AMBIENT AIR QUALITY STANDARD FOR OZONE

                    ("MINOR" REPORTS)
Tab A - Revisied Ozone Standard - (part 50 Notice)

    B - Calibration Package (Part 50 Notice)

    C - Implementation Regulations  (Part 51 Notice)

    D - Federal Register Notice of 6/22/78

    E - Summary of Contents (PEDCo)

    J - Summary Statement from the EPA Advisory Panel on Health
        Effects of Photochemical Oxidants

    L - Alternative Forms of the Ambient Air Quality Standard for
        Photochemical Oxidants

    Q - The Use of Judgemental Probobility Distribution in Setting
        NAAQS for Ozone

    S - CWPS/RARG Report

    T - Memo form Walt Barber to Dave Hawkins  (re: CWPS/RARG Report)

    U - Estimates of Economic Benefits Associated with Alternative
        Secondary Ozone Standards (Under Revision)

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                                                             11/21/73
                    ENVIRONMENTAL PROTECTION AGENCY
                          (40 CFR Part 50)
                  (FRL     Docket Number OAQPS 78-8)
                      PHOTOCHEMICAL OXIDANTS
                  Revisions to the National Ambient Air
                            Quality Standard

AGENCY:  Environmental Protection Agency.
ACTION:  Final Rulemaking.
SUMMARY:  In accordance with the provisions of Sections 108 and 109
of the Clean Air Act as amended, EPA has conducted a review of the
criteria upon which the existing primary and secondary photochemical
oxidant standards are based.  These standards were promulgated in 1971
(36 FR 8186) and were both set at an hourly average IGVO! of 0.08 part
per million  (ppm) not to be exceeded more  than 1 hour per year.  On
June 22, 1978, EPA proposed changes in the standard (43 FR 26962)
based on the findings of the revised criteria.  The proposed changes  in-
cluded  (1) raising the primary standard to 0.10 ppm, (2) retaining the 0.08
ppm secondary standard, (3) changing the chemical designation of the  standard
from photochemical oxidant to ozone, and  (4) changing to a standard with a
statistical  rather than deterministic form.  The final rulemaking will make
two further  changes in the standard;  (1)  raising the secondary standard to
0.10 ppm, and (2) changing the definition  of the point at which the standard
is attained  to "when the expected number of days per calendar year with maxi-
mum hourly average concentrations above 0.10 ppm is equal to or less  than
one."

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FOR FURTHER  INFORMATION CONTACT:
                      Mr.  Joseph  Padgett, Director
                      Strategies  and Air Standards Division
                      Office of Air Quality Planning and Standards
                      U.S.  Environmental Protection Agency, RTP, NC 27711
                      Telephone:  919-541-5204
AVAILABILITY OF RELATED INFORMATION:  A docket  (Number OAQPS 78-8) con-
taining information  used by EPA in revising the standards is available
for public inspection and  copying between 8:00  a.m. and 4:30 p.m.
Monday through Friday, at  EPA's Public Information and Reference Unit,
Room 2922, Waterside Mall,  401 M  Street SW., Washington DC 20460.  These
materials include  the "Air Quality Criteria for Ozone and Other Photo-
chemical Oxidants" and "Control Techniques for  Volatile Organic Emissions
from Stationary Sources,"  both of which were issued simultaneously when
this standard was  proposed.  The  Control Techniques Document and staff
papers pertaining  to the form of  the ozone standard, risk assessment
method, secondary  standard, and health panel assessment are available
upon request from  Mr. Joseph Padgett.  Statements of the environmental,
economic, and energy impacts of implementing this standard revision are
also available upon  request from  Mr. Joseph Padgett, at the address
shown above.  The  Air Quality Criteria Document can be obtained from:
              Mr.  Michael  Berry
              Environmental Criteria and Assessment Office, MD-52
              Office of Research  and Development
              U.S. Environmental  Protection Agency
              Research Triangle Park, North Carolina 27711
              Telephone:   919-541-2266
     Revisions to  40 CFR Part 50, Appendix D, "Measurement Principle and
Calibration Procedure for  the Measurement of Photochemical Oxidants Cor-
rected for Interferences Due to Nitrogen Oxides and Sulfur Dioxide"
and Appendix H, "Interpretation of the National Ambient Air Quality
CH.  ,^,^ *n  n^nnp»  are described elsewhere in  this preamble.

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                                    3

      Revisions to 40 CFR Part 51, substituting  the word  "ozone" for

 "photochemical oxidants" throughout that part,  and to Section 51.14,

 pertaining to control strategies, are being promulgated  by EPA elsewhere
 in this issue of the Federal Register.


 SUPPLEMENTARY INFORMATION:

                               BACKGROUND

      On April 30,  1971, the Environmental Protection Agency

 promulgated  in the Federal Register  (36 FR 8186)  National Ambient

 Air Quality  Standards for photochemical oxidants.  The  scientific,

 technical, and medical bases for these standards  are contained in the

 air quality  criteria document for photochemical oxidants, published by

 the U.S. Department of Health, Education, and Welfare in March,  1970.

 Both the primary and secondary standards were set at an hourly average
 level of 0.08 ppm not to be exceeded more than once per year.  The

 preamble to the regulation stated:

      "The revised national primary standard of 0.08 ppm is based
      on evidence of increased frequency of asthma attacks in some
      asthmatic subjects on days when estimated hourly average concen-
      trations of photochemical oxidant reached 0.10 ppm.  A number
      of comments raised serious questions about the validity of
      data used to suggest impairment.of athletic performance at lower
      oxidant concentrations.  The revised primary standard includes a
      margin of safety which is substantially below the most likely
      threshold level suggested by this data.  It is the Administrator's
      judgment that a primary standard of 0.08 ppm as a 1-hour average
      will provide an adequate safety margin for protection of public
      health and will protect against known and anticipated adverse
      effects on public welfare."
The asthma study cited as evidence for the original study is oased on

work by Schoettlin and Landau.  As discussed in the June 22, 1978, pro-

posed revision to the original standard, EPA has reassessed its conclusions

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regarding this study.  This  reassessment, plus the evaluation of medical
evidence generated  since  1970,  led EPA  to propose, on June 22, 1978, a
revised primary standard  of  0.10  ppm  (43 FR 26962).  EPA did not
propose a change  in  the secondary welfare standard at that time.  The
proposal was accompanied  by  publication of revised criteria and control
techniques documents,  as  well as  various staff papers relating to the
standard itself and  to implementation of the standard.  EPA solicited written
comments on the proposed  standard and,  to accept oral testimony, sponsored
four public hearings (Washington, D. C. - July 18; - Atlanta, Ga. - August 17;
Dallas, Tex. - August  22;  Los Angeles,  Calif. - August 24).
     Oxidants are strongly oxidizing compounds, which are the primary
constituents of photochemical smog.  The oxidant found in largest
amounts is ozone  (0.,), a  very reactive form of oxygen.  Oxidants also
include the group of compounds referred to collectively as peroxyacyl-
nitrates (PANs) and  other  compounds, all produced in much smaller
quantities than ozone.
     Most of these materials are  not emitted directly into the atmosphere
but result primarily from  a  series of chemical  reactions between
oxidant precursors  (nitrogen oxides and organic compounds) in the
presence of sunlight.  The principal sources of organic compounds are
the hydrocarbon emissions  from automobile and truck exhausts, gasoline
vapors, paint solvent  evaporation, open burning,  dry cleaning fluids,
chemical plants and  other  industrial operations.   Nitrogen oxides are
emitted primarily from combustion sources such as electric power
generation units, gas  and  oil-fired space heaters, and automobile,
diesel  and jet engines.

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     The reductions in emissions of nitrogen oxides and organic
compounds are achieved through Federal and State programs that have
been formalized in regulations promulgated under the Clean Air Act.
The Federal programs provide for the reduction in emissions nationwide
through the Federal Motor Vehicle Control Program, the Federal
program for control of aircraft emissions, National Emission Standards
for Hazardous Air Pollutants, and the development of New Source
Performance Standards.  The State programs provide for additional
control measures through State Implementation Plans in those areas of
the country where the Federal programs are not sufficiently stringent
to permit attainment of air quality standards.
          LEGISLATIVE  REQUIREMENTS  AFFECTING THIS PROMULGATION
     Two sections of the Clean Air Act govern the development of a
National Ambient Air Quality Standard.  Section 108 instructs EPA to
document the scientific basis for the standard, and Section 109 provides
guidance on establishing standards and reviewing criteria.
     Air quality criteria are required by Section 108(a)(2) to reflect
accurately the latest scientific information useful in indicating the kind
and extent of all identifiable effects on public health or welfare that
may be expected from the presence of the pollutant in the ambient air.
     The Administrator is required to propose, simultaneously with the
issuance of these criteria, primary and secondary ambient air quality
standards based upon such criteria.  The primary standard is defined in

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Section  109(b)(l)  as  that  ambient air quality standard the attainment
and maintenance of which in the Administrator's judgment, based en such
criteria and allowing an adequate margin of safety, are requisite
to protect the public health.  The  secondary standard (Section 109(b)(2))
must specify a level  the attainment  and maintenance of which in the Admini-
strator's judgment, based  on such criteria, are requisite to protect
the public welfare from any known or anticipated adverse effects associated
with the presence  of  the pollutant  in the  ambient air.  These adverse
welfare effects, which are discussed in Section 302(h) of the Act, include
effects on soils,  water, crops, vegetation, man-made materials, animals,
weather, visibility,  hazards to transportation, economic values, personal
comfort and we11-being, and other factors.
     The Clean Air Act specifies that National Ambient Air Quality
Standards are to be based  on scientific criteria relating to the
level that should  be  attained to protect public health and welfare
adequately.  Considerations of cost  of achieving those standards or the
existence of technology to bring about needed reductions of emissions
are not germane to such a  determination, as the words of the Act and its
legislative history clearly indicate.  Section 109(d) directs the
Administrator to complete  a review  of all  existing standards and
criteria before the end of 1980 and  at 5-year intervals thereafter
and to revise them in whatever manner that review reveals is necessary.
This promulgation  is  the result of  such a  review.

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     Assuring attainment and maintenance of ambient air quality
standards Is the responsibility of the states.  Under Section 110 of
the Act, they are to submit to EPA for approval State Implementation
Plans (SIPs) that provide for the necessary legal requirements for
sources of the relevant pollutant so as to demonstrate attainment and
maintenance of the standards by certain deadlines.  In many areas of
the country the ambient air quality standards are not being attainea,
despite the fact that the deadline for attainment has long since
passed. As a remedy, Part D of the Act requires states with
violations of ambient air quality standards to submit revised SIPs
to ensure attainment of the standards and to meet certain new
requirements of Part D by January 1, 1979. (Section 129(c),
Publ. L. 95-95, note under 42 U.S.C. 7502.) The Act does not
authorize the Administrator to extend that deadline, and consequently
this revision of the photochemical oxidant standard does not affect the
deadline for submittal of SIP revisions.
     A state that submits a revised SIP meeting the requirements of
Part D by January 1, 1979, will escape the consequences of §§  llOfa)  (2.) 1(1)
and 176(a) of the Act, even if the target standard of the plan is
0.08 ppm.  Attainment of 0.08 ppm will ensure attainment of 0.10 ppm.

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                                  8

     There may be cases, however, where states will wish to revise
their newly submitted SIPs to reflect the change in the standard.
For example, where the air quality in a state is close to 0.10 ppm, a
plan that ensures attainment of a 0.08 ppm standard by 1982 may require
controls that a 0.10 ppm standard would render unnecessary.  These states
may want to revise their SIPs before the controls take effect.  Such
revisions can be accomplished quickly, since the difficult and time-
consuming tasks of developing an emission inventory and weighing the
reduction capabilities of various possible measures have already been
accomplished.
     In many cases, revisions of this type are expected to be un-
necessary.  States that cannot demonstrate attainment before 1982 must
include in  their 1979 submittals measures sufficient to demonstrate
reasonable  further progress  through  1982, but need not
include measures that demonstrate attainment until the SIP is further
revised in  1982.  Where the  1979 plan does not contain measures demon-
strating attainment,  the minor shift in  the target from 0.08 to 0.10 ppm
should not  affect the 1979 requirements.
     The time  schedule of any SIP revisions occasioned by  the raising
of  the standard will  be determined by the states.  Section 110(a)(l)
requires that  SIP revisions  be submitted within  9 months after a
standard is revised.  This,  however, refers to  situations  where  a
standard is tightened so  that existing  SIPs no  longer show attainment.
Where  a standard  is  relaxed, no  SIP  revision  is  required by  the  law,
since  states may  have more  stringent controls  than necessary if  they
choose.  Thus,  there is  no  deadline. On the  other hand, those states

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that do elect to revise their SIPs will undoubtedly act as quickly
as possible, for the reasons discussed above.
       SUMMARY OF GENERAL FINDINGS FROM AIR QUALITY CRITERIA FOR
                  OZONE AND PHOTOCHEMICAL OXIDANTS

      On April 20, 1977 (42 FR 20493), EPA announced that it was in
 the process of reviewing and updating the 1970 criteria document
 for photochemical oxidants in accordance with provisions of Section 109(d)(l)
 of the Clean Air Act as amended.  The notice called for information and
 data that would be helpful in revising the document.  In the process of
 developing the criteria document, EPA has provided a number of opportunities
 for external review and comment.  Two drafts of the criteria document
 have been made available for external review and EPA has received more
 than 50 written comments on the first draft and approximately 20 on the
 second draft.  The American Petroleum Institute has submitted extensive
 information that EPA has considered in this standard review.  The
 criteria document was the subject of two meetings of the Subcommittee
 on Scientific Criteria for Photochemical Oxidants of EPA's Science
 Advisory Board.  Each of these meetings has been open to the public
 and a number of individuals have presented both critical review and new
 information for EPA's consideration.  A full discussion of comments
 received during the review process as well as EPA's disposition of
 these comments can be found in the docket (OAQPS 78-8) assembled for
 this rulemaking.

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                                   10
     From the extensive review of scientific information presented in
the criteria document, findings in several key areas have particular
relevance for setting the ozone standard.
     1.  The concept of a "threshold" may not be an appropriate term
     for describing the impact of ozone on human health.  Since
     "thresholds" will depend upon who is studied and what is measured,
     it is unlikely that scientific evidence for a specific effects
     threshold can be satisfactorily derived for protecting public
     health.  Limited studies can be performed on groups of unusually
     sensitive persons.  Most experimental studies of humans are
     performed on small numbers of healthy subjects who do not
     adequately reflect the range of human sensitivity.  Animal exposure
     studies usually cannot provide appropriate models of sensitive
     human populations.  Thus, "thresholds" for sensitive persons
     are difficult or impossible to determine experimentally, while
     the "threshold" for healthy persons or animals is not likely to be
     predictive of the response of more sensitive groups.
     2.  Ozone is a broncho-pulmonary  irritant which affects the respiratory
     mucous membranes, other  lung tissues and respiratory functions.   It
     has been demonstrated  in clinical and epidemiological studies that
     ozone  impairs the normal mechanical function of the human lung and causes
     clinical symptoms such as chest tightness, cough and wheezing.  These
     effects may occur in sensitive individuals at short-term ozone concen-
     trations between 0.15 and 0.25 ppm.  The clinical studies data base on
     these effects  is far more extensive than that available in 1970 and
     these effects  have been demonstrated at lower levels than those
     cited in the  1970 criteria document.

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                                    11

3.  The best available evidence suggests that an elevated proportion
of asthmatics experience attacks on days when the peak hourly oxidant
concentrations reach about 0.25 ppm.  This finding is based on a
revaluation of the Schoettlin and Landau study and represents, a
revision of the 0.10 ppm estimate made in the 1970 criteria document.
4.  The key finding from toxicologic studies is the increased
susceptibility to bacterial infection in laboratory animals
exposed to 0.10 ppm ozone and a bacterial challenge.  Infection
rates are lower for animals exposed only to the bacterial
challenge.  Other effects such as biochemical changes, morpho-
logical abnormalities, and genetic changes have been shown in
some animal studies but the physiological significance of these
effects remains to be established.
5.  There is a limited amount of data that suggests that ozone
may accelerate the aging process in living organisms.  Exposure
of rabbits to unspecified concentrations of ozone for one hour
per week for a year has been reported to induce premature aging
symptoms such as premature cartilage calcification, severe
depletion of body fat, and general signs of aging.

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                               12

6.  The  fact  that  ozone  exposure  is  frequently  accompanied by
exposure to other  pollutants,  such as  sulfur dioxide  (S02), has
prompted several investigators to conduct  laboratory  evaluations
of exposure of  humans  to combinations  of 0-, and other pollutants.
Exposures to  0.37  ppm  0, and 0.37 ppm  SOg  simultaneously have
been reported to produce larger changes  in pulmonary  function
than does either pollutant alone. Other simultaneous exposure
tests using 0.25 ppm 0.,  and 0.3 ppm  nitrogen dioxide  (N02), as well as
0,, NOp,  and  30 ppm carbon monoxide  (CO),  showed no obvious effects.
Nevertheless, the  SO^  -  0^ synergism findings support the need for an
adequate margin of safety.
7.  There are no studies  that  link  exposure to ozone or
photochemical oxidants to  an increase in human mortality.  A number
of epidemiologic studies  have  been  designed and conducted to demon-
strate this effect, but all have been negative or inconclusive.
8.  Ozone accelerates the  aging of  many materials resulting in rubber
cracking, dye fading and  paint erosion.  These effects are related
to the total dose of ozone and can  occur at very low levels,
given long duration exposures.  Damage to vegetation occurs as
leaf injury, decreased growth  and yield, and disruption of
reproductive functions.
9.  All evidence presently available indicates that around urban
centers with severe oxidant problems, the major concern is the forma-
tion of photochemical oxidants from man-made organic and nitrogen oxide
emissions.  Control of these emissions will result in significant

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                                 13
    reductions in ambient ozone,  peroxyacetylnitrate (PAN),  aldehydes
    and photochemical aerosol.
                            RULEMAKING PETITIONS
     The Agency was petitioned  by the American Petroleum Ins-titute (API)  and
29 member  companies on December 9, 1976, and the City of Houston on
July 11, 1977, to revise the criteria, standards and control strategy
guidelines for photochemical oxidants.  These efforts were already
underway when both petitions were filed, and the Agency responded
that it was deferring decision  on their petitions until the rulemak'ing
was completed.  EPA considers this final rulemaking and the accompanying
one on control strategy guidelines to be the Agency's final action on
these petitions.  A summary of the two petitions and EPA's response  is
summarized below.
     The API  petition requested that  EPA revise the air quality  criteria
document for  photochemical oxidants in light of new information  regarding
the causes, effects, and extent of air pollution attributed to ozone and
other oxidants.   EPA has published a  revised air quality criteria
document for  photochemical oxidants which  in the Agency's judgment
accurately reflects the latest scientific  information  regarding  the
causes, effects,  and extent of air pollution attributed to ozone and
other oxidants.

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                                  14

     The  second  request  in  the  API  petition  was  that EPA establish
a national  primary ambient  air  quality standard  based on new studies
which allegedly  demonstrate no  significant adverse human health
effects at  or  below ozone levels  of 0.25  ppm for two-hour exposures.
The Agency  has,  as requested  by API and as required under the Clean
Air Act,  considered all  new studies published since 1971 that are
relevant  to setting a  revised primary  standard the attainment and
maintenance of which would,in the Administrator's judgment, protect the
public health  with an  adequate  margin  of  safety.  EPA differs with API's
conclusion  that  new studies conducted  since  1971  demonstrate no signifi-
cant adverse human health effects at or below 0.25 ppm.  A more detailed
discussion  of  EPA's judgments regarding reported or probaDle health
consequences at  concentrations  below 0.25 ppm is presented in the
rationale for  revising the  primary  standard  and  in tne  response to
comments, which  appear elsewhere  in this  notice.
     The  third request by API was that  the national secondary ambient
air quality  standard be based on adverse  effects on public welfare
as indicated by  studies using ozone-specific measurement methods.   In
addition, API urged  the Agency  to take  into account the full  range of
economic  and social  considerations  which  define the "public welfare"
as described under  Section  302(h) of the  Clean Air Act.  Since the
proposal  of  June 22, 1978,  EPA  has  added  to its assessment an analysis
of the estimated economic benefits  of a secondary standard more stringent
than the  primary.   Based on this analysis as well as effects  data
presented in the criteria document, EPA has concluded that a secondary
standard more stringent than the primary  standard does  not appear
necessary.

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                                     15
     Both the API and Houston petitions requested EPA to state the
primary and secondary standards so as to permit reliable assessments of
compliance.  EPA agrees that the present deterministic form of the oxidant
standard has several limitations and has made reliable assessment of
compliance difficult.  The revised ozone air quality standards are
stated in a statistical form which will more accurately reflect the
air quality problems in various regions of the country and allow more
reliable assessment of compliance with the standards.
     The API and Houston petitions requested that EPA specify the use
of an appropriate measurement method for the monitoring of ambient
concentrations of ozone.  API suggested the use of ethylene chemilumi-
nescence calibrated by either gas phase titration (GPT) or ultraviolet  (UV)
photometry.  As a result of EPA's continuing evaluation of several
calibration techniques the Agency has defined the reference method to
be ethylene chemiluminescence calibrated by UV photometry.i(See amendment
to Part 50, Appendix D in this edition of the Federal'Register.)  EPA is
allowing the use of a modified version of trie current calibration method
(acidified KI) as an interim measure to avoid problems whicn would result
from immediate conversion to UV photometry.
     Both the API and Houston petitions requested revision of the State
implementation plan (SIP) requirements to:  (1) delete the assumption
of no background concentration of photochemical oxidants; and (2) specify
more reliable, alternative oxidant prediction relationships  to replace
Appendix J for determining the degree of necessary precursor emission
reductions.

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                                  16
      EPA  realizes  that background concentrations  and  transport of ozone
from  upwind  locations can impact upon  high  levels of  ozone  in or near
an  urban  area  during the afternoon hours.   Therefore,  several revisions
are being made in  control  strategy and implementation  guidelines for
ozone.  The  revised guidelines  set forth procedures for consideration
of  both upwind transport and  irreducible natural  background by the States
in  calculating the necessary  reductions in  hydrocarbon emissions.  In
response  to  the second  request,  EPA nas determined that Appendix J of
40 CFR 51 no longer represents an  acceptable analytical relationship
between hydrocarbons  and ozone.   Appendix J is therefore being deleted.
EPA will  now allow States  to  use any of four analytical techniques to
determine the  amount  of hydrocarbon reduction necessary to demonstrate
attainment of  the  national ozone air quality standards.  The four tech-
niques include:  (1)  Photochemical  Dispersion Models,  (2) Empirical
Kinetics Modeling  Approach (EKMA),  (3)  Empirical  and Statistical Models,
and (4) Proportional  Rollback.   These  four  techniques  are discussed
further in the  revision  of Part  51  which appears  elsewhere in this edition
of the Federal  Register.
     The Houston petition  requested that: EPA consider  information in their
petition  relative  to  atmospheric conditions and other  factors tnat affect
photochemical  oxidants  in  the Houston  area.  The  petition claimed that
the air pollution  problems in Houston  warrant special  attention in
standard-setting and  "tailor-made"  control  strategies, because the emis-
sion and meteorology  situations  and the overall pollution picture in that
area are  "unique".
     In response to the  above claim, it should be noted tnat the majority
of the data presented  in  the  revised criteria document is baseci on

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                                17
ozone exposure.  Nearly all of the clinical and toxicological
studies are based on the effects of ozone.  The biomedical data also
suggest that many of the effects observed during periods of elevated
photochemical oxidant concentrations are reasonably attributable primarily
to ozone in the ambient air.  Since the primary and secondary standard
are based on the effects of ozone, the differences between areas in their
overall photochemical oxidant mixtures do not bear upon the setting of
national ozone air quality standards.
     EPA agrees with the Houston petition that components of the photochemical
oxidant mixture other than ozone may have an adverse impact on health and/or
welfare.  However, the data base is not sufficient at this time to
justify a separate standard for PAN or other non-ozone oxidants.
While EPA does not propose to establish separate standards for the
non-ozone constituents of the mixture  at this time, those measures
taken to reduce ozone precursor emissions will also reduce PAN and
other non-ozone oxidant concentration levels.  Finally, in response
to Houston's request for a unique standard based on their local
situation, it must be realized that the Clean Air Act does not
contemplate separate standards for different cities.  The Act, dealing
in terms of national ambient air quality standards, has charged EPA to
identify the air quality levels wnich must be attained and maintained
to assure, with an adequate margin of safety, that adverse health
effects will not occur.
     The Houston petition also requests that EPA "include realistic
requirements for the reduction of oxides of nitrogen as conditions
in the Houston area may indicate to be necessary to achieve the
revised standards."  EPA's response is that it is the responsibility
of the State of Texas and the City of Houston to submit State

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                                     18
implementation  plan  provisions  tailored  to the situation prevailing in
Houston.   If  the current SIP  is not  representative of the most efficient
means of reducing ozone in Houston,  then, with Houston's assistance, Texas
should submit a revision which  is consistent with local emission and
meteorological  conditions.
SUMMARY OF COMMENTS  RECEIVED
      EPA  has solicited public comment and critique on proposed
 revisions to the photochemical oxidant  air quality standard during all
 phases of the standard development  process.  Prior to proposal, (April 20,
 1977 - 42 FR 20493) EPA announced it was reviewing and updating the
 criteria document and called for information that might be helpful in
 revising the document.  Public comments were received on two drafts of the
 criteria document and the public was invited to two meetings of the Sub-
 committee on Scientific Criteria for Photochemical  Oxidants of EPA's
 Science Advisory Board.  In addition, a public meeting was held on
 January 30, 1978,  to receive comments from interested parties prior to
 development of any formal  agency position on the initial  proposed revision
 of the standard.   The results of this meeting are discussed in the proposed
 regulation (43 FR  26970)  and a transcript of the meeting is available in the
 OAQPS Docket 78-8.
      Following proposal,  EPA held four public meetings to receive comments
 on the proposed standard  revisions.  Meetings were held in Washington, DC -
 July 18,  Atlanta,  GA - August 17, Dallas, TX - August 22,  and
 Los Angeles, CA -  August  24;  transcripts are available in OAQPS Docket
 78-8.  In addition, 167 written comments were received during the formal
 comment period which extended through October 16, 1978.

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                                     19

     The principal comments and Agency responses are discussed in the
following paragraphs (individual responses to comments are contained in
OAQPS Docket 78-8).  EPA "also received comments on the proposed standard
after October 16.  Although EPA does not have a legal obligation to review
these comments, we have addressed and responded to all significant issues
raised in the post-October 16 comments as part of the discussion of
comments in this preamble.  As with all other documents considered o»- examined
by EPA as part of its decision process, these documents have been placed
in the public docket and have become part of the administrative record of
this decision.
      The majority of comments received (127/167) opposed EPA's proposed
 standard revision, suggesting either a more relaxed or a more stringent
 standard.  State air pollution control agencies generally supported a more
 relaxed standard of 0.12 ppm or higher.  State and Territorial Air Pollu-
 tion Program Administrators  (STAPPA)  supported a standard lavel of 0.12 ppm,
 municipal groups 0.12 ppm.or higher,and industrial groups 0.15 ppm or higher.
 Environmental groups encouraged EPA to retain the 0.08 ppm st*nHarH.
      Comments on the proposed revisions were received from five Federal
 agencies.   Three of the  agencies  endorsed  the proposed primary standard
 but one of these agencies requested that EPA consider formulating  the
 standard on  a daily maximum  hourly  average basis.   Another agency  expressed
 concern  that EPA had inadequately substantiated  the rationale  for
 raising  the  primary standard level  and requested  that the  final  revisions
 provide  further  analysis  in  this  regard.   Finally,  the Executive Office  of
 the President/Council  on  Wage and Price Stability through  the  Regulatory
 Analysis Review  Group  suggested that  the proposed  standard was  unnecessarily

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                                    20

 stringent and recommended an alternative methodology for setting the

 primary standard  that  focuses  on  the marginal costs per person-hour

 of ozone effects  avoided.

      Groups  and  individuals submitting comments are identified below:

          COMMENTS RECEIVED ENDORSING CURRENT PRIMARY STANDARD
                          LEVEL OF .08 ppm


Organizations and Agencies

American Lung Association of Colorado
American Lung Association of Colorado, West Region
American Lung Association of Louisiana
American Lung Association of New Jersey
American Lung Association of New York State, Inc.
Bangor-Brewer TB and Health Association, Maine
California Lung Association
Connecticut State Department of Health
Environmental Confederation of Southwest Florida
Environmental Defense Fund
Ms. Nancy C. Fahden, Supervisor District Two, Contra Costa County (Calif.)
 Board of Supervisors
Florida Lung Association
Green leaf Nurseries, Warsaw, IN
Issac Walton Teag"ue~Man~asbta Chapter"
League of Women Voters of the U.S.
League of Women Voters of Dallas, Texas
Maine Health Systems Agency
Maine Lung Association
Medford-Ashland Air Quality Maintenance Advisory Committee,  Oregon
Michigan Lung Association
Michigan Lung Association, Saginaw Valley Region
National Air Conservation Commission, American Lung Association
Natural Resources Advisory Committee, Cedar Grove,  N.J.
New Mexico Lung Association
Oregon Environmental Council
Oregon Lung Association
Queensboro Lung Association, Jamaica, N.Y.
Sierra Club
Sierra Club, Houston Chapter
South Shore (Ohio) Christmas Seal Association
Southwestern Ohio Lung Association
U.S. Department of the Interior
Washington Air Quality Coalition
Yale Environmental Law Association
Summary:
        35 comments from organizations, agencies or their representatives  ana
        38 comments from concerned citizens supporting the current
        primary standard level of .08 ppm.

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                                   21
          COMMENTS RECEIVED ENDORSING PROPOSED PRIMARY STANDARD
                           LEVEL OF .10 ppm


Organizations and Agencies

Air Pollution Control  League of Greater Cincinnati
Air Quality Advisory Committee, California Department of Health
California  Air  Resources Board
.Coalition of Labor  and Business (COLAB)
Co.lor.ado. Department of Health
Connecticut Department of Environmental  Protection
MasSjachusetts_Dep_artment of Environmental  Qualjty Engineering"
Public  Health Ser vice /U.S." Department of"HEW
Regional  Planning Commission for Jefferson,  Orleans,  St. Bernard and
  St.  Tammary Parrishes, Louisiana
Rhode Island Lung Association
Southern  Alameda  County Board of Realtors, California
U.S.  Department of  Energy
U.S.  Department of  Transportation
Wasatch Front Regional  Council, Utah
Wayne County Department of Health,  Michigan
Wisconsin State Department of Natural  Resources
 Summary:
           16  comments  from organizations,  agencies or their
           .representatives  and 1  comment, from a concerned citizen
           endorsing the proposed primary standard level  of .10 ppm.

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                                     22
        COMMENTS RECEIVED ENDORSING A PRIMARY STANDARD LEVEL OF
                                .12 ppm


State and Local Agencies

Alabama Air Pollution Control Commission
City of Philadelphia, Pennsylvania
Georgia Department of Natural Resources
Griffith, Berkely, Charleston,  Dorchester Council of Governments,  S.C.
Indiana State Board of Health
Kansas Department of Health and Environment
Kentucky Department for Natural Resources and Environmental  Protection
Maryland Environmental Health Administration
Michigan Department of Natural  Resources
Nebraska Department of Environmental Control
Nevada Department of Conservation and Natural Resources
New York Department of Environmental Conservation
North Carolina Department of Natural Resources and Community Development
Pennsylvania Department of Environmental Resources
Tennessee Department of Public  Health
Utah Bureau of Air Quality
Virginia Air Pollution Control  Board

Organizations and Companies

Area Cooperation Committee of Tidewater and Virginia Peninsula Chambers
 of Commerce
Evansville, Indiana, Chamber of Commerce
Sierra Pacific Power Company
State and Territorial Air Pollution Program Administrators
Texas Oil Marketers Association
Vulcan Materials Company, Wichita, KS
Summary:
         17 comments from State and local  agencies  and  6 comments from
         organizations and_corjprAtions.sup_pgr^ijg^_pjQmary standard
         level of .12 ppm.

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                                         23

           COMMENTS RECEIVED ENDORSING A PRIMARY STANDARD LEVEL HIGHER
              THAN .12 ppm AND/OR PROPOSED STANDARD TOO STRINGENT
Organization or Agency
Endorse Standard
Higher than .12
ppm	
American Petroleum Institute (API)
Association of Local Air Pollution Control Officials
Associated Building Industry of Northern California
Cook County Dept. of Environmental Control, Illinois
Dow Chemical Company
General Motors Corporation
Great Plains Legal Foundation
Greater San Antonio Ch amber of Commerce, Texas
Houston Chamber of Commerce, Texas
Iowa-Illinois Gas and Electric Company
Louisiana Air Control Commission
Manufacturing Chemists Association
Monsanto Chemical Intermediates Co.
Motor Vehicle Manufacturers Assoc.
National Flexible Packaging Association
New Orleans Public Service, Inc.
Oklahoma State Dept. of Health
Owens-Illinois
Packnett, Steams-Roger, Inc.
Rio Blanco Oil Shale Company
San Antonio Metropolitan Health District, Texas
St. Louis County, Missouri
Shell Oil Company
Tennessee Eastman Corp.
Texas Air Control Board
Texas Chemical Council
U.S. Council on Wage and Price Stability
Utah Manufacturers Assoc.
Virginia Air Pollution Control Board
Western Oil and Gas Assoc.
White River Shale Project
        X
        X
        X
        X
        X
        X
        X
        X
        X
        X
        X
Proposed Standard
Too Stringent
        X
        X
        X
        X

        X
        X
        X
        X
        X

        X
        X
        X
        X

        X
        X
        X
                          X
                          X
                          X
                          X
                          X
                          X
                          X
Summary:
         14 comments from organizations, agencies, and companies supporting
            a primary standard level higher than  .12 ppm,
          4 comments from concerned citizens supporting a primary standard level
            higher, .than. ...12 ppm. and. 23 comments stating the proposed standard
            is too stringent.

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                                     24

     The principal  issues raised during the comment period relate to
the following topics:
I.   HEALTH EFFECT  CRITERIA AND SELECTION OF PRIMARY STANDARD
     -  Definition  of an Adverse Health Effect
     -  EPA's Interpretation of Cited Studies
     -  Margin of Safety
     -  Use of Animal Studies
     -  Exposure of Sensitive Groups
     -  Synergistic Effects and Chemical Species of the Standard
II.  RISK ASSESSMENT METHOD
III. WELFARE EFFECTS AND SECONDARY STANDARD
IV.  IMPLEMENTATION AND ATTAINABILITY
     -  Value of Hydrocarbon Control Questioned
     -  Timing of SIP Submissions
     -  Cost of Control Should Be Considered in Setting Standard
     -  Natural Background
V.   PROCEDURAL ISSUES
     A review of the comments received and their disposition has been
placed in the rulemaking docket (OAQPS 78-8) for public inspection.
The following sections summarize the significant comments and present
the Agency's responses.

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                                  25
Definition of an Adverse Health Effect
Comment
     The proposed standard is unsuitable because EPA has never defined
what constitutes "protection of public health."  As a specific example,
EPA has not shown that pulmonary function and ventilatory pattern
changes are adverse health effects.
Agency Response
         As stated in the Criteria Document, the pulmonary function
changes which have been observed in clinical exposures of healthy
subjects to ozone are reversible, and the available evidence does not
suggest that small changes in lung function (unaccompanied by discomfort
systems or impairment of oxygen uptake) would interfere with normal
activity in healthy individuals.  However, even small changes in people
with underlying respiratory disease such as asthma, chronic bronchitis,
and emphysema can interfere with normal activity and thus may signal
impairment of public health.
Comment
         EPA should identify where adverse effects begin in the
continuum of responses  to pollutants.
Agency Response
         In conducting  a preliminary risk assessment, EPA interviewed
several biomedical experts to obtain their judgments as to the risk of
exceeding the threshold of adverse health effects  in sensitive persons
for alternative standard levels.  An essential  feature of this risk
assessment procedure  is the utilization of the  experts' judgments

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                                     26
 as  to the point in the continuum of physiological  responses to ozone in
 the ambient air which constitutes an adverse health effect.  As an
 example  of this point, several experts indicated that a 0.5% decrease in
 pulmonary function (  e.g.,  forced expiratory volume-1 second test)
 would be inconsequential, whereas a 50% decrease would be a severe
 effect in sensitive persons;  the experts stated they would
 begin to be concerned with  a  5-15% decrease.
 Comment
      Sever a l_comrnents_ stated  that quickly reversible ^irritation
      experienced  for  a short  period of time  is  a welfare effect
      related  to personal  comfort and well-being and should therefore
      be  addressed under the secondary standard.
Agency Response
          The  Criteria Document states that physical  discomfort,  as
manifested  by symptoms such as difficulty in  breathing,  chest  tightness,
and pain  on deep  inspiration,  has usually been  observed  in  clinical
studies  in  conjunction with pulmonary function1  changes.   Even  when
reversible, respiratory symptoms may restrict normal  activity  or
limit  the  performance of  tasks.   In  clinical  studies,  realistic
levels of ozone (0.3  ppm) have provided  sufficient  discomfort  in healthy
subjects  as to  prevent completion of experimental protocols, particularly
when  vigorous exercise was  involved.   Accordingly,  the Criteria Document
concluded that  increased  rates of respiratory symptoms constitute
impairment of public  health.   On this  topic, a physician  from  the California
Department of Health  stated his  medical  opinion  (Docket  OAQPS-78-8,
IV-F-31)  that symptoms such as tne above constitute  adverse

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                                    27

pulmonary function decrements and an increased pulmonary work load for
affected individuals.  He expressed his concern for the long-term
effect of repeated exposure to levels of ozone sufficient to induce
such symptoms.  EPA concurs in this view and considers such symptoms,
even though transitory, to be of concern in selecting the level of
the primary standard.
EPA's Interpretation of Cited Studies
Comments
     1.  DeLucia and Adams Study
         (a)  EPA has misread the DeLucia and Adams study in claiming
              significant effects have been reported at 0.15 ppm
              for 1 hour.
         (b)  Mouthpiece breathing may have invalidated the DeLucia
              and Adams study.
         (c)  Since DeLucia and Adams demonstrated effects at 0.15 ppm
              in healthy individuals, more susceptible populations would
              be expected to sustain effects at lower levels.
Agency Responses
     (a)  EPA acknowledges that DeLucia and Adams failed to demonstrate
any statistically significant decrements in pulmonary function resulting
from exposure to 0.15 ppm for 1 hour.  However, in groups as small as
those tested by DeLucia and Adams (six subjects), tests of statistical
significance are difficult to interpret.  The Criteria Document con-
cluded that the study by DeLucia and Adams, although unreplicated,
has raised the question of whether Q+  concentrations  as  low  as 0.15  ppm

exert effects in a portion of healthy subjects exercising vigorously.

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                                    28
 Indeed, DeLucia  and  Adams  specifically  state that the two most
 sensitive  subjects sustained markedly impaired respiratory function
 and exercise  ventilatory patterns  during  the two most stressful exercise
 protocols  in   the four  ozone-exposure experiments (i.e., both 0.15 ppm
 and 0.30 ppm).
     Furthermore, DeLucia  and Adams state that most of the subjects
 experienced subjective symptoms of discomfort (e.g., congestion,
 chest pain, and  cough) when exposed to  0.15 ppm for 1 hour under the
 most stressful exercise protocol (equivalent to running about 6 miles
 in an hour).  DeLucia and  Adams did not report the incidence of these
 symptoms in a quantitative manner, but  this fact does not remove EPA's
 concern about the implications for healthy persons such as those tested
 by DeLucia and Adams, or for more  susceptible persons who may sustain
more severe reactions or who may be affected at lower concentrations
 than those observed.
     (b)  As noted by the  Criteria Document, persons tend to breathe
 through their mouths when  exercising.   Thus, DeLucia and Adam's utilization
of mouthpieces to dispense 0- is probably representative of actual
exposures in persons who in the course  of their nbrmardaily activities are
 undergoing exercise.
     (c) EPA agrees with this comment,  as noted above.  EPA considered
 the implications of this study for more susceptible members of the
 population in its determination of the  margin of safety for the ozone
 standard.

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                                    29
Comments
2.   Schoettlin and Landau Study
     (a)  There are still problems with the reliance on  this  study
due to ambiguities which remain in its interpretation, and because
more recent studies of effects of 03 on asthmatics have  failed to
corroborate this study's conclusions.
     (b)  EPA's interpretation of the concentration at which
Schoettlin and Landau correlated increased incidence of  asthmatic
attacks is unnecessarily conservative.  There is good reason  to believe
that the 0.25 ppm oxidant concentration cited by Schoettlin and Landau
was a daily peak (5-minute average) concentration rather than a daily
maximum hourly concentration, as EPA claims.  Furthermore, the level of
ozone occurring on these high oxidant days would have been less than the
level of oxidant reported.
Agency Responses
     (a)  The Criteria Document recognizes that limitations exist
which render interpretation of the Schoettlin and Landau study difficult.
Nevertheless, Schoettlin and Landau concluded that the proportion of
asthmatics having attacks was significantly greater on days when the
oxidant concentration exceeded 0.25 ppm than on days when the concentration
was below that level.  EPA does not believe that this conclusion has been
convincingly refuted by more recent studies.  The reported results of the
recent epidemiological study by Kurata et al.. although  inconclusive,
are qualitatively similar to those of Schoettlin and Landau.   EPA's
analysis (Docket OAQPS 78-8 ,   )  of the findings presented in the Kurata
study indicates that a statistically significant elevation of the asthma
index occurred on days when the maximum instantaneous (5-minute average)
ozone concentrations exceeded 0.28 ppm.

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                                     30
     (b)  EPA acknowledges that  it is uncertain from Schoettlin and
Landau's paper what averaging time was used in correlating oxidant con-
centration and incidence of asthma attacks.  However, as stated in the
Criteria Document, consultations with the authors have established
that daily asthma attack rates were correlated with daily maximum
hourly average oxidant  levels.   EPA considers that these consultations
have satisfactorily resolved the controversy regarding the averaging
times used by Schoettlin and Landau.
     Furthermore there  is concern that ozone levels were lower than
the oxidant readings with  which Schoettlin and Landau correlated
asthma attack incidence.  Ozone  levels have been shown to range from
approximately 65 percent to nearly 100 percent of the total oxidant
levels.  For this reason, EPA is concerned that ozone in the ambient
air at daily maximum hourly average concentrations less than 0.25 ppm
may adversely affect asthmatic persons.
3.  Hammer et al: (Student Nurse Study)
Comments
     (a)  Methodological problems with this study diminish its use-
fulness.
     (b)  It is uncertain that oxidants caused the increase in symptoms
observed in this study.
Agency Responses
     (a)  As noted in the Criteria Document, the results of this
epidemiological study closely correlate with the results of clinical
studies.  This fact, along with  the extensive data base evaluated
(about 53,000  person-days of observation}, enhances the reliability
of Hammer's study.

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                                  31
     (b)  Hammer et al. found that symptom frequencies were more
closely correlated to photochemical oxidants than to several other
environmental parameters.(e.g., carbon monoxide and nitrogen dioxide).
In addition, the Criteria Document noted that the oxidant levels at which
cough and chest discomfort were observed to increase in the student
nurse population were quite similar to ozone concentrations which
have been observed to produce impairment of pulmonary function and
respiratory irritation in experimental exposures of healthy
subjects performing intermittent light exercise (0.37 ppm for 2 hours).
Consequently, it is reasonable to propose that photochemical oxidants —
and specifically ozone in the ambient air -- contributed substantially to
observed increases in rates of cough, chest discomfort, and headache.
4.  Hazucha Clinical Study
Comment
     Results reported by-Hazucha on impairment of pulmonary function
at ozone levels of 0.25 ppm for 2 hours are not statistically significant,
Agency Response
     The small number of subjects (3) examined at that exposure
precludes the application of statistical methods to the results.  The
absolute value of the pulmonary function decrements (about 5 percent)
is the more relevant factor in evaluating this study's results.
     As described in the Criteria Document, the small pulmonary function
changes observed by Hazucha in a 2-hour exposure of healthy subjects
undergoing intermittent light exercise lies along a continuum of
responses when compared with results at higher concentrations and similar
exposure regimes.  There is no indication that 0.25 ppm is the threshold
for that exercise level, and indeed DeLucia and Adams have shown sympto-

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                               32
matic effects  in healthy  individuals that are indicative of pulmonary
function impairment at  levels as low as 0.15 ppm.
 5.   Studies in which effects were not observed at levels above 0.15 ppm

 Comments
      (a)  The National  Academy of Sciences (NAS)  document,  Ozone and Other
 Photochemical  Oxidants, was cited in several  comments as concluding that  ef-
 fects in humans have been observed only from  ozone exposures above 0.25 ppm.
      (b)  Linn et al. found no adverse effects on asthmatics exposed
 to  0.20 - 0.25 ppm for 2 hours under conditions of  heat  and exercise.
      (c)  Hackney  et al.  observed human health  effects only at ex-
 posures above 0.25 ppm for 2 hours.
 Agency Responses
      (a)  The NAS document states that "some  limited studies show
 evidence of human health effects of exposure  to pure ozone  at concen-
 trations as low as 0.25 ppm . .  ."  This document was prepared before
 the publication of the DeLucia and Adams and von  Nieding et al. studies
 which suggest effects at lower levels.  Furthermore, this NAS document
 in  no way concludes that effects due to ozone, as it occurs in the ambient
 photochemical  mix, do not occur at concentrations below 0.25 ppm.
      (b)  While it is true that Linn et al. found no statistically sig-
 nificant impact on pulmonary function in their study, there was a slight
 increase in symptom scores during ozone exposure, and these investigators
 did find statistically significant changes in blood biochemical factors.
 While the clinical significance of these latter changes is  uncertain, they do
 represent alterations in normal body functions and cannot be discarded  in
 selecting a standard that protects public health with an adequate margin
 of safety.

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                              33

     (c)  Although the Criteria Document states that Hackney et al.
found no lung function changes of note at 0.25 ppm for 2 hours even
among "reactive" subjects (persons giving a history of cough, chest
discomfort, or wheezing in response to allergy or air pollution
exposure), this finding does not invalidate or permit EPA to ignore
other studies which report effects at 0.25 ppm or below.
6.  Other Human Studies
Comments

     (a)  Von Nieding has demonstrated effects on pulmonary function of
healthy individuals at 0.10 ppm ozone.
     (b)  EPA cannot justify a conclusion that Japanese epidemiological
studies indicate a risk of symptomatic effects in humans from ozone
exposures below 0.15 ppm for 1 hour.
Agency Responses
     (a)  EPA is concerned about the findings of von Nieding et al.
showing decreased oxygen pressure in arterialized blood and  increased  airway
resistance after 2 hours of exposure to 0.10 ppm ozone and intermittent
light exercise.  However, the Criteria Document points out several  limita-
tions of von Nieding's studies, most notably  the use of non-standard
physiologic measurement methods.  Thus, although von Nieding's findings
cannot be ignored in the standard-setting process,  they are  not conclusive,
and must be interpreted cautiously.
     (b)  Makino and Mizoguchi reported an epidemiological study of
Tokyo students  that  showed increased rates of discomfort symptoms
on days when the oxidant level  (believed to be a daily maximum hourly

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                                    34
average concentration) exceeded 0.15 ppm as compared with days when it
fell below 0.10 ppm.  Althounh the Criteria Document cautions that these
studies may not be applicable to ambient situations in the U.S., EPA
nonetheless must set a standard which considers uncertainties which medical
research has not yet resolved and must consider evidence such as the
Japanese studies in selecting an adequate margin of safety.
 7.   Validity of Clinical Studies in General
 Comment
      Testimony heard on August 22, 1977 at the Dallas public hearing
 alleged  that ozone generators used in clinical health studies were
 producing other toxic materials in addition to ozone.  It was further
 alleged that these additional oxidants were present in large quantities
 (as high as 300 percent greater than ozone) and that adverse effects
 noted in clinical  studies were probably a result of the additional
 oxidants and not ozone.
 Agency Response
      EPA has concluded that the experimental  evidence offered to support
 these findings is unconvincing and cannot be substantiated.   The issue of
 additional oxidants in the output of ozone generators is not a new issue
 and was addressed in the 1977 National Academy of Sciences document on ozone.
 This document focuses on three such oxidants, singlet oxygen and two forms
 of  atomic oxygen.   Although singlet oxygen is described as the most stable
 of  these materials, the National Academy of Sciences document concludes that
 even sinqlet oxygen is too unstable for any more than a minute fraction of
 the amount generated to be present at more than 0.1 seconds  downstream
 from the generator output.  Evidence submitted to EPA at the hearing indicates

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                                     35
that the sampling lines used in some of the experiments would require a
residence time of 20 seconds, far longer than the estimated survival
time for the additionally-produced oxidants.  Because of this, and
because new non-validated measurement techniques were used, EPA feels
that the higher numbers reported can probably be attributed to the reagent
used in the detection device and not to the actual presence of any additional
oxidant.  EPA has provided a more extensive discussion of this issue in
the docket as well as the results of laboratory work conducted to support
this conclusion.
Margin of Safety
Comment
     EPA has proposed a standard with an inappropriate margin of safety.
The margin of safety was criticized as being either inadequate or too great.
Agency Response
     The Clean Air Act requires that EPA set a standard that allows an
adequate margin of safety requisite to protect the public health.  As
stated in the support material to the Clean Air Act, the standard must
protect against hazards which research has not yet identified.  EPA feels
this is a judgment which must be made by the Administrator after weighing
all the medical evidence bearing on ozone.  This includes inconclusive
evidence as well as findings from studies which are considered definitive
and not subject to challenge.  Factors which must be considered by the
Administrator in selecting an adequate margin of safety include:  (1)
findings from animal studies which show increased mortality and other serious

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                                      36

effects  at  relatively low  ozone  levels, (2)  concern that health studies
may not  always  reflect the health  impact in  more sensitive segments of
the population,  and  (3)  concern  that  ozone may produce an enhanced effect
when combined with other elements  of  the photochemical mix commonly present
in the urban atmosphere  but not  present in clinical study chambers.
Use of Animal Studies
Comment
     EPA has failed  to give appropriate consideration to the results of
animal studies,  especially those involving young animals and those
examining reduced resistance to  infection.
Agency Response
     EPA is concerned about the  studies which have demonstrated enhanced
effects  in young animals and decreased  resistance to infection.  The in-
fection effect has been  demonstrated  at exposures as low as 0.08 ppm for
3 hours.  The Criteria Document  concluded that these findings have
definite human health implications, although different exposure levels
may be associated with such effects in  humans.  For this reason, these
results cannot be the sole factor  used  in selecting the level of the
primary standard.  However,  as is  the case with other inconclusive evidence,
EPA must consider these  studies  in selecting an adequate margin of safety.
Comment
     There is no evidence  of reduced  resistance to infection in epidemiologic
studies in places such as  Los Angeles.

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                                  37

Agency Response
     Epidemiological studies have been inconclusive in demonstrating
this effect in man.  However, EPA does not agree with this comment.
Durham's study of air pollution effects on college students, although
inconclusive, suggests that rates of new illness increase during short-term
exposures to elevated oxidant concentrations.  Also, several studies documenting
increased levels of mucous membrane irritation during periods of ozone ex-
posure suggest indirectly that susceptibility to infection may rise during
these periods.  While animal study findings cannot be directly extrapolated
to man, the criteria document concludes that the reactions observed in mice
represent effects on basic biological responses to infectious agents, and
there is no reason to believe that the pollutant-induced alterations of
basic defense mechanisms that occur in mice could not occur in humans.  Thus,
these studies cannot be ignored in the standard-setting process.
Exposure of  Sensitive Groups
Comment
      EPA is  being  unnecessarily stringent  in  selecting the  sensitive
population.   The standard could be much  less  stringent without endangering
the  health of such  persons  if  EPA accounted  for the  portion of time that
persons  are  indoors  and thus not exposed to  higher  ambient  concentrations.
Agency  Response
      The  legislative history of  the  Clean  Air Act makes  quite clear
Congress1  intention  to  protect sensitive persons  (asthmatics  and  emphysematous
patients are cited as examples)  who  in the normal  course of daily activity
are  exposed  to the ambient  environment.   Air quality standards  are to be
established  with reference  to  protecting the health of  a representative sample
of persons comprising the sensitive group rather  than a single  person in  such

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                                     38

 a  group.   Standards must be based on a judgment of a safe air quality  level
 and  not on an estimate of how many persons will intersect given  concentration
 levels.  EPA  interprets the Clean Air Act  as  providing citizens  the oppor-
 tunity  to  pursue  their normal  activities in a healthy environment.
Synergistic Effects  and Chemical  Species of Standard
Comment
     There were objections  to  the proposed change of  the  chemical designa-
tion of the standard from photochemical oxidants to ozone because the
health  impacts of photochemical air  pollution arise not only from ozone,
but also from the spectrum  of  other  gaseous and parti oil ate pollutants which
co-exist with ozone.   There was also  concern  that the change in the chemical
designation signalled  a change in emphasis in oxidant control efforts which
would impede progress  in the reduction of non-ozone components of the
photochemical oxidant  mixture  such as  peroxyacetylnitrate (PAN).  Specific
concern was expressed  regarding the  eye-irritating components of the mixture,
since at ambient  levels ozone  alone  is not an eye irritant.
Agency Response
     Studies  (such  as  Hazucha  and Bates) have demonstrated the potential
for greater health  impacts  resulting  from exposure to ozone in combination
with other pollutants  in the ambient  air than for ozone alone.  The ozone
standard is not intended merely to protect against the levels of ozone
which have been demonstrated to produce effects in clinical studips ex-
posing subjects to  highly purified air to which ozone has been added.
Rather, the standard is set to protect against  ozone  as it occurs

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                                39
in the ambient air, in combination with other pollutants.   Such considera-
tions are involved in determining an adequate margin of safety.
      One reason  for     changing  the  chemical  designation  of  the  standard from
photochemical oxidants to ozone is  to correct  an  inconsistency between  the
title of the standard (photochemical oxidants) and the chemical  species (ozone)
which has always been measured to determine compliance with the Standard.  Con-
sequently, no redirection of control efforts is comtemplated; i.e. reductions in
hydrocarbon  and nitrogen oxide emissions will continue to be required  in order
to reduce the levels of the secondarily generated pollutant (ozone) measured
to determine compliance with the standard.
     Furthermore, with regard to the issue of whether or not measures taken to
reduce ozone will also reduce other manifestations of photochemical pollution
such as eye irritation, the criteria document describes the evidence from
laboratory and theoretical studies as indicating that for urban
atmospheres, reductions in hydrocarbon and nitrogen oxide emissions should
have even greater impacts on ambient PAN than on ambient ozone.   Similarly,
laboratory data suggest a linear relation between hydrocarbon emissions and
ambient levels of photochemically produced aldehydes.  Since PAN and such
aldehydes as formaldehyde and acrolein are known to be eye irritants, the
criteria document concludes that emission control measures for ozone reduction
will probably have a positive effect on reducing eye irritation in those
situations where eye irritation is  associated with photochemical processes
(6.9.,  Los Angeles).

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                                40
Risk Assessment Method
Comment
     The risk assessment method should not be used at this time because
it has not been reviewed adequately by the Science Advisory Board or
the scientific community.
Agency Response
     The risk assessment method is not being used to set the ozone stand-
ard. However, in determining what ozone  standard has an adequate margin
of safety, the findings of  the  initial application of the risk assessment
method to ozone have  been- considered.  EPA agrees that the method has
not received sufficient review.  The method will be published  in the
open literature and the Science Advisory Board  is forming an ad-hoc
subcommittee to review the  method.
Comment
     EPA's risk assessment  method is incomplete.
Agency Response
     EPA agrees with  the comment.  As  applied to ozone, the risk assessment
method assesses the risk  (probability) that ozone would contribute to
heal'th effects in  some sensitive people  if alternative standards were just
met.  A complete risk picture would also include information on:
     (a)   a best  (point) estimate of  the number of peop-le affected;
     (a1)  the "expected number" (in a statistical sense) of people
           affected;
     (a")  various risks  (probabilities) that the actual number of people
           affected would be various amounts greater than the expected
           number;

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                              41
     (b)   a best (point) estimate of the amount of health damage;
     (b1)  the "expected" health damage; and
     (b")  various risks (probabilities) that the actual health
           damage would be various amounts greater than the expected
           health damage.
As is noted in the draft EPA document explaining the risk assessment
method, there are complex technical problems which must be dealt with
in developing responsible information of this type suitable for use in
setting National Ambient Air Quality Standards.  EPA is presently develop-
ing the capability to generate this type of information and will only
consider its risk assessment method complete when it includes this
capability.
Comment
     The main problem with the risk assessment method stems from its
purpose.  Instead of estimating health damage, EPA provides a table of
risk numbers without providing an estimate of their health significance;
these numbers serve no function.
Agency Response
     EPA agrees that the risk estimates provided do not serve the function
of estimating health damage, but we do not agree that the estimates are
without value.  The function of these estimates is to indicate the vary-
ing risk (or probability) that some sensitive people would suffer health
effects in a given period of time if alternative ozone standards were
just met.  For each health effect category the response which is of

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                               42
 sufficient concern to be deemed a health effect has  been  decided  and
 its  seriousness described.  Under EPA's interpretation  of the  intent
 of the Clean Air Act this is an important function to be  served by  a
 risk assessment that is to be used in setting National  Ambient Air
 Quality Standards.
      There were many comments on procedural  and technical aspects of  the
 risk assessment method.  EPA will address these comments  in  the detailed
 responses to be placed in the docket.  Some of the comments  point out
 improvements that can be made in the risk assessment, method, while  others
 reflect misunderstandings that will be addressed in the detailed  docket
 responses.  Some of the comments provide discussion and opinions  on
 various complex issues that arise in the subject areas  of risk assessment
 and  standard setting methodology.  EPA will  take these  comments  into
 advisement as it develops its risk assessment and standard-setting
'methodologies.
 Secondary Standard
 Comment
      EPA's proposal to retain the existing secondary standard  is  based
 entirely on evidence of possible damage to extremely sensitive vegetation.
 An  adequate economic analysis which considers the incremental  costs
 and  benefits of alternative secondary standard levels should be  conducted.
 EPA  should then weigh the economic costs of pollution control  measures
 against the benefits of reduced damages from lower ozone concentration
 levels before setting a secondary standard.

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                                  43
 Agency  Response
      The  Clean Air Act  requires EPA to set a national  secondary ambient
 air  quality  standard  at a  level which in the judgment  of the Administrator
 is "requisite to protect the public welfare from any known or anticipated
 adverse effects."  The  term "public welfare" is defined in Section 302(h)
 of the Clean Air Act  and includes among other things effects on crops,
 vegetation, wildlife, visibility, and climate, "as well as effects on economic
 values and on personal  comfort and well being."
     EPA agrees that both the incremental  control  costs and the benefits/
damages associated with alternative standard levels need to be carefully
considered in selecting the level  of the national  secondary ambient air
quality standard.  However, it should be kept in mind that there are large
uncertainties associated with both the estimation of control  costs and
benefits/damages associated with alternative standard levels.  For example,
the current state of knowledge and data base for making reasonably accurate
quantitative estimates of the economic loss due to ozone-related plant
damage are extremely limited and inadequate.  EPA has conducted a limited
economic analysis, employing the best data currently available, to obtain
a rough picture of the maximum benefits to be achieved by a secondary stand-
ard more stringent than the primary.. "(A copy of "the" staff report, entitled
"Estimate of Economic Benefits Associated with Alternative Secondary Ozone
Standards" has been placed in the docket.)  In concluding that a secondary
standard more stringent than the primary is not justified at this time, EPA
has considered the above mentioned analysis, discussions with expert plant
pathologists, the-data  in the criteria document on damages to plants and
materials, and the incremental control costs.

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                                      44
 Implementation and Attainability
     Comments were received regarding the effectiveness of hydrocarbon
controls in reducing levels of ozone in the ambient air as well as on
the issue of whether or not the statutory deadline for submission of
revised State implementation plans  (SIP) for non-attainment areas should
be postponed due to the changes in the photochemical oxidants standard.
The Agency responses to these comments are contained in the accompanying
Federal Register notice for the revision of the CFR Part 51 regulations
pertaining to the implementation of the standard.
Comment
     Cost of control should be considered in selecting the level of the
primary standard.
Agency Response
     The Agency's position  regarding  this point was  addressed  in  the  preamble
 to the proposed regulation (43 FR 26963);  this position remains
 unchanged.  The Clean Air Act specifies that National  Ambient Air
 Quality Standards are to be based on scientific criteria relating to
 the level  that should be attained to adequately protect public health
 and welfare.  Considerations of cost of achieving those standards or the
 existence of technology to bring about needed reductions of emissions are not
 germane to such a determination, as the words of the Act and its legislative
 history clearly indicate.  However, EPA has conducted an analysis of the
 cost and economic impacts of the control programs required to attain alterna-
 tive ozone standard levels in order that the public may be better informed
 of the consequences of the Agency's decision.  This analysis and the
 comments received in response to it are available to the States for
 their use in developing strategies to implement the standard.

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                                      45

Comment
     The cost estimates in EPA's cost and economic impact assessment
underestimate the actual costs incurred by specific industries.
Agency Response
     EPA has carefully reviewed and considered these comments and is pub-
lishing a revised economic impact assessment which is available from
Mr. Padgett at the previously mentioned address.
Comments on Natural Background Concentrations
     Several comments were made regarding the issue of natural source con-
tribution to ambient ozone concentrations.  These comments relate primarily
to the extent that natural background was considered in developing the
proposed standards and the attainability of these standards, considering
that natural background may at times contravene the proposed levels.
Some of the comments suggested that EPA ignored or did not adequately con-
sider natural background  in developing  the proposed  standards and
related control  programs.  While not emphasized  in the preamble  to  the
proposed rulemaking, EPA was  and is cognizant of  the background  levels
that can be attributed to natural  sources.   This  topic was  treated  ex-
tensively  in the Revised Criteria  Document.  Furthermore, EPA procedures
for preparation  of control plans recommend allowance for  natural  background
in developing control strategies for ozone.
     For several  years, EPA has had an  active field  and  laboratory  re-
search  program seeking to determine the nature and extent of  background
concentrations of ozone.  The results of these studies have been widely
publicized in EPA reports, scientific literature,  and  public  conferences.
One comment  indicated that EPA had ignored evidence  of natural source

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                                  46

impacts reported  in contract work done for the Agency and that this
information had not been released for public review.  Actually, all
pertinent information available to EPA were considered.  However, there
may have been some contractually developed information that had not been
released or could not be specifically cited because the contract studies
were still in progress  and the resulting data had not been fully validated
or analyzed.  Subsequent to the comment, all information in question were
released publically or  arrangements have been made to release them as soon
as possible.
     EPA's review of data indicative of natural background contribution
leads the Agency to conclude that such levels are usually well below the
proposed levels of the  standard, especially during the season when the
most active production  of photochemical ozone occurs.  However, it is
possible that natural events could occasionally contravene the proposed
standard levels.  EPA policy (see 40 CFR 51.15(d)) permits data for such
occurrences to be disregarded for regulatory purposes.  Such events are
usually distinguishable because they tend not to coincide with conditions
conducive to buildup of man-caused, photochemically produced ozone.  Field
measurements at some remote sites where man-caused ozone is likely to be
negligible have shown low, but not insignificant, rates of exceedances of
the 0.08 ppm level originally proposed for the secondary standard.  The
frequencies decrease markedly for concentrations above 0.10 ppm, such that
the occurrence of natural exceedances can be considered relatively rare
at any particular location.
     One comment  indicated that stratospheric tracer levels measured at
surface sites increase  by about 40 percent between the front and back
side of high pressure systems in the Eastern United States, thus suggesting

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                                    47
that stratospheric ozone, through subsidence and horizontal circulation
In highs, plays a significant role in the widespread buildup of ozone
that tends to occur in the back side of highs in the East during the
photochemically active season.  EPA's estimate is that, even if
commonly occurring natural ozone background were increased by 40 percent,
it would be insufficient to exceed proposed standard levels.  Also, a
corresponding increase between the tracer and ozone of stratospheric
origin would not be expected, since the tracer is chemically stable near the
surface, while ozone is rapidly depleted by reactions with surfaces and air
contaminants.
     Some comments referred- to possibly significant contribution to ozone
concentrations from reactions involving organic compounds emitted by
vegetation.  Such emissions are abundant, relative to man-made emissions,
but are relatively diffuse spatially.  A recent statistical study was cited
in some of the comments which reported a high correlation between
vegetative growth in the Bay Area of California, as indicaleu u> winter
rainfall, and the frequency of days with concentrations above the
0.08 ppm level.   EPA,  however, has not seen sufficient physical
evidence of a relative abundance of natural organics or associated
ozone increases  in ambient air to consider vegetative sources as
significant contributors to high ambient ozone levels.  The principal
source of natural ozone is still considered to be the stratosphere, with
gradual transfer accounting for the more commonly observed background
levels, and sporadic intrusions being the principal cause of anomalous high
values.
     Although research will continue to definitively assess natural source
contribution, EPA feels that adequate consideration has been given this

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                                    48
issue in developing  the  ozone  standards  and control programs.  Furthermore,
it is EPA's judgment that  natural  background  levels will not prevent
attainment of  the  standards.
Procedural  Issues
Comment
     EPA's use of  an "Advisory Panel  on  Health  Effects of Photochemical
Oxidants" was  procedurally incorrect  in  that  certain  legal requirements
on establishment and use of Advisory  Committees were  not followed.
Agency Response
     The Advisory  Panel  consisted  of  a group  of medical experts retained
by EPA as consultants for  the  purpose of obtaining their interpretation of the
evidence presented in a  preliminary version of  the criteria document.
Consequently,  EPA  considers that  the  Panel was  not subject to the requirements
of the Advisory Committee  Act  of 1972.   In  any  case,  all the objectives
of that Act  have been met, since the  Panel's  report has been in the  docket
and  subject  to comment since  proposal.   All viewpoints on the health  effects
of ozone have  been presented  to EPA and  have  been  given consideration equal
to that given  the  Panel's  report.
Comment
     EPA has failed  to comply  with the recommendations of the statutory
scientific  review  body,  the Science Advisory  Board  (SAB), in revising
its  criteria document, as  evidenced by the  SAB's refusal to approve  the
criteria document.
Agency Response
     EPA has responded to  each of the substantial  comments made by the SAB
subcommittee established to review the criteria document; these responses
have been  placed  in  the docket and are  available for  public review.   Follow-
ing  the  last meeting of the subcommittee in February  1978, EPA personnel

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                                      49
 consulted with  the  members  of  the subcommittee  individually to  resolve
 the objections  expressed  at that meeting.   In a subsequent correspondence
 with EPA, the subcommittee's chairman, Dr.  James L.  Whittenberger,  stated
 that "any remaining complaints I have are minor."  (Docket OAQPS 78-8,
 H-A-E-2-27).
 Comment
      EPA has failed to submit  the proposed  standard to the SAB  for
 review as required  by the Environmental  Research, Development,  and
 Demonstration Authorization Act of 1978  (P.L. 95-155).  EPA should do
 so before promulgating the standard.
 Agency Response
      EPA has not proceeded as  requested  by  this comment.  P.L.  95-155
 states that the SAB may comment on the technical and scientific basis
 of an EPA proposal.  The SAB has already extensively reviewed the
 criteria document and has given its advice  on the technical and scientific
 basis for the document.  Since this document is the principal basis for the
 proposed standard,  resubmittal to the SAB  is not necessary to effectuate
 P.L. 95-155.
          SELECTING THE LEVEL OF THE PRIMARY STANDARD
     EPA's objective in setting the standard level is to select an ozone
concentration that will reflect an accurate  consideration of the existing medi-
cal evidence and an  adequate assessment of the uncertainties in this evidence,
and thus will protect all population groups  with an adequate margin of safety.
     Relevant to this charge, the National Academy of Sciences reached the
following conclusion in 1974:

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                                     50
  ... in no case is there evidence that the threshold levels
  have clear.physiological meaning, in the sense that there are
  genuine adverse health effects at and above some level of
  pollution, but no effects at all below that level.  On the
  contrary, evidence indicates that the amount of health damage
  varies with the upward" and downward variations in the concen-
  tration of the pollutant, with no sharp lower limit.
     The House of Representatives  Committee on  Interstate and. Foreign
Commerce has observed that the concepts of threshold  and adequate margin
of safety that underlie the language of Section 109(b)(l) of  the Clean
Air Act are necessary simplifications to permit the Administrator to
set standards.
     The criteria document confirms that no clear threshold can be identified
for health effects due to ozone.   Rather, there is a  continuum consisting
of ozone levels at which health effects are certain,  through  levels at
which scientists can generally agree that health effects have been
clearly demonstrated, and down to  levels at which the  indications of
health effects are less certain and harder to identify.  Selecting a
standard from this continuum  is a  judgment of prudent  public  health
practice, and does not imply  some  discrete or fixed margin of safety that
is appended to a known "threshold."
     The uncertainties with which  such a judgment must deal are the
result of several factors.  First, human susceptibility to health effects
varies and we cannot be certain that experimental evidence has accounted
for the full range of susceptibility.  Second, we cannot be certain that
all effects occurring at low  ozone levels have been identified and demon-
strated.  Third, variations in weather create uncertainty as  to the expected
annual maximum ozone concentrations.

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                                   51

     The Clean Air Act, as the Administrator interprets it, does not permit
him to take factors such as cost or attainability into account in setting
the standard; it is to be a standard which will adequately protect public
health.  The Administrator recognizes that controlling ozone to very low
levels is a task that will have significant impact on economic and social
activity.  This recognition causes the Administrator to reject as an
option, setting a zero-level standard as an expedient way of protecting
public health without having to decide among uncertainties.  However, it is
public health, and not economic impact, that must drive the decision.  Thus,
the decision as to what standard protects public health with an adequate
margin of safety is based on the uncertainty that any given level is low
enough to prevent health effects, and on the relative acceptability of various
degrees of uncertainty, given the seriousness of the effects.
      In  selecting  the proper level  for the standard,  EPA must make
 assessments and judgments in five critical  areas:
      1.   Reported  effect levels from  human studies.
      2.   Characterizing the sensitive population.
      3.   Nature and severity of effects.
      4.   Probable  effect level  in sensitive persons.
      5.   Judgment  of a standard level below the probable effect level
          that provides an adequate margin of safety and  an acceptable
          level  of  risk.

                           REPORTED EFFECT LEVELS
      In  the preamble to the proposed  standard (43  FR 26965),  EPA presented
  a table of demonstrated effect levels in man ranging from 0.15 to  0.30.
  Based on suggestions received during the comment  period, that table has been
  expanded to  include  a greater  number of  studies where effects  have  been

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        52
REPORTED EFFECT LEVELS

Concentration,
pptn
0.01 -
0.30
0.03 -
0.30
0.10
0.10 -
0.15
0.15
0.20
0.20 -
0.25
0.25
0.25
0.25
0.25
0.28
0.30
0.30*
0.37
0.37
0.37
0.37
0.37
Exposure Duration,
hours (for clinical
studies); Averaging
tine (for epidera to-
logical studies)
binourly
average
hourly
average
Z
probably dally
maximum hourly
average
1
3
2
Z
2 and 4
dally maximum
hourly average
0.5 - 1
daily maximum
instantaneous
(5-minute)
average
1
dally maximum
hourly average
Z
2
2
2
Z
Pollutant
Measured
(0, = ozone,
0- » oxidant)
°3
°x
°3
°x
°3
°3
°3
°3
°3
°x
°3
°3
°3
°x
°3
S§3
°3
S°Z
Reported
Effect (s)
Lung function parameters in about Z5X of Japanese
school children tested were significantly corre-
lated with 0, concentrations (over the range of
0.01 - 0.30) In the 2 hours prior to testing.
Although significant correlation was observed be-
tween decreased athletic performance & 0 concen-
trations 1n the range of 0.03 - 0.30 ppm, the
Criteria Document concludes that no consistent
linear relationship could be detected below
about 0.10 pptn.
Decreased 0. pressure in arterial 1zed blood.
Increased airway resistance observed using non-
standard measurement techniques.
Increased rates of respiratory symptoms and head-
ache were reported by Japanese students an days when
0 concentrations exceeded 0.15 ppm as compared to
days when 0 concentrations were less than 0.10 ppm.
Subjective symptoms of discomfort were observed by
most subjects, and discernible but not statistical-
ly significant changes in respiratory pattern oc-
curred while performing vigorous exercise.
Reduction in visual acuity (night vision) ob-
served .
Asthmatic patients exposed under intermittent
light exercise conditions showed no statistically
significant changes In respiratory function.
Symptom scores Increased slightly during Oj ex-
posures. . Small but statistically significant Y
blood biochemical changes occurred.
Small changes in lung function were observed in 3
subjects performing intermittent light exercise.
No lung function changes of note were observed in
"reactive" subjects (who had histories of cough,
chest discomfort or wheezing associated with air
pollution or allergy) while performing inter-
mittent, light exercise.
The average number of asthma patients having
attacks was statistically significantly elevated
on days when Ox levels exceeded 0.25 ppm.
Blood samples of exposed subjects had increased
rates of sphering of red blood cells
Although the reported results are inconclusive, "
EPA's examination of the evidence presented
suggests exacerbation of asthma when 0, levels
are above 0.28 ppm.
Subjective symptoms of discomfort and statistical-
ly significant changes in pulmonary function were
observed In subjects undergoing vigorous exercise.
Increased rates of cough, chest discomfort, and
headache were observed in student nurses on days
when the Ox concentrations exceeded 0.30 ppm.
Discomfort symptoms & significant changes In lung
function were observed in subjects undergoing
Intermittent light exercise.
Exposure to 0, and SO, together produced changes
In lung function substantially greater than the
sum of the separate effects of the Individual
pollutants.
The observed 0, - SO. interactive effect on lung
function was considerably smaller than that seen
by Hazucha and Bates. The authors concluded that
the earlier study probably more nearly simulated
a smog episode in regions having high oxidant and
sulfur oollution.
Reference(s)
Kagawa and Toyama
(1975); Kagawa, et al.
(1976)
Wayne, et al.
(1967) 	
von Nieding, et al.
(1976)
Makino and Mlzoguchi
(1975)
OeLucia & Adams
(1977)
Lagerwerff
(1963)
Linn, et al.
(1978)
Hazucha (1973)
Hackney, et al.
(1975)
Schoettlin and
Landau (1961)
Brinkman. et al.
(1964)
Kurata, et al.
(1976)
OeLucia and Adams
(1977)
Hammer, et al.
(1974)
Hazucha, et al. (1973),
Folinsbee7"eT"al. (1975);
Silverman, eTlT. (1976)
Hazucha and Sates (1975)
Bell, et al. (1977)

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                                   53
reported.  EPA feels this is a more complete representation of the
medical evidence since it includes some less conclusive studies at low levels
which cannot be discarded in weighing the full body of health data.
     This table is not intended to provide, nor can  it  provide,  an  un-
disputed value for the adverse effect level in sensitive individuals.
It does indicate however that disruption or modification of normal
body functions most likely occurs at relatively low ozone concentrations.
The reported findings leave  open the question of increased intensity of
effects in more sensitive persons and the concern that  effects reported
in some studies may occur at lower concentrations when  ozone is in  combina-
tion with other urban pollutants.
                             SENSITIVE POPULATION
     The legislative history of the Clean Air Act indicates that in setting
primary ambient air quality standards, EPA is to direct its efforts at groups
of "particularly sensitive citizens such as bronchial  asthmatics and
emphysematics who in the normal course of daily activity are exposed to the
ambient environment." (S. Rep. No. 91-1196, 91st Cong.  2d Sess. 10  (1970).)
     Clinical and epidemiological studies have shown that persons with chronic
obstructive airway disease,  particularly asthmatics,, appear most sensitive
to changes in ozone concentrations.  This is because their airways  are hyper-
reactive to irritants such as ozone.  These people are thus judged to be the
principal sensitive group of concern in setting the standard.
     Studies have also established  that exercise effectively increases
the ozone dose delivered to the target tissues in the respiratory tract.
Thus, persons engaging in exercise  are particularly vulnerable to the
acutely  irritating effects of ozone.  However, the response of these
groups to such changes in concentrations has not been systematically studied.

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                                    54
                        NATURE  AND SEVERITY  OF  EFFECTS

 Impaired  Pulmonary Function  and  Clinical  Symptoms  — Ozone is a broncho-
 pulmonary irritant which affects the  mucous lining, other lung tissue
 and respiratory function.  Changes in lung  function appear as increased
 airway resistance,  and  reductions in  vital  capacity, expiratory flow rates
 and diffusion capacity.   These effects  are  greater in exercising individuals
 and individuals  with  hyper-reactive airways (history of developing
 symptoms  during  light activity in smog  or history of asthma).  Changes
 in lung function are  accompanied by clinical symptoms such as coughing,
 chest tightness,  and  lower chest soreness.
     Because the human  respiratory system is endowed with a large reserve,.
 even airway resistance  increases of 50  to 100  percent will not ordinarily
 be perceived in  normal  individuals.   However,  as stated in the criteria
 document,  "three considerations  suggest that oxidant-associated changes
 in lung function  may  signal  impairment  of public health.  First, in
 people with underlying  respiratory illness  such as asthma, chronic
 bronchitis, and  emphysema, even  small decrements in lung function often
 interfere  with normal activity.   Second,  at experimental ozone concen-
 trations  as low  as  0.30  ppm, decrements in  lung function have usually
 been accompanied  by physical discomfort,  as manifested in symptoms such
 as sore throat,  chest pain,  cough, and  headache.  At times this dis-
 comfort has been  great  enough  to prevent  the completion of experimental
 protocols, particularly  when subjects have  been exercising vigorously.
 It appears quite  likely  that the pulmonary  irritant properties of ozone
 (and perhaps other  oxidants) underlie both  the discomfort and the decre-
ments in  function.  Thus, at least when associated with ozone exposure,

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                                   55
changes in lung function often represent a level of discomfort which,
even among healthy people, may restrict normal activity or impair the
performance of tasks."
Decreased Resistance to Infection — This effect is represented by an
increased rate of mortality in laboratory animals subjected to both a
bacterial challenge and exposures to ozone.  According to some, studies,
the effect may be enhanced by the addition of such stresses as heat,
exercise, or the addition of other pollutants in combination with the
ozone dose.  Despite the  lack of confirmatory studies in man, and the
uncertainties involved in predicting human effects from animal studies,
most medical experts agree that decreased resistance to infection may
well occur in man and the lack of_such evidence is probably due
to the difficulty of detecting these responses in epidemiologic studies.
Aggravation of Chronic Respiratory Disease — It is generally accepted by
the scientific community that there is a link between ambient oxidant
levels and aggravation of pulmonary disease.  This link was demonstrated
by the Schoettlin and Landau study which related the frequency of asthma
attacks to measured ambient photochemical oxidant concentrations.  Several
studies have investigated the aggravation of emphysema and chronic
bronchitis without revealing any definitive links to photochemical oxidant
concentrations.
     Air pollution is one of the many stresses which can precipitate
an asthma attack or worsen the disease state in persons with chronic
cardiopulmonary disease.  Other factors which can act like ozone in
precipitating attacks include:  respiratory infections, passage of cold
fronts, seasonal pollens, extreme heat or cold, and!emotional
disturbances.

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                                      56
Eye Irritation — Eye  irritation  is associated with selected chemical
species (such as PAN)  in the photochemical oxidant mix and other organic
vapors.  There is no evidence that eye irritation is produced by
ozone.  Since EPA is redesignating the standard from photochemical
oxidants to ozone, the eye  irritation effect is not a critical one in
establishing the standard level.
Biochemical Effects ~ Experimental exposures of human subjects to ozone
have produced changes  in blood biochemistry, such as increased fragility
of red blood cells and altered enzyme activities in the serum.  The
significance of these  ozone-mediated changes is not yet known,; and
changes of the magnitude observed in experimental exposures have not
yet been linked to any clinical diseases.
Carcinogenic, Mutagenic and Related Effects — Studies have been conducted
in an attempt to relate ozone to  carcinogenic, mutagenic, and related
effects.  Available evidence in these areas is not particularly helpful
in setting ambient ozone standards because most of the studies are as yet
unreplicated, and because some effects observed in lower life forms are
of questionable significance to man.  The criteria document states that
the significance of effects such,  as chromosomal aberrations has hot been
established.  EPAis Science Advisory  Board has recommended that certain
studies, which have not been replicated, should not be emphasized in the
criteria document.

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                                       57
                                 PRIMARY STANDARD
     As illustrated in the table of reported effect levels, there is no
sharp break or threshold air concentration of ozone indicated by the data
as the onset of health effects.  It is EPA's best judgment that responses
which may or may not be adverse probably occur in sensitive persons at levels
approaching natural background.  At what point these responses become an
adverse health effect and at what level they most likely occur in sensitive
persons must necessarily be an informed judgment.  EPA made such a judgment
in the proposed revision to this standard and has received no convincing
evidence that would change that choice.  As stated in the proposal, this
judgment is based on:  (1) our understanding of the medical evidence presented
in the criteria document and the effect level table, (2) the findings of the
advisory panel on health effects, and (3) the judgment of medical experts
                                         -          i
as to the adverse effect level in sensitive persons.]  The health experts
who were consulted were asked to focus not only on the most sensitive
population group, but also on a very sensitive portion of that group
(specifically, those persons who are more sensitive than 99 percent of the
sensitive group, but less sensitive than 1 percent of that group).  The
lowest effect level estimate cited by the health panel and the median
values generated through the expert interview process are reasonably
consistent, ranging from 0.15 to 0.18 ppm.  (See table below.)  Based on
this data and on the effect levels cited in the criteria document (0.15 -
0.30 ppm) 1t is EpVs judgment that the most probable level for adverse effects
effects in sensitive persons is 0.15 ppm.

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                                           58
                              PROBABLE EFFECT LEVEL ESTIMATES
                       (Estimates  for Sensitive Population  Segments)
                Aggravation of Asthma,
                Emphysema, and Chronic
                   Bronchitis
Reduced Resistance in
Bacteria Infection -
(Animal Studies-)
 Reduction in
Pulmonary Function
Chest Discomfort &
Irritation of the
Respiratory Tract
Health panel
judgment of
effect level
Probable or median
effect level as
estimated from
0.15 - 0.25 ppm
0.17 ppm
( 0.14 - 0.25 ppm)
Not available
0.18 ppm
( 0.07 - 0.38 ppm)
0.15 - 0.25 ppm
0.15 ppm
( 0.07 -0.18 ppm)
0.15 - 0.25 ppm
0.15 ppm
( 0.11 - 0.18 ppm)
health experts
(Range of estimates
given in parentheses)
                It  is not EPA's  task,  however, to  identify a probable effects  level.
          EPA's  task is to set  an  ambient air quality  standard that protects  the
          public health and welfare with an adequate margin of safety.  EPA must
          therefore deal with the  uncertainty inherent in the judgment that the
          probable level for adverse  effects in sensitive persons is 0.15 ppm.
               Because the nature  and intensity of effects vary from pollutant to
          pollutant and because medical  research  produces new and different findings
          as science progresses, EPA  does not believe  that a fixed acceptable margin
          of safety can be established for all pollutants or for a single pollutant
          over time.  Each decision on a standard level must be made on the best
          evidence available at the time and should include considerations of such
          factors  as:

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                                 59

1.  Concern for sensitive groups whose response to ozone may
be different than the response of less sensitive persons tested in
reported studies.  Individuals with   underlying respiratory illness
such as asthma, chronic bronchitis,  and emphysema are particularly
sensitive to even modest impairments of pulmonary function resulting
from ozone exposure.  There is real  concern that effects reported
in some ozone studies may occur at lower concentrations, and may
be enhanced when ozone is in combination with other urban pollutants.
Laboratory studies of single pollutants (e.g., ozone in clean
filtered air), while important in elucidating physiological effects
peculiar to that pollutant, cannot be viewed as providing definitive
evidence of the minimum level at which these effects occur when the
source pollutant is present as only  a part  of the total  insult delivered
to an individual in the urban environment.   Thus, the effects of ozone
must be considered in the context of the total environment of the
exposed individual, including concentrations of other pollutants
consistent with their maximum allowable levels, high relative humidity,
high ambient temperatures, and high  levels  of physical stress.
2.  Long-term deleterious effects of ozone  — unfortunately, there
are few studies that have attempted  to document the long-term adverse
effect of human exposure to repeated peaks  of ozone. Some animal
studies do indicate that long-term oxidant  exposures seem to act
as an inducer of biochemical or morphological changes.  These
changes are transient, and, on a short-term basis, may have a
physiological significance in that they confer a resistance
against further lung injury in an oxidant environment (a similar

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                                60
response has been observed in human clinical studies).  However,
the long-term effects of these changes resulting frorm continued
exposure are yet to be determined.  Whether or not low-level
oxidant exposures can lead to enhanced aging, or development of
chronic bronchitis or pulmonary carcinoma, fibrosis, or emphysema
needs to be determined by long-term tests.
3.  Animal Studies — although evidence of reduced resistance to
bacterial infection has not reached the point where it can be
meaningfully used to extrapolate concentrations that would similarly
affect man, these studies cannot be dismissed in selecting a
standard level that provides an adequate margin of safety.
Most experts agree that this affect does occur in humans, and
that it is only the concentration at which these affects occur
that is uncertain.  Further, it is the kind of effect that is serious
enough in its implications to raise a need for caution.  Thus,
it is prudent public health practice to set a standard more stringent than
the probable effect level estimated from human studies, in order to
account in some measure for these unquantified  but possibly
serious effects.
4.  Inconclusive Studies Reporting Effects at Low Levels — a similar
caution is suggested by both the Japanese epidemiological studies
and the German (von Nieding) clinical studies reporting effects
at levels around 0.10 ppm.
5.  Uncertainties Arising from Variations in Air Quality Concentrations

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                                      61
     Due to Prevailing Meteorological Conditions — since EPA's revised
     standard is statistically based and permits an expected number of
     allowable violations per year, there is concerni about the magnitude
     of these excursions and how they might impact an exposed sensitive
     individual.
     6.  Findings from the Preliminary Risk Assessment—  the preamble
     to the proposed standard described a preliminary risk assessment
     method performed to aid EPA in accurately treating the uncertainties
     associated with a standard decision.   While this method cannot be
     used at this time as the sole tool for making that decision, we do
     believe its findings suggest caution in any relaxation of the standard
     above 0.10 ppm.
     The Administrator has thoroughly considered the reported effects level,
the comments provided during the public comment period, and the cautions
signalled by uncertainties in the. medical evidence.  Based on all these
data, EPA is revising the primary standard to 0.10 ppm.
             WELFARE EFFECTS AND THE SECONDARY STANDARD
      The Clean Air Act mandates the setting of a national secondary
 ambient air quality standard to protect the public welfare from any
 known or anticipated adverse effects associated with the presence of
 an air pollutant in the ambient air.  Ozone and other photochemical
 oxidants constitute a form of air pollution that has been shown to
 affect vegetation and materials, and that may have an impact on visibility.
 The resultant economic loss has been estimated to be in the range of
 several hundred million dollars per year nationwide.  Non-quantifiable
 losses to the natural environment occur as well.  A staff paper,

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                                   JL
"Assessment of Welfare Effects and the Secondary Air Quality Standard
for Ozone," has  been placed in the docket.  The following material
summarizes that report and information received subsequent to its release.
     Exposure of vegetation to harmful levels of ozone may result
in leaf injury, decreased growth and yield, or reproductive effects.
Visible leaf injury  is the most readily detectable and frequently
reported symptom of  ozone damage, this effect provides the best
available data base  for evaluating alternative standard levels.
     In the Federal  Register proposal of June 22, 1978 (43 FR 26968 -26969)
it was stated that several investigators suggested that foliar injury
rates in the range of 5 to 10 percent could produce detectable reductions
in growth or yield,  depending on the timing of the injury and other
environmental factors.  Since proposal of the standard in June, EPA
has conducted further discussion with experts in the field of
air pollution damage to vegetation, as to what level of leaf injury
should be of concern in protecting against significant reductions
in yield or growth to commercially important crops and indigenous
flora.  These experts emphasized the uncertainty associated with
correlating yield reduction with foliar injury.  Some stated that
detectable yield reductions would not occur until leaf injury reached
values as high as 10 to 20 percent and others felt that foliar
injury was an inappropriate indicator of yield reduction.
     The effects of  ozone on vegetation are not linearly dependent on
the dose (product of concentration" and exposure duration) sustained by
the plant.  A given  dose applied over a short period of time is more

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                                  63
damaging than if it were applied over a longer period.  A mathematical
model has been used to summarize for several crops the experimental
results which depict the variation in foliar response with short-term
(0.5-hour to 8-hour) ozone exposures.  The proposed rule stated that a
secondary ozone air quality standard set at an hourly average con-
centration of 0.08 ppm, expected to be exceeded only once per year,
was predicted (based on the mathematical model) to prevent any
important commercial crop from receiving more than 3 percent leaf injury.
     The following factors have led EPA to reassess the reasonableness
and uncertainties associated with the judgments that led to the
proposed 0.08 ppm 1-hour average secondary standard.  First, there are
potentially large incremental control costs associated with a secondary
standard more stringent than the primary standard.  Second, the rationale
for the proposed secondary standard was brought into question by field
measurements at some remote sites where man-caused ozone is likely to be
negligible.  Spring-time monthly averages ranging up to about 0.05 ppm
and maximum hourly averages up to 0.08 ppm were reported at these
sites.  Third, there are large uncertainties involved in the
assumptions relating yield reduction to foliar injury.  The mathe-
matical model employed to predict foliar injury was based on chamber
studies, not real field conditions.  EPA has been cautioned by various ex-
perts that these studies generally represent experimental conditions using
the most sensitive varieties of a given species and optimum moisture and
temperature conditions for producing injury.  In addition, a given dose of

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                                    64
ozone which can produce 5, 10, or even 20 percent foliar injury in a
given plant is unlikely to have an  impact on yield unless the exposure
occurs during the critical stage of growth in the plant's life cycle.
     As part of EPA's reassessment, a limited economic analysis (included
in the docket) has  been conducted by the Agency to estimate the maximum
benefits to be obtained by adoption of a secondary standard more stringent
than the primary standard.  Employing worst case assumptions with regard
to damage to vegetation,  the  analysis indicates that a secondary standard
more stringent than  the primary does not appear necessary at this
time based on ozone-related damage  to vegetation.
     Materials damage due to  ozone  can be described as an acceleration
of aging processes,  that  is,  rubber cracking, dye fading, and paint
weathering.  In contrast  to the effects of ozone on vegetation, these
effects are linearly dependent on the ozone dose sustained by the
material.  As a result, the annual  average concentration, not the short-
term peak exposure,  will  determine  the rate at which material damage
occurs.  Any nonzero ozone concentration  (including natural background
levels) will contribute to the deterioration of sensitive materials over
a sufficiently long exposure  duration.  While peak 1-hour concentra-
tions of ozone tend to be higher  in urban areas, rural areas remote from
man-made emission sources have been found to have similar annual
average concentrations.   This is due to the nighttime scavenging of
ozone by man-made pollutants  in the urban areas.  Reducing the
hourly peak exposure of ozone is not likely to result in a detectably lower

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                             65

annual average.  Therefore, a secondary standard more stringent than
the primary air quality standard will not reduce economic damage to
materials.
      For the above reasons, no effect-based rationale can be offered
to decide the level of the secondary standard needed to protect materials.
Additionally, on the basis of information presented in the 1977 NAS ozone
document, EPA believes that little if any effect on visibility results from
these low ozone exposures.  Based on the preceding considerations, EPA
has concluded that a secondary standard more restrictive than the primary
air quality .standard does_ not _appeajr j»ecessary at_this time._ Therefore,.
EPA is_revising the_s_econdary ai^ qualjty standard level^ for ozone	
to 0.10 ppm.
                       OTHER ASPECTS OF THE STANDARD
      Based on EPA's evaluation of evidence submitted and comments received
during the public review process, no major changes will be made in the
following aspects of the standard:  (1) averaging time — 1 hour, (2)
chemical species — ozone, (3) form — statistical, and (4) a separate
standard for PAN is not being promulgated.  As discussed below, minor
changes will  be made in the form of the standard and the definition of
compliance will focus on a calendar day of hours above the standard
and not on a single hour.
Form of the Standard
       In  an  attempt  to  account  for  the  random nature of meteorological
 variations,  the  present  deterministic  standard  permits  a  single  hourly
 exceedance per year.   In order  to  better  account for these  variations, EPA
-prgpr^ad-fr.ft-mftAi£y_i--ho_JLLanriard hy expressing it in a statistical  form;
 a further improvement  is now being made  based

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                                     66
on  comments  received on  the proposed standard.   This  improvement  is
to  employ a  daily interpretation when determining  the number  of times the
standard  has been exceeded.  The proposed  standard was structured in terms of
the number of hours exceeding the level  of the  standard.   As  indicated  in
the proposal, there were certain advantages to  employing  a daily  interpreta-
tion whereby a day is said to exceed the standard  if  the  maximum  hourly value
for the day  exceeds the  level of the standard.   Based upon comments received,
it  is evident  that there is considerable  support  for the use of  this
daily interpretation. The reason most commonly advanced  for  this
change was the dependence of successive hourly  ozone  values due  to
meteorological  factors.   In addition, for  a secondary pollutant such as
ozone there  is  a  time lag between the associated emissions and the measured
ozone values.  Consequently, once a high hourly ozone value above the level of
the  standard is recorded there is little that can  be  done to  immediately
reduce  the next hourly value.   A final  consideration  is that  precursor
emissions  are not easily manipulated on  a  short-term  basis.  This limits
the  likelihood  that emission sources could readily alter  emission patterns
to take advantage of the daily,  rather than hourly, interpretation.  In
view  of these factors, the ozone standard  has been  restructured in terns of
days  exceeding  the level  of the standard.
      A modification has  also been made to  the exclusion criteria  for missing
data.  The proposed standard permitted certain  missing values  to  be excluded
from  the estimated exceedances calculation if either  of two exclusion
criteria were satisfied.   The  first criterion dealt with  the magnitude
of adjacent  values to reflect  short-term meteorological influences.  This
should be  relatively easy to incorporate into data-handling schemes and
has been retained,  although  it now applies to daily values.  The  second
criterion  dealt with  comparisons with data from the previous three years.
The purpose  of this  second  criterion was to accommodate situations for

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                                     67

which ozone data for a particular season is not available and yet known
seasonal patterns of ozone and related meteorological  factors make it
unlikely that the level of the standard would have been exceeded.  This
second criterion would be more difficult to implement because it necessitates
the cross-referencing of earlier historical data.  It also requires that
historical data must be available in order to invoke this exclusion.
Thus this second criterion in the proposal is difficult to implement and
could be potentially burdensome in geographic areas where the climate
makes high ozone values during certain seasons very unlikely.  It is also
possible to accomplish the intended purpose of this exclusion through
provisions of 40 CFR 58 which would grant waivers of the ozone monitoring
requirements for certain times of the year at the discretion of the appro-
priate Regional Administrator.  Therefore, the second exclusion criterion
has been eliminated and the computation formulas have been modified to
reflect the number of required monitoring days for the year.
Definition of When the Standard is Attained — EPA is adding Appendix H to
40 CFR 50 to explain when the standard is or is not being attained.
Certain modifications to the proposal were necessary to accommodate
the daily interpretation and the previously mentioned changes in the
treatment of missing data.  In order to implement a daily, rather than
hourly, interpretation it is necessary to define what is meant by a valid
day of ozone data.  Such a definition must ensure that a sufficient number
of hours of the day have been monitored and that the hourly  values  in
question reflect the time of day when high ozone values are  likely  to

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                                      68
occur.  At the  same  time, this criterion should be relatively easy
to implement, it  should allow time for  routine maintenance, and yet
protect against high values being ignored merely because not enough
hours of the day  were measured.  In view of this, a daily maximum
will be considered valid  if 75 percent  of the hourly values from
9:01 a.m. to 9:00 p.m. (LSI) were recorded or if an hourly value above
the level of the  standard was measured.  This validity criterion is in-
tended as a minimum  requirement and not as a recommended schedule.
     The computation formula for calculating the estimated number of
exceedances per year has been modified  to correspond to the daily
interpretation  of the standard.  Allowance has also been made for any situa-
tion in which the Regional Administrator has granted a waiver of the
ozone monitoring  requirements under the provisions of the newly proposed
40 CFR 58 (43 FR  34892) and therefore the total number of required monitoring
days is less than a  full  year.  The use of the exclusion criterion may result
in an underestimate  of the probability  of an exceedance in some situations
but is relatively easy to implement and should suffice to account for the
effect of missing data.   It should be noted that the formula given in
Appendix H is necessary to show attainment.  However, accounting for
missing data can  never decrease the number of exceedances and thus it
is possible to  establish non-attainment without the use of this equation.
     These modifications to Appendix H  are intended to somewhat simplify
the calculations  and allow for more flexible monitoring schedules.  The
comments received on Appendix H were varied.  A few thought it was too
complicated while others suggested even more complex techniques.  However,
most comments were either supportive of the proposed approach, or at least

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                                 69
neutral.  One suggestion was to employ a minimum percent completeness
requirement, rather than estimating the number of exceedances.  However,
the problem with that type of approach is that it remains unclear as to
what should be done with data sets that fail to meet such a complete-
ness requirement.
     Some comments addressed the use of three years of data.  As indicated
in the proposal, the choice of a three year period represents a compromise
between added stability and reasonably current status assessments.  It is
worth noting that even under the previous once per year standard, attainment
designations (e.g. 40 CFR 81-107) were based on more than one year.
Although three years are used, it is still possible to establish non-
attainment after one year if, for example, four or more exceedances
were reported.  Therefore, an upper bound to exceedances during a
single year still applies under the new form.

                    ECONOMIC, ENERGY, AND ENVIRONMENTAL
                               IMPACTS
       As has been noted previously, the Clean Air Act specifically
  requires that National Ambient Air Quality Standards be based on
  scientific criteria relating to the level that should be attained to
  adequately protect public health and welfare.  EPA interprets the Act
  as excluding any consideration of the cost of achieving such a standard
  in determining the level of the standard.  However, in compliance with
  the requirements of Executive Orders 11821 and 11949 and OMB Circular
  A-107 and with the provisions of the recently issued Executive Order
  12044 for rulemaking  proceedings which are currently pending, EPA has
  prepared an analysis  of economic impacts associated with efforts to
  attain this standard.

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                                 70

     Ozone  air  pollution  is a pervasive problem  throughout  the  country.
Most urban  and  many rural  areas exceed the  existing  standard.   Even with
the less  stringent standard, most  of the major urban areas  are  not
expected  to attain the  standard in the near-term.  Control  of the
organic precursor  materials which  generate  photochemical  oxidants
is a major  effort  in this  country  and a multi-billion dollar program.
The existing control program includes measures to  reduce  organic emissions
from:  automobile  and truck exhausts, production of  chemical and petroleum
products, the dry-cleaning industry, most painting operations including the
automotive  industry, and other industrial operations.
     Because the attainment problem  in most urban  areas is  so severe,
the relaxation  of  the standard is "not expected to  change  the level of
control requirements in the near-term.  However, the move to a  0.10 ppm
standard will eliminate the need for major  control programs in  many rural
and wilderness  areas which currently exceed the  standard.
     With the relaxation of the standard, the longer-range  outlook
does indicate that many urban  areas  will achieve the standard by 1987.
However, even with aggressive  control  programs,  it will be  very difficult
for some urban  areas to achieve the  standard within  the next 10 years.
     In addition,  a document has been prepared assessing  the impacts
that efforts  to attain the standard  may have on  the  nation's energy
requirements.   Control of  oxidant  precursors will  often be  accomplished
by recovery of  organic materials that would otherwise be  emitted to the
atmosphere.   Because of such energy  savings, this  document  concludes
that oxidant  precursor control  measures may well lessen the nation's
energy requirements.

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                                 71
     Furthermore, environmental impacts associated with control of
oxidant precursors have been examined in a document available in
docket number OAQPS 78-8.  This study indicates that modifying the
current standard should have minimal environmental impacts..
     Copies of the above-mentioned analyses of the economic,
energy, and environmental impacts involved in the revised ozone
standard are available from EPA at the address given earlier.
                  REVISIONS TO PART 50 REGULATIONS
     In addition to the revised standard, this action necessitates two
other revisions to Part 50 as follows:
     1.  In Appendix D, as well as in the table of sections for
     Part 50, the title is revised to read as follows: "Appendix D -
     Measurement Principle and Calibration Procedure for the Measurement
     of Ozone in the Atmosphere." The substitution of "ozone" for "photo-
     chemical oxidants corrected for interferences due to nitrogen oxides
     and sulfur dioxide" is a result of the proposed change in the
     chemical designation of the standard.
     2.  Appendix H, "Interpretation of the National Ambient Air Quality
     Standard for Ozone", is added because additional guidance is
     necessary to understand the statistical nature of the revised
     standard.
                    REVISIONS TO PART 51 REGULATIONS
     Elsewhere in this issue of the Federal Register, three revisions to
Part 51 are promulgated concurrently with the revision to the photochemical
oxidant standard.  They are as follows:

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                                   72
     1.  The term  "photochemical oxidants"  is changed to "ozone"
     throughout Part 5J.
     2.  Section 51.14,  "Control strategy:  Carbon monoxide, hydro-
     carbons, photochemical oxidants, and nitrogen dioxide", is revised
     to allow the  states to use any of four analytical techniques in
     the place of  Appendix J to calculate the percent hydrocarbon reduction
     needed to attain the ozone standard.
     3.  Appendix  J is deleted from Part 51.
                     FEDERAL REFERENCE METHOD
     The measurement principle and calibration procedure applicable to
reference methods  for measuring ambient ozone concentrations to determine
compliance with the standard are not affected by this rulemaking.  Else-
where in this issue of the Federal Register, however, EPA is replacing
(superseding) the  current calibration procedure with a new, superior
calibration procedure based on ultraviolet  photometry.  The measurement
principle and the  current calibration procedure are set forth in Appendix
D of 40 CFR Part 50 (as  amended in the February 18, 1975 issue of the
Federal Register,  40 FR  7042).  Reference methods — as well as equivalent
methods — for monitoring ozone are designated in accordance with 40 CFR
Part 53 (40 FR 7044).  A list of all methods designated by EPA as reference
or equivalent methods for measuring ozone is available from any EPA regional
office, or from EPA, Department E  (MD-76),  Research Triangle Park, NC 27711.
      Date                                    Administrator

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                                  73

      EPA amends Part 50 of Chapter I, Title 40, of the Code of Federal
 Regulations as follows:
      1.  Section 50.9 is revised as follows:
      § 50.9  National primary and secondary ambient air qua-lity
            standards for ozone.
      (a)  The level of the national primary and secondary ambient air
      quality standards for ozone measured by a reference method based
      on Appendix D to this part and designated in accordance with Part
      53 of this chapter, or by an equivalent method designated in
      accordance with Part 53 of this chapter, is 0.10 part per million
      (196 yg/m ).   The standard is attained when the expected number of
      days per calendar year with maximum hourly average concentrations
      above 0.10 part per million ("196 yg/m3) is equal to or less than
      one, as determined by Appendix H.
      2.  In Appendix D, as well as in the table of sections for Part 50,
      the title is revised to read as follows:  Appendix D — Measurement
      Principle and Calibration Procedure for the Measurement of Ozone
      in the Atmosphere.
      3.  Appendix H is added as follows:
          APPENDIX H - INTERPRETATION OF THE NATIONAL AMBIENT AIR
                      QUALITY STANDARD FOR OZONE
 1.  General
      This appendix explains how to determine when the expected number
 of days per calendar year with maximum hourly concentrations above
0.10 ppm (196 yg/m3) is equal to or less than one.  An expanded discussion
 of these procedures and associated examples are contained in the "Guide-
 line for Interpretation of Ozone Air Quality Standards."  For purposes

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                                  74

of clarity in the following discussion, it is convenient to use the
term "exceedance" to describe a daily maximum hourly ozone measurement
that is greater than the level of the standard.  Therefore, the phrase
"expected number of days with maximum hourly ozone concentrations above
the level of the standard" may be simply stated as the "expected number
of exceedances".
     The basic principle in making the above determination is
relatively straightforward.   Most of the complications that arise
in determining the expected number of annual exceedances are
consequences of accounting for incomplete sampling.  In general, the
average number of exceedances per calendar year must be less than or
equal to 1.  In its simplest form, the number of exceedances at a monitoring
site would be recorded for each calendar year and then averaged over the
past three calendar years to determine if this average is less than or
equal to 1.
2.  Interpretation of Expected Exceedances
     The ozone standard states that the expected number of exceedances
per year must be less than or equal to 1.  The statistical term
"expected number" is basically an arithmetic average.  The following
example explains what it would mean for an area to be in compliance
with this type of standard.  Suppose a monitoring station records a
daily maximum ozone value for every day of the year during the past
three years.  At the end of each year, the number of days with maximum
hourly concentrations above 0.10 ppm is determined and this is averaged
with the results of previous years.  As long as this average remains
"less than or equal to 1" the area is in compliance.

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                                  75
3.  Estimating the Number of Exceedances for a Year
     In general, a value may not be available for eachi hour of the
year and it will be necessary to account for these missing values
when estimating the number of exceedances for a particular calendar
year.  It should be noted that the purpose of these computations is
to determine if the expected number of exceedances per year is less
than or equal to 1.  Thus, if a site has two or more observed
exceedances each year, the standard is not met and it is not necessary
to use the procedures of this section to account for incomplete sampling.
     The term "missing value" is used here in the general sense to de-
scribe all days that do not have an associated ozone measurement.  In
some cases, a measurement might actually have been missed but in other
cases no measurement may have been scheduled for that day.  A daily
maximum ozone value is defined to be the highest hourly ozone value
recorded for the day.   This daily maximum value is considered to be
valid  if 75 percent of the hours from 9:01 a.m. to 9:00  p.m.  (1ST) were
measured or if  the highest hour is greater than the level of  the  standard.
     In some areas the seasonal pattern of ozone is so pronounced that
entire months need not be sampled because it  is extremely unlikely that
the  standard would be exceeded.  Any such waiver of the  ozone monitoring
requirement will be handled under provisions  of the newly proposed 40 CFR
58.  To avoid unfairly penalizing such  areas,  some allowance must be made  to
allow  for  days  that were not actually measured but would quite  likely have
been below the  standard.  This  introduces a  complication in that  it

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                                   76

becomes necessary to define under what conditions a missing value
may be assumed to have been less than the level of the standard.  The
following criterion may be used for ozone:
     A missing daily ozone value may be assumed to be less than the
level of the standard if both the daily maximum preceding and the
daily maximum following this missing day do not exceed 75 percent of
the level of the standard.
     Let z denote the number of missing daily values that may be
assumed to be less than the standard.  Then the following formula
shall be used to estimate the expected number of exceedances for the
year:
e = v +[(v/n) * (N-n-z)]                  (1)
     (Indicates multiplication)
Where
     e = the estimated  number of exceedances for the year.
     N = the number of  required monitoring days in the year
     n = the number of  valid daily maxima
     v = the number of  daily values  above the  level of the standard
     z = the number of  days assumed  to be less than the standard level
     This estimated number of exceedances shall be rounded to
one  decimal  place  (fractional parts  equal to 0.05 round up).

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                              77

     It should be noted that N will be the total number of days
in the year unless the appropriate Regional Administrator has granted
a waiver under the provisions of 40 CFR 58.
     The above equation may be interpreted intuitively in the
following manner.  The estimated number of exceedances is equal to
the observed number of exceedances (v) plus an increment that accounts
for incomplete sampling.  There were (N-n) missing values for the
year but a certain number of these, namely z, were assumed to be less
than the standard.  Therefore, (N-n-z) missing values are considered to
include possible exceedances.  The fraction of measured values that are
above the level of the standard is v/n.  It is assumed that this same
fraction applies to the (N-n.-z) missing values and that (v/n)*(N-n-z)
of these values would also have exceeded the level of the standard.
    4.  Use of multiple years of data. - Ideally, the expected number
of exceedances for a site would be computed by knowing the probability
                            i
that the site would record 0, 1, 2, 3 ... exceedances in a year.  Then
each possible outcome could be weighted according to its likelihood of
occurrence and the appropriate expected value, or average, could'be com-
puted.  In practice, this type of situation will not exist because ambient
data will only be available for a limited number of years.
     Consequently, the expected number of exceedances per year at a site
shall  be computed by averaging the estimated number of exceedances for
each year of  available data during the past three calendar years.  In
other  words,  if  the estimated number of exceedances has been computed
 for the calendar years of  1974, 1975, and 1976 then the expected number
 of exceedances  is estimated by averaging those three numbers.  If

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                              78
this average is greater than 1, then the standard has been exceeded at
this site.  It suffices to carry one decimal place in this computation.
For example, the average of the three numbers 1, 1 and 2 is 1.3 which
is greater than 1.   If data is not available for each of the- last three
years then this average shall be computed on the basis of available
data from the remaining years in that period.

AUTHORITY:  Sections 109  and  301 of  the Clean Air Act,  as  amended
(42 U.S.C.  7409, 7601).

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                                 79
                             References
     Bell, K. A., W. S. Linn, M. Hazucha, J. D. Hackney, and 0. V.
Bates.  "Respiratory effects of exposure to ozone plus sulfur
dioxide in Southern Californians and Eastern Canadians."  Am. Ind.
Hyg. Assoc. J. 38:  696-706, 1977.
     Brinkman, R., H. B. Lamberts, and T. S. Veninga.  "Radio-mimetic
toxicity of ozonized air,"  Lancet J_ (7325):  133-136, 1964.
     DeLucia, A. J., and W. C. Adams.  "Effects of 03 inhalation during
exercise on pulmonary function and blood biochemistry."  J. Appl.
Physiol.:  Respirat. Environ. Exercise Physiol. 43 (1): 75-81, 1977.
 ____   _ __j__ f _-mw __                                      ^^^™                k.
     Durham, W.H.   "Air pollution and student health."  Arch. Environ.
Health. 28: 241-254, 1974.
     Follinsbee, L. J., F. Silverman, and R. J. Shephard.  "Exercise
responses following ozone exposure."  J. Appl. Physiol. 38_: 996-1001, 1975.
     Hackney, J. D., W. S. Linn, and others.  "Experimental studies on
human health effects of air pollutants."  Arch. Environ. Health 30_: 373-
390, 1975.
     Hammer, 0. I., V.  Hasselblad, B. Portnoy, and P. F. Wehrle.  "The
Los Angeles student nurse study."  Arch. Environ. Health 28:  255-260, 1974.
     Hazucha, M.  "Effects of ozone and sulfur dioxide on pulmonary
function in man."  Ph.D.  Thesis. McGill University,  Montreal, Canada.
1973.  233 p.
     Hazucha, M., and D. V. Bates.  "Combined effect  of ozone and sulfur
dioxide on human pulmonary function."  Nature 257 (5521):  50-51, 1975.
     Hazucha, M., F. Silverman, C. Parent, S. Field,  and D.V. Bates.
"Pulmonary function in man after short-term exposure to ozone."  Arch,
Environ. Health 27^:  183-188, 1973.

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                                  80
      Kagawa, J., and T. Toyama.  "Photochemical air pollution:
 Its effects on respiratory function of elementary school  children."
 Arch. Environ. Health 30: 117-122, 1975.
      Kagawa, J., T. Toyama, and M. Nakaza.  "Pulmonary function tests  in
 children exposed to air pollution."  In:  Clinical Implications of Air
 Pollution Research.  A. J. Finkel and W. C. Duel (eds.).   Acton, MA.   Pub-
 lishing Sciences Group, Inc.  1976.  pp. 305-320.
      Kurata, J. H.,  M. M. Glovsky, R. L. Newcomb, and J. G. Easton.
 "A multi-factorial study of patients with asthma.  Part 2:  Air pollution,
 animal dander and asthma symptoms."  Annals of Allergy.  37: 398 - 409,
 1976.
      Lagerwerff, J. M.  "Prolonged ozone inhalation and its effects
 on visual parameters."  Aerospace Med. 34: 479-489, 1973.
      Linn, W. S., R. D. Buckley, C. E. Spier, R. L. Blessey, M. P. Jones,
 D. A. Fischer, and J. D. Hackney.  "Health effects of ozone exposure  in
 asthmatics."  Amer.  Rev.  Resp.  Dis.  117: 835-843,  1978.
      Makino, K., and I. Mizoguchi "Symptoms caused by photochemical
 smog."  Japanese Journal of Public Health 22_ (8): 421-430, 1975.
      National Academy of Sciences - National Academy of Engineering.
"Air Quality and Automobile Emission Control."  Report for the 93rd
 Congress, 2d Session, Serial Number 93-24.  Prepared for  the U.S. Senate
 Committee on Public Works by the Coordinating Committee on Air Quality
 Studies, September 1974.

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                                81

     National Academy of Sciences.  Ozone and Other Photochemical Oxidants.
Prepared by the Committee on Medical and Biologic Effects of Environ-
mental Pollutants, National Academy of Sciences.  Washington, D.C. 1977.
     "Report of the U.S. House of Representatives Committee on Interstate
and Foreign Commerce on the Clean Air Act Amendments of 1977."  H.R.
Report 95-924, 95th Congress, 2d. Session, pp. 110-112.
     Schoettlin, C. E., and E. Landau.  "Air pollution and asthmatic
attacks in the Los Angeles area."  Public Health Repts. 76: 545-548, 1961.
     Silverman, F., L. J.  Folinsbee, J. Barnard, and R. J. Shephard.
"Pulmonary function changes in ozone — interaction of concentration and
ventilation".  J. Appl. Physiol. 41. (6): 859-864, 1976.
     U.S. Department of Health, Education, and Welfare.  Air Quality
Criteria for Photochemical Oxidants.  National Air Pollution Control
Administration, Public Health Service, U.S. DHEW.  NAPCA Publ. AP-63.
Washington, DC.  U.S. Government Printing Office. 1970.
     U.S. Environmental Protection Agency.  Air Quality Criteria for
Ozone and Other Photochemical Oxidants.  Preprint.  U.S. EPA Publ.
EPA-600/8-78-004.  Washington, DC.  April 1978.
     von Nieding, A.,_H.M. Wagner, H.L. Loellgen, and H. Krekeler.
Presented at the VDI Kommission Reinhaltung der Luft Colloquim on
Ozone and Related Substances in Photochemical Smog, Duesseldorf, W.
Germany, September 22-24,  1976.
     Wayne, W.S., P.F. Wehrle, and R.E. Carroll.  "Pollution and
athletic performance."  J. Amer. Med.  Assoc.  199 (12): 901-904,  1967.

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                                           TAB B

               ENVIRONMENTAL PROTECTION AGENCY
                      [40 CFR Part 50]
                                                         i
           MEASUREMENT OF OZONE IN THE ATMOSPHERE       P.-otacL:^ P-. -re
           Calibration of Ozone Reference Methods        nc« . ,
                                                         UtL «.. ^  J.97c
                                                           LIBRARY
AGENCY:    U.S. Environmental Protection Agency
ACTION:    Final rule.
SUMMARY:   Appendix D to 40 CFR Part 50 prescribes a measurement
principle upon which reference methods for the measurement of ozone*
in the atmosphere must be based.  This appendix also specifies a
procedure to be used for calibrating those ozone reference methods.
EPA has evidence that another calibration procedure for ozone refer-
ence methods is significantly more accurate and less variable than
the procedure currently specified in Appendix D.  Accordingly, EPA
is amending 40 CFR Part 50, Appendix D, to replace (supersede) the
current calibration procedure with a superior calibration procedure
based on ultraviolet photometry.
DATES:   Effective date: [30 days after publication in the FEDERAL
REGISTER].
*The term "ozone" is used herein to be consistent with another EPA
action in this issue of the FEDERAL REGISTER substituting  "ozone"
for "photochemical oxidants corrected for interferences due to
nitrogen oxides and sulfur dioxide," which was formerly used in
Part 50.
                                 1

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FOR FURTHER  INFORMATION  CONTACT:  Mr.  Larry J. Purdue,
Telephone 919-541-2666 (FTS:  629-2666).
ADDRESS:  Department  E (MD-77)
          Environmental  Monitoring  and Support Laboratory
          U.S.  Environmental  Protection Agency
          Research Triangle  Park, NC   27711
SUPPLEMENTARY  INFORMATION:
                              Background
     Part 50 of Title 40, Chapter I of the Code of Federal Regula-
tions specifies the National  Ambient Air Quality Standards for
several air pollutants including ozone.  Appendices to Part 50
provide information concerning the  reference methods which are
used to measure those pollutants.   In  particular, Appendix D to
Part 50 describes a measurement principle upon which ozone refer-
ence methods must be based,  and specifies a calibration procedure
to be used for  calibrating such methods.  Previously, the calibra-
tion procedure  specified by  Appendix D was based on assay of ozone
with 1% neutral buffered potassium  iodide (NBKI) and was known as
the "NBKI procedure."
     On June 22, 1978, EPA indicated its conclusion that another
calibration procedure was clearly superior to the NBKI procedure,
and accordingly EPA proposed  an amendment to Appendix D to replace
the NBKI procedure with  the  new procedure, based on ultraviolet (UV)
photometry (43  FR 26971-26984).  The rationale for the proposed
amendment was discussed  in the preamble to that proposal.

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 Interested persons and organizations were afforded an opportunity
 to comment on all aspects of the proposed changes.  The amendment,
 revised slightly after consideration of the public comments, is
 being promulgated today in conjunction with related changes in the
 ambient air quality monitoring requirements appearing elsewhere in
 this issue of the FEDERAL REGISTER.

                       Nature of Changes
     The amendment makes three salient changes to the previous
 requirements for calibration of ozone reference methods.  These
 are as follows:
     (1)  The NBKI calibration procedure is superseded by a pro-
 cedure based on UV photometry for the calibration of reference
methods for ozone.  Since no National Bureau of Standards (HBS)
 Standard Reference Material  is available for ozone, ozone standard
 concentrations established via the UV procedure are tantamount to
 primary ozone standards, and the UV procedure itself is thus
 referred to as a "UV standard" for ozone.
     (2)  Independent use of a manual KI procedure known as the
 "BAKI procedure" in lieu of the UV procedure is allowed for 18
months after the effective date of the amendment, with the recom-
mendation that the BAKI technique be related to a UV standard
whenever possible.
     (3)  The use of alternative procedures as transfer standards
 is specifically allowed if they meet certain transfer standard
performance guidelines set forth by EPA.  A transfer standard is

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any device or procedure which can be referenced to a UV ozone
standard and then used at another location to reproduce ozone
standards.  A practical transfer standard offers some important
advantages—such as lower cost, ruggedness, easier operation, or
convenience—over direct use of the UV procedure.

                New UV Calibration Procedure
     The new UV calibration procedure is quite simple.  After
generating a stable, dynamic ozone concentration with an ozone
generator, the operator assays it by passing all or a portion of
the gas flow through the cell of a UV photometer.  The photometer
readings are then used in a formula to calculate the ozone concen-
tration, which as noted earlier, is effectively a primary ozone
standard.  Most commercially available photometers do the photo-
metric calculations automatically, and some may also make tempera-
ture and pressure corrections automatically.  The primary burden
on the operator is to insure (1) that the photometer is operating
correctly, (2) that the apparatus is set up properly and is clean
and leak-free, and (3) that the calculations are complete and
accurate.  While none of these is particularly difficult, EPA has
prepared a Technical Assistance Document which explains these tasks
and provides other detailed information about the procedure.  This
document, which is still in draft form to allow further incorpora-
tion of user's comments, is available from the address specified at
the beginning of this preamble.

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     The photometer is obviously of critical  importance to the
procedure and must have a precision within 0.005 ppm or 3% of the
concentration, whichever is greater.  While a calibration photom-
eter can be assembled from laboratory components, EPA recommends
the purchase of a commercial  photometer which is either designed
specifically for this calibration procedure,  or which can be readily
adapted to it.  EPA is presently aware of 2 such commercial  pho-
tometers (available from Dasibi Environmental Corp., Glendale,
California, and Science Applications, Inc., La Jolla, California)
and expects others will become available in the future.
     UV photometers of the type used in ambient ozone analyzers
are likely to be suitable as  calibration photometers.  Conversion
of an ambient UV analyzer to  a calibration photometer is covered
in the Technical Assistance Document mentioned above.  However, it
is important to differentiate between the use of a UV photometer as
an ambient analyzer and its use as a calibration photometer.  This
distinction is predicated more on operational differences than on
any specific physical differences.  The new calibration procedure
requires that a photometer used for calibration must be dedicated
exclusively to such use, must be maintained under meticulous con-
ditions, and must De used only with clean, calibration gases.  UV
analyzers used for ambient monitoring should always be calibrated
wHh an independent calibration photometer or a certified transfer
standard.  A UV analyzer should not be considered to be "self-
calibrated" even though it contains a UV photometer which meets the

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specifications of the UV calibration procedure.

                   New BAKI Calibration Procedure
     The new BAKI calibration procedure is very similar to the pre-
viously specified NBKI procedure.  Relatively minor modifications
provide somewhat less variability than the NBKI procedure.  Agencies
which are famili-ar with the NBKI procedure should have no difficulty
switching to the BAKI procedure.  Independent use of the BAKI pro-
cedure is allowed only for direct calibration of ozone analyzers
(not transfer standards) on a temporary basis during the 18-month
transition period to permit agencies to adopt the new, UV calibra-
tion procedure.  Nevertheless,  the BAKI procedure has more varia-
bility than the UV procedure.   Therefore, EPA would urge agencies
to adopt the UV procedure as  soon as practical.  And, when possible,
the BAKI procedure should be  related to the UV procedure to improve
the overall accuracy.
     Following the 18-month period, the BAKI procedure will not
be authorized for  independent use, but can be used as a transfer
standard.  As such,  it must be  related to the UV procedure, and its
variability and accuracy must be monitored and controlled.  Thus,
agencies which find  the BAKI  procedure advantageous could continue
to use this procedure  as a  transfer standard.

                           Transfer Standards
     EPA  is specifically allowing transfer standards for  calibrating
ozone analyzers,  and has noted  a  number of advantages which can be
                                 6

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realized by their use.  Transfer standards for ozone can include
procedural techniques such as BAKI and gas phase titration, as well
as devices such as ozone analyzers and stable ozone generators.
EPA recommends that agencies consider the use of transfer standards
where advantageous.  But transfer standards must meet certain per-
formance specifications, and their performance must be monitored.
EPA has prepared a Technical Assistance Document on "Transfer
Standards for Calibration of Ambient Air Monitoring Analyzers for
Ozone," which gives the required performance specifications and
general guidance on the certification and use of any type of trans-
fer standard for ozone.  This document is also still in draft form
to allow incorporation of further user's comments, and a copy of it
may be obtained from the address given at the beginning of this
preamble.

                     SUMMARY OF COMMENTS RECEIVED
                 AND CHANGES MADE TO FINAL AMENDMENT

     Comments relative to the proposed amendment (43 FR 26971) were
received from 26 respondents representing EPA Regional Offices,
State and local air pollution control agencies, industrial  corpora-
tions, and other organizations.  Almost all of the respondents ex-
pressed general support for the proposed change to the UV photometric
calibration procedure.  Other comments ranged from issues of basic
policy to technical aspects of the proposed amendment.  After

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consideration of all the comments, several minor revisions and
improvements were made to the proposed amendment, although the
basic principles and objectives have not been altered.  Specific
changes to the proposed amendment are discussed briefly below.
A document containing a summary of all the comments received, the
identity of the respondents, the resulting changes made to the
amendment, and the rationale for adoption or rejection of each
comment is available from the address given at the beginning of
this preamble.  This document will also be added to Docket No.
OAQPS 78-8, which is available for public inspection during normal
business hours at the USEPA, Public Information Reference Unit,
Room 2922 (EPA Library), 401 M. Street, S.W., Washington, DC 20460.
     Several respondents pointed to the relatively high cost of
implementing the change in calibration procedures and suggested
that EPA should either provide the necessary funds to those
agencies with nonattainment and unclassified areas, or make
available, in each EPA Region, a reference photometer that could
be used to certify appropriate transfer standards.  Other comments
suggested a similar need for such reference photometers until
such time that commercial photometers become more generally
available.  EPA agrees with these general comments and intends to
pursue them, but this requires no actual change to the amendment
as proposed.
     Many of the comments indicated a concern for a lack of
reliability in present commercial UV systems.  Some of these same

                               8

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respondents recommended revisions in the UV calibration procedure to
incorporate procedures for checking or calibrating the photometer's
wavelength, path length, and optical density (or absorbancy).
However, EPA believes that the reliability of most commercial
photometers will be adequate.  The photometer specifications
require a non-dispersive optical system which is not likely to
experience changes in the wavelength.  Path length is normally
fixed and should be adequately specified by the photometer manu-
facturer.  Optical density checks with neutral density filters
(for example) are not practical because of the extremely small
optical density range over which the photometer normally operates.
The only practical way to check the response of the photometer is
with an absorbing gas such as ozone.  The linearity test described
in Section 5.2.3 serves this purpose.
     There was some concern for whether the absorption coefficient
of ozone at 254 nm (given in the procedure as 308 +_4 atm"  cm"
at 0°C and 760 torr) might be different at different temperatures.
Other comments indicated that the corrections for temperature and
pressure in the UV photometeric assay procedure were not always
clear.  The absorption coefficient of ozone is, in fact, quite
insensitive to temperature between 0 and 40°C--aside from the
normal effect of gas density change with temperature.  For
photometers used at temperatures and pressures other than 0° and
760 torr, corrections are required according to the perfect gas
laws.  Efforts are being made to further clarify these correction

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procedures in the ozone calibration Technical Assistance Document
mentioned earl ier.
     A series of comments from one respondent recommended revisions
to the proposed procedure to more clearly allow the use of other
UV photometer designs and other configurations of components
within the UV calibration system.  It was further pointed out
that, with certain configurations, some of the components shown
in the suggested configuration might not be necessary, and some
of the procedural steps in the proposed procedure might not be
necessary or even possible.  This respondent questioned whether
UV photometer linearity tests by the user are necessary if the
manufacturer of the photometer has already done the tests.
Modification of the commercial photometer might be necessary to
carry out the tests and any resultant leaks in the system or
improper dilution techniques might confuse the results.
     In response to these comments, EPA has revised Sections 3,
3.2, and  5.3 somewhat to more explicity allow alternate systems
or system configurations and to provide for appropriate variations
in the procedural steps to accommodate such systems.  Also,
Section 5.2.3 on linearity has been changed to allow acceptance
of the manufacturer's linearity test in lieu of the user-conducted
test if the manufacturer can show that the linearity error is
less than 3%.  When the user carries out the test, the error
specification remains at 5% to allow for some variation in the
necessary flow measurements.

                                10

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     There were several comments regarding the BAKI calibration
procedure and its use for an interim period of 18 months.  One
respondent questioned the wisdom of changing from a known procedure
(NBKI) to an unknown procedure (BAKI) and then changing again to
UV photometry within 18 months.  The respondent recommended that
EPA allow the continued use of the NBKI procedure on an interim
basis until the change to UV photometry can be implemented.
Another respondent questioned the necessity of allowing the
considerably more variable (than UV photometry) BAKI procedure
for the interim period, and recommended that comments from State
and local agencies directly affected should guide EPA in this
area.
     EPA agrees that the BAKI procedure is more variable than the
UV procedure bur believes thar seme t-ansition period is necessary
before the UV procedure is required exclusively.  There were few
comments to the contrary.  EPA considered allowing continued use
of the NBKI procedure during the transition period, but the BAKI
procedure is really only a slightly modified version of the NBKI
procedure and is thus very similar.  Since the change from NBKI to
BAKI is so easily made, and the performance of the BAKI procedure is
significantly better than the NBKI procedure, EPA feels the interim
change to BAKI is adequately justified.
                               11

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     A few relatively minor changes were made to the BAKI procedure
in Sections 1, 3.8, 4.4.4, and 4.4.5 where respondents suggested
a need for clarification or where various improvements to the
method could be realized.  For example, the units given as "eq"
in equation 5a of the BAKI were changed to "equivalents" in order
that they not be confused with equivalent weight.  Also, the
concentration of the hydrogen peroxide added in Section 3.8 has
been increased slightly and the specification for the resulting
absorbance increase has been reduced from 0.010 to 0.008.  And
the calibration slope specification in Section 4.4.5 has been
changed from 25,800 +_ 600 to 26,000 +_ 780.
     While several respondents endorsed the use of transfer
standards in general, one respondent questioned the advisability
of allowing the use of transfer standards based on methods known
to be highly variable even under ideal conditions.  EPA still
believes that the variability of such transfer standards will be
adequately controlled by the qualification and certification
requirements on transfer standards described in the transfer
standard Technical Assistance Document mentioned previously.
Hence, EPA has made no major changes to the transfer standard
concept as originally proposed.
     In regard to EPA's statement that no factor is available to
"correct" previously collected ozone measurements to make them
comparable to the new UV standard, one respondent thought that
EPA should allow individual states or Regions to make corrections
                                 12

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to  their previously obtained ozone air quality data if they have
consistent comparative data for the NBKI and UV photometric
calibration techniques.  EPA has re-evaluated this position, but
as noted below, still discourages such attempted corrections.

     Effect on National Ambient Air Quality Standard for Ozone
     Because of the substantial variability of the NBKI procedure
and the unpredictable bias results reported by various investigators,
the exact magnitude of any universal bias which may exist between
the NBKI and UV procedures cannot be determined.  However, avail-
able data suggest that any such bias probably does not exceed 10%
on the average.  For this reason, EPA believes that supersession
of the NBKI calibration procedure with the UV procedure should
have no effect on the magnitude of the National Ambient Air
Quality Standard for Ozone (being revised elsewhere in this issue
of the FEDERAL REGISTER). And for the same reason, EPA discourages
any attempt to "correct" or "adjust" previously obtained oxidant
or ozone measurements to make them "comparable" to measurements
based on the new UV calibration procedure—even when individual
agencies or laboratories try to determine a more precise, laboratory-
specific bias value.

Effect on Currently Designated Reference and Equivalent Methods
     As noted in the June 22 proposal, a change in the calibration
procedure specified in Appendix D of 40 CFR Part 50 does not

                                13

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affect the design or performance characteristics of existing
reference methods for ozone. The only effect of the change is on
the calibration procedure described in the operation manuals
associated with the analyzers.  EPA will  allow a 6-month period
of time after final promulgation for manufacturers to revise
their manuals, have the revised manuals approved by EPA, and
distribute revised manuals (or manual supplements) to all analyzer
owners.
     The two equivalent methods for ozone designated to date pre-
scribe the NBKI calibration procedure.  Because the UV calibration
procedure and the transfer standard concept are as beneficial to
equivalent methods as they are for reference methods, EPA will
also request that the manufacturers of the two equivalent methods
revise their respective manuals to specify the UV procedure or
certified transfer standards for calibration.  EPA believes that,
under the circumstances, such a modification to equivalent methods
for ozone is desirable and appropriate and should not jeopardize
their designated status.  Conversly, failure to make such a
change may be considered by EPA as possible grounds for cancellation
of the equivalent method designation under 40 CFR 53.11.  If all
manufacturers respond promptly to this request for appropriate
manual changes, there will be no impact (other than the change in
calibration procedure itself) to owners of designated ozone
analyzers.
                                14

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                            Revision Adopted
     Accordingly, with the final  changes as described above,
Appendix D of 40 CFR Part 50 is revised as set forth below.
       Date
                                            Administrator
                                 15

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is  amended J"
                             .icnts on the use of transfer standart
                             \nd on the transfer standard guideliny
                             re welcome.

                               JSE or NEW PROCEDURES PRIOR
                                PROMULGATION OF AMENDMENT

                              ^.indicated in this proposal, th* UV
                            calibration procedure—and to a ^esser
                            exten\ the  BAKI procedure—ye be-
                            lieved \to be scientifically superior to
                            the currently  prescribed NBJCI  cali-
                            bration procedure And it is very likely
                            that the\UV procedure (and the BAKI
                            procedure^ on a temporary  basis)  will
                            be  promulgated  to  supersede   the
                            NBKI  procedure. Accordingly,  agen-
                            cies  whichXhave  the capability  and
                            desire to commence using'these proce-
                            dures immediately would not be  dis-
                            couraged  frorn doing so  Immediate
                             use of transfer\standards could also be
                             considered on the same basis.

                                    PUBLIC KARTICIPATION

                              All documents arid information rele-
                             vant  to this  rulsmaking  are  being
                             placed in Docket iw. OAQPS 78-8, the
                             docket for  the proposed amendments
                             to  the standards  fcir photochemical
                             oxidants. That docneft, will be available
                             for public inspection during the hours
                             8.00 to 4.30 at,the PuSilic Information
                             Reference  Unit. Room\ 2922,  401 M
                             Street SW. Washington.\D.C.
                              Comments/on any aspect of this pro-
                             posed  amendment are solicited  from
                             interested  -persons or agencies. Com-
                             ments should  be  submitted to  Mr.
                             Larry  J. Purdue at the  address given
                             at the beginning of this nonce. Com-
                             ments should  be  receded \ttithm 60
                             dajs of.-"the date of publicationUor due
                             consideration prior to final prqrnulga-
                             tion. Copies of all comments received
                             will tie added to the docket.    \
                              Ir/addition  interested personsynay
                             ma/ce comments on the proposal otally
                             at/the public  hearing  on  the oacme
                             sttmdard scheduled for July 18. 1971

                              Dated- June 9. 1978.
                                              DOUGLAS  COSTLE.
                                                 Administrator.
                               It 10 propc
                                                  MM! Part 50 of
Title 40. Code of Federal Regulations
as follows:
  1 Appendix D is revised to read as
follows:

APPENDIX D—MEASUREMENT PRINCIPLE AND
  CALIBRATION PROCEDURE FOR THE MEASURE-
  MENT OF OZONE IN THE ATMOSPHERE
  AUTHORITY Section 109 301 of the Clean
Air Aci as amended (42 USC 57409. 7601)

         MEASUREMENT PRINCIPLE

  1. Ambient air and eihylene are delivered
simultaneously to a mixing zone »here the
ozone in the air reacts with the eihylene to
                    f:DEHAl REGISTER. VOl. «. NO. 121— THURSDAY, JUNE 22.  1978



                                          Ifi

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                                                                        PROPOSED  RULES
3.   Apparatus.   A  complete UV calibration
system consists  of an  ozone generator,  an
output port  or manifold,  a photometer,  an
appropriate  source of  zero air,  and  other
components as necessary.   The configuration
must  provide a stable  ozone concentration
at  the system output and  allow the
ohotometer to accurately  assay the output
concentration to the precision specified
for the photometer (3.1).   Figure 1  shows
a commonly used  configuration and serves
to  illustrate the  calibration procedure
which  follows.   Other  configurations  may
require appropriate variations in the
orocedural steps.   All  connections...
 emit light, which is detected by a photomul-
 tiplier tube  The  resulting photocurrent is
 amplified and is either read directly or dis-
 played on a recorder
  2 An analyzer based on this principle will
 be considered a reference method only if it
 has been designated as a reference method
 in accordance with Part 53 of this cnapter
 and calibrated as follows

         CALIBRATION PROCEDURE

  1 Principle The calibration procedure is
 based on the photometric assav of ozone
   concentrations  in  a dynamic  flow
 system. The  concentration of d in an ab-
 sorption cell  is determined from a measure-
 ment  of the amount of  254 nm lignt ab-
 sorbed b>  the sample This  determination
 requires knowledge of cl) the absorption co-
 efficient (u) of Oi  at 254 nm. (2) the optical
 path length U) through the sample. (3) the
 transmittanca. of  th,e s,afT?PlC_ j'j__it__jiii>e-_
 length of 25'ifim.  and U) the'temperature"
 (T) and pressure  IP) of  the sample  The
 transmictance is defined as the rano  I/I,,
 where  I is the intensity of light which
 passes through the cell and is sensed by the
 detector when the  cell  contains an O,
 sample, and I, is the intensity of light uhich
 passes through the cell and is sensed by the
 detector -Alien the cell contains zero air  It is
 assumed that all conditions of the s>stem.
 except  for the contents of the absorption
 cell, are identical during measurement  ot I
 and I, The quantities defined above are re-
 lated b> the Beer-Lamoeri absorption law.

         Trjm-.:tjice « *- • e"lCI         '')
                   3

 where

  a=absorption coefficient of  Oi  at  254
   nm = 30S=4 atm'1  cm'1 at O'C and 760
   torr !>•"«»•«'i           =  ^	
  c = d concentration in atmospheres
  J=optical path length in cm

  In practice, a stable O, generator is used
 to produce Oi concentrations o< er the re-
 quired range  Each Oj concentration is de-
 termined  from the  measurement  of  the
 trsinsmutance (I/I,) of the sample at 254 nm
 with a photometer of path length I and cal-
 culated irom the equation.
or.
          cum • -  — (.n II
          «;,-,, . . 12- ,,„
 "he calculated O, concentrations must be
corrected for O, losses vihich may occur m
the photometer and for the  temperature
and presiure of the sample
  2 Applicability  This proceaure is applica-
ble to the calibration of ambient air d ana-
lyzers, either directly or by  means  of a
transfer standard certified by  this proce-
dure. Transfer standards must  meet the re-
quirements and specifications set forth in
References	
  3 Apparatus I Piaq
                                                             tfro nu
                                                                        calii
                                                                                  "HtuGUiiU.il u UtuiL
                                                                                                         (space)
                                                                                                        (0  [zero])
                                                                                     afcste
                                                                                connections between
                                                             17
                                                    FEDERAL REGISTER. VOL 43,  NO. 121—THURSDAY, JUNE 22. 1978

-------
                                                                                 26975
     glass,  Teflon,  or  other    n
     relatively  inert materials.!
Devices  capable of  regulating
air  flows  as  necessary  to
meet  the output stability
and  photometer  precision
requirements.
 components in the calibration system down-
 stream  of  the  O. generator should be of
^^^Additional  informa-
 tion regarding the assembly of a UV photo-
 met nc calibration apparatus is given m Ref-
 erence 9 For certification of transfer stand-
 ards which provide their own source of O,.
 the  transfer  standard may replace the  O,
 generator and  possibly other components
 shown in Figure 1. see Reference 8  for guid-
 ance.
   3 1 tTV photometer. The photometer con-
 sists of a  low-pressure mercury discharge
 lamp, (optional) collimation  optics, an ab-
 sorption cell, a  detector, and  signal-process-
 ing electronics,  as illustrated  in Figure 1 It
 must be capable of measuring the transmit-
 tance. I/Io. at a wavelength of 254  nm with
 sufficient  precision such that the standard
 deviation  of the  concentration  measure-
 ments does not exceed the greater of 0 005
 ppm or 3% of  the concentration  Because
 the low-pressure mercury lamp radiates at
 several  wavelengths,  the  photometer must
 incorporate suitable means to assure 11.ai.
 no Oi is generated m the cell by the lamp.
 and  that  at  lease 995%  of  the  radiation
 sensed by the detector is 254 nm radiation
 (This can be readily achieved  by prudent se-
 lection  of  optical filter  and detector re-
 sponse characteristics > The  length of  the
 light path through the absorption cell must
 be  known  with an  accuracy of  at least
 99 5%  In  addition, the cell and associated
 plumbing must be designed to minimize loss
 of O> from contact witn cell  walls and gas
 handling components  See Reference 9 for
 additional information.
   3.2 Air flow controllers. Doviooo capable of
- maintaining oonotant air flow  within -!_ac"u
   3.3 Ozone  generator. Device capable  of
 generating stable levels of Oi over the re-
 quired concentration range
   3 4 Output manifold. The output manifold
 should be constructed of  glass. Teflon*"or   (delete  "R")
 other relatively  inert material,  and should
 be of sufficent diameter to insure a negligi-
 ble pressure drop at the photometer connec-
 tion  and other  output ports. The system
 must have a vent designed 10 insure atmos-
 pheric pressure  in the manifold and to pre-
 vent ambient air from entering the mani-
 fold.
   3 5 Two-way valve.  Manual or automatic
 valve, or other means to switch the  photom-
 eter  flow between zero air and the O, con-
 centration.
   3 6 Temperature indicator Accurate  to
 ±rc.
   3.7 Barometer or pressure indicator. Accu-
 rate to = 2 torr.
   4. Reagents.
   4 1 Zero  air The zero air must be free of
 contaminants which would cause  a detect-
 able  response from the O, analyzer, and it
 should  be  free of NO. C,H.. and other spe-
 cies which  react with O,. A  procedure  for
 generating suitable zero air is given in Ret-   ,  .
 erence 9. As shown m figure  1. the zero air   ( r )
 supplied to the photometer cell  for the I,
 reference  measurement  must be  derived
 from the same source as the zero air used
 for generation of the ozone concentration to
 be assayed (I measurement). When using
 the photometer to certny  a transfer stand-
 ard having its own source of ozone, see Ref-
 erence 8 for guidance on  meeting  this re-
 quirement.
                                                           18

-------
 26976
   5  Procedure
   5 1  General  operation  The calibration
 photometer must  be dedicated exclusively
 to use as a calibration standard  It should
 alwavs be  used with clean, filtered calibra-
 tion gases  and never used for ambient air
 sampling Consideration should oe guen to
 locntir.g the calibianon  photometer  in  a
 Cit?an laboratory where it can be stationary
 protected irom ph>sical shock, operated b>
 a responsible analyst and used as a common
 ^iandara for £11 field calibrations via trans-
 fer standards
   5 2 Preparation  Proper operation of the
 photometer is of critical  importance to the
 accuracy of this procedure  The  following
 hieps uill  help to  verify  proper  ope-anon
 The, stops are not necessarily required prior
 to each use of the  photometer Upon initial
 operation  of the  photometer, these steps
 s.iould be  earned  out  frequently, with all
 quantitative results or  indications recorded
 m a chronological  record either  in tabular
 form or plotted on  a graphical chart  As the
 performance  and  stability record of the
 photometer is established, the frequency of
 these steps may be reduced consistent  with
 the documented stability of the photometer
  521 Instruction manual. Carry out all set
 up and adjustment procedures or checks as
 described in  the  operation  or  instruction.
 manual associated with  the photometer
  522 Sjstem check Check the photometer
 s>si.em  for  integrity  leaks,  cleanliness.
 proper flow rates, etc Service or replace fil-
 ters and  rero air scrubbers or other consum-
 able materials, as necessary
  523 Linenrit\ *~-i Ten rhn photomutcr
 fop linearity n' dilution Generate and assay
 an O,  concentration near the upper range
 1'mit of the sv&tem  (0 5 or 1 0 ppm) then ac-
 curatelv  dilute that concentration vvtth  zero
 air and reas;>a\  it   Repeat at several difter-
 ciu dilution ratios  Compare  the assav of
 the ong'nal concentration with the assay of
 the diluted concentration  divided  bv the di-
 lution ratio, as follows
     5.2.3.  Linearity:   Verify  that  the
  photometer  manufacturer has  adequately
  established that the  linearity error
  of the  photometer  is  less  than 3%,  or
  test  the  linearity by dilution as
  follows:   Generate  ...
where
  E = !meaniv error percent
  A,=asiav 01 the onginal concentration
  A.=nssav of the diluted concentration
  R-dilution ratio = flovv of original concen-
   trai.on divided bv the total flow
  Tr-e linearitv. error rmist be less than 5<^
Since the accuracy of  the measured  flow-
rates »ill affect the linearity error as meas-
ured this  wav  the test is not necessarily
conclusive  Additional information on ven-
fMng linearity is contained in Reference 9
  524  Intercompanson  When   possible.
the photomerer should be occasionally  m-
te'compared  either directIv or via transfer
standards   'viih calibration   photometers
used bv ether agencies or laboratories
  525  Ozone losses  Some portion of the
O, mav be lost upon contact with the pho-
tome'.er cell walls and Jfas Handling compo-
r.ems The  magnitude of this loss must be
drterrninea  and used to correct the calculat-
ea O, concentration  This  loss must  not
Q\cvsd  5"^  Some guidel'nes for  quar.lita-
iivrl; de!er-rinmg this "oss are discussed in
Reference 9
--(g)
                                                    19

-------
                                      PROPOSED RULES
      allows
Insure  thatj-


Insure  thatj-
                              5 3  Assay of O, concentrations.
                              5 3 1  Allow  the photometer  system  to
                            warm up and stabilize
  532  AdjttsiJJthe floArate  through  the
photometer absorption cell. F.. to ft oonio-
rioni . dluo r,o ifratfthe ceil eett^be flushed in
a reasonably shoiO period of 'time (2 luer/
mm  is a typical flow.) The precision of the
measurements is  inversely  related  to  the
time required  for  flushing, since the pho-
tometer drift error increases with  time
  533  Atljuot'the flow rate into the output
manifold  to a  value-at  least 1  liter/mm
greater  than the toLar flowrate required by
the photometer and any other flow demand
connected to the manifold
  534  Adjast^the flow rate of zero air Pz.
te a valgT.at least 1  liter/nr.m greater than
trip flow rate required by the photometer
  535  With zero air flowing m the output
manifold,   actuate the  two-way  valve  to
allow the  photometer  to sample first the
manifold zero air. then P, The two photom-
eter readings must be equal (I=I0)
  NOTE   In some commercially  available
photometers, the operation of the two-way
\alve and  various  other  operations in  sec-
tion 5 3  ma> be carried out automatically by
the photometer
  536  Adjust the O, generator to produce
an O, concentration as needed
  537  Actuate the two-wav valve to allow
the photometer to sample zero air until the
absorption cell is  thoroughly flushed, and
'record the stable measured value of I,
  538  Actuate the two-way valve to allow
the photometer to sample the ozone concen-
tration  until the  absorption  cell  is thor-
oughly  flushed and record the stable meas-
ured value of I.
  539  Record the temperature and  pres-
sure of  the sample in the  photometer ab-
sorption cell.  (See Reference 9  for  guid-
ance )
  5 3 10   Calculate  the  O, concentration
from equation 4  An average of several de-
terminations mil provide  better precision.
-[Verify  that
-fro
                                   "j OUT
                                                 '.TT-
 where
  tOJoLT = Oj concentration ppm
  a = absorption  coefficient  of Oi  at  254
    nm = 308 atmr1 cm'1 at O'C and 7SO  torr
  /=optical path length, cm
  T = sample temperature. K
  P=sample pressure, torr
  L=correction  factor  for Oj  losses  from
    5 25=(l-fraction O, lostJQ  *
  Note —Some   commercial   photometers
 may automatically evaluate all <&y part of
 equation 4 It is the operator's responsibility
 to  verify that all of the information re-
 quired for equation  4 is obtained, either
 automatically by  the  photometer or man-
 ually  For •automatic* photometers which
 evaluate the first  term of equation  •) based
 on a linear approximation a manual correc-
 tion may  be required  particularly at higher
 O, levels See  the photometer instruction
 manual and Reference 9 for guidance
  5311  Obtain additional O, concentration
 standards as necessary by repeating steps
 5 3 6 to 5 3 10 or by Option 1
                                                                            (or)
                                              20

-------
  5 4  Certification of transfer standards A
 transfer standard is certified b;, relating the
 output  of the  transfer standard to one or
 more ozone standaids as determined accord-
 ing  to  section  5 3. The  exact  procedure
 varies depending on the nature and design
 of the transfer standard Consult Reierence
 8 for  guidance
  5 5  Calibration of ozone anahzers. Ozone
anal}zers  are calibrated  M  foiious  using
      .  .  71      •    analjzers are calibrated as  foiinus
Certified	^   ozone standards obininpd'ficcornmg
            -I      '   tion 5 3 or b> means ofHransfer stand
                                   to see-
 	... 	transfer standard* i^^^^^^
  551  Allow sufficient lime for the O, ana-        —(delete  "s")
lyzer  and the photometer or transfer stand-
ard to warmup and stabilize
  552  Allow  the O, anal\?e)  to sample
zero air until a stable response is obtained
and adjust (he Oi analjzers  zero control.
Offsetting the analyzer s zero adjustment to
-o^c  of scale  is recommenoed to lacihtate
observing  negative zero drift   Record the
stable zero air response an ' Z"
  553  Generate  an   O,   concentration
standard of approximately 80"~i of  the de-
sired upper range limit (URL) of the O, ana-
lyzer  Allow  the O, analv^cr to sample this
O, concentration standard until a stable re-
sponse is ootained
  554  Adjust the O. annlvzers  span con-
trol  to obta.n a convenient  recorder re-
sponse as indicated below
                        w here
                         URL=upper range limit of the O, analyz-
                           er ppm
                         Z=recorder response with zero air  *~t scale
                         Record  the O, concentration and the cor-
                        responding analyzer response  If substantial
                        adjustment of the span control is necessary
                        recheck the  zero and  span adjustment by
                        repeating steps 5 5 2 r.o 5 5 4
                         555  Generate several other Oj concen-
                        tration standards (at least  5 others are rcc
                        ommended) over the scale range of the O,
                        analyzer by  adjusting  the  O, source or by
                        Option 1  For each O, concentration stand-
                        ard,  record the O, concentration and the
                        corresponding analjzer response
                         5.5 6  Plot   the   O,   analjzer  responses
                        versus the corresponding O, concentrations
                        and draw  the Oi analjzcr s calibration curve
                        or calculate the appropriate response factor
                         557  Option ; The  various O, concentra-
                        tions required in steps 5311 and 555 may
                        be obtained oy dilution of the Oi concentra-
                        tion generated in steps 536 and 553 With
                        this option, accurate flow measurements are
                        required.  The djnamic  calioration  svstem
                                modified  as shown in Figure 2 to
                       aliow for dilution air to be metcred in down-
                       stream of the O, generator A miMng cham-
                       ber  between  the  Oi generator  and  me
                       output manifold is  also required  The flow
                       rate through the O, generator tF,,J and the
                       dilution air flow rate (Fn) are measured with
                       a reliable  flow or volume standard traceable
                       to NBS Eacn d concentration generated bv
                       dilution is calculated from
                       « here
                                         21

-------
                                                     PROPOSED RULES
   CO 1 m T=diliuen  the Gas Phase.
                    1  Rate Constant ind Actuation Sner^-es".
                    Int : Jour at Chcin. Kinetics, VI. 725 (19745
                     6 M  A A  Cl) ne ana J A Co\om.  Kinet-
                    ic Studies of O\y halogen Radical Systems".
                    Proc. Roy  Soc. A303 207 (1968)
                                                                                             	/ ,
                                                                                                v_
(7)
                                     J  Pajr. H A
 '-
w Trr-
\ I Tl-e U.t-aviole: Spectrun
 . J9. i:>03 1 1973)
                                                   26977
                                                          .
                                                   Photoly.
                                                   J C»iewi
(delete  "in
draft  form)
                     8  'Transfer Stnr.cards for Calinration of
                    Ambient  Air  Mor.itonng  Analjzers  for
                    Ozone  EPA_ Publication a'anaole
                    »nn irom tPA.  Department  E
                    Researcii Triangle Park XC 27711.

                        — 1f-P-i"!-^-3S-Sta"CM Doc'-!f:'6nt f"j"

                           EPA P.io!icatiop. •" "•li':["'
                         fro-. EPA.  Department  E
                    Research Tnanale Pa.-,:, X C J7711.
                                         rCalibration of  Ambient  Ozone
                                        illonitors",
                                         (77)
                                               22

-------
                                         PROPOSED RULES
ZERO
AIR

now
CONTROLLER

FO

°J
GcncRAtoR
I               FLOW
            CONTROLLER
         r
                        UV PHOTOMETER
                       Sic.'iai
                     PROCESSING
                     ELCCTHOrjICS
                                                                   OUTPUT
                                                                  MANIFOLD
                                                                                                 • VEKT
                                             VtUT
                                                                     1.1
                                                                               EXTRA OUTLETSC&PPEO
                                                                                 WHEN NOT IN USE
                                                                    T3I11ETOF ANALVZER
                                                                     U.'.DEP C4LI8RATIO'J
                                                                                  OfCS
                                                     ABSORPTION CELL
   DSOUPCE
     0
• EXHAUST
                      Figure 1  Sc'iemaiic I'lugram ol 3 lypicjl OV i>i.oiomt rn. Cu-iuicuoi. S.SK.'".
                                                                                             EXTRA OUIitTSripC
                                                                                               V.HEN -JOl I'J USE
                                                                                                               • VEM
                       F.nu-e ? Sc'-.c-'anc diagram of J i.pieal 'JV onc'o—? • c c: -'"afon :vs ,-m "OPT:;:1" :i


                   FEDERAL REGISTER, VOL. 43, NO. 121—THURSDAY, JUNE 22,  1978

                                                     23

-------
             Ozone is absorbed  in a 0 1M  l~"                                              _
             .so.) soiution containing i%    reacts  with  excess  iodide  ion  (I   )  to  form  triiodide
             e  It  released<• is  measured  !,•««  /T~\  , ,u-;^u
             netncally u ii»o Hmauntu .urn  I10n  U-j)  WhlCP  ...
  Terr.pc'ary Alternative Calibration Proce-
dure— 13onc Acia-Potassurn  Icaide)  This
procecvire .T&J oe used as an  alternative to
il-e  u;t~v.olet  Photometry procedure for
d.rect cal.ora: on of ozone analyzers—but
r.ot  to cer: fv r.-ar.sfer stanoaros—until C18
rr.cri'-.s  a::er the date of final  promulga-
tion! Alter that  time tms procedure can be
used or.lj  as a transfer standard in accord-
ance with the guioar.ce and  speculations
set form in  Reference  4. 'Transfer Stand-
ards  for Calibration of Ambient Air  Moni-
toring Analir.ers for O:o".e '
  1. Pr nciple  This calibration procedure (1)
is oased upon  the reaction between  ozone
(O:)  anc potassium looiae (KI)  to release
locme cl:j according to the stoichiometnc
equation (2)


The stoichior-.e:ry is such that the amount
of I: released is equivalent to the amount of
Oi absoroed  Ozone is absorbed  in a 0 1M
boric acid 'H,
KI.   and  the
spectropnotomet really
<*^at a «a<.elt-rlg:h of 352 nrr The output*
of a  stable O,  .rene-ator is  assayed sn r'lis
manner, ana -"e generator is immediately
used  :o  calibrate  the Oi analvzer  The Oi
generator  mjal  be used immediately alter
calibration ana Aithout p'ljsical movement.
and  it is -ecahoraied prior to  each use Al-
terrat.vely U-.e Oi inaljzer may be calibrat-
ed by assaiir.2 tne Oi concentrations using
the  preserved  procecure  vvniie simulta-
neously  measuring  the corresponding O,
analyzer  responses   Ozone  concentration
stancaras mnjr  also be generated by an op-
tional ciluuon technique With this option.
the lug.-ipst Oi concentration standard is as-
saied using the prescnoed procedure  The
aad.uonai  O. concentration  standards re-
quired are then obtained b> dil.ition
  2 Apparatus  Figures 1 and  2 illustrate  a
t.vpical  3AKI  O, calibration  bjstem and
SP.OA the  sj-'scsted  configuration of  the
components Ustsd oelovv All connections be-
tween co-naopeits downstream of the O,
gi-::erator  jr.oula  be of glass. Tcflonf ^ or
ot ler relati.e'j mer: material.
  2 1  Air no\\ controller Device capable of
maniiainm): a co:iotam air ilowrate thiough
trie Oi iii'ner.iior >vitnm  =2^1
  22  Air  ilo" meter  Calibrated  flov.meter
capaole  o! mcasunng  and monitontig  the
air  ilC'vratc  tnrough  the  O,  generator
within =Jrl
  23  Ozor.e  gcrierator  Device  capable of
gem'raiT.e stable le-.els of Oj over the re-
qicred concentration range
  J •{  O'Jtpi:: manifold The output mnni-_
folj  inou 3 be co:-s:ruc:ea of glass. Teflon^'i
or o:!'er  reMi. eiv inert material and should
be o: 3uific:c.T. oiarnete- to Tisure an  negli-
gible  pressure croo r.t fie anaijzcr connec-
tior.  Tl-p i;.item "iij-.t nave a vent des.ened
to insure a'r-.osonor'c pressure m the rnnni-
fola and  to pre ent arr.oieru air from enter-
ing ti:e rRiinifoU
  J 5  Irr.pir.gc-rs  All  glass impirgers with
the speciiicit ons ird.cated 'n F'guie  2 are
recorrmoideo T.:c irr.o'rigcrs  r"3>  be pur-
chas^ii irom  i-.ost major 2l.iss.>a:e -supp.:-
ers T vo 'mp'rjers connected  in series  are
usoa  to  ir.iure compete collection of  the
  2 ri  Air puri-ip and floa  controlior  Any
pump a:-.ti flo"  co:itrol  de1 ice capaole of
f.a!n;.-'i!''-is: .1 constant f'o-vrate  of  04-06
liter, mm  throiu'M  the  impmsers may be
iiacd A <.rii>cal orifice as described by Lodge
                                              Xdelete  "as  the  triiodide  ion  (13))
                                                -(delete  "R")
                                                •(delete  "R")
                                  FEDERAL REGISTER. VOL. 43, NO. 121— THURSDAY. JUNE  22. 1978
                                                             24

-------
                            PROPOSED RULES
500,  ]-
 et al (3) is recommended The orifice should
 be protected against  moisture and  panicu-
 late matter with a mem crane filter or mois-
 ture trap containing Dnente/Xsilica gel. or
 glass wool The air pump must be capaole of
 maintaining a  pressure  differential of at
 least 0 6-0 7 atmospheres across the critical
 orifice Alternatively, a  needle valve could
 be used with  the pump  to adjust the  flow
 through the impingers. A floumeter is then
 recommended  to  monitor the  flow   The
 neeoTe valve-floumeter combination should
 be protected against  moisture and  panicu-
 late matter with a membrane filter or mois-
 ture trap
   2.7  Thermometer Accurate to = 1'C.
   2 8  Barometer. Accurate to =2 torr
   29  Volumetric flasks  (Class A)  25. 100.
_2,0q*1000.ml              £
   2TO  Pipets (Class A)  I././ 5.  10. 15. 20,
 and 25-ml volumetric^ (•
   2 11  Spectrometer  Capable of measuring
 absorbance at 352 nm with an absolute accu-
 racy  of =!<"<>  and linear response over the
 range of 0-1 0 aosorbance units The photo-
 metric accuracy may oe checked using opti-
 cal glass filters  which have certified absor-
 ba.ice  values   at  specified   wavelengths.
 Matched  1-cir. or 2-cm cells should  be used
 for all absoroance determinations
   3  Reagents
   3 1 Zero air The  zero air must be free of
 contaminants vvrucn Will cause a detectable
 response on the Oi anaivzer or which might
 react  with  1% BAKI Air meeting  this re-
 quirement may be obtained by (1) passing it
 through silica gel for drying: (2) treating it
 with Oj to comert any nitric oxide (NO) to
 nitrogen  dioxide   (NO:).  <3>  passing  it
 through activated charcoal (6-14 mesh) and
 molecular  sieve (6-16 mesh,  type  4A> to
 remove any NO,, hydrocaroons. and traces
 of water < apor. and '4) passing ic through a
 2-micron  filter  to  remove  any paniculate
 matter
   3 2 Boric acid (K.BOJ  ACS  reagent grade
   33 Potassium iodide  (XI). ACS  reagent
 grade
   34 Kvdrogen  pe-oxide iH,O,).  ACS  rea-
 gent grade. Zf0 or 30~
   3.5 Potassium  lodate (KIO,). ACS  reagent
 graae certified 0 IN
   36 Suliunc acid .  ACS  reagent
 grade. 35aa to SS1^
   37 Distilled v.ater  Used for preparation
 of ->il reagents
   3 8 Absorbing reagent Dissolve 6 2  g of
 bone acid  
-------
                                                         26979
jsing  a
graduated
pi pet,  add
D.7
                absorbance units/cm g-eaier :han the first
                deierrr.ip.at.on. the  acsorb.ng  reagent  15
                reaay for "s* Jf_ no increase or an increase
                of .ess thanpHHO absorbance un.:s/cn is oo-
                ser\ ed. the KI reagent  probaoly contains an
                excessive amount of a reducing contaminant
                and  must oe disca.ra.ed In  this  event  pre-
                pare fresh absorbing reagent using a differ-
                ent numbered lot 01 KI If unacceptable ab-
                sorbing reagent results from cifferert lots
                of KI. test the possibility of contain.nation
                in the HiBO, by using a different numbered
                lot of H.BO,                     -
                  3 9 H>drogen peroxide solut:onVfl,an»'-.i
                Tiliii» il'iTil of 30«c o&JW ir.l of 3«". hydrogen
                peroxide (H,O,) >eto approximately 200 ml
                of distilled  wateriTfa'-BgBSaL volumetric
                flask, dilute to volume with dist
                and   mix  thoroughly   To  prepare  the
         c, -i    aiOOt8"iflSOlmion. ciastrt ml of the aooxe so-
         ">j    lulion into 50 ml of distilled water in a 100-
                ml volumetric flasK. d.lute to voiume vv.h
           -,    distilled  water,  and mix thorough'.!  This
U . UL)£ I ,a I L   Q.OQiarj»H.O, solution  must be prepared
                fresh eacn time a fresh  catch of absorbing
                reagent is prepared Therefore  tne renam-
                ing  contents of  both  volurretnc flasks
                should be discardec after  treatment of tlie
                BAKI aosoroir.g reagent  (see 3 3)
                  3 10 Standard potassium iCdtite  solution
                (0 IN) Use a commercial standard  solution
                of potassium lodate iKIOi) ha< ing a certi
                fied  normality
                  311 Suifunc acid (1>7)  D-lute 23 ml  of
                concentrated (95-98"^) sulfunc acid fH.SO.)
                to volume in a 1000-ml voiunetnc flask
                  4  Procedure.
                  4 1 Assemble an ozone ca!ibra:.on system
                such as sho
                           Ts = temperature  at sarr.plinc  concslions
                             'C
                           44   KI calibration  cur1, e
                           4 4  1  Prepare iodine  standards  fresh
                          when nceucd  as follow s
                           A Accurate^ pippt 10 ml of 0 IN standr.rd
                          poiaumm lodaie 'KIO.i solution 'nto a  iOl>-
                          ml volumetric tlask containiiiR approximate
                          Ij 50 ml of distilled vater  Ada 1 g of poiis
                          sium iodide  (KI) and  5  ml  of  IN siilfunc

-------
26980
acid (H.SO.). dilute to volume with distilled
water and mix thoroughly
  B Irrmeoiate'v- before use. cipet 10 ml of
Hie 'Odme (L) solution prepared in steo A
above into a 100-ml volumetric  flask  and
dilute to  volume with absoromg reagent.
Then  further dilute this solution by pioet-
tms 10  ml of 11 into a 200-ml volumetric
flask and diluting it to volume with absorb-
ing reagent
  C. In turn  pipet  5.  10. 15. 20 and 25 ml
aliquots of the final I, solution prepared in
step B above into a series of 25-ml voljmet-
ric  flasks  Dilute each to volume with ab-
sorbing  reagent  and  mix  thoroughly  To
prevent  Ii losses by volatilization, tne flasks
should remain stoppered unil absorbance
measurements are  made Absorbance mea-
surements (see 442) should be taken within
CO minutes after preparation of the I, stand-
ards
  4  4 J Determine  the absorbance of each
I.- standard at 352 nm. Also measure the ab-
sorbance of a sample of unexposed absorb-
irg reagent  Determine the  net absorbance
of each I, standard as.
  443  For each I, standard, calculate the
net absortance/cm as
  D=spectrophotometer ceil path length cm

  444  For each I, standard calculate the
I. concentration in mc'.c/ liter as
or.
\\jiere
                             (5b)
  CI.],=concentranon of each I, standard.
   mole I,/!!ter
              t%  of  KIO, (from 3
   hter
  V, = volune  of  I,  solution  (from step
   4 4 1 C) = 5. 10.  15  20 or 25 ml

  445 Plot  net  absorbance/cm  (y-axis)
versus tne mole I;/'lner (\-axis) for each I,
Standard and drau the KI calioration curve
Calculate  the slope  of the  ome in liter
•nole"' cm" and record as S, The value of
the slope should b
-------
           PROPOSED RULES
  4 5  Calioration of the ozone generator
  451  Adjust the  air flow through the O,
generator to the desired llOArate and record
as FJ  At all times the air flow  througn the
generator must be greater than  the  toial
flow,  required bj the sampling  ijsierr.s. to
assure exhaust flou at ihe vent
  452  With the O, generator off. flush the
system 'vith zero air for at least 15 minutes
to remove residual O, Pipet 10 ml of absorb-
ing reagent mio each  of  2  imomsers and
connect  them  into  the sampling  train as
shown  in  Figure   2   Draw  air from the
output  manifold   of  the  O,  calibration
svsterr.  through the sampling train at 0 4-
0 6 liter/mm  for 10  minutes Immediately
transfer the exposed solution-; to clean spec-
trophotometer cells Determine  the pet ao-
soroance  (sample  absortar.ce-unex?os?d
reagent absoruance) cf eacn solution at 352
nm within three minutes  And  the net ab-
sor'cnnces of the two solutions to obtain the
total net abscrbance  Calculite  the muicat-
ed Oi concentrat on is.vstem oiank)  as equiv-
alent.  O, concentration according to 4 5 4 If
the sjstem blank is greater than 0 005 ppm
O>. continue  fljs.-img trie  O,  generation
s> stem for an additional 30 minutes and re-
asterrr.ine the  s;.s;em blank If tne svstem
blanii is still greater than 0 COS ppm O, the
zero air prooaoly contains traces of an oxi-
d.zir.g contarr..r-ant. a^.d the activated  cnar-
coa! ana mclscj.ar sieve (see 31) snould be
reo'aced
  453  Adjust the Oi generator to  generate
an Oj concentration in the range cf interest
and  a..ou.  i,-.a sj.stsm  to equilicrate  for
aoout 15 minutes The uncaliorated O, ana-
lyzer  to oe  cal arat?d can corr.emencly be
used to indicate trie stiiotl.ty of  the O, gen-
erator  output  Wren i'.:e  d generator
ou:pjt has stabilized, pipec 10 ml of aosorb-
ir.g rsageni ir.to each impinger  Draw.  O,
from tr.e output mar.iicid cf the O, calibra-
tion system t.-.rci-g.i  the  sampling train at
04-06 l:tcr/rr..n  Use a sample  time of  be-
tween  10 and 33 minutes such that a total
net a^ssroar.cs between 0 1  and 1 0 absor-
oar.ce uni;s is cbta'nsd (At an O, concentra-
tion cf  0 1 ppm and a sampling rate of 0 5
!iter/T.in, a total net absorbance >0 1 absor-
tance s.r".s sr.ould os co:a:ned if a sampling
time of 20 rr.ir..:tes and l-cr»i scec:ropnoto-
rr.ster cells are ussa ) Immeciately after col-
lection  transfer  the exposed  solutions to
clean spsctrcphoiometsr  cells  Determine
the net absoroance  (sample absorbancs—im-
c\posed  reagent aosorbance) of each  solu-
tion  at  352  nm Kithin three minutes  Add
the net absorbances of the two  solutions to
obtain the total net absorbance
  454  Calculation of ozone concentration
  4541  Calculate the total \olume of air
sampled cor-ected to reference conditions
of 25 C and T60 torr as
                                             4542  Calculate the I, released in moles
                                            as.
w here

  VB = volume of  air sampled, corrected to
    reference conditions liier
  F» = sampling  flovvnto corrected to refer-
    ence conditions  liter/mm
  resampling time  mm
                                                      .,.   .
                                                        '
                                            where  total net aosorbnnce = sum of net ab-
                                            sorbances for the tuo solutions

                                             001=voiume of absorbing leagent m each
                                               impingcr. liter
                                             Se=sio^:  of  KI  cali'craLion carve   liter
                                               mo!c "' cm "'
                                             b = spectrophotomet?r ceil patn length cm

                                             4543  Calculate HIP u/ of O, absorbed as
                                            or.
                                                   ^/Oj = mole I.\24 -i
                                              4544  Calculate the O. conceniration in
                                            ppm as
                                              455  Repeat steps 453 an d 4 5 4 at least
                                            one more time at the same O, generator set-
                                            ting  Average tne I-AO  of the O, analvzer
                                              464  Allow the Oi anahzer  to  sample
                                            this O, concentration until n stable response
                                            is obtained Adjust the anal.vzer's bpan con-
                                            trol  to  obtain  a convenient  recorder  re-
                                            sponse as indicated below
                                               loir " °  concept-?tion at the output mani-
                                                fold ppm URL = upper  range  limit of
                                                the  O, anal\zer  ppm  Z  =  recoraer re-
                                                sponse v.uh zero air  "e scale
                                               28

-------
                                                      PROPOSED RULES
Record  the Oi corcertration and  the O»
an.ilizer response If substantial adjustment
of the span control is necessarj. reeheck the
zero and  span adjustments  by  repealing
steps 462 through 464

  4 S3   Generate  several other O. concen-
trations s also re-
quired The flow-rate through the O, gcr.tr-
ator 
are measured with a reliable flow, or '. oluine
standard traceable Co NBS The  highest O,
concentration stanaard required ' assaj mg the

-------
                                 26981

O, concentrations using the procedure in 4 5
while simultaneously measuring the corre-
sponding O, analyzer responses as specified
in 46.

               REFERENCES

  1 D  L. Plamm. "Analysis of Ozone it Loi
Concentrations  with Bone  Acid Buffered
KI." Environ. Sci. fechnol. 11. 978 (1977).

  2 B  E Saltzman and N Gilbert. "lodome-
trie  Microdeterrrunation of  Organic  Oxi-
dants  and  Ozone." Anal  Chem..  32,  1914
(1959).

  3.  J.  P  Lodge. Jr.  J   B.  Pate. B  E.
Ammons, and G  A Svianson. "The Use of
Hypodermic Needles as  Critical Orifices in
Air Sampling." J Air Poll Control Assoc..
16. 197(1966)

  4  "Transfer Standards for Calibration of
Ambient Air  Monitoring  Analizers  for        .    ,      „ .     ,    _.   ,.    „
Ozone.' EPA Publication available  «-****<——( delete    1 H  draft  TOrm
form from  EPA. Department E lMD-7<).
Research Triangle Park. N.C 27711.
                          30

-------
26982 .
                       PROPOSED RULES

O'
ZERO
AIR

FLOW
CONTROLLER




FLOV.'METER

F° .


03
GENERATOR


                                             OUTPUT
                                            MANIFOLD
        VENT
             EXTRA OUHETSCAPPEO
                U'HEiM NOT IN USE
                       TO ITJLETOF
                    Kl SAMPLING TRAIN
i

TO ff'RET OF ANALYZER
 UWOER CALIBRATION
Fujuro 1  Sclu'iiutic
                                                 o! ;i t/.nc.-l SAKi c^  i'.nuiion
                                                        31
                              FEDERAL REGISTER. VOL. 43. NO. 121—THURSDAY, JUNE 22. 1978

-------
                    PROPOSED RUL2S
                                         26983
                                                     HYPODERMIC
                                                       NEEDLE
                                                                        TO AIR
                                                                        PUMP
                                            CRITICAL ORIFICE FLOW CONTROL
  INSIDE
CLEARANCE
 3 TO 5 mm
jL
   10 mm O.D.
    24 40, CONCENTRIC WITH
    OUTER PIECE APJD WITH
    NOZZLE

  GRADUATIONS AT 5-ml
  INTERVALS. ALLTHE
  WAY AROUND
 NOZZLE ID. EXACTLY
 1mm: PASSES 0.09 TO 0.11
 cfm AT 1Z m H20 VACUUM.
 PIECES SHOULD BE INTER-
 CHANGEABLE,MAINTAINING
 NOZZLE CENTERING AND
 CLEARANCE TO BOTTOM
 INSIDE SURFACE
GLASS
WOOL  ,$£&,
     '
                                       TRAP
                      A
                                                                                f	[\l/1		^ TO AIR
                                                                                f f   l/Nl          PUMP
                                                                                  NEEDLE VALVE

                                                                                I
                                                         FLOWMETER
          ALTERNATE FLOW CONTROL
 ALL GLASS MIDGET IMPINGER (THIS IS A COMMERCIALLY
 STOCKED ITEM).
                   Figure 2.  Kl sampling tram.
                            32
   FEDERAL REGISTER, VOl. 43, NO. 121—THURSDAY, JUNE 27, 1978

-------
26984
PROPOSED RULES
                                                                03
                                                             GENERATOR
                                                                                           Mi XING
                                                                                          CHAMBER
                    VENT •*
                                                        OUTPUT
                                                       MANIFOLD
                              EXTRA OUTLETS CAPPED
                                 WHEN NOT IN USE
             Ill
              I
              t
          TO INLET OF
       Kl SAMPLING TRAIN
                                                                          TO INLET OF ANALYZER
                                                                           UNDER CALIBRATION
                 FKRIII- 3  Sc:i"i'\ntu; dunum of <.< ;vP'C.il BAKI cai'iirjtiOfi sysiL'iii (O.)iio;i 1)

                                     [FR Doc 78-17154 Filed 6-21-78 8 -S5 am]
                                                          33
                              FEDERAL REGISTER, VOL. 43. NO 121—THURSDAY, JUNE 22. 1978

-------
                                                          TAB  C


      UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                        WASHINGTON. D C  20460
                                                           OFFICE OF
                                                   AIR AND WASTE MANAGEMENT
SUBJECT:  Amendments to 40 CFR Part 51, Concerning Photochemical
          Oxidants—ACTION MEMORANDUM
FROM:  David G.  Hawkins, Assistant Administrator            Environmsniai
        for Air, Noise,  and Radiation                             -
                                                              Proteo.,0,-,
MEMO TO:  The Administrator                                       r  >-;,
   THRU:  AX
                                                                 LIBRARY

Purpose

     The accompanying Federal Register notice amends Part 51 in Title 40
of the Code of Federal Regulations with respect to photochemical oxidants.
A separate action involving 40 CFR Part 50 includes the redesignation of
the photochemical oxidant standard as an ozone standard.  Therefore, in
the action accompanying this memorandum, the appropriate nomenclature
changes are being made.  A copy of the entire Part 51, underlining the
terms "photochemical oxidants" and "oxidants," is being sent to the
Office of the Federal Register so that these terms can be changed to
read "ozone."

     Another part of the accompanying action is the deletion of Appendix
J of 40 CFR Part 51.  The deletion is necessary because the modeling
technique described by Appendix J is no longer recommended as the sole
acceptable technique for determining the relationship between ambient
ozone concentrations and hydrocarbon emissions.  Part 51.14 is being
amended to account for the deletion of Appendix J and to allow States to
use any of four analytical techniques which include consideration of
background concentrations and levels resulting from ozone transport.
EPA guidance is available to assist States in applying any of the four
techniques.

Major Issues

     The deletion of Appendix J was unanimously supported by those
commenters responding to the June 22 proposed action.  The use of the
four alternative techniques, however, represents a problem in that
different levels of control could result from one State to another,
depending upon the specific model employed.  EPA has responded to this
problem by requiring that States apply RACT regulations on large hydro-
carbon sources when any of the models except a photochemical dispersion

-------
model is used to demonstrate attainment of the ozone standard.  In.
consequence, States desiring to demonstrate attainment of the ozone
standard without the application of RACT regulations must do so only by
using a photochemical dispersion model to predict the level of control
needed.

Impact and Anticipated Reactions

     States have received notice of the possibility of revisions to the
ozone standard and to the techniques available to develop their ozone
control strategies.  Some States have claimed, however, that if the
amendments are not made sufficiently prior to the January 1, 1979,
submittal date for SIP revisions, then an extension will be needed.  EPA
is taking the position that the States must submit their ozone plan
(likely to be based on the old standard of 0.08 p.p.m.) on January 1, 1979,
as originally required.  States may then make further revisions to take
into account the revised standard at any point thereafter that they
choose.  It is anticipated that the States will comply with this ruling
in order to avoid possible sanctions set forth under the Clean Air Act.

Coordination

     This action was coordinated with OGC.

Recommendation

     I recommend that you sign the enclosed Federal Register notice of
final  rulemaking.

Enclosure

-------
                  Title 40—Protection of Environment
              CHAPTER I—ENVIRONMENTAL PROTECTION AGENCY
             PART 51—PREPARATION, ADOPTION, AND SUBMITTAL
                        OF IMPLEMENTATION PLANS
           Revisions  to Procedures Related to Photochemical
                           Oxidants (Ozone)

AGENCY:   Environmental Protection Agency.
ACTION:   Final Rulemaking.
SUMMARY:  In this action, the Administrator revises the procedures for
preparation of State  Implementation Plans for ozone (formerly photo-
chemical oxidants).  Throughout 40 CFR Part 51, the terms "photochemical
oxidant(s)," and "oxidant(s)" are changed to "ozone" to be consistent
with EPA's redesignation of the photochemical oxidant standard as an
ozone standard.  The redesignation action is being taken elsewhere in
this issue of the FEDERAL REGISTER.
     40 CFR 51.14 is  amended to allow States to use any of four analyt-
ical relationships for determining the hydrocarbon reductions necessary
to meet the ozone standard.  This particular amendment also involves the
deletion of Appendix J and section 51.14(c)(4).
EFFECTIVE DATE:  This rulemaking is effective upon publication.
ADDRESSES:  U.S. Environmental Protection Agency, Office of Air Quality
Planning and Standards, Control Programs Development Division (MD 15),
Research Triangle Park, North Carolina  27711.
FOR FURTHER INFORMATION CONTACT:  Joseph Sableski, Chief, Plans Guidelines
Section, at the above address or at 919-541-5437  (commercial) or
629-5437 (FTS).

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                       SUPPLEMENTARY  INFORMATION
                             1.   BACKGROUND
     On June 22, 1978, at  43 FR  26985, EPA proposed certain revisions to
40 CFR Part 51 concerning  the procedures for preparation of State Imple-
mentation Plans for photochemical oxidants.  This proposed action was
taken simultaneously with  related EPA proposals in the same issue of the
FEDERAL REGISTER to numerically  change the primary photochemical oxidant
standard from 0.08 p.p.m.  to 0.10 p.p.m., to redesignate the primary and
secondary standards as ozone standards, and to change to standards with
a statistical form rather  than a deterministic form (43 FR 26962); and
to replace the existing calibration procedure for the ozone reference
methods (43 FR 26971).
     A total of four public  hearings were held during July and August to
receive comments on all the  actions being taken relative to photochemical
oxidants (ozone).  In addition,  written comments were received through
October 16.  EPA received  comments on the proposed revisions to the
implementation requirements  from 23 commenters, including nine representa-
tives from industry, 10 from State and local governmental agencies, and
four from citizen's organizations and private citizens.
                 2.  SUMMARY OF  COMMENTS AND RESPONSES
     The following discussion summarizes the comments received on the
proposal to amend 40 CFR Part 51.  In some cases, similar comments are
considered together in order to  prepare a common response where appro-
priate.  Where an interested person wishes to identify individual
comments, a summary of all comments received, including those comments
pertaining to the other related  actions, and EPA's responses is available

-------
for public inspection during normal business hours in EPA's Public
Information Reference Unit (PM 215), 401 M Street, S.W., Washington,
D.C.  20460, telephone:  202-755-0707.
2.1  CONTROL STRATEGY
     In proposing the deletion of Appendix J, EPA also proposed that
States use instead any of four analytical techniques to determine the
amount of hydrocarbon reductions necessary to demonstrate attainment of
the national ozone standard.   The four techniques include:  (1) Photo-
chemical dispersion models, (2) Empirical Kinetics Modeling Approach
(EKMA), (3) Empirical and Statistical Models, and (4) Proportional
Rollback.
     Several commenters criticized the analytical techniques proposed to
replace Appendix J, citing various shortcomings of the techniques.  Some
commenters pointed to the failure of the EKMA and rollback techniques to
account for temporal and spatial distributions of sources in the design
of control strategies and pointed out that, since control of industrial
sources will be extremely costly, the most effective models should be
used in strategy development.   One commenter indicated that the level of
control necessary to achieve  the standard could not be predicted with a
satisfactory level of confidence since the various techniques produced
different results.  EPA acknowledges the fact that the various techniques
do produce different results  since different assumptions and different
data bases are required for each specific model.  Also, EPA agrees that
control strategies should be  based on the most effective models.  However,
effectiveness is in part determined by -he cost of gathering input data
and running a model.  If simple models, such as rollback, indicate the

-------
need for extensive controls, EPA feels it may not be necessary to expend
additional time and  resources to gather the information needed to run a
more sophisticated model which would reach the same general conclusion.
A  sophisticated model, i.e., a photochemical dispersion model, would
appear to be most warranted in cases where there is some doubt whether
extensive controls are needed to attain the standard.  EPA requires that
States attempting to demonstrate attainment and maintenance of the
                          t
revised ozone standard by 1982 without adopting reasonably available
control technology (RACT) regulations for large hydrocarbon sources must
employ photochemical dispersion modeling.  The use of other less rigorous
analytical techniques are only acceptable in areas where RACT measures
are also scheduled for implementation.  Where States are unable to
demonstrate attainment by 1982, EPA believes any of the models are
useful for indicating the magnitude of the ozone problem and for identi-
fying the need for major control programs to be implemented over the
next several years.  As these control programs are implemented and the
State moves closer to attainment, it is likely that sufficient information
will be acquired to  use dispersion models to adjust the control strategy.
Additionally, it should be noted that the city-specific version of EKMA
can account, to a limited extent, for temporal and spatial distribution
of sources.
     Another commenter stated that the annual emission inventory may not
be readily adaptable to the models and to refine the inventory into
hourly segments may  be very costly, time-consuming, and inaccurate.  In
response, EPA points out that of the techniques specified, only photo-
chemical dispersion  models require a detailed emission inventory to

-------
arrive at their predictions (with the exception of the more sophisticated
city-specific version of EKMA which can consider emission data).   The
other techniques primarily utilize ambient air quality data.  At  the
same time, EPA recognizes the importance of an accurate emission  inventory
in translating the requirements forecast by these simple models into
actual control programs.  For example, suppose EKMA predicts that a 70
percent control requirement is needed to meet the standard.  If the
emission inventory only includes 50 percent of the emissions, a 70
percent reduction in the inventory would only result in a 35 percent
reduction in actual emissions.  Photochemical dispersion models,  on the
other hand, do require explicit information concerning hourly emissions.
It would obviously be impractical to make hourly measurements for every
source.  However, hourly rates can be estimated by superimposing  observed
diurnal emission patterns on annual average emissions.  Such patterns
have been observed in several cities so that it would be possible to
utilize annual emissions data.
     Several persons commented that there is an inadequate understanding
of the relationship between hydrocarbons and ozone, and that controlling
hydrocarbon emissions may or may not be effective in reducing maximum
ozone concentrations.  This particular issue was addressed in a recent
                                                                 2
published report for the Manufacturing Chemists Association (MCA)  which
noted a lack of any clear downward trend in Houston's ozone levels
despite control measures to reduce hydrocarbons.  This report concluded
that existing ambient air quality data do not necessarily support the
hypothesis that reducing hydrocarbon emissions reduces ambient ozone
levels.  At least two difficulties exist which prevent straightforward

-------
interpretation of the study's findings.  First, the period of record was
relatively short (two to three years of data) and no attempt has been
made to normalize the trends for meteorological differences.  It is
generally believed by EPA that at least a five year period of record may
be needed to discern a trend in air quality attributable to changes in
emissions.  A recent review of ozone trend data conducted for EPA in
areas having long periods of records suggests that periods as long as
eight years may be required.3  Thus, while efforts are underway within
EPA to develop procedures for "normalizing" trends for differing meteorology
during short periods of record, at the present time trend analyses are
useful in only a limited number of areas.  The second difficulty in
using the conclusions drawn from the study is that it appears as though
some of the controls may have been initiated prior to any substantial
air quality measurement programs.
     EPA believes that convincing evidence exists to say that reducing
hydrocarbons will reduce ambient concentrations of ozone.  This position
                                                         4-15
rests primarily upon experimental and theoretical studies     which have
clearly established a physical cause-effect relationship between organic
pollutants and ozone in the presence of oxides of nitrogen.  Smog chamber
studies have shown that maximum ozone concentrations are particularly
sensitive to hydrocarbon controls when the ratio of non-methane hydro-
carbons (NMHC) to nitrogen oxides  (NO  ) is lower than 15-20:1.  In fact,
                                     rt
the lower the ratio the more effective the hydrocarbon strategy is
likely to be.  Examination of available NMHC and NO  data suggests that
                                                   A
most U.S. cities experience ratios in the order of 6-12:1.  Also, there
is a limited number of areas having ambient air quality data and emission
estimates over sufficiently long periods of record that tends to confirm
the theory of smog formation.

-------
     Two commenters indicated that a consequence of relaxing the standard
could be the change of some urban areas from nonattainment to attainment
status, thus, permitting greater hydrocarbon emissions than allowed by
their former status.  In one case the commenter argued that prior to
revising the standard EPA should ascertain that existing downwind viola-.
tions would not be further aggravated.  The other commenter opposed the
revision because, when coupled with current EPA control strategy policy,
the burden of control would be shifted to the States where ozone is
measured and away from States where emissions originate.  EPA does not
believe that consideration of such arguments is appropriate in setting
the national primary ambient air quality standard.  The Clean Air Act
requires that primary standards be based solely upon effects on public
health.  However, the consequences indicated by the commenters are valid
concerns in the formulation of policy and guidance to assist States in
developing a control strategy to meet the standards.  EPA responds to
these comments by stating first, that few urban areas are expected to
change from nonattainment to attainment areas as a result of the revised
standard.  EPA estimates that only five urban areas have the potential
for being redesignated as attainment areas.  On this basis, it would be
difficult to anticipate widespread aggravation of air pollution in areas
downwind of an attainment area.  Second, EPA does not consider the long
distance transport of precursors (e.g., hydrocarbons) to be as important
in the formation of ozone at downwind locations as the transport of
ozone itself.  If the transported precursors are insufficient to violate
the ozone standard when they are at relatively high concentrations near
the source area, it is unlikely they will make significant contributions

-------
to observed violations in areas far downwind particularly in the presence
of freshly emitted precursors.  The transport of increased amounts of
ozone itself, while more significant in contributing to downwind violations,
should generally be offset by the fact that the recorded violations
downwind will also be based on a higher standard.
     EPA is concerned, however, that the transport of ozone itself may
be a problem when it originates in areas for which insufficient monitoring
data preclude classifying the area as either attainment or nonattainment.
EPA is now taking steps to identify areas which are currently unclassified
but which have a high potential for exceeding the national ozone standard.
Within such areas, States will be urged to require controls on existing
large stationary sources.  If controls are not subsequently adopted, the
States will be required to monitor for ozone, whereupon, the area in
question will be classified nonattainment if violations are identified.
These areas would then be subject to the requirements to control hydro-
carbon emissions from existing stationary sources as in other nonattain-
ment areas.  EPA believes that the present policy focuses the limited
resources of air pollution control agencies and industry on the areas
(i.e., nonattainment areas) where the controls will be most effective.
     One commenter suggested that the chemical diethylhydroxylamine
(DEHA) be dispersed in the atmosphere to scavenge free radicals as an
effective means of controlling ambient concentrations of photochemical
oxidants.  The use of various scavenger compounds has been suggested in
the past as a means of reducing pollutant concentrations.  When considering
this type of approach, such concerns as how, when, and where to introduce
the chemicals to the ambient air  constitute a problem whose solution is
                                  8

-------
extremely difficult to resolve in practice.   Furthermore, irradiation of
mixtures of NO  , hydrocarbons, (HC), and DEHA was carried out in a
              /\
large smog chamber at EPA's Research Triangle Park, North Carolina,
facility.  The results indicate that after the DEHA is used up, smog
could sharply increase.  Prolonged irradiation of DEHA resulted in
increased formation of ozone and ozone producing chemicals.  Thus, EPA
does not consider DEHA to be a suitable additive to reduce ambient ozone
concentrations.
     Several commenters claimed that the ozone problem is an urban
problem and EPA requirements for control strategies should concentrate
on the urban area while paying special attention to the present levels
of NOV and the NMHC/NO  ratio.  EPA agrees that the ozone attainment
     X                X
problem is primarily an urban problem.  Consequently, the most stringent
requirements are imposed in urbanized areas with a population greater
than 200,000.  Low NMHC/NO  ratios primarily occur in such urbanized
                          /\
areas, thus the required controls would be effective in controlling
ozone levels.  However, EPA does not feel it is appropriate to ignore
hydrocarbon emissions outside the urbanized areas because these emissions
may contribute to the overall ozone problem, particularly during adverse
meteorological conditions.  EPA therefore believes it is justified in
requiring that large hydrocarbon sources  (more than 100 ton/year potential
emissions) in  rural nonattainment areas implement reasonably available
control techniques (RACT) to reduce their organic emissions.
     One commenter claimed that EPA has failed to issue timely guidance
on control techniques as required by the  Clean Air Act and as needed by
States  in revising their implementation plans.  The commenter's argument

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is based upon  Section  108(b)(l)  of the  Clean Air Act which requires
control technique  information  to be issued simultaneously with the
issuance of health  and welfare related  air. quality criteria.  EPA acknow-
ledges that no additional  control  technique information was issued
simultaneously with the  recently revised health and welfare criteria.
This is because the original control  technique information is not invali-
dated by revisions  made  to the air quality standard.  Further, the Clean
Air Act does not require information  on control techniques to be reissued
in the event that  air  quality  criteria  are revised, only that such
information from time  to time  be reviewed, modified, and reissued as
appropriate (Section 108(c).).
     EPA has published a series  of Control Technique Guidelines (CTGs)
which define reasonably  available  control technology (RACT) for stationary
sources of volatile organic compounds (hydrocarbons).  This guidance is
designed to assist  State and local  jurisdictions in the development of
air pollution  control  regulations  for hydrocarbons which contribute to
the formation  of ozone.  Although  additional guidelines are planned for
future publication,  the  1979 ozone plan submissions required of States
are to reflect the  application of  RACT  to those stationary sources for
which EPA published CTGs by January,  1978.  As additional CTGs are
published, States will be  required to adopt and submit additional RACT
regulations on an annual basis beginning in January, 1980, for those
CTGs that have been published  by January of the proceeding year.
     One commenter  inquired as to  why the proposal did not retain the
original statement  contained in  Section 51.14(c)(4) which-allowed States
to assume that the  hydrocarbon emission reductions necessary to attain
                                 10

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the ozone standard would also be adequate to attain the national  hydro-
carbon standard.  EPA's response is that this statement was uninten-
tionally omitted from the June 22 proposal, and this omission is  being
corrected in today's action.  Previously, statements concerning the
attainment of the ozone standard and the hydrocarbon standard were both
contained in Section 51.14(c)(4).  To take the actions described  herein,
EPA is deleting (and reserving) paragraph (c)(4) of Section 51.14 and
establishing three new paragraphs (c)(7), (c)(8), and (c)(9).  Paragraph
(c)(7) is to be used to set forth the four analytical techniques  for
determining the amount of hydrocarbon reduction necessary to demonstrate
attainment of the ozone standard; paragraph (c)(8), describes specific
considerations to be made in developing the ozone control strategy; and
paragraph (c)(9) addresses attainment of the hydrocarbon standard.
2.2  SUBMITTAL OF SIP REVISIONS
     Several industrial and governmental agency spokesmen expressed the
opinion that EPA should grant States extensions of up to nine months to
correct their SIPs to be consistent with the revision of the ozone
standard.  EPA's response to this request is provided in detail in the
preamble to the revision of the ozone standard appearing elsewhere in
today's FEDERAL REGISTER.  In summary, States are still expected  to
submit their plan revisions to EPA on January 1, 1979, as required by
the Clean Air Act.  These plans will most likely be based upon the old
standard of 0.08 p.p.m.  However, once submitted, any State is free to
make the additional revisions necessary to account for the revised
standard, if they so desire.  Thus, the time schedule for submitting the
latter revisions is to be determined by each State.
                                11

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                     3.  OTHER CHANGES  FROM PROPOSAL
     In reviewing the June 22 proposed  rule, EPA has determined that two
changes from the proposal are necessary even though no comments addressing
these particular matters were received.  With regard to the first change,
EPA originally proposed to change the  terms "photochemical oxidants" and
"oxidants" to "ozone" in 40 CFR Parts  51 and 52 to be consistent with
the proposed redesignation of the photochemical oxidant standard to an
ozone standard.  EPA has decided not to proceed with the proposed nomen-
clature changes in Part 52 at this time.  The reason for this decision
is that in numerous  places throughout  Part 52 the terms "photochemical
oxidants" and "oxidants" are used either as part of the title of a State
Implementation Plan  or to denote use of the terms within the plan
itself.  EPA therefore, feels that it would be proper to wait until
States made the appropriate nomenclature changes in their plans prior to
enacting any changes to Part 52.
     The second change concerns EPA's  proposal to allow States to use
photochemical grid models as one of four analytical techniques for
determining the needed hydrocarbon emission reductions.  The intended
terminology for such models should have been photochemical dispersion
models.  There are two major types of  dispersion models - grid (or
Eulerian) and Lagrangian.  EPA intends  to allow either type model to be
used where appropriate.  Thus, the more inclusive terminology (i.e.,
photochemical dispersion models) will  appear in Section 51.14(c)(7)(i).
                                  12

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                       4.   REFERENCES

     1.   Uses, Limitations and Technical  Basis  of Procedures  for
Quantifying Relationships  Between Photochemical  Oxidants  and  Precursors.
U.S. EPA, Research Triangle Park, N.C.  27711,  EPA 450/2-77-021 a,
November, 1977, p. 31.

     2.   Examination of Ozone Levels and  Hydrocarbon Emissions
Reduction. Final Report, DCN 77-100-151-04,  Prepared by the Radian
Corporation, Austin, Texas, for the Manufacturing Chemists Association,
Washington, D.C., November, 1977.

     3.   Wayne, L., et  al., Detection and Interpretation  of Trends
in Oxidant Air Quality, Prepared for U.S. EPA  by Pacific  Environmental
Services, Santa Monica, Calif., EPA 450/3-76-034 (October, 1976).

     4.   U.S. Department of Health, Education  and Welfare, Air
Quality Criteria for Photochemical Oxidants. AP-63,  (March,  1970),
Ch. 2.

     5.   Altshuller, A.P., and J.J. Bufalini,  "Photochemical  Aspects
of Air Pollution:  A Review,"  Environmental Science and  Technology,
5_, 39 (January, 1971).

     6.   Dimitriades, B.,  Photochemical Oxidants in  the Ambient
Air of the United States.  U.S. EPA, Research Triangle Park,  N.C. 27711,
EPA 600/3-76-017, (February, 1976), Ch. 3.

     7.   Air Quality Criteria for Ozone and Other Photochemical
Qxidants, Volume I. U.S. EPA, Washington, D.C., EPA  600/8-78-004,
(April, 1978),
Ch. 4.

     8.   Dimitriades, B.,  "Effects of Hydrocarbon and Nitrogen
Oxides in Photochemical Smog Formation,"  Environmental Sciences
and Technology. 6_, 253  (1972).

     9.   McCracken, M.C.,  et al., Development  of an  Air Pollution
Model for the San Francisco Bay Area. Volume I. NTIS No.  UCRL-51920,
(October, 1975).

    10.   Dodge, M.C., Combined Use of Modeling Techniques and Smog
Chamber Data to Derive Ozone-Precursor Relationships. U.S.  EPA,
Research Triangle Park, N.C. 27711, EPA 600/3-77-001b, p. 881,
(January, 1977).
                                  13

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     11.  Dimitriades, B., "Oxidant Control  Strategies,  Part  1:  An
Urban Oxidant Control Strategy Derived from Existing Smog  Chamber
Data," Environmental Science and Technology. 1J_,  p.  80 (1977).

     12.  Anderson, G.E., et al., Air Quality in  the Denver Metro-
politan Region 1974-2000, Prepared for U.S.  EPA by Systems Applica-
tions, Inc., San Rafael, Calif., EPA 908/1-77-002, (May, 1977),
Ch. 2.

     13.  Seinfeld, J.H., and K.R. Wilson, International Conference
on Oxidants, 1976 - Analysis of Evidence and Viewpoints.  Part VI,
The Issue of Air Quality Simulation Model Utility, EPA 600/3-77-118,
(November 1977).

     14.  Air Quality Criteria for Ozone and Other Photochemical
Oxidants. Volume I. U.S. EPA, Washington, D.C., EPA 600/8-78-004,
(April 1978), Ch. 6.

     15.  Guideline for the Evaluation of Air Quality Trends,
Guideline Series OAQPS No. 1.2-014, U.S. EPA, Research Triangle
Park, N.C. 27711, (Feburary 1974).

     16.  Altshuller, A.P., "Evaluation of Oxidant Results at CAMP
Sites in the United States," Air Pollution Control Association J,
25., 19 (January 1975).

     17.  Trijoim's, J.C., et al., Emissions and  Air Quality  Trends
in the South Coast Air Basin. EQL Memo No. 16, Environmental  Quality
Laboratory, California Institute of Technology, Pasadena,  CA  91125.

     18.  Gise, J.P., Recent Ozone Trends in Texas, AICHE, 83rd
National Meeting, Houston, Texas, (March 1977).

     19.  Trijom's, J., et al.. Verification of the Isopleth  Method
for Relating Photochemical Oxidant to Precursors, Prepared for U.S.
EPA by Technology Services Cooperation, Santa Monica, Calif., EPA
600/3-78-019, Ch. 2-3, (February 1978).
           Date                             Administrator
                                  14

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     The Code of Federal  Regulations, Title 40, Chapter I,  Part 51,  is
amended as follows:
1.   Wherever the terms "photochemical oxidant(s)" or "oxidant(s)"
appear in Part 51, they are changed to read "ozone."
2.   Appendix J is deleted and reserved.
3.   Section 51.14(c) is amended by deleting and reserving  paragraph (4)
and by adding new paragraphs (7) and (8) as follows:
     § 51.14  Control strategy:  Carbon monoxide, hydrocarbons, ozone,
and nitrogen dioxide.
*****
     (c)  * * *
     (4)  [Reserved].
*               *                *               *                *
     (7)  In selecting an appropriate model to determine the amount of
hydrocarbon reductions necessary to demonstrate attainment of the ozone
standard, one of the following techniques must be applied:
     (i)  Photochemical dispersion models - These models are based on
the most accurate available physical and chemical principles underlying
the formation of ozone.
     (ii)  Empirical Kinetics Modeling Approach  (EKMA) - This model
represents a compromise between rigorous treatment  of chemical and
physical principles  underlying ozone  formation and  dispersion and the
extensive data  requirement that would be necessitated by such an  approach,
     (iii)  Empirical  and statistical models - These models reflect
observed relationships between ozone  and other variables.
                               15

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     (iv)  Proportional rollback - This model assumes a linear relation-
ship between hydrocarbon emissions and ambient concentrations of ozone.
     (8)   In developing an ozone control strategy for a particular area,
background concentrations and ozone transported into an area must be
considered.  States may assume that the ozone standard will be attained
in upwind areas.
     (9)  The degree of total hydrocarbon emission reduction necessary
for attainment of the national standard for ozone will also be adequate
for attainment of the national standard for hydrocarbons.
AUTHORITY:  Sections 110 and 301(a), Clean Air Act, as amended (42
U.S.C. 7410, 7601).
                                   16

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U21740
                        TAB 0

                         PART II
                   ENVIRONMENTAL
                     PROTECTION
                       AGENCY
                     PHOTOCHEMICAL
                       OXIDANTS;
                    MEASUREMENT OF
                     OZONE IN  THE
                      ATMOSPHERE;
                   REQUIREMENTS FOR
                      PREPARATION,
                     ADOPTION,  AND
                      SUBMITTAL OF
                     IMPLEMENTATION
                  Environmsntal  PLANS
                 Protection Agency
                   RO^'TI o
                  DEC 20 1978

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26962
           PROPOSED RULES
[6560-01]

   ENVIRONMENTAL PROTECTION
              AGENCY

            [40 CFR Part SO]

 CPRL 886-4 Docket Number OAQPS 78-81

       PHOTOCHEMICAL OXIDANTS

 Proposed Revisions la (he National Ambient
          Air Quality Standard

AGENCY:  Environmental Protection
Agency.
ACTION: Proposed rule.
SUMMARY: In accordance  with the
provisions of Sections 108 and 109 of
the Clean  Air Act as amended. EPA
has conducted a review of the criteria
upon which the existing primary and
secondary   photochemical   oxidant
standards are  based. The revised crite-
ria are being published simultaneously
with the issuance of this proposed ru-
lemaking. The existing primary  and
secondary standards  for photochemi-
cal oxidants are currently set at  0.08
ppm, l-hour average not to be exceed-
ed more than once per  year.  As  a
result  of the  review and  revision of
health and  welfare criteria, EPA  pro-
poses to raise the primary  standard
level to 0.10 ppm. 1-hour average. EPA
also proposes  that the secondary  wel-
fare-based  standard  remain  at  0.08
ppm.  1-hour average. Other  changes
proposed in this rulemaking include:
(1) changing the chemical designation
of the standard  from  photochemical
oxidants to ozone, and (2) changing to
a  standard  with a  statistical rather
than deterministic form. i.e. allowable
exceedances will  be stated as an ex-
pected value, not an explicit value.
  During the period between this  pro-
posal and  final promulgation of the
standard. EPA will continue its exami-
nation of health and welfare criteria
and seek to further involve the public
and other affected parties  In the final
decision on the air quality standard.
DATES:  Comments  must  be  received
by August 18, 1978.  There will be  a
public  hearing at 9:00 aan. on July 18,
1978. This hearing may be  extended
into the following day, July 19. as nec-
essary. The standard will  be promul-
gated by the end of September. 1978.
ADDRESS:  Send comments to  Mr,
Joseph Padgett  (MD-12V  Director.
Strategies and Air Standards Division.
U.S.     Environmental    Protection
Agency. Research Triangle Park. NC
27711.
  The  public hearing will  be held at:
Environmental Protection Agency, 401
M Street SW., Room 2117. Washing-
ton. DC 20460.

FOR   PUHTUUK   INFORMATION
CONTACT:
  Mr. Joseph Padgett. Telephone:  919-
  541-5204 (PTS 629-5204).
   Availability of supporting informa-
  tion: A docket (Number OAQPS 78-8)
  containing information used by  EPA
  in development of the proposed stand-
  ard  is available for public  inspection
  between  8:00 ajn.  and   4:30  p.m.
  Monday  through  Friday,  at  EPA's
  Public  Information  and   Reference
  Unit. Room 2922.  Waterside Mall. 401
  M Street  SW., Washington. DC 20460.
  These materials Include the "Air Qual-
  ity Criteria'for Ozone and Other  Pho-
  tochemical  Oxidants"  and  "Control
  Techniques for Volatile Organic Emis-
  sions from Stationary Sources",  both
  issued simultaneously with this  pro-
  posal. In addition, staff  papers  per-
  taining to the form of the ozone stand-
  ard, risk  assessment  method, second-
  ary standard, and  health panel assess-
  ment are also available. These docu-
  ments can be received upon request
  from Mr.  Joseph Padgett.
   Revisions to 40 CFR Part 50. Appen-
 .dix  D, "Measurement  Principle  and
  Calibration Procedure  for  the Mea-
 -surement of Photochemical Oxidants
  Corrected for Interferences Due to Ni-
  trogen  Oxides  and  Sulfur  Dioxide"
  and  Appendix B.  "Interpretation  of
  the  National  Ambient  Air  Quality
  Standard for  Ozone"  are described
  elsewhere in this preamble.
   Revisions to 40 CFR Part 51 substi-
  tuting the word "ozone" for "photo-
  chemical  oxidants" throughout  that
  part, and to Section 51.14  pertaining
  to control strategies are  being  pro-
  posed by  EPA elsewhere in this issue
  of the FEDERAL REGISTER.
   Statements  of  the environmental.
, economic, and energy Impacts of im-
  plementing this standard revision are
  available   upon "request  from  Mr.
  Joseph Padgett, at the address shown
  above.

  SUPPLEMENTARY INFORMATION:

              BACKGROUND •

   On April 30.. 1971,-  the Environmen-
  tal Protection agency promulgated in
  the  FEDERAL  REGISTER  (36  FR 8186)
  National  Ambient Air Quality Stand-
  ards for photochemical oxidants. The
  scientific, technical, and medical basis
  for these  standards is contained In the/
  air quality criteria document for  pho'
  tochemical oxidants published by the
  U-S.  Department  of Health. Educa-
  tion, and Welfare In  March.  1970.
  Both  the  primary  and   secondary
  standards were set at a level of 0.08
  ppm. hourly average not to  be exceed-
  ed more than once per year. The pre-
  amble to the regulation stated:
   "The revised national primary standard of
  0.09 ppm Is based on evidence of increased
  frequency  of asthma attacks in some asth-
  matic subjects on  days when estimated
  hourly average concentrations of photoche-
  mical oxidant reached 0.10 ppm. A number
  of comments raised serious questions about
  the validity of data used to suggest Impair-.
  ment of athletic peformance at lower oxi-
dant concentrations. The revised primary
standard Includes a margin of safety which
Is  substantially  below  the most  likely
threshold level suggested by this data. It Is
the Administrator's judgment that a prima-
ry standard of 0.08 ppm as a 1-hour average
will provide an adequate safety margin (or
protection of public health and will protect
against known and anticipated adverse ef-
fects on public welfare."
  The asthma study cited above as evi-
dence  for  the  original  standard  is
based  on work  by  Schoettlin  and
Landau. Effect  level estimates  from
this study have changed and are dis-
cussed elsewhere in this proposed reg-
ulation.
  Oxidants are strongly oxidizing com-
pounds which  are  the  primary con-
stituents of photochemical smog. The
oxidant found  in largest amounts  is
ozone  (O>).  a" very reactive  form of
oxygen. Oxidants  also  include  the
group of compounds referred to collec-
tively as peroxycylnitrates (PANs) and
other  compounds  all  produced  in
much smaller quantities than ozone.
  Most of these materials are not emit-
ted directly  Into the atmosphere but
result  primarily from  a  senes  of
chemical reactions between  oxidant
precursors-(nitrogen oxides and organ-
ic compounds) in the presence of sun-
light. The principal sources of organic
compounds are the hydrocarbon emis-
sions  from automobile .and truck ex-
hausts,  gasoline vapors, paint solvent
evaporation, open burning,  dry clean-
ing fluids, chemical plants  and other
industrial  operations. Nitrogen oxides
are emitted primarily from  combus-
tion sources  such  as  electric  power
generation units, gas  and  oil-fired
space heaters, and  automobile, diesel
and jet engines.
  The reductions in emissions of rutro--
gen oxides and organic compounds are
achieved through ..Federal and State
programs which have been formalized
in regulations promulgated under the
Clean Air Act. The Federal programs
provide for the reduction in emissions
nationwide through the Federal Motor
Vehicle Control Program, the Federal
program for control of aircraft emis-
sions. National Emission Standards tor-
Hazardous Air Pollutants, and the de-
velopment of New Source  Perform-
ance Standards. The State programs
provide for  additional control meas-
ures through State  Implementation
Plans in those areas of  the country
where the Federal  programs are not
sufficiently stringent to permit attain-
ment of air quality standards.

 STATUTORY REQUIREMENTS AFFECTING
          THIS PROPOSAL

  Two sections of the Clean Air Act
govern the development of a National
Ambient Air Quality Standard. Sec-
tion 108. instructs EPA to document
the scientific basis for the standard.
and Section  109 provides guidance on
establishing  standards and reviewing
criteria.
                              FEDERAL REGISTER, VOL 43, NO. 121—THURSDAY, JUNE 22, 1978

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                                               PROPOSED RULES
                                                                   26963
  Air quality criteria are required by
section 108(a)(2) to accurately reflect
the latest scientific Information useful
in Indicating the kind and extent of all
identifiable effects on public health or
welfare which may be expected  from
the presence of the pollutant in the
ambient air.
  Simultaneously with the Issuance of
these criteria, the Administrator is re-
quired to propose primary and second-'
ary  ambient  air  quality  standards
based upon such criteria. The primary
standard is defined In section 109
as that ambient air quality standard
the  attainment  and maintenance of
which, based on such criteria and al-
lowing an adequate  margin or safety,
is in  the  Administrator's judgment
requisite to protect the public health.
The  secondary   standard   (section
109
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26964
          PROPOSED RULES
effects  such as biochemical changes.
morphological  abnormalities, and  ge-
netic changes  have  been  shown in
some animal studies  but the  physio-
logical significance of-these effects re-
mains to be established.
  5. There is a  limited amount of data
that suggests that ozone may acceler-
ate the aging process in living organ-
Isms. Exposure of rabbits  to unspeci-
fied concentrations of ozone for one
hour per week  for a year has been re-
ported  to  induce premature  aging
symptoms such as premature cartilage
calcification, severe depletion of body
fat.  and general signs of  senescence.
Inhalation of 0.20 to 0.25  ppm ozone
by animals and humans over 30 to 60
minute periods increased the  rate of
sphering of red blood cells when their
blood  samples were  irradiated, sug-
gesting an acceleration In the aging of
the cells.
  6. Acknowledgement of the fact that
ozone exposure is  frequently accompa-
nied by exposure  to other pollutants,
particularly sulfur dioxide (SO,), has
prompted several  investigators to con-
duct  laboratory evaluations of expo-
sure of humans to combinations of Ot
and SOi.
  Exposures to 0.37 ppm Oi and 0.37
ppm SO* simultaneously have been re-
ported  to  produce  enhanced decre-
ments in pulmonary function as com-
pared  with either  pollutant alone.
Other  simultaneous   exposure  tests.
using d  and nitrogen dioxide (NO,)
and Oj, NO,  and carbon monoxide
(CO) produced few important physio-
logical  changes and only mild symp-
toms. These findings suggest the need
for an  adequate margin of  safety as
well as the need-for  more  definitive
data.
•  7. There are no health studies that
link exposure to ozone or photochemi-
cal oxidants to an increase in human
mortality.  A number  of epidemiologic
studies have been designed and con-
ducted  to demonstrate  this effect, but
all have been negative or inconclusive.
  8." Ozone accelerates  the  aging of
many materials  resulting  In rubber
cracking, dye fading and paint erosion.
These effects are  related to- the total
dose  of ozone  and can occur at very
low  levels,  given  long  duration expo-
sures. Damage to  vegetation occurs as
leaf  Injury, decreased growth  and
yield, and disruption  or reproductive
functions.
  9. All evidence presently available In-
dicates that  around  urban  centers
with  severe oxidant  problems,  the
majoc-concern  Is the formation of pho-
tochemical  oxidants  from man-made
organic and nitrogen oxide emissions.
Control of  these emissions will effect
significant  reductions  in   ambient
ozone,  peroxyacetylnitrate (PAN), al-
dehydes and photochemical aerosoL
 GENERAL APPROACH TO  SELECTING THE
  LEVEL OF THE PRIMARY OZONE STAND-
  ARD

 'Revision of  the National Ambient
 Air Quality Standard  for ozone  re-
 quires  certain  judgments  b'y  EPA
 about the relationship  between con-
 centrations of ozone in the air and
 possible adverse health effects experi-
 enced by the public. This relationship
 is greatly complicated by the fact that
 there is variability of response among
 individuals exposed to ozone, and that
 there are numerous effects of ozone
 on health occurring at different levels
 of  exposure. In selecting the proper
 level for  the revised  standard.  EPA
 must make judgments relating to four
 critical areas:             -  -
  1. The range of demonstrated health 'ef-
 fects.. "
  2. The sensitive population.
•  3. The seriousness of the health effect and
 the level at  which  the health effect has
 been demonstrated to occur.
  4. What constitutes an adequate margin of
 safety to protect the public health.
 DEMONSTRATE HUMAN HEALTH EFFECTS
  AND  EFFECTS OBSERVED  IN ANIMAL
  STUDIES
  Tne purpose of  this discussion Is to
 describe the health effects attributed
 to  ozone that are of concern in setting
 an ozone air quality standard. The dis-
 cussion attempts to put these effects in
 perspective, and where possible, relate
 them to common personal experiences
 of  the average person.
  Impaired Pulmonary Function and
 Airway Resistance—Ozone  Is a  bron-
 chiopulmonary Irritant  which affects
 the mucous lining, other lung tissue
 and respiratory functions. Changes in
 lung function  appear  as  increased
 airway resistance, reductions in vital
 capacity, expiratory flow rates and dif-
 fusion  capacity.  These effects - are
 greater in exercising individuals and
 individuals  with  hyper-reactive air-
 ways (history of developing symptoms
 during light activity in smog or history
 of  asthma). Changes In lung function
 are accompanied by clinical symptonis
 such as coughing, chest  tightness, and
 lower chest soreness.     -
  Because   the   human  respiratory
 system is endowed with a large capac-
 ity, even airway resistance increases of
 50  to 100 percent will not ordinarily be
 perceived in normal Individuals.  How-
 ever, a portion of the population with
 respiratory problems may be operating
 at  the limit of their lung capacity even
 in  normal activity states, and  any In-
 crease In air flow  resistance will affect
 their ability to perform or aggravate a
 pre-existing  pulmonary disease. For
 healthy individuals engaged in strenu-
 ous activity, a SO to 100  percent in-
 crease  In airway  resistance might be
 accompanied by  shortness of breath
 and fatigue. Since these sensations are
 normally associated with strenuous ac-
tivity,  it would be difficult to detect
the  air  pollution induced  effect  in
healthy  persons. In a  light  activity
state, it is unlikely that any observable
effect  could  be noted from changes
even as high as 50 to 100 percent in-
crease in flow resistance.
  Decreased Resistance to Infection—
This effect Is represented by  an In-
creased rate of mortality In laboratory
animals subjected to both a bacterial
challenge and exposures to ozone. Ac-
cording to some studies,  the effect
may be enhanced by the addition  of
such stresses as heat, exercise, or the
addition of other pollutants in combi-
nation with the  ozone  dose.  Despite
the  lack of  confirmatory  studies  in
man. and the uncertainties involved in
predicting human effects from animal
studies, most medical experts agree
that decreased  resistance to Infection
most likely does occur in man and the
lack of such evidence is probably due
to the difficulty of detecting these re-
sponses in epidemiologic studies.
  Aggravation of Chronic Respiratory
Disease—It  is generally  accepted by
the scientific community that there is
a link- between ambient oxidant levels
and aggravation of pulmonary  disease.
This link  was  demonstrated  by the
Schoettlin and Landau study which, re-
lated the frequency of asthma attacks
to  measured ambient photochemical
oxidant concentrations.  Several stud-
ies "have Investigated the aggravation
of emphysema and chronic bronchitis
without any. definitive links to photo-
chemcial oxidant concentrations.
  Air pollution  Is one  of  the many
stresses  which   can precipitate  an
asthma attack  or worsen the disease
state in persons  with chronic cardio-
pulmonary  disease.  Other  factors
which  can act .like ozone in precipitat-
ing attacks include:  respiratory infec-
tions, passage of cold fronts, seasonal
pollens,  extreme heat  or cold,  and
even emotional disturbances.
 " Eye Irritation—Eye irritation is asso-
ciated  with selected chemical species
(such as PAN) in the photochemical
oxidant mix and other organic vapors.
There Is no evidence that eye Irrita-
tion Is associated with ozone. Since
EPA plans to redesignate the standard
from photochemical oxidants to ozone.
the eye irritation effect is not a criti-
cal one  in establishing the standard
level.
  Biochemical  fleets—Experimental
exposures of human subjects to ozone
have produced changes in blood bio-
chemistry, such as increased fragility
of red blood cells and altered  enzyme
activities  in  the serum. The  signifi-
cance of these ozone-mediated changes
is not  yet known, but changes of the
magnitude observed In experimental
exposures have not yet been linked to
any clinical diseases.
  Carcinogenic, Mutagenic  and Relat-
ed Effects—Studies have been conduct-
                              FEOERAL REGISTER, VOL 43, NO. 121—THURSDAY, JUNE 22, 1978

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                                                PROPOSED  RULES
                                                                    26965
ed in an attempt to relate ozone to
carcinogenic,  mutagenic,  and  related
effects.  These studies are not deemed
to be  important  in  setting ambient
ozone standards because of the failure
of researchers to replicate much of the
work and because of the questionable
significance to man of some effects ob-
served in lower life forms. The criteria
document states that the significance
of effects such  as chromosomal aber-
rations   has  not  been  established.
EPA's Science Advisory Board has rec-
ommended not  including some of the
studies  in  the criteria  document lest
they receive unwarranted emphasis.
        SENSITIVE POPULATION
  Clinical and epidemiological  studies
have shown that asthmatics and other
persons with reactive airways  appear
most sensitive to changes in ozone con-
centrations and are thus judged to be
the principal  sensitive  group of con-
cern in setting  the standard.- This is
because their airways are hyper-reac-
tive to irritants such as ozone.
  Studies have  also established  that
exercise   effectively   increases   the
ozone dose delivered to the target tis-
sues in  the  respiratory tract. Thus.
persons engaging in exercise are par-
ticularly vulnerable to the acutely irri-
tating effects of ozone. However,  the
response  of  these  groups to such
changes  in  concentrations has  not
been systematically studied.
 SELECTING THE LEVEL OF THE PRIMARY
              STANDARD             . .
  The language  of section 109(b)(l) re-~"
quires EPA to set a primary standard
that, based on the air quality criteria
and  allowing  an adequate  margin of
safety,  is  requisite  to protect  the
public health.
  Relevant to this charge, the Nation-
al Academy  of  Sciences reached  the
following conclusion in 1974:
• • •  in no case Is there evidence that the
threshold levels have clear physiological
meaning. In the sense that there are genu-
ine adverse health effects at the above some
level of pollution, but no effects-at all below
that level. On the contrary, evidence indi-
cates that the  amount of health  damage
vanes with the upward and downward vari-
ations m the concentration of the pollutant.
with no sharp lower limit.
  The House of Representatives Com-
mittee on Interstate and Foreign Com-
merce has observed that the concepts
of threshold and adequate margin of
safety that underlie  the language of
section  109(b)(l) of the Clean Air Act
are necessary simplifications to permit
the Administrator to set standards.
  The criteria document confirms that
no  clear  threshold can be identified
for health effect due to ozone. Rather.
there  is  a continuum  consisting of
ozone levels at which  health effects
are certain,  through levels at which
scientist  can  generally  agree  that
health effects have-been clearly dem-
onstrated, and down to levels at which
the indications  of  health  effects are
less certain and harder to identify. Se-
lecting  a standard from this  contin-
uum is  a judgment of prudent public
health  practice, and does not  imply
some  discrete or fixed margin of safety
that is appended to a known "thresh-
old".
  The uncertainties with which such a
judgment must deal are the result of
several  factors.  First, human suscepti-
bility to health effects vanes and we
cannot  be certain  that experimental
evidence  has accounted for the  full
range of  susceptibility.  Second,  we
cannot  be certain that all effects  oc-
curring at low ozone levels have been
identified  and  demonstrated.  Third,
variations in weatheacreate uncertain-
ty- as to  the expected  annual maxi-
mum  ozone concentrations.
  The decision is made more difficult
by the fact that the Clean Air Act. as
the Administrator  interprets  it, does
not permit him  to take factors such as
cost or attainability into  account in
setting  the  standard;  it  is to be a
standard  which wfll adequately pro-
tect public health.  The Administrator
recognizes, however,  that controlling
ozone to very low levels is. a task that
will have»significant impact  on  eco-
nomic and social activity. It is thus im-
portant that the standard not be any
more  stringent than protection of the
public health demands.
  Human health effect levels  cited in
the criteria document from published
studies  vary from  0.15  to 0.30 ppm.
The studies documenting effect levels
are presented below:
                      DSMONSZE
                                  i EFFECT LEVELS IB MAN
      Aggravation of asthma
                                Redaction In pulmonary
                                     function
              Chest dtaconxfort and bntauoo
                . of the respiratory tract
0 29 p/m—eplderaiotogie (aehoettlln and 0 19 p/m to 0 30 p/m elbilcal
 Landau).                      
-------
 26966
         PROPOSED RULES
 effect of reduced resistance to bacte-
 rial infection in man., The criteria doc-
 ument cites numerous epidemiologlcal
 studies that fail to link increased mor-
 tality or increased hospital admissions
 with. ozone   or   oxidant   exposures.
 Those few studies which  do  suggest
 such a link are described as Inconclu-
 sive  in the criteria document, and all
 these studies are deemed to have seri-
 ous limitations.

  Based on the  studies cited In 'this
 section,. EPA concludes that the dem-
 onstrated, human effects levels as cited
 in  the  criteria document vary from
 0.15 ppm to 0.30 ppm. Additional opin-
ions were  sought  from  an  advisory
panel of health experts  (referred to
hereinafter as the health panel) and
other selected medical experts, who
were asked to assess the literature re-
ported in the.criteria document.

  Estimates made by these experts are
based on their understanding and in-
terpretation of  those health  critieria.
A summary statement from the health
panel has  been placed in 'the docket
and is available from EPA at the ad-
dress given earlier. As an added aid for
addressing' the uncertainties  associat-
ed with setting an adequately protec-
tive standard, EPA has used an analyt-
 ic   technique  of  risk  assessment.
 Formal interviews of selected medical
 experts were evaluated using a meth-
 odology known as subjective probabil-
 ity  encoding. This analysis estimated
 the probability of various health ef-
 fects occurring in-sensitive persons at
 alternative  ozone  levels.  A  report
 which  discusses the basis for and ap-
 plication of the analytic  method has
 been placed in the docket and is avail-
 able from  EPA at the address given
 earlier.
  The  most probable  effect levels for
 various health effects as estimated by-
 the health panel and  by the risk -as-
 sessment procedure are shown below:
                          PROBABLE EFFECT LEVEL ESTIMATES— Estimates for sensitive population segments

                                                    [Parts per million]
                              Aggravation at asthma.  Reduced resistance In bacteria
                             emphysema, and chronic   Infection (animal studies)
                                   bronchitis
                                Reduction In pulmonary
                                      function
               Chest discomfort and irritation
                 of the respiratory tract
Health panel judgment of effect level. -
Probable (median) effect level as estl- '
  mated from interviews with health
  experts—
                                     0.15-0.29
                                         0.1T
                                    (0.14-0.25)
                    .  0.18
                  (0.01-0.38)
                                                                                   0.19-0.33
        0.13
   (007-018)
                                                                                                         0.15-0.25
    015
(0 11-0.18)
  •Not available.

   These  estimates are based on  the
 most sensitive population-segments. In
 the-case of the risk assessment inter-
 views,-the experts were asked to focus
 not only on the most sensitive popula-
 tion group, but also on a very sensitive
 portion  of  that  group  (specifically;
 those persons who are more sensitive
 than 99 percent of the sensitive group.
 but  less 'sensitive  than 1  percent of
 that group).  However,  these  people
 should not be considered as medically
. handlcaped as a result of their sensi-
 tivity. Their outward  appearance may
 be perfectly normal-,-but when exposed -
 they could have adverse reaction. The
 lowest effect level estimate cited by
 the health panel and those generated
 through the expert- interview process
 are  reasonably  consistent,  ranging
 from 0.15 to 0.18 ppm. Based on  this
 data and on the  demonstrated  effect
 levels cited in the criteria document, it
 can  be  concluded  that health  effects
 have been  demonstrated  at  ozone
 levels of 0.15 ppm.
   The criteria document contains  sev-
 eral indications of the uncertainties
 discussed above that  have/glven EPA
 reason  to  believe  that a  standard of
 0.15 ppm would not be adequately pror
 tective. Of particular importance  arer
 (1) new and replicated animal studies
 showing reduced resistance to  infec-
 tion at ozone  levels of 0.10 ppm; (2)
 Japanese epidemiologlcal  studies  re-
 porting an increase In respiratory dis-
 comfort and other symptoms in school
 children  at  oxidant concentrations
 below 0.15 ppm.
  Evidence t>f  reduced  resistance to
bacterial infection has not reached the
point where It can  be meaningfully
used- to  extrapolate  concentrations
that would similarly affect man. Most
experts agree, howeVer. that the effect
occurs in humans, and that it is only
the concentration at which r these ef-
fects occur that is uncertain. Further,
it is the kind of effect that is serious
enough in its implications to  raise a
need for caution. Thus, there is a need
for setting a standard more.stringent
than the effect level which  has been
demonstrated in  human studies, in
order to account in some measure for
these unquantified but possibly seri-
ous effects.                -          -.
  A similar caution is suggested by the
Japanese epidemiological studies.  The
Science Advisory Board questioned the
merit  of the  studies  because there
exists the possibility  that some of the
symptoms observed1 may have been In-
duced 'by the subject's knowledge of
the prevailing  levels. Nevertheless, it
would not be wise to totally disregard
the studies on  the basis- of this possi-
bility.
  An added uncertainty which must be
considered is the variation In air qual-
ity concentrations due to prevailing
meteorologic conditions. Since EPA's
proposed standard   will be  attained
when  the expected number of hours
per calendar year with concentrations
above the standard level is equal to or
less than one, there is concern for the
magnitude of this one allowable excur-
 sion. The probabilities for several al-
 ternative standard levels that this ex-
 cursion will exceed the demonstrated
 effect level are shown below.

 PROBABILITY THAT THE ALLOWABLE STANDARD
  EXCEEDANCE WILL BE AS  OR  ABOVE THE
  DEMONSTRATED EFFECT LEVEL OF 0.15 F/M
  FOR ALTERNATIVE STANDARD LEVELS
    Standard level (p/m>
                            Probability
 0.08.
 0.10.
 0.12.
 0.14.,
        
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                                                PROPOSED RULES
                                                                     26967
report has been submitted to the EPA
Science Advisory Board  for  review.
However,  the review is not yet com-
plete nor has the report received ade-
quate review by others in the scientific'
community. Consequently,  the  prob-
                                       ability  estimates presented  therein
                                       and summarized below should be con-
                                       sidered preliminary.
               Probability that effect threshold wtB be exceeded S times or more in 5 years for alternate standard levels'
  Hourly average standard  . CD Aggravation of asthma,   (2) Reduced resistance to  (3) Reduction  (4) Chest discomfort and  Probability of exceeding 1 or
 level (1 expected exceedance   emphysema, and chronic   bacterial Infection (animal  In pulmonary Irritation of the respiratory more of the thresholds for
       per year)       •       bronchitis              studies)           function          tract          the Individual categories
OOflppm .„ u, 	
0.08 ppm 	 	 	
0.10 ppm._._« .. 	



0.02
0.06
0.16
0.28-0 29
0.40

0.08 - ~ 0.11
0.1S 0.19-0.20
0.21 0.27
0 26 0.3S
&29 0.44
0.03
0.06
015
0.27
0.39
0.21
0.36
0.52
0.67
0.78-0.80
•Pmhnhllitv vnliin nnrmed an ranre to reflect runffff of anumDttom nmr^tne dtatrihutlim of pea* ozone vaitu*.
  In the above  table, the right-hand
column estimates the probability that
the threshold concentration for one or
more of the four health effect catego-
ries  will  be exceeded five  or more
times in five years. The term "thresh-
old" as used in this context applies to
people in  a narrowly defined range of
sensitivity, namely, persons more sen-
sitive than 99 percent of the sensitive
population  but  less sensitive than 1
percent of that  group. For a standard
level of 0.10 ppm. the probability that
persons within this range of sensitivity
win experience an effect is about 0.5.
  These figures illustrate  several  im-
portant  points: (1)  all  alternative
standard  levels  reflect some risk.  (2)
there is no sharp break in the prob-
ability estimates that  would  suggest
selecting   one  alternative  standard
level over another, and (3) the choice
of a standard between zero and a level
at which  health effects are virtually
certain (0.15 ppm) is necessarily sub-
jective.
  The Administrator has thoroughly
considered  the  demonstrated effects
levels, our new understanding of  the
study that served as the primary basis
for the 0.08 standard, and the uncer-
tainties  introduced  by  the various
studies discussed in the criteria docu-
ment. Based upon an these data, it has-
been determined that a standard of
0.08 ppm  does not appear necessary to
protect the public health. However, at
this time it appears that a  standard
above 0.10 ppm would- not adequately
protect public health.  It is therefore-
proposed  that  the primary  standard1
for ozone be revised1 to- ft 10 ppm. Com-
ments are solicited on whether a  less
stringent   standard could adequately
protect public health.
    OTHER ASPECTS OPTHK STANDARD
  Chemical Species of the Standard—
EPA is proposing  to redesfgnate  the
photochemical oxidant standard* as an
ozone standard. Evidence  in the re-
vised criteria document indicates that:
  1. The majority of  data, presented in the
revised criteria doaimmit Is based on ozone
exposure. Nearly an of the clinical and toxl-
cological studies are based  on effects  of
  3. Some more recent epldemiological stud-
ies  associate advene effects- more closely
with ozone than with total oxidants.
  3. Effects observed in clinical studies with
ozone alone are similar to those effects ob-
served  In  epidemiologial  studies  where
ozone occurs,  along the complex  mix  of
urban pollutants. These findings from the
health data further suggest that health ef-
fects- observed during periods of  elevated
photochemical oxidants concentrations are
reasonably attributable primarily to ozone
In the ambient air.
  The-existing standard for photoche-
mical  oxidant ostensibly  was estab-
lished for the entire class of this com-
plex' mix of compounds. Unfortunate-
ly,  there are no satifactory methods
for accurately  and reliably measuring
this collective class of pollutants. The
reference method used to estimate am-
bient oxidant levels and to determine
compliance  with  trig  standard has
always measured only a single compo-
nent of the oxidant mix—ozone. Thus.
the chemical designation of the stand-
ard and the chemical composition of
the pollutant  measured to determine
compliance have not been  stated con-
sistently.  Ambient  ozone  concentra-
tions can range from approximately 65
percent to nearly  100 percent of the
total photochemical oxidant  concen-
tration; consequently, ozone can be  a
poor indicator of  the  quantity and
composition  of the non-ozone  oxidant
In the ambient air. Also of concern  is
the fact that aside from PAN. which  is
an important constituent of the photo-
chemical oxidant mix. the non-ozone
oxidants  remain essentially unidenti-
fied, cannot be measured, and  have
not been uniquely  associated with ad-
verse effects,
  The  inconsistencies   cited'   above
argue for ch»»>g<"g the  designation
from a  total  photochemical  oxidant
standard' to, an ozone standard.
  Promulgation  of a  Primary Stand-
ard for PAS—EPA does not propose to
establish a separate standard for PAN
                                       at this time. Although PAN is ah eye.
                                       irritant, the health data upon which
                                       to base a separate PAN standard are
                                       inadequate and routine PAN measure-
                                       ment methods are not available. Most
                                       of the studies which have documented
                                       the effects of PAN have used ozone or
                                       total oxidants as a surrogate for the
                                       material causing the adverse effect.
                                         Ozone is not a reliable indicator of
                                       PAN. Recorded  data  shows  ozone/
                                       PAN ratios ranging from 3:1 to 150:1.
                                       This variation in the ratio of ozone to
                                       PAN makes it extremely  difficult to-
                                       correlate the eye  irritation effects of
                                       PAN with specific ozone values.  How-
                                       ever, it has been shown that at ozone
                                       levels of about 0.1 ppm. PAN concen-
                                       trations win be at a level below those
                                       associated with perceptible eye irrita-
                                       tion effects. This is true even for low
                                       ozone/PAN ratios.
                                         Despite the lack of a separate PAN
                                       standard,  those  measures  taken to
                                       reduce oxidant/ozone precursor emis-
                                       sions will also reduce PAN levels. In
                                       fact, smog  chamber studies indicate
                                       that, control of oxidant precursor emis-
                                       sions have  a greater impact-on PAN
                                       levels than on ozone/oxidant levels.
                                         Farm of the Standard—The current
                                       standard  specifies  that   the  hourly
                                       average ozone concentration must not
                                       exceed 160  /ig/m* (approximately 0.08
                                       ppm) more than once per year. As dis-
                                       cussed in a report placed in the docket
                                       and available from EPA at the address'
                                       given earlier, this deterministic (once-
                                       per-year) approach has several limita-
                                       tions, one of which is the fact that it
                                       does not adequately take into account
                                       the random nature of meteorological
                                       variations.  The  original  purpose of
                                       permitting a single exceedance was to
                                      . allow, for unique meteorological condi-
                                       tions that were unrepresentative of air
                                       quality  problems in a given area. Un-
                                       fortunately, the current standard does
                                       not achieve this objective because it
                                       specifies In effect that there be zero
                                       probability  that  the  second-highest
                                       concentration  measured  in a  year
                               FEDERAL REGISTER; VOL 43, NO. 121—THURSDAY. JUNE 22, 1978

-------
26968
          PROPOSED RULES
exceed  the standard  level.  However,
when'a single exceedance of the stand-
ard  is  permitted, there  is a definite
possibility that a second or third ex-
ceedance will also occur. If this prob-
ability  is to be zero, there cannot be
even a single exceedance of the stand-
ard. This limitation means that com-
pliance with the standard, and conse-
quently pollutant emission control re-
quirements,  would be  determined qn
the  basis of exceedingly rare adverse
weather conditions.
  Another fundamental problem wijh
the  current standard is that it focuses
on  a  single  measured  value,  the
second-highest observation. This value
is subject to instrument error, is not a
stable statistic, and also will vary in
any given area over a  period of time.
For a given year, the true second-high-
est  value in an  area may not  be. ob-
served because of gaps in the monitor-
ing  record. Use of such a random sta-
tistic  to- determine  compliance  and
levels of control can  lead  to  values
that are unrepresentative of the true
air quality problems in an area.
  Because of these and  other  limita-
tions in the current form of the stand-
ard, EPA proposes that the ozone air
quality standard be stated in a statisti-
cal' form. This would mean that the al-
lowable number of exceedances of the
standard would be expressed  as an
average or expected number per year.
The standard would be attained when
the expected number of hour per cal-
endar year with concentrations above
0.10 ppm is less than or equal to one.
The average or  expected value would
be calculated from data obtained over
several years, as .explained below.
  Definition of When the Standard is
Attained—EPA proposes  to add Ap-
pendix H to 40 CFR Part 50 to explain
how to determine when the standard
is or is not being attained. The proce-
dure proposed in Appendix H requires
that States  compute  a  three-year
moving average  of  -the  number of
hours above the standard and adjust
that average  for missing* data. This
would,   mean   that   the  allowable
number of exceedances of the stand-
ard, i.e.. the times when the standard
level is  allowed to be exceeded, would
be expressed as an expected number of
hours,  during the three-year  period.
' The central feature of this approach is
a description  of how  missing  hourly
values  are handled.  The calculations
required would add the number of ex-
ceedances of the standard expected to
be present in the hourly values miss-
ing during any calendar year  to  the
actual  number of exceedances  meas-
ured during that year. The three-year
average of the expected number of ex-
ceedances so computed would have to
be equal to or less than one in order to
attain the ozone air quality standard.
   There is strong similarity between
determining attainment of the present
 oxidant standard and determining at-
 tainment of the proposed ozone stand-
 ard. In both cases, the number of ex-
 ceedances of the level of the standard
 is used. The current approach requires
 that the level of the standard never be
 exceeded more than once in any year
 while the proposed form of the stand-
 ard would permit two or more excee-
 dances in any year provided that the
 average number of exceedances during
 the most recent three-year period does
 not exceed I. For example,  if three
 successive years of ozone monitoring
 data showed annual exceedances of 2,
 1, and  0, the current standard would
 not be attained  since the first year re-
 corded more than  one  exceedance.
 Under  the  proposed  approach,  the
 same exceedance  pattern would lead
 to a decision of attainment since the
 average number  of- exceedances for
 the three years was not above one. De-
 tails  of  the  calculations  discussed
 above are given in Appendix H.
   A period of three successive years
 was chosen as the basis for determin-
 ing attainment  for two reasons. First.
 increasing tha  number of  years in-
 creases the stability, of the resulting
 average  number   of   exceedances.
 Stated differently, as more years are.
 used, the greater  the chance of mini-
 mizing the effects of. an extreme year
 caused by unusual weather conditions.
 The second  factor is that extending
 the number of successive  years too far
 Increases the risk of averaging data
 during a period  in which a real shift in
 emissions and air quality has occurred.
•This would penalize  areas  showing
 recent   improvement  and  similarly
 reward areas which  are  experiencing
" deteriorating ozone air quality. Three
 years is thought by EPA to represent
 a proper balance between these two
 considerations.
   Another modification that was con-
 sidered  during 'this  review  was to
 change the  form of the standard to
 permit one calendar  day in which the
 hourly standard  could be  exceeded.
 This form of the standard has several
 advantages, including: (1) the  require-
 ments for less manipulation and inter-
 pretation of data in calculating attain-
 ment  or non-attainment.  (2)  reduced
 time and resources on the part of state
 and local agencies to validate low con-
 centration  values occurring  in  the
 evening and  morning  hours,  and (3)
 greater stability  in  design statistics
 needed  for control strategy develop-
 ment'.  However,  based on potential
 conflicts with other air quality  man-
 agement programs such as prevention
 of significant deterioration, EPA does
 not propose to make such a change in
 the form of the ozone standard at this
 time.
   EPA believes the statistical  form of
 the standard coupled with the proce-
 dures explained in  Appendix H will
 ameliorate the problems  experienced
with the present form of the standard.
Comments are invited on the form of-
the standard and the method in*-Ap-
pendix H for determining when the
standard is or is not being attained.
  Averaging Time of the Standard—
EPA does not propose a change in the
current one-hour  averaging time of
the  standard.  Most  clinical  studies
clearly show impairment of lung func-
tion in moderately exercising healthy
subjects  exposed  to  ozone  for  two
hours. Since the impact of ozone is re-
lated to the total dose delivered to the
respiratory tract and since more in-
tense exercise would shorten the time
required to deliver an equivalent dose,
exposure  durations of less  than two
hours are of concern for protection of
individuals engaged  in  intense  exer-
cise. A recent clinical  study  published
last year by DeLucia and Adams con-
firms this thesis  at  its shows lung
function  changes  in  exercising sub-
jects after a one-hour exposure to rela-
tively low ozone levels.

 WELFARE EFFECTS AND THE SECONDARY
             STANDARD

  The Clean Air Act mandates the set-
ting of  a  national secondary ambient
air quality standard  to protect the
public welfare from any known or an-
ticipated  adverse  effects  associated
with the  presence of an  air pollutant
in the ambient  air. Ozone and other
photochemical  oxidants  constitute  a
form of air pollution that affects vege-
tation and materials. The  resultant
economic  loss has been estimated to be
in the range of several hundred mil-
lion dollars per year nationwide. Non-
quantifiable losses to the natural envi-
ronment  occur as welL A report dis-
cussing these issues has been placed in
the docket and is available from EPA
at the address  given earlier. The fol-
lowing  material  summarizes  that
report.  Exposure  of  vegetation to
harmful levels of ozone may result in
leaf  injury,  decreased  growth  and
yield, or  reproductive effects. Visible
leaf injury is the most readily detect-
able symptom- of ozone exposure and
for this  reason has  commonly been
used  in attempts to quantify damage
to  economic  crops.  Decreases  in
growth and yield can occur without
such visible symptoms; however, since
leaf injury is the most readily detect-
able and frequently reported symptom
of ozone  damage,  this effect provides
the best available data base for evalu-
ating   alternative  standard  levels.
While it  is not currently possible to
make  definite  correlations of  foliar
Injury with reductions in yield, several
investigators  have   suggested   that
foliar injury rates in^the range of 5 to
10  percent could  produce  detectable
reductions in growth or yield, depend-
ing on  the timing .of  the  injury and
other environmental  factors.  Ozone
exposures which  may be  reasonably
                               FEDERAL REGISTER, VOL 43, NO. Ill—THURSDAY, JUNE 22. 1978

-------
                                                PROPOSED RULES
                                                                    26969
expected  to  produce  injury ratings
within this range in commercially im-
portant crops or indigenous  flora are
undesirable; therefore, the basis of the
secondary National Ambient Air Qual-
ity Standard  for ozone will be to pro-
tect against such exposures.
  The .effects of ozone~ on vegetation
are not linearly dependent on the dose
(product of concentration and  expo-
sure  duration) sustained by the plant.
A given dose  applied over a  short
penod of time is more damaging than
if it were applied over  a longer period.
A mathematical model has been  used
to summarize for several crops the ex-
perimental results which depict  the
variation in foliar response with short-
term (0.5-hour to 8-hour) ozone expo-
sures. Based on  these results, no com-
mercially  important crop is  predicted
to receive more than 3  percent leaf
injury as  a result of short-term peak
ozone  exposures  at  sites where  an
hourly  average  concentration above
0.08  ppm is  expected t« occur  only'
once per year. Such a level of air qual-
ity should thus protect agricultural
crops  from   detectable  effects   on
growth and  yield due to short-term
peak  ozone exposures, even  after  al-
lowing  for  possible   interaction  be-
tween  ozone  and other air pollutants.
In addition, studies which have exam-
ined  the effects of long-term, intermit- •
tent  ozone exposures  on growth and
yield of vegetation indicate that no de-
tectable effects are predicted to occur
as a result of the long-term pattern of
ozone  exposures anticipated  when  an
hourly average  concentration of 0.08
ppm is expected to be exceeded only
once per year.
  It should be noted  that the above
predictions were based on air quality
relationships (e.g.. the ratio  of the 1-
hour-average  peak  concentration  to
the   corresponding   8-hour-average
value) which  were judged to  be repre-
sentative for urbanized areas  where an
hourly  average concentration above
0.08  ppm is  expected to occur  only
once  per year.  Equivalent  relation-
ships for rural  areas  have  not been
quantified, yet there is  reason to be-
lieve that higher  8-hour-average con-
centrations may occur at a rural site
than at an urban site when  both are
attaining  the  same  hourly  average
standard. EPA has attempted to factor
this uncertainty into its analysis of al-
ternative  hourly  average   standard
levels, but is soliciting  comments as to
whether the standard should  be set
for an averaging  time  of  8 hours
rather than 1 hour in order  to insure
the protection of vegetation in rural."
areas.
  Material damage due to ozone can be
described  as  an acceleration of aging
processes,' e.g..  rubber cracking,  dye
fading, and paint  weathering. In con-
trast to the effects of ozone on vegeta-
tion, these effects appear to be gov-
erned by the ozone dose sustained by
the material. As  a result,  the  annual
average concentration will determine
the rate at  which  material  damage
occurs, and any nonzero ozone concen-
tration (including natural background
levels) will contribute to the deteriora-
tion of sensitive materials if the expo-
sure  is  sustained long  enough.  In
remote  areas selected to  be  as free
from man-made influences as possible,
annual  average ozone concentrations
are comparable  with those seen in
urgan areas,  due to strong nighttime
scavenging of ozone in urban areas by
man-made pollutants. For the above
reasons, no effect-based rationale can
be offered to decide  the  level of the
secondary standard needed to  protect
materials. As a result, EPA proposes to
evaluate the level of the secondary
standard principally  on  the basis of
the air  quality  required  to   protect
vegetation from growth and yield  ef-
fects,  since- there is no level at which
some  material'damage will not occur
given sufficient times-
  Based  on  the   preceding consider-
ations, EPA  proposes to  set the sec-
ondary  ozone  air quality standard
level at an hourly average, concentra-
tion of  0.08  ppm expected to be ex-
ceeded only once per year.

       ECONOMIC, ENERGY, AND
      ENVIRONMENTAL IMPACTS  •

  As has been noted previously, the
Clean  Air Act  specifically requires
that National  Ambient  Air  Quality
Standards be' based on scientific crite-
ria relating to the level that should be
attained to adequately protect public
health  and   welfare.  EPA interprets
the Act  as excluding any consideration
of the cost of achieving such a stand-
ard in determining the level  of the
standard. However. In compliance with
the requirements of Executive Orders
11821 and 11949 and OMB Circular A-
107 and with the provisions of the re-
cently issued Executive Order 12044
for rulemaklng proceedings which are
currently pending, EPA has prepared
an analysis of economic impacts asso-
ciated with efforts to attam this pro-
posed standard.
  Ozone air  pollution is  a pervasive
problem  throughout  the  country.
Most  urban  and many  rural areas
exceed the existing standard. Even if a
less stringent standard (as proposed) is
promulgated, most of the major urban
areas  are not expected to attain the
standard in the near-term. Control of
the organic precursor materials which
generate photochemical oxidants is a
major  effort  in" this country and a
multi-billion  dollar program. The ex-
isting control program includes meas-
ures to reduce organic emissions from:
automobile and truck exhausts, pro-
duction  of  chemical  and  petroleum
products, the  dry-cleaning industry*
most painting operations including the
automotive industry, and other indus-
trial operations.
  Because the attainment problem in
most urban areas is so severe, the pro-
posed relaxation of the standard is not
expected to change the level of control
requirements in the near-term. How-
ever, the move  to a 0.10 ppm standard
would  eliminate  the need  for major
control programs  in many rural and
wilderness   areas  which  currently
exceed the standard.
  With the proposed relaxation of the
standard, the  longer-range  outlook
does indicate that many urban areas
will  achieve  the  standard  by  1987.
However, even with aggressive control
programs, it will  be very difficult for
some  urban areas to achieve the pro-
posed  standard within  the next  10
years.
  In addition,  a  document has been
prepared assessing the  impacts  that
efforts to attain  the proposed stand-
ard may have on  the  nation's energy
requirements. Control  of oxidant pre-
cursors will often  be accomplished by
recovery of  organic  materials  that
would  otherwise be emitted" to the  at-
mosphere,  or by more efficient com-
bustion.  Because of such energy sav-
ings, this document concludes that ox-
idant precursor control measures may
well lessen the  nation's  energy  re-
quirements.
  Furthermore,   environmental   im-
pacts associated with  control of oxi-
dant precursors have  been examined
in a  document  available  in  docket
number OAQPS 78-8. This study indi-
cates   that modifying  the  current
standard  as  proposed  should  have
minimal environmental impacts.
  Copies of the above-mentioned anal-
yses of the economic, energy, and envi-
ronmental impacts involved in the pro-
posed ~ ozone standard  are  available
from EPA at the address given earlier.

  REVISIONS TO PART 50 REGULATIONS  '

  In addition to the revised standard.
this action necessitates two other revi-
sions to Pan 50 as follows:

  1. In Appendix D. as well as in the Cable of
sections for  Part 50. the  title is revised to
read as follows Appendix D—Measurement
Principle and Calibration  Procedure for  the
Measurement of Ozone in the Atmosphere.
The substitution  of "ozone" for "photoche-
mical oxidants- corrected for Interferences
due to nitrogen oxides and sulfur dioxide" is
a result of the  proposed  change in  the
chemical designation of the standard.
  2. Appendix H.  "Interpretation of the Na-
tional Ambient  Air Quality. Standard  for
Ozone". is added because additional guid-
ance is necessary to understand the statisti-
cal nature of the revised standard.

  REVISIONS TO PART 51 REGULATIONS

  Elsewhere in  this issue of the FEDER-
AL REGISTER three revisions to Part 51
are proposed concurrently with the re-
vision  to the  photochemical oxidant
standard. They are as follows:
                              FEDERAL REGISTER, VOL 43, NO. 121—THURSDAY, JUNE 27, 1978'

-------
26970
         PROPOSED RULES
  1. The  term "photochemical oxidants"
will be changed to "ozone" throughout Part
51
  2. Section 51.14. "Control strategy: Carbon
monoxide, hydrocarbons, photochemical ox-
idants. and nitrogen dioxide". Is being re-
vised to allow the states to use any of four
analytical techniques in the place of Appen-
dix J to calculate the percent hydrocarbon
reduction  needed to attain the ozone stand-
ard.
  3. Appendix J Is being deleted from Part
51.
  With  regard to SIP development under
Part 51. the proposed ozone standard should
have  little impact on the attainment status
designation of most areas. However, where -
sufficient  data is available  to support a
change  in designation, either the  State or
EPA  may Initiate such a change under the
terms of section 107 of the  Clean Air Act
after the standard is promulgated. The pro-
posed standard  may  Impact" the control
strategies needed in some areas. These Im-
pacts will  need to be analyzed on a case-by-
case basis and EPA will provide guidance on
this matter when the standard is promulgat-
ed. The  standard will  not substantially
affect New Source Review requirements.

     FEDERAL REFERENCE METHOD •

  The measurement principle and cali-
bration procedure applicable to refer-
ence methods for measuring ambient
ozone  concentrations  to  determine
compliance with the standard  are not
affected by the proposed amendments.
Elsewhere in this issue of the FEDERAL
REGISTER, however,  EPA  is proposing
to replace (supersede) the current cali-
bration procedure with a new. superior
calibration procedure  based on ultra-
violet photometry. The measurement
principle and the current  calibration
procedure are set forth in Appendix D
of 40. CFR Part 50 (as amended in the
February 18. 1975 issue of the FEDERAL
REGISTER.  40  FR  7042).  Reference
methods—as well as equivalent meth-
ods—for monitoring, ozone are desig-
nated in accordance with  40 CFR  Part
53 (40  FR 7044). A list of all methods
designated by EPA as  reference  or
equivalent  methods  for  measuring
ozone is available  from  any EPA re-
gional  office, or from EPA.  Depart-
ment E  (MD-76).  Research Triangle
Park, NC 27711.

        PUBLIC PARTICIPATION

  EPA has  solicited public comment
and  critique, on draft  revisions to the
criteria document as well  as comments
on several  staff position  papers de-
scribing  possible modifications to the
standard. Comments on the two draft
revisions  of  the  criteria document
have been considered in the final doc-
ument published simultaneously  with
the  issuance of this proposal. An ex-
planation of how EPA addressed  each
of these comments will be provided as
a part of the docket number  OAQPS
78-8 prior  to  promulgation  of  this
standard. On December 30. 1977.  EPA
announced  in  the  FEDERAL REGISTER
(42 FR 65264) a public meeting to dis-
cuss issues related to possible revisions
of the  national  ambient air quality
standard for photochemical oxidants.
In that  notice,  EPA announced  the
availability of staff papers describing
preliminary recommendations:  (1) re-
designating the standard from oxidant
to ozone; (2)  proposing not to set  a
separate standard at this time for per-
oxyacetylnitrate (PAN); (3) redefining
the  standard  in  a statistical,  rather
than deterministic, form; (4) retaining
the  one-hour  averaging time for  the
standard; and (5)  establishing  the
standard level somewhere in the range
between 0.08 ppm and 0.15 ppm. The
public meeting was held'January 30.
1978; a transcript of the  meeting  is
available  through-  docket ' number
OAQPS 78-8. During the meeting  and
afterwards,  comments  were received
which addressed  the aforementioned
issues as well as other topics related to
the  standard  or  to  control measures
required to attain the  standard. The
greatest area of controversy was with
the  interpretation of health data. In-
dustrial groups criticized much of the
available  data as incomplete,  unreli-
able, or not applicable to the determi-
nation  of health effects threshold.
Most of these groups maintained that
there exists little evidence for health
effects below  0.25 ppm. As discussed
elsewhere in this proposed regulation,
EPA does not agree with this judg-
ment of a demonstrated effect level.
Comments from other groups such as
the American Lung Association argued
that hyperreactive  asthmatics  may
suffer health  effects below 0.15 ppm
and  suggested that there may not be a
no-effect threshold for ozone.
  The use of  the "risk" analysis ap-
proach to aid in selecting a standard
was   generally  supported.  However,
there were several  criticisms jot  the
specific methodology selected by EPA.
The  American   Petroleum  Institute
(API)  doubted  that the  population
considered at risk could be adequately
characterized. The health department
of the city of Houston. Texas did not
feel  the  probability encoding tech-
nique  was  valid for  extending  the
range  of knowledge beyond  experi-
mental data. The API  also called on
EPA to seek peer review of the entire
risk assessment methodology. We have
accepted the API's suggestion for  fur-
ther review  of  the methodology, as
mentioned earlier, and have submitted
the  material to the EPA Science Advi-
sory Board for review. We have  also
been cooperating with the API by  pro-
viding them with information  on all
aspects of the development of the  risk
assessment  methodology. We  do  not
agree with the city of Houston on the
lack of the utility of the probability
encoding technique. The approach  is
probably the best technique for quan-
tifying an expert's knowledge of un-
certainty. Some measure of this uncer-
tainty is extremely useful as input for
establishing an adequately protective
standard.
  Changes in the form of the standard
and the chemical  designation of the
standard received little criticism as a
result  of  the  public review process.
The  recommendation not to promul-
gate  a PAN standard at the present
time was not challenged.
  A number  of comments were  re-
ceived  regarding implementation of
the air quality standard. Representa-
tives of industry and areas with high
ozone concentrations felt that the cur-
rent air quality standard could not be
attained. The  principal reasons cited
were high 'natural  background levels
of ozone and transport of ozone from
other locations. In addition, comments
were  made  that  the  hydrocarbon
abatement  strategies  required for im-
plementing a stringent standard were
unproven. ineffective, and  excessively
destructive of  social and economic ac-
tivity.  Since these factors are not re-
lated  to  health and  welfare criteria,
they are not germane to the establish-
ment of the standard, but are impor-
tant considerations in developing state
implementation plans. EPA will assure
that these comments are given proper
attention.
  Dated: June  9.1978.
              DOUGLAS M. COSTLE,
                     Administrator.

  EPA proposes to  amend  Part  50 of
Chapter I. Title 40, of the Code of Fed-
eral Regulations as follows:
  1. Section 50.9 is revised as follows:

§50.9  National  primary  and secondary
   ambient  air  quality  standards  for
   ozone.
  (a) The level, of the national primary
ambient air quality standard for ozone
measured by a reference method based
on Appendix D to this part and desig-
nated  in accordance  with  Part  53 of
this  chapter,   or  by an  equivalent
method designated in accordance with
Part 53 of this chapter, is 0.10 part per
million (196 jig/m3).  The standard is
attained when the expected number of
hours  per calendar year with concen-
trations above 0.10 part per million
(196 pg/m3) is equal to or less than
one, as determined by Apperfdix H.
  (b) The level of the national second-
ary ambient air quality standard for
ozone, measured as in § 50.9(a) is: 0.08
part  per  million  (157  jig/m3).  The
standard is attained when  the expect-
ed number of  hours per calendar year
with concentrations  above 0.08. part
per million (157 pg/m3) is  equal to or
less  than one. as  determined by Ap-
pendix H.
  2. In Appendix D, as well as in the
table of sections for Part 50, the title
is revised to read as follows' Appendix
D—Measurement Principle and Cali-
bration Procedure  for the Measure-
ment of Ozone in the Atmosphere.
                               FEDERAL REGISTER, VOL 43, NO. 121—THURSDAY, JUNE 22. 1978

-------
                                                     PROPOSED RULES
                                                                           26971.
  3. Appendix H is added as follows:

   APPENDIX H—INTERPRETATION OF THE
 NATIONAL AMBIENT AIR QUALITY STANDARD
               FOR OZONE
  1. General—This Appendix explains how
to determine  when the expected number of
hours per calendar year with concentrations
above 0.10 part per million  (196 pg/m*) is
equal to or less than one. An expanded dis-
cussion of these procedures  and associated
examples  are contained in the "Guideline
for Interpretation of the Ozone Air Quality
Standard." For purposes of clanty in the
following discussion,  it Is convenient to use
the  term  "exceedance"  to  describe an
hourly ozone measurement that is-greater
than  the level of the standard. Therefore.
the  phrase "expected number  of  hourly
values with concentrations above the level
of the standard" may be simply stated  as
the "expected number of exceedances."
  The basic principle in making the above
determination is. relatively straight-forward.
Most of the complications that arise in de-
termining the expected number of annual
exceedances are consequences of accounting
for incomplete sampling. In  general, the
average number of exceedances per calendar
year must be less than or equal to 1. In  its
simplest  form, the number of exceedances
at a monitoring site would be recorded for
each calendar year and then averaged over
the past three calendar years to > determine
if this average is less than or equal to L
  2. Interpretation of expected number of ex-
ceedances.—The ozone standard states that
the  expected number of exceedances per
year must be less than  or equal to 1. The
statistical term, "expected number" is basi-
cally an  arithmetic average. The following
example explains what it would mean for an
area to  be in compliance with this type of
standard. Suppose a monitoring station rec-
ords an ozone value for every hour of the
year during the past 3 years. At the end of
each year, the number  of hours with con-
centrations above 0.10 part per million is de-
termined  and this is averaged with the  re-
sults of previous years. As long as this arith-
metic average remains "less than or equal to
1" the area is in compliance.   -
  3.  Estimating the number of exceedances
for a year.—ID general, a value is not availa-
ble for each hour of the year and it will be
necessary  to account  for  these missing
values when  estimating the number of ex-
ceedances for a- particular calendar year. It
should be noted that the purpose of these
computations is to' determine if the expect-
ed number of exceedances per year Is less
than or equal to 1. Thus, if a site has two or
more observed exceedances each year,-1he-
standard is not attained- and it is not neces-
sary to use the procedures of this section to
account for incomplete sampling.
  The-term "missing value" is used here in
the  general sense to describe all hours that
do-not  have an associated ozone measure-
ment. In some cases, a measurement might
actually have been missed but in other cases
no measurement may have  been scheduled
for that hour.
   Many State and local air pollution-control
agencies deliberately design their schedules
so that missing data associated with instru-
ment maintenance  occur  at  times  when
there is virtually no- chance of violating the
standard. Also, in some areas the seasonal
pattern  of the pollutant is so pronounced
that entire months may be omitted because
it is extremely unlikely  that the standard
would be exceeded. To avoid unfairly penal-
izing such areas, some allowance must be
made to allow for hours that were not actu-
ally measured but  would  certainly have
been below the standard. This introduces a
complication in that it becomes necessary to
define  under what   conditions  a  missing
hourly value may be assumed to have been
'less than the level of  the standard. The fol-
lowing criteria shall be used for ozone.
  A missing hour of ozone  data shall be as-
sumed to be less than the level of the stand-
ard If either of the following conditions is
met:
  (a) An  individual  missing hourly  value
shall be assumed to be less  than the level of
the standard if both the hour preceding and
the hour following this missing value have
values that do not exceed  79% of the level
of the standard^
  (b) In cases where consecutive  mining
hours occur,  a  missing  hour shall  be  as-
sumed to be less than the level of the stand-
ard If no hourly value for that same  hour of
any day In the particular month in question
has exceeded 75% of  the standard level
based upon the most recent, three calendar
years of available monitoring data.
  Let z denote the number of missing values
that is  assumed to be less than the stand-
ard. Then to establish that the ozone stand-
ard has been met. the  following formula
shall be used  to estimate the number of ex-
ceedances for the yean
                        (Hl-l)
                                       (1)
 Where:

   N=the number of hours in the year.
   n=the number of hourly ozone measure-
    ments.
   v=the number of hourly values a'Bove the
    level of the standard,
   z=the number of hours assumed to be less
    than the standard level, and
   e=the estimated number of'exceedances
    for the year.

   The  estimated number  of  exceedances
 shall-be rounded to one decimal place (frac-
 tional parts equal to O.OS round up).
   The above equation may be interpreted in-
 tuitively in the following manner. The esti-
 mated  number of  exceedances  is equal to
 the observed  number  of exceedances (v)
 plus an increment  that accounts for Incom-
 plete sampling. There  were (N-n) missing
 hourly values for  the. year but  a certain
 number of these, namely z. were assumed to
 be below  the  standard. Therefore, (N-n-z)
 missing values are considered to Include pos-
 sible exceedances. The fraction of measured
 values that are above the level of the stand-
 ard Is v/n. It is assumed that this same frac-
 tion applies to the (N-n-z) misamg values
 and that

1  -                . (HIM)
                   n

 of these values would  have also exceeded
 the level of the standard.
   4. Use of multiple yean  of data.—Ideally,
. the. expected number of - exceedances for a*
 site  would  be  computed  by knowing the
 probability that the site would record 0,1.2.3
 .  . exceedances in a year. Then each possi-
 ble outcome could  be weighted according to
 its likelihood of occurrence and the appro-
 priate expected value, or average, could be
computed. In practice, this type of situation
will not exist because ambient data will only
be available for a limited number of years.
  Consequently, the expected number of ex-
ceedances per year at a site shall be comput-
ed, by  averaging the estimated number of
exceedances for each year of available data
during the  past three  calendar years. In
other words, if the estimated number of ex-
ceedances- has been computed for the calen-
dar years of  1974. 1975. and 1976 then the
expected number of-exceedances is estimat-
ed by averaging those three numbers. If this
average is greater than 1. then the standard
has been exceeded at this site. It suffices to
carry one decimal place in this computation.
For example, the average of the three num-
bers 1, 1  and 2 is-1.3 which is grater than 1.
If data is-not available for each of the last
three years then this average shall be com-
puted  on the basis of available data from
the remaining years in that period.

  AUTHORITY: Sections 109 and 301 of the
Clean Air Act, as amended (42 U.S.C. 7409.
7601).
               REFERENCES

  DeLucia  A. J. and W. C. Adams. "Effects
of Oi inhalation during exercise on pulmon-
ary  function and blood biochemistry."  J.
AppL  Physiol.. Respirat. Environ. Exercise
Physiol.  43 (1): 75-81. 1977.
  Hammer. D. I., V. Hasselblad, B. Portnoy,
and P. F. Wehrle. "The Los Angeles student
nurse study." Arch. Environ. Health 28: 255-
260.1974.
  Hazucha, M. "Effects of ozone and sulfur
dioxide on pulmonary function in man." Ph.
D.  Thesis.  McGill University, Montreal,
Canada.  1973. 233 p.
  National Academy of Sciences—National
Academy of Engineering. "Air Quality and
Automobile Emission Control." Report for
the  93rd   Congress,  2d  Session,  Serial
Number 93-24. Prepared for the O.S. Senate
Committee on Public Works by the Coordi-
nating Committee on  Ah-  Quality  Studies,
September 1974.
  "Report  of the UJS. House of Representa-
tives Committee on Interstate and Foreign
Commerce on the Clean Air  Act  Amend-
ments of 1977." HJl.  Report 55-924,  95th
Congress, 2d Session, pp. 110-112.
  Schoettthn. C. E. and E. Landau. "Air pol-
lution and asthmatic attacks in the Los- An-
geles  area." Public Health Repts.  76  (6):
545-548. 1961.
  U.S. Environmental  Protection  Agency.
Air Quality Criteria for Ozone and  Other
 Photochemical    Oxidanta.   Publication
Number EPA-800/8-78-004. April 1978.   '

  CFR Doc. 78-17153 Piled 6-21-78; 8:45 am]
 [6560-01]

              [40 OTU>nrt 50]

 ' CFRL 914-1 Docket Number OAQPS 78-8]

      MEASUREMENT OF OZONE IN THE
               ATMOSPHERE
 Calibration  of  Ozone  Reference Methods

 AGENCY:  Environmental Protection
 Agency.

 ACTION: Proposed rulemaking.

• SUMMARY:  Appendix  D to 40 CFR
 Part SO  prescribes  a  measurement
                                  FEDERAL REGISTER, VOL 43, NO. 121—THURSDAY, JUNE 22, 1978

-------
 26972
         PROPOSED  RULES
 principle upon which reference meth-
 ods for the measurement of ozone' in
 the atmosphere must be  based. This
 appendix also specifies a procedure to
 be used for calibrating those ozone ref-
 erence methods. EPA  now  has  evi-
 dence that at least one other calibra-
 tion procedure  for ozone  reference
 methods is significantly more accurate
 and less variable than  the procedure
 currently specified in Appendix D. Ac-
 cordingly. EPA is proposing an amend-
the October 6, 1976, issue of FEDERAL
REGISTER  (41  FR 44049),  EPA pub-
lished a notice indicating that EPA
was aware of some inherent shortcom-
ings- with the NBKI procedure. In ad-
dition, the notice described evidence to
suggest that one or more alternative
calibration procedures may be superi-
or to the NBKI procedure. The notice
also indicated EPA's  intention to in-
vestigate  this  situation  by  testing,
evaluating, and-soliciting public com-
 ment to 40 CFR Part 50, Appendix D;  ment on  the alternative procedures.
 to replace (supersede) the current cali-
 bration procedure with the new, supe-
 rior  calibration procedure  which is
 based on ultraviolet photometry.
 DATES:   Comments  relative to  the
 proposed amendment must be received
 by August 18. 1978.

 ADDRESS: Send  comments  to:  Mr.
 Larry J.  Purdue. Department E (MD-
 76).  Environmental  Monitoring  and
 Support  Laboratory, U.S. Environmen-
 tal  Protection  Agency.  Research  Tri-
 angle Park, NC 27711.
 FOR  FURTHER   INFORMATION
 CONTACT:
   Mr. Larry J. Purdue. Telephone 919-
   541-3076 (FTS 629-3076).
 SUPPLEMENTARY INFORMATION:

        INCIDENTAL INFORMATION.

   This proposal is indirectly related to
 EPA's proposal to change the National
 Ambient  Air   Quality  Standard  for
. photochemical oxidants (ozone) speci-
 fied  in 40 CFR Part 50, which appears
 elsewhere in this issue of the FEDERAL
 REGISTER.

             BACKGROUND

   Part 50 of-Title 40. Chapter I of the
 Code of  Federal Regulations specifies
 the  National   Ambient  Air .Quality
 Standards for several air pollutants In-
 cluding ozone.  Appendixes to Part 50
 provide  information  concerning  the
 reference methods  which are used to
 measure  those pollutants. In particu-
 lar. Appendix D to Part 50 describes a
 measurement  principle  upon  which
 ozone  reference methods  must  be
 based and a calibration  procedure to
 be* used for calibrating such methods-.
 It is the latter—the calibration proce-
 dure prescribed for reference methods
 for  ozone—that would be changed by
 the   amendment    being    proposed
 herein.
   The calibration procedure presently
 contained in Appendix D is based on
 assay of ozone with  1% neutral buf-
 fered potassium iodfde~XNBKI) and* is
 known as the  "NBKI procedure".- In

   'The term "ozone"  Is used herein, to be
 consistent with another EPA action propos-
 ing to substitute "ozone" for "photochemi-
 cal oxidants corrected for interferences due
 to nitrogen oxides  and sulfur dioxide."
 which is currently used In Part 50.
and to propose to revise or replace the
NBKI procedure as appropriate based
on  the results of that investigation.
The amendment to 40  CFR Part 50,
Appendix D, being proposed today is a
direct result of that course of action.
Interested readers are referred to the
October  6, 1976, notice  for additional
background information.

              \ TESTS

  The October- 6, 1976, FEDERAL REGIS-
TER notice described 3 candidate proce-
dures which were likely to be supenor
to the NBKI procedure.  These were
identified as gas phase titration (OPT)
with  excess, nitric oxide, ultraviolet
photometry  (UV).  and  OPT  with
excess ozone, and were set forth as al-
ternates  A.  B. and C, respectively,  in
Attachment A to  that  notice. Subse-
quent to the "drafting of the notice, a
fourth promising procedure, based on
a  boric-  acid  potassium iodide  tech-
nique  and  identified as  the "BAKI
procedure", became available.
  The performance (precision and ac-
curacy) of each of these 4 procedures
jias been laboratory tested by EPA
and compared. The tests were conduct-
ed  with   volunteer technicians _from
both  within and outside EPA.  Each
volunteer was asked to  become famil-
iar with  and  then use  the  procedure
being  tested.  The results from each
volunteer were compared quantitative-
ly to a highly stable, controlled labora-
tory reference system. Results from all
of the volunteers were then used to es-
timate the  precision (variability) and
accuracy (bias) for each  method.

          TEST CONCLUSIONS

  Interpreting the results  of these
tests  is difficult because of a number
of .variables which were impossible  to
control. The primary uncertainty is. in-
estimating  the * representativeness  of
the test  data to  the actual  perform-
ance of the procedure in real applica-
tions.  Most of the procedures are de-
pendent  on the accuracy  and reliabil-
ity of the required equipment and ap-
paratus,  and  on the  capability  and
skill of the operator. These factors are
difficult   to  quantify.  Nevertheless,
EPA  believes  certain conclusions are
valid,  based on statistical and judge-
mental evaluation of the  test data  as
well   as'  information   from  other
sources.
  Briefly,, the UV calibration proce-
dure showed very low calibration vari-
ability in the tests. Its accuracy is be-
lieved to be excellent because 'it is a
direct measurement of ozone based on
the well-established ozone absorption
coefficient.  Also,  independent com-
parisons of the procedure among var-
ious researchers agree within a  few
percent. The other three procedures
showed considerably  greater variabil-
ity in the tests than the UV procedure,
probably reflecting their relative com-
plexity and large equipment  depen-
dence.  While the test showed  no sig-
nificant average bias for the BAKI
procedure,  the two  OPT procedures
were shown to have  an average  posi-
tive bias of 7 to 8% with respect to the
UV reference.
  Additional  information  concerning
the test results can be obtained from a
summary  report which  summarizes
the test results of all four procedures.
More specific  information concerning
the tests and. test results is given in
the individual  test reports  for  each
procedure. All of these test reports can
be obtained  upon request  from  De-
partment  E (MD-78), Environmental
Monitoring and Support Laboratory,
Environmental Protection Agency. Re-
search Triangle Park. N.C.. 27711 and
will be available in a docket [Number
OAQPS 78-8] for Inspection and copy-
ing at the United States Environmen-
tal Protection Agency, Public Informa-
tion Reference Unit, Room 2922 (EPA
library).  401  M Street.  Washington
D.C. 20460.

-   SUMMARY OF COMMENTS RECEIVED

  The October 6, 1976 FEDERAL REGIS-
TER notice specifically solicited public
comments  on the three alternative
calibration procedures set forth in the
notice, and on EPA's proposed course
of action.  Comments  were received
from  12  respondents, representing 5
air pollution control agencies and 5 in-
dustrial organizations. While many of
the respondents recognized inadequa-
cies  in the  present version  of  the
NBKI  procedure and  generally sup-
ported  EPA's  intended  course  of
action, several of the respondents ex-
pressed a desire to retain the present
procedure or to adopt  a  modified KI
procedure demonstrated  to  have im-
proved accuracy and precision. In gen-
eral, these respondents indicated the
need for an inexpensive,  easy  to per-
form- procedure 'compatible with exist-
ing equipment. Some respondents  of-
fered evidence of acceptable perform-
ance of the NBKI procedure in the re-
spondents' agency or laboratory.
  Several of  the respondents favored
adoption of the UV photo-metric pro-
cedure as the primary calibration pro-
cedure because it  appears  to  be the
least complex, the most direct, and the
least operator-dependent  of the alter-
native procedures under consideration.
                               FEDERAL REGISTER, VOL 43. NO. 121—THURSDAY, JUNE 22, 1978

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                                               PROPOSED RULES
                                                                   26973
The GPT procedures were  generally
judged to be the least desirable alter-
natives  because they are considered
too difficult to perform. There  was
some concern for the reliability of the
required standards  (NO  standard for
GPT, 0. absorption coefficient for UV)
and  the availability of  the required
equipment. The effect of water vapor
and other potential interferences on
the GPT and UV procedures was  also
questioned. A few of the respondents
felt  that certain statements  in  the
notice  regarding the performance of
the NBKI procedure and the consist-
ent agreement  between  the UV  and
GPT procedures were in  conflict with
the results of the various studies cited
in the notice.,
  Some comments  were  received  re-
garding the  use of ozone generators
and ozone analyzers as transfer stand-
ards and the  effect  of  atmospheric
pressure on the performance of these
devices. Several respondents  showed
concern that the additional documents
cited in the  notice  (e.g.  the Transfer
Standard Document and the Techni-
cal Assistance  Documents)  were not
available for public  review at the time
of publication of the FEDERAL REGISTER
notice.
  A more detailed summary of all of
the comments  received and  EPA's re-
sponse to them is available from De-
partment E at the address specified at
the beginning of this notice.

   SUPERSESSION OF NBKI PROCEDURE

  As noted in  the October 6.  1976.
notice.  EPA was aware  of shortcom-
ings with the prescribed  NBKI proce-
dure—substantial variability and an
apparently positive but unpredictable
bias.-The tests of the four alternate
calibration   procedures   confirmed
EPA's surmise  that at least one of the
procedures was sufficiently superior to
the NBKI procedure to consider su-
persession. However, although accura-
cy and precision are of primary Impor-
tance, many other  factors had to be
considered as well before supersession
by a  new  procedure  could be  pro-
posed—factors  such  as  complexity.
cost and availability  of equipment,
field  portability,  operator  training.
evaluation of benefits to be obtained.
and overall  impact to user agencies.
Another question was whether or not
to consider replacing the NBKZ proce-
dure by more than one new calibration
procedure to  provide  flexibility of
choice by users.
   EPA  has  carefully  considered all
these factors as well as all public com-
ments,  and  is  proposing what it be-
lieves  to be the optimum  course of
action.  The  proposed changes are as
follows:
   (1) Supersede the NBKI calibration
procedure with a procedure based on
UV photometry for the  calibration of
reference  methods for ozone.   (As
 noted In the  October 6. 1976, notice,
 no Standard  Reference  Material is
 availabe for ozone. Hence, ozone con-
 centrations established  via the  UV
 procedure would be tantamount to pri-
 mary  ozone standards,  and  the  UV
 procedure itself is thus often  referred
 to as a "UV standard" for ozone.).
   (2) Allow the independent.use of the
 BAKI procedure in lieu of the UV pro-
 cedure, for 18 months after promulga-.
 tion of the amendment, with  the  rec-'
 ommendation that  the BAKI tech-
 nique be related to a  UV standard
 whenever possible.
 - (3) Specifically allow the use of al-
 ternative procedures as transfer stand-
 ards  if  they meet  certain  transfer
 standard performance guidelines to be
 set forth by EPA. A transfer standard
 would  be   any  device or  procedure
 which can be referenced to a UV ozone
 standard and  then used at another lo-
 cation to reproduce ozone standards. A
 practical  transfer  standard  would
 offer  some  important  advantages-
 such as lower cost, ruggedness. easier
 operation, or  convenience—over direct
 use of the UV procedure.

   RATIONALE FOR PROPOSED CHANGES

   Of all the procedures tested, the UV
 procedure  clearly  has the best  per-
 formance—low variability, high accu-
 racy, and minimum operator involve-
 ment. From a scientific viewpoint, it is
 perhaps the most Ideal technique pres-
 ently available for assaying pure ozone
 concentrations  below 1 ppm.  While
 the procedure  is  not  without some
 practical disadvantages, these appear
 to be relatively few and  minor,  and
 EPA  believes  they are  adequately
 minimized as discussed below. There-
 fore, the UV  procedure appears to be
 the logical choice to replace the NBKI
 procedure.
   EPA is also convinced that the UV
 procedure is the only procedure which
 should be promulgated to replace the
 NBKI procedure—for several reasons:
 First, since no primary ozone concen-
 tration standards (e.g. Standard Refer-
 ence Materials) are available,  the cali-
 bration procedure is actually  a means
 for obtaining primary  ozone  stand-
 ards. In this important respect, singu-
 larity is necessary for uniformity and
 comparability, and to  avoid  conflicts
'or discrepancies which  could arise If
 more than one Independent standard
 were  allowed.  Second,  none of  the
 other procedures can match the preci-
 sion and accuracy of the UV proce-
 dure. And finally, flexibility to use al-
 ternate techniques is adequately—and
 possibly better—provided  by  allowing
 their use as  transfer standards. As a
 transfer standard, an alternative tech-
 nique would have to be tested for per-
 formance  and related to a UV ozone
 standard. Thus, accuracy would be de-
 termined by  the UV procedure, not
 the  alternative  technique, and each
user would have to determine and con-
trol the  variability of the technique
under his own individual conditions of
use.
  The  UV procedure  has not  been
widely used by air monitoring agencies
in the past, and many agencies are not
familiar with the procedure and may
not own a UV photometer meeting the
requirements of the procedure.  Also,
the availability of UV  photometers is
somewhat limited presently  (a situa-
tion which  should' improve  shortly
after promulgation of the procedure).
In view of this situation,  and in  re-
sponse to a number of the public com-
ments. EPA proposes  an  18-month
transition period to allow agencies to
acquire  the  necessary  equipment,
become familiar with  the  UV proce-
dure,  and phase it into their calibra-
tion and quality  control  programs.
During this 18-month period, use of
the BAKI procedure would be accept-
able until the UV procedure can be  im-
plemented.  The  BAKI procedure is
very  similar  to  the  currently pre-
scribed  NBKI  procedure,  and  any
agency equipped for and familiar with
the NBKI procedure should have no
trouble adapting to the BAKI proce-
dure.  Unfortunately, the BAKI proce-
dure shares some of the same  prob-
lems associated with the NBKI proce-
dure  (general  variability).  But  the
tests showed low bias, and the variabil-
ity  of the BAKI should be  easier to
control because the BAKI procedure is
much less sensitive to  such factors as
color   development  time,   unpinger
typeT'and water vapor effect.
  .In addition. EPA is proposing and
advocating the use of transfer stand-
ards for calibration of field-sited ozone
analyzers. Transfer standards would
have  to  be  related to primary ozone
standards obtained by the UV proce-
dure,  but would offer several  impor-
tant advantages such as the following:
  1. The UV  calibration photometer
could be permanently located in a lab-
oratory  and operated by  an experi-
enced, responsible person under labo-
ratory conditions to maximize the pre-
cision and accuracy of the procedure.
This would also spare the photometer
from  possible physical damage from
being moved about to field locations.
  2. Agencies would have flexibility to
select a transfer standard technique or
device of their choice, and still have
comparability to the UV ozone stand-
ard.
  3. Costs could be reduced by using a
single UV photometer to certify as
many transfer standards as needed by
the agency. Small agencies may even
avoid the purchase of a photometer if
they could gain access to one through
a cooperating larger agency, a State or
Regional EPA Office, an agency coop-
erative, or by  commercial certification
of transfer standards.
  4. Transfer  standards could- be de-
signed to better survive the demands
                              FEDERAL REGISTER, VOL 43, NO. 121—THURSDAY, JUNE 22, 197a

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 26974
         PROPOSED RULES
 of frequent transportation  and field
 use.
   5. Transfer standards could be used
 to  Intel-compare   UV  photometers
 among various agencies to assure accu-
 racy.
   6. Transfer standards  may also be
 more  convenient,  easier to operate.
 and less expensive.
   Finally.  EPA emphasizes  that the
 proposal to supersede the NBKI proce-
 dure arises more from the demonstrat-
 ed superiority  of  the UV  procedure
 than from the  degree of unreliability
 of the NBKI procedure itself. Thus su-
 persession is specifically  not intended
 to imply that ambient ozone measure-
 ments  obtained  with reference  (or
 equivalent) methods  calibrated with
 the NBKI procedure are categorically
 invalid or useless.

   EFFECT ON NATIONAL AMBIENT Am
 QUALITY STANDARD FOR PHOTOCHEMICAL
              OXIDANTS

   EPA believes that  supersession of
 the NBKI  calibration procedure with
 the U.V. procedure requires no revi-
 sions to the oxidant standard (or pro-
 posed new ozone standard) for the fol-
 lowing reasons; Because of the sub-
 stantial variability and unpredictable
 bias in the NBKI procedure the exact
 magnitude of  any bias which may
 exist cannot accurately be determined.
 Thus no precise quantitative factor is
 available for use as a basis for revision
 of the standard. (For the same reason.
 no factor  is available to '"correct" or
 "adjust" previously obtained data.)
   Comparative studies cited in the Oc-
 tober  6. 1978 notice suggest that the
 differences between the  NBKI proce-
 dure and the  GPT and UV procedures
 generally  do  not  exceed' 10 percent.
 This degree of bias is not sufficient to
 warrant revision of the standard and is
 adequately accounted  for within the
 margin of safety included in  the stand-
 ard at the time of promulgation  (36
 FR 8186. April 30.  1971). EPA will con-
 tinue to study health and other effects
 related  to  ozone  using this new cali-
 bration procedure. If any evidence  be-
 comes available to indicate- that revi-
 sion of the standard should  be consid-
 ered,  EPA will address  the issue at
 that time.

   EFFECT ON CURRENTLY DESIGNATED
  REFERENCE AND EQUIVALENT METHODS

   As noted In  the October 6; 1976.
 notice, replacement of the calibration
 procedure specified in  Appendix D of
 40 CFR Part 50 would not affect the
 design or  performance characteristics
 of existing  reference  methods  for
 ozone.  Thus  the  only effect of the
 change  would  be  on the calibration
-procedure described in the  operation
 manuals associated with the  analyzers.
 EPA proposes to provide a reasonable
 period of  time—probably  6 months
 after  final promulgation—for  manu-
facturers to revise their manuals, have
EPA approve the revised manual, and
to  distribute  revised  manuals  (or
manual supplements) to all analyzer
owners. Also, since the two equivalent
methods which have been  designated
to date prescribe the NBKI calibration
procedure. EPA sees  no reason why
they could not be treated in the same
way.  If all  manufacturers  respond
promptly, there would be  no impact
(other than  the change  in calibration
procedure Itself) to owners of desig-
nated ozone analyzers.

   NEW UV CALIBRATION PROCEDURE

  Unlike  the  currently  prescribed
NBKI procedure, the new UV calibra-
tion procedure  is quite  simple. After
generating  a stable,  dynamic  ozone
concentration with an  ozone  gener-
ator, the operator assaysJt  by passing
a portion of the gas flow through the
cell of the UV  photometer. The pho-~
tometer readings are  then used in a
formula to calculate the ozone concen-
tration, which,  as noted earlier, is  ef-
fectively a  primary ozone standard.
(Some photometers do  the calcula-
tions   automatically.)  The  primary
burden on the operator .is to insure  (1)
that the photometer is operating cor-
rectly, (2) that the apparatus is set up
properly and is clean and leak-free.
and (3) that the calculations are accu-
rate. While none of these are particu-
larly-difficult.  EPA  is •preparing  a
Technical Assistance Document which
will explain these  tasks and provide
other detailed information about the
procedure. A draft form of this docu-
ment will be available from the ad-
dress specif led. at the beginning of this
notice.
  The photometer is obviously of criti-
cal importance to  the procedure and
must  have  a precision  within  0.005
ppm  or 3%  of the  concentration.
whichever is greater. While a calibra-
tion  photometer can be  assembled
from laboratory components. EPA rec-
ommends the purchase of  a commer-
cial photometer which  is  either de-
signed- specifically for this calibration
procedure,  or which  can  be  readily
adapted to it. EPA  is  presently aware
of  2  such  commercial  photometers
(available from Dasibl Environmental
Corp.. Glendale. California, and Sci-
ence Applications. Inc.. La Jolla. Cali-
fornia) and expects  others will become
available in the future.
  UV photometers of the type used in
ambient ozone  analyzers are likely to
be-suitable as calibration photometers.
(Conversion of an ambient UV analyz-
er to  a calibration photometer  Is cov-
ered in the Technical Assistance Docu-
ment mentioned above.) However, it is
important to differentiate between the
use of a UV photometer as an ambient
analyzer and its use as a  calibration
photometer. This distinction  is predi-
cated more on operational differences
than on  any specific  physical differ-
ences. EPA proposes to require that a
photometer to be used for calibration
be dedicated  exclusively to such use,
be maintained under meticulous condi-
tions, and be used only with clean.
calibration  gases. UV analyzers  used
for ambient monitoring should always
be calibrated with an Independent cali-
bration   photometer  or  a  certified
transfer  standard.  A UV  analyzer
should not be considered to be "self-
calibrated" even though it contains a
UV photometer which meets the speci-
fications  of the UV calibration proce-
dure.

  NEW BAKI CALIBRATION PROCEDURE

  As noted earlier,  the BAKI proce-
dure is an improved form of the cur-
rently  prescribed  NBKI  calibration
procedure. Its independent use would
be allowed  only for  calibration  of
ozone analyzers (not  transfer stand-
ards) on  a temporary basis  during a
18-month transition period to permit
agencies to adopt the new. UV calibra-
tion  procedure.  However,  the BAKI
procedure has considerable variability
and is distinctly inferior to  the UV
procedure. Therefore, EPA would urge
agencies to adopt the UV procedure as
soon as practical. And, when possible,
the BAKI procedure should be related
to the UV procedure  to improve the
overall accuracy.
  Following the  18-month period, the
BAKI procedure would not be author-
ized for independent use, but could be
used as a transfer standard. As such, it
would have  to be related  to the UV
procedure, and its variability and accu-
racy would have to be monitored and
controlled. Thus agencies which find
the  BAKI  procedure advantageous
could continue to use this  procedure
as a transfer standard.

         TRANSFER STANDARDS

  As indicated'earlier, EPA intends to
specifically allow transfer  standards
for calibrating ozone analyzers, and
has noted  a number of  advantages
which might be realized by their use.
Transfer standards for ozone could in-
clude any of  the alternate techniques
(GPT. BAKI) as well as devices  such
as ozone analyzers and stable ozone
generators.  EPA  recommends  that
agencies  consider the use of  transfer
standards where advantageous.  But
transfer standards are not without pit-
falls and disadvantages of their  own.
EPA is preparing a fairly comprehen-
sive  guideline/Technical  Assistance
Document on transfer standards for
ozone. This document is available (in
draft  form),  and a copy may be  re-
quested  by   writing to the  address
given for comments. If the  use  of
transfer standards for ozone proves to
be successful and  widely accepted,
EPA intends to consider extending the
concept to SO,, NO,, and CO. Com-
                               FCDERAL REGISTER. VOL 43, NO.  121—THURSDAY, JUNE 22, 1978

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                                                   PROPOSED  RULES
                                                                         26975
ments on the use of transfer standards
and' on the transfer standard guideline
are welcome.

   USE OF NEW PROCEDURES PRIOR TO
    PROMULGATION OF AMENDMENT

  As indicated in this proposal, the UV
calibration procedure—and to a lesser
extent the  BAKI procedure—are  be-
lieved to be scientifically superior  to
the  currently prescribed NBKI cali-
bration procedure. And it- is very likely
that the UV procedure (and the'BAKI
procedure on. a temporary basis) will
be promulgated  to supersede  the
NBKI  procedure. Accordingly,  agen-
cies which  have  the  capability  and.
desire to commence using these  proce-
dures  immediately would not be dis-
couraged  from  doing  so.  Immediate
use of transfer standards could also ba
considered on the same basis.

         PUBLIC PARTICIPATION

  All documents and  information rele-
vant   to  this rulemaking   are  being
placed in Docket No.  OAQPS 78-8* the
docket for the  proposed amendments
to  the  standards for photochemical
oxidants. That docket will be available
for public inspection  during the hours-
8:00 to 4:30  at the Public Information.
Reference  Unit, Room  2922, 401  M
Street SW..  Washington. D.C.
  Comments on any aspect of  this pro- .
posed amendment are  solicited from
interested persons or  agencies. Com-
ments should   be  submitted to  Mr.
Larry J. Purdue at the address given
at the beginning of  this notice. Com-
ments should  be received  within  60
days of the  date of publication for due,
consideration prior to final promulgar
tion. Copies of  ail comments received
will be added to the docket.
   In addition interested persons-  may-
make comments- on the proposal orally
at the  public  hearing on  the ozone
standard' scheduled for July 18.1978:

   Dated; June ft 1OT&
                   DOUGLAS Cassia.
                      'Adottmatmtm.

   It Is proposed to amend Part 50 of
Title  40, Code of Federal Regulations-
as follows:
   L. Appendix D ia revised  to read as
follows::

APPBMDQC. P—MUMBHEHtHNg PttBCmB AHA.
  GujBR&nas PnocKDtns. FOB
  KENT Of Qy""f pt tint
  AUTHORITY: Section 189,  sn of file CTestt
Air Act as amended (42  USC 57409. 7601).
emit light, which Is detected by a photomul-
tlplier tube. The resulting photocnrrent is
amplified and Is either read directly or dis-
played on a recorder.
  2. An analyzer based on this principle win
be considered a reference method only if it
has been designated as a reference  method
In accordance with Part S3 of this  chapter
and calibrated as follows:

          CALIBRATION PROCEDURE"

  1. Principle The calibration procedure la
based  on  the' photometric  assay of ozone
(Ot>  concentrations  in a dynamic  flow-
system. The concentration of O, In an  ab-
sorption cell Is determined  from a measure-
ment of the amount  of 254  nm light  ab-
sorbed by the sample. This determination
requires knowledge of (1) the absorption co-
efficient (a) of O, at 254 nm. (2) the optical
path length (Z> through the sample. (3) the
transmittance  of the sample at a wave-
length of  254am. and (4)  the temperature
(T) and pressure (P) of the sample.  The
transmittance Is defined as the ratio I/I..
when I "Is the Intensity   of light which
passes through- the cell and is. sensed by the
detector when  the  cell  contains an  O,.
sample, and I. Is the Intensity of light which
passes through the cell and Is sensed by the
detector when the cell contains zero air. It is-
assumed that all conditions of the-system.
except for the  contents of the absorption
cell, are Identical during measurement of I
and I* The quantities, defined above are re-
lated by the. Beer-Lambert absorption law.
           TmmtniK*
                                      (1)
          UEASO

  1. Ambient air and ethylene are delivered
 simultaneously to a mixing zone  where the
 ozone in the air reacts with the ethylene to
 where:

    over the re-
 quired concentration  range.
    3.4 Output manifold. The output manifold
 sltould -be constructed of  glass. Teflon*, or
 other relatively  Inert material, and should
 be of sufficent diameter to insure a negligi-
 ble pressure drop at the photometer connec-
 tion and  other  output ports.  The  system
 must have a vent designed to insure atmos-
 pheric pressure In the manifold and to  pre-
 vent  ambient air from entering the mani-
 fold,
    3.5  Two-way valve. Manual or automatic
 valve, or other means to switch the photom-
 eter flow  between zero air and the Oi con-
 centration.
    3-.A Temperature indicator.  Accurate to*
  ±1'C.
    3.7  Barometer  or pressure indicator. Accu*
-rate to ±2 torr.
    4. Reagents:
    4J  Zero- air. The zero air must-be- free of
  contaminants which would cause a detect-
  able response front the O> analyzer,  and it
 should be. free of NO, C.H.. and other spe-
  cies which react with O». A procedure for
  generating suitable zero air Is given in Ref-
  erence 9.  As shown In figure 1. the aero air
  supplied  to the  photometer cell- for the I.
  reference measurement  moat be derived
  from the same source as  tbe zero  aiv used
-  for generation.ot tbe ozone concentration to
  be assayed  U measasementx  When, using-
  the photometer  to certify a. transfer stand- .
  ard having its own source  of ozone; see Ref-
  erence 8  for guidance on meeting this re-
  quirement.
                                 FEDERAL REGBKfr, VOL «, NO. 12T—THOBWAr, JUNE 2Z 197»

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26976
           PROPOSED  RULES
  5. Procedure.
  5.1  General operation.  The calibration
photometer must be dedicated exclusively
to use as a calibration standard.  It should
always be used with clean, filtered calibra-
tion gases, and never used for ambient air
sampling. Consideration should be given to
locating  the  calibration photometer in a
clean laboratory where it can be stationary,
protected from physical shock, operated by
a responsible analyse, and used as a common
standard for all field calibrations  via trans-
fer standards.    —
  5.2  Preparation. Proper  operation  of  the
photometer is of critical importance to  the
accuracy of "this procedure. The  following
steps will help to venfy proper operation.
The steps are not necessarily required pnor
to each use of the photometer. Upon Initial
operation of  the photometer, these steps
should be  earned out  frequently, with all
quantitative results  or  indications recorded
in a chronological record  either in tabular
form or plotted on a graphical chart. As the
performance  and stability  record of  the
photometer is established, the frequency of
these steps* may- be  reduced consistent with
the documented stability of the photometer.
  5.2.1 Instruction manual: Carry out all set
up and .adjustment procedures or  checks as
described in  the  operation or instruction
manual associated with the photometer.
  5.2.2 System check: Check the photometer
system  for   Integrity,  leaks,  cleanliness.
proper flowrates. etc. Service or replace fil-
ters and zero air scrubbers or other consum-
able materials, as necessary.
  5.2.3 Linearity  test: Test the photometer
for linearity by dilution. Generate and assay
an Oi concentration near the upper range
limit of the system (0.5 or  1.0 ppm). then ac-
curately dilute-that  concentration with zero
air and reassay it. Repeat at several differ-
ent  dilution ratios.  Compare  the assay of
the anginal concentration with the assay of
the diluted concentration  divided  by  the di-
lution ratio, as follows-
where:
  E=linearity error, percent
  A.=assay of the original concentration
  A,=assay of the diluted concentration
  R=dilution ratio = flow of original concen-
    tration divided by the total flow
  The linearity error-must  be less  than 5%.
Since the accuracy of the measured flow-
rates will affect the linearity error as meas-
ured  this way. the test Is not  necessarily
conclusive. Additional information on veri-
fying linearity is contained in Reference 9.
  5.2.4  Intel-comparison:  When  possible,
the photometer should be occasionally tn-
tercompared. either directly or via transfer
standards,  with  calibration  photometers
used-by other agencies or laboratories.
  5.2.5  Ozone losses:  Some portion of the
O> may be lost upon contact with the pho-
tometer cell  walls and has handling compo-
nents. The magnitude of this  loss must  be
determined and used to correct the calculat-
ed  Oi concentration. This loss  must not
exceed  5%.  Some guidelines  for  quantita-
tively determining this loss are discussed in
Reference 9.
  5.3  Assay of O, concentrations.
  5 3.1 Allow the  photometer  system to
warm up and stabilize.
  532 Adjust the  flowrate  through the
photometer absorpcion'cell. P., to a conve-
nient value so that the cell can be flushed In
a reasonably short penod of time (2 liter/
min is a-typical flow). The precision of the
measurements is Inversely  related to the
time  required for  flushing, since the pho-
tometer drift error increases with tune.
  5.3.3 Adjust the flowrate into the output
manifold  to  a value at least 1 liter/mm
greater than the total flowrate required by
the photometer and any other flow  demand
connected to the manifold.
  5.3.4 Adjust the flowrate of zero air. Fz.
to a value at least 1 liter/mln greater than
the flowrate required by the photometer.
  535 With zero  air flowing In the output
manifold,  actuate  the  two-way valve to
allow the photometer to sample first the
manifold zero air. then Ft. The two photom-
eter readings must be equal (1 = 1.).
  NOTE: In  some  commercially available
photometers, the operation of the  two-way
valve and various  other operations in sec-
tion 5 3 may be earned out automatically by
the photometer.
  5.3.6 Adjusfthe O> generator to  produce
an Oi concentration as needed.
  5.3.7 Actuate the two-way valve  to allow
the photometer to sample zero air until the"
absorption cell Is  thoroughly flushed and.
record the stable measured value of  I..
  5.3.8 Actuate the two-way valve  to allow
the photometer to sample the ozone concen-
tration until  the  absorption  cell  is thor-
oughly flushed and record the stable meas-
ured value of I. '
  5.3.9 Record the  temperature and pres-
sure of the sample  in the  photometer  ab-
sorption  cell. (See Reference  9 for guid-
ance.)
  5.3.10 Calculate  the  O»  concentration
from  equation 4. An average of several de-
terminations will provide better precision.
where:
  COj]0uT=O, concentration, ppm
  a=absorption  coefficient of  O, at  254
    nm=308 atm'1 cm'1 at 0"C and 760 torr
  2=optical path-length, cm
  T=sample temperature. K
  P=sample pressure, torr
  L=correction  factor for O,  losses from
    5.2.5= concentration and the cor-
responding analyzer response. If substantial
adjustment of the span control is necessary.
recheck the zero and span adjustments by
repeating steps 5.5.2 to 5.5.4.
  5.5.5 Generate several other O, concen-
tration standards (at least 5 others are rec-
ommended)  over the scale.range of the O>
analyzer by adjusting the O, source or by
Option 1. For each O, concentration stand-
ard,  record  the Oi concentration  and the
corresponding analyzer response.
  5.5.6 Plot  the  O>  analyzer  responses
versus the corresponding O> concentrations
and draw the O, analyzer's calibration curve
or calculate the appropriate response factor.
  5.5.7  Option 1. The various O, concentra-
tions required in steps 5.3.11 and 5'5.5 may
be obtained by dilution of the O, concentra-
tion generated in steps 5.3.6 and 5 5.3. With
this option,  accurate flow measurements are
required. The  dynamic calibration system
must be modified as shown in Figure 2  to
allow for dilution air to be metered in down-
stream of the O, generator. A-tmxing cham-
ber  between  the  Oi generator and the
output manifold is also required. The flow-
rate through the O, generator (F0) and the
dilution air  flowrate (F0) are measured with
a reliable flow or volume standard traceable
to NBS. Each O» concentration generated by
dilution is calculated from:
                       A-
where:
                                   FEDERAL REGISTER, VOL 43, NO. 121—THURSDAY, JUNE 22,  1978

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                                                    PROPOSED  RULES                                             26977

  [O,]'our=cliluted O, concentration, ppm        3.-W. B. OeMore and O. Raper, "Hartley     J. W. Simons. R. J. Paur, H. A. Webster.
  F0=flowrate  through  the  O, generator.   Band  Extinction Coefficients of Ozone  in   and E. J. Bair. "Ozone Ultraviolet Photoly-
   llter/mln                               the Gas Phase  and  In  Liquid Nitrogen.   sis. VI. The Ultraviolet Spectrum". J-. Ctiem.
  Po = diluent air flowrate. liter/min          Carbon  Monoxide,  and Argon".  J.  Phya.   Phya., 59, 1203 (1973).
  1.EC.Y. inn and Y. Tanaka. "Absorption
Coefficient of Ozone In the Ultraviolet and     5. K. H. Becker. U. Schurath. and H. Seitz.   s.i'.       v
Visible Regions". J. Opt  Soc. Am., 43. 870   "Ozone Olefin Reactions in the Gas Phase   Kesearen inangie rars. «.c.
(1953).                                    1. Rate Constants and Activation Energies",     9.  "Technical Assistance  Document for
  2. A. G. Hearn. "Absorption of Ozone  In   IntT. Jour, of Chen. Kinetics, VI. 725 (1974).   the  Chemiluminescence' Measurement  of
the Ultraviolet  and Visible Regions of the     6. M. A. A. Clyne and J. A. Coxom. "Kinet-   Ozone". EPA Publication available in draft
Spectrum". Proc.  Phya. Soc. (London).  78,   ic Studies of Oxy-halogen Radical Systems".   form from  EPA. Department E (MD-76).
932 (1961).                                 Proc. Roy. Soc.. A303. 207 (1968).             Research Triangle Park. N.C. 27711.
                                 FEDERAL REGISTER, VOL 43, NO. 121—THURSDAY, JUNE 22, 1978

-------
26978
PROPOSED RULES
                   ZERO
                   •in

FlOW
CONTROLLER

F»


Oj
GENERATOR
                                                                                   OUTPUT
                                                                                  MANIFOLD
                                                                                                               •VENT
                                                                                    TO INIET OF ANALYZER
                                                                                     UNDER CALIIRATION
                                                                                              EXTRA OUTLETS CAPPED
                                                                                                WHEN NOT IN USE
                                                                                                 OPTICS
                                                                                                         SOURCE
                                                                                                          o   I
                                                                                                      •EXHAUST
                                        Figure 1  Schematic diagram of a typical UV photometric calibration system
                                                                                                            EXTRA OUTLETS CAPPED
                                                                                                              WHEN NOT IN USE
                                                                                                                            -VENT
                                                                           —— ;..»«?."» —  PUMP  —--EXHAUST
                                        . Figure 2  Schematic diagram of a typical UV photometric calibration system (OPTION 1)
                                                       , VOL 4X NO. Ml—THUBSDAY. JUNE 2fc 197»

-------
                                                      PROPOSED RULES
                                                                                      26979
  Temporary Alternative Calibration Proce-
dure—(Boric  Acid-Potassium  Iodide). This
procedure may be used as an alternative to
the Ultraviolet Photometry procedure for
direct  calibration-T>r ozone analyzers—but
not to certify transfer standards—until [18
months after the  date of final promulga-
tion]. After that time this procedure can be
used only as  a transfer standard in accord-
ance with the guidance  and specifications
set forth in Reference 4. "Transfer Stand-
ards for Calibration of Ambient Air Moni-
toring Analyzers for Ozone".
  1. Principle. This calibration procedure (1)
is based upon the reaction between ozone
(Oi) and potassium  iodide (KI) to release
iodine (I,) according to  the stoichiometiic
equation: (2)
     O,+2I-+2H*-I.+H,O+O,
(1)
The stolchiometry is-such that the amount
of I. released is equivalent to the amount of
O> absorbed. Ozone  is absorbed In  a 0.1M
boric  acid (HJ3O.) solution containing  1%
KI,  and  the   I>  released  la  measured
spectrophotometrically as the trllodide  Ion
(!••> at a wavelength of 352 nm. The output
of a stable O, generator Is assayed In this
manner,  and the generator Is immediately
used to calibrate the O, analyzer. The O,
generator must  be used immediately after
calibration and without physical movement.
and It is recalibrated prior to each use. Al-
ternatively, the O> analyzer may be calibrat-
ed by assaying the O, concentrations using
the  prescribed  procedure while  simulta-
neously measuring  the  corresponding  Ot
analyzer  responses.  Ozone  concentration
standards may also be generated by  an  op-
tional dilution technique. With this option.
the highest O, concentration standard Is as-
sayed using the prescribed procedure. The
additional O, concentration  standards  re-
quired are then obtained by dilution.
  2. Apparatus. Figures  1'and 2 Illustrate a
typical  BAKI O, calibration system and
show  the suggested configuration  of  the
components listed"below. All conneatlons be-
tween components downstream of  the Oi
generator should  be of glass.  Teflon* or
other relatively inert material.
  2.1  Air flow controller. Device capable of
maintaining a constant air flowrate through
the O> generator within ±2%.
  2.2  Air flowmeter. Calibrated flowmeter
capable of measuring and monitoring  the
air flowrate  through  the Oi generator
witlun-±2%.
  2.3  Ozone generator. Device capable of
generating stable levels of Oi.over the re-
quired concentration range.
. 2.4  Output manifold. The output mani-
fold should be constructed of glass. Teflon*.
or other relatively inert material and should
be of sufficient diameter to Insure an negli-
gible pressure drop at the analyzer connec-
tion. The system must have a vent designed
to Insure atmospheric pressure In the mani-
fold and to prevent ambient air from enter—.
ing the manifold.            .     '
  2.S  Implngers: All glass Imp'lngers witbT
the specifications indicated In Figure 2  are
recommended. The unpingers may be pur-
chased from most major  glassware suppli-
ers. Two unpingers connected In series  are
used to Insure complete collection  of  the
sample.
  2.6  Air pump  and flow controller. Any
pump, and flow control  device capable of
maintaining a constant flowrate of  0.4-0.6
liter/nun  through the  unpingers may be
used. A critical orifice as described by Lodge
 et aL (3) Is recommended. The orifice should
 be protected against moisture and particu-
 late matter with a membrane (flier or mois-
 ture trap containing Drterite", silica gel. or
 glass wool. The air pump must be capable of
 maintaining a  pressure  differential  of at
 least 0.6-0.7 atmospheres across the critical
 orifice. Alternatively, a needle valve could
 be used with the pump to adjust the flow
 through the Impingers. A flowmeter is then
 recommended  to monitor the  flow. The
 needle valve-flowmeter combination should
 be protected against moisture and panicu-
 late matter with a membrane filter or mois-
 ture trap.
  2.7  Thermometer. Accurate to ±TC.
  2.8  Barometer. Accurate to ±2 torr.
  2.9  Volumetric flasks (Class A). 25,  100,
 200, 1000-mL
  2.10  Plpets (Class A). 1. 2, 3. 5. 10.  15, 20.
 and 25-ml-volumetric.
  2.11  Spectrometer. Capable of measuring
 absorbance at 352 nm with an absolute accu-
 racy of ±1% and linear response over the
 range of 0-1.0 absorbance units. The photo-
 metric accuracy may be checked using opti-
 cal glass filters which have certified  absor-
 bance  values   at  specified   wavelengths.
 Matched 1-cm  or 2-cm cells should be used
 for all absorbance determinations.
  3. Reagents.
  3.1 Zero air.  The zero ait must be free of
 contaminants which will cause a detectable
 response on the O. analyzer or which might
 react with  1%  BAKI. Air meeting this re-
 quirement may be obtained by: (1) passing it
 through silica  gel for drying: (2) treating it
 with Oi to convert any nitric oxide (NO) to
 nitrogen dioxide  (Nd);  (3)  passing  it
 through activated charcoal (6-14 mesh) and
 molecular sieve (6-16 mesh,  type 4A) to
 remove any NO,, hydrocarbons, and  traces
 of water vapor and (4) passing it through a
 2-micron filter to remove any partlculate
 matter.                v
  3.2 Boric add (B^BO,). ACS reagent grade.
  3.3  Potassium iodide  (KI), ACS reagent
 grade.
  3.4  Hydrogen  peroxide (H.O.). ACS  rea-
 gent grade. 3% or 30%.
  3.5 Potassium lodate (Kid). ACS reagent
 grade, certified 0.1N.
  3.6  Sulfuric   acid  (H£O.>. ACS reagent
 grade. 95% to 98%.
  3.7  Distilled  water. Used^for preparation .
 of all reagents.
  3.8  Absorbing reagent. Dissolve  6.2 g of
 boric acid (HUBOi) in approximately 750 ml
 of distilled water In a nonactinometric 1000-
 ml  volumetric flask.  The  flask,  may  be
 heated gently to speed dissolution of the
 HiBO* but the solution must then be  cooled
 to room temperature or below before  pro-
 ceeding 'With  the  reagent  preparation.
 CWhile the HiBOt solution is cooling,  pre-
 pare the hydrogen peroxide (H,O,; solution
 according  to the directions in 3.9.1  When
• the H»BO. solutlonhaa cooled, add 10 g of
 potassium Iodide (KI) to the BUBO, solution
 and dissolve. Add 1 ml of 0.0018% H,O. solu-
 tion (see 3.9) and mix -thoroughly. Within 5
 minutes after adding the peroxide, dilute to
 volume with" distilled water, mix. and deter-
 mine the absorbance of this BAKI solution
 at 352 nm against distilled water as the ref-
 erence. The pH of the BAKI solution must
 be 5.5x0 2.
  Set the absorbing solution  aside  for 2
 hours and then redetemune the absorbance
 at 352 nm against distilled water as the ref-
 erence.  If  the resultant  absorbance from
 this second determination is at least 0.010
absorbance units/cm greater than the first
determination, the  absorbing  reagent  is
ready for use. If no increase or an Increase
of less than'03) 10 absorbance units/cm is ob-
served, the KI reagent  probably contains an
excessive amount of a reducing contaminant
and must be discarded. In this  event, pre-
pare fresh absorbing reagent using a differ-
ent numbered lot of KI. If unacceptable ab-
sorbing reagent results from different lots
of KI, test the possibility of contamination
in the H>BOi by using a different numbered
lot of BUBO,.
  3.9 Hydrogen peroxide solution (0.0018%-).
Pipet 3 ml of 30% or 30 ml of 3% hydrogen
peroxide (H,O.) into approximately 200 ml
of distilled  water  in a 1000-ml  volumetric
flask, dilute to volume with distilled water.
and   mix  thoroughly.  To  prepare  the
0.0018% solution, pipet 2 ml of the above so-
lution Into 50 ml of distilled water in a 100-
ml volumetric flask, dilute to volume with
distilled  water, and  mix thoroughly. This
0.0018%  HjOi solution must be prepared
fresh each time a fresh batch of absorbing
reagent is prepared. Therefore, the remain-
Ing  contents of  both  volumetric  flasks
should be discarded after treatment  of the
BAKI absorbing reagent (see 38).
  3.10  Standard potassium  tcdate solution
(0.1N). Use a commercial standard solution
of potassium lodate > having a certi-
fied normality.
  3.11  Sulfunc add (IN). Dilute 28 ml  of
concentrated (95-98%)  sulfuric acid (H,SO.>
to volume In a 1000-ml volumetric flask.
  4. Procedure.
  4.1 Assemble an ozone calibration system
such as shown in Figure 1.
  4.2 Assemble the KI sampling train such
as shown in Figure  2.  All connections be-'
tween the various components must be leak
tight  and may be made using  grease-free.
ball Joint fittings, heat-shrtnkable Teflon"'
tubing, or Teflon* tube fittings. The connec-
tion to the O> output manifold should be
made using 6 mm (1/4 in.) Teflon"  tubing
not to exceed 1.5 meters in length.
  4.3  Calibrate all flowmeters and critical
orifices under the conditions of use against
a reliable flow or volume standard such as a
NBS traceable bubble flowmeter  or wet-test
meter. Correct all volumetric flowrates  to
25'C and 760 torr as follows:
                                                                      >S - "HZO
                                                               r, • f« •	  •
                                                    . where:
                                                       F,=flowrate corrected to reference condi-
                                                        tions (25* C and 760 torr), liter/nun
                                                       F,=flowrate at sampling conditions, liter/
                                                        nun
                                                       Pi=barometric pressure at sampling  con-
                                                        ditions, torr
                                                       PBW=vapor pressure of R, at T9. torr  (For
                                                        wet volume standard. For  a dry stand-
                                                        ard. PTO=0)
                                                       Tj=temperature at sampling  conditions.
                                                        •C

                                                       4.4  KI calibration curve.
                                                       4.4.1   Prepare  iodine  standards,  fresh
                                                     when needed, as follows:
                                                       A. Accurately pipet 10 ml of 0.1N standard
                                                     potassium lodate 
-------
26980
           PROPOSED RULES
acid (H.SO.). dilute to volume with distilled
water, and mix thoroughly.
  B. Immediately before use. plpet 10 ml of
the iodine (I,) solution prepared  in step A
above Into  a 100-ml volumetric  flask and
dilute to volume with  absorbing reagent.
Then further dilute this solution by pipet- •
ting 10  ml  of it into a  200-ml volumetric
flask and diluting it to- volume with absorb-
ing reagent.
  C. In  turn,  pipet 5.  10. 15. 20. and 25 ml
aliquots of the final !• solution prepared in
step B above into a senes of 25-ml volumet-
ric  flasks. Dilute each to volume with ab-
sorbing  reagent  and  mix  thoroughly. To
prevent I, losses by volatilization,  the flasks
should1  remain stoppered until absorbance
measurements are  made. Absorbagce mea-
surements (see 4.4.2) should be taken within
20 minutes after preparation of the I> stand-
ards.
  4.4.2  Determine  the absorbance of each
I, standard  at 352 run. Also measure the ab-
sorbance  of a sample  of  unexposed absorb-
ing reagent. Determine the net absorbance
of each I, standard as:
  / tuoli'
•  IIHOrMM
                         .  • LJSWSM,J
  4.4.3  For each  T, standard, calculate the
net absorbance/cm as:


          Mt .norwu/c. .' Mt »..r«.nc.        (<)
where:

  bispectrophotometer cell path length, cm

  4.4.4  For each I. standard, calculate the
It concentration in mole/liter as;
 or.
        [Wi=NI,i,xV,xlO-i
                               <5b)
 where:

  (Iili=concentration  of each  Ii standard.
    mole It/liter
  NMO>=normality  of  K3O, (from 3.10). eq-
    liter
  V,=volume  of   !•  solution  (from  step
    4.4.1.0=5, 10.15. 20. or 25 ml

  4.4.5 Plot  net  absorbance/cm  (y-axis)
 versus the mole I,/liter (x-axis) for each I,
 standard and draw the KI calibration curve.
 Calculate  the slope of the  curve In liter
 mole-' cm-' and record as S* The  value of
 the slope should be 25.800±600. If the slope
 Is not within this range, and .the photomet-
 ric  accuracy   of  the spectrophotometer
 meets the specifications given in 2.11. repeat
 the procedure using  freshly  prepared  !•
 standards. If the slope is still not within the
 specified range, repeat the procedure using
 a different lot of certified 0.1N KIO. to pre-
 pare the Ii standards.
  4.5  Calibration of the ozone generator.
  4.5.1  Adjust the air now through the O,
generator to the desired flowrate and record
as P.. At all times the air flow through the
generator must  be  greater  than the  total
flow required by the sampling systems, to
assure exhaust flow at the vent.
  4.5.2  With the O, generator off. flush the
system with zero air (or at least 15  minutes
to remove residual O* Pipet 10 ml of absorb-
ing reagent Into each of 2 Impingers and
connect 'them into the  sampling train as
shown  in  Figure 2. Draw  air  from  the
output  manifold  of  the  O,  calibration
system  through the sampling train at 0.4-
0.6 liter/mm for 10  minutes. Immediately
transfer the exposed solutions to- clean spec-
trophotometer cells. Determine  the net ab-
sorbance   (sample   absorbance-unexposed
reagent absorbance) of each solution at 352
ran within three minutes. Add the net ab-
sorbances of the two solutions to obtain the'
total  net absorbance. Calculate the indicat-
ed Oi concentration (system blank) as equiv-
alent O> concentration according to 4.5.4. If
the system blank is greater than 0.005 ppm
CX. continue  flushing  the  O,   generation
system  for an additional 30 minutes and re-
determine the system blank. If  the system
blank is still greater than 0.005 ppm Cs. the
zero air probably contains traces of an oxi-
dizing contaminant, and the activated  char-
coal'and molecular sieve (see 3.1) should be
replaced.
  4.5.3  Adjust the Oi generator to-generate
an Oi concentration in the range of interest
and allow  the  system  to  equilibrate for
about 15 minutes. The uncalibrated O, ana-
lyzer to be calibrated can conveniently be
used  to indicate the stability of  the O, gen-
erator  output.  When   the  O, generator
output  has stabilized, pipet 10 ml of absorb-
ing reagent into each  unpinger. Draw O,
from the  output manifold of'the O» calibra-
tion system through the sampling train at
0.4-0.6  Uter/mln. Use a  sample  time of be-
tween 10 and 30 minutes such that a total
net absorbance between 0.1 and 1.0 absor-
bance units is obtained. (At an O, concentra-
tion of 0.1  ppm and a sampling rate of 0.5
liter/mln. a total net absorbance >0.1 absor-
bance units should be obtained if a sampling
time  of 20 minutes and  1-cm spectrophoto-
meter cells are used.) Immediately after col-
lection, transfer the exposed solutions to
clean spectrophotometer cells.  Determine
the net absorbance (sample absorbance—un-
exposed reagent absorbance) of each solu-
tion  at 352 run within three minutes. Add
the net absorbances of the  two solutions to
obtain the total net absorbance.
   4.5.4.  Calculation of ozone concentration.
   4.5.4.1  Calculate the  total volume  of air
sampled,  corrected  to reference conditions
of 25'C and 760 torr as:
                                                                          4.5.4.2  Calculate the I, released in moles
                                                                        as:
              V.=F.xt,
 where:
                                                                                 DDK I,
                                                                                       UUl Mt 
-------
Record  the O> concentration and  the O»
analyzer response. II substantial adjustment
of the span control is necessary, recheck the
zero and  span adjustments  by repeating'
steps 4.6.2 through 4.8.4.

  4.6.5   Generate several other O> concen-
trations (at least 5 others are recommended)
over the scale range of  the O. analyzer by
adjusting the O, generator settings (prefer-
ably the same settings as used In 4.5) or by
Option  1.  For each O, concentration, allow
for a stable analyzer response, then record
the response and the corresponding O>  con-
centration.

  4.6.6  Plot  the  Or analyzer responses
versus the corresponding O> concentrations
and draw the O, analyzer's calibration curve
or calculate the appropriate response factor.

  4.6 7  Option 1: The various O, concentra-
tions required in step 4.6.5 may be obtained
by dilution of the O, concentration generat-
ed In 4 6.3. With this option, accurate  flow
measurements are  required.  The  dynamic
           PROPOSED RULES

calibration system must  be  modified as
shown in Figure 3 to allow for dilution air to
be metered in downstream of the O, gener-
ator. A mixing chamber between the O,  gen-
erator and the output manifold is also re-
quired. The flpwrate through the O> gener-
ator (F0> and the dilution air flowrate  (PD)
are measured wjth a reliable flow or volume1
standard traceable to NBS. The highest O>
concentration standard required (80% URL)
Is assayed according to the procedure In 4.5.
Each Oi concentration  generated by dilu-
tion Is calculated from:
                                      (11)
                        v^'
where: COJ'our = diluted Oi concentration.
    ppnv F. = flowrate through the O, gen-
    erator, liter/nun; F0 =  diluent air flow-
    rate, llter/mln.

  NOTE.—Direct calibration of the O, analyz-
er may also be accomplished by assaying the
                                 26981

O, concentrations using the procedure in 4.5
while simultaneously  measuring the corre-
sponding Oi analyzer responses as specified
in 4.6.

               REFERENCES
  1. D. L. Plamm, "Analysis of Ozone at Low
Concentrations  with  Boric -Acid Buffered
KI," Environ. Sa.-TechnoL, 11. 978 (1977).

  2. B. E. Saltzman and N. Gilbert. "lodome-
tric  Mlcrodeternunation  of  Organic  Oxi-"
dants  and Ozone." AnaL  Chem.,  31,  1914
(1959).         '  -
  3.  J.  P. Lodge. Jr..  J.  B.  Pate. B.  E.
Ammons.  and G. A. Swanson. "The Use of
Hypodermic Needles as Critical Orifices in
Air Sampling." J. Air Poll Control Assoc.,
16, 197(1966).
  4. "Transfer Standards for Calibration of
Ambient  Air  Monitoring  Analyzers  for
Ozone." EPA Publication available  in draft
form from EPA. Department  E (MD-T8).
Research Triangle Park. N.C. 27711.
                                  FEDERAL. REGISTER. VOL 43, NO.  Ml—THURSDAY, JUNE 22. 1978

-------
26982
   PROPOSED RULES

O*
ZERO
AIR

FLOW
CONTROLLER



FLOWMETER

fQ ^
•
03
GENERATOR.


                                            OUTPUT
                                           MANIFOL-D
        VENT
                                               i.r
             EXTRA OUTLETS CAPPED
                WHEN NOT IN USE
   TO INLET OF
Kl SAMPLING TRAIN
TOINLETOF ANALYZER
 UNDER CALIBRATION
                     Fiqure 1  Schematic diayram of a typical BAKI calibration system
                             FEDERAL REGISTER, VOL 43. NO. 121-THURSDAY, JUNE 22. 1978

-------
                                    PROPOSED RULES
                                                                    26983
                                                                     HYPODERMIC
                                                                       NEEDLE
                                                             CRITICAL ORIFICE FLOW CONTROL
                                                                                        TO AIR
                                                                                         PUMP
Smml.D.-^  [«-
1
1
i
E
r-
^
<
(
9
i
a
a

3
3
/
















u


M
m
•»
>




fi h — — •
INSIDE 25mm
CLEARANCE 0.0.
3 TO 5 mm

*— 	



1
                                                   /	——*> T0A|R
                                                   |j—IAr~        PUMP
                                                      NEEDLE VALVE
                 _L
                 T
10 mm 0.0
                                                    f  FLOWMETER
                  ?  24/40, CONCENTRIC WITH
                     OUTER PIECE AND WITH
                     NOZZLE

                   GRADUATIONS AT 5-ml
                   INTERVALS. ALL THE
                   WAY AROUND
                  NOZZLE I.D. EXACTLY
                  1mm; PASSESO.09TOO.il
                  dm AT 12 in. H20 VACUUM.
                  PIECES SHOULD BE INTER-
                  CHANGEABLE, MAINTAINING
                  NOZZLE CENTERING AND
                  CLEARANCE TO BOTTOM
                  INSIDE SURFACE
                                      ALTERNATE FLOW CONTROL
                             ALL GLASS MIDGET IMPINGER (THIS IS A COMMERCIALLY
                             STffCKED ITEM).
                                    Figure 2.  Kl sampling train.
                     KDHAL REOISra, VOL 43, NO. 171— THURSDAY, JUNE 2Z 1971

-------
26984
  o
PROPOSED RULES

     F0
                                                               03
                                                            GENERATOR
                                                                                         MIXING
                                                                                        CHAMBER
                   VENT
OUTPUT
MANIFOLD
i
i

u V 'i

H
                                 WHEN NOT IN USE
                                                      TO INLET OF-
                                                    Kl SAMPLING TRAIN
                           TO INLET OF ANALYZER
                            UNDER CALIBRATION
                Fiqure 3  Schematic ciiaqranvof a typical BAKI calibration system (Option 1)

                                    [PR Doc. 78-17154 Filed 6-21-78: 8.45 am]
                              FCDHtAL REGISTER. VOL 43. NO. 121—TNURSOAY, JUNE a, 1979

-------
                                              PROPOSED RULES
                                                                   26985
[6560-01]

             CFRL 914-2]

        [40 CFR Part* 51 and 52]

REQUIREMENTS  FOR PREPARATION.  ADOP-
  TION, AND  SUBMITTAL OF IMPLEMENTA-
  TION PLANS
Approval and Promulgation of Implei
               Plan.
                              irtatld
AGENCY:  Environmental Protection
Agency.
ACTION: Proposed rule.
SUMMARY:  In this  action,  the Ad-
ministrator proposes _ to make certain
revisions to the procedures for prepa-
ration of State Implementation Plans
for photochemical  oxidants. Specifi-
cally, he proposes  the following ac-
tions:
  1. Change the terms "photochemical
oxidant(s)"   and   "oxidant(s)"   to
"ozone" throughout Parts 51 and 52.
  2. Delete  Appendix J of 40 CFR Part
51 and  revise 40 CFR 51.14  with re-
spect to the method for calculating
needed  reductions  in hydrocarbon
emissions.
  The   terms  "photochemical   oxi-
dants"  and   "oxidants"  are  being
changed to "ozone" to be consistent
with EPA's  proposal  to  redesignate
the photochemical  oxidants standard
as an ozone standard. The redesigna-
tion of  the standard, along with the
reasons for it. will be proposed as a
separate  FEDERAL  REGISTER  action.
Thoughout the rest of these actions
the word "ozone" will be used in place
of "oxidant". except when reference Is
made to existing language in the Code
of Federal Regulations.
  Appendix J Is being deleted to make
the Part 51 regulations consistent with
EPA's current  policy on development
of State Implementation Plans (SIPs)
to meet the ozone standard. States will
be  allowed to use any of  four pre-
scribed techniques to relate ozone con-
centrations to hydrocarbon emissions.
The techniques will be set forth In the
proposed   revisions   to   40   CFR
51.14(0(4).

DATES: Comments  must  be received
by August  18. 1978. Comments submit-
ted will facilitate internal distribution
and public availability.
ADDRESSES:  Persons may  submit
written comments on this  proposal to:
U.S.    Environmental    Protection
Agency. Office of  Air  Quality  Plan-
ning and Standards, Control Programs
Development  Division (MD  15), Re-
search Triangle Park. N.C. 27711. At-
tention: Mr. Darryl D. Tyler.
  EPA  will make  all comments re-
ceived within 30 days of publication of
this proposal available for public in-
spection during normal business hours
at: EPA Public Information Reference
Unit, 401  M Street, SW.. Room 2922,
Washington. D.C. 20460.
FOR   FURTHER  INFORMATION
CONTACT:
  Joseph Sableski, Chief Plans Guide-
  lines Section, Control Programs De-
  velopment Division (919-541-5437).

     SUPPLEMENTARY INFORMATION

  In connection with the review of the
NAAQS and  associated  SIP  require-
ments for ozone, EPA has determined
that certain changes in  40 CFR Part
51 are appropriate.

             APPENDIX J

  Petitions to  EPA from- the American
Petroleum Institute (and  29  member
companies) on December 9, 1976, and
the City of Houston on July 11. 1977.
recommended revisions to the method
of calculating needed hydrocarbon re-
ductions specified in Appendix J. EPA
has studied various methods by which
these  calculations can  be made and
has determined that Appendix J of 40
CFR 51 no longer represents the only
acceptable analytical relationship be-
tween hydrocarbons and ozone. There-
fore, Appendix J is being proposed for
deletion.

            SECTION 51.14

  The Administrator is also proposing
to, amend 40 CFR  51.14(0(4)  to allow
the  use of alternate analytical  rela-
tionships for' determining the hydro-
carbon reductions necessary  to meet
the ozone standard. EPA is conducting
further studies and will propose alter-
. natives or a replacement for Appendix
J when  the  studies are concluded.
During the interim period, for the pur-
poses of SIP control strategy  develop-
ment, any one of four modeling tech-
niques  may be used. EPA has  pub-
 lished  a  document entitled. "Uses,"
Limitations and  Technical  Basis  of
Procedures for Quantifying Relation-
ships   Between   Photochemical  Oxi-
dants  and  Precursors"  (November.
 1977; EPA 450/2-77-02 la) which refer-"
ences  analytical   techniques  that
States  must  consider.  These tech-
 niques include the following:
   (1)  Photochemical grid  models—
 These  models are  based on the most
 accurate available physical and chemi-
 cal  principles underlying the forma-
 tion of ozone.
   (2) Empirical Kinetics Modeling Ap-
 proach (EKMA>—This  model repre-
 sents a compromise between  rigorous
 treatment - of chemical  and  physical
 principles underlying the formation
 and dispersion of ozone and the exten-
 sive  data requirements necessary to
 represent  such  principles in model
 form.  EKMA is  not as  accurate or
 flexible as the grid models. However. It
 does reflect reality to a greater extent
than the empirical  and statistical ap-
proaches.
  (3)   Empirical   and   Statistical
Models—These models reflect observer
relationships between ozone and other
variables. However,  they do not imply
cause-effect relationships; hence, their
applicability to estimating the impact
of substantial control programs is lim-
ited  because  the  conditions,  under
which the  relationships in the model
have been  derived,  will be altered by
control programs.
  (4)   Proportional   Rollback—This
model  assumes  a linear relationship
between  hydrocarbon  emissions  and
ambient concentrations of ozone. Pro-
portional rollback appears to be useful
as a lower  bound for estimates of hy-
drocarbon  controls needed  to attain
the ozone standard  in most U.S. cities.
  EPA will  also make  available  com-
puter  programs  and  other  aids to
enable States to use the techniques de-
scribed above.
  Background    concentrations   and
transport of ozone  from upwind loca-
tions can impact upon high levels of
ozone in or near an urban area during
afternoon hours. Therefore, considera-
tion of  background  and  transport
should be made in applying any of the
techniques  to develop an ozone control
strategy. Means for measuring trans-
ported  ozone  and interpreting  the
measurements,  as well as procedures
for assessing the impact of transport
in an urban area are described in the
EPA document referenced above. In
developing  the ozone control strategy
for  a  particular area. States   may
assume that the ozone standard will
be attained at upwind locations.

               IMPACT

  In accordance with Agency policy as
set forth in 39  FR 37419. EPA has re-
viewed the proposed changes  and de-
termined that they do not constitute
"significant" "revisions or  modifica-
tions (as defined in 39 FR 37419) and
therefore do not require  an environ-
mental impact statement.

  Dated: June 9,1978.
              DOUGLAS M. COSTLE,
                    Administrator.

  In Title 40. Chapter I. EPA proposes
to amend Subchapter C as follows:

PART 51—REQUIREMENTS FOR PREPARATION.
  ADOPTION, AND SUBMITTAl OF IMPLEMEN-
  TATION PLANS

  1. Wherever the terms "Photochemi-
cal oxidanUs)" or "oxidant(s)" appear
in Part 51. they are changed  to-read
"ozone."
  2.  Appendix  J  is deleted  and re-
served.
  3.  Section 51.14(0(4) is revised to
read as follows:
                              FEDERAL REGISTER. VOL 43, NO. 121—THURSDAY. JUNE 22. 1978

-------
26986

§51.14  Control  strategy:  Carbon monox-
    ide, hydrocarbons, photochemical oxi-
    dants, and nitrogen dioxide.
  (c)
     •      •      •     •      •
  (4) In selecting an appropriate model
to determine the amount of hydrocar-
bon reductions ^necessary   to  demon-
strate  attainment of  the ozone stand-
ard, one of the following  techniques
must be applied:
  (i)  Photochemical  grid  models—
These  models  are  based on the most
accurate available physical and chemi-
cal -principles  underlying  the forma-
tion of ozone.
          PROPOSED RULES

  (ii) Empirical Kinetics Modeling Ap-
proach  (EKMA>—This  model  repre-
sents  a compromise  between rigorous
treatment of  chemical  and physical
principles underlying ozone formation
and dispersion and the extensive data
requirements that would be necessitat-
ed by- such art approach.
  (ill)   Empirical    and-  Statistical
Models—These models reflect observer
relationships between ozone and other
variables.
 "(iv)    Proportional  Rollback—This
model  assumes a  linear relationship
between hydrocarbon  emissions- and
ambient concentrations of ozone.
  In developing ozone control  strate-
gies for a-particular area, background
concentrations and ozone transported
into an- area  must  be  considered.
States  may assume  that  the  ozone
standard will be  attained  in upwind
areas.
 PART 52—APPROVAL AND PROMULGATION
       OF IMPLEMENTATION PLANS

  4. Wherever the terms "photochemi-
cal oxidant(s)" or "oxidant(s)" appear
in Part 52, they are changed to read
"ozone".

  AUTHORITY: Sections 110 and 301(a). Clean
Air Act. as-amended (42 U.S.&-9410. 7601).)

 (PR Doc. 78-17155 Filed 6-21-78: 8:45 am]
                                 FORM. RCQUTfX. VOL. 4& NO; 1«—THURSDAY. JUKI 7Z I97»

-------
                                                      TAB  E


021740

                 DRAFT  - October 12, 1978

               (Through IV-F-40 and  IV-D-122)


                        STAFF  REPORT



 REVIEW OF PUBLIC COMMENTS  CONCERNING PROPOSED REVISION OF
            THE NAAQS FOR PHOTOCHEMICAL OXIDANTS

               Washington,  D.C. , July 18, 1978
                Atlanta, GA, August  17, 1978
                 Dallas, TX, August  22, 1978
              Los Angeles,  CA, August 24, 1978
                         Prepared  by

                  PEDCo Environmental,  Inc.
                     11499 Chester Road
                   Cincinnati,  Ohio  45246
                   Contract No.  68-02-2515
                         Task No.
                        Prepared for

            U.S. ENVIRONMENTAL PROTECTION  AGENCY
               Pollutant Strategies Section  of
            Strategies and Air Standards Division
                        October, 1973
  Environmental
Protection Agency
    p^Tinn 0

  DEC  20 197P

    LIBRARY

-------
                 Review  of Public Comments Concerning
       Proposed Revision of the  NAAQS for Photochemical Oxidants
                               Summer 1978
                            1.0  INTRODUCTION

     EPA has conducted a review  of the criteria upon which the existing
primary and secondary photochemical oxidant standards are based.  The
revised criteria have been published (EPA-600/8-78-004, Volumes I and
II, April 1978) and the  proposed revision to the standard appeared in
the Federal Register on  June 22, 1978 (Vol. 43, No. 121, pp 26962-
26986).  The Federal Register announcement included a preamble which
identified supporting information used by the EPA in developing the
proposed standard, and supplementing information pertinent to the proposal,
     The existing primary and secondary standards for photochemical
oxidants are currently set at 0.08 ppm, 1-hour average not to be exceeded
more than once per year.   As  a result of the review and revision of
health and welfare criteria,  EPA has proposed to raise the primary
standard level to 0.10 ppm,  1-hour average.  EPA also has proposed that
the secondary welfare-based  standard remain at 0.08 ppm, 1-hour average.
Other changes proposed include:  (1) changing the chemical desgination
of the standard from photochemical oxidants to ozone, and (2) changing
to a standard with a statistical rather than deterministic form, i.e.
allowable exceedances will  be stated as an expected value, not an explicit
value.
                                   1-1

-------
     During the period between the June 22 proposal  announcement and
final promulgation of the standard, EPA will  continue its examination of
health and welfare criteria and seek to further involve the public and
other affected parties in the final decision  on the air quality standard.
     Public hearings regarding the proposal were held at Washington,
D.C., on July 18, 1978, at Atlanta, GA, on August 17, 1978, at Dallas,
TX, on August 22, 1978, and at Los Angeles, CA, on August 24, 1978.
Written comments on the proposed revision are due on or before September
24, 1978.
     Section 2.0 of this report is an outline and summary of specific
issues discussed in the oral presentations in the hearings and of written
comments received.
     Section 3.0 is a general overview and summary of the presentations
and written comments outlined in Section 2.0.
     In the document notation the  IV-F- series are transcripts and
written materials from the hearings; the IV-D- series are other written
materials supplied relative to the proposed standard.
                                   1-2

-------
                      2.0   Outline of Key Issues


I.    Summary of Comments on Level of Standard
     A.    Primary standard
          1.   Endorse current standard level, 0.08 ppm
               Rauch, EOF, IV-F-1, p.15 (Any doubt, resolve in favor
                 of current standard.)
               Wilber, Concerned citizen, Broomfield, CO,  IV-D-1
               Leven, Concerned citizen, Walden, CO, IV-D-2
               Wilson, Natural Resources Advisory Committee, Cedar Grove,
                 N.J., IV-D-4
               Roberts, Concerned citizen, Denver, CO, IV-D-5
               Mannchen, Concerned citizen, Houston, TX,  IV-D-6
               Martin, Sierra Club, Houston, TX, IV-D-7
               Marth, Concerned citizen, Costa Mesa, CA,  IV-D-8
               Hillestad, Concerned citizen, Denver, CO,  IV-D-11
               Hartzler, Concerned citizen, Goshen, IN, IV-D-12
               Ellman, Concerned citizen, Tiburon, CA, IV-D-13
               Gross, Concerned citizen, Wichita, KS, IV-D-14
               Barcus, Concerned citizen, Wichita, KS, IV-D-15
               Glover, Concerned citizen, Houston, TX, IV-D-18
               James F. Presso, Concerned citizen, IV-D-23
                 (current standard or lower level)
               Gluckman, Florida Lung Assoc., IV-F-11, p.67
               Rains, Manasota 88; Manasota Chapter, Issac Walton League,
                 and the Environmental Confederation of Southwest Florida,
                 IV-F-11, p.78
               Martin, Houston Sierra Club, IV-F-17, p.21; IV-F-19
               Bass and Titus, League of Women Voters of  Dallas,  IV-F-17,
                 p.70; IV-F-23
                   •
               Dixon, California Lung Assoc., IV-F-31, p.55
               Goldsmith, Sierra Club, IV-F-31, p.61; IV-F-37
               C. Freeman Allen, Concerned citizen, IV-F-40
               Coombs, Maine Health Systems Agency, IV-D-24; IV-D-25
               Fryan, Florida Lung Assoc., Northeast Branch, IV-D-27
               Sagady, Michigan Lung Assoc., IV-D-28
                                   2-1

-------
Chalupnik, Washington Air Quality Coalition, IV-D-39
Serra, Michigan Lung Assoc., Saginaw Valley Retion,
  IV-D-45
Dtyzel, New Mexico Lung Assoc., IV-D-49
Platt  and Renstrom, Oregon Environmental Council,
  IV-D-50
American Lung Assoc. of New Jersey, IV-D-52
Vogel, South Shore (Ohio) Christmas Seal Assoc.,
  IV-D-53
Curfman, Southwestern Ohio Lung Assoc, IV-D-55
Woodhull, Connecticut State Dept.  of Health, IV-D-57.
  (Allows very slight margin of safety.)
Lui, American Lung Assoc. of Colorado, IV-D-58.
Mehlhaff, Oregon Lung Assoc., IV-D-59.
  (Objects of proposed relaxation of current standard
   to  0.10 ppm.)
Monteith, Concerned citizen, IV-D-61
Knudson, American Lung Assoc. of Colorado, West Region,
  IV-D-62
Ahlers, Queensboro Lung Assoc., Jamaica, N.Y., IV-D-64
McNulty, League of Women Voters of the U.S., IV-D-71
Raymond, American Lung Assoc. of Louisiana, IV-D-73
Lund,  Concerned citizen, IV-D-79
Lee, Bangor-Brewer TB & Health Assoc., IV-0-80
Jensen, Medford-Ashland Air Quality Maintenance Advisory
  Committee, IV-D-82
Mayer, Concerned citizen, IV-D-85
Ragadale, American Lung Assoc.  of New York State, Inc.,
  IV-D-89
Meierotto, U.S. Dept. of the Interior, IV-D-97
Malchon, National Air Convervation Commission, American
  Lung Assoc., IV-D-102
Burk, Maine Lung Assoc., IV-D-107
Kuhn, Concerned citizen, IV-D-113
Randle, Yale Environmental  Law Assoc., New Haven, CT.,
  IV-D-14 (health hazards associated with the  new standard
  as proposed  would be substantial)
Davis, New York Lung Assoc., IV-D-121
                    2-2

-------
2.   Endorse proposed standard level, 0.10 ppm
     Regional Planning Commission for Jefferson, Orleans,
       St. Bernard and St. Tammany Parrishes, Louisiana,
       IV-D-29
     James Pitts, Concerned citizen, IV-F-31, p.27;  IV-F-33
     England, COLAB (Coalition of Labor and Business),  IV-F-31,
       p.66; IV-F-38
     Rokaw, Air Quality Advisory Committee, California  Dept.  of
       Health (endorsement of 0.10 ppm PO ),  IV-F-31,  p.70; IV-F-39
       (S.M. Rokaw, M.D., who testified d§es  not personally
        endorse, but does not oppose 0.10 ppm PO ,  IV-F-31, p.79)
                                                A
     Auberle, Colorado Dept. of Health, IV-D-22
     Morgan and Lash, U.S. Dept. of Transportation,  IV-D-31
     Foege, Center for Disease Control, USDHEW, IV-D-38
     Moss, Wasatch Front Regional Council, Utah, IV-D-40
     Jones and Johnson, Southern Alameda County (CA)  Board of
       Realtors, IV-D-51
     MacCorison, Rhode Island Lung Assoc., IV-D-81
     Cortese, Div. of Air and Hazards Materials, Massachusetts
       Dept. of Envir. Quality Engineering, IV-D-99
     Warner, Wayne County Dept. of Health, MI, IV-D-111
     Howison, Air Pollution Control  League of Greater
       Cincinnati, OH, IV-D-119
     Austin, California Air Resources Board,  IV-D-120
3.   Endorse level higher than 0.10 ppm
     0.12 ppm:
     Osegueda, Virginia APC Board, IV-F-1, p.131-132
     Mattson, Virginia APC Board, IV-D-16
     Schnetzke, Evansville, IN, Chamber of Commerce,  IV-F-1,
       p.137-138 (0.12 or 0.13 ppm)
     Hovey, STAPPA, IV-F-1, p.114
     Hodges, Tennessee Dept. of Public Health, IV-D-20
     Williams,  Indiana State Board of Health, IV-D-32
     Ledbetter, Georgia Dept. of Natural Resources,  IV-D-33
     Rickers, Utah Bureau of Air Quality, IV-D-34
     Jones, Sierra Pacific Power Co., IV-D-35
     Noren, Maryland Environmental Health Administration,
       IV-D-42

                         2-3

-------
Serdoz, Nevada Dept. of Conservation and Natural Resources,
   IV-D-48
Lokey, Texas Oil Marketers Assoc., IV-D-54
Reilly, City of Philadelphia, PA, IV-0-63
Smither, Div. of Air Pollution Control, Kentucky Dept.
   for Natural Resources and Environ. Protection, IV-D-68
Hambright, Bureau of Air Quality Control, Pennsylvania
   Dept. of Environ. Resources, IV-D-69
Saiger, Bureau of Air Quality and Occup. HHh., Kansas
   Dept. of HHh. and Environ., IV-D-77
Robinson, Air Pollution Control Div., Nebraska Dept.
   of Environ. Control, IV-D-78
Rector, Air Quality Division, Michigan Dept. of Natural
   Resources, IV-D-86
Robinson, Vulcan Materials Company, IV-D-87
Berle, N.Y. Dept. of Environ. Conservation, IV-D-92
Terrell, Area Cooperation Committee of Tidewater &
   Virginia Peninsula Chambers of Commerce, IV-D-96
   {averaging time 2, 4, or more hours.)
McRorie, N.C. Dept. of Natural Resources and Community
   Development, IV-D-100
Hovey, STAPPA, IV-D-101
Leak, S.C. State Development Board,  IV-D-108
Cooper, Alabama Air Pollution Control  Commission,  IV-D-112
Griffith, Berkeley, Charleston, Dorchester Council  of
   Governments, S.C., IV-D-115 (if clinical  studies
   documenting effects at 0.15 ppm are proved to be valid.)
0.13 ppm:
Harrison, San Antonio (TX)  Metropolitan Health District,
   IV-F-17, p.93; IV-F-26
J.R. Strausser, Concerned citizen, IV-D-37
0.14 ppm:
Rhoades, St.  Louis County,  MO,  IV-D-110
0.15 ppm:
Huess,  General  Motors,  IV-F-1, p.95
Coerver, Louisiana Air  Control  Commission  IV-D-106
                    2-4

-------
     0.20 ppm;
     Stewart, Texas Air Control Board, IV-F-17,  p.28;  IV-F-20
       (Basis: epidemiologic studies; apparently rejects  experi-
        mental studies because of singlet oxygen possibility.)

     Hurstell, New Orleans Public Service, Inc., IV-0-90
       (0.20 ppm 3-hour average, 1 exceedance/year.)

     0.20 - 0.25 ppm:
     Cyphers, Texas Chemical Council, IV-F-17,  p.44;  IV-F-21

     0.20 - 0.30 ppm:
     Conder, Dow Chemical Co., IV-D-109

     0.23 - 0.35 ppm:
     John H. Engle, Jr., Motor Vehicle Manufacturers  Assoc.,
       IV-F-31 , p.18 (response to question)

     0.25 ppm:
     L.B. McDonald, Concerned citizen, IV-D-41  (0.25  ppm, 2-hour
       average, 10 exceedances/year)

     Miller, Rio Blanco Oil Shale Co., IV-D-93

4.   Oppose proposed standard, no specific level given

     Walker, Monsanto Company, IV-F-17, p.Ill;  IV-F-28
       (Proposed changes are of such minor practical  conse-
        quences that they will serve only to delay more
        appropriate changes.)
     Mattson, Va. Air Pollution Control Board,  IV-D-70
     Foster, Div. of Air Pollu. Control, State  of Tennessee
       Dept. of Public Health, IV-D-104 (Standard should  be
       set at 80 percent of effects level.  This amends
       statments recommending standard should be set  at
       80 percent of 0.15 ppm, i.e. 0.12 ppm, made in
       IV-F-11 and IV-F-13.)
     Griffith, Berkeley, Charleston, Dorchester Council of
       Governments, S.C., IV-D-115 (should not  set standard
       at this time because of lack of scientific concensus
       on harmful concentration of ozone.)

     Too lenient:
     Mannchen, Concerned citizen, Houston, TX,  IV-D-6

     Kramer, Georgia Clean Air Council, IV-F-11, p.85;
       IV-F-16

                         2-5

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Paul Miller, Concerned citizen, IV-F-31,  p.34;  IV-F-34
M. Mehlhaff, Oregon Lung Assoc., IV-D-59
  (Change from 0.08 would be going downward  instead  of
   upward.)
Bennett, Dept. Vegetable Crops, Univ. of  California,
  IV-D-72
Rogers, Natural Resources Council  of Maine,  IV-D-122
  (should impose standard stricter than 0.08 ppm.)
Too Stringent:
Pierrard, API, IV-F-1, p.42
Hawk, API, IV-F-1, p.83
Huess, General Motors, IV-F-1, p.86,98
Osegueda and Mattson, Va ARC Board, IV-F-1,  p.131-132;
  IV-D-16 (24-hour averaging time is suggested.)
Gall ion, Oklahoma State Dept. Health, IV-D-10
Starke, Shell Oil Co., IV-F-11, p.16; IV-F-12
Packnett, Steams-Roger, Inc., IV-F-17, p.74; IV-F-24
  (implied)
Feldcamp, Houston (TX) Chamber of Commerce,  IV-F-17,
  p.104; IV-F-27
McKenzie, Association of Local Air Pollution Control
  Officials,  IV-F-17, p.132
Greater San Antonio  (TX) Chamber of Commerce, IV-F-30
Engel, Motor Vehicle Manufacturers Assoc., IV-F-31,  p.15;
  IV-F-32 (Prepared  testimony)
Spaulding, Western Oil and Gas Assoc., IV-F-31, p.42;
  IV-F-35
Edwards, Tennessee Eastman Corp., IV-D-26
Mole, Cook County (IL) Dept. of Environmental Control,
  IV-D-30
Melchior, Associated Building Industry of Northern
  California,  IV-D-56
Hatladay, Utah Manufacturers Assoc., Salt Lake City,
  UT, IV-D-66
Smith, Iowa-Illinois Gas & Electric Co.,   IV-D-105
Clark, Manufacturing Chemists Assoc., IV-D-116
Madsen, White  River  Shale Project, UT, IV-D-117
Potter, General Motors Corp., IV-D-118
                    2-6

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B.    Secondary standard
     1.   Endorse proposed (current) standard level, 0.08 ppm
          McNulty, League of Women Voters of the U.S., IV-D-71
          Austin, California Air Resources Board, IV-0-120
     2.   Alternate proposals and criticism of proposed level
          Paul R. Miller, Concerned citizen, IV-F-31, p.37
            (0.05 ppm for 8 hours should be considered.)
          0.10 ppm:
          Williams, Indiana State Board of Health, IV-D-32
          Jones, Sierra Pacific Power Co., IV-D-35
          Warner, Wayne County Dept. of Health, MI, IV-D-111
          0.12 ppm:
          Rickers, Utah Bureau of Air Quality, IV-D-34
            (Recommend same as primary standard: 0.12 ppm.)
          Smither, Div. of Air Pollution Control, Kentucky Dept.
            for Natural Resources and Environ. Protection, IV-D-68
          Griffith, Berkeley, Charleston, Dorchester Council  of
            Governments, S.C., IV-D-115
          Proposed level too stringent (no level stated):
          Huess, General Motors, IV-F-1, p.98 (Protection  of
            vegetation requires secondary standard no more
            stringent than primary standard.)
          Hovey, STAPPA, IV-F-1, p.120
          Collum, Georgia Dept. of Natural Resources, IV-F-11,  p.61;
            IV-F-15 (Implied too stringent)
          Ledbetter, Georgia Dept. of Natural Resources,  IV-D-33
            (consider 8-hour averaging time)
          Greater San Antonio (TX) Chamber of Commerce, IV-F-30
          Hambright, Bureau of Air Quality Control, Pennsylvania
            Dept. of Environ. Resources, IV-D-69
          Rector, Air Quality Division, Michigan Dept. of  Natural
            Resources, IV-D-86
          Berle, N.Y. Dept. of Environ. Conservation, IV-D-92
            (Suggests either regional  secondary standard or permit
            each State to sec its own.)
          Hovey, STAPPA, IV-D-101  (Suggests new nationwide dose
            related secondary standard or separate standard for
            each AQCR.)

                              2-7

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               Foster,  Div.  of  Air  Pollution  Control,  State  of
                 Tennessee Dept.  of Public  Health,  IV-D-104

               Potter,  General  Motors,  Corp.,  IV-D-118

               Howison, Air Pollution  League  of Greater  Cincinnati,
                 OH,  IV-D-119

               Eliminate secondary  standard:

               Bargren, Illinois  Manufacturer's Assoc.,  IV-D-43

II.   Health Effects Criteria and  Selection  of Primary  Standard

     A.    Completeness  of data  and  general  validity of conclusions

          1.    Science  Advisory Board  suggested changes  in EPA  interpre-
               tation of various  studies;  EPA has  failed to  correct  many
               of the most significant defects. Hawk, IV-F-1,  p.25.

          2.    Concern  that EPA Science Advisory Board has recommended
               that certain studies not be  included in the Criteria
               documents lest  they  receive  unwarranted emphasis; studies
               should be a valid  part  of the  record unless refuted.
               Rauch, EOF, IV-F-2,  p.2.

          3.    EPA has  not adequately  justified a  primary standard  level
               of 0.10  ppm. Faulkner, Arkansas Dept.  of Pollution  Control
               and Ecology, IV-F-17, p.13;  IV-F-18, and  Stewart, Texas
               Air Control Board, IV-F-17,  p.23; IV-F-20.

          4.    Evaluations of  the validity  and inconsistency of the
               evidence has not been given  sufficiently  objective
               appraisal by EPA.   E.W.  Starke, Shell Oil Co.,  IV-F-11,  p.10;
               IV-F-12.

          5.    The Criteria documents  lack  the kind of convincing evidence
               we'd like to have.  McKenzie,  Assn.  of  Local  APC officials,
               IV-F-17, p.129.

          6.    An ozone standard  based solely on peak  exposures and  annual
               concentration extremes  fails to account for total ozone
               dosage.   Stewart,  Texas Air  Control  Board, IV-F-17,  p.25;
               IV-F-20.

          7.    A large  part of  the  data on  which the standard  is based  used
               measurements of  total oxidants made with  the  inadequate
               potassium iodide method.  McKee, Houston  Health  Dept.,  IV-F-17,
               p.54;  IV-F-22
                                   2-8

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8.   An oxidant or ozone standard should require the presence of
     threshold levels of one or more co-existing substances or
     conditions.  These could include concurrent concentrations
     of: NO  , N02-N0 ratio, NMHC, NO -NMHC ratio, aldehydes, and
     various meteorologic parameters.  Drone, Univ. of Florida,
     IV-D-29.

9.   There is no sound evidence as to health effects to humans
     from oxidants at levels below 0.25 ppm/hr.  EPA should
     consider all evidence and information and should base
     the standard on sound technical data.  Melchior, Associated
     Building Industry (Calif.), IV-D-56.

10.  Properly conducted studies subject to peer review
     support a Threshold no less than 0.30 ppm.  Reilly, E.I.
     Du Pont De Nemours & Co., IV-D-91.

11.  The proposed standard is unsuitable because it is based
     on faulty interpretation of pivotal data, because EPA
     has never defined what constitutes "protection of public
     health", and because the risk assessment technique on
     which it is based in flawed.  Miller, Rio Blanco Oil
     Shale Co., IV-D-93.

     Singlet Oxygen Possibility -

12.  It has just been discovered in Texas Air Control Board
     studies that ozone generators of the corona discharge and
     U.V. types yield ozone and another oxidant, designated
     "singlet oxygen", simultaneously; the amount of singlet
     oxygen produced has been found to be as much as 3 times
     the amount of ozone produced.  This may make worthless
     effects studies using such generators.  Stewart, Texas
     Air Control Board, IV-F-17, p.26-27; IV-D-20.

13.  There is no direct evidence that singlet oxygen is bio-
     logically reactive in the human respiratory tract, and
     finding it in the generated air stream does not warrant
     invalidation of conclusions drawn from experimental
     biological research on ozone.  (The theoretical half-life
     of singlet oxygen.in dark space, such as that in the  lung,
     is only 9.0 X 10"  minutes, that for ozone is 5000 times
     greater.)  Shy, Inst. for Environ. Studies, Univ. of  N.C.,
     IV-D-75.

14.  Further experiments by the Texas Air Control Board indicate
     that the additional oxidant is not singlet oxygen; the specific
     identity remains an open question.  Stewart, Texas Air Control
     Board, IV-D-88.


                         2-9

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B.    Definition of "Adverse Health Effect"

     1.    The term "adverse" (relative to health effects)  has  not
          been adequately defined, but should be used in terms of
          those that we recognize as being  the most susceptible.
          Mullenix, API, IV-F-1.

     2.    It has not been determined whether changes in pulmonary
          function, changes in mean tidal volume or respiratory
          rate, indicate adverse  health effects; scientists  are
          beginning to question whether a change in biochemical
          enzymes is an indication of adverse health effect.   (On
          inquiry to Hackney and  DuBois neither could say
          definitely that change  in respiratory rate or mean  tidal
          volume would lead to a  long-term disease or cause  any
          problem other than a temporary physiological change.)
          Millenix, API, IV-F-1,  p.58-59. (Note: Mullenix implies that
          temporary or reversible changes are not adverse effects.
          IV-F-1, p.60-61.)

     3.    Answers to question of  what constitutes an adverse  effect
          in the continuum of responses which the body makes  to
          pollutant exposures are critical  to the issue at hand.
          Huess, General Motors,  IV-F-1, p.91.

     4.    Quickly reversible irritation experienced for a  short-
          period of time falls in the category of comfort and  well-
          being and is contemplated to be taken into account  in a
          secondary standard.  Van Voorhees, API, IV-F-1,  p.70.

     5.    EPA has failed to adequately define what constitutes an
          adverse health effect and at what  point a measurable
          response is a normal physiological fluctuation within
          homeostasis.  Engel, Motor Vehicle Manufacturers Assoc.,
          IV-F-31, p.9; IV-F-32.

     6.    In response to a question regarding DeLucia and  Adams'
          results and identification of adverse effect:  "...whether
          chest tightness is really a health effect or is  simply
          a  change, I really don't know	"  Engel, Motor Vehicle
          Mfgr. Assoc., IV-F-31,  p.17.

     7.    In response to a panel  question:  "As an M.D. do  you  believe
          that difficulty in breathing or tightness of the chest  as a
          symptom of exposure to  ozone constitutes an adverse  health
          effect?"  Answer: "Yes".  Rokaw, Air Quality Advisory
          Committee, California Dept.  of Health, IV-F-31,  p.72.
                              2-10

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C.   Comments on key studies

     DeLucia and Adams

     1.   EPA significantly misreads the DeLucia and Adams study
          as reporting significant effects at 0.15 ppm.  Mullem'x,
          API, IV-F-1, p.36.

     2.   The DeLucia and Adams study showed no statistically
          significant changes is respiratory pattern (0.15 ppm
          implied).  Mullenix, API, IV-F-1, p.66.

     3.   In DeLucia and Adams studies no data on symptoms are given;
          raw data should be given to permit judgement of its signi-
          ficance.  Huess, General Motors, IV-F-1, p.90.

     4.   Regarding the DeLucia and Adams studies, it is not clear
          that inhalation of ozone via mouthpiece during stressful
          exercise has application to ambient air standard; inhalation
          by mouthpiece itself might have effects.  Schnetzke, Evans-
          ville, IND., Chamber of Commerce, IV-F-1, p.140.

     5.   DeLucia and Adams saw no significant effects from ozone
          exposure below 0.30 ppm in heavily exercising subjects.
          Starke, Shell Oil, IV-F-11, p.12.

     6.   Effects shown by DeLucia and Adams probably include the
          effects of singlet oxygen.  Stewart, Texas Air Control
          Board, IV-F-11, p.27.

     7.   Powers quotes Mullenix, items II.C.I and II.C.2 above.
          Powers, EXXON, IV-F-17, p.80.

     8.   Results of DeLucia and Adams do not support EPA interpre-
          tation.  With or without DeLucia and Adams, real health
          effects due to ozone do not occur in man below 0.25 ppm.
          Walker, Monsanto, IV-F-17, p.112.

     9.   EPA misreads DeLucia and Adams as showing effects at 0.15  ppm
          ozone.   It is asserted that DeLucia and Adams published
          response data for .15 ppm ozone, along with reponse data
          supplied by Adams for two additional  subjects, fail  to  demon-
          strate significance.   Engel, Motor Vehicle Mfgr. Assoc.,
          IV-F-31, p.11-14.

     10.   DeLucia and Adams demonstrated effects at 0.15 ppm ozone
          on six healthy young non-smokers.  The necessary inference
          is that more susceptible populations (asthma  and emphysema
          victims, the elderly, and the young)  would have shown similar
          symptoms at lower level  exposures.   Dixon, California Lung
          Assoc., IV-F-31,  p.56.


                               2-11

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11.  EPA reaches conclusions from DeLucia and Adams  not
     supported by the data.   Reilly, E.I. Du Pont De Nemours
     & Co., IV-D-91.

12.  EPA has misinterpreted  the meaning of the DeLucia and
     Adams study.  Clark, Mfgr. Chemists Assoc.,  IV-D-116.

     Schoettlin and Landau

13.  Even with reinterpretation of Schoettlin and Landau studies,
     there remain problems with reliance on the studies  because
     of: (1) ambiguities in  the studies, and (2)  failure to
     consider more recent well  conducted studies  on  asthmatics
     (Kurata, Hackney).   Mullenix, API, IV-F-1, p.33-34.

14.  Reinterpretation of Schoettlin and Landau results attributes
     an increase in asthmatic attacks to a level  of  0.25 ppm ozone.
     Schnetzke, IV-F-1,  p.138.

15.  Same observation as II.C.14 above.  Collum,  Georgia Environ.
     Protection Division, IV-F-11, p.58.

16.  Upward reassignment of  effects levels have been made for the
     Schoettlin and Landau study; there still remains confusion
     on how to interpret this study.  Engel, Motor Vehicle Mfgr.
     Assoc., IV-F-31, p.10.

17.  EPA's new interpretation of Schoettlin and Landau is
     unnecessarily conservative.  Randle, Yale Environ.  Law
     Assoc., IV-D-114.

     Hammer, et al

18.  An unreliable diary technique was used and there is question
     whether something other than oxidants caused symptoms in
     the Hammer student nurse study.  Mullenix, API, IV-F-1., p.37.

19.  EPA assertions regarding the Hammer study, among others,
     should be reexamined.  Starke, Shell Oil, IV-F-11,  p.12.

20.  Hammer's study has a number of problems; 38 percent of sub-
     jects were smokers and  25 percent had history of allergy.
     No adjustments were made for these.  Engel,  Motor Vehicle
     Mfgr. Assoc., IV-F-31,  p.11.

     Studies showing no effect at levels higher than
     the propsed standard

21.  None of the evidence would justify a standard based on a
     finding of adverse health effects below the range of
     0.25-0.30 ppm (ozone) for 2 hours.  EPA seriously misinter-
     prets the work of DeLucia and Adams.  Hawk,  API, IV-F-1, p.23.

                         2-12

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22.   EPA  identifies  three  kinds  of effects  demonstrated in humans
      at low levels (of  ozone  exposure):  aggravation of asthma,
      reduction  in  pulmonary function,  and chest discomfort and
      irritation of the  respiratory tract.   None of these effects
      has  been demonstrated in even susceptable humans at 0.25 ppm
      ozone  for  2 to  4 hours.   Mullenix,  IV-F-1, p.32.

23.   Hackney exposed asthmatics  to 0.20  ppm ozone for 2 hours
      under  conditions of heat and  exercise  and found no significant
      effect from ozone.  Mullenix, API,  IV-F-1, p.34.

24.   Linn,  et al,  have  shown  no  adverse  effects on asthmatics
      exposed to 0.20 ppm ozone for 2 hours  during exercise.
      Mullenix,  API,  IV-F-1, p.38.

25.   Results by Hazucha (doctoral  thesis) on impariment of
      pulmonary  function at ozone exposures  of 0.25 ppm for
      2 hours are not statistically significant; OeLucia and
      Adams  did  not report  any statistically significant
      effects from  ozone exposures  below  0.30 ppm.  Mullenix,
      API, IV-F-1,  p.36-37.

26.   The  National  Academy  of  Science concluded in 1977 that
      the  effects on  humans  have  been observed only from ozone
      exposures  above 0.25  ppm.   Mullenix, API, IV-F-1, p.38.
      (Note:  Dr.  J.H.B. Gardner,  EPA, pointed out that the
      National Academy of Science recommended to the Congress
      that the 0.08 ppm standard  be maintained. IV-F-1, p.54.)

27.   Human  health  effects  have been observed only from ozone
      exposures  well  in excess  of 0.25  ppm for 2 hours.  Starke,
      Shell  Oil,  IV-F-11, p.10.

28.   The Von Nieding study, Hazucha and  Bates, and various
      Japanese studies should  be  reexamined  by EPA before
      promulgating  a  final   standard.  Starke, Shell Oil,
      IV-F-11, p.12.

29.   Hackney, Bates  and Hazucha, Kerr, Folinsbee, and others
      have observed human effects only  after exposures above
      0.25 ppm ozone  for 2 or more  hours, Starke, Shell Oil,
      IV-F-11, p.12.

30.   Health  effects  are observed above 0.15 ppm 0. in the
      range of 0.37 ppm for 2  hours; no significant adverse
      health  effects  have been observed at lower concentrations
     or dosages.   E.W.  Starke, Shell Oil Co.,  IV-F-11, p.15;
      IV-F-12.

31.  The National Academy of Science has concluded that  exposure
      to 0.25 ppm ozone for 2 to  4  hours is a level  at which
     no adverse effects are observed.   Cyphers, Texas Chemical
     Council, IV-F-17,  p.41.   (In  response to  a question,
     Cyphers stated that this is not an explicit conclusion of
     NAS.    IV-F-17, p.45.)

                         2-13

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     32.  EPA is unable to show that real health effects due to ozone
          occur in man below 0.25 ppm; this is consistent with the
          consensus of most of the informed medical community even
          for susceptible humans.  Walker, Monsanto, IV-F-17, p.112;
          IV-F-28.  (In response to questions, Walker identified
          4 physicians whom he thinks hold this view.  IV-F-17.
          p.121-122.)

     33.  There appears to be no sound evidence of health effects of
          oxidants on humans at levels below 0.25 ppm.   Trimpey,  Bay
          Area League of Industrial Assocs., Inc., IV-D-47.

          Other human studies

     34.  EPA cannot justify a conclusion that Japanese epidemio-
          logical  studies indicate a risk of symptomatic effects  in
          humans from ozone exposures below 0.15 ppm for 1 hour,
          methodology deficiencies undermine their reliability.
          Mullenix, API, IV-F-1, p.40.

     35.  The Science Advisory Board subcommittee urged EPA  to re-
          evaluate the interpretations of findings of Goldsmith's
          and Von  Nieding's studies.  Starke, Shell Oil, IV-F-11, p.20.

     36.  Von Nieding has demonstrated effects on pulumonary function
          of healthy individuals at 0.10 ppm ozone.  Randle, Yale
          Environ. LawAssoc., IV-D-114.

D.   Use of animal studies

     1.    Reference is made to Criteria statements that ozone appears
          to much  more severly affect very young animals than the
          adults of the species, and that recent reports from Japan
          reveal that very young human children experience upper
          airway difficulty at 0.04 ppm ozone.   Rauch,  EOF,  IV-F-1,
          p.12.

     2.    EPA has  not produced an adequate rebuttal to  its observation
          of two years ago that 0.08 ppm ozone can reduce the capability
          of body  defense of animals to fight off infectious bacteria.
          Rauch, EOF, IV-F-1, p.13.

     3.    There is no agreement among experts that humans experience
          the effects which have been attributed to some animals.
          Mullenix, API, IV-F-1, p.39.

     4.    The animal infectivity model gives no reason  to believe that
          an effect in humans would occur as low as 0.10 ppm ozone.
          Huess, General Motors, IV-F-1,  p.94.
                              2-14

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     5.   Health experts do not agree on extrapolation of the animal
          infectivity experience to man.  There is no evidence of
          infection effect in epidemiologic studies in places like
          Los Angeles.  Huess, General Motors, IV-F-1, p.100-101.

     6.   Animal studies show effects at low levels; there are
          difficulties in translating adverse effects in animals
          to adverse effects in humans.  Starke, Shell Oil, IV-F-11,
          p.20.

     7.   Research done with young animals addresses a basic problem.
          Animal studies are critical because they look at mechanisms
          whereby humans might be affected but cannot be tested; one
          will not subject a three-week old infant to experimental
          exposures to oxidants.  Gluckman, Florida Lung Assoc.,
          IV-F-11, p.69.

     8.   Findings in five successfully replicated studies show
          that test animals suffer increased susceptibility to
          respiratory disease and mortality after 3-hour exposures
          to ozone at 0.08 to 0.10 ppm.  Dixon, Calif. Lung Assoc.,
          IV-F-31, p.57.

     9.   Susceptibility of experimental animals to respiratory
          infection increases after exposure to 0.10 to 0.15 ppm
          ozone.  Since the biochemistry in man is similar to such
          animals in most respects it is reasonable to expect that
          humans may be affected at these concentrations.  Allen,
          Concerned citizen (Pomona College), IV-F-40.

E.   Exposure to sensitive groups
     (See also II-C-11, 12, 13, 19, 20, 21, 29)

     1.   Sensitive people should be protected, but the degree
          and nature of that protection requires thought and
          discussion....  Staying indoors for a few hours a year
          may be sufficient to protect the most sensitive people.
          Huess, General Motors, IV-F-1, p.91-92.

     2.   Testing methods are deficient because one does not test
          sick humans to learn how much sicker they become when
          subjected to increased levels of oxidants.  Gluckman,
          Florida Lung Assoc., IV-F-11, p.73.

     3.   The public should  be warned that the concept of thresholds
          may be inappropriate in the case of ozone; yet tables in
          FR26966-7 are based on threshold estimates for a precisely
          defined segment of the most sensitive population.  EPA
          should not be obligatea at this time to express a standard
          which addresses the most sensitive population; EPA states
          that there is insufficient data to get such a standard.
          Faulkner, Arkansas Dept. Pollution Control and Ecology,
          IV-F-17, p.11-12.

                                2-15

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     4.    Exposure to ozone in the range 0.15-0.25 ppm may impair
          mechanical  function of the lung and may induce respiratory
          and related symptoms in sensitive groups; this has  important
          public health implications, particularly for the developing
          lungs of young children.  (Quoting EPA Health Advisory
          Panel), Martin, Houston Sierra Club, IV-F-17, p.19.

     5.    A person who is sensitive to ozone should be given  credit
          for an ability to recognize when he's affected by ozone
          and go indoors.  The concept of protecting the most
          vulnerable subjects is open-ended because the sensitivity
          begins at zero and works upward.  Walker, Monsanto,
          IV-F-17, p.126.

     6.    Although laboratory investigations with humans have apparently
          not demonstrated significant effects at levels below about
          0.25 ppm, they were done with ozone, not smog, and  on healthly
          subjects, not those with respiratory problems.  Pitts,
          Concerned citizen, IV-F-1, p.23.

     7.    The reactions of healthy young adults at 0.15 ppm ozone
          implies effects at lower levels for more susceptible
          people.  Oixon, Calif. Lung Assoc., IV-F-31, p.57.

     8.    If 0.10-0.15 ppm ozone causes observable effects in
          normal exercising human subjects, then it is reasonable
          to expect that lower levels may cause similar effects
          in exercising sensitive elements of the population.
          Allen, Concerned citizen, IV-F-40.

     9.    Exposure to oxidants can bring on asthma attacks in sensitive
          people.  Current standards are based on effects  on  adults;
          relaxation of the standard would pose an even greater threat
          to children, whose tolerance is lower and susceptibility
          higher to such pollutants.  Lui, American Lung Assoc. of
          Colorado, IV-D-58.

     10.   Concern is expressed for exposures of young  children,
          especially concern for protection of children with  asthma.
          Mehlhaff, Oregon Lung Assoc., IV-D-59.

F.    Additive and synergistic effects, mixed exposures, and 0  vs 0.,
                                                             A     J
     1.    Total exposure to the mixture of photochemical oxidants
          should be the target, including peak concentrations  of
          synergistic materials.  Faulkner, Arkansas Dept. of
          Pollution Control and Ecology, IV-F-17, p.10.

     2.    We must have more information about human health effects
          of ozone and more research on the synergistic reactions
          of ozone with other atmospheric agents.  Martin, Houston
          Sierra Club, IV-F-17, p.21.

                               2-16

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     3.   Measured ozone  levels raise serious questions about possible
          health effects  of other oxidant constituents such as
          aldehydes,  peroxyacetylnitrate, peroxides, and others.  McKee,
          Houston Health  Dept., IV-F-17, -.57.

     4.   A report in  Environment, June 1978, indicates that some
          insecticides  produced toxic effects 30 times greater with dust
          and ozone than  without.  Bass, Dallas League of Women Voters,
          IV-F-17, p.71.

     5.   Ozone does  not  occur alone in urban atmospheres; it must
          be considered in relation to other contaiminants.  Harrison,
          City of San Antonio, IV-F-17, p.93.

     6.   The health  impacts of photochemical air pollution arise not
          only from ozone, but also from the spectrum of other gas and
          particulate  pollutants which coexist with it.  Pitts, Concerned
          citizen, IV-F-31, p.23.

     7.   Additive health effects are real; nitrous oxides have much the
          same effects  as ozone.  Goldsmith, Sierra Club, IV-F-31, p.63.

     8.   The effects of  ozone may be more severe in the presence of
          other pollutants.  Though not extensively studied, this has
          been demonstrated and there is no reason to believe that the
          worst case  situation has yet been identified.  Allen, Concerned
          citizen, IV-F-40.

     9.   The presence  of other oxidants and the possibility of
          additive or synergistic effects of ozone and other pollutants
          argue against changing the standard.  Chalupnik, Washington
          Air Quality Coalition, IV-D-39.

     10.  Synergistically the effects of chemicals can be far more
          damaging to health (than the agents alone, -implied).  Lui,
          American Lung Assoc. of Colorado, IV-D-58.

     11.  Relaxing the  standard now when there is new evidence for
          effects from  combinations of ozone and other common pollutants
          appears irresponsible.  Mehlhaff, Orgeon Lung Assoc., IV-D-59.

G.   Margin of safety

     Inadequacies:

     1.   Quote, Chairman, Panel for Photochemical Oxidants, WHO, "It is
          apparent that any primary protection standard between 0.05 and
          0.10 ppm will provide the narrowest margin of safety against
          some possible detrimental effects in the more susceptible
          segments of the population."  Rauch, EOF, IV-F-1, p.11. (Rauch:
          Don't believe they have adopted the standard. IV-F-1, p.17.)

                               2-17

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2.   Criticizes means by which EPA reached the proposed level  of
     0.1 ppm ozone; quotes Federal Register preamble p.26967,  col.l,
     2nd complete paragraph:

               "These figures illustrate several  important
          points: (1) all alternative standard levels reflect
          some risk, (2) there is not sharp break in the
          probability estimates that would suggest selecting one
          alternative standard level over another, and (3) the
          choice of a standard between zero and a level at which
          health effects are virtually certain (0.15 ppm) is
          necessarily subjective."

     The next paragraph states in part:
               "Based on all these data, it has been determined
          that a standard of 0.08 ppm does not appear necessary
          to protect public health.  However, at this time it
          appears that a standard above 0.10 ppm would not
          adequately protect public health."

     EPA has not justified  it decision in terms of the statutory
     requirement for an adequate margin of safety, and the
     conclusion  is  legally  inadequate.  Rauch, EDE,  IV-F-1,
     p.10-11.

 3.   EPA must develop a  legal rationale for a margin of safety.
     Rauch, EOF, IV-F-1, p.18.  This is necessary in situations
     wherein no  threshold p_er_ se_  can be identified.  Rauch, EOF,
     IV-F-2, p.3.

 4.   With health effects occurring  around 0.15 ppm ozone, a
     standard of 0.10 ppm gives an  excessively low safety
     factor.  No information  is offered on how the effects of
     the proposed  increase  in ozone level will synergistically
     interact with  other air  pollutants.  Mannchen,  Concerned
     citizen,  IV-F-6.

 5.   Quotes NAS  1974 review of standards  for  Senate  Committee on
     Public Works  to the effect that a 20 percent margin of
     safety is unreasonably low when experimental error  in
     controlled  experiments is a  least 35 percent and  is probably
     much greater  in uncontrolled  epidemiologic  studies.  Dixon,
     Calif. Lung Assoc.,  IV-F-31,  p.59.

 6.   Health effects data, public  responses, and  new  laboratory
     experimental  work  indicate that for  0.1  ppm level the margin
     of safety against  health effects  is  quite scanty.   Rokaw.
     Air Quality Advisory Committee, Calif. Oept. of Health,
      IV-F-31,  p.71.

 7.   The present 0.08 ppm standard  allows a very slight  margin
     of safety.  Woodhull,  Conn.  Oept. of Health,  IV-D-57.


                            2-18

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Adequate:

8.   There are questions regarding  the DeLucia and Adams studies,
     but proceeding  on  the  basis  that they are valid, the ENCON
     and STAPPA  proposed standard of 0.12 ppm ozone will still
     have an adequate 25 percent margin of safety.  Hovey, STAPPA,
     IV-F-1, p.116.

9.   If there is confidence that effects below a particular level
     are unlikely  even  in sensitive groups, then an adequate margin
     of safety has been identified  and the standard may be set at
     that level.   Hawk, API,  IV-F-1, p.28.

10.  Somewhere in  the range 0.25 to 0.30 ppm is the level at which
     no significant  health  effects  occur.  Adding to that a margin
     of safety,  0.02 ppm was  used in the 1971 standard, suggests
     an appropriate  standard.  Hawk, API, IV-F-1, p.54.

11.  Regarding a panel  question on margin of safety:  Two things
     at least should be considered, (1) attainability of the
     standard, and (2)  the  magnitude of risk associated with any
     particular  level.  Starke, Shell Oil Co., IV-F-11, p.18.

12.  Consistency with past  decisions would have the new standard
     set at 80 percent  of the health effect level.  Foster, Tenn.
     Dept. Public  Health.   IV-F-11, p.30.

13.  The standard  should be 0.12 ppm for 1 hour; this maintains
     the 25 percent  margin  of safety of the original standard.
     Collum, Georgia Envir. Protection Division, IV-F-11, p.59.

H.  The margin of safety previously used would result in a new
     standard of 0.2 ppm ozone	  An additional  margin of
     safety is provided by  the fact that indoor levels of ozone
     have been shown to be  less than half the outdoor levels.
     Cyphers, Texas  Chemical Council, IV-F-17, p.42.

15.  Indoor ozone levels are lower than corresponding outdoor
     levels; for sensitive  people, usually indoors, an additional
     margin of safety is provided.  Feldcamp, Houston Chamber  of
     Commerce, IV-F-17, p.104.

16.  We should establish a  standard at 0.02 ppm below a health
     effects threshold level.   Engel,  Motor Vehicle Mfgr.  Assoc.,
     IV-F-31, p.17.

17.  A 0.12 ppm standard with a 0.15 ppm effects level  has the
     same 20 percent margin of safety  as was  adopted for the
     current standard.   Ledbetter, Ga.  Dept.  of Natural  Resources,
     IV-D-33.


                           2-19

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Excessive:

18.  With no effects identified below  0.30 ppm (ozone)  EPA has
     offered inadequate explanation for the excessive margins
     of safety inherent in the present standard and the  proposed
     primary standard.   Huess, API, IV-F-1, p.22.

19.  EPA concludes that the margin of safety should be 2 1/2
     times greater than that set in 1971.   This is based on
     several studies which supply scanty support.   Mullenix,
     API, IV-F-1, p.39.

20.  The proposed standard has an unjustifiably large margin of
     safety.  Starke, Shell Oil Co., IV-F-11, p.15.

21.  In opting for such a large safety factor (0.1 ppm standard
     vs 0.25 ppm effects level) EPA overlooked a major safety
     factor in the enormous difference between (outdoor) monitoring
     values and actual  (indoor) exposures.   Walker, Monsanto,
     IV-F-17., p.113.

22.  Considering Schoettlin and Landau, DeLucia and Adams, and
     the Japanese studies, it is concluded  that a NAAQS  of 0.12 ppm,
     or possibly 0.14 ppm ozone would provide an adequate margin
     of safety.  Robinson, Vulcan Materials Co., IV-D-87.

23.  EPA has used an excessive margin of safety in the current
     proposal.  Clark,  Manufacturing Chemists Assoc., IV-D-116.

24.  Reconsider whether 0.05 ppm margin of safety is essential.
     Potter, General Motors, Corp., IV-D-118.

Cost Considerations:

25.  EPA should consider cost/effectiveness in evaluations to
     determine the margin of safety for the standards.  Huess,
     General Motors, IV-F-6.

26.  The tremendous impact on the economy by restrictive
     standards should persuade EPA to weigh carefully whether
     a safety margin as large as 0.05 ppm is essential.   Huess,
     General Motors, IV-F-1, p.98.

27.  Since the proposed standard is substantially below  the
     level of adverse health effects, the attainability  and
     economic impact of the standard become important consider-
     ations in determining the margin of safety.  Stone, Western
     Oil and Gas Assoc., IV-F-31, p.49.

28.  Cost is a consideration in factor of safety for any level
     above zero.  Reilly, E.I. De Pont De flemours & Co., IV-D-91.
                           2-20

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     General considerations:

     29.  In setting a standard the margin of safety is critical
          (concern for effect on children).  Ellison, Council woman,
          Ventura, CA.,  IV-F-31, p.31.

H.   Procedural issues

     1.   EPA has chosen to rely on an irregular Advisory Panel
          instead of on  recommendations of the statutory Science
          Advisory Board.  Hawk, API, IV-F-1.

     2.   EPA has developed the standard through an irregular
          process based  on conclusions rejected or severly ques-
          tioned by the  legitimate expert scientific review body.
          Hawk, API, IV-F-1, p.26.

     3.   API questions  whether the appropriate or even the required
          use was made of the Scientific Advisory Board which has
          legal status under the Clean Air Act and is concerned with
          procedural aspects relative to the Advisory Panel on  Health
          Effects.  Hawk, API,  IV-F-1, p.50-51.

     4.   API contends that certain legal requirements on establishment
          and use of Advisory Committees were not followed in the case
          of the Advisory Panel on Health Effects.  Van Voorhees,
          API,  IV-F-1, P.51.

     5.   The Advisory Panel on Health Effects met privately and a
          complete record of its deliberations has not been made
          available to the  public.  Powers,  EXXON, IV-F-17, p.82.

     6.   EPA did not  seek  Science Advisory  Board Review of the proposed
          standard and failed to accord  proper weight to SAB recommen-
          dations for  changes in the  revised criteria document.  EPA
          did not place  primary reliance for the choice of standard
          on the revised criteria, but used  staff papers, an irregular
          Advisory Panel, and an unreviewed  experimental risk assess-
          ment  technique.   Spaulding, Western Oil and Gas Assoc.,
          IV-F-31, p.44.

     7.   EPA does not incorporate the provisions of the Clean  Air
          Act which deal with significant deterioration into the
          revision of  the standard.   Faulkner, Ark. Dept. of Pollution
          Control and  Ecology,  IV-F-17,  p.12.

     8.   The advisory panel on health effects contravenes the  Federal
          Advisory Committee Act of 1972, and was not "fairly balanced".
          Reilly, E.I. Du Pont  De  Nemours &  Co.,  IV-D-91.

                                2-21

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III.  Welfare Effects  Criteria and Selection  of the Secondary Standard

     A.    Completeness and reliability of data and conclusions

          1.   In considering effects  on  vegetation there is a  failure  to
               distinguish between the effects of ozone and those  of other
               photochemical  oxidants. There is  apparent reliance on the
               results of vegetation studies using extremely sensitive
               strains which  overstate the aggregate effects caused by
               ozone  in the ambient air.   Hawk, API, IV-F-1, p.30.

          2.   Experiments on vegetation  are flawed because in  their
               design the large natural ozone burden was not taken into
               account; clean filtered air was used for control  rather
               than natural ozone.  Huess, General Motors, IV-F-1, p.97.

          3.   It has not been adequately demonstrated that secondary
               standard of 0.08 ppm is necessary  to protect welfare.
               Smither, Div.  of Air Pollution Control, Kentucky Dept. for
               Natural Resources & Environ.  Protection, IV-D-68.

     B.    Effects levels and  damage functions

          1.   There  is no evidence that  a secondary standard more stringent
               than the primary standard  is  necessary to protect vegetation -
               generally thought to be the main basis for the secondary
               standard.  Huess, General  Motors,  IV-F-1, p.86.

          2.   Except for limited sensitive  species most plants  are not
               harmed at levels well above the secondary standard;  review  of
               the proposed level and  averaging time is advocated.   Suggest
               consideration  of a growing-season  standard is a  secondary
               standard is justified.   Hovey, STAPPA, IV-F-1, p.120.

          3.   Setting a standard for  ozone  alone fails to consider other
               phytotoxic pollutants;  synergistic interactions,  principally
               of ozone and sulfur dioxide,  can cause injury at  lower concen-
               trations than  can the pollutants separately.  Miller, U.S.
               Forest Service, IV-F-31, p.34.

     C.    Cost and benefits

          1.   An adequate economic analysis will  reveal  that the  pro-
               posed  secondary standard is far too stringent to protect
               the public welfare.  (To be expanded in written comment.)
               Hawk,  API, IV-F-1, p.29.

          2.   Economic assessment for welfare effects is based on  overly
               optimistic assumptions  of  ozone air quality improvements
               resulting from RACT;  the RACT cost estimate is substantially
               low; inflationary impact is ignored.   Pierrard, API,  IV-F-1,
               p.46-47.
                                   2-22

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          3.   The analysis  done on  the  secondary standard doesn't allow
               increment analyses  to show  total cost in achieving various
               levels of a standard; costs  and benefits cannot be portrayed.
               Everett, API,  IV-F-1, p.79.

          4.   There are alternative strains of vegetation, more resistant
               to ozone damage, which should be considered in the trade-offs
               of cost-benefit analyses.   Everett, API, IV-F-1, p.82.

          5.   Costs of controlling  from 0.10 to 0.08 ppm ozone is estimated
               by EPA to range from  $1 billion to $3 billion, but the economic
               benefit is unknown; it must  be less than the $300 million which
               EPA estimates  to be the vegetation damage from ozone.  Huess,
               General Motors, IV-F-1, p.97.

          6.   It is obvious  that  an impact  (by pollution) on cultivated
               crops would adversely affect  food productivity and the national
               economy; erosion of air quality standards in incompatible with
               the long-term  maintenance of  these national assets.  Miller,
               U.S. Forest Service,  IV-F-31, p.36.

          7.   The Clean Air  Act requires  consideration of economic factors
               in setting the secondary  standard; EPA has failed to do so.
               The required cost-benefit analyses have not been done.  Stone,
               Western Oil and Gas Assoc.,  IV-F-31, p.50.

          8.   The cost figure of  significance is the differential cost
               of control necessary  to achieve the secondary standard
               over and above the cost to  achieve the primary standard.
               Hambright, Bureau of  Air  Quality Control, Pennsylvania
               Dept. of Environ. Resources,  IV-D-69.

          9.   The level of  the secondary  standard is improper because
               it does not account sufficiently for economic values and
               improper criteria for plant damage were adopted.  Miller,
               Rio Blanco Oil Shale  Co., IV-D-93.
IV.   Risk Assessment
          1.   EPA's risk assessment technique remains incomplete, its use in
               standard setting is premature and inappropriate.  (Defects will
               be detailed in API's written comments.)  Hawk, API, IV-F-1, p.27.

          2.   The risk assessment method used extensively by EPA in arriving
               at the proposed 0.10 ppm standard has not had complete review
               by the Science Advisory Board or others.  If it is to be so
               used, the method should be published with opportunity for
               comment before the new standard is promulgated.  Stewart,
               Texas Air Control Board, IV-F-17, p.24.
                                    2-23

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          3.    EPA has not had adequate review of the risk assessment method-
               ology.   Powers, EXXON,  IV-F-17, p.81.

          4.    The risk assessment results are unclear.   The states  would
               like to review the EPA  assessment approach.  Hovey,  STAPPA,
               IV-F-1, p.117.

          5.    There is need to assess risk to human  health.  Starting with
               the lowest  level for which there is significant adverse effect
               on health one would assess risks at that  level  and below that
               level.   Starke, Shell Oil  Co., IV-F-11, p.18.

          6.    We need to  reassess the total  system and  the methods  by which
               EPA establishes standards.  We are giving economic consideration
               too much weight.  Gluckman, Fla. Lung  Assoc., IV-F-11, p.73.

          7.    The risk assessment technique should not  be used because
               it has not  been reviewed adequately by the Science Advisory
               Board or the scientific community.  Miller, Rio Blanco
               Oil Shale Co., IV-D-93.

V.   Form of the NAAQS

     A.   Ozone standard vs oxidant standard

          1.    Ozone standard is preferred to oxidant standard

               Huess, API, IV-F-1, p.85.
               Hovey, STAPPA, IV-F-1,  p.117.

               Schnetzke,  Evansvilie,  Ind., Chamber of Commerce,
                 IV-F-1, p.136.

               Starke, Shell Oil Co.,  IV-F-11, p.8.
               Foster, Tenn. Dept. Public Health, IV-F-11, p.38.
               Coll urn, Ga. Environmental  Protection Division,
                 IV-F-11,  p.57.

               Martin, Houston Sierra  Club, IV-F-17,  p.18
                 (Standards are needed for other photochemical
                  oxidants as well.)
               Stewart, Texas Air Quality Control Board, IV-F-17, p.70.
               Bass, Dallas League of  Women Voters,  IV-F-17, p.70.
               Powers, EXXON, IV-F-17, p.79.
               Walker, Monsanto, IV-F-17, p.111.
               Stone, Western Oil and  Gas Assoc., IV-F-31, p.47.

               Sierra Club, IV-F-37.
               Beadle, U.S. Dept. of Energy,  IV-D-21.
               Auberle, Colorado Dept. of Health, IV-D-22.


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     Morgan and Lash, U.S. Dept. of Transportation,  IV-0-31.
     Noren, Envr. Health Admin., Maryland Dept.  of Health
       and Mental Hygiene, IV-D-42.
     McNulty, League of Women Voters of the U.S., IV-D-71 .
     Bennett, Dept. Vegetable Crops, Univ. of Calif.,  IV-D-72 .
     Robinson, Vulcan Materials Co., IV-D-87 .
     Hurstell, New Orleans Public Service Inc.,  IV-D-90.
     Berle, N.Y. Dept. of Environ. Conservation, IV-D-92.
     Scott, Arizona Dept. of Health Services, IV-D-98.
     Cortese, Div. of Air and Hazardous Materials, MA,  IV-D-99.
     Hovey, STAPPA, IV-D-101.
     Peterson, Eastman Kodak Co., IV-D-103.
     Smith, Iowa-Illinois Gas & Electric Co., IV-D-105.
     Coerver, Louisiana Air Control Commission,  IV-D-106.
     Griffith, Berkeley, Charleston, Dorchester  Council of
       Governments, S.C., IV-D-115.
     Clark, Manufacturing Chemists Assoc., IV-D-116.
     Howison, Air Pollu. Control League of Greater Cincinnati,
       OH, IV-D-119.
     Oxidant standard is preferred to ozone standard
     Roberts, Concerned citizen, Denver, CO., IV-D-5.
     Henke, Water and Wastewater Systems, Streamwood,  IL.,
       IV-D-9 (03 is water additive.)
     Pitts, Concerned citizen, IV-F-31, p.23.
     Rokaw, Air Qua!. Advisory Comm., Calif. Dept. of
       Health, IV-F-31, p.70.
     Sagady, Mich. Lung Assoc., IV-D-28.
     Serdoz, Nevada Dept. of Conservation and Natural
       Resources, IV-0-48.
     Okey, Envirotech Research Center,  Utah, IV-D-65,
       (03 is water and wastewater additive.)
     Kominek, Envirotech,  EIMCO Process Machinery Div.,
       Utah, IV-D-67. (03 is water additive.)
     Austin, Calif. Air Resources Board, IV-D-120.
3.    General
     Redesignation as an ozone standard (vs oxidant)  does  not
     remove the confusion of these agents in the criteria
     document.  McKee, Houston Health Dept., IV-F-17,  p.53.
                           2-25

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          Although the new standard addresses  ozone only,  the
          discussion relates to the entire photochemical  system;
          other constituents are not properly  addressed.   McKenzie,
          Assoc. of Local  ARC Officials,  IV-F-17,  p.130.

B.   Separate PAN standard

     1.   Agree with EPA that a separate  PAN standard should not  be
          promulgated at this time:

          Starke, Shell Oil Co., IV-F-11,  p.8.

          McKee, Houston Health Dept.,  IV-F-17,  p.58.
            There is insufficient knowledge at this time,  but  the
            problem may be as serious as  that  of ozone.

          Auberle, Colorado Dept. of Health, IV-D-22.
            PAN should be a pollutant of  concern and specific
            studies undertaken.

          Bennett, Dept. Vegetable Crops,  Univ.  of Calif., IV-D-72
            (PAN standard should be developed  as soon as  possible.)

          Cortese, Div. of Air & Hazardous Materials, MA,  IV-D-99.

C.   Statistical form vs deterministic  form

     1.   Statistical form is preferred over deterministic form

          Schnetzke, Evansville, Ind. Chamber  of Commerce, IV-F-1,
            p.141.

          Powers, EXXON, IV-F-17, p.79.
            (Need detailed technical analysis  supporting  specific
             choice of form.)

          McKenzie, Assoc. of Local APC officials,  IV-F-17, p.132.
            ("We ask that a still more  improved  statistical base
             be utilized in determining the exceedance kind of
             discussion.")

          Stone, Western Oil and Gas Assoc., IV-F-31, p.46.
            (Form adopted still has problems.)

          Beadle, U.S. Dept. of Energy, IV-D-21.

          Auberle, Colorado Dept. of Health, IV-D-22.
            (Grave reservation concerning  some aspects of
             statistical form proposed.)

          Morgan and Lash, U.S. Dept. of  Transportation,  IV-D-31.

          Serdoz, Nevada Dept. of Conservation and  Natural Resources,
            IV-D-48.

          Bennett, Dept. Vegetable Crops,  Univ.  of  Calif., IV-D-72.

          Miller, Rio Blanco Oil Shale  Co., IV-D-93.
            (Some reservations regarding  proposed  form.)

                                2-26

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          Cortese,  Div.  of  Air  &  Hazardous Materials, MA, IV-D-99.

          Peterson,  Eastman Kodak,  IV-D-103.

          Smith,  Iowa-Illinois  Gas  &  Electric Co., IV-D-105.

          Coerver,  Louisiana Air  Control Commission, IV-D-106.

          Austin, Calif. Air Resources  Board, IV-0-120.

     2.   Oppose  statistical form

          Hovey,  STAPPA, IV-F-1,  p.118.
             (Prefers deterministic  to the proposed statistical
             form,  IV-F-1,  p.127-129.)

          Collum, Georgia Envr. Protection Div., IV-F-11, p.61.
             (Prefers deterministic, IV-F-11, p.64.)

          Faulkner, Ark. Dept.  Pollution Control and Ecology,
             IV-F-17, p.10,11,15.

          McNulty,  League of Women  Voters of U.S., IV-D-71.

          Rector, Air Quality Div., MI, IV-D-86.

          Scott,  Arizona Dept.  of Health Services, IV-D-98.

     3.   General comments

          Deterministic  form is inappropriate, but it is doubtful
          that the  proposed statistical form is an improvement.
          Starke, Shell  Oil  Co.,  IV-F-11, p.9.

          Both current (deterministic) and proposed (statistical)
          forms,  based on peak  exposures, fail to account for total
          ozone dosage.  Stewart, Texas Air Control Board, IV-F-17,
          p. 25,  30-32.

          Weibull distributions have a tendency to predict highest
          or second highest  annual  values greater than actually
          occur.  Ollison,  Amer.  Petroleum Institute, IV-D-76.

          A more  sophisticated  procedure is needed in handling of
          missing data.  Hovey, STAPPA, IV-D-101.

D.   Allowable exceedances

     1.   Opposes relaxing  exceedances from 1  hourly average to 1
          day with hourly averages over the standard.  Mannchen,
          Concerned citizen, Houston, TX, IV-F-6.

     2.   Supports 1-hour averaging time for both primary and
          secondary standards.   Bennett, Oept. Vegetable Crops,
          Univ. of Calif.,  IV-D-72.


                                2-27

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3.   Assess compliance on basis of number of days with one or
     more hourly exceedances: (Problem: multiple exceedances
     in successive hours.)

          Pierrard, API, IV-F-1, p.42-43.
          Hovey, STAPPA, IV-F-1, p.118,126.

          Cyphers, Texas Chemical Council, IV-F-17, p.45.

          McKenzie, Assoc. of Local APC Officials, IV-F-17,
            p.134.

          Stone, Western Oil and Gas Assoc., IV-F-31, p.47.
          Morgan and Lash, U.S. Dept. of Transportation,
            IV-D-31.
          Saiger, Bureau of Air Quality and Occup. Hlth,
            Kansas Dept. of Hlth. & Environ., IV-D-77.

          Rector, Air Quality Div., Michigan Dept. of Natural
            Resources, IV-D-86.

          Berle, N.Y. Dept. of Environ. Conservation, IV-D-92.
          Miller, Rio Blanco Oil Shale Co., IV-D-93.
          Beuforado, Minnesota Minning & Manufacturing Co.,
            IV-D-94.
          Hovey, STAPPA, IV-D-101.

          Clark, Manufacturing Chemists Assoc., IV-D-116.

Other limits of exceedance

4.   Recommends averaging time interval of 24 hours.   Osegueda,
     Virginia APC Board, IV-F-1, p.131.  (Because of reference
     to STAPPA this is assumed to mean hourly exceedances  in
     one day.)

5.   Propose that there be allowed more consecutive hours  at
     lower readings before there is a designation of non-
     attainment.  Schnetzke, Evansville Chamber of Commerce,
     IV-F-1, p.143.

6.   Suggest that the standard disregard exceedances  attributable
     to natural causes; determinations of freon concentrations
     and Be  activity can be used to distinguish anthropogenic
     genesis and incursions.  Foster, Tenn. Dept.  of  Public
     Health, IV-F-11, p.32.

7.   Recommends consideration of several  days or several conse-
     cutive hours of exceedance in  determining violations.
     Collum, Georgia Envir. Protection Division, IV-F-11,  p.64.

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8.   Exceedances should discount events associated with unusual
     meteorological conditions.  Faulkner, Ark. Oept.  of Pollution
     Control and Ecology, IV-F-17, p.11.

9.   Violation should be based on 3 or more days of exceedances.
     Cyphers, Texas Chemical Council, IV-F-17, p.43.

10.  The number of allowable exceedances should have sound
     statistical basis; it should take into account unique
     meteorologic events causing more than 1 high hour in a
     single day or single high levels during non-ozone seasons.
     Auberle, Colorado Dept. of Health, IV-D-22.

11.  A minimum of 20 exceedances should be allowed to compensate
     for God made ozone.  Mole, Cook County Dept. of Envr. Control,
     (IL), IV-D-30.

12.  A one hour value one time per year is overkill.  Daniel,
     Va. ARC Board, IV-D-36.

13.  A localized normal should be established for abnormal
     meteorological events leading to exceedances.  Moss, Wasatch
     Front Regional Council (Utah), IV-D-40.

14.  Provision must be made for setting aside events in aerometric
     data record which are due to natural sources.  Bailey, API,
     IV-F-1, p.56.

15.  A standard involving only one hour is untenable.   Mattson,
     Va. Air Pollution Control Board, IV-D-70.

16.  Exceedances caused by metorological events and instrument
     malfuction or unusual event should be discontinued.  Koslow,
     Yolo-Solano, Air Pollution Control District, IV-D-83.

17.  Averaging time for exceedances should be 3 hours.  Hurstell ,
     New Orleans Public Service, Inc., IV-D-90.

18.  Prefer assessment of compliance to be based on percent of
     hourly exceedances per year.  Cortese, Div. of Air &
     Hazardous Materials, MA,  IV-0-99.

19.  Recommend statistical standard based on a percentile of
     hours (preferably days) of exceedances.  Coerver,
     Louisiana Air Control Commission, IV-D-106.

20.  Allowable frequency of exceedance should be changed to a
     more robust statistic.  Potter, General Motors Corp., IV-D-118.
                           2-29

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          Secondary standard
          21.   There appears to  be  no  justification  for  the  secondary standard
               of 0.08 ppm on a  1-hour average.  Consider  a  growing season
               standard if a secondary standard  is justified.  Hovey, STAPPA,
               IV-F-1, p.120.
          22.   8-hour secondary  standard  may  be  appropriate.   Cortese,
               Div. of Air & Hazardous Materials, MA,  IV-0-99.
          23.   Favor 0.08 ppm 8-hour averaging time.   Smith,  Iowa-
               Illinois Gas & Electric Co.,  IV-D-105.
VI.  Implementation and Attainability
     A.    Natural background levels of ozone
          1.    Standard should consider high  natural  background  levels of ozone
               Hawk, API, IV-F-1,  p.29.
               Pierrard, API, IV-F-1,  p.43,44,48.
               Bailey, API, IV-F-1, p.56.
               Huess General Motors, IV-F-1,  p.86.
               Hovey, STAPPA, IV-F-1,  p.126.
               Osegueda, Mattson,  Virginia APC Board,  IV-F-1,  p.131.
               Packnett, Steams-Roger, Denver,  CO,  IV-0-17.
               Faulkner, Ark. Dept. of Pullution Control and Ecology, IV-F-11,
                 p.10.
               Melchior, Associated Building  Industry  of Northern California,
                 IV-D-56.
               Milbrodt, South Lake Tahoe, Calif.,  IV-D-60.
               Smither, Div. of  Air Pollu. Control,  Kentucky,  IV-D-68.
               Koslow, Yolo-Salano, IV-D-83.
               Berle, N.Y. Dept. of Environ.  Conservation, IV-D-92.
               Miller, Rio Blanco  Oil  Shale  Co., IV-D-93.
               Beuforado, Minnesota Mining &  Manufacturing Co.,  IV-D-94.
               Hovey, STAPPA, IV-D-101.
               Griffith, Berkeley,  Charleston, Dorchester  Council of
                 Governments, S.C., IV-D-115.
               Madsen, White River Shale  Project,  IV-D-117.

                                     2-30

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     2.    Standards  are  unattainable because  of  natural  background

           Congress  intended  standards to  be attainable;  the  proposed
           secondary  standard is  rendered  unattainable  by natural back-
           ground ozone.   Hawk, API,  IV-F-1, p.29.

           Extreme measures in SIP's  will  not  achieve attainment because
           of the impact  of natural ozone.  Pierrard, API,  IV-F-1, p.48.

           Increasing evidence indicates that  ozone from  natural sources
           precludes  attainment of present  standards in many, if not most,
           areas.  Starke, Shell  Oil  Co.,  IV-F-11, p.10.

           0.08  ppm standard  is exceeded by natural background ozone.
           Foster, Tenn.  Dept. of Public Health,  IV-F-11, p.31; IV-D-104.

           Natural ozone  may  exceed 0.08 to 0.12  ppm on a regular basis.
           Davis, Ga.  Inst. Tech.,  IV-F-11, p.40.

           0.10  ppm ozone cannot  be achieved in some pristine areas
           because of natural  background.   Packnett, Steams-Roger,
           IV-F-17, p.73.  (e.g.  at elevations  over 5,000 to 6,000 ft.,
           IV-F-17, p.76.)

           Standard will  be impossible to meet  because of intrusions
           of stratospheric ozone.  Hodges, Tenn. Dept. of Public Health,
           IV-D-20.

           In remote  parts of the country natural God made ozone frequently
           exceeds the standard.   Mole, Cook County Dept. of Environmental
           Control, IV-D-30.

           Natural Ozone  will  exceed  0.10 ppm.  Potter, General  Motors
           Corp., IV-D-118.

B.   Non-background  attainment problems

     1.    Relaxation of  the  standard  may change some urban areas from
           non-attainment to  attainment, permit greater hydrocarbon
           emissions, and contribute  to or  aggravate violations  downwind.
           Rauch, EDF, IV-F-1, p.14.

     2.    EPA's failure  to consider  adequately the role of nitrogen
           oxides in  its  control  strategies is a serious deficiency.
           The proposed revision  of Part 51 to recognize the importance
           of nitrogen oxides  in  ozone formation is commendable.
           Pierrard, API, IV-F-1, p.45.

     3.    EKMA fails to account  for  temporal  and spatial  distributions
          of sources in  the design of control  strategies.  Because
          control efforts will be extremely costly,  control  strategies
           should use the most effective models.  Pierrard,  API
           IV-F-1, p.46.


                                 2-31

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     4.   Annual emission inventories may not be adaptable to modeling
          for means to control 1-hour average levels.  Hovey, STAPPA,
          IV-F-1, p.119.

     5.   Present standards cannot be attained in most areas even if
          widespread gasoline rationing and/or massive industrial
          shutdowns were put into effect.  Starke, Shell  Oil Co.,
          IV-F-11, p.10.

     6.   A rural non-attainment area faces economic sanctions when
          an offset policy is imposed on a prospective industrial
          establishment.  Drye, Buncombe County, N.C., IV-F-11, p.27.

     7.   Both rollback techniques and EKMA approaches to control
          strategies proposed by EPA have shortcomings.  Stone,
          Western Oil and Gas Assoc., IV-F-31, p.48.

     8.   Relaxation of the standard, along with EPA control strategy
          policy, increases the difficulty of achieving the standard
          by shifting more of the burden of control to the states
          where ozone is measured and away from those where emissions
          originate.  Schneidermeyer, Conn. Dept. of Environmental
          Protection, IV-D-46.

     9.   Resort areas at high elevations face special attainment
          problems because of (1) elevation, (2) high natural hydro-
          carbons (terpenes), (3) many visiting motor vehicles are
          adjusted for operation at lower elevations.  Milbrodt,
          South Lake Tahoe, Nev., IV-D-60.

C.   Congressional intent on attainability of standards

     1.   Congress contemplated that primary standards should be
          attainable.  Van Voorhes, API, IV-F-1, p.78.
          (Note: Lee, EPA, observed that standards (secondary?) need
           not be immediately attainable or attainable by current
           technology, IV-F-1, p.79.)

     2.   While the legislative history of the Clean Air  Act indicates
          that EPA may set standards beyond the reach of  current techno-
          logy, we cannot believe that Congress would expect control
          below the natural  background.   Huess, General Motors, IV-F-1,
          p.89.

     3.   Congress intended standards to be set at the highest possible
          level consistent with protection of public health; it wished
          to minimize the social  and economic disruptions attendant
          on attaining and maintaining air qualitv.  Starke, Shell  Oil
          Co., IV-F-11,  p.15.
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     4.   Standards are  to be based on criteria relating to the level
          needed to protect public health and welfare; cost of achieving
          the standards  or existence of control technology are not germane
          to the determination.  Martin, Houston Sierra Club, IV-F-17,
          p.20.

D.   Control of hydrocarbons and its correlation with ozone levels

     1.   Relaxation of  control requirement may permit greater
          amounts of hydrocarbon carcinogens as well as oxidant
          precursors to  be emitted.  Rauch, EOF, IV-F-1, p.14.

     2.   Hydrocarbon control may or may not be effective in reducing
          maximum ozone  concentrations.  Pierrard, API, IV-F-1, p.45.

     3.   Time requirements for implementation of control of hydro-
          carbon emissions from painting processes is difficult; much
          more could be  done by 1987 than by 1982.  Huess, General
          Motors, IV-F-1, p.99-100.

     4.   Use of free radical scavenger atmospheric additives (e.g.
          diethylhydroxylamine) is an effective means for controlling
          ambient concentrations of photochemical oxidants.  Reaction
          products of DEHA are not deleterious and DEHA does not reach
          the stratosphere. Heicklen, Penn. State Univ., IV-F-1,
          P.105,109,112.

     5.   Poor correlation exists between control of hydrocarbons and
          ozone level.   Packnett, Steams-Roger, Denver, CO, IV-D-17.

     6.   Despite reactive compound emission reductions of 40 percent
          in the Houston Region and 46 percent in the Southeat Texas
          Region, reductions in ozone concentrations are not demon-
          strated.  Foster, Tenn. Dept. of Public Health, IV-F-11,
          p.32.

     7.   It is not known whether reduction of hydrocarbon emissions
          while allowing nitrogen oxide emissions to increase makes
          urban air more or less healthful.  Stewart, Texas Air Control
          Board, IV-F-17, p.26.

     8.   Hydrocarbon control appears to have been ineffective in
          reducing ozone episodes in Houston.  Perhaps ozone forma-
          tion is limited by oxides of nitrogen rather than by hydro-
          carbons.  McKee, Houston Health Dept., IV-F-17, p.52-56.

     9.   Recent studies in the Houston area have shown negative
          correlation between ozone and ncnmethane hydrocarbon
          concentrations. Packnett, Sterns-Roger, IV-F-17, p.74.

     10.  In areas (e.g. rural) where NMHC to NO  ratios are greater
          than 30:1, ozone formation if insensitive to initial
          hydrocarbon concentration, so hydrocarbon control is
          inappropriate  for ozone control.  Miller, Rio Blanco Oil
          Shale Co., IV-D-93.
                                   2-33

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Data collection and monitoring methodology

1.   Agree with change in calibration technique

     Pierrard, API, IV-F-1,  p.42.

     Hovey, STAPPA, IV-F-1,  p.119.
     Starke, Shell Oil Co.,  IV-F-11, p.9.

     McKee, Houston Health Dept.,  IV-F-17, p.56.
      (recommends holding in abeyance prospective change to
       boric acid method.)

     Powers, EXXON, IV-F-17, p.79.
     Stone, Western Oil and Gas Assoc., IV-F-37, p.46.

     Hodges, Tenn. Dept. of Health, IV-D-20.
     Moss, Wasatch Front Regional  Council, Utah, IV-D-40.

     Smither, Div. of Air Pollution Control, Kentucky
       Dept. for Natural Resources & Envir. Protection,
       IV-D-68.
     Bennett, Dept. Vegetable Crops, Univ. of Calif., IV-D-72.

     Rector, Air Quality Div., Michigan Dept.  of Natural
       Resources,  IV-D-86.
     Berle, N.Y. Dept. of Environ. Conservation, IV-D-92.

     Scott, Arizona Dept. of Health Services, IV-D-98.

     Hovey, STAPPA, IV-D-101.
     Warner, Wayne County Dept. of Health, MI,  IV-D-111.

     Austin, Calif. Air Resources Board,  IV-D-120.

2.   Agree with chemiluminescence monitoring method.
     Starke, Shell Oil Co.,  IV-F-11, p.9.

3.   EPA  should expand its monitoring system for measuring
     background levels of natural ozone.   Huess, General
     Motors,  IV-F-1,  p.86.

4.   The  proposed  formula penalizes those  northern states
     which may sample on  a seasonal basis.  Hovey, STAPPA,
     IV-F-1, p.118.

5.   Development of a weighted formula expressed in  terms of
     contact/concentration hours for determining compliance is
     suggested.   Schnetzke,  Evansville, Ind., Chamber of Commerce,
     IV-F-1, p.141.

6.   Criticizes EPA for  setting a standard then proposing a new
     monitoring method.   Foster, Tenn. Dept. of Public  Health,
     IV-F-11,  p.33.

                           2-34

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     7.   Concerned that data analysis procedures (accounting for
          missing data) will promote redundant monitoring at expense
          of monitoring in dirty areas.  Faulkner, Ark. Dept. of
          Pollution and Ecology, IV-F-17, p. 11.

     8.   We should not rely on ozone monitoring for assurance that
          photochemical oxidant problems are being solved.  Martin,
          Houston Sierra Club, IV-F-17, p.18.

     9.   An adequate monitoring network must consider vertical as
          well as horizontal distributions  (mountain elevations).
          Miller, U.S. Forest Service, IV-F-37, p.34.

     10.  None of the four modeling techniques acceptable to EPA are
          applicable to predicting ozone concentrations in rural
          areas.  Miller, Rio Blanco Oil Shale Co.,  IV-D-93.

     Effect of standard promulgation on SIP submissions

     1.   Revision of standard may adversely affect  timely submission
          of SIP revisions.

          Hawk, API, IV-F-1, p.30.

          Hovey, STAPPA, IV-F-1, p.118.

          Starke, Shell Oil Co., IV-F-11, p.16.
            (Recommends 9-month extension from promulgation date.)

          Bass, Dallas League of Women Voters, IV-F-17, p.70.

          Harrison, City of San Antonio, IV-F-17, p.94.

          Spaulding, Western Oil and Gas Assoc., IV-F-37, p.43.

          Mattson, Va. Air Pollu. Control Board, IV-D-70.

          Miller, Rio Blanco Oil Shale Co., IV-D-93.
          Terrell, Area Cooperation Committee of Tidewater &
            Virginia Peninsula Chambers of Commerce, IV-D-96.
G.   Cost
     1.   Peak hourly natural ozone concentrations between 0.08 ppm
          and 0.10 ppm occur in remote locations in the order of
          once a year.  0.08 ppm  is unachievable and cost benefit
          studies hsould be done  on whether secondary standard more
          stringent than primary  standard  is needed.  Huess, General
          Motors, IV-F-1, p.88,97.

     2.   Substantial cost savings can be  made by control agencies
          when seasonal monitoring can be  practiced.  Hovey, STAPPA,
          IV-F-1, p.118.
                                2-35

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          3.   Controlling ozone to low levels  will  have  significant  impact
               on economic and social  activity, the  standard  should be  no
               more stringent than protection of the public health demands.
               Hovey, STAPPA, IV-F-1,  p.121.

VII.  Other

     A.    Speakers stated intentions to supply  written  comments

          Hawk, API, IV-F-1,  p.26,27,30,49.

          Pierrard, API, IV-F-1, p.41,44.

          Huess, General Motors, IV-F-1,  p.85,101;  IV-F-6, p.6,19.

          Hovey, STAPPA, IV-F-1, p.118,119,121,125,129.

          Osegueda, IV-F-1, p.134. (Supplied  as IV-D-36.)

          Starke, Shell  Oil Co., IV-F-11,  p.26.

          Feldcamp, Houston Chamber of Commerce, IV-F-17,  p.106.
           (Objective regarding Houston health  effects  study.)

          Walker, Monsanto, CO,  IV-F-17,  p.125.
           (Re: references on exposure levels vs monitored levels.)

          Engel, Motor Vehicle Mfgrs.  Assoc., IV-F-37,  p.21.
           (Guidance regarding definition  of  adverse health effect -
            equivocal answer.)

          Rokaw, Air Quality Advisory Committee, Calif. Dept.  of  Health,
            IV-F-37, p.78.

     B.    Wish to put questions to EPA

          Hawk, API, IV-F-1,  p.49,84.
                                     2-36

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                       3.0  OVERVIEW AND SUMMARY

     A review of the public comments outlined in Section 2.0 reveals
that there is still disagreement on interpretation of health effects
information compiled in Criteria documents and on the selection of the
primary standard.  Environmental groups and private citizens in general
advocate retaining the current 0.08 ppm one-hour standard.  Some control
agencies, associations, and individuals endorsed the proposed 0.10 ppm
primary standard, but control agency spokesmen generally support
relaxation to 0.12 ppm hourly average to be exceeded on no more than one
day per year.  Industry representatives advocated higher levels, in the
range 0.15 ppm to 0.25 ppm, or did not recommend specific levels, but
criticized the proposed level as being too stringent.
     Adequacy and/or interpretation of specific studies cited for health
effects (DeLucia and Adams, Schottlein and Landau, Hammer et al, Japanese
epidemiologic studies) were criticized, primarily by industry spokesmen,
but in some control agency testimony as well, as not justifying the
proposed standard.  Particularly noteworthy in regard to experimental
studies is a report by the Texas Air Control Board that common types of
ozone generators, as used in experimental studies, produce an oxidant,
identified in August 22 testimony as "singlet oxygen", which, although
generated in substantial concentration, is not measured by the ozone
analytic procedure; it is suggested that this may invalidate a number of
experimental studies.  By letter of September 18, 1978, the Texas Air
Control Board advised that laboratory experiments done since August 22
indicate that the additional oxidant, though still present, is not
singlet oxygen.
                                   3-1

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     An issue was raised on the definition of "adverse health effect".
There was difference of opinion, unresolved in the hearings, on what is
merely an observable physiological response (e.g. compensation) and what
is an effect on health.  Responses to exposures at 0.15 ppm reported by
DeLucia and Adams were generally characterized by critics as not being
significant health effects.  A number of speakers maintained that
significant health effects in humans have not been demonstrated at
levels below 0.25 ppm ozone.  Others disagree with this contention that
0.25 ppm (or other reported "no effect" level) is a valid index level
for no effect because any such reported level relates to responses of
generally healthy young adult experimental subjects, not to susceptible
segments of the population - particularly infants, young children, and
ill people - who are never used as experimental subjects.   It was pointed
out that animal work showing differences between responses of adults and
the very young is especially important in this regard.  Further, actual
ambient exposures are to mixtures of pollutants with their  synergistic
activities, not to the single pollutant, ozone, as used in  experimental
exposure systems.
     Rauch of the Environmental Defense Fund maintains that methods
reported to have been used by EPA in deciding on the proposed primary
standard are legally vulnerable,  particularly on the statutory margin of
safety issue.  Some speakers felt that the margin of safety  in the
proposed standard was marginal or inadequate; about the same number  felt
that it was excessive.  Several speakers consider a standard set 20  to
25 percent below the lowest reported effect level comprises an adequate
margin of safety.  A few maintain that a margin of 0.02 ppm (an absolute
value  from the 1971 standard) is  appropriate.
                                   3-2

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     Use of the ad hoc Advisory Panel on the Health Effects of Photo-
chemical Oxidants by  EPA  in its development of the proposed standard was
criticized, primarily on  procedural grounds, by industry spokesmen.
Rauch, EOF, criticized dismissing some studies which, in the judgement
of the Science Advisory Board, might receive unwarranted emphasis
(carcinogens, mutagenesis, chromosomal aberrations?), unless these
studies have been shown to be invalid.
     Little was said  of the proposed secondary standard except that some
speakers consider it  to be unrealistically low, subject to violation by
natural background ozone, and/or that it is not necessary for it to be
lower than the primary standard.  It was stated that only especially
sensitive vegetation  species are damaged at ozone levels as low as
0.08 ppm.
     The thrust of discussion on risk analysis, primarily by industry
spokesmen, was that use of the method in standard setting is premature.
Additional scientific scrutiny is needed.
     Most agencies which  addressed the matter favor an ozone standard
over an oxidant standard, although there was some support for an oxidant
standard.  There was  no testimony in favor of a PAN standard at this
time.
     Although a number of persons supported a statistical form of the
standard, there was still substantial support for the deterministic
form, particularly by the STAPPA spokesman and some State air pollution
control agencies.
     Several speakers and persons submitting written testimony observed
that two or more consecutive hours of exceedance may occur in a single
day and advocated that determinations of compliance or violation of the
                                   3-3

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standard be based on the number of days on which one or more hourly
exceedances occur.  Support for the current limit of one hour per year
exceedance is implied, but was not explicitly stated, by supporters of
the current standard.
     Discussion of attainment problems included frequent mention of
ozone concentrations from natural sources approaching or exceeding the
proposed standards.  Control programs, or mechanics of control  received
little mention except for discussion of the lack of positive correlation
between non-methane hydrocarbon emission and ozone concentrations in the
Houston region.
     There was general agreement with the proposed change in instrument
calibration technique.
     There was some disagreement with the EPA position that revision of
the oxidant standard will not upset the time schedule for revisions of
SIP's due January  1, 1979.
                                   3-4

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           EPA amends Part 50 of Chapter I, Title 40, of the Code of Federal
      Regulations as follows:
 /")       1.  Section 50.9 is revised as follows:
 c. -
 -r'"      I 50.9  National primary and secondary ambient air qua-lity
,,                standards for ozone,
J   ,-ri
<^j<''       (a)  The level of the national primary and secondary ambient air
  1>-L      quality standards for ozone measured by a reference method based
           on Appendix D to this part and designated in accordance with Part
           53 of this chapter-, or by an equivalent method designated in
           accordance jw-ith' Part 53 of this chapter, is O.le part per million
           (Wfr ug/m3).  The standard is attained when the expected number of
           days per calendar year with maximum hourly average concentrations
                    /*-                          ^
           above O.JQ part per million 096 ug/nTJ is equal to or  less than
           one, as determined by Appendix H.
           2.   In Appendix  D,  as well as  in  the  table  of sections  for  Part 50,
           the  title  is  revised  to read  as  follows:  Appendix D -Measurement
           Principle  and Calibration  Procedure for the Measurement of  Ozone
            in  the Atmosphere.
           3.   Appendix  H is  added as  follows:
                APPENDIX  H - INTERPRETATION  OF THE NATIONAL AMBIENT AIR
                            QUALITY STANDARD FOR OZONE
       1.  General
            This appendix explains how to determine when the expected number
       of days per calendar year with maximum hourly concentrations above
      0.10 ppm (196 ug/m3) is equal to or less than one.  An expanded discussion
       of these procedures and associated examples are contained in the "Guice-
       line for Interpretation of Ozone Air Quality Standards."  For purposes

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                                 74

of clarity in the following discussion, it is convenient to use the
term "exceedance" to describe a daily maximum hourly ozone measurement
that is greater than the level of the standard.  Therefore, the phrase
"expected number of days with maximum hourly ozone concentrations above
the level of the standard" may be simply stated as the "expected number
of exceedances".
     The basic principle in making the above determination is
relatively straightforward.   Most of the complications that arise
in determining the expected number of annual exceedances are
consequences of accounting for incomplete sampling.  In general, the
average number of exceedances per calendar year must be less than or
equal to 1.  In its simplest form, the number of exceedances at-a monitor'
site would be recorded for each calendar year and then averaged over the
past three calendar years to determine if this average is less than or
equal to 1.
2.  Interpretation of Expected Exceedances
     The ozone standard states that the expected number of exceedances
per year must be less than or equal to 1.  The statistical term
"expected number" is basically an arithmetic average.  The following
example explains what it would mean for an area to be in compliance
with this type of standard.  Suppose a monitoring station records a
daily maximum ozone value for every day of the year during the past
three years.  At the end of each year, the number of days with maximum
hourly concentrations above 0.10 ppm is determined and this is averaged
with the results of previous years.  As long as this average remains
"less than or equal to 1" the area is in compliance.

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                                  75
3.  Estimating the Number of Exceedances for a Year
     In general, a value may not be available for each hour of the
year and it will be necessary to account for these missing values
when estimating the number of exceedances for a. particular calendar
year.  It should be noted that the purpose of these computations is
to determine if the expected number of exceedances per year is less
than or equal to 1.  Thus, if a site has two or more observed
exceedances each year, the standard is not met and it is not necessary
to use .the procedures of this section to account for incomplete sampling.
     The term "missing value" is used here in the general sense to de-
scribe all days that do not have an associated ozone measurement.  In
some cases, a measurement might actually have been missed but in other
cases no measurement may have been scheduled for that day.  A daily
maximum ozone value is defined to be the highest hourly ozone value
recorded for the day.   This daily maximum value is considered to be
valid if 75 percent of the hours from 9:01 a.m. to 9:00 p.m.  (1ST) were
measured or if  the highest hour is greater than the level of  the standard.
     In some areas the seasonal pattern of ozone is so pronounced that
entire months need not be sampled because it is extremely unlikely that
the standard would be exceeded.  Any such waiver of the ozone monitoring
requirement will be handled under provisions of the newly proposed 40 CFR
58.  To avoid unfairly penalizing such areas, some allowance must be made to
allow for days  that were not actually measured but would quite likely have
been below the  standard.  This introduces a complication in that it

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                                   Ur
                                                                       >"**  {
                                                                               .
                                                                         0
_j/                                                                    Yvyw"%
 P/o             becomes necessary to define under what conditions a missing value
                 may be assumed to have been less than the level  of the standard.   The
                 following criterion may be used for ozone:
                      A missing daily ozone value may be assumed  to be less than the
                 level of the standard if both the daily maximum  preceding and the
                 daily maximum following this missing day do not  exceed 75 percent of
                 the level of the standard.
                      Let z denote the number of missing daily values that may be
                 assumed to be less than'the standard.  Then the  following formula
                 shall be used to estimate the expected number of exceedances for the
                 e = v +[(v/n) * (N-n-z)]                  (1)
                      (indicates multiplication)
                 Where
                      e  =  the estimated  number  of  exceedances for the year.
                            -  ^
                      N  =  the number of  required monitoring days in the year
                      n  =  the number of  valid daily maxima
                      v  =  the number of  daily values  above the level of the standard
                      z  =  the number of  days assumed  to  be less than the standard level

                      This estimated number of  exceedances shall be rounded to
                  one decimal  place  (fractional  parts  equal to 0.05 round up).

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                             77

     It should be noted that N will be the total number of days
in the year unless the appropriate Regional Administrator has granted
a waiver under the provisions of 40 CFR 58.
     The above equation may be interpreted intuitively in the
following manner.  The estimated number of exceedances is equal to
the observed number of exceedances (v) plus an increment that • accounts
for Incomplete sampling.  There were (N-n) missing values for the
year but a certain number of these, namely z, were as'sumed to be less
than the standard.  Therefore, (N-n-z) missing values are considered to
Include possible exceedances.  The fraction of measured values that are
above the level of the standard is v/n.  It is assumed that this same
fraction applies to the (N-n.-z) missing values and that (v/n)*(N-n-z)
of these values would also have exceeded the level of the standard.
    4.  Use of multiple years of data. - Ideally, the expected number
-of exceedances for a site would be computed by knowing the probability
that  the site would record 0, 1, 2, 3  ... exceedances in a year.  Then
each  possible outcome could be weighted according to  its likelihood of
occurrence and the appropriate expected value, or average, could be com-
puted.   In practice, this type of situation will not  exist because ambient
 data  will  only be available for a limited number of years.
      Consequently, the  expected number of exceedances per year at a site
 shall be computed by  averaging the estimated number of exceedances for
 each year of available  data  during the past three calendar years.   In
 other words, if the  estimated number of exceedances has been computed
 for the calendar years  of 1974, 1975,  and 1976 then the expected number
 of exceedances is estimated  by  averaging those three  numbers.  If

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                              78
this average is greater than 1, then the standard has been exceeded at
this site.  It suffices to carry one decimal place in this computation.
For example, the average of the three namoers 1, 1 and 2 is 1.3 which
is greater than 1.  If data is not available for each of the- last three
years then this average shall be-computed on the basis of available
data from the remaining years in that period.

AUTHORITY':   Sections  109  and  301  of the Clean Air Act,  as amended
 (42 U.S.C.  7409,  7601).

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                                                TAB 0
   SUMMARY STATEMENT FROM THE EPA ADVISORY PANEL

    ON HEALTH EFFECTS OF PHOTOCHEMICAL OXIDANTS
                  January, 1978
Prepared for the Environmental Protection Agency
under the supervision of the Institute for Envirunmental
Studies of the University of North^Carolina.at Chapel Hill
                                   re

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I.  Composition of the Panel
    The Advisory Panel on Health Effects of Photochemical  Oxidants (here-
after called the "Health Panel") was convened at the request of the
Office of Air Quality Planning and Standards, U. S.  Environmental
Protection Agency.  The Institute for Environmental  Studies, University
of North Carolina at Chapel Hill, served as advisor in the selection of
panel members and as host for the panel meeting held in Chapel Hill,
N. C. on June 7th and 8th, 1977.  Panel members were:
     Carl M. Shy, (Panel Chairman), Director, Institute for Environmental
     Studies, University of North Carolina at Chapel Hill
     Stephen M. Ayres, Chairman, Department of Internal Medicine,  St.
     Louis Univeristy School  of Medicine
     David V. Bates, Dean, Faculty of Medicine, University of British
     Columbia
     T. Timothy Crocker, Chairman, Department of Community and Environmental
     Medicine, University of California College of Medicine, Irvine
     Bernard D. God!stein, Associate Professor, Department of Medicine
     and Department of Environmental Medicine, New York University School
     of Medicine
     John R. Goldsmith, Environmental Epidemiology Unit, California State
     Department of Public Health
Staff and scientists of the U. S. Environmental Protection Agency participated
in the discussions of the Health Panel; documents prepared by EPA staff
were distributed and, where appropriate, commented on.  The conclusions and
recommended guidelines for protection of public health given in this
summary statement represent a consensus of the panel members only.

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II.  Purpose and Scope of the Meeting

     The purpose of the panel discussions was to interpret the current
state of knowledge on health effects of ozone and other photochemical
substances, with the objective of developing a guideline to the Environ-
mental Protection Agency (EPA) for the protection of public health.
These discussions were prompted by EPA's current program for review
and re-assessment of the existing air quality standard for photochemical
oxidants.
     The panel reviewed studies relating to the following categories of
health effects:
     A.  Human studies
          1.  Mechanical function of the lung (controlled human exposures)
          2.  Asthma  and lung function in children
          3.  Athletic performance
          4.  Other effects:  mortality, occupational hazards
     B.  Toxicological studies
          1.  Experimental infection of animals
          2.  Morphological abnormalities of the respiratory system
          3.  Biochemical effects
          4.  Mutagenic and teratogenic potential
          5.  Performance and behavioral effects
In its discussions, the Panel considered several issues bearing on the
overall interpretation of reported studies.  Among the major issues were:
relative weights to be given to published and unpublished reports, concept
of threshold concentrations for effects, human health significance of
toxicological data, chemical specificity of the air quality standard
("ozone," "oxidants," "photo-chemical substances") margins of safety, and
the health significance of exceeding a stated concentration one or more
times.

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III.  Format for Discussion of Health Effects

     The EPA staff requested the Panel  to consider three characteristics
of population exposure that bear upon protection of public health:   the
concentration at which human health risk would be increased, the duration
of exposure which is related to this risk, and the temporal exposure
pattern that would be associated with increased risk.   In its deliberations
on each category of health effects, the Panel addressed the probability
that the health effects are induced by exposure to ozone or other photo-
chemical substances, the severity of each health effect and the uncertainties
of the evidence.
IV.  Concept of Threshold Concentrations
     A threshold was defined as a concentration between a no-effect
level and the lowest concentration at which a health effect was demon-
strated.  Identification of a threshold relevant to protection of public
health requires evidence for specific exposures that produce no effect
as well as exposures that produce effects in susceptible segments of the
population.  The Panel emphasized that biological reactions to pollutants
are not characterized by sharp discontinuities in dose-response relationships,
and that demonstration of no-effect levels is dependent upon the sensi-
tivity of the measurement of effects and exposure, as well as the selection
of the most sensitive groups and reaction systems.  Since "thresholds"
will depend upon who is studied and what is measured, it is unlikely that
scientific evidence for a specific effects threshold can be satisfactorily
derived from existing data.  Limited studies can be performed on groups
of unusually sensitive persons.  Most experimental studies of humans are

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performed on small numbers of healthy subjects who do not adequately
reflect the range of human sensitivity.  lexicological studies
usually cannot utilize appropriate models of sensitive human popu-
lations.  Thus, the Panel concurred in the statement that thresholds
for sensitive persons are difficult or impossible to determine experi-
mentally, while the threshold for healthy persons or animals is not
likely to be predictive of the response of more sensitive groups.
     The Panel discussed alternatives to the "threshold" concept for
arriving at recommended guidelines for protection of public health.  An
acceptable alternative considered by the Panel was
     (1)  to state at what level health effects have been demonstrated
          in population groups, in controlled human exposures, and in
          experimental animals,
     (2)  to evaluate the relationship between the responses of subjects
          or animals studied and sensitive segments of the population,
     (3)  to assess the severity of each category of effect,
     (4)  to recognize the uncertainty in this body of evidence,
     (5)  to propose guidelines for a margin of safety, given the
          strength of the evidence, the severity of the effects, and
          the magnitude of the uncertainties,
     (6)  to recognize that decisions on margins of safety involve
          more than scientific evidence.

V.  Acceptabiliy of Cited Reports
     In their assessment of evidence from the various sources of information
on health effects, Panel members agreed that greater weight should be
given to peer reviewed publications than to unpublished reports or reports
published without this review.  The Panel felt that the latter category
of data should be considered, but could not serve as a major contribution
to its  recommendations concerning public health protection.  Overall,

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there was a sufficient body of peer reviewed publications to serve alone
as the basis for the Panel's recommendations.   In the one instance where
a significant human effect was demonstrated at a  low ozone exposure,  the
Panel took account of the data but made its conclusion -primarily on the
basis of other published evidence.

VI.  Human Studies
     A.  Mechanical function of the Lung
     The Panel focused its discussion on the more recently published
human exposure data as reported by von Nieding, et al. (1977a, 1977b),
Hackney et al. (1975a, 1975b, 1975c, 1977), Bates and Hazucha (Bates
and  Hazucha  1973, Hazucha 1973, Hazucha et al. 1973, Hazucha and Bates
1975).  The  Panel agreed that there was convincing evidence for pro-
nounced effects on mechanical function of the lung, as variously
measured by  flow  rates, airway resistance and other parameters of
ventilatory  function, at ozone exposures of 0.37 to 0.75 ppm for two
hours under  conditions of intermittent moderate exercise.  The Panel
also accepted the validity of findings showing an effect on lung
function at  0.25  ppm, but recognized that these effects were less
pronounced  than at  higher concentrations and  that they occurred  in
Montreal subjects and not  in  Los  Angeles subjects studied under  iden-
 tical  protocols.  The difference  between the  dose-response  relationships
 for  Los  Angeles and Montreal  subjects was felt to be  explainable by  one
or more  of the  following  factors:   adaptation in Los  Angeles  subjects,
 admixture  of submicronic  aerosols in the Montreal chamber,  and/or
 selective  migration away  from Los Angeles of  persons  who could  not tolerate
 previous repeated ambient ozone  exposures without undue  reactions.

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     The Panel also identified the fact that a plateau in the dose-response
relationship in Montreal subjects was not demonstrated, and therefore that
effects may be produced at even lower concentrations than those employed.
In support of this hypothesis were the data from recent publications of
von Nieding et al. (1977a, 1977b).  Differences from other study protocols
in the measurement of airway resistance and of arterial partial pressure of
oxygen were recognized.  The small standard error about mean values of airway
resistance was also noted.  The Panel felt that these aspects of the von
Nieding studies required replication of their results by other investigators
but that the data  waSrtfhereby invalidated.  The Panel concluded that
results of the von Nieding studies served to reinforce the conclusion that
changes in mechanical function of the lung may well occur in some subjects
at ozone concentrations less than 0.25 ppm for two hours, and that there may
be some risk of inducing functional changes at levels  in the range of 0.15
to 0.25 ppm.
     The Panel considered the  issue of repetitive experimental exposures,
and asked whether effects on mechanical function would be more severe
with repetition of exposure or would possibly occur at lower concentrations
with repetition of exposure.   The Panel consensus was  that the risk  of
effect was related to  the total  dose of ozone delivered  to the respiratory
tract within  a day (but not over long  periods), and that this  dose
increased with the frequency of  exposures, with the concentrations  of a
single exposure,  and with the  intensity of exercise of exposed subjects.
     The Panel concluded  that  the evidence for a  relationship  between ozone
exposure and  effects on mechanical  properties was  conclusive.   In
discussing the severity of this  effect,  the  Panel  agreed that  one  exposure

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.ay not portend risk of serious consequences in healthy individuals.  How-
ever, a single exposure of a sensitive individual such as an asthmatic,
or other persons with airway disease, may induce a serious health effect,
and repeated exposures even of healthy individuals may lead to increased
risk of respiratory impairment in the form of irreversible effects or
susceptibility to chronic respiratory disease.  However, the Panel
recognized that judgments concerning repetition of exposures fall in
the area of greatest uncertainty because experimental human studies have
not been conducted to evaluate repetitions of exposure.  The Panel
also cited recent experimental evidence that the maximum stimulus to
histamine release in the lung occurred 24 hours after ozone exposure,
suggesting that exposed persons with sensitive airways may experience
untold  delayed effects.   These findings are not fully understood  and
generally have not been incorporated into the assessment of ozone
induced health effects.
     B.  Asthma and Lung Function in Children
     The Panel reviewed the air quality data available for interpreting
the findings of the Schoettlin and Landau (1961) asthma study.  Although
there was some confusion in the early reviews of this study, it is now
clear that oxidant measurements for each day were made by the Los
Angeles Air Pollution Control District, that these data were obtained
by the potassium iodide method, and that there were significantly more
asthma epidodes in subjects on days when peak oxidant concentrations
exceeded 0.25 ppm, and finally that these peak concentrations were
associated with average maximum hourly oxidant concentration of about
0.20 ppm.  From these data, the Panel agreed that the evidence supported
the statement that a proportion of asthmatics will be affected by maximum

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                                    8
hourly oxidant concentrations of 0.20 ppm, and that the effect is  likely
to occur at concentrations in the range of 0.15 to 0.25 ppm in some
asthmatics or other persons with sensitive airways.
     The Panel also considered the recent reports of Kagawa and Toyama
(1975) and Kagawa et al. (1976) on the association of changes in lung
function of school children with oxidant exposure.  These published
reports show a decrease in ventilatory function of school children
associated with increasing ambient ozone concentrations, from 0.1  to
0.30 ppm.  The Panel noted that the authors stratified the data into
low and high temperature seasons, but could not isolate the effect of
ozone from other measured pollutants, since population exposures only
occur in the presence of pollutant combinations, not for single pollutants
in isolation.  The Panel concluded that these studies further supported the
evidence for an increased health risk from ozone exposures over the  range
of 0.15 to 0.25 ppm, and for the likelihood of a lesser but real health
risk at even lower concentrations.
     The Panel expressed additional concern for ozone exposures of
young children, in view of the findings of Bartlett et al. (1974) which
demonstrated a reduction in lung elasticity and overdistention of the
lungs of rats exposed at 3-4 weeks of age for 30 days to 0.2 ppm ozone.
The Panel felt that these data were particularly significant since there
is continuous growth of lung capacity, in humans,  both in terms of
number of alveoli and ventilatory function from birth to age 8 or 9
years, and since  ozone exposures which compromise  lung development at
these ages might  have serious  implications for risk of impairment later
in life.

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     The evidence that ozone effects may be enhanced  by other concurrent
pollutants (Bates and Hazacha 1973) was interpreted  by the Panel  as
indicating the desirability of providing a margin of  safety between
these observed effects and the primary standard for  ozone and other
photochemical substances.
     C.  Respiratory and Other Symptoms in Human Populations
     Experimental exposures of humans and epidemiological observations
support the conclusion that ozone exposures in the range of 0.15 to
0.25 ppm are associated with increased risk of cough, chest discomfort,
susternal soreness, headache and eye irritation.  Respiratory symptoms
are enhanced by more intense exercise.  The Panel judged that the attempts
to obtain threshold estimates for  these effects  (Hammer et al., 1974)
violated biological evidence for nonlinear dose-response relationships,
and that in  general, segmental regression  analysis ("Hockay-stick"
function) is inappropriate  for determining the onset  of health risk.
      In reviewing the  several Japanese  reports on acute respiratory and
other  symptoms  in school  children  during  "photochemical smog" episodes,
the Panel  noted the  occurrence of acute  effects at ozone  levels of 0.15
ppm and above.  The  Panel  attributed the  high  rate of reporting  of
symptoms  in  the Japanese episode  to a  combination of  several  factors.
      (1)  biological  reactions  producing  manifest symptoms,  particularly
           in actively exercising  school  children,
      (2)   Probable  combination  of ozone with other  pollutants which  interact
           in their  biological effects,
      (3)   sociological factors  which in one culture  may result  in  repression
           of perceived symptoms and in another articulation of  perceived
           symptoms,  and

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                                       10
     (4)  psychological factors which may alter the individual's judgment
          concerning the severity of symptoms.
          One or more of these factors may account for the apparently high
          incidence of chest discomfort and eye irritation in affected
          juvenile groups and for the associated extrapulmonary mani-
          festations such as numbness, fainting and necessity for
          hospitalization.  Thus the Panel concluded that the Japanese
          reports of symptoms at 0.15 ppm should be given due weight
          in arriving at a guideline for public health protection.
          The repetition of these episodes with associated symptoms
          adds to their significance.
     D.  Athletic Performance
     The Panel's previous comments concerning the inappropriateness of
segmental regression analysis was stated to apply to Wayne et al.'s (1967)
study of athletic performance.  The data as presented in the original
study do not suggest a plateau in the dose-response function.  Never-
theless, some members of the Panel were unconvinced of an association
between impaired performance and oxidant concentrations less than 0.15
ppm.  However, these members stated that their judgment was based on a
visual  truncation of data points rather than on quantitative statistical
analysis.  The Panel noted that a recent paper (Folinsbee et al. 1977)
has documented a decline in maximal oxygen uptake in healthy young
subjects exercising under controlled experimental exposure to 0.75 ppm
ozone,  thus suggesting a mechanism for the effect on athletic performance.
     E.  Other Effects:  Mortality, Occupational Hazards
     Review of existing studies fails to show any evidence for increased
risk of mortality in association with daily oxidant concentrations
measured in the Los Angeles basin.  The Panel stated that there was no
new evidence to alter this conclusion.
     The Panel expressed concern with the absence of studies of different
groups occupationally exposed to ozone.  These groups include airline
pilots and crews, workers exposed  to coronal discharges  in the electric

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                                        11
utility industry, and other persons working in the vicinity  of ultraviolet
lights, e.g., in cold storage rooms.   The Panel  was quite  convinced  that
some adverse reactions would be produced in these occupational  settings,
and expressed concern that the absence of systematic studies will  lead  to
continued exposures without identification of the induced  health  risks.
     F.  Conclusions from Human Studies
     The Panel reached consensus on the conclusion that short term exposures
to ozone in the range of 0.15 ppm to 0.25 ppm may impair mechanical  function
of the lung, and may induce respiratory and related symptoms in sensitive
segments of the population.  These symptoms and effects will be more
readily induced in exercising subjects, particularly in a  complex urban
atmospheric environment in which ozone can interact with other pollutants.
     Short term exposures only 3 or 4 times this level, that is,  exposures
to 0.75 ppm for two hours, can induce severe symptoms in exercising  sub-
jects.  Such experiments are ethically unacceptable.
     The Panel judged that the occurrence of respiratory symptoms and
alteration of mechanical function of the lung have important public  health
implications, particularly for the developing lungs of young children.
Although such effects appear to be reversible in exposed young adults,  they
represent a potentially serious risk for asthmatics and other individuals
with airway disease.  In the population of individuals with varying states
of biological adaptability, exposures which produce the above described
effects may at times overwhelm the biological defense of some persons.   Thus
reversibility of effects in experimentally exposed healthy subjects should not
be generalized to  the entire population.
     The Panel related many of the experimental  human effects to a two-hour
averaging time.  However,  the Panel noted  that more intense exercise was

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                                         12
likely to bring about respiratory symptoms and ventilatory function effects
within a period of one hour.  Panel members concurred that it was not
possible to perform a fine tuning on the averaging tine associated with
this category of effects, and agreed that a one-hour averaging time represented
a satisfactory estimate of the exposure duration which should be considered
in a primary air quality standard aimed at protection of public health.
To some extent, a one-hour averaging time may provide a desirable addition
to the margin of safety, in that it may better protect actively exercising
persons.
VIII.  Animal Toxicology Studies
     A.  Experimental Infection of Animals
     Increased susceptibility to bacterial infection following ozone exposure
at 0.1 ppm is described by several investigators (Coffin et al. 1968, Ehrlich
et al. 1976, Gardner et al. 1974) in reports that do not fulfill the desi-
deratum of peer reviewed publications.  These reports are, however, con-
sistent with a larger body of published evidence (Coffin and Gardner 1972,
Goldstein et al. 1971a, 1971b, Goldstein and Hoeprich 1972, Goldstein et al.
1974 and others) that establishes indices of infection or of mortaility
from bacterial infection as sensitive measures of the effect of ozone in
rodent lung.  Additional stress such as heat, exercise or a combination with
other pollutants, according to some reports, may enhance the effect of
ozone on susceptibility to  infection, and may thereby lower the ozone
dose at which the organism  will be adversely affected.
     The Panel agreed that  these finding  have definite human  health implications
although an  exposure level  associated with such effects in humans may be
different.   These reactions in mice represent basic  biological  responses to
infectious agents, and  there  is no reason to believe that  pollutant  induced
alterations  of  basic defense  mechanisms  in experimental mice  would  not

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                                        13

occur in similarly exposed and challenged humans.   However,  the Panel  is  not
aware of epidemiological evidence that susceptibility to infection increases
in persons exposed to ozone and other photochemical materials.   However,
the biochemical and cellular alterations described below for rodents  suggest
that multiple epithelial and biochemical targets are perturbed by ozone
exposure.  Since similar epithelial perturbations occur in humans when
viral infection precedes the onset of bacterial pneumonia, it is reasonable
to expect that chemical injury to respiratory epithelium will predispose  to
infection.  Ozone induced irritation of the major bronchi in man does
occur at ozone concentrations in the range of 0.25 ppm.  Hence it is
possible that ozone damage at the level of respiratory bronchioles and
alveoli occurs in man as well as rodents, leading to promotion of sus-
ceptibility to bacterial infection of the lower respiratory tract.  The
Panel observed that it may be particularly difficult to demonstrate these
relationships because bacterial pneumonia is a disease of low incidence,
occurring more in the winter season when  oxidant concentrations are
typically low.   It is possible that concentrations of ozone  high enough
to  injure macrophages do not reach the  alveoli in man but do so in rodents
because of anatomic differences between human  and  rodent lungs.   In this
case, the significance  of  the  animal  data on ozone-induced  susceptibility
to  infection  lies  in  the demonstration  that a  measurable effect on a
biologically  important  system  (defense  against infection) occurs  in rodents
at  concentrations  that  also  produce measurable responses  in man  (altered
mechanical  function of  the lung).
      B.  Morphological  Abnormalities  of the  Respiratory System
      A  range  of  morphological  effects was noted  in association with  experi-
mental  ozone  exposures  of 0.2  to 1.0 ppm.  These  effects varied from
 replacement of Type I with Type II alveolar cells, which are not known to

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                                        14
have associated harmful  consequences,  to emphysematous changes  and  terminal
bronchiole and alveolar  damage.   These effects occurring after  long-term
low concentrations, raise the level  of suspicion that repeated  or chronic
exposures have the potential  for inducing similar effects in humans.
     C.  Biochemical Effects
     The Panel observed  that there is  an impressive variety of  biochemical
alterations associated with ozone exposures over the range of 0.1 to
1.0 ppm.  The Panel judged that effects induced by 0.1 to 0.2 ppm exposures
are probably largely adaptive while effects caused by levels of 0.5 ppm
and greater have definite toxic potential.  The Panel judged that these
biochemical changes are significant in demonstrating that there are
ozone-induced effects at cellular sites and organ systems distant from
the lung.  While many of the biological reactions were in the nature of
a protective response and could possibly be prevented or reversed with
increased vitamin E levels in the lung or increased antioxidants at
other  tissue sites, nevertheless they represented the organism's response
to stress.  The Panel agreed that such perturbations  in biological systems
may pose a health risk to the population of impaired  or susceptible
individuals.  One of the panel members noted  that, in experimental
studies, Canadian subjects who manifested greater change  in mechanical
function of the lung than in Los Angeles  subjects also  showed greater
hemolysis of  red  blood cells.  These observations suggest  that ozone
levels which  produce lung function  changes can  also  lead  to biochemical
changes and other reactions  of definite  concern to health,  and vice versa.
Overall,  the  Panel  felt  that there  is  not a sharp dividing line  between
protective  responses and  potential  for pathological  consequences.

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                                       15

     D.  Genetic and Teratogenic Potential
     The Panel focused its attention on the reports of chromosomal  abnor-
malities in peripheral leukocytes first observed upon exposure of intact
hamsters to 0.2 ppm ozone for five hours  (Zelac, 1971)-  One experimental
study of humans (Merz et al. 1975) found  similar abnormalities in individual';
exposed to 0.5 ppm ozone.  The significance of chromosomal aberrations in
peripheral blood cells has not been determined.  Furthermore these studies
have not,been replicated, and the Panel agreed that there was insufficient
evidence to evaluate the long term implications of these reports.   Although
confirmation of the results may suggest another category of ozone-induced
effects, the preliminary evidence does not suggest these effects occur at
drastically lower levels of exposure.  It was further noted that genetic
consequences of population exposures to human mutagens are very difficult
to identify, even for such well recognized mutagens as ionizing radiation.
     Veninga's observation  (1967) of increased neonatal deaths and congenital
abnormalities in newborn mice was cited by the Panel as grounds for raising
the  index of  concern over  the potential teratogenic effects of ozone.  The
evidence  for  the mutagenic  effect of ozone in  bacterial systems and lung
tumorigenesis was  also  noted.   The  Panel  observed  that, were  similar
findings  demonstrated  for  food  additives  or  pesticides, these substances
would  undoubtedly  be banned from use.
     E.   Performance and Behavioral  Effects
     Few experimental  studies  of performance and behavioral  effects of
ozone  have been reported and the Panel considered this category of effects
 to be  a neglected area of research both in animal  and human ozone studies.
 The effects of ozone and other oxidant exposure on athletic performance
 (Wayne et al. 1967) and on motor vehicle accidents (Ury 1968) provide
 epidemiological evidence for impact on performance in humans.

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                                        16
     F.   Implications of Animal  Toxicology  Data
     The Panel observed that the ozone dose which  caused  chronic  tissue
damage in the lungs of experimental  animals was  much closer  to  ambient
concentrations than are the doses of carcinogens employed to produce  tumors
in laboratory animals.  The chronic  respiratory  diseases  related  to similar
tissue changes in humans were felt to be at least  as important, from  a
public health perspective, as respiratory cancer.   Thus,  it  was noted
that the margin of difference between ozone concentrations that produce
serious toxicological effects in animals (as well  as symptomatic  and  lung
'unction changes in humans) and ambient levels of ozone is much smaller
than for any other atmospheric pollutant.  The Panel also emphasized  that
there was a remarkable clustering and convergence of various toxicological
experimental human, and epidemiologically observed effects within a  narrow
ozone concentration range, that is 0.2 to 0.6 ppm.  These findings further
reinforce the judgment that there is not a sharp cut-off for ozone dose-
response relationship.  The Panel hypothesized that exposures above maximum
observed background levels of 0.05-0.06 ppm may well be associated with
some increased health risk; this perception is based on the  convergence
of various effects at concentrations minimally above background  (less than
one order of magnitude).
     The Panel pointed out  that chronic disease effects of long  term
ozone exposure in man  cannot be quantitatively  related to specific ozone
concentrations of  short  (hourly or  daily)  averaging times due  to the long
period  of disease  induction and  the varied exposures of  individuals during
the period of induction.   Epidemiological  studies  may establish  relation-
ships between long-term  ozone  exposure  and human  chronic  disease risk,
but we  must  rely on  toxicological studies  to  guide us  in  quantifying the
ozone level  that may induce chronic effects.

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                                       17
VIII.  "Ozone" vs. "Oxidant" Standard
     The question was raised by the EPA staff whether the Health  Panel  felt
that an ozone standard or a standard for ozone and other photochemical
substances was required for protection of public health.  The Panel  agreed
that two characteristics of ozone exposure should be cited with reference
to public health protection:  (1) ozone itself is a primary cause of most
of the health effects reported in toxicological and experimental  human
studies and the evidence for attributing many health effects to this
substance alone is very compelling, and (2) ozone measurements should
be considered as an index for the complex of atmospheric photochemical
substances some of which are known to produce health effects which either
are not attributable to pure ozone, e.g., eye irritation, or which may
possibly augment the effects of pure ozone.  The Panel judged that it was
not appropriate at this time to consider a primary air quality standard
for specific photochemical compounds other than ozone.
     The Panel agreed that when ozone is measured specifically, in contrast
to measurements of total oxidants, it should be considered both as a
causal agent of adverse health effects in its own right and as an index
for the photochemical mixture which is associated with  a broader range
of health consequences.  Beyond this, the Panel did not reach consensus
as to whether the primary air quality standard should be expressed solely
as an ozone standard or as a standard for ozone and other photochemical substances,
Some Panel members were concerned  that a standard for ozone alone would lead
some to dismiss epidemiological evidence relating health effects to  "oxidant"
concentrations and  further  to discount the occurrence of symptoms and
effects not attributable to  pure ozone.  Other  Panel members  believed  that
citing ozone  as an  index as  well as  primary  agent  in  its own  right would
obviate these problems.

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                                       18
IX.  Recommended Guidelines for the Protection of Public Health

     In considering the margin of safety between concentrations that

represent a public health risk and the recommended standard,  the Health

Panel called attention to several conslusions that were previously

stated:

     1.  There appears to be a finite probability of health risk
         associated with population exposure to ozone concentrations
         above observed maximum background levels, i.e., 0.05 to 0.06
         ppm.  Specifically, there is evidence from studies of ozone
         and other photochemical oxidants for alterations of
         mechanical function of lung in humans, for exacerbation of
         asthma in humans, for alteration of ventilatory function in
         school children, for induction of acute respiratory symptoms
         in exercising children and young adults, for impaired athletic
         performance in young adults.  The Panel judged, as discussed
         in the previous sections, that these effects may be induced
         by short term exposures to ozone in the range of 0.15 to 0.25 ppm.
         An unreplicated study of airway resistance in humans and
         repeated studies of susceptibility to experimental respiratory
         infection in animals further suggest the possibility of adverse
         effects in some persons at short term ozone exposure of 0.10 ppm.

     2.  In contrast to most other atmospheric pollutants, there is a
         convergence of experimental animal, experimental human, and
         epidemiological studies demonstrating effects at relatively
         low ozone concentrations, 0.15 to 0.35 ppm.  These concentrations
         represent a relatively small margin of difference between
         observed minimum background levels and concentrations causing
         increased health risks.

     3.  The implications of these demonstrated health risks are
         significant to the overall health of human populations.

     4.  There is new evidence for biological reactions to combinations
         of ozone with other commonly occurring atmospheric pollutants.

     In reviewing the body of evidence on health effects, the Health

Panel concluded that there is no compelling reason to suggest a change

from the concentration defined by the existing primary air quality

standard, namely, 0.08 ppm.  This conclusion was based upon the previously

cited Panel consensus that a variety of adverse effects are likely to

occur in some segments of the population from short-term ozone exposures

of 0.15 to 0.25 ppm, and upon other evidence that suggests, though less

conclusively, the possibility of effects at concentrations as low as 0.10

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                                       19
ppm.  The Panel recognized that this standard provides very little margin
of safety, for the reasons cited immediately above.
     In considering the appropriate averaging time to be associated with
this recommended concentration limit, the Panel judged  that a one-hour
exposure limit would provide some slight margin of safety for exercising
individuals, whereas two or three hour exposures at the same level would
tend to increase the delivered dose and thus raise the level of risk.
Thus the Panel concluded that a primary standard of 0.08 ppm for one
hour represents a level of exposure which would be consistent with pro-
tection of public health.
     The issue of how many times the 0.08 ppm one-hour level could be
exceeded without increased health risk was addressed.  The Panel agreed
that the level of health risk  increased  (1)  in proportion  to the hourly
concentration  above 0.08 ppm,  (2) in proportion to the number of hours
in  one day above 0.08 ppm, and (3)  in proportion  to  the frequency  of
days in which  hourly averages  exceed 0.08 ppm, though the  latter
conclusion was recognized  to  be quite judgmental  and generally  lacking
in  confirmatory  studies.   Nevertheless,  the  Panel could cite no medical
reason to  suggest that  any exceedances of the  standard  were without
health risk.
     In  offering its  recommendation of a 0.08  ppm one-hour exposure limit
as  a guideline for  the  protection  of public  health,  the Panel  proposed
that this  guideline be  considered  as a public  health objective for
developing control  strategies, rather than  a signal  for injunctive legal
actions.   Excursions  above the 0.08 ppm  hourly limit should call  for
evaluation of implementation strategies  and not for crisis reactions

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that are disruptive of normal activities.   As previously stated,  the
level of health risk is judged to be proportional  to the conceniration,
duration and frequency of exposures above the standard.  The Panel  is
not suggesting that small health risks are acceptable, but that occasional
excursions should be evaluated in the context of long tern goals and
the difficulty of reducing the primary emissions necessary to achieve
the standards.  Overall, however, the Panel judges that there is now
mnre experimental and epidemiological evidence to be concerned with
ozone exposures above the standard  than when the standard was originally
established, and that this concern  should  reinforce the determination
to  implement the control strategies required to achieve the primary
standard.

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Bartlett, D., C. S. Faulkner, and K. Cook (1974).  Effect of chronic
ozone exposure on lung elasticity in young rats.   J.  Appl.  Physio!.
37:92-96.

Bates, D. V. and M. Hazucha (1973).  The short-term effects of ozone on
the human lung.  In National Academy of Sciences, Proceedings of the
Conference on Health Effects of Air Pollutants, October 3-5, 1973.
Senate Committee on Public Works Print Serial Ho. 93-15.  Washington,
D. C.:  U. S. Government Printing Office, pp. 507-540.

Folinsbee, L. J., F. Silver-man, and R. J. Shephard (1977).   Decrease
of maximum work performance following ozone exposure.  J. Appl.  Physio!.
42:531-536.

Coffin, D. L. and D. E. Gardner (1972).  Interaction of biological
agents and chemical air pollutants.  Ann. Occup.  Hyg. 15:219-234.

Coffin, D. L., E. J. Blomer, D. E. Gardner, and R. Holzman (1968).
Effect of air pollution on alteration of susceptibility to pulmonary
infection.  Proceedings of the Third Annual Conference on Atmospheric
Contaminants in Confined Spaces.  Wright Patterson Air Force Base,
Ohio.  Aerospace Medical Research Lab., pp. 71-80.

Ehrlich, R., J. C. Findlay, J. P. Fenters, and D. E.  Gardner (1976).
Health effects of short term exposures to N02 - 0- mixtures.  Proc.
Internet. Conf. on Photochemical Oxidant Pollution and its Control.
Raleigh, N. C., EPA Publication #EPA-600/3-77-0016, pp. 565-575.

Gardner, D. E., J. W. Illing, and D. L. Coffin (1974).   Enhancement  of
effect of exposure to 0^ and N0~ by exercise.  (Abstract).   Toxicol.
Appl. Pharm.  29:130.  J

Goldstein, E. and P. Hoeprich (1972).  Influence of ozone on pul-
monary defense mechanisms of silicotic mice.  Arch. Environ. Health
24:444-448.

Goldstein, E., W. Tyler, D. Hoeprich, and C. Eagle (1971a).  Ozone
and the antibacterial defense mechanisms of the murine lung.  Arch.
Environ. Med.  128:1099-1102.

Goldstein, E., W. Tyler, P. D. Hoeprich, and C. Eagle  (1971b).  Adverse
influence of ozone on pulmonary bactericidal activity of murine lung.
Nature  229:262-263.

Goldstein, E., D. Warshaver, W. Lippart, and B. Tarkington  (1974).   0^
and N02 exposure.  Arch. Environ. Health 28:85-90.

Hackney, J. D., W. S. Linn, R. D. Buckley, E. E. Pedersen, S. K. Karuza,
D. C. Law, and A. Fischer (1975a).  Experimental studies on human health
effects of air pollutants.  I.  Design consideration.  Arch. Environ.
Health  30:373-378.

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lljckripy, ,J.  D., W.  S. Linn, J.  G.  Mohlor, C.  F.  Pedersen, P.  Brnisacher,
cind A. Russo (197%).  Experimental  studies on human health effects of
air pollution.   II.  Four-hour exposure to ozone alone and in combination
with othr-r pollutant qases.  Arch. Environ. Health  30:379-384.

Hackney, J.  D., W.  S. Linn, D.  C.  Law, S. K.  Karuza, H. Greenberg,  R.  D.
Buckley, and L. C.  Pcdersen (1975c).  Experimental studies on human
heaU.h effects of air pollutants.   III.  Two-hour exposure to ozone
dlonr and in combination with other pollutant qases.  Arch. Environ.
Health  30:305-.'WO.

Hackney, J.  n., W.  S. Linn, S.  K.  Karuza, R.  n.  Buckley, D. C. Law,
D. V. Bates, M. Hazucha, L. D.  Penqelly and F. Silverman (1977).
Effects of ozone exposure in Canadians and Southern Californians.  Arch.
Environ. Health 32:110-116.

Hazucha, M.  (1973).  Effects of ozone and sulfur dioxide on pulmonary
function in man.  Ph.D. Thosis, McGill University, Montreal, Canada,
pp. 223.

Hdzucha, M.  and D. V. Bates (1975).  Combined effect of ozone and sulfur
dioxide in human pulmonary function.  Nature 257:50-51.

Hazucha, M., F. Silverman, C. Parent, S. Field, and D. Bates  (1973).
Pulmonnry function in man after short-term exposure to ozone.  Arch.
Environ. Health 77:183-188.

Hmmicr, D.  I., V. Hasselhlad, B.  Portnoy, and P. F. Wehrle (1974).
Los Anqeles student  nurse study.  Daily  symptom reporting and photochemical
oxidants.  Arch. Lriviron. Health  28:255-260.

Kaqawa, J. and T. Toyama (1975).  Photochemical air pollution:   its
effects on respiratory function of elementary school children.  Arch.
Environ. Health  30:117-122.

Kagawa, J., T. Toynma, and M. Nakaza  (1976).  Pulmonary  function tests
in children exposed  to air pollution.   In  Clinical  Implications  of Air
Pollution Research,  A. J. Finkel  and  W.  C. Duel,  editors.  Acton,
Mass.:  Publishing Sciencinq Group,  Inc.,  pp. 305-320.

Merz, T., M. A. Bcndor, II. n. Kerr, and  T. J. Kullc (1975).   Observations
of aberrations  in  chromosomes of  lymphocytes  from human  subjects exposed
to ozone at concentrations of 0.5 ppm for  G and 10 hours.  Mutat.  Res.
31:299-302.

Schoettlin, C-  E.  and  F.. Landau (1961).  Air  pollution and asthmatic
attacks in  the  I os Anqoler, aroa.  Public Health Repts.   76:545-548.

Ury,  II. (1968).  Photochnnicnl air  pollution  and  automobile  accidents  in
Los  Angplos.   Arch.  Environ. Health 17:334-342.

Vemnqa, T.  (1967).  Toxicity of  ozone in  comparison with  ionizing
radiation.  Strahlontherapie  (Munich)  134:469-477.

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von Nieding, G., M. Wagner, H. Lollgen, and H. Krekeler (1977a).   Zur
akuten wirkung von ozon auf die lungenfunktion des menschen.   Proceedings
of the VDI Commission Colloquium on Ozone and Related Substances  in
Photochemical Smog, VDI Report No. 270, Dusseldorf:  VDI-Verlag GmbH,
pp. 123-129.

von Nieding, G. and H. M. Wagner (1977b).  Experimental studies on the
short-term effect of air pollutants on pulmonary function in  man:  two-
hour exposure to NO^, 0^ and SO

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                              TAB L
         ALTERNATE FORMS
                 OF THE
AMBIENT AIR QUALITY STANDARD
 FOR PHOTOCHEMICAL OXIDANTS
                   May 1978
                Staff Summary Paper
            Strategies and Air Standards Division
           Office of Air Quality Planning and Standards
            U.S. Environmental Protection Agency
          Research Triangle Park, North Carolina 27711

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ALTERNATE FORMS OF THE AMBIENT AIR QUALITY STANDARD FOR PHOTOCHEMICAL OXIDANTS
                                     Summary

       The present review of the primary and secondary ambient air quality
  standard for photochemical oxidants includes an examination of the overall
  form of the standard as well as a consideration of the appropriateness of
  the concentration level and averaging time.  The present form appears to
  be simple and readily understood.  By using the annual second highest
  hourly average, an apparently simple means is available for determining
  compliance.  However, analysis shows that there are problems of sufficient
  importance that alternate forms must be given serious consideration.
       Because the annual second highest concentration is a single measurement
  a large measurement error may occur and missing monitoring data may cause
  the true second highest value to be missed.  Further analysis reveals a
  more fundamental difficulty which has not been as generally recognized.
  Photochemical oxidant concentrations are subject to random changes in weather
  and in daily precursor emission levels.  Therefore, the average concentration
  observed in any hour has a random aspect not recognized in the present form.
  The standard concentration of 0.08 ppm is allowed to be exceeded once annually
  but never more than once.  However, if at a given level of precursor emissions
  a certain meteorological condition can occur which will lead to oxidant
  concentrations above the standard once in a year, then there is a definite
  probability that these same conditions can occur two or more times in a year
  and, therefore, lead to multiple violations in some years.  The only way to
  assure compliance with the present standard over all years in a given area
  is to control precursor emission levels to the point that 0.08 ppm is never
  exceeded, which is not a  feasible expectation.
       Thus, the current standard  is more severe than apparent from first
  inspection.  As discussed  in  the report its seeming simplicity can lead to
  inconsistent treatment from one  AQCR  to the next in deciding both compliance
  and degree of emission control  required.   The  report  recommends that  the
  following  form be adopted:

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          X^  ug/m3 hourly average concentration with expected (average)
          number of exceedances per year less than or equal to one.

This form represents the least possible departure from the present form
while fully taking into account the random statistical nature of factors
influencing oxidant concentrations.  The recommended form allows for the
occasional occurrence in some years when more than one hourly average con-
centration will be above the standard (the number of such years is set by
the choice of the expected number of exceedances per year); it also provides
the basis for a consistent approach to decisions on compliance and degree of
emission control required.  Use of the recommended statistical form requires
the use of a substantial portion of the air monitoring data collected in
a given year.  Thus the statistical estimates that are needed to determine
compliance and degree of control are much less subject to measurement error
and statistical variation than the annual second highest concentration now
used.
Introduction
     The present primary and secondary ambient air quality standards for
photochemical oxidants are both the same and may be stated as follows:
          160 ug/cu. meter (0.08 ppm) maximum hourly average con-
          centration not to be exceeded more than once per year.
     The review of the oxidant standard now under way will not  only include
an examination of the appropriateness of the concentration level and averaging
time based on our present knowledge of health and welfare effects but will
also consider the appropriateness of the overall form (expression) of the
standard.  The form of the standard could be expressed in many  ways, examples
of which are:  the mean  (geometric and arithmetic); expected value; percentile;
and some level never to  be exceeded.  However, since health effects are of
primary importance, the  form must be compatible with current medical opinion
that adverse health effects occur when oxidant levels exceed  certain levels
for short periods of time.  Thus, any form of the standard selected must be
directed at minimizing excursions above  the designated standard level.
     While health and welfare  effects are the primary considerations  in
choosing  the most appropriate  form of the standard  it is  also  important  that
the form provide an adequate  and clear basis  for  defining the  overall quality
of ambient air  it  is desired  to  achieve.  We, therefore,  would want  the  form

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to be such that it:  1.  adequately defines what must be measured  to  determine
compliance and measurements which can be made with the needed accuracy;  2.
provides clear, unambiguous criteria for determining whether an area is  or
is not in compliance; and 3. provides a clear, unambiguous definition of
the air quality it is desired to achieve to serve as a target for the develop-
ment and verification of control strategies.   This report examines the form
of the standard from this point of view and will provide a proper basis  for
examining the impact of health and welfare effects on the form.

The Present Form of the Oxidant Standard
     The current form of the oxidant standard has several advantageous features;
1.  It seems to be simple and readily understood.  2.  It reflects medical
opinion that protection should be provided against the highest levels likely
to be encountered  in an area when brought under control.  3.  It  provides in
the annual second highest hourly average concentration, a simple, clear indi-
cation of the measurement to be made and a clear criterion for determining
compliance.  However, as the analysis in this section will show,  there are
problems with the  current form which are of sufficient magnitude  that alter-
native forms should be given serious consideration.
     Two aspects of the present form of the standard have been criticized by
workers in the field and are brought out in the recent petition of the
American Petroleum Institute (API) for review and  revision by EPA of the
oxidant standard.  The two  concerns stem primarily  from  the  fact that the
standard focuses on a single measurement for  determining  compliance, the
annual second highest hourly average concentration.  The  petition points
out that Air Quality Control Regions (AQCR) differ widely in the  completeness
of their monitoring data over a given year.   Because of  missing data the
probability of capturing the actual  second highest concentration can vary
from as little as  1% to  as  high as 99%  from one AQCR to  the  next, depending
upon the data  retrieval  rate.   This  can  result  in  underestimation of control
levels needed  on man-made  emissions.   In  some areas a  more  serious  result
would be the erroneous judgment that the  areas  are in  compliance  with the
standard when, in  fact,  they  are  not.
     The second concern  is  that the  second high is a single  measurement and,
therefore,  bears  the full  brunt of experimental error.   The  petition suggests
this error  may be  almost equal  in magnitude  to the second high itself at the
0.08 ppm  level.

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      The  effects  of these problems  can  be  reduced by improved monitoring
equipment and procedures.  They  can also be  reduced substantially by changing
to a  form which  requires  the  use of more of  the available data to develop a
more  "robust" statistic,  that is, a statistic whose estimates have lower
variance  or  are  less  subject  to  random  error.  Examples might be: the expected
(or average)  value  of the second high,  the expected (or average) number of
exceedances  of the  standard,  the arithmetic  mean of the hourly averages, or
the geometric mean.
      Further  consideration  of the form  of the present standard, however,
shows that it has a more  fundamental problem than those discussed in the
proceeding paragraphs  and one which has not  been generally recognized.   The
present form  does not  provide a  clear,  unambiguous definition of the air
quality it is desired  to  achieve, and,  therefore, does not provide a clear
target for the development  of control strategies and their verification.
The present  standard  appears  to  establish as a target a quality of ambient
air over  an AQCR  such  that  one hourly average concentration in a given  year
may exceed 0.08 ppm but never more  than one.  This is a situation, however,
which does not appear  to  be feasible.   There is no level of control of  oxidant
precursor  emissions which will yield a  situation in which the standard  can
be exceeded once  in some  years but  never more than once.  Hourly average
oxidant concentrations are  subject  to the random changes in weather and
in emission levels.   If at  a  given  level of  precursor emission control  a
certain meteorological condition  can occur which will lead to oxidant con-
centrations above the  standard once in  a year, then there is a finite
probability that  these same conditions  can occur two or more times in a
year and,  therefore,  lead to  multiple violations in some years.  In this
situation  the area will comply with the standard some years and be out  of
compliance in other years.
     For example, if  under  a  given  level of  emissions the probability any
given hourly  average  oxidant  concentration will exceed 0.08 ppm is 1 in
8760 (the  number  of hours in  one year), the  percentage of years 0.08 ppm
would be exceeded a given number of times is shown in Table 1.  In 74 years
out of 100, the AQCR  in question would  be in compliance with the standard
(either one or zero exceedances), whereas in 26 years out of 100 it would
not be.  On the average,  the  AQCR would violate the standard about once every

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                                TABLE 1
 VIOLATIONS PER YEAR WHEN  STANDARD  EXCEEDED AN AVERAGE OF ONCE PER YEAR
NUMBER OF TIMES
STANDARD EXCEEDED
IN A GIVEN YEAR
0
1
2
3
£4
PERCENT OF YEARS

OCCURRING*
37
37
18
6
2
CUMULATIVE
PERCENT
OCCURRENCE
37
74
92
98
100
'ASSUMES INDEPENDENCE OF HOURLY AVERAGES AND UNIFORM PROBABILITY OVER
ALL HOURS

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 four years.   The average number of exceedances  per year over a number of
 years is one in this example (see Note  #1).   Although the above numbers
 are not fully applicable to real  situations,  owing to seasonal and diurnal
 variations and interdependence of hourly averages, they do illustrate the
 principle involved.
      The only way to assure compliance  with the present standard over all
 years in a given area is to control  emission  levels to the point that
 0.08 ppm is  never exceeded.   Thus, both from  the point of view of compliance
 and emission control, the present standard is fully equivalent to a standard
 in  which the hourly  average concentration 0.08 ppm is never to be exceeded.
 The present  standard requires,  therefore, a greater level of control than is
 apparent from superficial  inspection of its form.  It seems unlikely that
 this  situation  was intended by  its formulators.  This is the reason for saying
 the current  form seems  to be simple  and easily understood when its advantages
were  listed  at  the beginning of this section.  The statement of the standard
 is  straightforward,  but its  true  meaning is understood only when the stochastic
or  random  aspect of  oxidant  concentrations is appreciated.
      From  the proceeding arguments it is clear that the present form has
difficulties  of a fundamental nature.   The end state of overall air quality
the  standard  appears to define  is not realizable.  In fact, the standard can
only  be  satisfied by an end  state in which exceedances never occur.
      This  latter point  has  not  been  fully recognized in establishing guide-
lines for  developing emission control strategies for meeting the standard.
For example,  if,  for the purposes of this discussion, it is assumed the
current  Part  51  Guidelines  for  calculating control levels needed for com-
pliance  give  correct results, the level  of overall air quality that would
be  attained  in  a given  area  is  such  that the  area could be in violation
 (more than one  exceedance  per year)  50% of the succeeding years.  The present
practice is  to  apply Appendix J (or  Proportional Rollback) to the second
highest  hourly  average  observed in a base year to calculate the degree of
control  needed  to make  0.08  ppm the  second highest value.  However, because
the hourly oxidant values  are subject to the  random behavior in weather patterns
and daily  emissions, the observed second highest values will tend to vary
from one year to the next.   The potential impact of this variation on the
calculation of  required control levels  is shown in Figure 1.
     Here  it  is  assumed that the  AQCR under consideration has an air quality
such that  the most probable  value of the second highest concentration is 0.18
ppm.  The  observed second  highs in any  year around this most probable value

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                                 FIGURE  1


EFFECT OF STOCHASTIC  BEHAVIOR OF SECOND HIGH CONCENTRATION ON  APPARENT

 AMOUNT OF CONTROL  NEEDED  AND VIOLATIONS OF STANDARD AT CONTROL  LEVEL
                       Amount  Control  for No Violations     '
                                               Distribution I
                                               of second high
                                               concentration^
                  0.08
0.18
                                         0.18
note:  Shaded area represents fraction of years  standard  violated
       whpn farnof- rnntrnl 1 oval ^«»/-w«/J

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                                       8

are represented by the probability density function centered about 0.18 ppm.
The distribution functions shown are purely hypothetical and only serve
to illustrate the stochastic (random) behavior of the annual second high.
The top illustration in the figure shows the situation in which data for
only one year are available and the most probable value of the second
high was observed in this base year.  The line marked "apparent control
needed" divided by 0.18 ppm (the observed second high) gives the amount of
control required by the proportional rollback method.  If it is assumed that
this level of control shifts the distribution in a manner such that the
most probable second high would be at 0.08 ppm, then it is seen that in half
the years the second high will be above 0.08 ppm and the standard will  be
violated half the years.  This would be approximately the situation for
most AQCR's having this distribution of second high values.
     The middle illustration shows the outcome if the observed second high
was on the high side of the distribution.  In this case a higher
level of control would be calculated.  But there still would be some years
in which the standard is violated.  In the bottom illustration the observed
second high is below the most probable value.  A lower level of control is
calculated and the resulting air quality will lead to violations in excess
of 50% of the years.  Thus, the current form, by focusing on the second
high hourly average, has led to recommended procedures that are not likely
to lead to compliance and, furthermore, can give rise to unequal treatment
of AQCR's having the same air quality.
     The top illustration in Figure 1 also shows the degree of control  that
would be required to bring the AQCR into full compliance, that is the over-
all air quality in which no exceedances of 0.08 ppm occur.  This is, as seen,
a higher level of control than would be required through use of the observed
second high in any one year.
     The situation depicted in Figure 1 is most directly applicable to the
situation in the early  1970's when  implementation plans were first being
formulated.  At this time the base year was given as  1971 and, generally,
there was little data from other years to modify the  second highest value.
The most recent guidelines  (Guideline Series, OAQPS NO  1.2-047, January 1977)
allow the use of the second high concentration  from one year  if data from
other years is not available, but  recommends  using the  highest of the  second

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high values from three ormor-e years when available.   When applied,  this
procedure tends to favor the case shown in the middle illustration  of
Figure 1.  Even in this case there will tend to be some years in  violation
and, overall, the effect on different AQCR's will  be uneven.   Differences
will be greatest when AQCR's use different numbers of years to determine
the second high.  Those which use the smallest numbers of years will  tend
to have relatively more lenient control requirements.
     Other approaches have been suggested which may provide more  uniform
treatment.  R. Larsen has suggested the (average)  annual maximum  hourly
average could be used for calculating the required degree of control.  But
this measure does not flow as naturally from the standard as does the
second high, and there will be some years in which the standard will  be
violated.  Larsen estimates 1 in 8 years will exceed the standard more than once
if the annual expected maximum is used as a "design  value" to calculate required
control.  The method, therefore, does not lead to an overall air quality which
will fully meet the  implicit requirements of  the standard.

Alternative  Forms of the Oxidant Standard
     From the previous discussion  it  is clearly worthwhile,  in reviewing
the potential impact of  the current understanding of health  and welfare
effects  on the  form  of the  standard,  to consider alternatives  which  avoid
the problems  inherent in the current  form.  To provide  a clear, unambiguous
definition of the air quality which will  provide the desired protection of
the public health and welfare it will  be  necessary  that  the  form take  into
account  the  stochastic nature of ambient  concentrations  of oxidant.   Forms
meeting  this requirement will generally define a  statistic that  is estimated
from  a significant  fraction of  the total  data base.   The measured  statistic
will  be  more robust  than the  second high  and, therefore, not as  sensitive  to
missing  data and measurement  error.
      An  exception  is the nonstochastic form:   0.08 ppm hourly average  never
to be  exceeded.  This form provides a well  defined end state and a simple
 test  of compliance  and is, therefore, acceptable  in these respects.   However,
 the maximum possible ozone level in an AQCR is infrequently observed (the
 maximum value observed in a given year would typically be below  this value),
 and would need to be estimated in some way in order to use currently available
 methods for calculating degree of control needed.

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                                       10

      Table 2 lists several  alternate  statistical  forms each of which
 unambiguously defines a desired end state  of overall  air quality.  The
 forms shown were chosen to  parallel the  present standard in limiting
 exposure  to extremal  values of the  hourly  average oxidant concentration.
 The  first five forms  do this directly, the last two indirectly.  There
 should be no difficulty in  defining the  appropriate statistical forms
 should medical  opinion  change concerning the type of  protection needed.
      The  first alternative  departs  least from the present form.  By
 placing the number of exceedances on  an  expected or average value basis
 it avoids the pitfalls  of the present standard.  Under the statistical form,
 years  in  which the 0.08 ppm hourly  average was exceeded more than once
 would  not be considered in  violation of  the standard  unless the estimate
 of the expected  number  of exceedances was  greater than one.  Setting the
 expected  exceedances  at one is  roughly equivalent to  the situation depicted
 in Table  1  (see  Note  #1).   We would, therefore, expect violations of the
 present form (more than one exceedance per year) to occur on the average of
 approximately once in four  years if the  alternate were adopted.  Note also
 from Table  1  that  three or  more  violations  in a year  would occur an average
 of approximately only once  in every 12 years.
     If it  is considered that the excursions  above 0.08 ppm would be too
 frequent  with the  expected  number of exceedances set  at once per year, the
 number can  be set  at  a  more stringent value such as 1 in 5 years.  Thus
 EPA has two  parameters,  the concentration  level and expected number of exceedances,
which  can be  adjusted to obtain whatever level of protection is needed.
     At the  present time this general form is recommended over the others
 in the table  because  it represents  the least  departure from the present form,
 is easy to  understand,  and  the expected  number of exceedances  can be readily
 estimated from the distribution  of  hourly  averages over one or more years
 (see Note $2}.
     An example  of how  health considerations  enter into the form of the
 standard  is  seen in the following variation of the recommended form:
 0.08 ppm  daily maximum  hourly average with  expected exceedances per year
 less than or  equal  to one.   This form would be preferred if medical opinion
 shifted from  the current emphasis on hourly average concentrations to
 concern about maximum daily hourly  average  concentrations.

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                                  11
                               TABLE 2
            ALTERNATE STATISTICAL FORMS OF OXIDAHT STANDARD


•  0.08 ppm HOURLY AVERAGE WITH EXPECTED NUMBER OF EXCEEDANCES PER
   YEAR LESS THAN OR EQUAL TO ONE.

•  0.08 ppm-HOURLY AVERAGE WITH 90% PROBABILITY (CONFIDENCE) THAT THIS
   CONCENTRATION WILL NOT BE EXCEEDED IN ONE YEAR.

e  0.08 ppm HOURLY AVERAGE NOT TO BE EXCEEDED ON THE AVERAGE BY MORE
   THAN 0.01% OF THE HOURS IN ONE YEAR.

•  0.08 ppm ANNUAL EXPECTED MAXIMUM HOURLY AVERAGE.

•  0.08 ppm ANNUAL EXPECTED SECOND HIGHEST HOURLY AVERAGE

•  0.0125 ppm ANNUAL AVERAGE.

•  0.0100 ppm ANNUAL GEOMETRIC MEAN.

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                                        12

      The second form in Table 2 also has two adjustable parameters  and
 has the desirable feature of directly displaying the  level  of confidence
 that the given concentration level will not be exceeded in  a  given  year.
 However, the confidence level is not readily deduced  from ambient air
 data.   At the present time, it would be necessary to  use  existing equations
 developed from extreme value and order statistics which assume no inter-
 dependence of the hourly averages.  Since these assumptions are not correct
 for hourly average oxidant concentrations the use of  this form, or  any
 form requiring these assumptions,  is not recommended  at the present time.
 If  independence of hourly averages is assumed,  a confidence level of about
 37% would provide the same air quality as the first alternate form  (see
 Note #3).
      The third form is  essentially equivalent to the  first but refers
 directly to  the distribution of hourly averages.   Notice  that in order
 to  avoid the problem of the present form  it is  necessary  to talk about
 average  (or  expected)  percentage of exceedances.   This  form is considered
 less  desirable than  the first alternate because  using a percentage  figure
 forces the use of a  very small  number, such as  the 0.01%  in the illustration.
 There will be less intuitive grasp of the effect of this number of years
 (the first form).  The  third and the first forms,  as stated in the  table,
 give roughly equivalent protection (see Note #4).
     The  next two  forms each involve a single parameter and thus provide
 less flexibility than  the  preceeding forms.   As  in the  case of the  second
 form in  the  table, they also require the  assumption of  independence of hourly
 average  concentrations  if  their values are  to be  estimated from hourly
 average  ambient air  data.   The  use of an  expected  or average value  results
 in  two distinct air  quality end states for these  two forms.   Based  on the
 discussion in  the  last  section,  an AQCR meeting  the expected maximum value
 standard would (assuming independence of  hourly  averages) violate the
 present standard  an  average of  1 in  8 years,  while an AQCR meeting the
expected second high  form  would violate the  present standard an average
of every other year.   If the two forms  were  based  on observed maximum
or second high values  in a given year,  the  only way either standard could
be met consistently year after  year  would be  to  achieve an air quality where
0.08 ppm would never  be exceeded.   This is,  of course, the problem with the
present standard.   In  fact,  the  form 0.08 ppm not  to be exceeded by the
second highest hourly  average  in a given  year is equivalent to the present

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                                       13
form of the standard.
     The final two forms are included to bring attention to the suggestion
which has been made occasionally that mean values be used in the oxidant
standard in place of extremal values because the former use all the avail-
able hourly average data.  They are, therefore, much more robust than
forms based on extremal values.  The presumption is that there exists a
correlation between the extremal values and mean values of hourly averages.
Supporting data has been advanced to show this to be the case.  While good
correlations may exist, it would be preferable that the standard reflect
the type of protection desired from health and welfare effects.  Present
medical opinion is that protection should be directed against the excur-
sions in oxidant concentrations rather than at maintaining average levels
below some value.  Thus the standard should be based on minimizing excur-
sions of the highest ozone concentrations above certain levels.  The use
of standards based on extremal values would not prevent the use of cor-
relations between average values and extremal values as a means of developing
control strategies or confirming compliance with a standard based on extremal
values.

Application of Statistical  Forms
     An understanding of how  alternate statistical forms such  as the first
form in Table 1 might be used in practice can be obtained from examining
three potential problems with their  use which have been suggested.  The
first  is that year to year  variations  in weather and emission  levels will
make it difficult to obtain  a stable estimate of the statistic.  This
difficulty applies to  any statistic  whose yearly value must be estimated.
The second highest oxidant  value observed in  a  given year  is,  in fact,
more subject  to this source  of variance than  the alternate  statistical
measures given in Table  2.   For example,  even  if general weather patterns
and emission  levels  did  not shift  from year to  year, the observed  second
high would change from year to year  due to  fluctuations  in weather and
emissions within  the year  to year  patterns.   There would be  an additional
source  of  variation  arising from  lack  of  a  complete  data set  and the effect
of random  experimental  error on a  single  observation.

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                                       14
     In contrast, if the  first form in Table 2 were adopted, the overall
air quality for a given AQCR could be characterized by that hourly average
concentration level for which the expected number of exceedances was one.
It would not be correct to estimate this statistic by finding the second
highest oxidant value for that year.  Ambient air data would be plotted on
a suitable probability paper and a "best line" fitted to the data (see
Note #2).  The concentration above which 1/8760 of the data for one year
lie is read  from the line.  The expected exceedance of this concentration
is once per year.  The concentration corresponding to an expected exceedance
of one determined by the  above procedure would be expected to show relatively
small changes from year to year unless there were significant shifts in
overall weather and emission patterns.
     The present guidelines use year to year data to define a highest
second high for a period  of several years.  This highest second high is
also subject to statistical variance as well as trends over time in weather
and emission levels.  It  would be possible to apply this same procedure to
the forms in Table 2.  For example, the highest concentration corresponding
to an expected exceedance of 1 could be determined from such concentrations
for several consecutive years.  In reducing the effects of weather and emissions
variations within any given year by using more of the available data, the
estimated oxidant concentration (expressed in any of the forms in Table 2)
would be more reliable and statistically valid because within year variations
would be adjusted out.  Subsequently, longer-term (year to year) changes  in
weather and emissions levels also could be separated out of the statistic.
The improved statistical  forms would therefore allow more accurate tracking of
progress in improving air quality.
     The second potential problem suggested is that the statistical forms in
Table 2 do not provide a  positive indicator that an AQCR is out of compliance.
This consideration is only potentially applicable to situations in which  an
AQCR is close to compliance since the statistical forms would easily detect
regions significantly out of compliance.  Before considering the statistical
forms it will be worthwhile to examine the limitations of the trigger provided
by the second high concentration.   First, the absence of an incomplete data
base and experimental error may cause the second high value to indicate
compliance when an AQCR  is not in compliance.  Second, experimental error
can  also lead to a false  indication  that  the  AQCR is in compliance.  These
problems are  reduced with the more  robust measures provided by the  statistical
forms.

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                                        15
     Probably more important is the year to year variation in the  second
high due to "within year" and "year to year" variations in weather and
emissions.  As discussed in earlier sections, even after emission  levels
have been brought to the levels indicated necessary by the second  high
value in a base year or over several years, the AQCR will continue to
violate the standard in some years.  If further control action is  initiated
after each violation (two exceedances in a year), violations will  continue
to occur after each new control action until finally a level of control  is
reached in which the 0.08 ppm level is never exceeded.  This would be  overkill
in terms of the air quality which was desired but would be the inevitable
consequence of triggering control action every time the 0.08 ppm was exceeded
twice in one year.
     In actual practice this is not likely to happen.  If the control  levels
which have been calculated from the base year(s) have been reached and a
given year is mildly in violation  (say three exceedances), control officials
recognizing the variability of oxidant concentrations likely will  wait to
view the number of violations occurring next year or over several years
before requiring further control.   If these years also show violations
they would probably impose further controls.  If violations occurred rela-
tively infrequently in succeeding years the officials would probably be
disinclined to act further since a substantial amount of additional control
might be required to totally eliminate violations.  Thus, the positive
trigger provided by the present form would probably not  be  fully acted on
by knowledgeable control officials.  Such discretion on  the part of control
officials would not be required with the new form of the standard which would
correctly allow for occasional excursion above the standard.
     With regard to the alternative  statistical forms, it is possible to
make these  into as positive triggers as desired.  The  statistic in eacl*
of these forms can be estimated solely from the hourly average data within
a given year  using the approaches  discussed in preceeding paragraphs.  If
the estimate  indicates a violation,that year could be  established as a new
base year and further controls imposed.
     However, even though  these estimates are less subject  to variation
than the observed  second high  it would  still be unwise to use the yearly
estimates of  these statistics  alone as  positive triggers.   Since  the yearly

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                                         16
estimates  are  only estimates of  the real statistic corresponding to the
overall air  quality for  a  given  level of control, it would be better to
establish  confidence intervals around these estimates.  If a predetermined
confidence level  1s exceeded, further control action could be taken.
These procedures  would only be needed when the region was close to com-
pliance.   At this point, each year of additional data would build increased
confidence in  the estimate of the compliance statistic and provide a  more
reliable test  of  departure from compliance.  There is, therefore,  no
Inherent problem  with the alternate statistical forms as triggering mechan-
isms for control  action.
     The third potential problem area is concerned with how to handle an
AQCR with  multiple sampling sites.  The most stringent method would be to
pool all hourly averages from all sites in determining compliance by whatever
form chosen.   In  this  case an area with several monitors experiencing an
oxidant episode spread  relatively uniform  over  the region would almost
certainly  be in violation.  Since it is the same episode over the area this
procedure  seems rather  strict.   In the case of  the third, fourth, and fifth
forms in Table 2  there would be  no convenient way to  apply  this procedure.
With these forms, data  from the  different  monitoring  sites would  in effect
be simply  averaged.
     The  second alternate would  be  to  pool all  the data  from all  sites
 in determining the probability distribution but calculate  the  statistics
on the  basis of 8760 observations  (the  hours in one  year).  This  would put
all  the forms in the table on the  same  footing.  But it  would  also dilute
 the  effect of the sites experiencing the  highest ozone  levels  during an
 episode.
      A third alternate would  be to  apply the standard to each  site separately.
 In this way if the data from any one site in the area is in violation  the
 whole  AQCR would be considered in violation.   This  alternate  is intermediate
 in effect between  the two above methods.   It appears to combine the  positive
 features of each and, therefore, seems the most reasonable.  This alternate
 1s  recommended for use with the present standard in the most  recent  air
 quality standards  guideline.   (Guidelines for the Interpretation of Air
 Quality Standards, EPA-OAQPS-MDAD,  February, 1977).

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                                     17
     Other concerns with statistical forms which have been  expressed  are
that they lack the simplicity and directness of the present form and, there-
fore, may not be as readily understood by the public and may present  problems
in legal proceedings.  However, it is clear that the form of the present
standard is flawed.  If the present standard is applied  as  stated,  an AQCR
will only attain full compliance when conditions are such that  the  standard
concentration will never be exceeded.  This, as was shown,  is a direct
consequence of the variable or random aspect of hourly average  oxidant con-
centrations.  This stochastic feature of oxidant concentrations can only be
taken into account by statistical  forms such as those shown in  Table  2.
These forms are also based on more robust statistics than the second  high
and provide clear, unambiguous targets for compliance and the development
and verification of control strategies.

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                                    18
                                 Notes
1.  Probability theory shows that if the probability  that a certain
    event will occur in a given trial is p then  the probability, Pm,
    that the event will occur m times in n repeated independent trials
    is:

         D  _   n* _ _m /i _\n-m
         P--     P  (1'p)   •
This equation is known as the binomial distribution.   If  it  is assumed
that p(C) is the probability that the average concentration  for any
hour of the year is greater than or equal  the hourly  average concen-
tration C  (assumption of independence of hours),  the probabilities
of 0, 1, 2, 3 exceedances of a given concentration in the 8760 hour
in a year can be calculated.
For example:

   For no exceedances per year:

     P  =  876°    (  i ,9,     i x
                        M  "     J
          0   0! 87601 W60    " 8760
                      1  8760
                   8760}     = °'3679'
      For one exceedance per year:

        P  -   8760'      _ r  *  U1 -   ]
         1   1!  (8760  - 1)1 ^8760MI   8760

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                                    19
        For  two  exceedances  per year:

                R7fin'         i  2      1   8758
          _   _   o/ou.       /   i  \  /I   _J	\
          2 " 2!  (8760-2)1  V8760      8760;
                87KQ          i   8758
                   9    (1  -  o^n)     = 0.1840.
               2 x 8760

    The  expected or average  number of exceedances per year is obtained
    by summinq    each  number of exceedances per year weighted by its
    probability of occurance.   Referring to Table 1,

        Expected exceedances per year =  0.37 x 0 + 0.37 x 1 + 0.18 x 2

                                        + 0.06 x 3 + 0.02 x 4 + etc.
    Thus the concentration which corresponds  to p(C) =  1/8760  is also
    the concentration with an expected  exceedances/year of one.

2.  The cummulative distribution of hourly averages over  one or more years
    1s defined as a function f(C) where f(C)  is the fraction of hourly
    averages which exceeds the concentration  C.   This  function can be
    estimated from a collection of one  or more years of hourly average
    concentration data by standard plotting techniques.
    If the standard concentration level is 0.08 ppm then  the relative
    frequency f(0.08) multiplied by 8760 is the average or expected
    number of exceedances per year of the standard concentration.  This
    follows directly from the definition of f(C). This frequency, f(C),
    is read from the "best fit" line drawn through a  plot of hourly
    average concentration vs. frequency data.
         Another useful statistic is the concentration which corresponds
    to    exceedances/year of one.  In this case  the  concentration corres-
    ponding to f(C) = 1/8760 is read from the best fit line.

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                                    20
        Recent studies suggest that the log normal  distribution  function
    does not give a good fit to the distribution of hourly average oxidant
    concentrations, but the Weibull distribution does.   In any case,  if a
    statistical form of the standard is adopted, detailed guidance will
    need to be given on how to treat the air monitoring data to  obtain
    the needed statistics.

3.  The probability that a given concentration level will not be exceeded
    1n a given year corresponds to PQ of the binomial distribution given
    under Note 1.  As shown, for p(C) = 1/8760 the expected exceedances/
    year is one (corresponding to the first alternate form of the standard
    in Table 1), and for p(C) = 1/8760,  PQ = 0.37 (corresponding to  the
    second form of the standard in Table 1).
        Note that calculation of P_ assumes independence of hourly average
    concentrations.  At the present time there are no formulas for exactly
    calculating P  for the nonindependence case.

4.  By the definitions in Note #2, 100 x f(C) is the per cent frequency
    to be used in the third alternate form.  f(C) = 1/8760 for the concen-
    tration with an expected exceedances/year of one, and, therefore,
    1/8760 = 0.0114% = approx. 0.01%.

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'•pre*^
'/ 1 \ y*
                                           TAB Q

                       THE USE  OF JUDGMENTAL
                       PROBABILITY DISTRIBUTIONS IN
                       SETTING  NATIONAL AMBIENT AIR
                       QUALITY  STANDARDS FOR  OZONE
                       By:
                       Daniel J.Quinn


                       Prepared for:
                       U.S. Environmental Protection Agency
                       Research Triangle Park
                       North Carolina


                       SRI Project 8780
                       SRI International
                       333 Ravenswood Avenue
                       Menlo Park, California 94025
                       (415) 326-6200
                       Cable: SRI INTL MPK
                       TWX: 910-373-1246

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                               Abstract
     This report documents the conduct of interview sessions held with
health experts for encoding their judgmental probability distribution
over the health effects level of ambient ozone concentration.  The
interview sessions were conducted by EPA staff in conjunction with a
review of the primary National Ambient Air Quality Standard for
ambient ozone.  The encoding techniques used are documented in a
companion report, The Use of Judgmental Probability in Decision Making
by Daniel J. Quinn and James E. Matheson.
Introduction and
     This report documents work performed by a member of the Decision
Analysis Department of SRI International in response to an EPA
task-ordering agreementUJ^ The work was~~carried out to assist EPA in
                              it-.y distributions on the health effects of
photochemical oxidants as measured by ambient ozone concentrations and
to verify the validity of the techniques used.  Motivation for this
project derives from SPA's review of the National Ambient Air Quality
Standard (NAAQS) for ambient ozone.

     The Clean Air Amendments of 1970 [2] give the Environmental
Protection Agency responsibility for setting NAAQS for a number of
pollutants.  The 1977 Clean Air Amendments [3] require that EPA review
its current NAAQS for a number of pollutants by 1980.  The EPA staff has
developed an explicit formal procedure for incorporating the judgment of
health experts into the setting of standards. [U]  This procedure
requires the encoding of probability distributions from health experts
concerning the health effects of ambient ozone concentrations.

     The Decision Analysis Department of SRI International has had
extensive experience in the practical aspects of encoding probability
distributions, and was asked to assist EPA staff in the probability
encoding procedure.  This report documents that work.  A companion
report, The Use of .Judgmental Probability in Decision Making (Reference
5) , contains a general discussion of the concept of judgmental
probability, including its definition, past applications in government,
and a procedure for its assessment developed at SRI International.  The
term 'subjective probability' has often been used; we prefer 'judgmental
probability,' or, even better, Just 'probability.'

     This report is divided into three sections.  The second section
briefly indicates the role of judgmental probability distributions in
setting air pollution standards.  It contains a brief justification of
the use of judgmental probability (further information is contained in
Reference 5, which was prepared concurrently).  The third section
discusses the three encoding sessions participated in by SRI and offers
some general observations concerning the encoding sessions.

     The distributions encoded are a reasonable representation of the
judgment of the health experts consulted.  They represent a great

                                  1

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improvement in the communication of that state of judgment over  other
methods.
The Use of Judgmental Probability Distributions  in Setting
Air Quality Standards

     The results of the encoding sessions are documented  in  the  next
section.  However, before presenting the results, it is useful to
discuss the role of Judgmental probabilities in  setting air  quality
standards.

     The social regulation of pollutant levels is a complex  process,  one
requiring technical and scientific, as well as political, judgment.   In
the absence of perfect information about health  effects of pollutants,
and given the need to extrapolate to the population as a  whole from
limited situations where objective knowledge is  available, the encoding
of experts' probability distribution can play a  useful role.

     The Clean Air Act states:

          National primary ambient air quality
        standards...shall be ambient air quality standards,
        the attainment and maintenance of which  in the
        judgment of the Administrator, based on  [air
        quality] criteria and allowing an adequate margin of
        safety, are requisite to protect the public
        health.[6]

     Supporting material to the Act states:

          An ambient air quality standard, therefore, should
        be the maximum permissible ambient air level of an
        air pollution agent or class of such agents (related
        to a period of time) that will protect the health of
        any group of the population.[7]

     To set an ambient air quality standard, according to the Act and
its supporting material, one needs to know the level of a given  air
pollution agent that will cause health effects in the most sensitive
group of the population.  Because this level is  uncertain, the standard
should provide an adequate margin of safety.

     There are thus two types of judgment needed to set a standard:
judgment about the health effects level and the  uncertainty  in that
level, and normative judgment, to define an 'adequate'  margin of safety.
Both scientific and normative judgment need to be brought to bear on  the
definition of health effects.

     The Air Quality Criteria document (Reference 8) reviews available
scientific knowledge bearing upon che effects of photochemical
oxidants/ozone on human health and welfare.  The air quality criteria
document is reviewed by the scientific community.

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     Unfortunately, knowledge of health effects  i3 never complete  ~
available scientific knowledge is not sufficient to unambiguously  set  a
standard that will protect the health of the most sensitive group  of the
population, yet be as high as possible so as not to be unduly
restrictive.  Available data must be interpreted and  related to  the
specific question of an ambient health effects standard.

     The use of probability distributions on the health effects  level
(related to a period of time) encoded from health experts, is  intended
to allow the maximum use of the health experts'  knowledge and  Judgment
in this necessary proce.ss of integration and interpretation of data.
Judgmental probability distributions have the additional advantage of
being an unambiguously defined, quantitative, and concise way  of
specifying the state of information and judgment of the health experts.

     A judgmental probability distribution is a  quantitative
representation of a person's current state of knowledge; it is the
distillation of all the knowledge the expert would bring to bear about
the given effects level and the uncertainty in that effects level, if  he
or she had to act today, based upon the information at hand.   This
information is summarized in the air quality criteria document.

     The alternative to using judgmental probability distributions to
convey the state of information of an expert is  to rely on verbal
formulae such as 'highly likely' or 'there is a  small chance.1   In the
present case, the use of judgmental probability  distributions  has
enabled a much more precise communication of the experts' judgment.
Several factors contributed to this result:

     o  The precision and lack of ambiguity of the
        probability curve as compared to verbal
        formulations,

     o  The focus of the encoding sessions on results
        relevant to the standard-setting procedure,

     o  The interviewing of the health experts separately,
        allowing them to express their true judgment without
        interferences resulting from the social  dynamics of
        a group discussion.

     EPA has proposed a methodology that includes using judgmental
probability distributions to allow the scientific judgments of the level
and its uncertainty to be made in precise, unambiguous fashion,  so chat
this data may be of maximum use to EPA when it sets the standards.  This
methodology is explained and justified in Reference 4.  Reference  5
discusses the justification for using judgmental probability
distributions, and documents past uses of this means of quantifying
expert judgment in both the public and private sectors.

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Conduct of the Encoding Sessions

     This section documents the procedures used during  the actual
encoding sessions.  The results obtained, as well as the precise
definition of the health effects level encoded, are in  Reference 4.

     A total of nine experts (listed in Reference Uj were interviewed  in
the standards-setting procedure.  This section is based on observations
made during three representative sessions that were attended by Dr.
Daniel J. Quinn of SRI International.

     The lead role in probability encoding sessions was taken by Mr.
Thomas Feagans of EPA.  For two sessions, he was assisted by Dr. William
Biller, an EPA contractor.  Dr. Quinn1s function was to observe and
assist in the probability encoding task, and to assure  that proper
techniques (see, for example, References 5 and 9) were  being followed  to
assure chat the judgmental probability distributions corresponded  to the
best judgment of the experts interviewed.  It wag deemed sufficient to
have Dr. Quinn's assistance at three of the nine interviews.

     The structure of the encoding session was designed using the
accumulated experience of the Decision Analysis Department of SRI
International.  This group has been instrumental in the development and
application of the concept of judgmental probability distributions over
the past 12 years [5, 9f and 10].  The assessment of probability
distributions is an integral part of the practice of decision analysis,
a methodology that has been applied to a number of decisions involving
risk and uncertainty in complex environments in both the public [11] and
private  [12] sectors.  General principles to guide the  encoding of
probability distributions are given in References 5 and 9.  Reference  10
is a bibliography of literature concerning the encoding and use of
probability distributions.  The application of decision analysis to
problems of concern to tne EPA is discussed in Reference 13.

     The sessions followed the procedure described in  Reference 5>  The
process was divided into five phases, motivating, structuring,
conditioning, encoding, and verifying.
                                                                       » . •
     The motivating phase introduced the importance and purpose of the
probability encoding.  It was stated that the expert  should not include
a  'margin of error1 in his judgment; on the other hand, he should  not
favor  what has been unequivocally scientifically demonstrated over what
is most  likely in view of current evidence.  What was  wanted was his
best current judgment regarding the actual health effects level.
                                                                       >—
     The structuring phase was especially involved, because the health
effects  chreshhold, the quantity on which expert judgment was sought,
was particularly complex to  specify.  It was defined very carefully and
unambiguously.   (See Reference U for the definition of the health
effects  threshhold.)

     The conditioning, encoding, and verifying  phases  were as described
in Reference 5.

-------
     It is important to note that the subjects were not 'led by the
hand1 in any way.  The interviewers were careful not to suggest values
that were 'good1 or 'bad.1  The subjects themselves provided the range
of values encoded and were comfortable with the'scale in which the
values were expressed.  The subjects verified that the final probability
distribution obtained represented their best judgment, both by direct
examination and by confirming their acceptance of logical implications
of the distributions as discussed in Reference 5.

     The experts were quite cooperative, and tried to make their
responses correspond to their true judgment.

     The distributions encoded are a reasonable representation of the
judgment of the health experts consulted.  They represent a great
improvement in communication of that judgment over other methods.

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References

 [1]  EPA Contract No. 68-02-2835 (9/21/77).  SRI International
      Internal Charge No. 6780-1.

 [2]  Clean Air Act, Section 109, 42 U.S.C.

 [3]  Public Law 95-95, August 1977.

 [4]  EPA Staff, "A Method for Assessing the Health Risks Associated
      with Alternative Air Quality Standards for Photochemical
      Oxidants, Strategies and Air Standards Division, Office of Air
      Quality Planning and Standards, Office of Air & Waste
      Management, U.S. Environmental Protection Agency, Research
      Triangle Park, North Carolina (External Review Draft, January 6,
      1978); a final version of this document is scheduled to appear
      in May 1978.

 [5]  Quinn, Daniel J., and James E. Matheson, "The Use of Judgmental
      Probability in Decision-Making," SRI Report,  May 1978.

 [6]  Clean Air Act, Section 109, 42 U.S.C.

 [7]  Senate Committee on Public Works, A Legislative History of the
      Clean Air Amendments of 1970,  1974.

 [8]  Oxidant/Ozone Health Effects Air Quality Criteria Document,  EPA.
      February, 1978.

 C9]  Carl S. Spetzler and C.-A. S.  Stael von Holstein, "Probability
      Encoding in Decision Analysis," Management Science, Vol. 22,  No.
      3, November 1975.

[10]  C.-A. S. Stael von Holstein, "A Bibliography on Encoding of
      Subjective Probability Distributions," unpublished manuscript,
      SRI International, 1972.

[11]  Representative applications of decision analysis in the public
      sector have included the following:

       1. Howard, Ronald A., James E. Matheson, and D. Warner North,
      "The Decision to Seed Hurricanes," Science, 16 June 1972, Vol.
      176, pp. 1191-1202.  Letters appeared in Science, 23 February
      1973, Vol. 179, pp. 744-747; and 14 September 1973, Vol. 181,
      pp. 1072-1973.

       2. D. Warner North and M. W.  Merkhofer, "Analysis of
      Alternative Emissions Control Strategies," in Air Quality and
      Stationary Source Emission Control, a report by the Commission
      on Natural Resources, National Academy of Sciences, National
      Academy of Engineering, and National Research Council, prepared
      for the Committee on Public Works, U.S. Senate,  Serial Ho.  94-4,
      U.S. Government Printing Office, #052-070-02783-5 (March 1975).

-------
       3.  North,  D. Warner,  Fred  L.  Offensend,  and  C.  N.  Smart,
      "Planning Wildfire  Protection  for  the  Santa Monica  Mountains:
      An  Economic Analysis  of  Alternatives," Fire Journal.  January
      1975.

       4.  Cazalet,  Edward G.,  "Recommendations  for  a Synthetic Fuels
      Commercialization Program," Vol. II  of "Cost/Benefit  Analysis  of
      Alternate Production  Levels."   Report  submitted by  the Synfuels
      Interagency Task Force to  the  president's Energy Resources
      Council, November 1975.  Includes  a  decision  analysis of
      synthetic fuels commercialization  program alternatives.
      (Available  from the U.S. Government  Printing  Office,
      #041-001-00111-3, price  $4.30.)

       5.  Barrager, Stephen M.,  Bruce R. Judd,  and  D.  Warner North,
      "The Economic and Social Costs of  Coal and Nuclear  Electric
      Generation:  A Framework for Assessment and Illustrative
      Calculations  for the  Coal  and  Nuclear  Fuel Cycles."  Prepared  by
      SRI International for the  National Science Foundation, March
      1976.   (Available from the U.S.  Government Printing Office,
      #038-000-00293-7, price  $2.05.)

       6.  Judd, Bruce R., et al., "Decision  Analysis Framework for
      Future Electrical Planning," Vol.  I  of Electricity  Forecasting
      and Planning  ReportT  prepared  by the Office of Planning and
      Analysis, Energy Assessment Division,  California Energy
      Resources Conservation and Development Commission,  November
      1976.

       7.  Merkhofer, M. W., and  D. J.  Quinn, "Methodology for
      Back-Contamination  Risk  Assessment for a  Mars Sample Return
      Mission,"  prepared  by SHI  International for  the Jet Propulsion
      Laboratory, Pasadena, California,  April 1977.

[12]  The SRI International Decision Analysis Department  has assisted
      dozens of  corporations to  make decisions  involving  major
      committments  of  assets,  such as capital expenditures,
      acquisitions, and new product  development.

[13]  A philosophy  and  a  methodology for making environmental
      protection  decisions, based upon the principles of  decision
      analysis,  is  found  in:

      Howard, Ronald A.,  James E. Matheson,  and D.  Warner North,
      "Decision  Analysis  for Environmental Protection Decisions,"
      prepared for  the  National  Academy of Sciences, June 1977.

      A copy of  this  report is enclosed.  A general discussion of the
      role of analysis  vis  a. vis expert  judgment and policy making
      decisions  in public policy is in:

      Barrager,  Stephen  M., and  D. Warner North, "Analyzing the
      Decision on Radioactive  Waste Management," paper prepared for
      the SPA workshop,  "Issues  Pertinent  to the Development of
      Environmental Protection Criteria  for Radioactive Wastes,
      February 3-5, 1977.

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                                                   TAB S
                  EXEa_rnvE OFF1CE OF THE PRESIDENT

           COUNCIL ON WAGE AND  PRICE STABILITY
                        726 JACKSON  PLACE. N.W.
                        WASHINGTON. DC   2O5O6

                                OCT 1 6 1978
Honorable Douglas M.  Costle
Administrator
U.S. Environmental Protection Agency
401 M Street, S.  W.
Washington, D. C.  20460

Dear Mr. Costle:

The Regulatory Analysis Review Group has completed its review  concerning
the proposed revision to the national ambient air quality standards  for
photochemical oxidants (the ozone proposal).  On September 15  and  28,
respectively, I submitted for the Environmental Protection Agency  s
public record a notice that this proposal had been selected ror review
and a list of the  issues the Review Group expected to address.  The
outcome of this- review is the enclosed report which I. request  be placed
in the public record for this proceeding.

                                        Sincerely,
                                        Barry P. Bosworth
                                        Director
 cc:   Members  of Regulatory  Analysis Review Group

      Mr.  Joseph Padgett  (MD-12), Director
      Strategies and Air  Standards Division
      U.S. Environmental  Protection Agency
      Research Triangle Park,  N.C.  27711
                                                      Environmental

                                                     Protection Agan
                                                            r!«« O
                                                       DEC 20 19TP

                                                        "LIBRARY

-------
                   Environmental Protection Agency's
                  Proposed Revisions to the National
                   Ambient Air Quality Standard for
                       Photochemical Oxidants ]/
                            Report of the
                   Regulatory Analysis Review Group
                               Submitted by the
                Council on Wage and  P_Hce Stability 2J

                             QCT 1 S  1978
I/  Federal Register. June 22,  1978  (43 FR 26962-26985).
2/  The Council on Wage and  Price  Stability is an organization created by
the Council on Wage and Price Stability Act (P.L. 93-387) within the
Executive Office of the President,   The authority of the Council to inter-
vene in governmental rulemaking and  ratemaking proceedings, conferred by
Section 3(a) of the Act, has been  delegated to the Director of the Council
(see 40 ££52882).

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     The current primary and secondary national ambient air quality standards

for photochemical oxidants are 0.08 parts per million (ppml for a one hour

average, not to be exceeded more tfian once a year.
                            i/
     EPA's proposed revision   to these standards has the following key

provisions:

          The standards are to be defined in terms of ozone rather

          than photochemical oxidant.

          The primary standard is to be changed to the proposed

          level of 0.10 ppm for a one hour average, not to be

          exceeded more than once a year on an expected value

          basis  (using a  three year average of occurrences)..

          The secondary standard is to remain at  0.08 ppm.

     The primary and secondary ambient air standards become the  target  for

State  Implementation Plans and the Federal Motor  Vehicle Emissions  Control

Program in  controlling hydrocarbon and nitrogen oxide emissions  (ozone  results

from such emissions).

                                 Sunnaarv

          In developing its primary standard, EPA has pursued a methodology

           that  does not consider aggregate exposure  to ozone; EPA has  not

          provided an adequate rationale  for  its  crucial policy choices in

           the  application of  its methodology.

           EPA's decisions and judgments  in applying  its methodology have

           pushed the standard in  a  direction  that  may be more  stringent than

           is  necessary.
 It   Federal Register,  June 22,  1978 (43 FR 269.62-Z69851.

-------
             estimates  the  costs  of  meeting che  0.10 ppm standard to be

          S6.9  -  $9.5  billion per  year;  these costs  are understated, and

          more  accurate  figures  indicate at  least a  doubling of EPA's cost

          figures,  to  $14.3  - $18.8 billion  per year.

          An  alternative methodological  approach, focusing on  likely

          aggregate unhealthy exposure to ozone,  indicates that the

          marginal costs of  EPA's  proposed standard  may be in  the range of

          $1,100  - $4,100 per reduced person-hour of ozone exposure, which

          causes  discomfort  but  is reversible and apparently has no  long-term

          debilitating effects.

          There is little documented scientific support and none of  the

          balancing which appears  required for the determination of  the

          secondary standard.

          The absence of thresholds and of totally safe  standards  suggests

          the need for a different methodology which focuses  on  che  choice

          among exposure levels and on the consistency of choices  across

          pollutant control efforts, other health efforts by  government,

          and general private behavior.

     The  following  discussion supports  these  conclusions.

                    A.  Setting the Primary Standard

     The  Regulatory Analysis  Review Group (Review Group! agrees with EPA

when it states in  the Proposal:

          The Administrator  recognizes...that controlling ozone to
          very low levels is  a  task  that will have  significant impact

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                                  _ 3 -


          on economic and social activity.  It is thus important that
          the standard not be any more stringent than protection of
          the public health demands.—

     There are four important characteristics of ozone exposure.   First,

for any given individual, there probably is not a sharp threshold effect

but rather a continuum, starting vith very minor physiological effects

and continuing through to major health effects.  EPA has recognized this

when it echoes the National Academy of Sciences in concluding that

          no clear threshold can be identified for health effect
          due to ozone.  Rather there is a continuum consisting of
          ozone levels at which health effects are certain, through
          levels at which scientists can generally agree that health
          effects have been clearly demonstrated, and down to levels
          at which the indications of health effects are less certain
          and harder to identify.  Selecting a standard from this
          continuum is a judgment of prudent public health practice,
          and does not imply some discrete or fixed margin of safety
          that is appended to a known "threshold."!'

     Second, this continuum of effects is not identical for all people but
                                                                   '±J
rather varies with individual sensitivities, states of health, etc.

Thus, a sensitive person  (e.g., an asthmatic) is likely to experience

any given health effect at a lower ozone  concentration level than a less

sensitive person.  Accordingly, there is  no single continuum but rather a

series of continuums that extends  from the most sensitive  to the least sensitive

person in the United States.

     Third,  there  is considerable  uncertainty as to  the location and shape

of  these continuums  — i.e., for an  individual  of certain  characteristics,
 2/    43 FR 26965.

 3/    43 FR 26265.
 4/   See U.S.  E?A,  "Summary Statement  from the EPA Advisory Panel on Health
 ~    Effects  or  Photochemical Oxidants,"  January 1978,  p.  3;  and Strategies
      and Air  Standards  Division,  Office of Air Quality  Planning and Standards,
      U.S. EPA, "A Method cor Assessing the Health Risks Associated with Alternative
      A,-. rt.,an-« «i.9m«srrf«." Julv 1978. no. 2-25 co 2-27.

-------
                                 - 4 -


at what ozone concentrations will a given health effect be experienced?

     Finally, there  is  considerable meteorological variability in ozone

concentrations over  time.   This variability  is best expressed by a probability

distribution of ozone concentration levels for a given geographical area.

     EPA's approach  to  setting  the ozone standard might be characterized as

follows:  From the continuum of effects, EPA has focused on a particular point

as defining the onset of  health effects.  EPA has relied on the advice of its

scientific experts to define this point with respect  to four categories

of health effects:   impaired pulmonary  function, chest discomfort and airway

resistance, decreased resistance  to  infection, and aggravation of chronic
                     5/
respiratory disease.

     Next, EPA has tried to determine  the ozone  concentration level at which

this critical point  (the onset  of  health effects) occurs.  Here, EPA has used
                                                                           —I
two approaches:   It  has examined  (with  the assistance of a panel of experts  )

the existing  toxicological and  epidemiclogical  literature on ozone.  From

that literature,  EPA has concluded that "the demonstrated human effects"
                                         IJ
levels..-vary  from 0.15 ppm to  0.30 pom."

     Further,  it  has asked a  different  (but  somewhat  overlapping) panel  to

provide  its  best  judgment as  to the ozone  concentration  level at which

health effects would be felt  by "those persons  who  are more  sensitive  than

99 percent  of  the sensitive group [asthmatics  and  others with breathing

difficulties and individuals engaging in vigorous  exercise]  but  less
                                         i/
 sensitive than 1 percent of that group."    The panel provided median  estimates
 5/   43 FR 26964.

 6/   "Summary Statement from the EPA Advisory Panel,"_op. cit...

 Tj   43 FR 269.66.

 8/   43 FR 26966.

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                                 - 5 -


of 0.15-0.18 ppm as the point at which health effects are likely to occur,

for the four categories of effects, for the 99th percentile individual.  The

panel also provided a full probability distribution on the likelihoods, for

this 99th percentile individual, of the health effects occurring at Lower or

higher ozone concentrations.

     Next, EPA has characterized the time pattern of ozone concentrations

with a particular probability distribution, the Weibull distribution.  With

specific parameters for that distribution, EPA can, for alternative ozone

standards, determine the probability of the occurrence of ozone concentration

at or above any particular level.

     Accordingly, EPA has combined the Weibull distribution of occurrences with

the 0.15 ppm level at which, it argues, "health effects are virtually  certain,"

to obtain the likelihood of health effects being experienced, at alternative
                10/
ozone standards.     EPA has also combined the Weibull distribution with  the

full probability range  (of the  likely point of the onset ofjnealth effects

for the 99th percentile individual) provided by its panel to obtain a  second

set of probabilities of health effects being experienced, at alternative ozone
          il/
standards.

     Finally, EPA has concluded that a standard of 0.10 ppm provides a  satis-

factorily low risk of health effects being experienced.

     In summarizing EPA's approach, we aight characterize it as a "critical

point, critical person" methodology:   From  the continuum of effects,  EPA has
      43 FR  269.67.

  _   43 FR  26966.

 ll/   43 FR  269.67.   In  its  Risk  Assessment  document,  EPA  also provides  risk
      ribbons  that  demonstrate the  full  range  of uncertainty concerning the
      experiencing  of health effects.  See  ''A  Method  for  Assessing...." op.  cit.,
      pp.  2-29 to 4-39.

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                                   -  6  -






chosen a particular point and  characterized  it as representing the onset of




health effects; from  the range of  individual continuums, it has chosen the




99th percentile individual  (among  the  sensitive group). aad tried to locate




the ozone level at which this  individual  first experiences health effects.




(Even with EPA1 s alternative  approach  or concluding that 0.15 ppm is the level




"at which health  effects are virtually certain," these effects are clearly




experienced  only  by individuals at the most  sensitive end of  the spectrum and




not by less  sensitive individuals.1  Then,  incorporating the  full uncertainties




of the location of  this critical point (for  this critical individual) and the




uncertainties  of  meteorology,  EPA  has  set a  standard  that it views as offering




a satisfactorily  low  risk.



     The Review Group has  three major  criticisms of  the approach.  First, and




most fundamentally,  this  "critical point, critical person" methodology ignores




the question of aggregate  exposure to  unhealthy ozone concentration  levels.  By




focusing on the risks that a particular point  for a  particular  individual  (or




class  of  individuals) will be exceeded, EPA's  approach  ignores  the full--




continuum  of effects  and the complete  range of  continuums across  individuals of




differing  sensitivities.   Second,  the  "critical  point,  critical person"




  methodology requires a number of  steps or decisions,  for which there are  no




adequate  rationales  or methodologies  (e.g., why did EPA choose  the  99th percentile




 individual as the critical person?  How did EPA decide  what  was  a  suitably low




 risk?).   Third,  EPA's assessment of the existing literature  and its  panel  selection




 procedures deserve comment.




      The following discussion  expands on these points.




 1.   Ignoring Aggregate Effects



      3y focusing on  "those persons "who are more" sensitive'than" 99~percent




 of the sensitive group but less sensitive than 1 percent  of that group," EPA

-------
                                  - 7 -


has effectively ignored the full range of sensitivities among individuals.

In particular, the remaining 1% of the sensitive population will likely

experience health effects at lower ozone concentration chan does the "critical
        127
person,"    possibly all the way down to zero.  Thus, focusing on the risks

of the "critical person" experiencing health effects totally neglects the

greater risks (or, indeed, virtual certainty) that yet more sensitive

individuals will experience health effects.  Also, there are slightly less

sensitive individuals than the "critical person" who also run risks of

experiencing health effects (albeit lower risks than the "critical person").

Again, the focus on the "critical person" ignores these other risks.

     Further, EPA's approach ignores the continuum of effects.  The "critical

individual" is likely to experience yet more severe health effects at ozone

concentrations that are higher than the "critical point;" these higher con-

centrations have a small but finite possibility of occurring.  Yet, these more

severe consequences do not enter into EPA's calculus of decision.  Similarly,

the more sensitive 17, are likely to experience more severe health effects at

the same ozone level that just induces the "critical point" health effects in

the "critical person."  Again, these more severe effects are ignored.  And,

equally, the effects just below the "critical point" are ignored for all

individuals.

     Another way that the "critical point, critical person" methodology ignores

aggregate effects is through E?A's neglect of the considerable variation  in

ozone concentration levels across geographic areas within an Air Quality Control

Region (AfjCR) .  EPA's proposal appears to assume that any observed exceedance

of the standard will be experienced equally by all people living in the AOCS..
12/  EPA's Risk Assessment document acknowledges this point.  Ibid, pp. 2-25
     to 2-27.

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                                   -  8  -

la face, however, ozone  concentration  levels vary substantially across an
                               13/
AQCR at any one point  in time.     For example,  in 1975 there were nine

monitors measuring  ozone concentration levels  in the Denver AOCR.  These

monitors reported,  respectively,  the following numbers of days in which

average one-hour ozone concentration levels exceeded 0.10 ppm for at least a
                                                       14/
single one-hour period:   24,  21,  19, 10,  2, 2, 0, 0, 0.     If only the

highest of these readings (24 exceedances)  is  used, Denver's population of

1,228,000 would appear to be  exposed a total of  29,427,000 person-days to ozone

concentration  levels  in  excess of  0.10 ppm.  In  fact, people living in the

areas adjacent to  the  last three  monitors experienced no concentrations of ozone

above 0.10 ppm, even  though there  were exceedances in other areas.  Thus, when

the geographical variation in exceedances and  the population densities in che

Denver area are taken into account,  the  actual exposure was only half as
                                !£/
large — 14,700,000 person-days.     Further data directly showing the variation

across a number of  monitors in the AOCRs of the  Northeast are provided in

Appendix A.
13/   See  Committee on Medical and Biological Effects of Environmental Pollutants,
      Division of  Medical Sciences,  Assembly of  Life Sciences, National Research
      Council, National Academy of Sciences, Ozone and  other  Photochemical
      Oxidants,  1977,  pp. 130-163; and U.S.  Council on  Environmental Quality,
      Environmental Quality-1977.  December 1977,  pp. 153-159.

14/   This data has been provided  by Dr.  Kay Jones of CEO.

15/   Even this figure slightly over-estimates the likely  exposure, since the
      population figures are based on residential location.   Peak ozone
      concentration levels tend to occur  in the  afternoon, when many people
      are  at work in the central city, where peak ozone concentration levels
      tend to be lower.  CZQ figures indicate roughly the sane 50% reduction  in
      person-days of exposure for  six other cities that have  been studied:
      Portland, Oregon; St. Louis; Boston; Louisville,  Philadelphia; and
      Washington,  D.C.  And an EPA study  shows a similar 5QZ  factor for
      exceedances for 0.08 ppm in  the Los Angeles AOCR. See  Y, liorie, A. S. Chaplin,
      and  E. D. Helfenbein, Population Exposure  to Oxidants and Nitrogen Dioxide	
      in Los Angeles,  Volume II:  Weekday/Weekend and Population  Mobility Effects,
      Office of Air Waste Management, Office of  Air Quality Planning and Standards,
      U.S. EPA, January 1977, pp.  20-36.

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                                  - 9 -


     Exposure variability has clear implications.   Since populations are

dispersed across AQCIls and ozone concentrations reach peaks in some areas

(which are monitored for compliance with the standard) but are lower in other

areas, then any standard set to achieve a certain level of health protection

can be set more leniently and still achieve the desired level of protection.
                                                                  16/
     Further, ozone levels tend to be lower indoors than outdoors.     The

NAS  has suggested that indoor peak concentrations may reach only 70% of the
                       W
level of outdoor peaks.    Many people, therefore, experience appreciably lower

ozone concentration levels than those registered by outdoor monitors.  Again,

this means that a more lenient standard can be set that will nevertheless
                                               17a/
achieve the desired level of health protection.

     In sum, the "cirtical point, critical person" methodology does not provide

the complete picture of the consequences of ozone exposure.  In Section C, we

will propose an alternative methodology that has the potential for providing

this complete picture.

2.  The Absence of a Rationale for the Crucial Steps in the "Cricital Point,
    Cricital Person" Approach

     Development of the ozone standard on the basis of the "critical point,

critical person" approach requires three crucial judgmental decisions:   (1). What

is the critical point  in the continuum of effects at which a health effect is

considered to be present?   (2) Which  individuals, in the range of sensitivities
 167  NAS, op. cit., pp. 163-165; CEQ, op. cit., 167.

 JL77  NAS, op. cit., p. 164.

 17a/ Note that we are not suggesting  that people should be required  to go indoors
     (or leave the area) during a period of high ozone concentrations.  Rather,
     we believe  that an ozone  standard  should  be set_so. as to_achieve, an
     intended level of protection.  If  the standard is set on the assumption  that
     all people  are outdoors during the period of peak concentration, whereas
     actually some people are  normally  indoors Cor living in a  lower ozone
     neighborhood) at that  time, the  standard  is over-protective; a  more lenient
     standard would achieve the intended level of protection.

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                                  -  10 -


across Che entire population, will  be chosen as  the critical individual, for whom

the critical point must  be determined?   (3) What level of risk (that this

critical individual will experience health effects) is tolerable?

     The first decision  is one  on which  scientific opinion must be relied,

although, again, this  focus on  the  critical point ignores the effects on

both sides of it.  The latter two decisions, however, clearly involve policy

choices rather than scientific  decisions.  Yet,  EPA has not offered an

adequate rationale or  methodology to show how  it arrived at its choices.  How

was the scope of the sensitive  group, from which the 9.9.th percentile individual

was selected, determined? Should it be  asthmatics, asthmatics plus anyone
                                                                                 18/
exercising vigorously, or asthmatics, exercisers, plus the young and the elderly?

Further, and equally importantly, why has EPA  chosen the 59th percentile individual?
                                                    18a/
Why not the 95th percentile?  Or the 90th percentile?      Since the sensitive

group itself is only a small  fraction of the population (e.g., asthmatics and

others with breathing  difficulties  are 3-5% of the population), the choice of

the 95th or 90th percentile individual would still have implied only a

comparatively small number of yet more sensitive people who would receive less

protection.

     Similarly, the determination of the level of acceptable risk of health

effects for the critical individual has  no adequate rationale.  Why is a 0.52

probability of a health  effect  being experienced at the Q.10 ppm standard acceptable,
18/   Apparently,  various members of the expert  panel  had  differing views as
      to  the  categories to be included in this  sensitive group.   "A Method for
      Assessing....," op. cit.,  p.  4-5.   This raises the possibility that each
      of  the  experts was characterizing  a different individual as '"the"
      99th percentile person.

 18a/  EPA has considered these alternatives,  and did ask  the expert panel for the
      probabilities concerning the 9Jth and 90th percentile  individuals.  See "A
      Method  for Assessing..," pp. 2-25 to 2-27, 4-30, 4-31, and 4-34.  But  in the
      end thev have not offered an adequate rationale  for  their  choice.

-------
                                  - 11 -

                                                               197
whereas a 0.67 probability at a Q.12 ppm standard unacceptable?     EPA's

statement that "the choice of a standard between zero and a level at which
                                                                         2_0/
health effects are virtually certain (0.15 ppm) is necessarily subjective"

is simply not sufficient.  In Section E, we will suggest an approach that

removes a good deal of the subjectivity from this choice.

3.  Assessment of Existing Literature and Panel Selection

     With respect to the currently available evidence, EPA appears  to  rely
                                 21/
heavily on the De Lucia and Adams    study for concluding that 0.15 ppm  of

ozone is the concentration level at which "health effects are virtually
         22/
certain."     Unfortunately, the De Lucia and Adams  study simply will  not

support such a conclusion, as EPA's criteria document  indicates:

          De Lucia and Adams studied the effects of graded exercise on
          lung function and blood biochemistry in six men after one hour
          of exposure to 290 yg/m3 (0.15 ppm) and 590 yg/m3 (0.30 of
          ozone via a mouthpiece.  The workloads were 25 percent, 45 per-
          cent, and 65 percent of each individual's maximum oxygen
          uptake (VQ- max.).  Ventilation volume and V^ were unaffected
          by even the most severe exposure/excessive protocals.  However,
          most subjects demonstrated signs of toxicity (symptoms such as
          congestion, wheezing,  and headache) during the most stressful
          protocols.  In addition,  vital capacity,  forces expiratory
          after volume at 1 second, and midmaximum flow rate decreased
          significantly after inhalation for 1 hour of 59JD ,^g/m2 CO.30 ppm)
          at 65 percent VQ2 max.  Discernible though not statistically
          significant changes in resniratory pattern were also observed
          after exposure to 290 yz/ia? (0.15 ppm) ozone and exercise ac
          65 percent VQ2 max.?-P/  [Emphasis added.]

Further,  it  is worth emphasizing that  the  De Lucia  and Adams  study involved

tests on only six  individuals.
I?/43  FR 26967.

2_0/   43  FR  26967.

21/   A.  J.  De Lucia and W.  C.  Adams,  "Effects on 0, Inhalation During  Exercise
      or  Pulmonary  Function and  Blood Biochemistry,   J. Appl.  Physio.:   Respirat.
      Environ.  Exercise Physiol.   43(1):   75-S1, 19.77.

 22_/   43  JR 26967.

 23/   Office of Research and Development,  U.S.  EPA,  Air Quality Criteria far
      Ozone and Other Photochemical Oxidants, Volinre II (April ISJSi, Ch. 9_, p. 13,

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                                - 12 -
     Virtually all of  Che  remaining  clinical  studies cited  in the criteria
document  describe health  effects  found  at  ozone  concentrations of 0.25 ppm
                                                                      25_/
or above.  The main exception  is a German study by Von  Nieding et. al.    which

describes some effects at  0.10 ppm,  but  substantial methodological questions
                                   W
have been raised about  this  study.     Similarly,  the epidemiological studies

cited in the criteria document mostly  focus on health effects found at levels
                                            _27/
of 0.25 ppra or above, though Wayne et. al.     found effects on athletic
                            28'
performance at lower levels     and Japanese studies have  found effects at

low ozone concentrations.  Again,  there  may be serious  methodological problems
                           _29/
with these latter  studies.     It  should also be  stressed that a  number of

studies have failed  to  find  statistically significant effects in  the  range
                    30/
of 0.25 - 0.37 ppm.

     A balanced  summary of the evidence  would appear  to supper* the  following:
 !£/  Ibid, Ch. 9.

 25/  A Von Nieding, H. M. Wagner, H. Loellgen, and H. Krekeler, paper presented
      at the VDI Kommission Reinhaltung der Luft Colloquium on Ozone and Related
      Substances in Photochemical Smog, Duesseldorf, West Gernany, 1976.

 26/  Among these, other pollutants nay not have been adequately removed, and
      the measurement procedures appear to have been different from those usually
      used in  the U.S.  See Phyllis'J. Mullenix, ''Health Effects of Photochemical
      Oxidants," submitted to  the American Petroleum Institute, February 15. 1978.

 27/  W. S. Wayne, ?. P. Wehrle, and R. E. Carroll, "Pollution and Athletic
      Performance,"  J. Amer.  Med. Assoc.  1990.2).:  901-9.04, March 20, 1967.

 28/  There is a serious methodological question as to whether the relationship
      that Wayne et. al. found is linear  between ozone and performance or has a
      threshold at 0.12 ppm.   See Alan Gittelsohn, "Evaluation of Hocky Stick
      Functions Used to Establish Pollution Health Effect Thresholds," submitted
      to the American Petroleum Institute, June 29, 1977.  Also, Wayne et.  al.
      related  relative athletic performance  (this week versus last week) to ozone
      concentrations this week. The proper comparison should have been with
      the  relative ozone concentrations  (this week versus last week).	

 29/  Some of  the symptons observed may have  been  induced by the subjects'
      knowledge of prevailing  ozone  levels.   A3 FR 26966.

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                                - 13 -


         Health effects appear to have been demonstrated with a high

         degree of  certainty  in the range of  ozone  concentration above

         0.37  ppo.   In  Che  range of 0.25 - 0.37,  effects are less  certain,

         with  the  least certainty at the lower  end  of  this  range.   The

         evidence  for human health effects below 0.25  ppra is quite sparse,

         and  the evidence of  significant adverse effects  below this level
                        317
         is even weaker.      Put another way, the evidence  does not appear

         to support the claim that significant  human health effects have

         been "clearly  demonstrated" or  are  "virtually certain" at 0.15 ppra

         or even at 0.20  ppm.

     Further,  it is important to  note  that  all of the ozone-related health

effects that have  thus far been measured  appear to be short-term and reversible.

Thus, although the  affected persons may experience discomfort  during exposure

to high ozone  concentrations, individuals regain their previous state of

health shortly afterward.   Thus far,  ozone exposure has not  been demonstrated to

have long-term debilitating consequences in hunians.

     In addition to surveying the currently available evidence, as noted

above, EPA has asked a panel of experts to provide their judgments as to the

probability that various  ozone concentration  levels would cause health  effects
                       327
in the critical person.     Though the panel  consisted of nine experts, only

three offered  their judgments on any particular health effect category.  This
 31/  Animal studies have demonstrated decreased resistance to infection and
     long-term non-reversible effects from relatively low ozone concentrations.
     See  "Summary Statement from the EPA Advisory Panel	," op. cit., ?p. 12-16
     and  Air Quality  Criteria:..., op. cit, Volume I, Ch. 8.  These effects
     have not vet been  demonstrated in hunans, however, and the epidemiological
     studies have yet to produce any evidence of long-term effects in humans.

 I2j  Strategies and Air Standards Division, Office of Air Quality Planning
     and  Standards, U.S. EPA, "A Method for Assessing the Health Risks
     Associated with  Alternative Air Quality Standards  for Ozone," July  19.78.

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 is an  extremely small sample and raises Che possibility  of  a very  large




 potential variance in the conclusions of the panel.   Ideally,  the




 panel  would accurately reflect the views of the experts  in  the field  (and




 the  degree to rfhich there is or is not a consensus  of  opinion).   Other




 things being equal,  the larger the panel, the smaller the potential variance




 in the representation of the views of the entire population  of  experts.  We




 recognize that the costs of larger panels are not  trivial,  but the cost




 differences among alternative ozone standards are  quite  large  (see Sections 3




 and  C) ;  more accurate information has sizable consequences.  We urge EPA to




 consider the use of larger panels for these risk assessment studies.








     It  is worth reviewing the major conclusions of  this seccion.  EPA has




 pursued  a "critical point, critical person" methodology. In so doing it has not




 taken  into account the full continuum of effects and  the full  range of




 sensitivities among the population.  Questions of  geographic variability




 of ozone concentrations within an AOCR and indoor-outdoor differences have not




 been addressed.  It has thus not focused on nor provided a  measure of total




 unhealthy exposure or total effects.  Further, EPA has not  justified its




 crucial  policy choices within the "critical point, critical person" framework.




 And  EPA appears to have inappropriately interpreted  the  existing literature




 concerning ozone.





     Even  if  one  were to  accept  the general  aethodology  that EPA has used,  a




less stringent  standard would  appear to  achieve  the goal of protecting the




public health.  The  inclusion  of  geographic  variability  and indoor-outdoor




differences alone  would probably  allow  the standard to be .raised-to-0.12-opm-

-------
                                  - 15 -
and still achieve the same consequences as EPA believes it is achieving
                           33/
with its 0.10 ppra standard.     Alternatively if EPA decided to focus

on the 95th percentile or the 90th percentile of the most sensitive group

(again, we are still considering a small fraction of the population),
                                                                   34/
standards of 0.12 ppm or 0.14 ppm, respectively, would be adequate.

As yet another alternative, if EPA concluded that the currently available

evidence points to 0.25 ppm as the proper critical point, a standard of

0.16 ppm would  be adequate.   We urge EPA to reconsider its "critical

point, critical person" methodology and to consider adopting an alternative

methodology which would focus on total effects.  But if EPA persists with its

current methodology, we strongly urge it to reconsider these proximate

decisions at each stage and thus reconsider its overall standard.
337  This would be true if, say, when the reading at the high monitor was 0.18 ppm,
     the average exposure — because of the geographic variability and because
     of the 70% indoor reduction in exposure — was 0.15.

34/  These consequences are derived from examinations of the "risk ribbons" on
     pp. 4-29, 4-30, and 4-31 of "A Method for Assessing	" op. cit.

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                                  -  16 -


                   B.   Determining the Costs of Compliance

     EPA has estimated the  likely coses involved  in achieving compliance with
                             357
alternative ozone  standards.     These cost  estimates provide a useful backdrop

for understanding  one  important  set  of consequences of the alternative standards.

Also, as noted in  Section D,  these cost estimates are an important component

of the balancing that  is necessary for the determination of the secondary standard.

     The cost estimates are derived  in the following manner for each of the

90 AQCRs:  A background concentration level of ozone is assumed.  Likely growth

in hydrocarbon emissions from various sources is  projected.  Two alternative

models, rollback and EKMA (Environmental  Kinetic  Modeling Approach), are used

to estimate the reductions  in hydrocarbon emissions that would be necessary

to achieve the alternative  ozone standards.  Where possible, present and likely

future emissions reductions possibilities are identified and costed.  Finally,

any remaining hydrocarbon reductions necessary to achieve the standard are

assumed to take place,  through unspecified means, at a cost of $1,000-$1,300

per ton.

     We believe that the estimated costs  of meeting the alternative standards

have been substantially understated  for a number  of cost categories.

1.   The Federal Motor Vehicle Control Program (FMVCP)

     The EPA considers the  costs of  the FMVCP to  be a fixed cost, which will

be incurred at all likely ozone  standards.  This  may be an inappropriate

assumption, since  one  of the major justifications that has been advanced for

the stringent control  standards  of the FMVCP is that they are necessary to
35/  Economic Analysis  Branch,  Strategic  and Air Standards Division, Office
     of Air Quality  Planning  and  Standards, U.S. EPA, "Cost and Economic
     Impact Assessment  for Alternative  Levels of Che National Ambient Air
     Quality Standard  for Ozone,"  June  1978.

-------
                                   -  17  -

                                                                               36/
 allow AQCRs  to  come  into compliance  with  the stringent ambient ozone standard.

 Nevertheless, we  shall follow EPA and assume that these costs are fixed.   Thus,

 they do  not  affect the marginal  cost calculations reported in Table 1.

      EPA reports  that  control of hydrocarbons (HC)  and carbon monoxide  (CO) for

 light duty vehicles  will involve "an installed cost of approximately $218 per
          377                          37a/
 vehicle."    This figure is  far too low.   It includes only the cost of the

 hardware installed on  the car and totally neglects the extra fuel, maintenance,

 and  inconvenience costs of the control  technology.

      The proper costs  may be  calculated as follows:  For 1981 and after,

 automobiles  will  have  to meet emission  standards  of 0.41 grams/mile for HC and

 3.4  grams/mile  for CO  (and 1.0 grams/mile  for N"0X).  In 1974, the National

 Academy  of Sciences  -  National Academy  of  Engineering study estimated that a

 car  meeting  the standards of  HC=0.41 grams/mile,  C0=3.4 grams/mile, and NOX=2.0
                                                                          3&/
 grams/mile would  have  a discounted lifetime cost  of $361 over a 1970 car.

 These costs  include  initial hardware, extra maintenance, and extra fuel.   An

 additional cost of $30 should be added  for pre-1970 controls on HC and  CO.

 Part of  these costs  are due to the NOX  controls.   But since the 2.0 grams/taile

 NOX  standard is not  very severe, perhaps  S&O of this cost should be subtracted
 36/   See Air  Quality,  Noise,  and Health,  Report  of a Panel of the Interagency
      Task Force  on Motor Vehicle Goals  Beyond  1980, Department of Transportation,
      March 1976,  pp.  5-55.

 37/   "Cost and Economic Impact....," op.  cit.,  p.  4-2.

37a/  EPA has subsequently acknowledged that its $218 figure is coo low and
     believes  that it is higher, though not as  high as the $441 figure
     mentioned below.

 38/   Coordinating Committee on Air Quality Studies, National Academy of
      Engineering, Air Quality and Automobile Emission Control.  Volume IV,
      prepared for the U.S.  Senate, Committee on  Public Works, September 1974,
      p.  64.

-------
                                   - 18 -


to account for the NO,,  standards.   This leaves S331 as  the lifetime cost  of  the
                                                 39/
HC and CO controls,  as  of  1974,  or $441 in 1978.      Thus, EPA has understated

the annual FMVC?  costs  by  50%.   EPA states that these annual costs are likely  Co

be S2.8 to $3.0 billion.   la fact they are likely  to be $5.6 to $6.0 billion.

2.  The Inspection and  Maintenance Program for Automobiles

     EPA estimates that the net  cost of mandatory  inspection and maintenance (I&M)

programs for automobile emission controls will only be  $5 per car, because main-

tenance costs of  $26-536 per car serviced will be offset by gasoline savings  of
                            40/
roughly the saiae  magnitude.     A^ain, this cost figure is too low, because  the

repair costs appear  to  be too low and the likely gasoline savings from the

required maintenance appear to  be very small.

     EPA has conducted  a series  of evaluations of  restorative maintenance of

vehicles co meet  the 1975 standards, in Detroit, Chicago, Washington, D.  C.,
                   41/
and San Francisco.      Among other things, these studies estiaiated the costs of

the required maintenance and measured fuel economy before and after maintenance.

For the  first  three  cities, the average inspection and maintenance costs for 300

cars was  §41.44  per  car, including those that did  and did not require maintenance.

Thus,  EPA's  S26-$36  per car should probably apply  as an average to all cars
  39/   Between May 1974 and May 1978, the Consumer Price Index for new cars
       increased by 33.1%.

  40/   "Cost and Economic Impact	" op. cit., pp. C-8 to C-9.

  41 /   See R.  Gafford and R. Carlson, Evaluation of Restorative Maintenance on
       L975 and 1976 Light-Dutv Vehicles in Detroit. Michigan (May 19//;;
       n  R  r-Mj^hi 2nd  T. Terrv. Evaluation of Restorative Maintenance on
       1975 and 1976 Light-Duty Vehicles in Chicago. Illinois U*nuary 1977 ;
       L. H. Washington?  Evaluation of Restorative Maintenance on 1975 and 1976
       Light-Dutv Vehicles  in Washington. D.C.  (March  L977) and Automotive
       ,:„..,•>.	a^i g»erome, Tnr..  EvalTHtToTT  of Restorative Maintenance on 1975
       and  1976 Light-Dutv  Vehicle  in San Francisco.  California  (October  19" >•
       All  four are oublished by  Emission Control Technology Division, Of.ice or
       Mobile  Source" Air  Pollution  Control, Office of  Air  and Waste Management,
       U.S. EPA.

-------
                                  - 19 -
                           41a/  •
noc just to those serviced.      Further,  the average fuel economy improvement
                               42/
for the 300 cars was only 1.5£.     For San Francisco, where maintenance had to
                                                                           43/
resore the cars to a tighter standard, fuel economy actually fell slightly.

Even a 1.52 fuel economy improvement does not save much money.  In 1987, if average

fleet mileage is 25 MPG, if cars in AQCRs travel an average of 12,000 miles per

year, and if gasoline costs 70c per gallon (in 19-73 dollarsJ, average annual

gasoline costs per car will be $336.  A 1.5% fuel economy improvement would only

yield annual savings of $5.04 per car.

     Thus, the net costs of inspection and maintenance are likely to be around $25

per car or five times the  figure that EPA has provided.   If  there are 70 million
           	             '                                       44/
cars ia the 90 AOCRs, the  total annual costs will be  $1.75 billion.     By contrast,
                                                                         45/
EPA estimates the total annual costs  at only $350 million -  $450 million.

     Also these I&M cost estimates  ignore the likelihood  that I&M programs will

be imposed state-wide in most  states, not just in AOCRs.  Thus,, the actual costs  of

the I&M program are likely to  be yet  50% higher  than  the  $1.75 billion  figure.

(Nevertheless, we shall use the $1.75 billion in cost adjustments below and  in

Section C.)
41a/ It is not clear how much of the costs (JLa the evaluation studies) are devoted
     to inspection that would not need to occur under more realistic circumstances.
     Also, it is not clear if costs of these magnitudes would continue to apply
     if I&M were on an annual basis.  Offsetting this is the fact that the study
     only considered relatively new cars; restorative maintenance on older cars Bay
     be more extensive and more costly.  And the 1987 standard will be considerably
     more stringent than the 1975 standards.  Maintenance costs cer car in San
     Francisco, where the more stringent California standards were the target, were
     25% above those for the other three cities.
 42/  J. C. Bernard and J. F. Pratt, An Evaluation of Restorative Maintenance
      on Exhaust Emissions of. 1975-1976 Model Year In-Use Automobiles, Emission
      Control Technology Division, Office of Mobile Source Air Pollution Control,
      Office of Air and Waste Management, U.S. EPA, December 1977, p. B-18.

 43/  Automotive Environmental Systems, op. cit., p. 24.

 44 /  If fewer AQCRs require I&M at more lenient standards, the cost would
      obviously be less.


 — 7
      pp
      nhff6  fi8-f ".,*?? gained b^ *ulci?lyinS  S530/ton  of hydrocarbons  times
      0.66 - 0./6 million tons.  See "Cost and Economic  Impact....  " on  c*c
        p- 3-15 and 4-6.                                                    "   '

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                                - 20 -

     As a final methodological 'note, we  should  point out  that even if the EPA

were right  in assuming  that gasoline cost  savings would offset inspection costs,

the real costs of  the I&M program must nevertheless be higher, because of the

inconvenience    costs  involved  (which have  not been included but would raise our
estimates  even higher).  If maintenance actually paid  for itself, motorists

would  do  it voluntarily, and there would be no need for  mandatory inspections!

Since  this  is  not  the case,  Che inconvenience costs involved in  both the

inspection  and the maintenance must clearly be non-trivial.

3.   Emission  Controls  for Heavy-Duty  Vehicles and  Motorcycles

     The  Clean Air Act  includes heavy  duty vehicles (trucks  and  buses) and

motorcycles, as well as automobiles,  in its emission control requirements.

There  currently are interim control requirements  on these vehicles  (controlling

perhaps 50% of emissions on heavy duty vehicles and 35/2  on motorcycles), and

the Act mandates reductions  in HC and  CO by 1983  for these vehicles  that are
                                                  46/
as stringent as the requirements for automobiles.      Indefinite delays in the

enforcement of these requirements are  permitted,  so enforcement  is far from certain.

     EPA has completely excluded the costs of these controls from its estimate

of the costs of the FMVCP program.   These costs should properly  be included,

though they should also be considered  a  fixed cost  that  will be  present for all

alternative standards.

     Specifically, if the 1983 requirements are put into  force,  the  emission

control costs  per  new heavy-duty vehicle should be  at  least  as great as they

are for automobiles. As we  saw,  the new car costs  of  the FMVCP  were likely

to be  S5.6-S6.0 billion per  year.   Sales of new heavy  duty vehicles  have

averaged  30% of the sales of  automobiles,  so che  annual  costs of the FMVCP

program for heavy-duty  vehicles should  be at least  SI.7-31.8 billion.

     The costs of  motorcycle controls  are acre difficult  to  calculate.

Current controls are being met at very modest costs, but  the 1983 controls
46/  Clean Air Act as Amended,  August 1977,  Sec.  202(a)(3)(A)(ii)(I).

-------
                                  -  21 -
promise greater problems.  Yet, the control costs per new motorcycle could not

equal that for new cars, since costs of this magnitude would bulk too large

compared to the price of a new motorcycle.  If we take a quarter of the new

car control costs as a. conservative estimate of new motorcycle control costs,

and we take motorcycle rates at 5% of new car sales, we add another $75 million

to the costs of the FMVCP program.

     The only costs that EPA does recognize with respect to reducing emissions

from heavy duty vehicles and motorcycles are those from some modest transportation

controls.  The estimated annual cost is $30 million, composed of $l,000/ton
                                  '±U
times 0.03 million tons reduction.

     In addition, it seems quite likely that I&M, comparable to that required

for automobiles, will occur.  The truck fleet will average 302 of the size of

the automobile fleet; the motorcycle fleet will average 5%.  If, as we estimated

above, the automobile I&M annual  costs are likely to cost SI.75 billion, the

truck and motorcycle I&M annual costs are likely to be S610 million.  And,

again, if truck and motorcycle I&M are required state-wide rather than just in

AOCRs, the costs would increase by another 50%.

     The I&M for these vehicles would reduce HC emissions by roughly 0.22
             48/
million tons.    This reduces the emission control requirements from other sources

by the same amount, so 0.22 million tons will be subtracted from the fieuras below.

4.  Other Costs

     We have not tried to calculate alternative cost estimates for other

categories of emission controls.  We are,  however, uneasy concerning the "they
47/  Ibid., pp. 3-15 and £-6.

&8 /  EPA estimates automobile I&M will reduce automotive emissions by 37"; we
     have used the same assumptions to arrive at Q.22 million tons.   Ibid., p. 3-15,

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                                    - 22 -
 pay  for  themselves in recovered materials, therefore they are costless"


 arguments  that appear in a few places, especially in the discussion of


 petroleum  refining.

       There is one residual category of costs, however, that is particularly


 troublesome.   This is the "additional reduction required" category, which is


 simply the residual reduction required after all identified reductions have been


 accounted  for.  EPA uses alternative cost estimates of Sl,000-$l,500 per ton
                                                                           49/
 for  the  residual category, which EPA admits is a "lower-bounds estimate."


       This  figure is far too low.  The I&M programs at their true costs
                                            50/
 calculated above, cost roughly S2,50Q/ton.     It is unlikely that the

 unidentified, residual reductions will be any easier or cost any less.  If


 we use this 52,5007ton figure instead, the costs of the 0.10 ?pm standard


  increase by Sl.O billion (using rollback) or $2.9 billion (using EXMA),  with

                                                   5I7
smaller cost increases at less stringent standards.


        It is worth noting  how just  the higher  costs  identified here  —  the


  higher motor vehicle costs  and the higher residual costs  — increase  EPA's  cost


  estimates.   EPA estimates  the  costs of meeting the O.LO ppm standard  at  S6.9

  billion  (rollback)  to §9.5  billion (EKMA).   The higher costs identified  here

  raise these  figures to $14.3 billion (rollback) and $L8.8 billion  (EXMA).   Thus,


  the likely costs of meeting the 0.10 ppm standard  appear to be at  least  twice


  as  large  as  EPA's estimates.
   49/  Ibid.,  p.  4-14.

   5Q/  The automobile I&M will cost SI.75 billion and remove 0.66-0.76  million
        tons of HC.

   51/  The residual costs here incorporate what the EPA considers "advanced"
        reasonably available technology, but the 0.2 million tons removed by
        truck and motorcycle I&M have been subtracted.

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                                   - 23 -


                         C.  An Alternative Approach

      It  is worth recounting the important aspects of the ozone problem:   there

 is a  continuum of  effects; there is a range of continuums, stretching  from  the

 most  to  the least  sensitive person; the location of the continuum for  any class

 of seasons is uncertain; and ozone concentration over time are best described

 by a  probability distribution.  A proper approach, then, should incorporate

 all of these aspects.  The dose-response patterns for given individuals  (at

 successively higher ozone concentrations, what effects does a given individual

 experience?) and across the population (e.g., at what ozone concentration level

 does  the most sensitive 0.01% of the population feel a given effect?   The most

 sensitive O.l%?  The most sensitive 1%, etc.) should be estimated.  With  these

 dose-response relationships (including any uncertainty surrounding them)  and a

 probability model  for temporal and geographical occurrences of ozone concentra-

 tion  levels, one could estimate and then compare the expected annual person-hours

 of exposure to ozone that are likely to generate effects,  using dif^e^en'-
                           52/
 proposed ambient standards.     The choice among alternative standards,  then,

 would have to be based on how many person-hours of unhealthy exposure are

 considered tolerable.

     Unlike EPA's "critical point,  critical person" approach,  this alternative

 approach would make explicit use of all of the aspects  of  the ozone problem

 that EPA agrees are likely to be true,  and it would develop directly the

 quantitative measures  of likely unhealthy exposure at  any  alternative standard.

A more explicit statement of the consequences of  alternative  standards  should

 help in the development of public  policy.
52/  It is worth noting that this approach is quite consistent with that
     suggested by the NAS Ozone Study,  op. cit.,  p. 130.

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                                  - 24 -

                                                                            53/
     In Table  1, we offer an  example  of  the  application of this methodology

Appendix B contains the  detailed  description of  the specific formulation used

here.  We should stress  that  the  specific  numbers are meant to be suggestive

rather than our definitive  statement  of  what we  think the numbers exactly to be.

We do believe, however,  that  the  general form  of the outcome of this example

has general validity  for the  ozone  problem and that the general magnitudes are

correct.

     In Table  L, Column  (1) shows the assumed  standard.  Column (2) shows the

expected annual number of person-hours of  unhealthy exposure, as explained

above and  in Appendix B. Column  (3)  shows the difference  in person-hours of

health effects as  one goes  from one standard to the next more stringent standard.

     As one would  expect, the Table indicates  that as the  standard  is  tightened,

the expected annual number  of person-hours of  unhealthy exposure to ozone

decreases  (but not to zero  at any standard short of zero!).  But over  this

range or  feasible  standards,  the  Tnarginal  reduction in person-hours of

unhealthy  exposure decreases as  the  standard becomes  tighter.

     There is  no  obvious cut-off  point for establishing the  standard.  There

is  no absolute level of  safety.  At all standards  there will be health effects.

EPA's choice  among these alternative standards, using these  kinds  of  outcomes,

will not  be an easy one.  But this kind of methodological  framework helps  to

make  the  consequences of the choice more explicit.

     We  can also incorporate the estimated  costs of meeting  the alternative

standards, discussed in Section  B, into the analysis.   In  Table  1,  EPA's
 53/  In the absence of readily available dose-response curves for given
      individuals and of a readily available weighting scheme for different doses
      of ozone for an individual, we have, for the purposes of this example, used
      only the critical point, the onset of a health effect, as explained in
      Appendix 3.

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(1)
Standard
0.08 pI>m
0.10
0.12
O.l/i
0. 16
0.1H
0.20

(2)
Expected
Person-
1 lours of
llnlieal Lliy
Exposure
Ln Ozone
8.JS7.201
8,827,200
9,746.584
10,977,856
12,623,848
14,882,704
18,082,608

(3)
Difference
in Expected
Person-Hours
639,999
919,389
1,231,272
1,645,992
2,258,856
3,199,904


(4) (5)
Estimated
Coses of
Meeting
Standard,
Rollback Difference
HodelH/ Jn Costs
$8.5 bll.
$1.7 bil.
$6.9
$1.0
$5.9
$0.7
$5.2
$0.4
$4.8
$0.2
$4.6
$0.2
$4.4
(bj
Extra
Cost per
Reduced
Person-
Hour of
Unhealthy
Kxpoaure
$2,660
$1,090
$570
$240
$90
$60


(7)
Estimated
Cost of
Meeting
Standard. EKMA
Model a/
$12.1 bll.
$9.5
$7.5
$6.7
$6.0
$5.6
$5.3
(9)
(8) Extra
Cost per
Reduced
Person-
Hour of
Difference Unhealthy
in Costs Exposure
$3.6 bll. $5,630
$2.0 $2,l'bO
$1.8 $1,460
$0.7 $430
$0.4 $180
$0.3 $90

a/  Costs are ihe sum of the costs of the Federal Motor Vehicle Control Program, new source control, reasonably
"~   dvulldhlu control technology, and $l,500/tou la reduce any remaining emissions necessary to meet the
    alternative standards.  These arc annual costs, »a of 1987, Jn 1978 dollars.

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                                  -  25 -


original (unadjusted) cost estimates are used.  Since  the cost estimates vary,

depending on whether a  roll-back  model or  an EKMA model  is used to estimate the

needed hydrocarbon  reductions, both  cost estimates  are provided in Columns  (4)
        Ii'
and (7).     The  extra  costs  of meeting  the next more  stringent standard are

provided in Columns (5) and  (8).  And  the  extra cost per reduced person-hour of

health effects  is provided in Columns  (6)  and  (9).

     Again, as  one  would expect,  the costs of  meeting  the ozone standard

become higher as  the standard becomes  more stringent.  And  the marginal costs

of meeting  the  more stringent standards  become progressively higher.   Finally,

the marginal  costs  per reduced person-hours of unhealthy exposure  climb rapidly

at more  stringent standards,  both because the marginal costs are rising and

because  the reduction in the number of person-hours of unhealthy exposure  falls

off.   If we use the roll-back model, the marginal cost of  a reduction of one

hour  of  unhealthy exposure to ozone is roughly SHOO when  we go  from a 0.12 ppm

 standard to a 0.10 ppm standard;  for the EKMA model, the marginal  cost per

 person-hour is roughly 52,200 for the same change.  3y contrast, when we  go

 from a 0.18 ppm  standard to  a 0.16  standard,  the rollback model  indicates  a

 marginal cost per  person-hour of only $90, whila the  EKMA model indicates

 S180 for the same  change.

      Table 2 contains  similar cost  calculations embodying the revised cost

 estimates discussed in Section 3.   We have added the  new FMVCP costs  (auto and

 truck) as a fixed  cost to all alternative  standards.  The maximum amount of

 the new  inspection and maintenance  costs  (auto and truck) and new residual costs
  54/   The  costs differ slightly from those  provided  in  "Cost and Economic Impact...
       op.  cit.   The cost levels here are the sum of  the costs of the Federal Motor
       Vehicle Control Program,  new source control,  identified reasonably available
       control technology, and an assumed cost of $l,500/ton for reducing remaining
       hydrocarbons necessary to meet the standards.   These figures  have been
       provided by Deborah Taylor of the Office of Planning and  Evaluation,  U.S.

-------
                                                      - 25a -
  <0
                             Table 2;  Costs of Person-Hours of Exposure, Revised Costs
(4)
(5)
              Estimated Costs of
     (6)

fixtra Cose per
Reduced Person-
    (7)

Estimated Cost
of Meeting
(8)
  (9)
Extra Cost
per Reduced
Person-Hour
Standard
0.08

0.10

0.12

0.14

0.16

O.IH

0.20
Meeting Standard.
Rollback Model -
$17.4 bil.

$14.3

$12.4

$H.(>

$10.2

$9.7

$9.2
Difference
in Costs

$3.1 bil.

Si.y

$1.4

$0.8

$0.6

$0.5

Hour of Unhealthy
Exposure b'

$4840

?2070

$1140

$490

$270

$]60

Standard. EKMA
Model -'
$23.2 bil.

$18.8

§15.0

$11.4

$12.0

$11.0

$10.1
Difference
in Costs

$5.4 bil.

$3.8

$1.6

$1.4

$1.0

$0.9

of Unhealthy
Exposure J*/

$8440

$4130

$1300

$850

$440

$280

«/  Cost nitres Include those shown in Table 1, plus revised FMVCP, T&H, and residual costs.  See text for details.

b/  Sue Table 1 for relevant exposure numbers.  '

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                                  - 26 -





has been added co the 0.08 ppm standard, with proportionately less added to the




more lenient standards,  and no:hing added  to the 0.20 ppm standard.



     As can be seen, HPA's proposed 0.10 ppm standard is now calculated to



cost $1A.3-$18.8 billion.  The marginal costs of going from a 0.12 ppm standard



eo a 0.10 ppm standard are $1.9-$3.8  billion, and the marginal costs per



person-hour of unhealthy exposure are now  In the range of S2100-S41QO,  By



contrast, in going  from  a O.L8 ppm standard to  a 0.16 ppm standard the marginal



costs  per person-hour  of unhealthy exposure are only $270-3440.



     It  is worth  emphasizing  again that  the health  effects  that we have been



describing  as  occurring  as  a  consequence of ozone exposure  are  largely those



of discomfort;  the  effects  are  reversible, and  there is  at  present no evidence



of long-term  debilitating effects from exposure co  ozone at  the concentration




 levels we are considering.

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                                  - 27 -


                    D.   Setting the Secondary Standard

     The secondary standard is supposed to be set at a level that will "protect
                    !!/
the public welfare."     The Clean Air Act later indicates that

           "All language referring to effects on welfare includes,
           but is not limited to, effects on soils, water, crops,
           vegetation,  man-made materials, animals, wildlife, weather,
           visibility,  and climate, damage to and deterioration of
           property, and hazards to transportation, as well as effects^
           on economic  values and on personal comfort and well-being. 56_/
           ^Emphasis added^_/

     EPA has set the secondary standard for ozone at 0.08 ppm, apparently relying
                                                      EJ
entirely on evidence of possible damage to vegetation.     There has been no

consideration of the "effects on economic values."  As we saw in Tables  1 and  2,

the economic costs  of  the 0.0$ ppm standard are quite substantial.  We urge

EPA to weigh these  economic costs against  the benefits of reduced damages from
                                                                      58/
lower ozone concentration level before setting  the  secondary standard.
 55/   Clean Air Act as  Amended August 1977,  Sec.  109,  (b)(2).

 567   Clean Air Act as  Amended August 1977,  Sec.  302,(h).

 _57/   43 FR 26963-26969.

 587   See the Petition of American Petroleum Institute and Member Companies for
 ~   Review and Revision, in Re:   Air Quality Criteria,  National Ambient Air
      Quality Standard and Control Program for Photochemical Oxidants, before
      the Administrator,  U.S. EPA, December 9, 1976, pp.  9-10.

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                                   -  28  -






                            E.  A  New Methodology




     la Section A we  offered  a critique of  EPA's  procedures in setting the




primary standard.  We argued  that EPA's "critical point, critical person"




methodology  ignored the  total effects of  ozone  exposure.  Further, we argued




that crucial policy choices in applying the methodology had not been justified.




In Section C we offered  an  alternative  methodology, based on person-hours of




unhealthy exposure.   We  believe that this alternative methodology deals with




ozone-related health  problems in  a superior fashion.  Yet even that methodology




offers no explicit guidelines as  to  the specific  cut-off point, the specific




standard  that should  be  chosen, when all  possible standards imply some




unhealthy exposure.   In  this  section we will offer  a new methodology which




addresses this last problem and which  is  still  consistent with the goal of




"protecting  the  public health."




     The  fundamental  problem  in  setting standards resides in the conflict




between Congress's apparent hope  that  there would be  unique threshold




concentrationsbelow which the public health (of everyone) would be protected




and  the  likely reality that ao such  thresholds  exist.  If there are no




thresholds,  if there  is  a continuum of effects, if  individuals vary substantially




in  their  sensitivity, then there  is no way  to protect  the health of everyone.




There  are no safety margins.

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                                   - 29 -
     The position that there are no thresholds for pollutants and other

dangerous substances is one toward which the scientific community has been
       597
moving.     The Report by the Committee on Interstate and Foreign Commerce,

House of Representatives, on the 1977 Amendments to the Clean Air Act appears
                               607
to have endorsed this position.

     In the absence of thresholds, there will be some health effects felt

by some fraction of the population (albeit small) at any possible standard.

Any attempts by a government agency to find a "safe" level with a "safety

margin" must be misleading and is poorly conceived policy.  Instead, any

effort to "protect the public health" must squarely accept the fact that no

safe level/and instead must decide on what degree of likely exposure constitutes

sensible public policy.

     Let us now try to establish a few principles that are consistent with

this orientation.  First, other things being equal, the more serious the

health consequences of exposure, the more worthwhile it is to restrict

exposure.  Thus, sensible public policy should call for greater restriction

in the public's exposure to a serious pollutant, such as lead, than to a

less serious pollutant, such as ozone.

     Second, in the case of two or more pollutants the health consequences

of which are roughly equal, restriction of exposure to each should be adjusted

to the point at which the marginal dollar of costs related to restriction
59/  See the summary of comments contained in the Report by the Committee
     on Interstate and Foreign Commerce, House of Representatives, on the
     Clean Air Act Amendments of 1977, Report Mo. 93-294, May 12, 1977,
     pp. 110-112.

60/  Ibid., ??. 110-112.

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                                  - 30 -
(e.g., controlling emissions), yields  the  same amount of protection (e.g.,




health effects avoided)  for  each  pollutant.  Any violation of this principle



would mean that  the public health could be better protected  (fewer health



consequences) at  Che  same total cost Co society by altering  the expenditures



among pollutants  until  Che principle was satisfied.



     Third, at equal  degrees of restricted exposure, it  is worthwhile for



society  to spend  larger sums per  marginal  reduction  in health effects for



more serious  pollutants and  smaller sums per marginal reduction in health



effects  for less  serious pollutants.   Again, any violation of this principle



would mean that  the public health could be better protected  fay altering




expenditures  among  pollutant categories.



     The three  principles  enunciated thus  far would  escablishva proper



consistency across  pollutant categories  and  ensure  the best  protection of



the public health for  any total expenditure on  controlling  pollutants.



Acceptance and  activation  of these principles" by  regulatory  agencies would




be a  large  step forward in improving the regulatory process  and better




protecting  Che  public health.



      Fourth,  regulatory efforts to restrict  exposure to  pollutants  (once these



efforts have  been made consistent across pollutants) should  be  consistent with



other efforts by the Federal Government to improve  the  public health  and



 safety, in terms of marginal costs per effect achieved.   Again,  the same



 logic of best protecting the public health for any  given amount of  societal




 spending applies.

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                                  - 31 -


     Finally, after this widespread consistency has been achieved,  we are

still left with the problem of determining where the final line should be

drawn:  how much should be spent on health, how much spending should government

regulation require from the private sector?  Again, absolute safety, absolute

protection cannot be achieved short of zero levels of pollutants.  But the

zero levels are impractical.  As the House Committee on Interstate and Foreign

Commerce stated in its Report on the 1977 Clean Air Act Amendments, "...this

no-risk philosophy ignores all economic and social consequences and is
             61/
impractical."     And the regulatory agencies,by not setting standards at

zero pollutant levels, have implicitly-accepted this view.


     Consequently, a line must be drawn.  These lines are currently drawn ia

an implicit  fashion by the regulatory agencies.  Good policy requires that

they be made explicit and that they be consistent, as we have argued above.


     Accordingly, regulatory  efforts  to restrict exposure to pollutants  (and

other Federal  health efforts) should  be consistent with  the preferences  and

behavior of  the general population with respect to health and with  respect

co other goods and services in  the economy.   In the  end,  this will  aean  some

very  difficult valuation  nroblems.  But in a  world without  thresholds and in

which a zero risk  solution  "ignores all economic and  social  consequences  and

is  impractical,"  these valuation problems  cannot be  avoided.  Decisions  to

"protect  the public  health" must necessarily  focus on  these valuation problems,

air  then  thoroughly, and  try  to reach correct and  consistent judgments.
 61/  Ibid.,  p.  127.

-------
                              Appendix A


                                                              i/
     The tables in this appendix, taken from Cleveland, et. al.   show


the hourly ozone concentration levels at a number of monitors in a few


AOCRs in the northeastern U.S. for a few days in 1974.  The tables indicate


substantial variation in ozone concentrations across monitors within an


AQCR at any given time.  They thus strongly support the argument in


Section A concerning geographic variability in ozone concentration.


     These data (as do the other data and computations in the Celveland et.  al.


paper) also point to a possible problem in enforcement and in determining


responsibility for non-compliance.  The monitors are arranged on the page


from far northeast at the top to more southwest at the bottom.  The prevailing


winds were blowing from the southwest (i.e.,  from the monitors at the bottom


of the page toward the monitors at the top of the page) .   There is a clear


diagonal pattern of high ozone values,  running from lower left to upper  right


i.e., running from mid-morning upwind to mid- and late-afternoon downwind.


     This implies that some downwind AOCRs (e.g., central Connecticut)  are


unlikely to attain compliance with the ozone  standard unless nearby upwind


AOCRs also attain compliance.
I/   W. S. Cleveland, B.  Kleiner,  J.  E. McRae, and J. L. Warner,  "The
     Analysis of Ground-Level Ozone  Data  from New Jersey, New York,  Connecticut,
     and Massachusetts:  Transport from the New York City Metropolitan Area,"
     Bell Laboratories, 1975.



                    TftW**    »•>+    \*

               ccyy •

-------
                              Appendix B


     As explained in the  text in Section C, we wish  to  substitute a methodology

focusing on expected aggregate unhealthy exposure  for EPA's methodology.   Our

goci is to try to determine the expected annual number  of person-days of

unhealthy exposure to ozone at the alternative standards.

     We start with the pattern of the dose-response relationship across  the

population.  We use median estimates for this example,  though a more complete

model would include complete information on the probabilities surrounding  this
                      y
dose-response pattern.    At 0.0 ppm, none of the  population experiences any

health effect from ozone.  At 0.15 ppm. 0.1% of the  overall population  are
                                         y
likely to be experiencing health effects.    At 0.30 ppm, 10% of the overalll
                                                     JJ/
population are likely to be experiencing discomfort.    These three points can
                                                                 A/
be used to fit a smooth logit distribution of the  following form.   :
      T    i.o + ell.616 - 31.397c                                     (3-1)


where c is the ozone concentration level and P_ is the percentage of the

population experiencing health effects at an ozone concentration level of

c or less.
I/   In the absence of readily available dose-response curves for giver.
     individuals and of a readily available weighting scheme for different doses
     of ozone for an individual, we have, for the purposes of this example,
     used only the critical point, the onset of a health effect.

2J   EPA estimates that 5% of the population are asthmatics and others with
     chronic breathing problems; perhaps another 5% on average are engaged
     in vigorous activity — work or play: and the EPA experts put 0.15 ?pn
     as the rough point at which the least sensitive person of the most
     sensitive 1% of the sensitive population experiences health effects.

_3_/   This is taken from S.  Leung et.  al. , Human Health Damages  from >to'oile Source Ai
     Pollution:  A Delphi Study, Corvallis environmental ^esearca i-aaoracary, .3  -^.^ >
     April 1977, p.  4.
4/   This "logit form, with these coefficients, fits these three points exactly.
     It shows ?T(.37) =  .5, whereas Leung et. al. put ?T(..5Q) = .5, but at
     the alternative standards which are considered the probability of
     occurrences above ozone concentrations of 0.37 ppm is extremely remote,  so
     this difference is probably not important.

-------
                                  B-2


     Next, we cake the Weibull distribution, as suggested by EPA, as

characterizing the distribution of  ozone  concentration levels over time:
     ?c = l-e-               CSTD                                 (B-2)


where c is the ozone concentration  level,  CSTQ  is  the standard, and ?c

is the probability of ozone concentration  of  c  or  less occurring  in a single
     5/
hour.  The corresponding  density function  is


     p  = ln<8760)   m   -  /ln(8760)  •  C/CSTD                       (B-3)
            CSTD

     The combination of the dose-response  relationship and  the probability

density of ozone concentrations, when integrated over all ozone concentration

levels, yields the expected person-hours of ozone  exposure  that is likely to

generate health effects,  at any given standard.  The expected annual number

of person-hours of unhealthy ozone  exposure,  then,  is

                                oo

     H - 142  x 106  • 8760     I  PT • pcdc,                       (B-4)

                            o

where 8760 is the number of hours  in a year and  142 x 10   is the number  of

people living in  the 90 AOCRs. H  is  calculated separately  for each alternative

standard.  This formulation  thus  far  neglects the  geographic variability and

indoor-outdoor differences.   In Table 1 in che  text, we  have assumed, as a

rough approximation,  that these factors would reduce the number of person-

hours of unhealthy  exposure by 50%.
 5/  For the purposes of our calculation, we have assumed that the "shape factor,"
      k, in the Weibull distribution, is 1.0. -

-------
                  "NITED STATES ENVIRONMENT/               TAB T

        C21740
         Council  on Wage and Price  Stability/Regulatory         DATE:   08 NOV 1979
         Analysis Review Group  Critique  of  the Proposed
         Ozone Ambient Air Quality  Standard                        Envsronms.-.^
                                    f'''-~-                        Protection r	
h " M:    Walter C.  Barber, Director ..i^.r                             Re-;-* *
         Office of Air Quality  Planning'and Standards
                                                                   DEC  20 I97f
T0:       David G. Hawkins, Assistant Administrator
           for Air, Noise, and  Radiation                             LIBRARY


              The purpose of this memo  is to summarize and  respond  to  the ozone
         air quality standard critique  prepared  by  the Regulatory Analysis Review
         Group (RARG) and submitted to  EPA  as a  formal comment  by Barry  P. Bosworth,
         Director of the Council on Wage and Price  Stability  (CWPS).

         Summary

              The RARG criticizes the EPA decision  methodology  used in arriving
         at its proposed ozone  air  quality  standard.  RARG  also argues that the
         EPA's selection of assumptions  results  in  an overly  restrictive standard.
         As a part of their critique, RARG  suggests both  a  new  methodology and
         revised input data that they feel  will  provide a better assessment for
         decision-makers.

              RARG contends that a  new methodology  is necessary because  health
         effect threshold levels for ozone  probably do not  exist or are  uncertain,
         thus prompting the need for other  decision criteria  such as aggregate
         exposure parameters and marginal cost.   RARG does  not  comment on the
         disallowance by the Clean  Air Act  of an economic test  to determine the
         level of the standard.  RARG believes that EPA has over-stated  the
         seriousness of health  effects and  the levels at  which  they occur, and
         has underestimated the cost of  controlling hydrocarbon emissions.  RARG
         suggests that based on their interpretation of the economics  of health
         protection, the proposed ozone  air quality standard  is too restrictive
         and could be relaxed up to a level in the  range  of 0.15 to 0.16 ppm.

              We agree with RARG's  comment  that  economic  cost and benefits be
         weighed in selecting the secondary standard level.   We are reassessing
         the need for a secondary standard  more  restrictive than the primary.
         However, we strongly disagree with RARG's  suggestion that  a simplistic
         model be substituted for careful judgment  as the principal tool in
         selecting the primary  standard  level.

              The following paragraphs characterize both  the  EPA and RARG ap-
         proaches to setting a  National  Ambient  Air Quality Standard as  well as
         my serious reservations regarding  the accuracy and appropriateness of
         the RARG comments and  suggestions.
EPA F»im 1320-6 (Rev. 6-72)

-------
Characterization of EPA and RARG Standard-Setting Methods

     EPA - EPA's approach to setting a- National  Ambient Air Quality
Standard is keyed toward the protection of sensitive persons from the
adverse effects of ubiquitous air pollutants.   This approach is not
an efficiency optimizing method and it does not take into account
aggregate measures of cost-effectiveness.   EPA's interpretation of the
statute does not permit consideration of cost  and attainability 1n a
standard decision.  We feel Congress has confirmed this interpretation
through its action to extend attainment dates  in those cases where
cost or attainability constraints appear unreasonable.

     The EPA air quality standard-setting approach attempts to evaluate
all pertinent evidence, and to incorporate it  into the final decision.
Selection of an air quality standard with an adequate margin of
safety is a complex judgment that must be based on the careful
consideration of inconclusive scientific and medical evidence.  Given
the uncertainty in the available data, the judgments cannot be simpli-
fied to an objective choice based strictly on  a comparison of marginal
costs.

     RARG - The RARG methodology is keyed to economic efficiency and
resource allocation.  This approach focuses on aggregate health impacts
and not on the health of sensitive individuals.  The RARG model avoids
complex judgments regarding medical evidence by arbitrarily assigning
no value to less conclusive indications of health risk associated with
low levels of exposure.  The RARG approach selects only the most
conclusive studies for use in the cost model and assigns no value to
uncertain risks at lower levels.  The RARG further suggests that EPA
move toward a regulatory decision model that equates marginal cost
across different public safety and health programs.  RARG argues that
this approach would more equitably distribute public health and safety
dollars among competing programs.

Evaluation of the RARG Report

     The RARG report has several principal flaws which strictly limit
its value as an alternative standard-setting methodology or as an
input to a refined or improved EPA standard-setting approach.  These
limitations fall in three categories:  (1) RARG fails to provide full
consideration and evaluation of the complete array of medical evidence;
(2) the RARG approach is presently illegal; and (3) the control costs
estimates provided by RARG are over-stated.

Full Consideration of all Medical Evidence - The most serious flaw in
the RARG approach is that it tends to oversimplify the National Ambient
Air Quality Standard setting process.  It fails to recognize that
complex judgments regarding the full array of medical evidence, both
conclusive and inconclusive, must be considered by the Administrator

-------
in selecting a standard level that protects public health  with  an
adequate margin of safety.  RARG offers a simplistic model  which not
only fails to consider these concerns but also precludes  them from
consideration by the decision-maker.   This principal defect of  the RARG
approach is clearly illustrated on page 13 of their report.   On that
page and in one paragraph, RARG completely dismisses the  entire body of
medical evidence regarding adverse effects attributed to  ozone  and
photochemical oxidants, with the exception of irrefutable  clinical
studies showing effects at concentrations of approximately 0.37 ppm.
Such a choice by RARG totally eliminates from consideration by  the
Administrator that body of medical evidence reporting effects at con-
centrations down to 0.10 ppm.  (Enclosure 1).

     RARG's treatment of inconclusive data and characterization of
ozone-induced effects as short-term,  reversible, and with  no long-term
debilitating consequences, is not a complete and accurate  representation
of the evidence.  Decreased resistance to bacterial infection has  been
conclusively demonstrated in laboratory animals.  The effect in this
case is increased mortality, and as such warrants consideration by the
Administrator in making a standard choice.  Animal studies also indicate
that long-term or low-level oxidant exposures seem to act as an inducer
of biochemical and morphological changes.  These changes  are transient,
and, on a short-term basis, may have a physiological significance  in
that they confer a resistance against further lung injury in an oxidant
environment (a similar response has been observed in human clinical
studies).  However, the long-term effects of these changes resulting
from a continued exposure are yet to be determined.  Whether or not low-
level oxidant exposures can lead to enhanced aging, or a  development of
chronic bronchitis or pulmonary carcinoma, fibrosls or emphysema needs
to be determined in long-term tests.   RARG erroneously assumes  that the
lack of this kind of evidence from definitive human studies indicates
that the effects do not occur.  The correct interpretation must be that
the existence of effects is uncertain and that the risk of effects is
real.

     RARG has also not considered those studies which show a synergistic
or enhanced effect of ozone in the presence of other pollutants.
Laboratory studies of single pollutants (e.g., ozone in clean,  filtered
air), while important in elucidating physiological effects peculiar to
that pollutant, cannot be viewed as providing definitive  evidence  of the
minimum level at which these effects occur when the source pollutant is
present as a part of the total insult delivered to an individual in the
urban environment.  Thus, the effects of ozone must be considered  in the
context of the total environment of the exposed individual, including
concentrations of other pollutants consistent with their  maximum al-
lowable levels, high relative humidity, high ambient temperatures, and
high levels of physical stress.

-------
     Other evidence, erroneously dismissed by RARG,  which  I  feel  is
germane to a prudent public health decision on the  ozone standard
includes:  (1) Symptomatic evidence of ozone toxicity in Japanese school
children and in actively exercising healthy adults  after short-term
exposure to ozone levels in the range of 0.10 - 0.15 ppm,  (2)  reduced
visual acuity in humans at 0.20 ppm, (3) statistically significant blood
biochemical changes in humans at 0.20 - 0.25 ppm,  (4) increased sphering
of human red blood cells at 0.25 ppm, and (5) judgments by medical
experts, responsible for conducting medical research, that adverse
effects most likely occur in sensitive subjects at  about 0.15  - 0.18
ppm.  This evidence plus the concern that effects  reported in  some
studies may occur at lower concentrations when ozone is in combination
with other urban pollutants, and may be more intense in sensitive
individuals, must be brought to bear on the ozone  decision and cannot  be
dismissed as suggested by the RARG.

     A final note of caution regarding the health  data concerns the
simple fact that numerous U.S. cities, where citizens perceive a photo-
chemical oxidant smog problem, record worst day ozone levels (Enclosure
3) that are at concentrations (0.16 ppm) that RARG appears willing to
consider for a standard.  Despite RARG's objective of improving and
simplifying the decision process, there is clearly something wrong with
an approach that would characterize present air quality in cities like
Atlanta (Enclosure 3) as currently healthful and safe with an  adequate
margin of safety.

Legality of the Suggested RARG Approach - A critical omission  of the
RARG  report is that it fails to properly deal with the Clean Air Act's
disallowance of weighing of costs in setting National Ambient  Air
Quality Standards.  Nowhere in the report does RARG recognize  this
statutory limitation thus implying that the Agency is without  such a
constraint.  In promulgating the National Ambient Air Quality  Standard
for lead (43 FR 96247), EPA explicitly enunciated its interpretation  of
the Act, and thus the official administration position, as disallowing
the use of cost-benefit analysis.  Since the CWPS has formally submitted
a statement that conflicts with the EPA position,  it could undermine
EPA's  interpretation of the statute and its decision on the  lead standard.

      RARG recommends a methodological approach keyed to resource allo-
cation across different public safety and  health programs.  Nowhere does
the Act authorize such balancing of costs  and benefits across  pollutant
and media lines.  The Act does not authorize the Administrator to abandon
air pollution control simply because the marginal  cost is  less for a
comparable health unit in another public health or safety  program.

-------
     You should also be aware that the President's Council  on Environ-
mental Quality has reviewed and critiqued the RARG report (Enclosure 2)
and essentially agrees with our views on RARG's improper treatment of
health data and on their use of marginal cost models to set air quality
standards.

Estimates of Control Costs

     The cost figures presented in the EPA paper are based  on numerous
calculations, involving many different type sources and projections, all
of which involve uncertainties.  The RARG selected two sets of these
calculations for further study and from which it reached the conclusion
that EPA had underestimated the total cost by at least a factor of two.
The two areas addressed by RARG include the Federal Motor Vehicles
Control Program (FMVCP) and Inspection and Maintenance (I&M).  The RARG
then uses its calculation of the I&M cost (which contains errors that
will subsequently be discussed) to estimate the cost of controls for
certain other sources.  Differences between EPA and RARG cost estimates
are summarized below, followed by a brief discussion of plans to update
the EPA study.

     RARG uses a 1974 National Academy of Sciences (MAS) report to
ascertain the cost of meeting a 0.41/3.4/2.0 gram per mile  standard for
Light Duty Vehicles (LDV) as $361  per LDV (in 1974 dollars).   RARG then
assumes that $60 of this cost is for NOx control.   The remaining $301  is
assumed to be for HC control (no adjustment is made for part of the $301
due to CO control).  The $301 figure is further revised by  assuming that
an additional $30 must be added since the NAS figure is cost above 1970
controls.  Finally, RARG adjusted the figure by a factor of 1.33 to
account for new car price escalation between 1974 and 1978--making the
cost of HC control $441 per LDV (1978 dollars).

     Although we were aware of the 1974 NAS report, it was  not the most
current data available.  We elected to use the more recent  data, just as
Congress and the Administration did in preparation of the 1977 Clean Air
Act Amendments.  This data was generated from studies prepared by the
Office of Mobile Source Air Pollution Control (OMSAPC) which estimated
the cost of controls for LDV's to be $218 per vehicle.  Although these
studies cited the $218 value as including both HC and CO control,  we
chose not to adjust the figure for CO control.  This was done to offset
not being able to account for the cost of the heavy-duty vehicle (HDV)
control as is further discussed below.

     It was our judgment that insufficient data existed to  estimate the
cost of the heavy duty vehicle and motorcycle (MC) standards.  However,
as noted above, it was felt that attributing all of the above $218 cost
for LDV's to HC control, offset most of this omission.  RARG

-------
chose to estimate the cost for controls of HDV and motorcycles  as  equal
to that of the LDV's.  Thus, RARG estimates the cost of the HDV's  and
motorcycle standards to be $1.7 - $1.8 b.illion and $0.075 billion,  re-
spectively.

     In the EPA analysis it was estimated that the maintenance  cost of
an I&M program would be nearly offset by improved fuel  economy—making
the cost of an I&M program about $5.00 per car inspected.   RARG uses
results from several recent studies to conclude that only a small  portion
of the maintenance costs are offset by improvements in  fuel  economy.
Consequently, RARG estimates that the I&M cost will be  $25 per  car.
However, RARG then erroneously applies this value to all  cars in  the
AQCR--whereas in reality only 30 percent of the cars require maintenance.
Thus, RARG estimates a much larger cost for I&M than does EPA--$1.75
billion vs. $0.23-$0.26 billion.  (NOTE:  RARG cites EPA's estimates as
$0.35-$0.45 billion for I&M; however, this figure includes both I&M and
other transportation control measures.)  RARG extends the I&M program to
include HDV and motorcycles adding an additional  $0.61  billion  to  the
cost of the I&M program.  We do not include these controls in our  cost
estimates since there are currently no known plans for  a HDV and motor-
cycle I&M program.

     As you know, OMSAPC just recently updated its cost estimates  for
both the FMVCP and I&M.  Generally, these new cost estimates are  sup-
portive of the values EPA used in its study (in fact the new numbers
indicate that EPA may have overestimated the cost).  However, because
there are slight changes in the cost numbers and because improved
emissions inventories have been ascertained, we plan to update  our
study.

     In the EPA analysis, it was found that even after  application  of
all definable Reasonably Available Control Techniques (RACT), certain
areas would require additional control for attainment.   Because this
additional control has not yet been technically defined, its cost  was
estimated as at least $1000/ton.  RARG, based upon its  erroneous cal-
culation of the I&M cost, estimated that "additional control" would cost
at least $2500/ton.  Finally, RARG assumed that an I&M  program  would be
implemented in all AQCR's studied, whereas EPA included the cost of an
I&M program in an AQCR only if it was determined that such a program
would be needed for attainment.

     The table below provides a preliminary estimate of how the revised
EPA analysis will compare with our earlier analysis and with the  RARG
estimates in those areas where RARG focused their study.  The values for
the updated EPA analysis are based upon the upper limit of cost estimates
for mobile sources as supplied by OMSAPC.  For this presentation,  we
have chosen to continue to use the $1000/ton value for  the identified
RACT since we do not agree with the technique RARG used to determine its
estimate of this cost.  We do, however, plan to continue to investigate
this estimate.

-------
            .  DIFFERENCES BETWEEN EPA AND RARG COST ESTIMATES  FOR
              	CONTROL STRATEGIES EXAMINED BY RARG	
                               (Billions of $)

                         Earlier EPA Analysis       RARG    Updated  EPAm
                         	   Estimates   u;

FMVCP (LDV & LOT'S)              3.0<2)             5.6(2)            2.2(3)

HDV and MC                       0                 1.78             0.78

LDV and LOT I&M                  0.26              1.75             0.39

HDV I&M                          0                 0.61             0

Unidentified RACT^         0.8 - 3.0            1.8 - 5.9     0.8  -  3.0^


'  'The cost estimates are subject to revision but represent best estimates
   at this time.
   Figures are based on controls for both HC and CO.
   Figure contains only the HC controls.
'  'Upper range based on EKMA; lower range on linear rollback.
'  'We are continuing to investigate this category of sources in an attempt
   to better define the costs.  The above figures are based upon $1000/ton.
   Also, the value shown for the table may change slightly due to  several
   other parameters which are undergoing slight modifications  at this
   time (i.e., assumptions regarding background etc.).

Enclosures

cc:  Rick Neustadt
     Mike Walsh

-------
Co-oi !jtix,ri of -es'ii'S Seaorted  in Hunan  itudii"  nammim Dzone or

Concentration.
ppm
0.01 -
0.30
0.03 -
0.30
0.10
0.10 -
0.15
0.15
0.20
0.20 •
0.25
O.Z5
0.2S
0.25
0.25
C 23
0.30
0.30
0.37
r> } 7
6.37
0.37
C.37
Exposure duration,
hours (for clinical
studies); Averaging
tine (for jpidemio-
logical studies)
bihourly
average
hourly
average
2
probably dally
naxirum hourly
average
1
3
2
2
2 and A
dai iy -.ax mum
hourly average
0.5 - 1
oaily maxmum
instantaneous
(5-ainute)
average
1
dai ly maxinurn
hourly average
2
2
2
2
2
Pollutant Reported
Measured tffect(s)
(0. - ozone.
Ojj = oxidant)
0. Lur-g function parameters in about 25« of Japanese
school cnildien tested /.'ere significantly corre-
lated «ith 0, concentrations (over the range of
0.01 - 0.30J in the 2 hours prior ro testing.
0 Although significant correlation .it; ooserved be-
tween decreased athletic performance 1 0 concen-
trations In the range Of 0 03 - 0.30 ppm. the
Criteria Document concludes that no consistent
linear relationship could be detected below
about 0.10 pom.
0, Decreased 0, pressure in arterial ized olood,
increased airway resistance observed using non-
standard measurement techniques.
Reference(s)
r.agawa and Toyana
(1375). Kagjua. st al.
(1976)
Wayne, et .il .
(1967)
von :;ieding, et al .
(1976)
QX Inci eased rates of respli story synip'..J.mf aiij M«U- M.uino aim MUQ.MCin
ache iere reported by Japanese students on Jays «hen (1975j
0^ concentrations exceeded 0.15 ppm as ccnparec ro
days «inen Ox concentrations .iere less than O.iO pom.
0. Subjective synptoms of discomfort were ooserved by
most subjects, and discernible but not statistical-
ly significant changes in respiratory pattern oc-
curred juhile performing vigorous exercise
0. Reduction in visual acuity (night vision) oo-
served.
0, Asthmatic patients en regions njjini; hi n jxiian. J'ic
DeL'jcia i 4dars
(1977)
Laaer«erff
(1963)
Linn, et al.
(1973)
Hazucna (1973)
(i97=j/> ~:-Lli
Ldnri.iu (1961)
6rn<.ran, H 3'.
(196-)
.. al ,!977)

-------
                  ENCLOSURE 2


          :X£CUTIVE OFFICE OF THE PRESIDENT
                   ON CNVlPONMfiNTAI. QUALITY
                          , 0. C 27335
                          October.18, 1978
MEMORANDUM FOR WILLIAM D.'NORDHAUS
               Council of Tconomic Advisors
                    ^-.-/^rrrv-^ .
          Comments on RRHG Report on EPA's Ozone
          Standard Proposal


Attached are CEQ's comments on the subject report.
appreciate this opportunity to cojfuf.ent-.
cc:  Dave
     Bill Drayton
                            (H.

-------
                 Comments From CHQ on the
                Draft RARG Soport on. EPA's
                      Ozone Proposal
 1.  v:e do  not  believe that tha report properly deals with

 tho Clean  Air  Act's  intent that costs, should not be a  primary

 consideration  in  setting health related standards.  Although

 we recognize that some cost onalyr.is is necessary to dor.crmina

 the tradeoffs  between uncertainty and public health protection

 und^r the  no threshold approach, nuch data should only be used

 consistent -with statutory requirements.  EPA is the agency

 charged with interpretation of the statute and has determined

 that cost  analysis r.hall be precluded as a direct consideration.

 EPA enunciated f.his  precedent in sotting the ambient standard

 for lead.  Section 109 of the Act directs that ambient stanSaic?

 bo sot at  a level which will be protective of public health

with an adequate  jnaryin of nafoty.   WG feel that the RAi*G report,

by emphasizing morginal, oconomic costs and benefits, is

inconsistent vith t.hc intent of thn Act .ind the Aclmi niotration ' i>

current intorpretation of its provisions.


2.  The report seems  to be deficient in its discussion of

EPA's health effects  dot*.   It discredits the validity of

sever.il .stxidics in order to suggest, thnt 0.15 is not the  lower

liriut of observed  effects  on human  health.   The report suggests
                   »
that if the observed  threshold were higher,  thon Lhe standard

coul
-------
 agroo with this argunsnt .  Although questions have been raised
 about the studios which  show physiological effects below  .15
 ppm,  they cannot be dismissed out of hano.  Further, tha
 aniinal toxicology data cannot bo ignored  which show effects
 at 0.10 ppm.   Ue recognize that animal  data is not directly
 translatable  to huiiiari effects, but  such data confirms that
 effects can occur at low exposure levels.   Therefore, EPA
 roust  bf» prudent in its interpretation of  available health
 effects information.
 3.  CKQ  agrees  with the report th.it nn Actual  population
 fjxpopure risk analysis would proviuc greater insight into
 the iTingnitviue of  the Cation's o^onc problem.   Ifowcvor,  I. ho
 stat<2 of the art  of such analysis i s in i Us infancy.   EPA
 must operate ujider  the time constr.Tintc imposed  by  the  7*ct
 vhich precluded the TlovcJ opncn t ancl execution  of  such nn^l
 Rsthrjr than specirically critirr-i^c i-his particular  reoulatory
 action we suggest that the rncthodoJ ogy proposed  in  the  report
 ba loo/tcd upon an objective for futvire environmental  impact
 analysis .

 4.  Although we* have  so?na  dasaijre«jT«»nts with thr;  report  as
noted nbove we feel that  thra report was very well prepared.

-------
DAUA  KOKST CASi:  1970 O.'CKii: CONCUTKA1 lU»->  Lli ihLi:i:itJ UillMJJ A

[•.me oC Cicy
I New York. NY
(In., mi.. II.
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1 Muuphlb, IN
:. Culumbus, Oil
1 Dcnvor, CO
Ac.lanC.-i, CA
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f> Cincinnati, Oil
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356
365
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309
Djys in 0*onu Conccncrnc ton (ppm) Cacci;orlcs
<.««
un
316
257
328
JO-'.
24/i
246
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287
Ml
305
306
152
320
317
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it
11
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7
18
14
3
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10
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9
6
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2
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4
3
4
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8
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< .16
it
1
7
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8
0
2
6
2
3
4
3
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3
5
3
1
2
I
2
> .16
< .IB
7
0
1
I
L
1
6
0
1
3
0
1
0
0
0
2
1
0
1
0
0
0
> .in
<-20
7
0
2
0
L
0
2
0
2
2
0
0
I
0
0
0
1
0
0
0
0
2
> .20
< .22
0
0
1
1
0
0
2
0
1
0
0
0
0
0
0
0
0
0
0
1
0
0
> .?2
< .24
0
0
1
0
0
U
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
>.24
<.26
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0

^.26
<.28
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0

>.28
<.30
0
0
0
0
0
0
0
0
0
0
0
^
0
0
0
0
0
0
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0
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0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0

Uiys
Above
.08 |ipm
59
17
.54
35
24
63
83
10
20
79
31
57
57
'35
If.
48
- 69
54
51
73
40
36
NA>,nu:i
DAY
(Pl«n)
.19
.16
.24
.21
.19
.J7
.22
.12
.12
.19
.16
.16
.19
.15
1
.14
.18
.18
.16
.16
.21
.16
.20

-------
                                                IJAILY  I.OKbl' CASi. l'j;6 (S/.0.3L Cu.VLNi K/il i-O.'JS  IN SLlLoltU Ui'.M1  «Hl


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MAX1W:
I),\Y
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IB
.17
.16
.16
.16
.19
  The monitoring sitc<> selected uere  those  with  the  highest daily maximum hour ozone concentration in 1976 which  Mere  located in the principal urban core
  area having at ledst flOi  (290 days)  of the days  monitored in the year.  Since no ozone data was available  for Atlanta,  GA,  the site in Decatur, GA  -tith
  only 187 days of d.tta   is shown.  This may overestimate the ozone problem in Atlanta.  The Lowell, MA site  is shown  because ozone is  monitored there only
  throughout the ozone season  (Apr-Get)  and this distribution reflects the high ozone days.
bTlUs summury reprtsuncs 19?7 ilaca vhlcli was  used because  die  1976  data were questionable.

-------
      UNITED STATES ENVIRONMEN  "
p                                                 TAB U
^                                       (Currently under  Revision)
          '
SUBJECT    Estimate  of  Economic Benefits Associauad with Alternative Secondary
          Ozone  Standards
                                                                    Environmsr.
  KROM    Harvey Richmond                                           protection A^-
          Pollutant Strategies Branch                                  Re»icn p
    T0    Mikp Jones                                                QEC 20 I97t
          Pollutant Strategies Branch
                                                                       J.IBRARY
          1.0  Introduction
               It has  been found  that ambient concentrations of ozone  are ro-
          sponsible for  economic  losses that arise from accelerated aging of
          certain materials  (e.g.,  rubber cracking, dye fading, and paint
          weatnenng), damage  to  vegetation (e.g., foliar injury, growth
          reduction, and yield reduction),  and reduction in visibility. This
          analysis  attempts  to quantitatively assess  the difference in economic
          loss associated with alternative  secondary  ozone  standards.
              Only crude estimates  were possible for the reduction in economic
          aaj:;j(jc to forest products  and ornamentals.   The analysis used a first-
          cut approach to obtain  an  upper boundary estimate on  reduction of
          damage for major farm crops.   Reduction in  ozone  damage is estimated
          for 350.6 billion  of the  $54.6 billion  (1977 value of production)
          in  major  farm  crops  for which the U.S.  Department of  Agriculture
          keeps  economic data  (reference 3).   For the 5 crops that accounted
          for the bulk of the  difference in economic  loss,  and  for other
          crcp-j  ")r  winch the  first-cut approach  was  not helpful,  v/e consulted
          with bcvero'i plant pathologists to obtain an improved estimate for
          reduction  in damage.  For  materials anu visibility v/e concluded there is
          i-o  difference  in economic  damaqe  between the alternative standards.
    .•-
-------
2.0  Method of Analysis for Determining Reduction in Economic
     Loss For Commercially Important Crops
     The support and criteria documents (references 1, 2) estimate
that ozone-related damage to vegetation may be approaching $300
million (1974 dollars) at the farm level.  The goal of this analysis
is to estimate the incremental reduction in damage that would result
from adoption of alternative secondary standards (0.08 ppm/1-hour,
0.10 ppm/1-hour, or 0.12 ppm/1-hour).
     At ozone concentration levels in the range of 0.05 - 0.12 ppm
it is the 8-hour average, not the 1-hour average, which is significant
in determining the amount of damage to vegetation.  An analysis of
available air quality data indicated that attainment of a 0.12 ppm/
1-hour average standard would prevent an 8-hour average concentration
of 0.10 ppm from being exceeded more than once per year.  A 0.10 ppm/
1-hour average standard would prevent an 8-hour average of about 0.09
ppm from being exceeded more than once per year.  Similarly an 0.08 ppm/
1-hour average standard would prevent an 8-hour average of about
0.07 ppm from being exceeded more than once per year.  The remainder
of this report is based upon two comparisons:  (1) allowing only one
0.10 ppm/8-hour versus 0.09 ppm/8-hour peak exposure per year and
(2) allowing only one 0.09 ppm/3-hour versus 0.07 ppm/8-hour peak
exposure per year.
     In order to evaluate the difference in economic damages between
alternative standard  levels,  it is necessary to have a dose-response

-------
function relating ozone concentrations and duration of exposure to
percent yield reduction or damage.  Heck and Tingey have developed
a mathematical model that quantitatively predicts the extent of
foliar injury in certain classes of crops due to single, acute
exposures as a function of ozone concentration and exposure time
(See Table 11-5, reference 2).
     However, foliar injury is an imprecise measure of the effect 01
ozone on plant growth and/or yield.  Work has been started by
researchers, such as Ron Oshima, (U. Calif.) and Al Heagle, (N.C.
State), to obtain dose/response relationships for ozone in terms
of yield reduction; however, very little data from these new experi-
ments are currently available.  It is thus necessary to utilize the
foliar injury response to evaluate alternative levels of the secondary
standard.
     For the purposes of this analysis,  a first-round estimate is made
based on the assumption that the acute foliar injury response to the
peak exposure permitted by the standard can be used to predict biomcss
(growth) reduction (and presumably yield reduction or economic damage)
caused by chronic exposure to ozone levels up to and including the peak
value permitted by the standard.  We consulted Or. Ray Wilhour (U.S.
EPA-Corvallis) regarding this important assumption.  He recommended
that we recognize the uncertainty involved in this assumption by  pre-
senting a range in the damage estimates.  His best quess was tliat
the ratio of the percent damage (yield reduction) to acute foliar
injury percentage may be as low as 1:1 or as high as d:\.

-------
     In discussions with plant pathologists around the country, we
were cautioned.that_while there appears to be a fair  amount of
correlation between foliar injury percentage and biomass reduction,
there is a great degree of variability in the relationship between
biomass reduction and reduction in yield (the economically important
parameter for most crops).  For example, significant damage or yield
reduction can occur in some crops without any noticeable foliar
injury.  In contrast, it is possible to have significant foliar
injury and biomass reduction and yet have no noticeable effect on
yield.  The timing of an air pollution episode in the crop's life
cycle and the presence of other environmental stresses (e.g., drought
conditions) are often crucial determinants of how much yield and/or
biomass reduction will result from a given degree of foliar injury.
In considering the results of this analysis, the above caution should be
kept in mind.
     Another important caveat is the fact that the Heck and Tunjey
equations were derived from studies which generally exposed plants in
greenhouses under the most likely conditions to produce injury (e.g.,
high humidity, high soil moisture, and medium temperature).  The levels
of injury suggested by the Heck and Tingey model almost certainly
exaggerate the amount of damage for the significant portion of the U.S.
crop which is grown under less sensitive conditions (e.g.,  low humidity,
low soil  moisture).   These less sensitive conditions  are  particularly
found in  the central  and northern  plains regions of the United States.

-------
     The commercial crops studied are divided into the following
categories depending upon which part of the plant is of economic
value:  foliar  (tobacco, broccoli), seed  (corn, wheat), root (radish,
onion) and fruit (oranges, cucumber).  For foliar type crops it is
assumed that there is no threshold, i.e., any foliar injury percentage
will result in  some economic damage.  However, for non-foliar type crops
the assumption made is that only foliar injury in excess of 5 percent
will lead to yield reduction or economic damage.  This 5 percent
threshold is based on the comments of several researchers to the
effect that 5 percent foliar injury is usually required before there
is a detectable reduction in biomass and/or yield in sensitive plants.
     Using the  above assumptions a percent damage is determined using
the equations in Table 11-5 for each major commercial crop known to be
sensitive to low ozone levels and for which economic data is readily
available.  The difference in percent damage associated with allenialivc
standard levels is listed in Tables 2 and 3 as A % damage.
     The data needed to enable conversion of A % damage to a dollar
value estimate are:
     (1)  the economic value of production of each crop at the farm
          level;
     (2)  the percentage of each crop that is of a sensitive or
          intermediate cultivar (i.e., variety).
     The production value of each major crop is obtained from the U.S.
Department of Agriculture (reference 3) and is in terms of 1977 production
and dollars.   A first-cut,  systematic  estimate of the share of  the total

-------
                                  6

crop that is of a sensitive (or intermediate) variety is calculated
by one of two methods.  Both methods rely on Table 11-24 in the MAS
ozone document (reference 4) which categorizes the varieties examined
by plant  researchers as sensitive, intermediate, or resistant.  Where
four or more cultivars for a crop are listed, it is assumed that the
percent of sensitive (intermediate) cultivars for that crop (as reported
in Table 11-24) is equivalent to the sensitive (intermediate) fraction
of the crop presently being grown on the nation's farms.  So if 12
cultivars for oats are listed and 6 of them are in the sensitive
category, then 6/12 or 50 percent of the oats grown are assumed to be
of the sensitive variety.  Where fewer than 4 cultivars of a given
crop are listed, a percentage of sensitive cultivars for that type of
crop (i.e., seed, foliar, fruit, or root) is used to determine the
share of the crop that is sensitive.  For example,  fewer than 4 cullivars
are listed for sweet corn in Table 11-24, but 24 percent of the seed-type
cultivars fall in the sensitive category.  Therefore, it is assumed
that roughly 24 percent of the sweet corn grown is  of a sensitive
variety.
     Utilizing the above estimates and the assumptions they are based
upon,  the difference in economic loss  between two alternative ozone standards
is calculated by multiplying the difference in percent damage for the
sensitive crops, the share of the crop that is sensitive,  and the
economic value of the total production at the farm  level  for each crop

-------
and multiplying the difference in percent damage for the
intermediate crop, the share of the crop that is intermediate,
and the economic value of the total production at the farm level
for each crop, and summing the products for all major commercial  crops.
                    n
A Economic Loss =   Z (A % Damage   (% of crop that is)  (1977 value
(1977 dollars and  i=l for sensi-   sensitive)           of production
production)            tive cropi)                       for crop i)
                      + (A % Damage    (% of crop that   (1977 value of
                        for inter-     is intermediate)  production for
                        mediate crop .i)                  cr°P i)
     In determining the reduction in economic loss associated with a 0.07
ppm/8-hour as opposed to a 0.09 ppm/8-hour standard, it is found that
for crops of intermediate sensitivity the A % damage is zero or nearly zero
for the crops considered.  Thus no loss data for intermediate crops appears
in Table 2.  However, as one compares a .09 ppm/8-hour and a .10 ppm/8-hour
standard, ozone damage to intermediate crops should be considered because
the 5% injury threshold is generally exceeded for a peak exposure of
0.09 ppm/8-hour average or greater.
     The above estimate of the annual difference in economic loss
associated with alternative standards assumes that production will
remain at 1977 levels and that the value or price per unit for each
crop would remain unchanged even if more of the crop were produced due
to reduced ozone levels.

-------
                                  8

3.0  Economic Loss to Commercial Farm Crops
     Using the above mentioned assumptions an upper-boundary  (worst-
case) estimate was made to identify which crops might be responsible
for the bulk of the reduction in economic damages.   It was found
that the vast majority of the estimated economic loss was accounted
for by the following 5 crops:  corn for grain, hay, soybeans, tobacco,
and wheat.  In addition, the systematic approach outlined above was not
helpful in providing even a first-cut estimate for several important
crops, of which cotton was the most prominent in terms of the total
production value.  Therefore, in order to obtain more realistic estimates
of the reduction in damage to these major farm crops associated with
alternative standards, various plant experts were consulted with on the
assumptions used in the initial analysis and the total values obtained.
Based on these conversations, the first-cut estimates were revised for corn
and tobacco, and original estimates were made for cotton and several other
crops.  These improved results are shown in Tables 2 and 3.  The following
paragraphs detail the bases for these revisions.
     Al Heagle, a plant pathologist at N.C. State, has suggested that
the percent of field corn (corn for grain) that is of a sensitive variety
is probably on the order of one-half of the percentage of sweet corn
that is sensitive.   Since the systematic estimate of this percentage was
the same for both crops (24 percent), this recommendation lov/ered the
damage estimates for field corn by 50 percent from the first-cut estimate.
Thus, Table 2 gives a range of $77 million to $155 million as the re-
duction in damage for attaining a 0.07 ppm/8-hr as opposed to a 0.09 ppm/
3-hr peak exposure.

-------
     The initial crude estimate of the incremental reduction in damage
to tobacco was estimated to be from $94 to 5186 million (0.09/8-hour
0.07/8-hour).  This was based on the systematic estimate that 70 percent
of the tobacco crop is of a sensitive variety.  This esLimale is almost
certainly too high.  In North Carolina, where nearly 50% of the U.S.
tobacco crop is grown, the maximum annual damage attributed to ozone in
the period 1973 - 1977 occurred in 1976.  The estimated diseases loss
was only 0.38 percent or $3.655 million for that year  (reference 5).
Dr. Todd of N.C. State estimated in personal communications that about
28 percent of the North Carolina flue-cured tobacco crop (types 11 - 14)
was Speight G-28 and that this variety was the most sensitive of the
flue-cured types presently grown.  However, he believed that Speight G-28
would fall in the intermediate category using the NAS  classification
system.  Dr. Todd also mentioned that most of the ozone (weather fleck)
damage was to the lower leaves of the tobacco plants.  There is currently
a surplus of these leaves on the market and farmers are being encouraged
to destroy these leaves.  Thus at present there is little if any ozone
related economic damage to the tobacco crop in North Carolina.
     For Burley Type 31 tobacco, which makes up roughly 31 percent of
total tobacco crop, Dr. Hadden (Univ. of Tennessee) estimates that
the maximum weather fleck (ozone) damage suffered in recent years
was around 0.5 percent of the crop.  Since Burley Type 31 and flue-
cured types 11-14 make up 91 percent of the total tobacco grown and
are of intermediate or resistant susceptibility to ozone, something
less than 9 percent of the tobacco crop could be of a  sensitive variety.

-------
                                  10

If the remaining 9 percent of the tobacco crop were of a sensitive
type, then the reduction in tobacco damage from adopting a 0.07 ppm/
8-hr peak exposure standard instead of an 0.09 ppm/8-hour average
standard would be estimated to range from 12 to 24 million dollars
using the methodology described previously.
     Dr. Todd also estimated that 26 percent of the total tobacco crop
nationwide was of an intermediate variety.  This value is used in
generating the reduction-in-loss estimate in Table 3 for intermediate
type tobacco.
     Finally, we consulted H.E. Heggestad of the U.S. Department of
Agriculture at Beltsville, MD regarding his work with cotton.  While he
noted that some cultivars were found to be more sensitive than others,
he offered his judgment that no cotton tested would show a difference
in yield for either of the alternative standards.  Tables 2 and 3 reflect
his judgment.
     Heggestad further commented that the entire approach taken in
this analysis grossly  overestimates the differences in economic damage
between the alternative standards.  He based this coiiiinenl on (1) the
fact that this analysis extrapolates acute foliar injury results obtained
in greenhouses under sensitive conditions to yield reductions in the
field,  (2) his belief that our correlation of 1-hour to 8-hour
average peak concentrations produces higher 8-hour average levels than
he has  observed, and (3) his own experience with field tests of crops

-------
                                  11
such as cotton, snap beans, and potatoes1.  His judgment on this
matter is summarized as follows:  he feels that maintaining the
secondary standard lower than the proposed primary standard of 0.10
ppm / 1-hour average cannot be justified on the basis of protecting
farm crops from economic damage.  At the time of consultation, he had
not yet formed an opinion regarding the possibility of setting the
secondary standard as high as 0.12 ppm/ 1-hour average.
4.0  Ozone Damage to Other Vegetation
     This report has made quantitative estimates of the reduction in
damage to commercial farm crops which would result from attainment of
alternative ozone standards.  It should be realized that current ambient
ozone levels also cause damage to our national forests and parks, to com-
mercial timber growth, and to commercial and home-grown ornamentals.
     As the support document states, "it is very difficult Lo quantify
adequately the  importance of natural ecosystems  tu  the public welfare,
and consequently to provide monetary estimates of the impacts of oxidant
pollution on natural ecosystems" (reference 1).
     Using the systematic methodology discussed previously for farm
crops, a very crude (worst-case) estimate can be made of the maximum
reduction in damage to all commercial forestry and ornamental products
associated with the alternative standards.  In 1972, the total value
for all commercial forestry products was S2.9 billion.  If the
oercentage of the sensitive trees grown is equivalent to the fraction of
tree species listed in Table 11-24  (reference 4) that are sensitive
(20%) anJ the difference in damage  for the 0.09 ppm vs. 0.07 ppm/0-hr

-------
                                   12

 levels  is  about  5  percent  (the value obtained using  the all-sensitive-
 plants  equation),  then  for  the case where  percent yield reduction
 is assumed  to equal % foliar  injury, the reduction in damage  is:
      (20%)  (5%)  ($2.9 billion) = $29 million (1972 dollars)
 Thus, the  range  of the  estimate given  in Table 2 is S29-58 million
 (0.09ppm/8-hr -  0.07ppm/8-hr.
      A  similar crude estimate can  be made  for commercial ornamentals
 and shrubs:
      (19%)  (5%)  (SI.3 billion) = $6.5  million (1974 dollars)  ( .09?pm/8-hrs
 .07ppm/8-hr).
 The range  of the estimated  reduction in damage to ornamentals would be
 S6 -  $13 million for attainment of a .07 ppm/8-hour standard  as opposed
 to a  .09 pprn/8-hour standard.
      Quantitative estimates of damage  to home-grown crops, ornamentals,
 and shrubs were  not made due both  to the lack of information on how
much  of each type of vegetation is grown and the difficulty of
placing an economic value estimate on  damage to shrubs and plants.
 These plants may be damayed by ozone such  that their appearance is
marred  but still the plant  continues to survive.  Since these plants
 are not subject  to any market mechanism, it is very difficult to place
an economic value on the partial  damage that is caused by exposure to
ozone.
5.0  Ozone Carnage to Materials and Reduction in Visioiluy
      In the case of materials damage any non-zero ozone concentration
will  contribute  to the deterioration of sensitive materials if the exposure

-------
                                   13

 is  long  enough.   As  described  in  the support document (reference  1)
 the annual  average concentration,  not a short-term peak exposure,  will
 determine  the  rate at  which  material  damage  occurs.   While  peak  1-hour
 concentrations of ozone  tend to be higher  in urban areas, rural areas
 remote from man-made emission  sources have been  found to have  similar
 annual averages.  This is  due  to  the nightime scavenging of ozone  by
 man-made pollutants  (NO  ,  HC)  in  the urban areas.   Thus, reducing  the
                        ^
 annual peak exposure by  0.02 ppm  or 0.04 ppm is  not likely  to  result
 in  a detectably  lower  annual average.   Since it  is projected that  there
 is  no difference  in  the  annual averages associated with the alternative
 standards,  it  is  estimated that there is no  difference  in the  materials
 damage that will  result  from either standard.
      The impact on visibility  of  adopting an  0.08  ppm/1  hour,  0.10 ppm/
 1-hour,  or  0.12 ppm/1  hour ozone  standard cannot be  accurately determined
 based on the current state of  knowledge.  However,  figure 3-4  in the
 NAS  document (reference  4) seems  to  indicate  thai  at  levels  up to
 0.12  ppm ozone, there  is no  measurable  impact on visibility.
 6.0   Summary and  Observations
      Utilizing the assumptions and methodology described previously,
 it  is estimated that the maximum benefit (in  terms of reduced  damage
 to  all commercial types  of vegetation)  associated  with  a 0.08  ppm/
 1-hour standard as opposed to  a 0.10  ppm/1  hour standard, is from
-S466--- 932 million .    The maximum benefit of  adopting a  0.10 ppm/1 hour
 standard as opposed  to a 0.12  ppm/1-hour standard  is estimated to be from
 S665  - 1,330 million.  It  should be remembered that  the  above  estimates

-------
                                  14

are likely to be worst-case, upper-boundary values and do not
represent our best judgment of the most likely economic damage asso-
ciated with alternative standards.
                              References
1.   U.S. Environmental Protection Agency, Assessment of Welfare
     Effects and the Secondary Air Quality Standard for Ozone,
     June 1978.
2.   U.S. Environmental Protection Agency, Air Quality Criteria
     for Ozone and other Photochemical Oxidants.   Publication
     No. EPA-600/8-78-004,  April  1978 (preprint).
3.   Department of Agriculture, Crop Values 1975-1976-1977,  Washington,
     O.C., January 18, 1978.
4.   National Academy of Sciences (NAS) Ozone and  other Photochemical
     Oxidants.  NAS, Washington,  O.C.  1977.
5.   Todd, Furney,  Extension-Research on Wheels:   Summary Report of
     1977 Data,  North Carolina Agricultural Extension Service,
     November, 1977.

-------
                             TABLE  J




             SELECTED VEGETATION GENERA AND  SPECIES  GROUPED liY




                      SENSITIVITY TO  OZ0NE








   Sensitive                    Intermediate                Resistant










Bean (4)a                       Bean (5)                    Bean (5)




Cucfcumber  (1)                   Cucfumber  (2)              Cucmimber (1)





Oats (6)                        Oats (5)                    Oats (1)




Soybean  (14)                    Soybean (19)                Soybean   (6)




Spinach  (4)                     Spinach (3)                Spinach (1)




Tobacco  (35)                    Tobacco (12)                Tobacco (1)




Tomato (7)                      Tomato (6)                  TuimiLo (3)
 Numbers in parentheses  (  )  are  the  numbers of varieties of thu apocLcs
 for which reports of ozone response t/ere  re
-------
Table 11-5.  CONCENTRATION. 1IMC,  FILSPONSL  EQUATIONS FOR THREE SUSCEPTIBILITY
    GROWS AMD TOil SaCClCO I'lAfllS Ull  PLAN!  TYITS WITH KESPICT TO OZONE
Plants (C=A0 < A, I + A?/T)b
Sensitive
All plants -0.0152 + 0.00101
Grasses -0 0:JG5 + 0.00401
Lcgj-os 0 0152 + 0.0(1361
TO«J:O -0 0023 + 0.00431
Cat -0.0-127 * 0.00511
Bean -0.0090 T 0.00301
Tobacco 0.0245 + 0.00341
Interrelate
All plants 0.0244 + 0.00651
Vcge'iblus -0.0079 + 0.006-11
Grasses 0.0107 + 0.00591
Legits 0.0116 + 0.007-11
- Fere -.rial 0.0748 + 0.00701
I. Clc.er -0.0099 + 0.00711
0 Utit -0.0036 + 0.00811
lco::-o 0.0631 i 0.00871
Re si s t j-'.t
All r- lints 0.1 6B9 + 0.00951
Lee- '-s 0 0090 " 0.01021
Grists 0.1906 + 0.0117!
U-gi-isDles 0.1979 + 0.012CI
pii.its 0.2312 + O.OOt-11
CUC---.LI- 0.1505 + 0.01411
Chi • :jnthc~u:r
0.2060 + 0.00521

+
+
t
t
+
+
4

+
+
+
+
f
\
+
t

+
•i-
+
+
+
+

+

0.213/T
0.291/1
0.172/T
0.243/T
0.273/T
0.164/T
0.137/T

0.290/T
0.263/T
0.292/T
0.32S/T
0.237/T
0.262/T
0.302/T
0.152/T

0.278/T
0.304/T
0.263/T
0.107/T
0.205,/T
0 106/T

0.256/7
pC

0.57
0.74
0.46
0-50
0.76
0.58
0.52

0.74
0.79
0.02
0.81
0.77
0.95
0.68
0.70

0.51
O.B2
0.55
0.70
0.45
0,63

0.40
Threshold ^
conr«!iilrdLlon , p_[iir" _ No. daU
Tlir 4~hr " ~0"lir points

0.22
0.1'G
0.2-1
0.10
0.26
0.17
0.18

0.35
0.29
C.33
0.38
0.35
0.29
0.34
0.26

0.50
0.45
0.51
0.38
0.47
0.33

0.49

0.06
0.04
0.11
None
O.OG
O.Ob
G.08

0.13
0.09
0.11
0.13
0.17
0.09
0.11
0.14

0.27
0.22
0.31
0.29
0.31
0.25

0.30

0.03
0.01
0.09
llOltC
C.02
0.03
0.06

0.09
0.06
0.09
0.09
0.14
' 0.06
0.08
0,13

0.25
0.1G
0.20
0.20
0.30
0.23

0.27

471
71
100
20
'30
62
197

373
25
66
104
27
24
15
59

291
36
13
16
46
16

45
Moan values0
Cone. ( C J , 1 1 me ( T )
ppni hr

0.29
0.37 '
0.34
0.31
0.37
0.30
0.23

0.37
0.41
0:39
0.40
0.36
0.28
0.47
0.20

0.<5
0.30
0.45
0.55
0.39
0.41

0.39

1.74
1.66
1.42
1.50
1.66
1.23
1.90

1.67
1.29
1.61
1-59
1.91
2.13
1.25
1.99

1.55
1.69
1.47
1.50
2.50
1.41

2.17
, Responsc(l

45.4
50.9
40.1
56.5
40.2
47.2
38.9

27.0
33.5
31.0
25.0
22.9
23.0
28.9
15.7

10.6
12.2
6.5
17.6
7.8
13.3

12.6
[), Dose,
pfm-hr

0.503
0.608
0.480
0.491
0.611
0.370
0.448

O.G25
0.532
o.:::
0.642
0.687
0.595
0.5C8
0.551

0.696
0.722
0.655
0.819
0.905
0.581

0.847

-------
 equations  vert? developed from exposures  limited  in  time  (0.5  to  8  nr,  except  for  2  to  12 lir  points in
 the sensitue group)  arid denote  acute  responses  of  the plants.   Concentrations  range  from  0.05  to
 0.99 (1.0) ppm and responses  from 0  to 99  (IQO)X of  control.   Reference  3.

*C 1s ozone concentration in ppm;  I is  percent  injury; T  is  Mme  in hours;  and AQ, A,,  and  A,
 are constants (partial  regression coefficients)  that are  specific  for  pollut.ml,  plant spectes  or
 group of species,  and environmental  conditions used.

'Multiple .correlation  coefficient  squared,  which  represents  the percent variation  explained by  the
 model.

 For 5t  response in 1, 4, and  0 hr periods.

"From the ccir.puter  analysis.

-------
to Tann Crop*,  Forest
ELitiNialct of UeilucLion  in I rniiuunt. I'-wiiy
*, Forest  Prnilucli. and Ornamentals (  'I/-.OT)


1 1'




' i'i -, ' • , /



.Kill 1 1 'll
1 1

II • 1 1 II 1 1
•• 1

•
.07 .09
'•ll/'. ,11 '. Ml.ll/ !l| •

0|'p1e«: (O) 14.6

l»ii» ley (s)

14.6
be*ns, dry ,„ ,
eihble (s) y>J
broccoli (F
14.6
..
1. ill ,t
III, HI 1

: iii»i i. M>
il 1 I
Yll'l'l ' •• -I » I'll!
(,' !! ) hi, ill,
1 yi>» ••• 	 -MI v :•
il ••''-.




•
»"
.07 .09
|i| .,!/ In •; nr if '.. ,
ii
Y ' 1 1
J
19.6 all sens. 9.6

19.6




i


• i
. i i.gi
( ill 1 1 n.,i )

14.6 5.0 6? I.I)
plants
all sens. 9.6
P 1 an is -
-, - all sens. ,. _"
CO . C. N 1*1 . 3
Ibcans
,„ , all sens." ,,. ,
]9'6 (plants ...1*'.6 .
| cabbage (f) 14.6 ! 19.6
coin. For
tjraiii (s)
corn, sweet
(s)
col ton
cucun'bpr
grapes (Fr)
14. 6
14.6
~
19.6"
19.6

14.6
14. f.
hay (F) IB. 8
oats (s)
i
onions {r)
19.6
19.6
all sens. ,. ,
plants , 14'6
all sens.
plants
all sens.
plants

all sens.
plants
all sens.
plants
"all sens.
"•' (grasses
15.4 19.3
14.6
orancies ,. ,
f r \ 1*1.1)
(f» J . - -
pcatiuls Is)
U.6
"9.6
9.6

9.6
9.6
10.0
all sens. ( ,Q „
oats |
,„ e al 1 sens. • Q n
,19'6 Iplanljs.. | 9*6
"•6 plants . . '
"l9.6
all sens. 1 „ ,
plants y._
14.6

19.6
19.6
14.6
14.6

5.0

5-0
5.0
713.7
35C 3
Ofl.O
176.1
5.0 , 12,OC7.0
5.0 220.3
0
14.6
5.0
14.6 | 5-0
22.9 , 4.1
4,013.7
13C.5
776.1
6.741.7
U.3 j 3.9 B53.4
14. 6 ; 5.0
U.6 ' 5.0
u.6 ' r>.o
227.1
64n.i
770.9



,





•nil 1 1 	 .1
t r>F Ci np i '
1.1, a 1 K; | .,,.,.
rcn'-iliuo i(|i|lu,ii
-------
                     TAULC 2  (cont.)
    Revised CstimaLes  of  Reduction  in Economic Damage
lo Farm Crops,  forest  Products,  ami Oinamentals  (.07*.09)


1 ''i

,
.11
II t , .11
'
poUtues
rice (s)
sorghum (s)
1
soybeans! s)
• ipltMi.ll (f )
1
InlKirco (f)
1 umd 1 (> ( f I )
i
wlit'dts (s)
ru()




' I'll.1! 1 	 y
'.' ' l
.07 .09
i.|in/.? in •, |>i>ii,/:;'ii s
14.6
14.6
14.6
0.9
14.6
8.4
2«.3
•
14.6

(farm ft ops j
i
t inus I
( riips
(II IMIIIL'Ill ills
•Hill Sill UllS

14.6
10. 6

i
IOIALS
f
19.6
19.6



.
..ii'ii ii- ul
•••|.| I' I.HI .
1 • •!
l»l Lll
IllJ.ir"/
all sens.
plants
all sens.
plants
19 6 a" sens-
Iplatits
G.5
19.6
.4.2
33.0
19.6
-


all sens.
1 eyiiines
at l sens."
plants
all sens'
1 obacco _
al1"s"ens~.
tomato
all'sens.
plants
. 	


in c al 1 SCilS.
l9'6 ||,1anLs
19.6

-
•
all sens.
plants

-
,
4 iMin.nji? (ni i .
Y'rl.l ft,., •! t |,l|l
; .' R j in. loii i,-
I y\t>! < i >MI| Y :<
I.I. - ^ •.}•'. \ ui
•"'•- 	 )
.07 .09
(ii-.il/irtii '.
9.6
9.6
9.6
0.0
14.6
" 8.4
23.3
9.6
-


14.6
14.6


i
iii'in/1 In

14.6
14.6
14.6
1.5
19.6
14.2
28.0
14.6
	

.




,:,..ij,-
H
Y H -:" i

5.0
5.0
5'°.
1.5
5.0
5.8
	




• i _ It|
. M.|>
{Mil 1 1 liiMS)

1.275.3
920.7
1.357.3
9.945.0
24.0
2.293.8
4.7 914.1
5.0


i
19.6 ; 5.0
l'J.6 5.0
!
...
i
4,677.0

50. 647. 5

2,900.0
1,300.0

-
1
.. .




t uf Cio
that is
sensitive
25.0
24.0
24.0
36.0
50.0
9.0
44.0
24.0



A>.0
9.0


_
	




• i. • . i
.. < i i ,

{Millions
310. 8
222.9
325.0
3. 500. 2
12.0
206.4
402.2
1.122.5
•


500.0
117.0
"i
— -- -
.......




millions)
Y H 1 1 r „• t 1
II .1
15.9
11.1
16.3
53.7
.6
12.0
10.9
56.1
- -
431.4

29.0
b.9

-- - - - —
l 466. J
31.9
?2.3
32.6
107.4
1.2
J4.0
37 »
112.2

802.11

M.O
II.H


HV.6

-------
                         TABU 3
    Revised Estimates of Reduction  in economic liomaijc
to farm Crops, Forest Products,, anil Ornamentals  (.09».10)


'I.1



I .ml
> i i
apples (fr)
apples (fr)
barley (s)
bai ley (s)
bean1., rli y
i c'hlile (s)
beans, dry
i edible (s)
luucrol i ,f .
brociol i . . .
(.nbbiUjij ( f )
(.abbdcje (f)
corn, foi
ijrciin (s)
Lorn, for
> y> am (s)
1 ( orn, sweet
(s)
coin, sweet
(>)

11.6
0.0
11.6
0.0
21. 2
0.0
19.6
1.5
I9.6
1.5
11.6
0.0
11.6
0.0

(if I .I.
MI I i. -n
r I ii I i. n
is 	 I i \\
1 n'. 'in
i • •)
1 /
.10
1 1 "/'• i'l '.
. I7'1
1.1
.!'•'.'
1.1
?1.5
1.1
22.1
6.1
22.1
6.1
17.1
1.1
17.1
1J
-





,' - •. ji-
il
(M.\ 1.
2.5
. V
"
1.1
3.3
.. . !•! _
2.5
1.6
2.5
1.6
2.5
I.I
2.5
1.1
0





i • In-- nl
i nip
(. II III. Ml'.)
621.0
621.0
713.7
7,3.7"
358.3
350.3
08.0
88.0
176.1
176.1
12,887.0
12. 8117. 0
2?0.3
^0.3
1.013.7



.'. "i i 1 1 |i
I'.il 1',
•II III /(••
IH ( Mil -I
H;I ill id1)
25.0
(25.0)
21.0
(63.0)
23.0
(38.0)
5I.O
(32.0)
5I.O
(32.0)
12.0
(63.0)
21.0
(63.0)
0
-


Value of
Sensitive
( Interme-
diate)
Crop
SMilhons)
155.3
(155.3)
171.3
(119.6)
8?.1
(136.2)
11.9
(28.2)
U9.8
(b6.1)
1.516.1
[a. no. a)
52.9
(130.0)
0




•'S

Y.K. I I
l-l
3.9
1. 7
1.3
5.0
2.7
1. 9
I.I
.5
2.2
.. •*.' "
30.7
H9.3
I.3
I 5
n




111 I ions)

t : i
.' 1
7.8
3 1
8.6
IO.O
5 1
3. l«
2 2
1.0
1.1
1. 8
77 4
l/U.G
2.6
J.O
0

-------
                     TABLE 3 (Conl.)
    lie vised Eslnnat.es of ReJucLion  in
to Fann Crops, I'orest Products, anil Or
Economic Damage
nanientals (.09 •»  .10)


1 i,TI'

1 ! l
1 II
1 i 1 • ml
'. 1
1
cuciiinburp .
cucuiTrbcr
(fr)
yiapes (fr)
y rapes (fr)
hay (f)
hay (f)
oats (s)
Odls (s)
unions (r)
on KIIV, (i )
ordiujcs
(ft)
01 JlKJuS
(f'l
pi.'dimts (s)
loryluiin . .
sonjliuiii (s)



•' i J|
' 1 UP
(Vli II inn.)
136.5
136.5
776.1
	 ;__
6,741.7
6.741.7
853.4
«53.4
227.1
227.1
648.5
648.5
7/0.9
1,357.3
1.157.3



'', nl 1 Hip
II. .1 Is
; , | 1 | ,
Hi ( lllll.l
IIIC"I|.|I I1)
25.0
(50.0)
37.0
(48.0)
..
__ '
(50.0)
50.0
'
26.0
(42.0)
50.0
(50.0)
6.0
24.0
(63.0)


Value of
Sensitive
(Interme-
diate)
Ciop
(Millions)
34.1
(68.3)
287.2
13/2.5,
2.051.8
(3.370.9)
426.7
(358.4)
59.0
(95.4)
324.3
(324.3)
45.6 ,
. . . .
32'j.8
(UbS.I)




'\ ! (11

Y 11 1 1
I.I
.9
.8
7.2
4.1
43.1
53 9
— - —

"~3.~9
1.5
1.0
U.I
3.6
1.1
8.1
9.4




111 1 ions)

/.•: I 1
. 1
1.8
I.C
14.4
8.2
86 2
IO/.8
17.0
7.8
3.0
2.0 '
16.2
7.2
2.2
16.3
IU.U

-------
                     TABLE 3 (Cont.)

    Revised Estimates of Reduction in Economic Uamaije
to Faun Cio|>s, Koiebt Produtls, anJ Ornamentals (.09 >• .10)



1 ' III1

. 1 • .
II 1 1 II 1 1
'-, . .1
•.oybeans
(5) .
soybeans
K)
\ * 1
spinach (f)

spinach (f)
potatoes, ,
i (' '
'pot (it OPS, >
i ice (s)
I HC (s)
tobacco (t )
tobacco (f)
lonialo (fr)
tomato (fr)
wheat (s)
wlic-at (s)







l.il i .1

.09
, | III,' t III S
6.5
5.0


19. 6

4.5
19.6
4.5
I'J.6
4.5
14. i
.9
33.0
4.5
10. C
6.9







In en y
1 . .
.10
I.I.../MH .
9'3
6.4


22.1


22.1
"6.1
22.1
6.1
17.2
2.1
35.3
6.1
22.1
U.I







.inn i !• .ii
,'i ii 	
lull i,
III (III /
all sens.
legumes
all HI tor.
legumes

all sens.
plants
all inter.
plants
"all sens"."
plants
all inter .
plants
all sens.
plants
all intur.
plants
all sens.
tobacco
all inter.
tobacco
all sens.
tomato
all inter.
plants
alt sens.
plants
alt inter.
wheat


i IJ.iiii.'.ji'
Vl.jl.l U.'.
(f.K.) I-
»•*'•!
L ,1'-' i 1 i-l
*• j i * • • i
i i

.09
| 'nil/. .In ,
1.5
0.0


19.6

4.5
14.6
0.0
14.6
0.0
14.2
0.9
20.0
0.0
14.6
1.9



(IM.'L
'.I Ll. Ml
II 1 U 1 1 U"
is ni'1 Y K

i .i" °l
.10
I'l "/ i.r .
;.3
1.4


22.1

6.1
17.1
1.1
17.1
1 .1 ~
17.2
2.1
30.3
1.1
17. 1
3.1

'







H
Y It l 1
2.8
1.4


2.5

1.6
2.5
1.1
2.5
1.1
3.0
1.2
2.3
I.I
2.5
1.2

"







. i ,i« >H
i il'|l
i, ill 1 1 Ions)
9,945.0
9.945.0


24.0

24.0
1,275.3
1,275.3
928.7
928 7
2.29J.8
2,293.8
914.1
914.1
4,6/7.0
4.6//.0
_






.nl ( i n|i
i >, ,i i •
. ll ,|l U.
•• ( 	 • -
I.-.M .1. )
36.0
(54.0)


50.0

(38.0)
25.0
(50.0)
24.0
(63.0)
9.0
-
(26.0)
44.0
(3M.O)
?4.0
(63.0)






Value of
Sens it ive
( liilyniifi-
(1 1 .1 1 e )
Cl Op
'SMillions;
3,580.2
(5,370.3)


12.0

(9.1)
318.8
(637.6)
222.9
(5135.1)
206.4
-
(596.4)
402.2
(347.4)
I.1P2.5
(2.M46.5)
„

_





t J|
V H I.I
I.I
100.2
75.2


.3
	 	 	
.1
8.0
7.0
5.6
6.4
6.?
- *
7.2
9.3
3.8
28.1
35.4


. ._





•III! ions)
f ': i i
• 1
2UU.4
150 -1


" .6
	
.2
15.9
14.0
11. 1
12.9
12.4
14.4
18.6
7.f>
50 ?
AI.8


-

-------
Lo r.inn Crops,  lurest  !Yr><|i,i.      u,j UMM'• S
"

19.6
fl.5
19.6
1.5
. 	

• ™ " "
™ -~


I

	




I'M ' /

.10
fi, /Mil '.


22.1
G.I "
22. 1
__*:Ll"

.. __
.
.



	




'"" 	 ^
> ,i, .11 .
\ "
i "i I.H
miii>y


afl iciis
.plants
all inler.
Ptants .
all sens.
plants
aft inter.
Plants 	





• • •
	

'i I1' ['.•"(<•
1 \r> li| ljo
('-I'.) '•

• 1 I -
I i 1" |
.09
J pill/.' I.I S
"


_
19. G
4.5
19 6
1.5



-•




("'"' I I--
.. 1 J


	
."
1.6
" r.;
1.6

-



'








1 ' .
(' .1 II n..,


2,100 ll
2, 900.0
1 .3DO.O
	
1.300,0












. ,.i i . "ii

. . • i ,.•
, i 	
h i<< )


?0.0
(2(1.0)
9.0






..





v.iiue of
'.orr, 1 1 ivc
( |nli.JM..«-
MMlf.1)
1 i 'i|i
.ill, Hums)


.
i30 0
(510.0)
117 0
(?/3 0)
. __ _. .

	
—










• t
i"ii
1 I

i.m u
1-1.5
.
9.3
2.0
	 1 -1 	
31.1
"ftos.y
*~ • • "

._


.





ii 1 1 t'.ii' j
i !
1

I,.1! If, 11
ft n
I!1. 1.
-*.'•
r.r
i-? .
l . un .1







-------
                                                Table   4

                        Growth and Yield fl'tpontn  of  Plar'j. t>i Oione

                                  Compared with Foliar Injury 3eiponip
t
Pl."t species
. CuUivar (CV.)
i
"Alfalfa.
i cv. Vernal
Bean.
Cv. Pinto
C'jcutrser.
:v. Ohio .Tsuc
Onion,
cv. Spartan Ira
cv. Cherry 3eile
Radisn.
CV. Cherry Jell*
cv Hood
and Cire
Cv. Oar*
cv. Golden Midget
Tobacco.
cv. del t-3
Tobacco,
cv. a«l V-3
Tooacca.
CV. Burley-Jl
Icmata.
CV. H.ll
0. concenlratipn.
ppiti*
O.OS (.)
0.30
0.30
0.30
0.30
1.0
1.0
1.0
1.0
0.05C-)
0.151')
O.i5(*)
3.CS(*>
0.10(*)
0.05 I*)
o.io(-)
0.05(-)
O.IO(»)
Exposure pattern
Number of hours(h)
days(d). i wee«s(«
8h/d. Sd/w, 12w
0.5h/d. I4d
lh/dt 14d
2h/d^ 144
3n/d. Ud
In
4n
in
3n/d, Sd/.. S-
4h
Sh/d. S^w. 3w
8 h/d. Sd/-, 3w
6h/d, 133d
6h/d. 133d
6h/d, 6Jd
6h/d, Wd
acbient: often
X).05PP«(») *«*
O.CS(.)
0.05(.)
0.23(»)
o.:s(-)
8n/d, Sd/«, 4w
3h/d, Ed/w. 4w
2.Sn/d. 3d/«.
2.5 h/d. 3d/w.
Plant gro«ln or yield Foliar tnjurjr
. response. - reduction resoon'.e. ~ increase
) from control Over control
12fr. foliage dry wt; 0
22»». root dry wt ,
11*. leaf dry wl; 22°
14*. tlrm dry wt ;
231. root dry .t.
40». leaf dry wt: 82 s
57J. item dry wt;
65*. root dry wt;
70». leaf dry wl; S3 b
BO*. »to» dry wt;
BJ/. root dry -t;
76*. 1»iC.Jry wt; 90 B
85*. sle^i dry wt;
68», root dry wt;
19», too dry wl; 1'
37». top dry wt; IB*
21». plant dry wl; 2*
48*. plant dry wt; 6*
10**. leaf dry wt; t
SO*', root dry wt;
No significant effect 13
33rr. folUoe dry wt; 80
lltt, root ery wt;
2*. top fresh wt: 8*
. 3?. .root fresn »t;
21.'. top frej1! wt;- 19*
I4». root fneih. wt;
3*. ie«l yteld; 19*
2f, plant freih wt;
5Sf. \ffd yield; 37J
6Sf, plant frvsn wt;
9*, k«rnrt;
42»f . root dry wt;
No significant reductions trace
IS- !••. fruit yield. eiiennv». consio-rjole
32'», too dry wt. anoant o' dr'oliatian
11". root ory wt,
15w 4V« fruit yi»ld; utentive. »lnotl
72*f. too dry -t. cwoletely defoliated
53*r. root dry »t.
Reference
30.7, .83
31
32
82
U
30.73
84
8*
•Ml
I/.ZJ
30. n
10.79
£3
".o * latisncil ly sinnifieint d<"erence '<-
-------
from  the  National  Academy  of  Sciences  ]977  reporc
on Ozone  and  other Photochemical  Oxidants   (ref.   4)
       5,.]              OZONE A.ND  OT1IF.R  PHOTOCHEMICAL OXIDANTS
                               O «<*J»IOOIII |K
                               a «i M (Q>ln>
                               O Pfw-rwil
                               O  -^(-.. K MI
                                 [10'IUCCI
                                                     ft i
                                                     I"
                                                     III
                        	itO »• BiWH l!»
               [•'l(il)UI: .)••!  Cnrix'hlmti iK'lwccn llxiill .nul in.uini.il n/inii: I-IIIKTII-
               IIMliiin. ll.iscil mi 2-li ,IVCI.IJ;L'I| tl.il.i l.iki-n in lilt 1.111 Aii^do. full-
               lonn.1. area. Kcpnnltd mill pcriiussion Iruni I Inly."

-------
             UNITED STATES  DEPARTMENT OF AGRICULTURE
                  SCIENCE AND EDUCATION ADMINISTRATION
                                                       1224 Gardner Hall, Botany Dept
FEDERAL RESEARCH                                           NORTH CAROL.NA STATE UMVIR.!^
SOUTHERN REG.ON                                            RALE.GH. NORTH CAROLINA 27«3O
                                                       September 27, 1978


     Subject:  Estimate of Economic Benefits Associated with Alternative
               Secondary Ozone Standards

     To:       Mr. Don Lokey
               Mr. Harvey Richmond
               U. S. Environmental Protection Agency
               MD-12
               Research Triangle Park, N. C. 27711

     I have scanned with interest your development of  the  above subject
     matter.  You have made use  of data that was generated for this use.
     I had hoped  to do something like that  for the NAS  document but time
     did not permit.

     I have problems with  some  of your assumptions but  you have well stated
     these problems and have  included comments from many people with whom
     you have communicated.   Your approach  is clearly  given,  your  caveats
     are well stated and your discussions with experts  are well presented.
     I  personally have no  problems with your presentations.

     However, based on observations in field work here  at  NCSU, I  have some
     of  the same  concerns  voiced by Dr. Heggestad.  I  will raise some
     questions without really giving you any answers.

      1.  I question the 0.07  and 0.09 ppm 0_ for 8 hrs  when the hourly is
         0.08 and 0.10 respectively.

      2.  Further, if  the  hourly is 0.08  or  0.10  ppm,  what  would you expect  to
         find  in  terms of  numbers of days  from Ma/  -  September when the  8 hr
         average  each  day  would be above  say 0.06  ppm?

      3.  I would  tend  toward  a  different  ratio  for  the best and worst  case
         of  yield:injury  ratio.  The worst  would be  1:1 and the best  1:2.
         This would not be for  leafy  crops  used  for  human  consumption  where
         a  10:1  ratio  could hold.

      4.  I  would also  stress  the dangers of extrapolation  from short  term
         acute  exposures  with injury  as  the prime  response to long term
         chronic exposures where harvested  yield is the prime concern.

      I still like your approach and  believe it  is  a first  effort  that  should
      be submitted.   At the least,  it  will make  others seriously look  at
      economic  impact.

-------
Page 2
Mr. Don Lokiiv
Mr. Harvey Richmond

I would encourage you Co Look at che paper by Larsen and ,-r/self.  Larsen
cook the same data that is in the NAS document and develio-id cnunt Lons
for the same groupings of plants.  I had wanted  to use the Larson-Heck
equations in the NAS document but the data was not readv in c Lne  to
make our NAS deadline.  I personally believe these equations are  more
realistic than the Heck-Tingey equation.  The data is available,  if
you want to make use of it at any time.

I appreciate the chance to review your efforts and commend you on the
Walter W. Heck
Research Leader
Southern Region, SEA

WWH/rsnc

-------