2. Modeling techniquea acceptable.
3. Exercise level assumptions reasonable.
4. Averaging times appropriate.
5. Aggravation of angina described as adverse
health effect.
€, Use 1978 Aronow passive ainoklng study in
considering margin of safety.
-------
FIGURE S {Continued)
Chronology of CASAC Meetings, Agendaa, and Major Recommendations
Date
ftgenda
Major Concluaions/Eecommendations
June 15-16, 1979
March 17, 1980
Report to CftSAC of CO Subcommittee on
Criteria document and staff paper reviews
Committee Procedures
Review of EPA Issues paper, ''Facts amd
Issues Associated with the Need to
Develop a Hydrocarbon Criteria Document"
Briefing bf EPA Qxidants Research
Committee Cochairmen
CASAC authorizes preparation of.memo to the
Administrator affirming conclusions of CO
Subcommittee
CASAC adopts l
-------
FIGURE 5 (Continued)
Chronology of CftSAC Meetings, agendaa, and HaJOE Recommendations- •
Date
Agenda
Ita j o r Corrclua ions/Recommendations
November 13-14, 1980 Revised HOX criteria document
staff paper
February 6, 1981
(Subcommittee
on Health Effects
of NO2)
Briefing on proposed revisions
to ambient CO standard
staff paper
March 10-11, 1981
Preparation of report to Administrator
and Congress of principal findings and
recommendations.
Document adequately addresses previous CASAC
criticisms and is scientifically adequate for
standard setting. Authorization provided to
Inform Administrator of CASAC conclusions through
preparation of a closure memorandum.
Welfare effects data adequately presented and
Interpreted. Health effects studies over-
interpreted. Health studies need further discussion
by CASAC.
1, Ho clear-out evidence of Adverse health effects
In clinical studlea at HOj levels below 1 ppm,
2. No single study- seen aa providing a quantitative
basis for selecting effects levels, SPA should
draw from a composite of: animal r clinical, and
epidemiclogical data to determine an effects
level,
3, Subcommittee recognized the need to protect
against both short and longrterm health effects,
but no consensus was drawn on the form of a
standard,
4, Staff paper will be revised and resubmitted to
CASAC,
1. Re-affirm use of ambient standards to control
criteria pollutants.
2, Expand CASAC review role in HAAQS development.
3, Establish new research grant progreun specifically
to support standards development.
4, Strengthen procedures for development of
next five-year cycle of criteria, documents,
5, Prepare more interpretive criteria documents and
Include discussion of the possible forms, ranges,
and numercial values for the standard in the
staff paper,
6. Continue development of risk assessments for use
In setting standards.
7, Public participation in CASAC meetings has
improved the HAAQS standard-setting process,
8. EPA-CASAC working relationship is constructive.
-------
FIGURE 5 (Continued3
Date
Chronology of CASAC Meetings, agendas, and Major Recommendations
Agenda Major Conclusion a /Recpnunenda t iona
July 7-9, 1981
Revised SOX/PM Criteria Document
Partieulate Hatter Staff Paper
1. With revisions suggested by CASAC to be
incorporated in Vols, II—V, and with the
preparation of a revised Vol. 1 which the
Committee will receive by mail,, CRSAG agrees
in principle that the criteria document is
scientifically adequate for use in standard
setting.
I, CASJVC recommends a 10 micrometer size cut for
a revised ambient particulate standard.
2. EPA staff should develop a stronger case in
support of a secondary standard for fine
particles,
3, The numerical ranges stated in the staff paper
are reasonable, but more work is needed to
supplement epidemiological studies with human
clinical and animal fcoxicologlcal data at both
the upper end and lower end of the ranges.
4, The caae for a 3 mile aircraft visibility standard
has not been made,
5, Duplications a.ncl inconsistencies between the staff
paper and various sedtions of the ceitejfia document
Should be resolved; also, further modifications in
the criteria, document suggested by CASRC should
result in similar revisions in the sbaCf paper.
-------
FINDINGS, RECOMMENDATIONS, AND COMMENTS OF THE CLEAN AIR
SCIENTIFIC ADVISORY COMMITTEE
1, National Ambient Air Oua^lity Standards
The Clean Air Act calls for the development and promulgation
of National Ambient Air Quality Standards for ubiquitous
pollutants which, in the Administrator's judgment, have adverse
effects on public health or welfare. The Act also provides for
the establishment of technology-based emission standards to
control pollutants. Thus, Congress decided to utilize two
distinctive yet complementary approaches to standards for
pollution control, i.e., an ambient standards approach to be
implemented by the states, and a technology performance approach,
utilizing emission standards, to be applied to selected categories
of mobile and stationary sources. Hazardous pollutants are to be
controlled through emission standards applied to both existing and
new sources.
Both approaches have advantages and disadvantages* Ambient
air quality standards are most appropriate for pollutants which
originate from numerous, varied, and widespread sources such as
furnaces for heat and power production. They are also useful for
pollutants such as ozone and nitrogen dioxide which form in the
atmosphere. Technology-based emission standards are most
appropriate for new sources, which can more readily apply the
latest control technology, and for sources of ha2ardous air
pollutants, where the major sources are limited in number and
readily identifiable.
National Ambient Air Quality Standards are an effective way
of controlling atmospheric levels of pollutants such as carbon
monoxide and sulfur dioxide which are directly emitted from a
variety of sources of different types. Conventional emission
standards, alone, would not be sufficient for the control of
atmospheric levels of such pollutants, whose concentrations are
superimposed in the atmosphere.
National Ambient Air Quality Standards are also a reasonable
way of controlling pollutants formed in the atmosphere, such as
ozone and other photochemical oxidants and nitrogen dioxide. In
principle, the control of emissions of the precursors of such
pollutants should be sufficient to limit atmospheric levels of the
reaction products to any prescribed level. However, the available
models relating air quality to emission sources are not good
enough to use emission standards by themselves to protect air
quality for pollutants formed in the atmosphere.
For some pollutants, both approaches are utilized
simultaneously. Emission controls on motor vehicles are needed to
approach or achieve the ambient air quality standards for carbon
monoxide and ozone, whose atmospheric concentrations are primarily
attributable to motor vehicle emissions. In the areas where the
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standards are exceeded, other control approaches can be utilized
to supplement the emissions controls, such as restrictions on
motor vehicle usage, mandatory inspection and maintenance of
control device performance, etc* This may be preferable and more
cost effective than a uniform, national tightening of the
performance requirements for emission controls.
The NAAQS's need to be periodically reviewed to determine
whether they are adequate in form or numerical values to protect
the public health and welfare. The five-year review cycle
established by the 1977 Clean Air Act Amendments is an appropriate
time frame in relation to the rate of advance of the pertinent
scientific data bases.
2. Current Limitations on the Role of CASAC in Reviewing Ambient
Air Quality Standards .
Most of CASAC1s efforts, to date, have been devoted to the
review of draft criteria documents, one of its major
responsibilities as established by statute. To bridge the gap
between the large volumes of scientific data summarized in the
criteria documents and the critical evaluation of these data
needed by the Administrator in developing a standard, the EPA's
Office of Air Quality Planning and Standards (GAQPS) has prepared
a "staff paper" for each criteria pollutant. The staff paper
discusses those data, cited in the criteria document, which OAQPS
believes provide the best scientific basis for a standard. At the
request of OAQPS, CASAC has also reviewed its staff papers. The
CASAC input to the standard-setting process has, to date, been
largely limited to these document reviews, which are part of the
overall process illustrated in Figure 6, In this figure, CASAC*s
input is included in the two boxes labelled "Public and Scientific
Peer Review."
Following the review of a criteria document and its
associated staff paper by CASAC, OAQPS prepares a Regulatory
Decision Package (RDP) which, for the first time, addresses the
issue of one or more numerical values for the air quality
standard. EPA has not sought CASAC advice on the RDP perhaps
because it believes that CASAC input at this stage would involve
the Committee in policy as opposed to scientific issues and would
limit the freedom of the Administrator to select the form and/or
the numerical values of the proposed standards.
CASAC believes that EPA should take more advantage of
CASAC's extensive knowledge of pollutant effects gained through
its reviews of the criteria document and staff paper. CASAC does
not seek to select the form or values of the standard. That is
the responsibility of the Administrator. However, CASAC believes
that the Administrator can benefit from its advice on the
implications of alternative forms and values of the standard to
public health, environmental quality, and the technological
feasibility of monitoring and controls.
-ig.
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FIGURE 6 NATIONAL AMBIENT AIR QUALITY STANDARDS
SETTING PROCESS
OAQPS (OANR)
REGULATORY IMPACT
ANALYSIS
SCIENTIFIC
COMMUNITY
ECAO (GRD)
ECAO (GRD}
OAQPS (OANR}
OAQPS {OANR)
SCIENTIFIC
RESEARCH
CRITERIA
DOCUMENT
KJ
O
T
STAFF PAPER
INTERPRETING KEY
STUDIES IN
CRITERIA DOCUMEN1
PUBLIC AND
SCIENTIFIC
REVIEW
REGULATORY
DECISION
PACKAGE
V
I
PUBLIC AND
SCIENTIFIC PEER
REVIEW
ADMINISTRATOR
DECISION
V
AGENCY
REVIEW
PROPOSAL
PUBLIC MEETINGS
AND COMMENTS
AGENCY RE¥IEW
REGULATORY DECISION
PACKAGE REFLECTING
PUBLIC COMMENTS
(ORD1-OFFICE OP RESEARCH AND DEVELOPMENT
(ECAO)-ENVIRONMENTAL CRITERIA AND ASSESSMENT OFFICE
(OANH)-OFFICE OF AIR, NOISE, AND RADIATION
(OAQPS)-OFFICE OF AIR QUALITY PLANKING AND STANDARDS
ADMINISTRATOR
DECISION
FKUMU LGATION
-------
Although CASAC can comment on the proposed standard after it
has been published in the Federal Register, EPA's credibility
would be damaged unnecessarily by public criticism from CASAC on a
proposed standard. In additiont CASAC1s input on the RDP would
improve the scientific quality of decisionmaking on NAAQS.
To summarize, CASAC believes that it should review RDPfs in
the current, uncompleted round of NAAQS reviews* If, however*
there are legal or scheduling impediments to its participation in
the review of the RDP in this round, CASAC believes that these
impediments should be removedf so that it can contribute to future
reviews.
3. Need for Long-Term Commitment to Research in.Support of Air
Quality Standards Development
In recent CASAC reviews of the air quality criteria
documents, it became clear that major gaps remain in current
knowledge about the nature of the health effects, the dose-
response relationships and the temporal and spatial variations in
the concentrations of criteria air pollutants. Furthermore, for
pollutant classes such as NQ^ and so^, there are major
temporal and spatial variations in the proportions present as
vapors and those present as particles. Some of these chemicals
are primary pollutants (e.g., NO and SC^) which serve as
precursors for atmospheric transformations to more toxic
pollutants (e.g., NC»2 and E^SQ^), which in turn are
transformed to less toxic pollutants (NHANQ3»(NH4)2SQ4).
For the pollutant class known as particufate matter which includes
secondary aerosols resulting from the oxidation of NQX and SOX
as well as ash, soil, diesel exhaust particles, etc., there are
substantial variations in particle size distribution and trace
cocontaminants which affect health and welfare.
The gaps in our knowledge make the selection of NAAQS's very
difficult. In the face of the scientific uncertainties, the
Administrator may feel impelled to utilize a greater margin of
safety in selecting an NAAQS than would be necessary and prudent
if there were a more adequate and reliable scientific data base.
An excessively stringent NAAQS can impose enormous incremental
societal costs in terms of the installation and maintenance of
emission controls, additional monitoring of ambient air, and
governmental enforcement activities.
The information gaps can be addressed by research programs
which focus on the critical scientific questions. However, some
of the information needs identified in the recent round of
criteria document reviews are too large to be readily filled by
short-term, highly targeted research projects. There is a need
for long-term programs which enlist a broad range of investigators
willing to make a continuing commitment to research in areas
related to setting ambient standards.
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A long-term commitment of support by EPA is essential to an
effective program. It not only takes time to formulate programs
designed to address some of the complex issues in standards
development, but it takes time, even for the best investigators,
to develop the background, specialized techniques, and
perspectives needed to perform the series of experiments and
studies which can resolve these issues. In the past, crash
programs have been initiated only two years or less before the
data were needed for decisions. Such a time frame makes it
difficult to enlist the services of the kinds of research talents
needed to address the fundamental questions. Some of the research
needs which face EPA today were apparent when the initial air
quality criteria documents were prepared in 1969. These
information gaps might have been resolved had there been a
commitment of resources guided by a standards development policy
and overseen by a suitable group of senior scientific advisors.
EPA does have mechanisms for performing and supporting
research needed for ambient air quality standards development.
Intramural research performed in its Health Effects Research
Laboratory and Environmental Sciences Research Laboratory has
made, and will continue to make, important contributions. In
addition, some of the newly created university-based EPA-sponsored
research centers have program elements which involve research
related to the development of NAAQS's. Unfortunately, these
various research activities, valuable and important as they are,
fall short in terms of developing the broad scientific data base
needed for establishing NAAQS's which are both cost-effective and
protective of human health and environmental quality. Such
research cannot, by itself, do the job because it is too
restricted in scope and level of effort. It fails to enlist the
talents of the larger scientific community, especially in terms of
support of innovative, investigator-initiated research of the type
supported by the National Institutes of Health (NIH) and the
National Science Foundation (NSP). Some support for research
related to the development of NAAQS is available from NIH and NSP,
but these agencies tend not to support research perceived as
"practical" or program-oriented, preferring studies perceived as
"basic research."
EPA is an agency which always has been and probably always
will be on the "firing line." Public and Congressional pressures
cause it to divert funds and personnel to investigate and control
the "crisis-of-the-month." There is, therefore, concern about its
ability to effectively manage long-term research programs. On the
other hand, EPA is the logical federal agency to support long-term
research on standards development, since standards development
will continue to be a major statutory responsibility of the
Agency.
A. Effective Patterns of Research Support
There are several patterns of long-term research support
within and outside of EPA which provide proven mechanisms for a
research program in support of standards development. Within EPA,
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there is the highly successful peer review grants program which
was initiated about two years ago. In this system, the Agency has
solicited the submission of investigator-initiated research grant
applications directed at specific broad categories of Agency
program needs* These grant applications are evaluated for
scientific merit by a review panel composed primarily of academic
researchers, but also including some EPA research personnel.
There are currently four panels and they meet three times each
year. In the first full year of application, the panels reviewed
658 grant applications and approved 207 of them. Those that were
approved were given a scientific rating. These ratings and the
relevance of the research to EPA program needs were evaluated by
Agency personnel in deciding which of the approved grants to fund.
Of the approved grants, 103 were funded.
The EPA extramural grants program is similar to, and in many
respects is patterned after, the highly successful extramural
grants programs of the National Institutes of Health. In terms of
the scientific peer review procedures, there are not important
differences; those differences that do exist are reasonable given
the differing responsibilities of the agencies. On the other hand,
in terms of the secondary reviews, there are substantial and
significant differences. Each NIH Institute (NCI, NIEHS, etc.)
has a scientific council composed of extramural senior scientists.
Each council meets three times a year to evaluate the grants
assigned to that Institute and previously reviewed by one of the
discipline-oriented peer review panels (study sections). Uiey
weigh the scientific merits of each grant, as outlined to them in
the summary statements prepared by the study section, and the
relevance of the proposed work to the mission of that particular
Institute. As Institute advisors are not employees, they can and
do take a long-range view of the needs of the Institute program.
By contrast, the summary statements prepared by the program
area peer review panels of EPA (review panels) are reviewed by
Agency scientists, who are, of necessity, more influenced by
perceived short-term needs of the Agency and whose perspectives
may be more limited than those who would be chosen to serve on an
HIH-type council.
A further critical difference is the length of time that
research support can be committed. NIH Councils can make five-
year commitments of support for approved research grants (subject,
of course, to continued funding of the Institute by Congress). On
the other hand, EPA is limited by Congress to funding research
projects for a maximum of two years.
B. Need for a Special Long-Tferm Commitment for Support of
Research on Standards
Many research programs in support of standards development
need a commitment of more than two years, and mechanisms should be
established to permit such support. Also, recommendations about
which of the peer-review approved grants to fund should be made by
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a group of senior scientists who have broad perspectives of the
needs of the standards program and who are not influenced by the
short-term program needs and budgetary exigencies of the Agency,
Therefore, our key recommendation for improvement in the support
of research for standards development is the creation of a Council
for Research on Ambient Standards,Development to oversee the
research to be supported on a long-tern andT^ontinuing basis by a
specific line appropriation separate and independent of other EPA
research programs.
It may be desirable to constitute this Council as a
subcommittee or affiliate of CASAC since CASAC has the necessary
program perspectives and intimate familiarity with the research
needs in support of standards acquired in the course of its
reviews of the criteria documents. CASAC's major concern,
however, is not that it be involved in the activities of the
Council, but that such a mechanism be created to assure timely
delivery of scientific results. This mechanism could also be
helpful in communicating research needs to EPA, the Office of
Management and Budget, and the Congress to help in their budgetary
analyses,
Our specific recommendations for a new extramural research
program to support the development of ambient air quality
standards are summarized in figure 7.
4. Strengthening of Improved_Procedures for the Preparation of the
Next Five-Year Cycle of Criteria Documents
The preparation of the current round of criteria documents
and staff papers was not always expeditious and efficient. Some
of these documents will be completed after the December 31, 1980
deadline specified in the 1977 Clean Air Act Amendments, and they
will cost much more to prepare than had been anticipated.
Furthermore, the form and content of some initial drafts were
deficient. Some of the problems in schedule resulted from
litigation and were, therefore, beyond the direct control of EPA,
However, the problems of form and content were primarily derived
from the iPA's conception of the documents.
EPA staff are already well aware of most of CASAC's concerns
and have already initiated procedures to improve the development of
the next five-year cycle of air quality criteria documents. The
following represents CASAC's recommendations for the revised
procedures which the Environment Criteria and Assessment Office
should continue to implement in the preparation of criteria
documents,
Recommendations;
A, Identification of Critical Issues to be Addressed by
Criteria Documents
1, BCAO and QAQPS should prepare a compilation of the
critical unresolved issues relative to the setting of an
NAAQS for each of the criteria pollutants. For a given
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FIGURE 7
ing
of
CflSAC Recommendations for Establishing a Long-term Ongoing Research Program in Support of the
i
Development of Ambient Air Quality Standards i
I. Suggested Mechanisms for Support of Research
1. Solicitation of long-term (up to 5 years) research grant applications (patterned after the systems used by NIH,
i.e., Request for application (RFA), based upon broad description of research needs), \'
2. Peer Review of applications by current EPA supported Review Panels, or by special review panel with similar i
qualifications, providing summary statement on approval and priority score or disapproval,
3, Review of summary statements by a Council for Research on Ambient Standards Development for relevance to standards j
setting (similar to the advisory role of an HIM Council in the Hid Grants Program}, fe-f
4. BPA commitment to continuing support of the approval applications for up to 5 years, contingent upon f-
satiefactory progress. " ' j
II. Major Areas of Heeded Research for Ambient Standards Development
1» Fundamental Studies of Exposure-Heeponsa for Criteria Pollutants
a. Animal toxicology—short-term and chronic exposures
b. Clinical studies—short-term exposures of human volunteers
c. Population studies—epidemiology of exposed hmnana
2. Fundamental Studies of Atmospheric Composition
a. Primary pollutants—temporal and spatial distributions downwind of sources and potential for population j
exposure ' ' '
b. Atmospheric transformations—temporal and spatial distributions of secondary pollutants, their chemical and
physical properties, and their atmospheric lifetimes under various conditions of temperature, humidity,
actinic radiation, transport, etc.
c. Spatial variations within an airshed
1. center city vs. suburb [
2, ground level vs. elevated sites . I
3, outdoor vs. indoor ;
3. Development and Improvement of Air Samplers, Monitors and Devices for Determining Personal Exposures
a. Samples for sisse-selective sampling of aerosole—for both fixed station and personal sampling 1
b. Improved samplers and/or monitors for reactive apecles, such as HjjSC^, HGj, HNG3, volatile and/or reactive j
organics in or on aerosol particles and in gases, etc. !
i*
I
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pollutant the list should be prepared as soon as reasonably-
possible after the completion of each criteria document and
standard for the pollutant. In this manner, the lists can
guide EPA's research program in support of standards
development, as well as take advantage of the staff's
familiarity with the issues acquired during the preparation
of the criteria documents.
2. The critical issues lists should be refined in
consultation with CASAC.
3, At the beginning of each five-year review cycle of a
criteria document, ECAQ should conduct a public workshop to
develop, update, and refine the critical issues to be
addressed in preparing the criteria document, The workshop
panel should include a cross-section of scientists and
engineers having broad perspective and experience in the
field, and should not exceed twenty-five. The workshop
should develop a concise summary and list of
recommendations.
B. Assignment of Rejaponsibilities for Producing a Criteria
Document' "~ -••-<—<«— ..L_J_1-.J-,-r-
1. ECAO, with the advice of CASAC, should identify one
or more individuals having the appropriate background and
perspective to serve as the Criteria Document Manager (CDM).
This person should spend full-time on this activity, on
leave of absence from his or her permanent position within
EPA, or from a university on a leave of absence and on
temporary EPA assignment.
2. The CDM, appointed by ECAO, should prepare a document
outline and identify suitable authors for the chapters in
the document.
3. The CDM should coordinate development of the
individual chapter outlines for addressing the critical
issues with the chapter authors.
C. Review and Revision of Draft Criteria Document
1. The initial draft should be reviewed at a public
workshop including the CDM and the chapter authors.
2. The chapters should be revised by the authors to
incorporate the input from the authors* workshop.
3. The revised draft of the document should then be
reviewed at a workshop attended by the participants in the
original critical issues workshop,
4. The document should be revised by ECAO to incorporate
the input of the critical issues workshop panel and be
issued as the first external review draft.
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S* QAOPS should prepare a staff paper to highlight the
critical issues and information identified in the external
review draft which provide a scientific basis for proposal
of an air quality standard by the Administrator,
6. The external review draft, and changes in the
document which ECAG plans to make as the result of public
comments, should be reviewed by CASAC.
7. The criteria document should be revised, as
necessary, to obtain closure by CASAC.
5. Form and Content of ambient Air Quality Criteria Oocuments and
Staff Papers
The 1970 Clean Air Act specifies that criteria documents
must contain the latest scientific knowledge useful in indicating
the kind and extent of all identifiable effects on public health
and welfare. The criteria documents prepared by the Environmental
Criteria and Assessment Office of EPA during the current review
cycle have been criticized by CASAC as being overly inclusive
compilations of all available data on the subject pollutant, much
of which is of little relevance to standard-setting. The
documents, while massive, have been lacking in many kinds of
informed commentary and critical interpretation which are needed
by the Administrator in setting standards. CASAC recognizes that
all pertinent studies dealing with specific pollutant effects must
at least be identified in the criteria document. However, the
document should contain a judicious selection of studies for
extended discussion with an emphasis upon significant studies or
studies of high scientific quality. The remaining studies could
be referenced in a bibliography. EPA has agreed in principle with
this recommendation for development of the next five-year cycle of
criteria documents.
If the criteria document were so restructured there would be
less need for interpretation of the scientific data base in the
staff paper. The staff paper could then be expanded to include a
discussion of the possible forms and ranges of numerical values
for the standard and the implications of each of the alternatives
for the protection of the public health and welfare.
6. Risk Analysis and Air Quality Standards
In carrying out the Clean Air Act requirement to develop
ambient air quality standards, SPA must evaluate the "latest
scientific knowledge useful in indicating the kind and extent of
all identifiable effects on public health and welfare which may be
expected from the presence" of pollutants in the ambient air.
Pursuant to this Congressional mandate the Agency must also set
the standards to protect against adverse effects, protect
persons in sensitive groups, and include an adequate margin of
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safety to protect against effects which have not yet been
uncovered by research and effects whose medical significance is a
matter of scientific uncertainty.
One approach that has evolved to address these issues is
known as risk analysis. Risk analysis is a methodology used to
determine the probability that specified events will occur given
particular concentration levels of pollutants, and it attempts to
define the significance of the consequences to public health and
welfare following such occurrences, it consists of scientific
data collectioni assessment of the probabilities of risk based
upon available scientific data? and the evaluation of risks based
upon their probabilities as governed by the risk assessment
process and their value as determined by the policymaker.
EPA has initiated a Bisk Analysis Program in its Strategies
and Air Standards Division (SASD) to evaluate alternative risk
assessment methods with the aim of eventually incorporating risk
analysis into the process for setting ambient air quality
standards. A Subcommittee on Health Risk Assessment of the
Science Advisory Board has recommended that SASD develop and
"establish the credibility11 of these methods* and it is currently
advising that office on the identification and review of
alternative risk assessment approaches.
CASAC recommends that SPA should continue its efforts to
apply risk analysis in assessing and quantifying the range of
public health effects produced by exposure to individual or
combined class(es) of air pollutants. Such scientific/decision
analysis technique(s) offer promise in defining which of the range
of air pollution effects are adverse. By asking alternative sets
of questions of available scientific data, risk analysis could
assist the Administrator and the general public in evaluating
uncertainties in the medical evidence and would indicate more
explicitly the health risks associated with alternative standards.
The Committee also recommends that it be periodically briefed on
the degree of the Agency's progress toward incorporating risk
analysis into the standard-setting process.
7. Public Participation in Scientific Reviews
Throughout all of its meetings, CASAC has invited the
participation of individuals and groups representing the public.
Their input, in the form of formal presentations as well as more
informal question and answer sessions with the Committee and EPA
staff, has considerably enhanced the quality of the scientific
dialogue on issues of national concern. Committee meetings have
For a recent discussion of the role of risk analysis in
standard-setting see Si chard Wilson and Joseph J* Harrington "The
Sole of Risk Analysis in Setting Ambient Air Quality Standards,"
Business Roundtable Air Quality Project, Vol. I.
-28-
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provided a forum for the exchange of sometimes differing views. By
engaging in these discussions with CASAC and the public, EPA staff
have had to defend their assumptions and their interpretations of
scientific data and issues. The result has, we believe, enhanced
the decisionmaking process.
These discussions have not occurred without a certain amount
of confusion or frustration, particularly when legal conflicts
have surfaced which have affected the Committee's work* CASAC,
however, is committed to the public review process and it
reaffirms its policy of liberal participation by interested
members of the public.
8, The Working RelationshipBetween EPA and CASAC
An effective working relationship has developed between EPA
and CASAC. Through the closure statement the Agency depends upon
CASAC to advise it on the scientific adequacy of criteria
documents and staff papers. Closure thus provides a strong
incentive for cooperation between the Agency and the Committee. A
similar incentive is needed for the Agency to seek CASAC advice on
the scientific adequacy of standards.
-29-
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Appendix of Major CASAC Documents
A-l
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1MI2BD STATES ENVIRONMENTAL PROTECTION AGENCY
ABVTSOIY COMMITTEE CHARTER
ORGANIZATION AHD FUNCTIONS - COMMITTEES, BOARDS, PAHELS AND COUNCILS
CT.KAM AIR SCIENTIFIC ADVISORY COMMITTEE
OF THE SCIENCE ADVISORY BQAED
^•* POMPOSE>_ This charter is reissued for the Clean Air Scientific
Advisory Committee (of the Science Advisory Board) is accordance with
the requirements of section i(c) of the Federal Advisory Committee
Act, § U.S.C. CApp- I) 9{c).
2* JfflTHQglTY. The Committee is authorized under section 109 of the
Clean Air Act, as amended on August 7, 1977, (42 U»S.C- 7401 et sea.*).
3* OBJECTIVE AND SCOPE OF ACTIVITY ..._ The Coaoaittee shall provide
independent advice on the scientific and technical aspects of issues
related to the criteria for air quality standards, research related. .,
to air quality, sources ,of air pollution, and the strategies to
attain and maintain air quality standards and to prevent significant
deterioration of air quality. The Committee shall hold meetings,
perform studies, make necessary site visits and undertake other
activities necessary to meet its responsibilities* The Committee
vd.ll coordinate its activities with other committees of the Science
' Advisory Board and may, as it deems appropriate, utilize the
expertise of other committees and members of the science Advisory
Board. Establishment of subcommittees is authorized for any purpose
consistent with this charter. The Committee will report to the
Administrator of the U.S. Environmental Protection Agency.
4* JtWCTSOHS . The Committee will review criteria documents for air
quality standards and will provide independent scientific advice in
response to the Agency's request and, as required by the clean Air Act
Amendments of 1977, it shall:
- Hot later than January 1, 1980, and at five-year intervals
thereafter, complete a review of the criteria published under
section 108 of the Clean Air Act and the national primary and
secondary ambient air quality standards and recommend to the
Administrator any new national ambient air quality standards or
revision of existing criteria and standards as may be appropriate,
Initiated bys BM-213
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ADVISORY COMMITTEE CHASTER
- Advise the Administrator of areas where additional knowledge is
required concerning the adequacy and basis of existing, new, or
revised national ambient air quality standards,
- Describe the research efforts necessary to provide the required
information,
•* Advise the Administrator on the relative contribution to air
pollution concentrations of natural as well as anthropogenic
activity, and
- Advise the Administrator of any adverse public health, welfare,
social, economic, or energy effects which nay result from various
strategies for attainment and maintenance of such national
ambient air quality standards.
5. COMPOSITION BSD MEETINGS . The Administrator -will appoint, a
and six members including at least one member of the National Academy of
Sciences, one physician, and one person representing State air pollution
control agencies for terms up to four years. Members shall be persons
who have demonstrated high levels of competence, knowledge, and expertise
in. •scientific/technical fields relevant to air pollution and air quality
issues* Members of the Committee become members of the Science Advisory
Board, and 'the chairman of the Committee, or his designee, shall serve as
a member of the Executive Committee of the Science Advisory Board* The
Committee will meet three to six times per year. A full-time salaried
officer or employee of the Agency will be present at all meetings and is
' authorized to adjourn any such meeting whenever this official ' determines
it to be in the public interest. Support shall be provided by BPA through
the offices of the- Science Advisory Board. The estimated annual operating
cost will not exceed $150,000 and two work-years of staff support.
e" POSAflQN. The Committee will be needed on a continuing basis. This
charter will be effective until August 1, 1983, at which time the Committee
charter may be renewed for another two-year period.
JUN 2 6 1981
Approval Date Administrator
Date Filed with Congress
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UNITED STATES SNV1HONMEHTAL PflQTsCTtCN AGENCY
•U Q-C
14, 1S7S
Recssraended Procedures for Involving the Clean Air Scientific
Advisory Cassrittes { CASAC) 1n the levies Process for National
Aashient Air Quality Standards
Lsstsr 0, grant, PhJJ.
Dirtetsr, En vi foment Criteria and Assessment Off tea.
Gfffca. of Research asa DeveTopuwrt
Mr, Josapn Padgst±
.Director, Strategies and Air Standaria Division
Qfffcs of A1r Quality Plaunlnf imi Standarts
Mr. Terry r, YOST'S
Staff Offfcsr, Clean Air Scientific Advisory Caroittas
, Sclenca-Acvisory Soard
Intreductrfon . •
SPA staff have he-Id savin! discassloas' as a fallow-tip to the January
SAS/CASAC naaafing1 csneanring posslbls ways far CASAC -a be=aa» involvei in
the review procass far national Aroient A1r Quality Standards (NAAQS).
This assarsndun cantains a. list of proposals and procsaurss arrived at
durtia thesa dlscasslcrts. We ira hapeftil that agresnant cait be rsached with
i izss. 9ies&&rs on the czntiairt of these proposals at the fcr
of
EPA is ra?uirad ta raviw and revise , if necnssary, ssch ?IA5QS svsry
fiva years. Tne carrent sehadule for prtsposal of a revised standard, or
of an existing one, is as follows:
CO ' 'Augusrt 1S75
H&y Movesoer 1ST?
?irticitatas May ISiQ
my ism
Prowl gaticn would accyr six mtartns eftar proposal. These schadulas
include tine for SAS/CASAC ta rtview- the criteria dacssent in a public ssaatinc,
wi*a i.' cOTcingancy all owed far a second aesting.,. if needed. Acssrdln^ ta
the Class Air Acr ^nendrants of 1977, the reviews aatsr 3e caoole^adt i.e.
e rarfsai standard prosailga'ced (if neaded), sy Dacsasser 31, 192!.
The Science Advisory iaard. nas played a key role for sere rftsse in-
assuring tha* the critaria escsaant is sd err: ideally edessiat5 fo
serring* However, the SAB has not carsicisstad in the rsisin^r of rse
A- 4
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standards devel consent prscass, With the establishment -of the Clean Air
Scientific Advisory Cawittae, landatsd by Congress, we ne*d to develop
with CASAC procedures to define what CASAC should- review, the type of
output to result from sues reviews, and hew these reviews cm be
oatsistant wish Cangrsssi snail y aandstsd tine schedules.
For the purposes of discussion, the HMQS standings development precsss
C3it be divided. into the fallowing, eanponents., each of which we suggest be
considered for CASAC revise:
T. Crrtaria docssent
Z. Implications fur standard setting of critical health studies
•. 3. Risk assasssent
4* Regulatory analysis— •ecnmaric, environmental, energy, urban and
cssffiuni^ • insets
' a. Overall standards developaeiTt
cf G^SAC m eaei af «esa. csaponents is dlscasserf below.
Crftarta canent
review, of crr-Jsrla. dccasents is- a. traditional function of the
Advisory Boart (new the SAS/CASAC) and alrtidy has been integrated.
iirca cia standards davelapnent' schedule- One sicnirlcint issue that -
nsnains ta be rssalved,. however, is the aporsacf ay wrtich the Savironcairt
Crttsria Assiassaeiii: Offfcs ncsives. sooa wrfttan assessssent. frso CASIC
cancsminf ' tte -csntaat and quality of a criteria dosaseitt for Its use in
jranoards devel opaent. This, issae can- be taraed "e1osttrea. Clcsara
rgpr*sfflits a "sensa of the caaaittaa" detanri nation upon the scientific
cf a erf tan a cocanerrt for rsfulawi^ purposes at a specific point'
in -rfaa, based upon- ths infoma±ian carrsirtly available. Closare is ihtanded
'ta suppiesjerrt s^ner fonss of channel 1nc acvics sucn as transcripts* individual
rotas, and official cougritta* nrinutas." Tht overall purpose cf closure,
thersfars,, is zo snsari that the csaan'tta* has gives explicit written advlca
cpnearnin? a criteria docameiTt so that in tile furare lie caasnisas's position
will nor be nfs«nderffcoad- Eshodiad within the ccncaot; of closure 1s that,
wrten' necassary, individual esuiai tsaS' ssegiisenr can sabnit wrlttan srintjrity
r»aorts if they disacre- with all or part of the full csorittse report, A
sense of the csnattssa rsparf would he signed by'tne chainnan and staff
sfffcar. __,.., , • . , '
Seas additri'onal suggest lotia for how the closure prxscss* orient: be-
icsssplished ars- incltaed aosnf the apoended raatsrials wnleh sanazsrlsa
the si* phases, now typically involved in the preparation ana review of
crftaria docanen-3* The last, three pnasas- outlined in the apoendaa
sanmary csneam stsss involved in the external rev-fa* of the dsrtanents.
This includes, as Indicated, under- Fhasa IY» SAB/CASAC review of sny
initria.1 sstamal draft of z cocssent* Also, as indlcatsd tnent it would
S3a usgfy! ts havt fnas the, SAS/CASAC, or cne af its susessaittaas charged
with the raview, a fartsal staff report which details the sxtant ts which
the Csssnttae-cf -the-witol s ar sascansrittaa aitcars with the- cantsnts and
es«c;usions of the sncaant and- wirich also psinis art any specific chjscticns
or pralssss r^ar-ing tne axtamal draft.- Phase V, fQllowine the initial
SAS/CASAC seating, wayld involve: (1) nvislan of tha dgcsBBent by EPA/HIAO
A- 5
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in response to the points or issues raised by the public end the SAS/CASAC
in consenting on the extsmal draft', and (2) rssubsritcal of the document ta
SAS/CASAC for further evaluaticn. Phase VI, it is sufgestad, should involve:
(1) individual SA8/CASAC ccodttas slashers conveying their impressions of
the revised doffiaaant. ta the ehaifssn and (2) the chairman,, upon datsrsrfning
the overall sense of the cauirittag, then initiating appropriate further
staps» e*g, , call ins for another SAS/CASAC public review meeting or prepara- * •
tion of a final 'csnmrittss report. A proposed forsat for canst etas reports,
including particular issues or questions that we fe*l should be focused on in - *
their evaluations,. is -included on, page thrts of the Appendix. - j
1
Fttase nets the time periods that, we estimate should be associated with • j
aesaiplishing aaeh of the sis phases. In order to expedite the pracsss of .j
eamleting the final three phases* we suagast that acrsesant be raached , • -f
beaeen S'A and S^5/CASAC regarding a laxiaaa tiae within which writisr " "~ (
csaarfttss reports would be filed fallowing iny puhlic revia* mestinf sis j
initial external draft of the documents or their final ossiritsae raports |
Tatar, revised versions of docusents resuoaritrssd at the ^id of ,:
' V. Provision' cf the SAB/CASAC esaittsa reports to SPA within a i
rtlitively short, but nasanable tisa frase, is crucial 1n order to ensure
that the Aaancy can ba rasponsive to the advisary group and yet still
caimlets the critarla docaffients. aiid other, sufese^ent1 staps in tha standards
develcpnent process- in timely fashion- so as- ts sett Canfrfss
or C3art*<3rder5d deadlines.
lm' 1 cations for • S tendard ..... Setting of' Critj cal '_ Heal th _ Studies
wtna casspletion cf the critarfa docisffint, S?A oust develop a
rationale for a prspcsed standard. Fictars which oust be considered in
the- rationale- ars the relevant health studies and tssir aaal1ty» serious-
ness of health- affects, Identifi cation of saitsitive populations, risk to-
public health, avenging time, allowaisle gpscaedancas of the stuidard*
and Mrgin of safety csnsidentTons.' These factars an* tvaluatsd by tha
rsfulatory offics (QAQPS) in arriving at. a final recaaaandaticn ts the
Adjstnistrstor, It- is raesascended that CASAC svaluata, isrfor ta proposals
tha critical health studies and their rslevaaca in satting a standard,
as well as other factors which will influence the final standard.
Risk Assassssirt ' • _
A risk assassassnt -technique far applissrtcn ts-QA_QPS standards
development has been under development' within the Office of Air Quality
Planning ind Standards (OAQ?S) for about ts*o years., Qsgae was the
saajec; of Se first analysis. At sosza -nrtare trnfie, after intsraosncy
and peer rtvisws and incraased puhlic undarstandlng and scssptancs of
the tachniciie, we txpect to us« scae form cf risk assessaeirc ta help us
davelca ana lent standards-
A-6
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The QAQPS risk assessment technique was reviewed on April 15-20,
1173 by an SAI Sttofissscittas an risk assessssiri. Tne canarittee felt that
tills technique was not ytt ready for «se in setting ansaieirt standards
out strongly enearaged as ts continue develQpnint. EPA also was urgtd
to stroetara an expanded program which would develop, evaluate, and
possibly test alternative tacnrrlqties applieaolt to the standard setting
praeass.
The risk assessment essarfttss had no obj actions ts oar perforains a- *
risk assessment for CO as a raesns of continued develatsuefn: of risk
assesszerre methodology.. However, we have concluded" that, tha pctsrtial
difficulty we would have in assuring the puclic that tns results of a
risk assassaant would hav* no isipact m selecting 5 CO standard arcues •
far delaying tsis assessment antil at least after proposal.
Although there is a separate SAB caam'ttas sn risk assessasnt, we
racsxrend that GISAC as hrfefarf.^n iae QAQPS rasthadology and ftitars
develspsswt plans sinca we an aspect t5 use risk assasssent at scale
palrrt to help us set standards. A r-aport' m the April SAB risk assessment
suscaisarrttee mestring is an the. agasda for the »June CASAC saestlnc. We
rscaassertd- thst CASAC fas rnors fully ariefed in niturm aaatin^s on risk .
assessment, fotara plans, and issues raUtad ta usa in setting HMQS-. .
Hagtil ataryAna 1 vs-i s "
rtgu-latp.ry analyrfs- incladas ecsnczrie, iimronoental » energy,
and; ureas and caananity isipact' analyses. These ara' rtKpiirsd far all • '
smjor rsculatary actions and: ars nlsassd in draft, at the tisie of prapesal
TJie results are net tq &e csaisi dared in sstring the stsidard, however,
and tasnfore snould na-c lirfluanca SAI/CASAC in deveTosnng- the advics
ane/or raesasBandailcns ciscasssa ,in prior sections. It is planned tiiat
thasa cocjajseircs wilt be rada availaiala to- the CASAC at the time of
proposal. It is rscssraended that, the CASAC ravia* a set of ragalatcry
analysis docasen'cs far at least one. standard, aftar which- the csnsittas
caji decide whether • these docasents should b& rourine-ly rsYiewed-
Overs H_ St2nda.ni Setting Methodology
It 1s raesssandeji that. "the CASAC csnsidtr* frco tins to time, tha
overall stsndart setting lethadolooy. Of partlcaltr iTrtsrsst' ta £?A is
thft idanttf'i cation, of additional analyses1 and rssaarch- which stignt be
ne*dss, ta ifflprsve the- quality of the final decision on a standard*
A-7
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. PREPARATION ANQ IHTHSSAL SSVI3 OF ECAQ All
MO HEALTH EFF-CTS/IISK ASSSSI€HT GQCJ.MSTS
RjASc I: QOGflgrr PUWflMfi AMD DtmfitlOK (30 DATS)
Assi ttnffiHtt of Project Manager and other E£AG staff nerasrs ta
it af intsraal SPA Task p^rss and outside, esntriaut
csnsultsnts ;
of work plan and- time-table for dcosnent
Initlatian of litarstara saarch' and article pnjearssejit
PHASS II: PlgPAlWnON OF IK-HOU5a 05AFT (55-90 KYS)
AccaauUtlan and analysis, cf ' pertinent Iltarstan
Writing' of- reuoft drafts, of' daossant sections
Pr«lisrinary ffleatings of anthers and pelishinc af initrta.1 draf
Typinf and circulation cf pnlimiiiary review draft ts iirtsrsal
task forca and tnrss ts five outsids fsvia*ing cs
FMAH III: IMT53HAL -gyiSH OF IH-^COSg DHAFT f30 SAYS)
Canvenin? cf ECAQ Tens, daeanint authors, S?A intamal task f
and; rsviewins csnsultants at T-day in-fiisass rsvlsw wortsiiop
mes-efncs of E£AO staff, rsvia*ers and authars as
revision of' doc'jsant
Typing, editing, and printing cf sxtamal review draft
A-8
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SXTHMAL SEVIEH Or S^-fl AH C2JTSIA AND
HEALTH FrSCTS/IISit ASSHSSMSST SCCTSfTS
PtiASSJVi___RISUC;Rg/IIM QF 5CTHNAL DRAFT CoO - SO days)
PuhTI cation of Fsderal lefi'star Notice announcing1 availaoilit? of
'external review draft of doeasest
on of external draft ts other government. agencies, (SAI/CASAC)
and tiit general
Mtstina of SCAO staff, otiier EPA persoitael ,- sad cantr1faat?T« cansaltsnts
to anslyzi csaawtts aad prepare for SAE/CASAC nesting
and. revla* of sKtantsI draft at pwolic SQ/CASAC
SA5/CA3AC. csissrittas staff rsptsr; sausaarfsinf «4or csncsras or
PHASc Vi POST SAB/CASaC H£=TIM OCQ1MEST RSYISIQH ffip DAYS)
Dear! erf ntj of £CAO staff,- othsr S?A persanne! and
eatalatflna,. rerfa*, and analysis of"S«H/CASAC and
csaasnts frcn before, during,, and aftar the SAS/CASAC
Asslgaaant af saedfic rsrfsion- rsspcnsl kill ties ts SIAQ staff
and, eartrlfctfirisg consul tants
of revision assicOTients and csnsultstloii wlta individual
SA3/CASAC meusers as nesdaa ts rssolvt clarity and cantsirt' issues
Typing, editing, and rsBrodaction of rwisad draft and
of daeaejit ta- tne SAfl/CASAC
PHAgc_vi>_ . aa/CASAC aosag. .gLposiBsrr. .STATB. ..Cjg^g_
Report, of individual SAB/CASAC csesrfttaa swssers t3 dmiraan of grsaa
Detsntination by enairsau of overall sessa of' tne csaalttae- and
iiaplenentation of aapranriate optioits based .en foil oaring critaria;
afaatctions/ProSleas rsisliinc- — - Hold piatic rsvlw i
acjectnons/P real ems rssstiniTif — Kflla earfarsncs call
No* substantive praless rsamininc < — Pnsart sansa cf cssaittse r^c
If lat±sr-, prscasd wits ftnal adHriirs, printinc, and rsleasa of ssc
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3. • PHOPOSS FORMAT F3R SAS/CASAC
REVISI CTMlu'H, ISPGKTS
Gialnaan's susasary of overall csneansas or majority via* racers-
canal ttae's evaluation
Focus on evaluation of dccsasnt in tanas of;
Casjolttaness of litsntare r*svi» — csvenige up^ta-stata, kay
r^farstcas properly cansidargd or notsd?
Adequacy of nview anrf-e¥alut1riaii of stadias --cats accarcsely
descrlbad, intarpratarf, rsanalyzsd?
Cltrrty of prssaittfion cf cata and canclusions— effective'
prasantatlon of taxtt, tables, flgarts, sunaarfes?
Acsiney of overaTT intarpntatl-an of data fetss — fnain csnclusicns *
well-foundad and axtraaclitloits justified? _ . ":._-,
Si'gned. canoirrsica of conrfttas caairnaii and staff off! car on
raport— specifics' cf individual disssst ar snnorfty raptsrs appescsd.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
October 9, 1979
OFFICE Q? THE
ADMINISTRATOR
SUBJECT; Findings, Recommendations, and Comments of the
Subcommittee on Carbon Monoxide of the Clean
Air Scientific Advisory Committee (C&SAC)
Concerning the Revised Criteria Document for
Carbon Monoxide
FROM* Harry H. Hovey, Jr.
Chairman, Subcommittee on Carbon Monoxide
THRUi Sheldon K* Friedlander
Chairman, Clean Air Scientific Advisory Committee
TO: The Administrator
Introduc tion
The Clean Air Act Amendments of 1977 directed the Agency to
establish an independent scientific review, committee to complete
a review of the criteria published under Section 108 and the
national primary and secondary ambient air quality standards
promulgated under Section 109. Pursuant to this requirement,
the Agency chartered the Clean Air Scientific Advisory Committee
of the Science Advisory Board (SAB)*
On June 14-15, 1979 / a subcommittee of CASAC completed its
review of two documents that address the major scientific issues
associated with exposure to CO. These documents werei 1} the
Air Quality Criteria Document for Carbon Monoxide, and 2} a
Preliminary Assessment of Adverse Health Effects from Carbon
Monoxide and Implications for Possible Modifications of the
Standard (referred to henceforth as Adverse Health Effects memo-
randum}* The purpose of this memorandum is to .summarize the majo;
findings, recommendations, and comments provided by the sub-
committee to assist you in reviewing the data' necessary for pro-
posing ah ambient air quality standard for carbon monoxide as
required by law,
MajQjr^lsjsuesrFecj:_a_inlng to the Cr iter ia Document
Five major issues pertaining to the CO criteria document
were discussed by, subcommittee members. These issues include;
1. Does the criteria document adequately identify, discuss,
and evaluate the critical health studies for CO?
A-II
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2. Does the document address and assess in sufficient
detail the methodologies for measuring CO?
3. Does the document adequately identify exposure con-
ditions for the population as can best be ascertained
from presently available information?
4. Does the criteria document adequately address and
evaluate the global cycle of carbon monoxide"?
5. Does the criteria document fulfull the requirements
of law set forth in Section 108 of the Clean Air Act
Amendments of 1977?
ISmS_DE__#It Identification, Discussion, and Evaluation of Critical
Health Studies for CO.
In general, the subcommittee concluded that the criteria
document represents a comprehensive and balanced presentation
and interpretation of the information contained within tbe litera-
ture of critical health studies for carbon monoxide* Specific
comments were made in relation to" the role and importance the
Agency should attribute to particular studies and to related
health issues. Those studies and issues of a major concern
to the subcommittee included!
o the role of the 1978 Aronow study on passive smoking
Evaluation of the Aronow study was discussed within the
context of relating critical levels of blood carboxyhemo-
globin (COHb) to adverse health effects. Specifically,
the subcommittee was requested to advise whether Aronow's
conclusion that a concentration -of 1*8% COHb produced aggra-
vation of angina pectoris should be relied upon by the
Agency in determining the threshold level for adverse health
effects. In addressing this question, subcommittee members
commented upon the methodology of the Aronow study. In
measuring COHb levels in patients seated in an enclosed room,
Aronow did not account for individuals who were smoking;
consequently, he did not measure and did not account for
other components of cigarette smoke in the air. The health
effects of CO exposure alone upon COHb levels of the patients,
therefore, is in doubt. The conditions of this study, as
well as Aronow's 1972 freeway study, raise but do not resolve
the issue of whether there are interactions or synergissis
between CO and. other pollutants. The subcommittee recoissiended,
. however, that the Agency retain the use of the 1978 Aronow
; study in considering adverse effects.
A-12
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o populations at risk
The subcommittee concluded that the criteria document
adequately identifies the sensitive population groups at
risk from ambient CO concentrations. The subcommittee
recommended that members of the smoking population not
be listed as a sensitive group which a proposed standard
would be specially designed to protect.
ISSUE. 12: Methodologies for Measuring CO
The subcommittee concurred that the criteria document
adequately addresses and evaluates in sufficient detail the
models for measurement of carbon monoxide in the air and in the
blood. Individual members did suggest, however, that some minor
editorial or clarifying statements be incorporated that pertain
to measurement procedures and detectable levels of CO.
ISSUE13; Identification of the Exposure Conditions for the
Population Based upon Existing Information
The subcommittee concluded that, based upon existing infor-
mation, the criteria document contains the most practicable
analyses in identifying and assessing population exposure con-
ditions from CO, but it observed that the paucity of such infor-
mation limits a more precise understanding of health effects
that occur at ambient levels of CO, Pursuant to addressing this
problem of insufficient data, the subcommittee made the following
comments: (1) an apparent contradiction exists between measured
CO levels in cities and overall emission levels* In urban areas,
where monitoring stations are located, measured levels of ambient
CO has shown a decreasing trend. On a nationwide scale, however,
CO emissions continue to increase due to the greater number of
aggregrate vehicle miles traveled'. The criteria document should
address this issue. (2) CO concentrations represent a health
concern chiefly to population groups residing in cities. Host
available data utilized by the Agency, however, project nation-
wide CO concentrations. Consequently, there is a nee<5 to obtain
a better profile within specific urban areas, at the neighborhood
or street-level, to assess the health effects of CO exposures
at such "hotspots." The subcommittee recommended that the Agency
devote increased resources in the future to attain such profile
improvements in order to obtain a more realistic scientific
appraisal of urban CO exposures, (3) the criteria document should
place a greater emphasis upon the problem identified in item 2
above, and (4) a section on exposure concentrations resulting
from cigarette smoking should be included within the criteria
document.
A-13
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ISSUE |4? Global Cycle of Carbon Monoxide
The subcommittee concluded with a unanimous consensus that
the criteria document adequately addresses, presents, and interprets
information concerning the various sources and sinks of CO in the
global atmosphere.
ISSQ2 #5: Fulfilling the Bequirements of Section 108 of the Clean
Air Act Amendments of 1977
Section 108 of the Clean Air Act Amendments requires the
Agency to establish national primary and secondary ambient air
quality standards for air pollutants based upon air quality
criteria that "shall accurately reflect the latest scientific
knowledge useful in indicating the kind and extent of all identi-
fiable effects on public health or welfare which may be expected
from the presence of such pollutant in the ambient air, in varying
quantities. The criteria for an air pollutant, to the extent
practicable, shall include information on:
(A) 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?
(E) the types of air pollutants which, when present in the
atmosphere, may interact with such pollutant to produce
an adverse effect on public health or welfare; and
(C) any known or anticipated adverse effects on welfare."
The subcommittee, after reviewing the scientific information,
as identified, discussed, and evaluated in the criteria document
for carbon monoxide, and after receiving a reading of Section 108
of the Clean Air Act Amendments, reached a consensus that tha
criteria document adequately fulfills the requirements of law.
Major Issues_ Pertaining to the Adverse Health^Effects Memorandum
The subcommittee addressed "e number cf issues thai vill
influence a proposed ambient air quality standard for carbon mon-
oxide. The issues addressed and the recommendations include the
following:
o the role of the 1978 Aroncw study in standard seeding,
The subcommittee recommended that the Agency snou^d con-
tinue to rely upon the Aronow study in developing an
ambient CO standard but, given the :r,cartsinti = s stemming
from the methodological approach, i- should utilize the
A-I4
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study for margin of safety considerations rather than
using it for the determination of a threshold value.
the subcommittee discussed a range of CQflb concen-
tration levels addressed in the criteria document.
A majority consensus was reached that: 1} aggravation
of angina pectoris represents an adverse health effect,
and 2} the critical COHb level at which adverse health
effects do occur falls within a range of 2.7% - 3.0%
COHb. One member of the subcommittee dissented from
this finding and advised that the critical level was
reached at approximately 4,0% COBb.
the available health effects evidence indicates that
the population groups at greatest risk to low level
CO exposures include coronary artery and peripheral
vascular disease individuals.
the principal mechanism of toxicity for standard setting
purposes at this time is hypoxemia.
the Coburn model provides the best availabe tool for
predicting COHb levels resulting from CO exposures.
the findings of animal studies suggest that CO produces
detrimental effects on human fetal development. This
evidence relates primarily to animal studies showing
that the developing fetus is exposed to COHb concen-
trations considerably higher than the pregnant mother
for long-term CO exposures. However, such findings
cannot be extrapolated directly to identify specific
human effects levels.
the one hour and the eight hour averaging times in the
current ambient standard for CO should be retained
because they provide an appropriate time frame from
which to evaluate health effects from both short-term
and continuous exposures, respectively. In particular,
the one and eight hour standards provide reasonable
protection against the bolus effect (high spikes of
short duration) in the urban ambient environment.
the reduced 03 pressure at higher altitudes can result
in hypoxemia that may interact with the effect of CO
exposures upon persons with impaired cardiovascular
systems. The key issue of concern is adaptability.
While a healthy young person might adapt to hypoxic
stress, for example, an elderly person with coronary
disease might be adversely affected. The possible
A-15
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adverse effects on non-adaptable population groups should
be considered in selecting an adequate margin of safety
for the proposed CO standard.
Minority Report
As part of the working procedures adopted by the Clean Air
Scientific Advisory Committee, individual members may submit a
minority report to address those major issues or problems which
they believe remain unanswered or unresolved within the criteria
document.
The subcommittee on Carbon Monoxide achieved consensus on
each of the five major issues listed above, but such consensus
was not always unanimous. Dr. Domingo Aviado has participated
in both reviews, of the criteria document and believes that major
scientific problems remain to be resolved before it can be used
as a scientific basis for proposing an ambient air quality standard
for carbon monoxide. His report is appended to the report of the
subcommittee.
A-16
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Minority Report by Domingo M. Aviado
This member of CASAC would like to file an objection
to the final subcommittee report because the Criteria
Document on- Carbon Monoxide has failed to place in proper
perspective the observations on exercising subjects.
Results from only a few subjects/ suggesting that
exposure to carboxyhemoglobin levels as low as 1.8
to 3.0% for less than one hour can influence the
heart, cannot be used to determine the threshold for
adverse effects. Animal studies of daily exposure to
carbon monoxide for several hours or even up to 24 hours
daily for weeks or months indicate that there are no
adverse cardiovascular effects with 5.0% carboxyhemoglobin
saturation.
Almost all of my written suggestions (7 pages and
13 pages) have been rejected by the staff responsible
for the Criteria Document* I am not contesting this
because our group is entirely advisory in nature.
However, the Criteria Document of Staff Paper might
include a quotation from the National Academy of Sciences
Report on Carbon Monoxide on the significance of the
exercise studies:
A-17
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"If the results of the clinical studies are
applicable to this large population at risk, than
a major public health problem exists. Taking the
current results at face value suggests only that,
when patients with angina are exposed to low carbon
monoxide concentrations for short periods, they can-
not exercise as long on a bicycle or treadmill before
developing chest pain as those breathing'Compressed
air. There is no evidence from these results that
the exposure to carbon monoxide increases the frequency
and severity of chest pain or the development of other
complications or that it shortens life expectancy among
patients with angina pectoris or other clinical mani-
festations of heart disease. We can only infer the
existence of such a relationship."
There are other portions of the National Academy of
Science Report which would be .helpful in the preparation
of the Staff Paper, particularly the determination that
4.0 or 5.0% carboxyhemoglobin is the threshold for
adverse effect on human health.
DMA, 8/6/79
A-18
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SCIENCE ADVISORY 80ARO
CLEAN AIR SCIENTIFIC AOVISRY COMMITTEE
SUBCOMMITTEE ON CARBON MONOXIDE
CHAIRMAN
Mr, Harry H. Hovey, Jr., New York Department of Environmental Conservation,
50 Wolf Road, Albany, New York 12233
MEMBERS/COMJSULTANTS
Dr. Domingo M* Aviado, Allied Chemical, P. 0. Box 1021 R, Morristown,
New Jersey 07960
Dr» Stephen M. Ayres, St. Louis University, School of Medicine, Department
of Internal Medicine, 1325 S. Srand, St. Louis, MO 63104
Dr. Ronald F. Coburn, University of Pennsylvania, School of Medicine,
Department of Physiology, 200 Richards Bldg, Philadelphia, PA 19104
Dr. Edward Ferrand, Assistant Cojrenissioner for Science and Technology,
Mew York City Department for Air Resources, 51 Astor Place, New York,
New York 10003
SAB STAFF OFFICER
Mr. Terry F. Yosie, EPA Staff Officer, Science Advisory Board (A-101),
401 M Street S,W., Washington, D.C. 20460
A-19
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> ^^ \
I ^595^7 3 UN1TSO STATES ENV1RQNMSNTAL PROTECTION AGENCY
* .^M/VL *
WASHINGTON. P.C, Z0463
s 22, L5SO
M. Cos-tie
2aviroamestal ?ratsction
401 M Street, SW
, D.C. 23460
Dear Jir. Castles
"he Cleaa ft,ir Scieatific Advisory Coonittae of th«
Scieace Advisory Board has reviewed Sxteraal Review
Ho. 1, April/ 19SO - a.ir Quality Criteria for ?arti«
jiat-ar aad Sulfur Oxides; at its steetiag August 30-22, 1980.
"™!se results of this review will be available ia
f ia our raview of the technical ar$a ea-titlad
is the docuzaes- "acidic arediji-tatiea" it S«cam« evident:
that j
1* Shi* is aa area of ax-trtaa, sciaatific
i:i astaslishiag fira/ cTiaatitatiTa rela-tioaahipa
«jai.ss'ions of ralairaais polla-taats , * ozfaiatLioa. of acidic
dry aad wet deoagitissa pro^se-sis, and tie a'ffac'ts oa terras--
rrial aad aquatic *ce sy stems .
2. tJ. S. research, ia tais aram. has b««a scaaty bu-
is aow btir^eoiaiaf « H«w aad relevant research resal*s,s ar$
alaos-t daily.
3. Oocumaata-tioa of the coateaso^rarT' charae-ter of "wat:"
depositieu is/ as yet, iacompleta. ia«ra ara only about three
years of reliable ae-ft-work data ia the aortheas'ftara U*S», hut
this data base exaaads daily* Ta* spatial esverags ia tie
aisi-*w$5t aad weatara araas is gradually
4. Data a^ailah-le tJnas far show that influences oa
acidity iaclade ao-t oaly sulfur eompouads but also aitrogea
aad chloride aatarials as wsll as the faufferiiig role of
such as amaoaiai ealcitxa, sagaesitsa aad pot^ssitrm.
5. The ecosystem affects aow seem to be related to very
complicated iataractioas with soils aad waters with a s~t
daaeadeaee oa asolecular forms, aspecially aiaffiistsja*
A-20
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We cotii4 expand further oa -these complexities iaeladi
the currently uaauaatif ied atmospaeric traasfor-
ma-Eioc, processes taat change arisarY emissions to s«eoadarY
products which are transferred ia the atmosphere aad aubs«—
dspesi-tesd on land, »a*er- aad Tegeta-tioa. Howe-wer,
tie special character of acidia deposixioa kas
daseriSed. 2t iarolvea, as a mittiamm, ^h« criteria
ef oxides of sulfur r oxides of aitrogea, livdro-
aad th.* fiaa particle fractiea of snsp«ndad
pa.rt.icul a* es .
We sne-aest that/ witJa rhe above compl«jeit;iss ia. aiad,
•size SaTiroameatal Protection ^(?eacy prepare a sapara-fia
document tha-a caa. racogniz* aa«i iacorporatis -he aew isf
on causes, effac-ts aad data bases for all of the Tar
polla-taa-ts releTaat to acidic deposition (e.g., laud, air/
) »
W« recogaiaa tlie seed to iacsarporata escis-siac ia f
probably ia somewhat abbreviated fora/" ia th* prmseat TS? aad
Sulfur Oxides criteria Oociiaea-t but v* believe that S3A aad
ptablic iatsrests would b* v«ll served a? sae preparatioa of
a docusaeat that would iategrate the problea- of .dry aad wet
deposition of acidic products taat could result, ijt dftla-tari
ecological effects.
We sng-gest this documeat address "acidic Deposition"
ia a complete saase* &s such, it vould support aad a'ugment
criteria doc-oaaatatioa for foraalatioa
Siaeeraly,
SJieldoa £. Priedlaader, Chairmaa
Cleaa air Scieatific AdirisorY Coamitta*
Sciaace advisorY 3oard
A-21
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. 3.C. 20450 , '
OCT 2 3 1SHO
Mr. Sheldon K. Fried!ander
Chairman, Clean Air Scientific Advisory Committee
Sciince Advisory Board
401 H Street, S. W.
A-101
Washington, 0. C. E0450
Dear Mr, Fried!snder:
In your letter of August 22, 1980 you suggested that £?A presara a document
that can recognize and incorporate the nsw information on causes* affects and,
data bases for all of the various pollutants relevant to acidic deposition.
You rightfully point out that acidic precipitation is a complex phencsnanuni about
which we learn roars, almost daily, Because of this ! have askad ray staff to pull
together a contprtntnsivi document which lays out the state of our knowledge*
with regard to precursor emissions, pollutant transforaation to-acidic compoundsa
pollutant transport, pollutant deposition and the effects (both ineasurad and
potential) of acidic deposition. I have asked my staff to outline at the
appropriate live! of detail the contents of such a docyjnent for the review of
your committee.
Douglas M. Cost!a
A-22
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. O.C. 204SQ
Honorable DouerlaS M
a.! Protection Agency
401 « Street, SW
, D«C* 20468
Dear Mr. Cos±Ie:
our s«iri,*w of -tie Sraf-S: S02/PM criteria,
.'t one con-tiaaiag1 fr"is"tratioa wa-s **ie lack o* p*«3T
reTi.ew o£ -feis docamea*.. PraYieias docuaieatis had sueb review
aad were suiseffuea-ti? revised before sTiimissiea "to til* Claan.
Air Sciem-tific AdviserY Committee. ?h«a* reviews iad be«a
-------
I UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20450
December 10. USD
OFFICE Of
Scientific Re-view by the Cleaa. Air Scientific Advisory
Committee of the Air Quality Criteria, for
7ROMs Sheldon £. Friedlander, Chairman
Clean Air Scientific Advisory
Science Advisory
TO; Douglas M* Costle
r a t o r
an March 17, 1980, t.he Cleas Aiz- Scieatzific
Committee reviewed a sc-ieft-eific doerament "that addressed
the major scientific issues associated with ambimn't'
-.level exposures- of hydrocarbons. She docaaent entitled,
Facts, and Issues* Associated tfith ths Weed for a
_
Criteria Occ.tuaent, was produced by. the Office o£ Research
and. Cevelo.paeat to fulfill see-tion iQ§(d)C1) of the 1977
Clean Air Act requirement to update the- air quality
criteria far the national amhieat air quality standard for
hydrocarbons* She parpe-se o< this- aemorandtiia is to
summarize the major findings, reccsmeadations /• and
comm*ists provided by the Committee to assist you ia
reviewing the data • necessary for reaching regnlatory
decisioas on gas-phase Mydrocarbaag in the ambient air..
Malar Issues Partaiaia^ to ............ ^the ..gydrocarbon Dociiiseat
Three major scientific issues regardiag th« hydrocarbon
documeat were discussed and evaluated by the Committee.
These included:
1. Oo gas-phase hydrocarbons-, as a class, contribute
to- the formation of ozone and other photochemical
oxidants?
2. Can the attainment and aaintenance o£ a uaiforat,
nationwide ajnfaiant air concentration of volatile
noitmethane hydrocarbons eastwe the attainment and
aaiatanance of the astbient ozone standard?
3. Do gas-phase hydrocarbons, as a class, cause
adverse effects on public health or welfare at
or near aabient air
A-24
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<3as-pha,se hydrocarbons and the formation of
and a-ther -photo eireisKieal oxidaats
Issue £1
The Committee agreed that the scientif ic evidence
supports the premise that, gas-phase hydrocarbons, as a class,
do contribute to the formation of ozone and other _ photochemical
oxidaats. The data indicate that all hydrocarbons
participate in these -chemical reactions but th.e reactivities
of th* various hydrocarbons differ with respect to the
different oxidant products- As a result:, a general
relationship between oxidant . formation and total hydrocarbon
Cor non-methane hydrocarbon) concentrations, valid across
the nation, cannot be obtained.
The Committee requested incorporation, of information
in this and other doc-unseats (e.g. the sulfur- oxides/particula~e
matter criteria document. ROW in progress) on th*
role of hydrocarbons in, ozone
formation and their role as generators of chemical
species that also affect other atmospheric Processes,
such that control strategies are formulated with the
several impacts of hydrocarbons ia. mind. In. particular,
the action, of1 various radicals- on the oxidation, of methane
•• ia the- presence of nitrogen dioxide , and the
process by wbieh peroxide radicals act ia the formation
of acidic precipitation by oxidation "of sulfur dioscids
in cloud and rain water sfr >i&ld be included in any
evaluation of. controls res«. lire d for hydrocarbons.
Issue £2
S-ttainaunt and maintenance- of an ambient" air
concentration of volatile aon—mathane
hydrocarbons and its relationship to attainment
maintenance of an ambient ozone standard.
This issue is closely related to issue i1.
Hydrocarbon emissions- and ambient air levels are only
two of many variables- in th« atmospheric processes that
result in the formation of oxone ani otJiar ahotochemical
oxidaats* Other variables include the emissions of
other reactive fas-omase organics f and meteorological sad
feograp-hieal factors such as teaoerature, humidity/ wind
speed f latitude and longitude/ and topography- Because
of the many variables aad' uncertainties discussed under-
issues i-1 and f2, BO fixed level of gas-phase non»ethana
hydrocarbons can be used to ensure the attainment and
maintenance of the osone- standard. However, based upon
the evidence' which the Committee reviewed in the document,
the Committee concluded that the document adequately
identifies, discusses , and evaluates studies ia -the
current literature. The Comssistee identified some
minor issue* regarding- presentation of the iiif orsation,
hut these comments a^e included in the transcript-
A-25 •
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Issue
Health and welfare
hydrocarbons .
effects of ambient "level
was general agreement among Committee members
that; hydrocarbons at ambient levels, with th« exception
of bensens and ethylene, do not cause adverse health and
welfare effects, rese actively. leaaene has been, listed
as a hazardous air pollutant tiader section. 112 of the
Clean Air Act and regulatory actions are proceeding.
There are adverse effects upon vegatation from ethylene, btrt,
even though "ethylene is ubiquitous, these effects have not
be«a- measured in all parts of the country, partly because
the atore^ susceptible species (ornamentals) are not grown
in all parts of the country? the issue should net. be
dismissed, however, on the basis that adverse vegetative
effects from ethyleae are not a national problem*-
The Clean Air Scientific Advisory committee agrees-
with the Agency's conclusion that, in. the, absence
of a uniform- quantitative relationship nationwide between
hydrocarbon emissions and ambient air levels and resulting
osone-oxidant ambient air levels, there- is no
scientific basis for maintaining a national ambiant-
air' quality standard for hydrocarbons- The- Committee-
also- agrees with the agency's conclusion that, becaus*
of the absence of ambient-level, adverse health, or welfare
effects- from hydrocarbons, no aew, bas-is e^eista for an
anbient air quality standard for hydrocarbons.. ?ublic
heaLth and welfare will continue to be protected even in
the absence of a national ambient air quality standard
for hydrocarbons. Recision of a national ambient
hydrocarbon standard should also beneficially act to
streamline th* regulatory process,
The Committee urges, however, that efforts continue
to assess, aad where nece-ssary to control harmful compounds.
The control of scissions for hydrocarbons as a class
remains essential as a coaveaien,t: method of control.1 1'-ng ambient: levels-
The Committee made additional comments of an
editorial nature and requested further inf ortaation on
the results of source reconciliation studies -showing
contributions of. . various source categories to
hydrocarbons ia ambient air in one or more cities or
airsheds.- Tlaay also requested the ' inclusion of information
on (1) the possible role of the oxidation of methane and
carbon monoxide in the photoch«aical production oS os
(2) the effect of radicals generated from hydrocarbons
-------
on the cosTersion of sulfur dioxide t.o aulfalte;
(3) the ideatification of specific gas-phase hydrocarbons
known to b«* precursors to secondary oraanic aerosols-
With, the 'aaderg-inding that the rec^e5te4 changes are
included in the- revised document, t,h- Committee is *
satisfied that -the aoenmest meets the requirements of
section 103 of the Clean Air Act ss
A-27
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| UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
February 4, 1981
OFFICE OF
GENCRAl. COUNSEL.
MEMORANDUM
SUBJECT? Review and Revision of National Ambient Air Quality
Criteria and Standards? Draft. Guidance Document
FROM: Matthew B. Van Hook/ Attorney
Air, Noise & Radiation Division (A-133)
TO: Terry F. Yosie, Staff Officer
Clean Air Scientific Advisory Committee (CASAC)
Enclosed as you requested is a draft of the. guide EPA
has "been preparing to statutory and judicial authorities
bearing on EPA's periodic review and, as appropriate, revision
of criteria and standards under Sections 108 and 109 of the
Clean Mr Act, 42 U.S. C. §§ 7408, 7409. The document is
intended to provide a brief but useful source of reference
on thesei matters* and is being prepared by the Office of
General Counsel in conjunction with the Environmental
Criteria and Assessment Office (ECAO) of the Office of Research
and Development and the Office of Air Quality Planning and
Standards (OAQPS) of the Office of Air, Noise and Radiation.
The document is being prepared because questions regarding
legal aspects of the review and revision process have often
arisen during the many public workshops, meetings and hearings
that have occurred in connection with EPA's review of the
current criteria and standards. Although the document is not
ready for release in final form, the draft may provide useful
information for members of CASAC and interested members of
the public. EPA would appreciate any comments CASAC or the
public may have on the draft. As indicated on the cover page,
the paper is intended to be a convenient source for reference
but is necessarily rather general. Accordingly, ECAO, OAQPS
or the Office of General Counsel should be consulted if more
detailed or definitive information is necessary*
A-2S
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ESTABLISHMENT AND REVISION OF NATIONAL AMSIENT AIR QUALITY STANDARDS:
An Overview of. Statutory and Judicial. Guidance,
January IfSI Draft
United States Environmental Protection Agency
NOTE
This paper presents a brief review of statutory and
judicial guidance concerning establishment and revision of
national ambient air quality . standards (NAAQS) by EPA under
Sections 108 and. 109 of the Clean Air Act, and of statutory
authorities bearing on the role of the Clean Air Scientific
Advisory Committee of EPA's Science Advisory Board in that
process* The paper' and its several appendices are intended
as a convenient source for reference' on, these- matters but
are necessarily rather general*. EPA's Office- of General
Counsel should be consulted if more detailed, or definitive
interpretations are. necessary.
A-29
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3
Subject ' .- ' •• .'. • i ^ -..-•'..". . gage
X. SPA'S AUTHORITY TO ESTABLISH AND REVISE MAAQS . 1
A. Air Quality Criteria • »'.*' f ^ . . :; -1
-' - ™ "i. ' • ' "H. . '
B. Primary HAAQS ..' ''...', ' :r'p'- .,;'•' , , 1
i* Adverse Effects ''"'•;-•'* .' r •,. ,' .',-,' . 1
. li. Sensitive Population Groups, • • : • • 2
iijU Margin of Safety .-•'••' . •• '. • • 2. .
iv. Economic Cons iterations /Feasibility . .-. 2'
C» Secondary HAAQS • '.••'•,' 3
II , CASAC ' S AUTHORITY TO PROVIDE ADVICE OH . 3
CRITERIA DOCUMENTS AMD PROPOSED NAAQS
A. Existing Crit_eria_ Oocmoen-ts_ ^and NAAQS_ ' . 3'
B* Draft__Cgiteria Documents and Proposed SAAQS 4
.APPENDICES (To fee Supplied) . •
A* Clean Air Act., Sections 108 (Air Quality Criteria) 109' (NAAQS)
and 110(a)(2) (attainment dates for NAAQS), 42 O.S,C. §§ 7408,
7409 and 7410 (a) (2),
B. "^search Authorization Act of 1978,1* Section 8 of the Environ-
mental Researcli, Development and Demonstration Authorization. Act
of 1978, P.L. 95-135, Hov, 8, 1977 (Statutory basis for the
Science Advisory Board, and authority for the Board's advice
and conaaents to EPA on proposed criteria documents and standards)
C. Legislative^ History of the Clean Air' .Act Amendments of 1970 and
the Research Authorization Act of 1978 (excerpts).
D. "Lead Decision," excerpts 'from, a decision of the, U.S* Court; of
Appeals for the District of Coluaftia circuit in a case, involving
NAAQS for lead: kead Industries; Association et al v* EPA, __ _
F»2d ___, _ EEC (D.C.Cir.lSSQ), cert, denied P -S . _ (1980 ) .
E. Charters of the Science Advisory Board, and Clean Air Scientific
Advisory Committee,.
A-30
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I, EPA's AUTHORITY TO ESTABLISH AND REVISE NAAQS
A. Air Quality Criteria
Criteria documents are the basis for the MAAQS, and are-
required to "accurately reflect the latest scientific, knowledge-
useful in indicating the Kind and extent of all__identif xable
effects on public__hgalth _or _welf are from pollutants in the
ambient air." ""(Section 108fa) (2), Appendix A).Criteria
documents are not intended to contain conclusions concerning
which "identifiable" effects are "adverse," As discussed
below, such judgments are made by the Administrator in estab-
lishing KFA&QS, based on the criteria document. However,
criteria documents should contain information helpful in
assessing the relative significance {"kind and extent") of
the various reported effects - -. .
B. Primary JAAQS . . -
Primary standards "shall be ambient air quality standards
the attainment and maintenance of which in the judgment of the
Administrator t ba_sed_oii _ such. criteria and ^allowing. an._ adequate'
inajrcfin of safety, are, _requisite to protect. the public health*"
("Section 109(b) (!.}", 'Appendix "A")V" 'They are to be uniform,
nationwide standards, applicable' every place in the country,
and are to be attained within three years from the date state
implementation plans are approved. (Section 110(a)|2)(A),
Appendix A).
Major elements of EPA's interpretation of its authority
to establish, and re-vise KfAAQS were recently upheld', by the
U.S* Court of Appeals for the District of Columbia Circuit
in a. case involving MAAQS for lead. Lead Industries Association.
et. al. v, EPA, . F• 2d , SRC JD.C.Cir.. 1980), cert« denT
U.S. (19807 (hereafter "Lead Decision"}- Several of,
these elements are discussed below? w
• ^f.
i. Adverse Effects , , .'.
The primary standards are -not intended to protect against
all 'identifiable effects, only those judged by the Administrator
to> be^ "adverse." However, because the primary N&AQS were
intended by Congress to be- precautionary and preventive, the
Administrator is not free to define as adverse only those effects
which are clearly harmful or for which' there is a medical
consensus about the degree of harm, lather, the Administrator :'•
must evaluate- reasonable medical concerns and theory in deciding
which effects are significant enough to be considered adverse.";•
{Lead Decision, Appendix D)» :l;.
The health, effects Congress was concerned about at the
time the 1970 amendments were enacted ranged from cancer, .:
metabolic and respiratory diseases, and impairment; o£ mental
A-31
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processes, to ""headaches, dizziness, nausea . * . .*
(Legi 31ative History, Appendix C). To put the health effects
intended to be protected against by the N&AQS in some perspective,
Congress elsewhere directed that if a pollutant is found to
,result in an increase in "serious irreversible, or incapacitating
reversible, illness," it would qualify for regulation as a
hazardous pollutant under Section 112 (42 u.s.c. §7412).
ii. Sensitive Population Groups . - • / ^
Congress did not intend that only healthy persons be pro-
tected by the M&AQS. At the same time, the standards were not
intended to pr.otect those dependent" on a controlled internal
environment, such as persons in intensive care units* Instead,
Congress emphasized that the standards shoud protect "particut— •
larl*y sensitive citizens such as bronchial asthmatics and
emphysematics who in the normal course of daily activity are
exposed, to the ambient environment.'* (Legislative Hisnory,
Appendix C). The standard is statutorily sufficient whenever
there is "an absence of adverse effect on the health of a
statistically related sample o£ persons in sensitive groups
from exposure to the ambient air." (Id,.). Congress defined
a statistically related sample ms "the number of persons
necessary to test in order to detect a deviation in the
health of any person within such sensitive group which is
attributable to the condition, of the ambient air.." (Id.}.
,iii». Margin of Safety
Congress specified that the primary NAAQS include an
"adequate margin of safety" to protect against effects which
have not yet been uncovered by research and effects whose
medical significance is a matter of disagreement. (Lead
Decision, Appendix D). The requirement for a margin of
safety underscores that the primary M&AQS are"not simply
intended to protect against health effects that are known to
be clearly harmful,' Congress authorized the Administrator to
exercise his judgment in setting NAAQS precisely to permit
him to act in the face of uncertainty. (Id.)»
iv. Economic Considerations / Feasibility
Primary NAAQS' are to be based solely on the"protection
of human health; economic considerations play no part in the
setting of these standards.. {Lead Decision, Appendix D) -
The criteria on which the standards are based likewise do ;:
not address .such factors as economic and technological feasi- •••'
bility. (Id.*).. In short, the- Administrator is not required, ::'
and, in fact is not even permitted, to consider economic or1
technological factors in setting NAAQS. ' (Td_.)» The regulatory;
analysis which accompanies NAA.QS rulemaking packages is ;
intended to comply with the directives of several executive :
orders, and serves to inform the States, the public,, and
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Congress of the expected - impact of the N&AQS; However the
Administrator may not consider or base his decisions regarding
levels on the regulatory analysis*
G. Secondary NAAQS ' ;
.Secondary standards "shall specify__a level of_air quality
the attainment and maintenance of which in the judgment o£
the Administrator,, based^pn such. criteriaf is requisite to
protect the public welfare from any known or anticipated adverse
effects associated 'With.the Presence otI such air pollutant xn
the "aiaibjien;^^ 'lake 'the
primary standards, the secondary UAAQS are to be nationally
applicable, uniform standards. However, they are to be •
attained within a "reasonable time," in contrast to the specific
three year timetable set forth for primary MAAQS. (Section
110(a)(2)(A), Appendix A).' '
The welfare effects to be protected against include but
are not limited to effects on soils, water, crops, vegetation,
man-made materials, animals, wildlife, weather, visibility,
climatei damage to and deterioration of property* hazards to
transportation, as well as effects on economic values and on
personal comfort and w.ellbeing, (Section 302(h)» Appendix
A) * The reference to economic values does not include the
costs of compliance with NAAQSy it refers only to the economic
costs of pollution* (Lead_Deci§j.pn., Appendix D). Thus?
like the, primary NAAQS, secondary standards are to be based
on the"effec€s*' information detailed in the criteria document,
with the Administrator making a judgment concerning what.
level of effect is. to be considered,, adverse.*
II. CASAC''S AUTHORITY TO PROVIDE ADVICE ON DRAFT CRITERIA DOCUMENTS
MED PROPOSED NAAQS
The Glean Air Scientific Advisory Committee (CASAC) has two
sources of authority: (1) Section 109(d)(2) of the Clean Air
Act, and (2.) the Research Authorization Act >of 1978 (pertinent
parts of both statutes are reproduced in Appendices A. and B). Re-
flecting its dual authorities, CASAC is a constituent committee of
EPA's Science Advisory Board (SAB') (the: charters, of both CASAC and
the SAS are included in. Appendix £}..
A* Existing..Criteria Documents and HAAQS
CASAC' s. authority under the Clean Air Act concerns review j:
of existing criteria documents and NAAQS, and the giving of ad-;
vice to the Administrator' on a broad range of matters including;.
research needs and-'the health, economic "and energy effects of ,;
various strategies for attaining the NAAQS* (Section lQ9(d)(2J»
Appendix A). Accordingly, under Section 109(d)(2)(B) of the
Act CASAC is to review existing, criteria documents and NAAQS
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,
a
and recommend appropriate chang es to the Administrator one
year before the agency completes its own periodic, review
under Section ].09{d)(l). (Appendix B) .
* I... . . •'''.>•
^' t •' ' " "• •>'
B. Frgposed Criteria Documents and HAAJ3S_ '• -' "
• As the committee qf the Science Advisory Board charged with
responsibility for matters concerning HAAQS, C&S&C exercises the
Board's authority tinder the Research Authorization Act of 1978 .
to review proposed criteria documents and MAAQS* (Appendix B) .
. Section 8(e) of that Act provides that any time a proposed
criteria document or standard. is .provided to any other
Federal agency for formal review 'or comment, such docTimeat
or' standard is to be -made available to the Board, '"Ehereafter,
the Board (C&SJkC) "may make available to ; the __ Administrator ,
within the time specified by the_Admlnji$tratog , ,_._its advice and
conanents _ on the adequacy _gf_. the scientific and technical bas_is_"
of the proposed criteria document or NAAQS.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
THK AQMINISTHATQR'-
StTBJSCTs 'CASAC Review of the Air Quality Criteria Document
for Nitrogen Oxides
FHOMs Sheldon K. Friedlander, Chairman
.Clean air Scientific advisory Committee
TO; The Administrator
Introduction '
On November 13, 1?S0, the Clean air Scientific
Committee of the Science advisory Board completed its review of
the revised air Duality criteria document for the oxides of
nitrogen.^ This, was the second review of the criteria document
by the Co'Amitte«. ' The first review/ held January 29-30, 1979,
resulted in major CAS&C recoaiaendations for revisions in~tha
criteria doctiiaent. In -its moat recent meeting the Committee
concluded that its recoamenda tions had racaivad a fair an5
thorough avalaation by tlia Agency , evidenced ' IA the changes
incorporated iato the criteria doct^nsnt. The purpose of this
aemoraneiiim is to summarize for you the Committee's aajor conclusions
to assist you in reviewing the. scientific data necessary for
.proposing, an ambient air , quality stmadarS for . nitrogen . dioxide
as required by_law» This mentor andtia further advises- you of the
Committee's conclusion that the criteria document fulfills the
criteria set forth in section 108 of the Clean Air Act as amended,
which requires that such a document accurately reflect the latest
scientific knowledge, useful in indicating the kind and extent of all
identifiable effects on public health or welfare from pollutants
in the ambient air.
a separate memorandum which will address- the review of the staff
Paper for nitrogen oxides will, be sent to yoti following1 completion
of the Committee's review of that document.
Major _ Issues gertainiag- to the, HOx Criteria. 'Document.
Air Quality ,
N4trg_ge]i__CycIe— -Thgye is mxich duplication of information
concerning the nitrogen cycle throughout the- document which
could be presented more succinctly in Chapter 4. Nevertheless,
Chapter 4 itself is well written.
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Sources and EmAsaions-'-'As requested by CASAC, the revised
document contains, nxore information on HO/MO^ ratios and this is
adequately presented.
Snvironiaental Transport a Trans_f oraatiQn'-*"Tae
document adequately addresses current knowledge in this area.
Yery importantly, it disc-asses the- need for additional information
en NOx-— organics chemistry and "-the demr-th of quantitative
knowledge of wet and dry- removal processes and rates for NQx*
Sampling and S.naly3is__for Ambient TO? and NQx-1— -Derive-d
Pollutants— -This section of the criteria document describes
the Methods t procedures, and problems in the determination of
the ambient levels of SOx in a useful and complete fashion.
Of particular importance is the identification of uncertainties
in the earlier measurements of SOj. ( Jaeobs-Sochheiser method),
and for nitrate (artifact formation). Characterization, of such
uncertainties should ensure against the use of suspect data in
getting the standar.3*
welfare Effects1 • • •• • -• • • • •.•'••' '• • •
.Perturbations of the Stratospheric. Qsone 'I«ayer-— The relevant
studies .'are included in this section of the docuaent. It brings
out the iatpo-jrtant point, that NO ^and ^0^ released from surface
sources "ars not, expected to significantly effect, stratospheric oso
Effects of Ijtroeren Qaides o_a__7isi'oility--^?ha chapter arassnt
A good review of the scientific issues relatsd to visibility. The
role of JJQi in atmospheric discoloration is well described. The
chapter also adequately points out the ttttlti— pollutant aspects of
the regional haze" problem.
acidic Prgcipitation--chapter 11 is to be ratitled "Acidic
Deposition* to better define- its contents and to ensure that •
the role of dry deposition is recognized. The information.
presented in the criteria doeunent ia a. useful tutorial for
understanding acidic deposition. As. requested -by CA-SAC the
very importance of taulti-pollutant aspects of this environsaerttal
problem are being addressed by a separate document that is now
in preparation? thus, for the purpose of this criteria document
this chapter is adequate in ensuring that the role that nitrogen
compounds play in acidic '.deposition reactions is recognised1*
'Effects on Natural scoaysteai-s, _Ve«reta"t'igh ," and Micro—
organisms— -The criteria document provides a good review of
background information concerning potential effects on ecosystems
as well as the relations of the nitrogen, cycle. " Regarding
potentially harmful effects of HOx;> the document correctly
emphasises UQ^ since this is the taost . harmful oxide for the
effects of concern. Both visible effects and effects not
readily perceptible are discussed thoroughly.
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Threshold closes are given for.the Inhibition, of photosynthesis
under laboratory conditions* However, it would be desirable if
sensitivity wader these predisposing- conditions could "be compared
with sensitivity under field conditions«4 The plant varieties
used for these studies are relatively sensitive* but now does
this compare with more important and widely planted species?
Taylor t *fc« al • reported mostly no effects occurred on s'everal
field crops exposed to 10 ppm for 90 minutes*
From the document, we can conclude that sensitive plant
specle-3 siay be injured 'by one-half hoar to eight-hour exposure to
concentrations of" 10 to 2 ppa, respectively* If exposed for
several days, concentrations as low as 0.15 ppm may have soiae
effect, but a safe limit s'eemg to be in the neighborhood of
0*5 to 1 ppm ^Q£,« It would be helpful if these values were
compared with ambient baseline concentrations as reviewed in
Chapter 3*
Toxlcity of HQg. seems to be enhanced when SOz, also is
present* • Soweve-r, much of the- laboratory research, is inconsistent
and cannot provide a sound basis fas criteria. She relations
are especially indefinite in the field* This issue- is discussed
•well- in the document*
Finally/ the Committee would prsfar1 to see the blill-Sgraphy
of this and other chapters arranged alphabetically*.
Health Effects
Effects of Nitrogen CQTagounds_on Raiaals^TThere -ara so ma
problems with the overall format. There Is both detailed
description, of•individual papers and an unrefereaced interpretive
discussion of the patterns of cellalar and.tissue response to
oxides of nitrogen* What appears to be missing is interpretation
of individual papers and groups of papers, Uaere is little
atteapt to reconcile, or even point out, seemingly contradictory
findings-- Nor- does the review co«e to grips with the Implications
of the findings* One also expects a critique of those finding's
reported to occur at relatively low levels of nitrogen dioxide.
-------
Effects on HumajnjgTOcjf^Exaosure tomOxides of Nitrogen-—S
discussion, primarily focused on the revisions made to the
document since the last CASAC Meeting, and' whether those
revisions adequately dealt with previous comments from CAS&C
and the public. la reviewing Chapter 1S, the Committee specifi-
cally addressed the question of whether the chapter adequately
identified, discussed, and evaluated the critical health studies
for the oxides of nitrogen*
In general, it was concluded that the current revision of the
criteria document presented a-balanced and comprehensive critical
review of the pertinent literature on human health effects of the
oxides of nitrogen. It was agreed that new literature is
continually being add,e«5 to the subject, but that an arbitrary.
limit had to be set for the current document and that no studies
unpublished at the times of the meeting should be "included-
Tae emphasis placed upon specific stxrdies was 'appropriately
altered from the previous draft criteria document following
eowisents by . C&S&C. .Specifically* it was concluded that the
current document adequately de-emphasized the sigaificazice
of the Chattanooga studies of Shy, st al. The Committee also
believed that the "study by Qrehek had been appropriately considered
as relevant to safety factor considerations, and that it should
not be used for identifying a specific level for setting a
Standard*
C5.SAC also concluded that the discussion of gas stove
studies was scientifically acceptable. The Committee believed
that, there night be.a more concise .summary of-the- indoor SO •
exposurers relevant to the gas stove studies, but this represents
only a ainor refinement in the chapter.
The criteria document appropriately separated, affects on
sensory organs, pulmonary function and zssoiratory systems or
infection- When possible, most of these effects were considered
separately in healthy^and sensitive populations. The .limitations
of the different types of studies (huaan exposure, epidemiclogic)
were also considered.
The studies relevant to the critical issue of level of
lowest observed effect were discussed in the document ia a
balanced manner. It was recognized by CJLSAC that no body of
data is perfect and, subject to the •recommenda'tiottS suggested in
the paragraphs above, the criteria document had critically and
satisfactorily reviewed the existing data on human health
effects of the oxides of'nitrogen.
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Summation
The Committee made additional comments of an editorial
nature* -These remar&s, as well as • a more detailed discussion
of the recommendations and review provided' above, are included
In the transcript* With th,e understanding that the advised
changes are incorporated in the revised criteria docTiiaeat, the
Committee is satisfied thmt the air qttality criteria document •
for.the oxides of nitrogen is scientifically adequate *or use
in standard setting*
A-39
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Clean Air Scientific Advisory Committee
Science Advisory Board
Roster of Nitrogen Oxides Review Committee
Chairman Staff Officer
Dr. Sheldon £• Friedlander
Depfc* Q£ Chemical, Unclear and
Thermal Engineering
School of Engineering and
Science
Log Angeles, Calif. 90024
Member s/Conaultant 3
Dr. Mary Amdur
Dept* of Sutrition and Food Science
MI?
Cambridge, Mass. 02139
Dr. Judy A. Bean
College of Medicine
Dept- of Preventive Medicine and
Environmental Health
University of Iowa
Iowa City, IA." 52242
Dr» Bernard Goldstein
Rutgers Univ. Medical School.
B&pt. of Environmental and
Community Medicine
Plgcataway, H.J. 088S4
Dr. Donald Hall
Section on Ecology and Systestatics
Langmnir Laboratory
Cornell Univ.
University, N.Y. 14850
Or* Morton Lippmann
Inst-itate of Environaentml
Medicine
New York University
New York, H..YV 10016
Mr* Donald lack
1826 Opalocka
McLean v&» 22101
Mr. Terry F* Yosie
Science Advisory Board (A-101)
EPA
401 M. St. SW.
Washington, D.C. 20460
Dr* Domingo aviado
225 Hartiahorn Drive
Short Hills, N.OT. 07078
Dr*» Robert Dorfman
Dept* of Economics
Harvard University
325 Littamer
Cambridge, Mass* 02138
Dr. Hergchel Griffin
Saa Diego State University
Graduate School of Publlc
San Diego, Calif* 92132
Mr.. Harry Hovey
Hew York' £Jept- of Environmental
Conservation
50 Wolf Road
Albany, N.Y, 12233
Dr. Vaun Newill
Exxon Corporation
Research and Environmental Healt
Division-
F»O» BOX 235
East. Millstone, M.J* 08873
Or* Michael Uresaow
Oep-t* of Biology
University of Utah <
Salt Lake City, Utah 84112
Dr*» M'arc Schenker
Chaniiing laboratory
130 Longwood Ave
Boston, Mass* 02115
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE or THE
ADMINISTRATOR
July 9, 1981
Dr. Lester Grant, Director
Environmental Criteria and Assessment
Office
Office of Research and Development
US Environmental Protection Agency
Research Triangle Park, NC 27711
Dear Dr. Qrant:
The Clean Air Scientific Advisory Committee has completed its
second review of EPA's combined air quality criteria document for
sulfur oxides and participate matter. The Committee notes with satis-
faction the significant improvements in the document in air quality,
health effects* and welfare effects data made since the Committee's
review of the first external review draft in August, 1980.
The Committee has concluded that, with incorporation of changes
as suggested in the transcript, Volumes II through V are scientifi-
cally adequate for use in standard setting. Another version of Volume
I, reflecting these and previous revisions of Volumes II through V
needs to be prepared. The Committee requests that copies of these
latter volumes as further revised be sent to the members for their
reference in reviewing the revised Volume I. When the revised Volume
I is considered acceptable, an official closure memorandum will be
prepared reflecting CASAC's action on the entire criteria document.
Sincerely,
Sheldon K, Fried! anders Chairman
Clean Air Scientific Advisory
Committee
A-41
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•<
Clean..Mr ScientificAdvisory _Committae, Subcoimaittee oa Health
Effects of SOx/PM
*Dr» Mary Amdmr, Department of nutrition and Foo Calif. 90024
Dr. Bernard Goldstein,. Rutgers University Medical School,
Department of Environmental and Conmniiity Medicine, Piscataway>
HJ 08354
Dr. Herschel1 cSriffin, San Diego Stata University, School of
Inblic Health, San Diego /.' Calif ornia 92192
Dr* Timothy Laraen, Department of Civil Engineering, Mail Stop
FC-OS, tlnivergity of Washington, Seattle^ Washington 9819S.
Dr. Mortoa iippmann, Institute of Environmental Medicine, Hew
York University, Hew York, New Tork 1QQ2.S
Dr» Roger 0»> MaGlellan, Director of Inhalation Toxicology
Institute/ Lo^?€LaaS Foundation, P.O 3O± 539Q/,
Uew Mexico 37115 _
, *Dr. Vaun Newill, Exxon Corp., Associate Medical Dirsetor, 1251 Avenues of.
" the Americas, New York, NY 10020
j" ~ • ' -
Subcommittee on_ Wel£arg_ __S££a_gts^_o£ SQx/PM
!* '
Dr. Robert Dorfman, Departinent of Economies, Harvard University,.325
Cambridge* Mass. 02138'
*Dr. Sheldon Friedlander, School of Engineering and Applied Science,
LOS Ancreles, Calif., 90024
- Dr. Ronald Kali, "Section on Ecology & Systematics, Langmuir Laboratory, •
Cornell University, Ithaca, HY 14850'
**tr. Hajrry Hovey, New York Department, of Environmental-Conservation', 50 wolf load,
Albany, HY 12233
Dr. Undrew McFarland, De?t. Civil Engineering, Texas A&M University
Collaaa Station. Texas 77843
Dr. Peter McMurray/. Department of Mechanical lagjineeriag,
University of Minnesota, 111 Church Street, SB, Minneapolis,
Bfiun., S5455
Dr. Miehaei Ifrashow, Dept* of Biology,. University of tftah,
Salt Lake City, tJtah ' 84112,
*Mr. O^nald Pack, 1826 qpalocka Orive, McClean, Virginia 22101
* Denotes CSSSC Bfenfcca:
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