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Page 1 of 668 EO12866_O3
- NAAQS
- RIN2060
- AP38
- NPR
- Preamble_ 2014100 6 20141125 .docx 6560
- 50
- P

ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 50, 51, 52, 53 and 58 [EPA
- HQ
- OAR
- 2008
- 0699; FRL
- 9918
- 43
- OAR ]

RIN 2 060
- AP38 National Ambient Air Quality Standards for Ozone

AGENCY: Environmental Protection Agency (EPA).

. ACTION: Proposed rule

. SUMMARY: Based on its review of the air quality criteria for ozone (O 3 ) and related photochemical oxidants and nationa l ambient air quality standards (NAAQS) for O 3 , the EPA proposes to make revisions to the primary and secondary NAAQS for O 3 to provide requisite protection of public health and welfare, respecti vely ; . The EPA is p roposing to revise the primary standard to a level within the range of 0.0 65 to 0.0 70 parts per million (ppm), and to revise the secondary standard to within the range of 0.065 to 0.070 ppm , which air quality analyses indicate would provide air quality, in terms of 3

- year average W126 index values, at or below a range of 13

- 17 ppm

- h ou rs . The EPA proposes to make corresponding revisions in data handling conventions for O 3 ; to make and conformin g changes to the Air Quality Index (AQI); to revise regulations for the prevention of significant deterioration (PSD) permitting program to add

a grandfathering transition provision for certain pending permit applications from certain requirements with resp ect to the proposed revisions to the O 3 NAAQS ; and to propose schedules and convey information related to implementing any revised standards

. In addition, the The EPA Formatted: Centered Formatted: Left: 1"*** E.O. 12866 Review

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Page 2 of 668 is proposing changes to the O 3 monitoring seasons, the Federal Reference Method (FRM) for monitoring O 3 in the ambient air, Federal Equivalent Method (FEM) procedures for testing, and the Photochemical Assessment Monitoring Stations (PAMS) network. The EPA proposes to revise the primary standard for O 3 by setting the level of that standard to within the range of 0.0 65 to 0.0 70 parts per million (ppm) in order to provide increased public health protection , including for “at

- risk” populations such as children , older adults, and peop le with asthma or other lung diseases, against an array of O 3 - related adverse health effects

. T he Administrator solicits comment on alternative standard levels below 0.065
ppm , and as low as 0.0 60 pp m . The EPA is proposing conforming changes to the AQI for O 3 , proposing to set an AQI value of 100 equal to the level of the 8

- hour primary standard, and proposing proportional changes to the AQI values of 50, 150, 200 and 300. The EPA also proposes to revise the secondary standard to provide increased protect ion against vegetation

- related effects on public welfare. The Administrator proposes to conclude that air quality in terms of a three

- year average W126 index value within the range from 13 ppm

hours (ppm

- hrs) to 17 ppm

- hrs would provide the requisite prote ction against known or anticipated adverse effects to the public welfare. The EPA solicits comment on this proposed conclusion. To achieve that level of air quality, the Administrator proposes to revise the level of the current secondary standard to within the range proposed for the primary O 3 standard of 0.065 to 0.070 ppm , which air quality analyses indicate would provide air quality, in terms of three

year average W126 index values, of a range at or below 13

- 17 ppm

- hrs

. The EPA solicits comments on this proposed revision of the secondary standard. Further, with regard to identification of a W126 index value that would describe air quality providing requisite public*** E.O. 12866 Review

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Page 3 of 668 welfare protection, the EPA additionally solicits commen ts on values within the range extending below 13 ppm

- hrs down to 7 ppm

- hrs. The EPA also solicits comments on the alternative approach of revising the secondary standard to a cumulative, seasonal, concentration

- weighted form, the W126 index based on the
t hree consecutive month period within the O 3 season with the maximum index value, with daily exposures cumulated for the 12

- hour period from 8:00 am to 8:00 pm and with a form that averages seasonal W126 values across three consecutive years and a level wit hin the range of 1 3
ppm - hrs to 1 7 ppm - hrs. The EPA additionally solicits comments on such a distinct secondary standard with a level within the range extending below 13 ppm

- hrs down to 7 ppm

- hrs. Further, the EPA solicits comments on retaining the current secondary standard, without revision.
I n conjunction Along with proposing exceptional event schedules related to implementing any revised O 3 standards, the EPA is also proposing to apply this same schedule approach to other future revised NAAQS and to remove obsolete regulatory language associated with already for expired exceptional event deadlines for historical standards for both O 3 and other NAAQS pollutants.

. The EPA is also proposing to make m inor changes to the procedures and time periods for evaluating potential FRMs and equivalent methods (including making the requirements for nitrogen dioxide consistent with the requirements for O 3 ) and removing to

remov e an obsolete requirement for the annu al submission of documentation by manufacturers of certain particulate matter monitors . For additional information, see the Executive Summary, section I.A

. DATES: Written comments on this proposed rule must be received by [ INSERT 9 0 DAYS AFTER DATE OF PUBLICATION IN THE FR F EDERAL R EGISTER ]

. Formatted: Don't adjust space between Latin and Asian text, Don't adjust space between Asian text and numbers

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Page 4 of 668 Public Hearings: The EPA intends to hold three public hearings on this proposed rule in January 2015. These will be announced in a separate Federal Register notice that provides details, including specific dates, tim es, addresses, and contact information for these hearings. ADDRESSES: Submit your comments, identified by Docket ID No. EPA

- HQ

- OAR

- 2008

- 0699, to the EPA by one of the following methods:

 www.regulations.gov : Federal eRulemaking Portal: http:// www.regulations.gov

. Follow the on - line online instructions for submitting comments.

 Email: a - and

- r - Docket@epa.gov

 Fax: Email: A

- and

- R

- Docket@epa.gov . Include docket ID No. EPA

- HQ

- OAR

- 2008

- 0699 in the subject line of the message.

 Fax: ( 202

- ) 566

- 9744

.

 Mail: Docket No. EPA

- HQ

- OAR

- 2008

- 0699, Environmental Protection Agency, Mail code 6102T, EPA Docket Center (EPA/DC), Mailcode 28221T , Attention Docket ID No.
OAR

- 2008

- 0699, 1200 Pennsylvania Ave., NW, Washington, DC 20460

. Please include a total of two copies

.

 Hand /Courier Delivery: Docket No. EPA

- HQ

- OAR

- 2008

- 0699, Environmental Protection Agency, EPA West EPA D ocket Center , Room 3334 , EPA WJC West Building , 1301 Constitution Ave., NW, Washington, DC. Such deliveries are only accepted during the Docket’s normal hours of operation, and special arrangements should be made for deliveries of boxed information. Public Hearings : Three public hearings are scheduled for this proposed rule

. Two of the public hearings will be held on XXX, 2015 in XXX, XXX and XXX, XXX

. The third public*** E.O. 12866 Review

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Page 5 of 668 hearing will be held on XXX, 2015 in XXX, XXX

. The hearings will be held at the following locations:
XXX , XXX

– XXX, 2015 Example location Address Address Address Telephone: XXX, XXX

– XXX, 2015 Example location Address Address Address Telephone: XXX, XXX

– XXX, 2015 Example location Address Address Address Telephone: See the SUPPLEMENTARY INFORMATION under “Public Hearings” for further
information. Instructions: Direct your comments to Docket ID No. EPA

- HQ

- OAR

- 2008

- 0699. The EPA's policy is that all comments received will be included in the public docket without change and may be made avai lable online at www.regulations.gov , www.regulations.gov , including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other informat ion whose disclosure is restricted by
statute

. Do not submit information that you consider to be CBI or otherwise protected through www.regulations.gov or e - mail

. The www.regulations.gov www.regulations.gov or e - mail

. The Formatted: Font: Not Italic, Underline*** E.O. 12866 Review

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Page 6 of 668 www.regulations.gov website is an “anonymous access” system, which means the EPA will not know your identity or contact information unless you provide it in the body of your comment

. If you send an e

- mail comment directly to the EPA without going through www.regulations.gov www.regulations.gov your e - mail address will be automatically captured and included as part of the comment that is placed in the public do cket and made available on the
Internet

. If you submit an electronic comment, the EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD

- ROM you submit

. If the EPA cannot read your commen t due to technical difficulties and cannot contact you for clarification, the EPA may not be able to consider your comment

. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses

. For addi tional information about EPA’s public docket visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm

. http://www.epa.gov/epahome/dockets.htm

. Docket: The EPA has established dockets for these actions as discussed above. All documents in the se docket s are listed o n the www.regulations.gov website. www.regulations.gov website. This includes documents in the rulema king docket ( Docket ID No. EPA

- HQ

- OAR

2008

- 0699 ) and a separate docket, established for the Integrated Science Assessment ( ISA) ( Docket No. EPA

- HQ

- ORD

- 2011

- 0050 ), ) that has have been incorporated by reference into the rulemaking docket

. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute

. Certain other material, such as copyrighted material, is not placed on the Internet and may be viewed, with prior arrangement, at the EPA Docket Center. Publicly available docket materials are available either electronically in www.regulations.gov www.regulations.gov or in hard copy at the Air and Radiation Docket and Information Center, E PA/DC, EPA WJC West Building , Room 3334, 1301 Constitution Ave., Formatted: Font: Not Italic, Underline*** E.O. 12866 Review

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Page 7 of 668 NW, Washington, DC

. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays

. The telephone number for the Public Reading Room is (202) 566

- 1744 and the telephone number for the Air and Radiation Docket and Information Center is (202) 566

- 1742. For additional information about EPA’s public docket visit the EPA Docket Center homepage at : http ://www.epa.gov/epahome/dockets.htm

. http://www.epa.gov/epahome/dockets.htm

. FOR FURTHER INFORMATION CONTACT: Ms. Susan Lyon Stone, Health and Environmental Impacts Division, Office of Air Quality Planning and Standards, U.S. Environmental Protect ion Agency, Mail code C504

- 06, Research Triangle Park, NC 27711; telephone: ( 919

- ) 541

- 1146; fax: ( 919

- ) 541

- 0237; email: stone.susan@epa.gov

. stone.susan@epa.gov

. SUPPLEMENTARY INFORMATION: General Information
W hat Should s hould I Consider c onsider as I Prepare My Comments p repare m y c omments for
EPA?
1

. Submitting CBI

. Do not submit this information to the EPA through www.regulations.gov www.regulations.gov or email e - mail

. Clearly mark the part or all of the information that you claim to be CBI

. For CBI information in a disk or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is claimed as CBI

. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public Formatted: Font: Not Italic, Underline Formatted: Font: Not Italic, Underline Formatted: Font: Not Italic, Underline Formatted: Font: Not Italic, Underline Formatted: Font: Not Italic, Underline*** E.O. 12866 Review

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Page 8 of 668 docket

. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.
2

. Tips for Preparing Your Comments

. When submitting comments, remember to:

 Identify the rulemaking by docket number and other identifying infor mation (subject heading, Federal Register date and page number).

 Follow directions

– The Agency a gency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

 Explain why y ou agree or disagree, suggest alternatives, and substitute language for your requested changes.

 Describe any assumptions and provide any technical information and/or data that you used.

 Provide specific examples to illustrate your concerns, and suggest alt ernatives.

 Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

 Make sure to submit your comments by the comment period deadline identified. Availability of Related Information A number of documents relevant to this rulemaking are available on EPA web W eb sites. The Integrated Science Assessment ISA for Ozone and Related Photochemical Oxidants ( ISA ) ( EPA 600/R

- 10/076F, February 2013 ) is available on the EPA’s National Center for Envi ronmental Assessment web (NCEA) W eb s ite. To obtain this document, go to http://www.epa.gov/ncea , http://www.epa.gov/ncea , and click on Ozone in the Quick Finder section. This will open a page with a link to the February 2013 Integrated Science Formatted: Font: Not Italic, Underline

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Page 9 of 668 Assessment. ISA

. The 20 14 Policy Assessment , (PA) , Health and Welfare Risk and Exposure
Assessments , (HREA and WREA, respectively) , and other related technical documents are available on EPA’s Office of Air Quality Planning and Standards (OAQPS) Technology Transfer Network (TTN) web W eb site. The final 2 014 Policy Assessment PA is available at: http://www.epa.gov/ttn/naaqs/standards/ozone/s_o3_2008_pa.html http://www.epa.gov/ttn/naaq s/ standards/ozone/s_o3_2008_pa.html , and the final 2014 Health and Welfare Risk and Exposure
Assessments and other related techn ical documents are available at: http://www.epa.gov/ttn/naaqs/standards/ozone/s_o3_2008_rea.html

. http://www.epa.gov/ttn/naaq s/standards/ozone/s_o3_2008_rea.html

. These and other related documents are also available for inspection and copying in the EPA docket identified above. Public H earings The public hearings on XXX, 2015 and XXX, 2015 will provide interested parties the opportunity to present data, views, or arguments concerning the proposed rule

. The EPA may ask clarifying questions during the oral presentations, but will not resp ond to the presentations at that time

. Written statements and supporting information submitted during the comment period will be considered with the same weight as any oral comments and supporting information presented at the public hearing

. Written commen ts must be received by the last day of the comment period, as specified in this proposed rulemaking. The public hearings will begin at 9:30 a.m. and continue until 7:30 p.m. (local time) or later, if necessary, depending on the number of speakers wishing to participate

. The EPA will make every effort to accommodate all speakers that arrive and register before 7:30 p.m

. A lunch break is scheduled from 12:30 p.m. until 2:00 p.m.*** E.O. 12866 Review

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Page 10 of 668 If you would like to present oral testimony at the hearings, please notify Mr/Ms. XXX XXX (Cxxx

- xx), U.S. EPA, Research Triangle Park, NC 27711

. The preferred method for registering is by e

- mail (XXX.XXX@epa.gov)

. Mr/Ms. XXX may be reached by telephone at (919) 541

- xxxx . S/he will arrange a general time slot for you to speak

. The EPA will make every effort to follow the schedule as closely as possible on the day of the hearing. Oral testimony will be limited to five (5) minutes for each commenter to address the proposal

. We will not be providing equipment for commenters to show o verhead slides or make computerized slide presentations unless we receive special requests in advance

. Commenters should notify Mr/Ms. XXX if they will need specific audiovisual (AV) equipment

. Commenters should also notify Ms. XXX if they need specific tr anslation services for non

- English speaking
commenters

. The EPA encourages commenters to provide written versions of their oral testimonies either electronically on computer disk, CD

- ROM, or in paper copy. The hearing schedules, including lists of speake rs, will be posted on EPA’s web site for the proposal at http://www.epa.gov/ttn/naaqs/standards/ozone/s_o3_index.html prior to the hearing. Verbatim transcripts of the hearings an d written statements will be included in the rulemaking docket. Environmental Justice
A nalyses evaluating the potential implications of a revised O 3 NAAQS for environmental justice populations are discussed in appendix 9A of the Regulatory Impact Analysis (RIA) that accompanies this notice of proposed rulemaking. The RIA is available on the Web, through the EPA’s Technology Transfer Network website at http://www.epa.gov/ttn/naaqs/standards/ozone/s_o3_index.html

. Table of Contents The following topics are d iscussed in this preamble:*** E.O. 12866 Review

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Page 11 of 668 I. Background A. Executive Summary B . Legislative Requirements C . Related Control Programs to Implement O 3 Standards D . Review of Air Quality Criteria and Standards for O 3 E . Ozone Air Quality II. Rationale for Proposed Decision on the Primary Standard A. Approach B. Health Effects Information 1. Overview of Mechanisms 2. Nature of Effects 3. Adversity of O 3 Effects 4. Ozone

- Related Impacts on Public Health C . Human Exposure and Health Risk Assessments 1. Air Quality Adjustment 2. Exposure Assessment 3. Quantitative Health Risk Assessments D . Conclusions on the Adequacy of the Current Primary Standard 1. Summary of Evidence

- Based Considerations in the PA 2. Summary of Exposure

- and Risk

- Based Considerations in the PA 3

. Policy Assessment Conclusions on the Current Standard CASAC Advice 4. CASAC Advice 4. Policy Assessment Conclusions on the Current Standard

5 . Administrator’s Proposed Conclusions Concerning the Adequa cy of the Current Standard E . Conclusions on the Elements of the Primary Standard 1. Indicator 2. Averaging Time 3. Form 4. Level F . Proposed Decision on the Primary Standard III. Communication of Public Health Information IV. Rationale for Proposed Decision on the Secondary Standard A. Approach B. Welfare Effects Information 1. Nature of Effects and Biologically Relevant Exposure Metric a. Foliar Injury b. Effects on Forest Tree Growth, Productivity and Carbon Storage c. Crop Yield Loss 2. Potential Impacts on Public Welfare C. Exposure and Risk Assessment Information 1. Air Quality Analyses 2. Tree Seedling Growth, Productivity, Carbon Storage and Associated Ecosystem Services a. Overview and Summary of Key Results b. Key Uncertainties Formatted: Indent: Left: 1", Hanging: 0.19"*** E.O. 12866 Review

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Page 12 of 668 3. Crop Yield a. Overview and Summary of Key Results b. Key Uncertainties 4. Visible Foliar Injury a. Overview and Summary of Key Results b. Key Uncertainties D. Conclusions on Adequacy of the Current Secondary Standard

1. Evidence

- and Exposure/Risk

- Based Considerations in the Policy Assessment 2. CASAC Advice 3. Administrator’s Proposed Conclusion Conclusion s on Adequacy of the Current Standard E. Consideration of Alternative Secondary Standards 1. Ind icator 2. Consideration of a Cumulative , Seasonal Exposure

- based Standard in the Policy Assessment a. Form and Averaging Time b. Level 3. CASAC Advice 4. Air Quality Analyses 5. Administrator’s Proposed Conclusions F. Proposed Decision o n the Secondary Standard V. Appendix U: Interpretation of the O 3 Primary and Secondary NAAQS for O 3 A. Background B. Data Selection Requirements C. Data Reporting and Data Handling Requirements D. Considerations for the Possibility of a Distinct Secondary Standard E. Exceptional Events Information Submission Schedule VI. Ambient Monitoring Related to Proposed O 3 Standards A. Background B. Revisions to the Length of the Required O 3 Monitoring Seasons C. Revisions to the Photochemical Assess ment Monitoring Stations (PAMS) and Network Design 1. Network Design 2. Speciated VOC Measurements 3. Carbonyl Sampling 4. Nitrogen Oxides Sampling 5. Meteorology Measurements 6. PAMS Season 7. Timing and Other Implementation Issues D. Addition of a New Fed eral Reference Method (FRM) for O 3 E. Revisions to the Procedures for Testing Performance Characteristics and Determining Comparability Between Candidate Methods and Reference Methods for Ozone, Nitrogen Dioxide, and Particulate Matter VII. Implementation of Pr oposed O 3 Standards A. NAAQS Implementation Plans Formatted: Indent: Left: 1", Hanging: 0.19"

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Page 13 of 668 1. Background 2. Timing of Rules and Guidance 3. Section 110 State Implementation Plans 4. Nonattainment Area Requirements B. Implementing a Distinct Secondary O 3 NAAQS , i f One is Established C. Designation of Areas D. Prevention of Significant Deterioration and Nonattainment New Source Review Programs for the Proposed Revised Primary O 3 NAAQS and the Proposed Secondary O 3 NAAQS 1. Prevention of Significant Deterioration (PSD) 2. Nonattainment New Source Review E. Transportation and General Conformity Programs

1. What are Transportation and General Conformity? 2. Why is the EPA Discussing Transportation and General Conformity in this Proposed Rulemaking? 3. When Would Transportati on and General Conformity Apply to Areas Designated Nonattainment for a New or Revised O 3 NAAQS, if One is Established? 4. Will Transportation and General Conformity Apply to a Distinct Secondary O 3 NAAQS, if One is Established? 5. What Impact Would the I mplementation of a New or Revised O 3 NAAQS Have on a State’s Transportation and/or General Conformity SIP? F. How Background O 3 Is Addressed in CAA Implementation Provisions 1. Introduction 2. Exceptional Event Event s Exclusions 3. Rural Transport Areas 4. International Transport VIII. Statutory and Executive Order Reviews A. National Technology Transfer and Advancement Act A . Executive Order B. Paperwork Reduction Act C. Regula tory Flexibility Act D. Unfunded Mandates Reform Act E. EO 12866: Regulato ry Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review F. EO 12898: Federal Actions to Address Environmental Ju stice in Minority Populations and Low

- Income Populations G. EO 13045: Protection of Children from Environmental Health & Safety Risks H. EO B. Paperwork Reduction Act C. Regula tory Flexibility Act D. Unfunded Mandates Reform Act E . E xecutive O rder 13132: Federalism I. EO F . E xecutive O rder 13175: Consultatio n and Coordination with Indian Tribal Governments J. EO G. E xecutive O rder 13045: Protection of Children from Environmental Health & Safety Risks Formatted: Indent: Left: 0.5", Hanging: 0.19"

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Page 14 of 668 H . E xecutive O rder 13211: Actions that Significantly Affect Energy Supply, Distribution, or Use I . National Technology Transfer and Advancement Act J . E xecutive O rder 12898: Federal Actions to Address Environmental Ju stice in Minority Populations and Low

- Income Populations References I. Background A. Executive Summary This section summarizes information about the purpose of this regulatory action (I.A.1), the major provisions of this proposal (I.A.2), and provisions related to implementation (I.A.3)

. 1. Purpose of This Regulatory Action Sections 108 and 109 of the Clean Air Act (CAA) govern the establishment, review, and revision, as appropriate, of the NAAQS to protect public health and welfare. The CAA requires the EPA to periodic ally review the air quality criteria

— the science upon which the standards are based

— and the standards themselves. This rulemaking i s being conducted pursuant to these statutory r equirements. The schedule for completing this review is established by a federal court order , which requires that the EPA sign a proposal by December 1, 2014, and make a final determination by October 1, 2015

. The EPA completed its most recent review of the O 3 NAAQS in 2008. As a result of that review, EPA took four principal actions: (1) revised the level of the 8

- hour primary O 3 standard to 0.075 parts per million (ppm); (2) expressed the standard to three d ecimal places; (3) revised the 8

- hour secondary O 3 standard by making it identical to the revised primary standard; and (4) made conforming changes to the AQI for O 3 . In subsequent litigation , the U.S. Court of Appeals for the D istrict of Columbia Circuit upheld the EPA’s 2008 primary O 3 standard, but remanded the 2008 secondary standard

. State of Formatted: Indent: Left: 0.5", Hanging: 0.19"

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Page 15 of 668 Mississippi v. EPA , 744 F. 3d 1334 ( D.C. Cir. 2013 )

. With respect to the primary standard, the court held that the EPA reasonably determined that the existing primary standard , set in 1997, did not protect public health with an adequate margin of safety and required revision. In upholding the EPA’s revised primary standard , the court dismissed arguments that the EPA should have adopted a more stringent standard

. The court remanded the secondary standard to the EPA after rejecting the EPA’s explanation for setting the secondary standard identical to the revised 8

- hour primary standard. The court held that because the EPA had failed to identify a level of air quali ty requisite to protect public welfare, the EPA’s comparison between the primary and secondary standards for determining if requisite protection for public welfare was afforded by the primary standard failed to comply with the CAA

. This proposal reflects the Administrator’s proposed conclusions based on a review of the
O 3 NAAQS that began in September 2008. In conducting this review, the EPA has carefully evaluated the currently available scientific literature on the health and welfare effects of ozone, fo cusing particularly on the new literature available since the conclusion of the previous review in 2008. In addition, the EPA has also addressed the remand of the Agency’s 2008 decision on the secondary standard. Between 2008 and 2014, the EPA prepared dra ft and final versions of the Integrated Science Assessment, the Health and Welfare Risk and Exposure Assessments, and the Policy Assessment. Multiple drafts of these documents were available for public review and comment, and as required by the CAA , were p eer - reviewed by the Clean Air Scientific Advisory Committee (CASAC), an independent scientific advisory committee established by the CAA and charged with providing advice to the Administrator. The final documents reflect the EPA staff’s
consideration of th e comments and recommendations made by CASAC and the public on draft versions of these documents

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Page 16 of 668 2. Summary of Major Provisions The EPA is proposing that the current primary O 3 standard set at a level of 0.075 ppm is
not requisite to protect public health with an adequate margin of safety , and that it should be revised to provide increased public health protection. Specifically, the EPA is proposing to retain the indicator (ozone), averaging time (8

- hour) and form (annual fourth

- highest daily maximum , averaged over 3 years) of the existing primary O 3 standard and is proposing to revise the level of that standard to within the range of 0.0 65 ppm to 0.0 70 ppm. The EPA is proposing this revision to increase public health protection , including for “at

- ris k” populations such as children , older adults, and people with asthma or other lung diseases, against an array of O 3 - related adverse health effects . For short

- term O 3 exposures, these effects include decreased lung function, increase d respiratory symptoms and pulmonary inflammation, effects that result in serious indicators of respiratory morbidity such as emergency department visits and hospital admissi ons, and all

- cause ( total nonaccidental ) mortality . For long

- term O 3 exposures, these health effects incl ude a variety of respiratory morbidity effects and respiratory mortality. Recognizing that the CASAC recommended a range of levels from 0.060 ppm to 0.070 ppm, and that levels as low as 0.060 ppm could potentially be supported , the Administrator solicits comment on alternative standard levels below 0.0 65 pp m , and as low as 0.0 60 pp m . However, the Administrator notes that setting a standard below 0.065 ppm, down to 0.060 ppm, would inappropriately place very little weight on the uncertainties in the health effects evidence and exposure/risk information

. Given alternative views of the currently available evidence and information expressed by some
commenters, t he EPA is taking comment on both the Administrator’s proposed decision to revise the current primary O 3 standard and the option of retaining that standard.*** E.O. 12866 Review

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Page 17 of 668 In addition to proposing changes to the level of the standard, the EPA is proposing conforming changes to the A ir Quality Index (A QI ) by proposing to set an AQI value of 10 0 equal to the level of the 8

- hour primary O 3 standard, and proposing adjustments to the AQI values of 50, 150, 200 and 300. The EPA also proposes to revise the secondary standard to provide increased protection against vegetation

- related effects on public welfare. As an initial matter, the Administrator proposes to conclude that air quality in terms of a three

- year average seasonal W126 index value, based on the three consecutive month period within the O 3 season with the maximum index value, with daily ex posures cumulated for the 12

- hour period from 8:00 am to 8:00 pm, within the range from 13 ppm

- hrs to 17 ppm

- hrs would provide the requisite protection against known or anticipated adverse effects to the public welfare. The EPA solicits comment on this pro posed conclusion. In considering how t o achieve that level of air quality, the Administrator recognizes that air quality data analyses suggest that air quality in terms of three

- year average W126 index values of a range at or below 13 to 17 ppm

- hrs would be provided by a secondary standard level within the range of 0.065 to 0.070 ppm , and that to the extent areas need to take action to attain a standard in the range of 0.0 65 to 0.0 70 pp m , those actions would also improve air quality as measured by the W126 metric. Thus, the Administrator proposes to revise the level of the current secondary standard to within the range of 0.065 to 0.070 ppm

. The EPA solicits comments on this proposed revision of the secondary standard. The EPA also solicits comments on the alternative approach of revising the secondary standard to a W126

- based form, averaged over three years, with a level within the range of 1 3
ppm - hrs to 1 7 ppm - hrs. The EPA additionally solicits comments on such a distinct secondary standard with a level w ithin the range extending below 13 ppm

- hrs down to 7 ppm

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Page 18 of 668 Further, the EPA solicits comments on retaining the current secondary standard without revision, along with the alternative views of the evidence that would support retaining the current stand ard. 3. Provisions Related to Implementation As directed by the C AA , reducing pollution to meet national air quality standards always has been a shared task, one involving the federal government, states, tribes and local air agencies. This partnership has proved effective since the EPA first issued O 3 standards more than three decades ago, and is evidenced by significantly lower O 3 levels throughout the country. To be added provide a foundation that helps air agencies build successful strategies for attaini ng new O 3 standards , t he EPA will continue to move forward with federal regulatory programs, such as the proposed Clean Power Plan and the final Tier 3 motor vehicle emissions standards. T o facilitate the development of C AA

- compliant implementation plans a nd strategies to attain new standards , t he EPA intends to issue timely and appropriate implementation guidance and, where appropriate and consistent with the law , new rulemaking s to streamline regulatory burdens and provide flexibility in implementation. I n addition, given the regional nature of O 3 air pollution, the EPA will continue to work with states to address interstate transport of O 3 and O 3 precursors. This notice contains several proposed provisions related to implementation of the proposed standar ds . In addition to revisions to the primary and secondary NAAQS, the EPA is proposing to make corresponding revisions in data handling conventions for O 3 ; to revise regulations for the Prevention of Significant Deterioration (PSD) permitting program to add a provision grandfathering certain pending permits from certain requirements with respect to the proposed revisions to the O 3 NAAQS; and to convey sched ules and information related to implementing any revised standards

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Page 19 of 668 I n conjunction with proposing exceptional event schedules related to implementing any revised O 3 standards, the EPA is also proposing to extend the new schedule approach to other future r evised NAAQS and to remove obsolete regulatory language associated with expired exceptional event deadlines for historical standards for both O 3 and other NAAQS pollutants. The EPA is also proposing to make minor changes to the procedures and time periods for evaluating potential FRMs and equivalent methods, including making the requirements for nitrogen dioxide consistent with the requirements for O 3 , and removing an obsolete requirement for the annual submission of documentation by manufacturers of certai n particulate matter monitors.
B

. Legislative Requirements Two sections of the C AA govern the establishment and revision of the NAAQS. Section 108 (42 U.S.C. section 7408) directs the Administrator to identify and list certain air pollutants and then to issue air quality criteria for those pollutants. The Administrator is to list those air pollutants that in her “judgment, cause or contribute to air pollution which may reasonably be anticipated to endanger public health or welfare;” “the presence of which in the ambient air results from numerous or diverse mobile or stationary sources;” and “for which . . . [the Administrator] plans to issue air quality criteria....” Air quality criteria are intended to “accurately reflect the latest scientific knowledge us eful in indicating the kind and extent of all identifiable effects on public health or welfare which may be expected from the presence of [a] pollutant in the ambient air . . .” 42 U.S.C. § 7408(b)

. Section 109 (42 U.S.C. 7409) directs the Administrator to propose and promulgate “primary” and “secondary” NAAQS for pollutants for which air quality criteria are issued. Section 109(b)(1) defines a primary standard as one “the attainment and maintenance of which in the judgment of the Administrator, based on su ch Formatted: Font: Italic Formatted: Font: Italic*** E.O. 12866 Review

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Page 20 of 668 criteria and allowing an adequate margin of safety, are requisite to protect the public health.” 1 A secondary standard, as defined in section 109(b)(2), must “specify a level of air quality the attainment and maintenance of which, in the judgment of the Administrator, based on such criteria, is requisite to protect the public welfare from any known or anticipated adverse effects associated with the presence of [the] pollutant in the ambient air.” 2 The requirement that primary standards provide an ad equate margin of safety was intended to address uncertainties associated with inconclusive scientific and technical information available at the time of standard setting. It was also intended to provide a reasonable degree of protection against hazards tha t research has not yet identified. See State of Mississippi
v. EPA , 744 F. 3d 1334, 1353 (D.C. Cir. 2012 201 3 ) (“By requiring an ‘adequate margin of safety’, Congress was directing EPA to build a buffer to protect against uncertain and unknown dangers to hu man health”); see also Lead Industries Association v. EPA , 647 F.2d 1130, 1154 (D.C. Cir 1980); American Petroleum Institute v. Costle , 665 F.2d 1176, 1186 (D.C. Cir. 1981); American Farm Bureau Federation v. EPA , 559 F. 3d 512, 533 (D.C. Cir. 2009); Asso ciation of Battery Recyclers v. EPA , 604 F. 3d 613, 617

- 18 (D.C. Cir. 2010). Both kinds of uncertainties are components of the risk associated with pollution at levels below those at which human health effects can be said to occur with reasonable scientifi c certainty. Thus, in selecting primary standards that provide an adequate margin of safety, the Administrator is seeking not only to

1 The legislative history of section 109 indicates that a primary standard is to be set at “the maximum permissible ambient air level . . . which will protect the health of any [sensitive] group of the population,” and that , for this purpose , “reference should be made to a representative sample of persons compri sing the sensitive group rather than to a single person in such a group ”

. ” S. Rep. No. 91

- 1196, 91st Cong., 2d Sess. 10 (1970). 2 Welfare effects as defined in section 302(h) (42 U.S.C. § 7602(h)) include, but are 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

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Page 21 of 668 prevent pollution levels that have been demonstrated to be harmful but also to prevent lower pollutant levels that may pos e an unacceptable risk of harm, even if the risk is not precisely identified as to nature or degree. The CAA does not require the Administrator to establish a primary NAAQS at a zero

- risk level or at background concentration s , see Lead Industries v.
EPA , 6 47 F.2d at 1156 n.51 ; State of Mississippi v. EPA , 744 F. 3d at 1343, 1351, but rather at a level that reduces risk sufficiently so as to protect public health with an adequate margin of safety. In addressing the requirement for an adequate margin of safety, the EPA considers such factors as the nature and severity of the health effects, the size of sensitive population(s) 3 at risk, and the kind and degree of the uncertainties that must be addressed. The selection of any particular approach for providi ng an adequate margin of safety is a policy choice left specifically to the Administrator’s judgment. See Lead Industries Association v. EPA , 647 F.2d at 1161

- 62; State of Mississippi , 744 F. 3d at 1353. In setting primary and secondary standards that are “requisite” to protect public health and welfare, respectively, as provided in section 109(b), the EPA’s task is to establish standards that are neither more nor less stringent than necessary for these purposes. In so doing, the EPA may not consider the co sts of implementing the standards. See generally, Whitman v. American Trucking Associations , 531 U.S. 457, 465

- 472, 475

- 76 (2001). Likewise, “[a]ttainability and technological feasibility are not relevant considerations in the promulgation of national ambi ent air quality standards.” American Petroleum Institute v. Costle , 665 F. 2d at 1185.

3 As used here and similarly throughout this document, the term “ population ” refers to p eople having a quality or characteristic in common, including a specific pre

- existing illness or a specific age or life stage. Formatted: Font: Italic, No underline

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Page 22 of 668 Section 109(d)(1) requires that “not later than December 31, 1980, and at 5

- year intervals thereafter, the Administrator shall complete a thorough review of the criteria published under section 108 and the national ambient air quality standards . . . and shall make such revisions in such criteria and standards and promulgate such new standards as may be appropriate . . . .” Section 109(d)(2) requires that an independent scientific review committee “shall complete a review of the criteria . . . and the national primary and secondary ambient air quality standards . . . and shall recommend to the Administrator any new . . . standards and revisions of existing criteria and st andards as may be appropriate . . . .” Since the early 1980's, the Clean Air Scientific Advisory Committee (CASAC) has performed this independent review function. 4
C

. Related Control Programs to Implement O 3 Standards States are primarily responsible for ensuring attainment and maintenance of ambient air quality standards once the EPA has established them. Under section 110 of the CAA, and related provisions, states are to submit, for the EPA’s approval, state implement ation plans (SIPs) that provide for the attainment and maintenance of such standards through control programs directed to sources of the pollutants involved. The states, in conjunction with the EPA, also administer the Prevention of Significant Deteriorati on ( PSD ) program (CAA sections 160 to 169). In addition, Federal federal programs provide for nationwide reductions in emissions of O 3 precursors and other air pollutants through the Federal federal motor vehicle and motor vehicle fuel control program under title II of the Act ( CAA ( sections 202 to 250) which involves controls for emissions from mobile sources and controls for the fuels used by these sources, and new source

4 Lists of CASAC members and of members of the CASAC Oz one Review Panel are available at: http://yosemite.epa.gov/sab/sabpeople.nsf/WebCommitteesSubCommittees/Ozone%20Review% 20Panel. Formatted: Font: Italic Formatted: Font: Italic*** E.O. 12866 Review

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Page 23 of 668 performance standards for stationary sources under section 111 of the CAA. For some st ationary sources, the national emissions standards for hazardous air pollutants under section 112 of the CAA may provide ancillary reductions in O 3 precursors. After the EPA establishes a new or revised NAAQS, the CAA directs the EPA and the states to take steps to ensure that the new or revised NAAQS is met. One of the first steps, known as the initial area designations, involves identifying areas of the country that either are attaining or not attaining the new or revised NAAQS along with the nearby areas that contribute to the violations. Upon designation of nonattainment areas, certain states would then be required to develop SIPs to attain the standards. In developing their attainment plans, states would first take into account projected emission reduct ions from federal and state rules that have been already adopted at the time of plan submittal. A number of significant emission reduction programs that will lead to reductions of O 3 precursors are in place today or are expected to be in place by the time any new SIPs will be due. Examples of such rules include the Nitrogen Oxides ( NO X ) SIP Call, Clean Air Interstate Rule , (CAIR), and Cross

- State Air Pollution Rule , (CSAPR), 5 regulations controlling onroad and nonroad engines and fuels, the utility and indu strial boilers hazardous air pollutant rules, and various other programs already adopted by states to reduce emissions from key emissions sources. States would then evaluate the level of additional emission reductions needed for each nonattainment area to attain the O 3 standards “as expeditiously as practicable,” and adopt new state regulations as appropriate. Section VII of this

5 The Cross

- State Air Pollution Rule was recently upheld by the Supreme Court in Environmental Protection Agency v. EME Homer Ci ty Generation , U.S. (2014). The D.C. Circuit has since lifted the stay of the rule. Order, Document #1518738, EME Homer City Generation, L.P. v. EPA , Case #11

- 1302 (D.C. Cir. Oct. 23, 2014). Formatted: Normal Formatted: Font: Italic, No underline

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Page 24 of 668 preamble includes additional discussion of designation and implementation issues associated with any revised O 3 NAAQS.
D

. Review of Air Quality Criteria and Standards for O 3 The EPA first established primary and secondary NAAQS for photochemical oxidants in 1971 (36 FR 8186, April 30, 1971). The EPA set both primary and secondary standards at a level of 0.08 parts per million (ppm) , 1

- hr average, total photochemical oxidants, not to be exceeded more than one hour per year. The EPA based the standards on scientific information contained in the 1970 Air Quality Criteria for Photochemical Oxidants (U.S. DHE W, 1970). The EPA initiated t he first periodic review of the NAAQS for photochemical oxidants in 1977. Based on the 1978 Air Quality Criteria for Ozone and Other Photochemical Oxidants (U.S. EPA, 1978), the EPA published proposed revisions to the original NAAQS in 1978 (43 FR 16962) a nd final revisions in 1979 (44 FR 8202). At that time, the EPA revised the level of the primary and secondary standards from 0.08 to 0.12 ppm and changed the indicator from photochemical oxidants to O 3 , and the form of the standards from a deterministic (i .e., not to be exceeded more than one hour per year ) to a statistical form. This statistical form defined attainment of the standards as occurring when the expected number of days per calendar year with maximum hourly average concentration greater than 0.1 2 ppm equaled one or less. Following the final decision in the 1979 review, the City of Houston challenged the Administrator’s decision arguing that the standard was arbitrary and capricious because natural
O 3 concentrations and other physical phenomena i n the Houston area made the standard unattainable in that area. The U.S. Court of Appeals for the District of Columbia Circuit (D.C. Circuit) rejected this argument, holding (as noted above) that attainability and technological feasibility are not relevant considerations in the promulgation of the NAAQS. The court also Formatted: Font: Italic*** E.O. 12866 Review

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Page 25 of 668 noted that the EPA need not tailor the NAAQS to fit each region or locale, pointing out that Congress was aware of the difficulty in meeting standards in some locations and had addressed this difficulty through various compliance related provisions in the Act CAA . See API v. Costle , 665 F.2d 1176, 1184

- 6 (D.C. Cir. 1981). In 1982, the EPA announced plans to revise the 1978 Air Quality Criteria document (47 FR 11561), and in 1983, the EPA initi ated the second periodic review of the O 3 NAAQS (48 FR 38009). The EPA subsequently published the 1986 Air Quality Criteria for Ozone and Other Photochemical Oxidants (U.S. EPA, 1986) and the 1989 Staff Paper (U.S. EPA, 1989). Following publication of the 1986 Air Quality Criteria Document (AQCD), a number of scientific abstracts and articles were published that appeared to be of sufficient importance concerning potential health and welfare effects of O 3 to warrant preparation of a Supplement (U.S. EPA, 199 2). On August 10, 1992, under the terms of a court order, the EPA published a proposed decision to retain the existing primary and secondary standards (57 FR 35542). The notice explained that the proposed decision would complete the EPA’s review of informa tion on health and welfare effects of O 3 assembled over a 7

- year period and contained in the 1986 AQCD and its 1992 Supplement. The proposal also announced the EPA’s intention to proceed as rapidly as possible with the next review of the air quality criteria and standards for O 3 in light of emerging evidence of health effects related to 6

- to 8

- hour O 3 exposures. On March 9, 1993, the EPA concluded the review by affirming its proposed decision to retain the existing primary and secondary standards (58 FR 13008). In August 1992, the EPA announced plans to initiate the third periodic review of the air quality criteria and O 3 NAAQS (57 FR 35542). In December 1996, the E PA proposed to replace the then

- existing 1

- hour primary and secondary standards with 8

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Page 26 of 668 at a level of 0.08 ppm (equivalent to 0.084 ppm using standard rounding conventions) (61 FR 65716). The EPA also proposed to establish a new distinct secondary standard using a biologically based cumulative, seasonal form. Th e EPA completed this review on July 18, 1997 (62 FR 38856) by setting the primary standard at a level of 0.08 ppm, based on the annual fourth

highest daily maximum 8

- hr average concentration, averaged over three years, and setting the secondary standard id entical to the revised primary standard. In reaching this decision, the EPA identified several reasons supporting its decision to reject a poten tial alternate standard set at 0.07 ppm. Most importantly, the EPA pointed out the scientific uncertainty at low er concentrations and placed significant weight on the fact that no CASAC panel member supported a standard level set lower than 0.08 ppm (62 FR 38868). In addition to noting the uncertainties in the health evidence for exposure concentrations below 0.08 p pm and the advice of CASAC, the EPA noted that a standard set at a level of 0.07 ppm would be closer to peak background concentrations that infrequently occur in some areas due to nonanthropogenic sources of O 3 precursors (62 FR 38856, 38868; July 18, 1997 ). On May 14, 1999, in response to challenges by industry and others to the EPA’s 1997 decision, the U.S. Court of Appeals for the District of Columbia D.C. Circuit remanded the O 3 NAAQS to the EPA, finding that section 109 of the Act CAA , as interpreted by the EPA, effected an unconstitutional delegation of legislative authority. American Trucking Assoc. vs. EPA , 175 F.3d 1027, 1034

- 1040 (D.C. Cir. 1999) (“ ATA I ”). In addition, the court directed that, in responding to the remand, the EPA should consider th e potential beneficial health effects of O 3 pollution in shielding the public from the effects of solar ultraviolet (UV) radiation, as well as adverse health effects. Id. at 1051

- 53. In 1999, the EPA petitioned for rehearing en banc on several issues relat ed to that decision. The court granted the request for rehearing in part and Formatted: Font: Italic, No underline

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Page 27 of 668 denied it in part, but declined to review its ruling with regard to the potential beneficial effects of
O 3 pollution. 195 F3d F

. 3d 4, 10 (D.C Cir., 1999) (“ ATA II ”). On January 27, 2000, the EPA petitioned the U.S. Supreme Court for certiorari on the constitutional issue (and two other issues), but did not request review of the ruling regarding the potential beneficial health effects of O 3 . On February 27, 2001, the U.S. Supreme Court unanimously reversed the judgment of the D.C. Circuit on the constitutional issue. Whitman v. American Trucking Assoc ., 531 U. S. 457,
472

- 74 (2001) (holding that section 109 of the CAA does not delegate legislative power to the EPA in contravention of the Constitution). The Court remanded the case to the D.C. Circuit to consider challenges to the O 3 NAAQS that had not been addressed by that court’s earlier decisions. On March 26, 2002, the D.C. Circuit issued its final decision on remand, finding the 1997 O 3 NAAQS to be “neither arbitrary nor capricious,” and so denying the remaining petitions for review. American Trucking Associations, Inc. v EPA , 283 F.3d 355, 379 (D.C Cir., 2002)(“ ATA III ”). Specifically, in ATA III , the D.C. Circuit upheld the EPA ’s decision on the 1997 O 3 standard as the product of reasoned decision

- making. The Court With regard to the primary standard, t he c ourt made clear that the most important support for EPA’s decision to revise the standard was the health evidence and of insuf ficient protection afforded by the concerns it raised about setting a then

- existing standard level below 0.08 ppm (“the record is replete with references to studies demonstrating the inadequacies of the old one

- hour standard ”), as well as extensive informat ion supporting the change to an 8

- hour averaging time

. 283 F 3d at 378. 283 F

. 3d at 378. The court further upheld the EPA’s decision not to select a more stringent level for the primary standard noting “the absence of any human clinical studies at ozone co ncentrations below 0.08 [ppm] ” which supported EPA’s conclusion that “the most serious health effects of ozone are Formatted: Font: Italic, No underline

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Page 28 of 668 ‘less certain’ at low concentrations, providing an eminently rational reason to set the primary standard at a somewhat higher level, at least until additional studies bec ome available.” Id. (internal citations omitted). The Court also pointed to the significant weight that the EPA properly placed on the advice it received from CASAC. Id. at 379. The In addition, t he court further noted that “although relative pr oximity to peak background O 3 concentrations did not, in itself, necessitate a level of 0.08 , [ppm] , EPA could consider that factor when choosing among the three alternative levels.” Id. Independently of the litigation, the EPA also responded to the Court’s c ourt’s re mand to consider the potential beneficial health effects of O 3 po llution in shielding the public from effects of UV radiation. The EPA provisionally determined that the information linking changes in patterns of ground

- level O 3 concentrations to changes in relevant patterns of exposures to UV radiation of concern to public health was too uncertain, at that time, to warrant any relaxation in 1997 O 3 NAAQS. The EPA also expressed the view that any plausible changes in UV

- B radiation exposures from changes in patterns of ground

- level O 3 concentrations would likely be very small from a public health perspective. In view of these findings, the EPA proposed to leave the 1997 8

- hour NAAQS unchanged (66 FR 57268, Nov. 14, 2001). After considering public
comment on t he proposed decision, the EPA published its final response to this remand on January 6, 2003, re

- affirming the 8

- hour O 3 NAAQS set in 1997 (68 FR 614). The EPA initiated the fourth periodic review of the air quality criteria and O 3 standards in September 2000 with a call for information (65 FR 57810). The schedule for completion of that review was ultimately governed by a consent decree resolving a lawsuit filed in March 2003 by plaintiffs representing national environmental and pub lic health organizations, who maintained that the EPA was in breach of a mandatory legal duty to complete review of the O 3 NAAQS Formatted: Font: Italic, No underline Formatted: Underline*** E.O. 12866 Review

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Page 29 of 668 within a statutorily mandated deadline. On July 11, 2007, the EPA proposed to revise the level of the primary standard withi n a range of 0.075 to 0.070 ppm (72 FR 37818). Documents supporting this proposed decision included the Air Quality Criteria for Ozone and Other Photochemical Oxidants ( U.S. EPA, 2006a ) and the Staff Paper (U.S EPA, 2007) and related technical support documen ts. The EPA also proposed two options for revising the secondary standard: (1) replace the current standard with a cumulative, seasonal standard, expressed as an index of the annual sum of weighted hourly concentrations cumulated over 12 daylight hours dur ing the consecutive 3

- month period within the O 3 season with the maximum index value, set at a level within the range of 7 to 21 ppm

- hrs, or (2) set the secondary standard identical to the proposed primary standard. The EPA completed the review with public ation of a final decision on March 27, 2008 (73 FR 16436). In that final rule, the EPA revised the NAAQS by lowering the level of the 8

- hour primary O 3 standard from 0.08 ppm to 0.075 ppm, not otherwise revising the primary standard, and adopting a seconda ry standard identical to the revised primary standard. In May 2008, state, public health, environmental, and industry petitioners filed suit challenging the EPA’s final decision on the 2008 O 3 standards. On September 16, 2009, the EPA announced its intenti on to reconsider the 2008 O 3 standards, and initiated a rulemaking to do so

. At the EPA’s request, the Court held the consolidated cases in abeyance pending the EPA’s reconsideration of the 2008 decision. On January 19, 2010 (75 FR 2938), the EPA issued a notice of proposed rulemaking to reconsider the 2008 final decision. In that notice, the EPA proposed that further revisions of the primary and secondary standards were necessary to provide a requisite level of protection to public health and welfare. The EPA proposed to decrease the level of the 2008 8

- hour primary standard from 0.075 ppm to a level within the range of 0.060 to 0.070 ppm, and to change the*** E.O. 12866 Review

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Page 30 of 668 secondary standard to a new cumulative, seasonal standard expressed as an annual index of the sum of weighted hourly concentrations, cumulated over 12 hours per day (8 am to 8 pm), during the consecutive 3

- month period within the O 3 season with a maximum index value , set at a level within the range of 7 to 15 ppm

- hours. The Agency also solicited CASAC re view of the proposed rule on January 25, 2010 and solicited additional CASAC advice on January 26, 2011. After considering comments from CASAC and the public, the EPA prepared a draft final rule, which was submitted for interagency review pursuant to Execu tive Order 12866. On September 2, 2011, consistent with the direction of the President, the Administrator of the Office of Infor mation and Regulatory Affairs (OIRA ), Office of Management and Budget (OMB ), returned the draft final rule to the EPA for furthe r consideration. In view of this return and the fact that the Agency’s next periodic review of the O 3 NAAQS required under Clean Air Act CA A section 109 had already begun (as announced on September 29, 2008), the EPA decided to defer defer

red the decisions involved in the reconsideration until it complete d its statutori ly required periodic review. In light of EPA’s decision to consolidate the reconsideration with the current review, the D.C. Circuit Court of Appeals proceeded with the litigation on the 2008 final decision. On July 23, 2013, the Court upheld the EPA’s 2008 primary O 3 standard, but remanded the 2008 secondary standard to the EPA. State of Mississippi v. EPA , 744 F. 3d 1334 . With respect to the primary standard, the court first held that the EP A reasonably determined that the existing standard was not requisite to protect public health with an adequate margin of safety, and consequently required revision. Specifically, the court noted that there were “numerous epidemiologic studies linking healt h effects to exposure to ozone levels below 0.08 ppm and clinical human exposure studies finding a causal relationship between health effects and Formatted: Font: Italic, No underline*** E.O. 12866 Review

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Page 31 of 668 exposure to ozone levels at and below 0.08 ppm

. ” 744 F. 3d at 1345 . The court also specifically endorsed the w eight of evidence approach utilized by the EPA in its deliberations. Id. at 1344

. The court went on to reject arguments that the EPA should have adopted a more stringent primary standard. Dismissing arguments that a clinical study (as properly interpreted by the EPA) showing effects at 0.06 ppm necessitated a standard level lower than that selected, the court noted that this was a s ingle, limited study. Id. at 1350 . With respect to the epidemiologic evidence, the court accepted the EPA’s argument that there could be legitimate uncertainty that a causal relationship between O 3 and 8

- hour exposures less than 0.075 ppm exists, so that

a ssociations at lower levels reported in epidemiologic studies did not necessitate a more stringent standard. Id. at 1351

- 52

. 6 The court also rejected arguments that an 8

- hour primary standard of 0.075 ppm failed to provide an adequate margin of safety, no ting that margin of safety considerations involved policy judgments by the agency, and that by setting a standard “appreciably below” the level of the current standard (0.08 ppm), the agency had made a reasonable policy choice. Id. Finally, the court rejec ted arguments that the EPA’s decision was inconsistent with CASAC’s scientific recommendations because CASAC had been insufficiently clear in its recommendations whether it was providing scientific or policy recommendations, and the EPA had reasonably addr essed CASAC’s policy recommendations. Id. at 1357

- 58

. With respect to the secondary standard, the court held that because the EPA had failed to identify a level of air quality requisite to protect public welfare, the EPA’s comparison between

6 The court cautioned, however, that “perhaps more [clinical] studies like the Adams studies will yet reveal that the 0.060 ppm level produces significant adverse decrements that simply cannot be attributed to normal variation in lung function ”, , ” and further cautioned that “agencies may not merely recite the terms ‘ substantial uncertainty’ as a justification for their actions’”. actions

. ” Id. at 1350, 1357 (internal citations omitted). Formatted: Font: Italic, No underline

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Page 32 of 668 the primary a nd secondary standards for determining if requisite protection for public welfare was afforded by the primary standard did not comply with the Act CAA . The court thus rejected the EPA’s explanation for setting the secondary standard identical to the revised 8

- hour primary standard, and remanded the secondary standard to the EPA. Id

. at 1360

- 62

. At the time of the court’s decision, the EPA had already completed significant portions of its next statutorily required periodic review of the O 3 NAAQS. On September 29, 2008, the EPA announced the initiation of a new periodic review of the air quality criteria for O 3 and related photochemical oxidants and issued a call for information in the Federal Register (73 FR 56581, Sept. 29, 2008). A wide range of ext ernal experts, as well as the EPA staff, representing a variety of areas of expertise (e.g., epidemiology, human and animal toxicology, statistics, risk/exposure analysis, atmospheric science, ecology, biology, plant science, ecosystem services) participat ed in a workshop. This workshop was held on October 28

- 29, 2008 in Research Triangle Park, NC. The workshop provided an opportunity for a public discussion of the key policy

- relevant issues around which the EPA would structure this O 3 NAAQS review and the most meaningful new science that would be available to inform our understanding of these issues. Based in part on the workshop discussions, the EPA developed a draft Integrated Review Plan (IRP) outlining the schedule, process, and key policy

- relevant que stions that would guide the evaluation of the air quality criteria for O 3 and the review of the primary and secondary O 3 NAAQS. A draft of the IRP was released for public review and comment in September 2009. This IRP was the subject of a consultation with the CASAC on November 13, 2009 (74 FR 54562; October 22, 2009). 7 The EPA considered comments received from that consultation and

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Page 33 of 668 from the public in finalizing the plan and in beginning the review of the air quality criteria. The EPA’s overall plan and sc hedule for this review is presented in the Integrated Review Plan for the Ozone National Ambient Air Quality Standards

. 8 As part of the process of preparing the O 3 Integrated Science Assessment ( ISA ) , , the EPA’s National Center for Environmental Assessmen t ( NCEA ) hosted a workshop to review and discuss preliminary drafts of key sections of the ISA on August 6, 2010 (75 FR 42085, July 20, 2010) . The CASAC and the public reviewed the first external r eview draft ISA (U.S. EPA,
2011a ; 76 FR 10893, February 28, 2011) at a meeting held in May 19

- 20, 2011 (76 FR 23809; April 28, 2011). Based on CASAC and public comments, NCEA prepared a second draft ISA (U.S. EPA, 2011 b ; 76 FR 60820, September 30, 2011)

. CASAC and the public reviewed this draft at a January 9

- 10, 2012 (76 FR 236, December 8, 2011) meeting. Based on CASAC and public comments, NCEA prepared a third draft ISA (U.S. EPA 2012a; 77 FR 36534; June 19, 2012), which was reviewed at a CASAC meeting in September 2012. The EPA released the final
ISA ( EPA/600/R

- 10/076F) in February 2013. The EPA presented its plans for conducting the Risk and Exposure Assessments (REAs) that build on the scientific evidence presented in the ISA, in two planning documents titled Ozone National Ambient Air Quality Standards: Scop e and Methods Plan for Health Risk and Exposure Assessment and Ozone National Ambient Air Quality Standards: Scope and Methods

ite.epa.gov/sab/sabproduct.nsf/WebProjectsbyTopicCASAC!OpenView for more information on CASAC activities related to the current O 3 NAAQS review. 8 EPA 452/R

- 11

- 006; April 2011; Available: http://www.epa.gov/ttn/naaqs/standards/ozone/data/2011_04_OzoneIRP.pdf http://www.epa.gov/ ttn/naaqs/standards/ozone/data/2011_04_OzoneIRP.pdf Formatted*** E.O. 12866 Review

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Page 34 of 668 Plan for Welfare Risk and Exposure Assessment (henceforth, Scope and Methods Plans). 9 These planning documents outlined the sc ope and approaches that staff planned to use in conducting quantitative assessments, as well as key issues that would be addresse d as part of the assessments. The EPA released these documents for public comment in April 2011, and consulted with CASAC on Ma y 19

- 20, 2011 (76 FR 23809; April 28, 2011). In designing and conducting the initial health risk and welfare risk assessments, the EPA considered CASAC comments (Samet , 2011) on the Scope and Methods Plans and also considered public comments. In May 2012, the EPA issued a memo titled Updates to Information Presented in the Scope and Methods Plans for the Ozone NAAQS Health and Welfare Risk and Exposure Assessments that described changes to elements of the scope and methods plans and provided a brief explana tion of each change and the reason for it. In July 2012, the EPA made the first drafts of the Health and Welfare REAs available for CASAC review and public comment (77 FR 42495, July 19, 2012). The first draft Policy
Assessment 10 ( PA ) 11 was made available for CASAC review and public comment in August

9 EPA

- 452/P

- 11

- 001 and

- 002 ; April 2011; Available: http://www.epa.gov/ttn/naaqs/standards/ozone/s_o3_2008_pd.html http://www.epa.gov/ttn/naaqs/ standards/ozone/s_o3_2008_pd.html 10 The PA is prepared by the staff in the EPA’s Office of Air Quality Planning and Standards (OAQPS). It presents a staff evaluation of the policy implications of the key scientific and technical information in the ISA and REAs for the EPA’s consideration. T he PA provides a transparent evaluation, and staff conclusions, regarding policy considerations related to reaching judgments about the adequacy of the current standards, and if revision is considered, what revisions may be appropriate to consider. The PA is intended to help “bridge the gap” between the Agency’s scientific assessments presented in the ISA and REAs, and the judgments required of the EPA Administrator in determining whether it is appropriate to retain or revise the NAAQS. 11 The PA is prepared by the staff in the EPA’s Office of Air Quality Planning and Standards (OAQPS). It presents a staff evaluation of the policy implications of the key scientific and technical information in the ISA and REAs for the EPA’s consideration. The PA provides a tr ansparent evaluation, and staff conclusions, regarding policy considerations related to reaching*** E.O. 12866 Review

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Page 35 of 668 2012. These documents were reviewed by the CASAC O 3 Panel at a public meeting in September 2012. The second draft REAs and PA , made available by the EPA in January 2014 (79 FR 4694, January 2 9, 2014), were prepared with consideration of advice from CASAC (Frey and Samet, 2012a, 2012b) and comments from the public. These drafts were reviewed by the
CASAC O 3 Panel at a public meeting on March 25

- 27, 2014. The CASAC issued final reports on the se cond drafts of the HRE A on July 1, 2014 (Frey, 2014a), and the WREA on June 18, 2 014 (Frey, 2014b), respectively. The CASAC issued a final report on the second draft PA on June 26, 2014 (Frey, 2014c). Th e final versions of the Health REA ( HREA ) (U.S. EPA 2 014a), Welfare REA ( WREA ) (U.S. EPA, 2014b), and PA (U.S. EPA, 2014c) were made available by the EPA
in August , 2014

. These documents reflect staff’s consideration of the comments and recommendations made by CASAC, as well as comments made by members of the public, in their review of the draft versions of these documents

. E

. Ozone Air Quality Ozone is formed near the Earth’s surface due to chemical interactions involving solar radiation and precursor pollutants including vola tile organic compounds (VOCs), nitrogen oxides (NO X ), methane (CH 4 ) and carbon monoxide (CO). The precursor emissions leading to O 3 formation can result from both man

- made sources (e.g., motor vehicles and electric power generation) and natural sources (e. g., vegetation and wildfires). Occasionally, O 3 that is created naturally in the stratosphere can also contribute to O 3 levels near the surface. Once formed, O 3 can be transported by wind s before eventually being removed from the atmosphere via chemical

judgments about the adequacy of the current standards, and if revision is considered, what revisions may be appropriate to consider. The PA is intended to help “bridge the gap” between the agency’s scientific assessments presented in the ISA and REAs, and the judgments required of the EPA Administrator in determining whether it is appropriate to retain or revise the NAAQS. Formatted: Font: Italic Formatted: Font: Italic*** E.O. 12866 Review

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Page 36 of 66 8 re actions or deposition to surfaces. In sum, O 3 concentrations are influenced by complex interactions between precursor emissions, meteorological conditions, and surface characteristics. In order to continuously assess O 3 air pollution levels, state and loca l environmental agencies operate O 3 monitors at various locations and subsequently submit the data to the EPA. At present, there are approximately 1,400 monitors across the U.S. reporting hourly O 3 averages during the time time s of the year when local O 3 po llution can be important. Much of this monitoring is focused on O 3 measurements in urban areas where precursor emissions tend to be largest, as well as locations directly downwind of these areas, but there are also over 100 sites in rural areas where high levels of O 3 can periodically exist due to transport from upwind sources. Based on data from this national network, the EPA estimates that approximately 133 million Americans live in counties where O 3 concentrations were above the level of the existing health

based NAAQS of 0.075 ppm at least 4 days in 2012. High O 3 values can occur almost anywhere within the contiguous 48 states, although locations in California, Texas, and the Northeast Corridor are especially subject to poor O 3 air quality. From a tem poral perspective, the highest daily peak O 3 concentrations generally tend to occur during the afternoon within the warm er months due to higher solar radiation and other conducive meteorological conditions during these times. The exceptions to this general rule include : 1) some rural sites where transport of O 3 from upwind areas of regional production can occasionally result in high nighttime levels of O 3 , 2) high

- elevation sites periodically influenced by stratospheric intrusions, and 3) certain locations in the western U.S. where large quantities of O 3 precursors emissions associated with oil and gas development c an be trapped by strong inversions associated with snow cover during the colder months and efficiently converted to O 3 .*** E.O. 12866 Review

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Page 37 of 668 One of the challenging a spects of developing plans to reduce emissions leading to high
O 3 concentrations is that the response of O 3 to precursor reductions is nonlinear

. In particular,
NO X causes both the formation and destruction of O 3 . The net impact of NO X emissions on

ozone O 3 concentrations depend s on the local quantities of NO X , VOC, and sunlight which interact in a set of complex chemical reactions

. In some areas, such as urban centers where NO X emissions typically are high, NO X leads to the net destruction of ozone - O 3 , mak ing ozone O 3 levels lower in the immediate vicinity. This phenomenon is particularly pronounced under conditions that lead to low ozone O 3 concentrations (i.e. during cool, cloudy weather and at night when photochemical activity is limited or nonexistent)

. H owever, while NO X can initially destroy ozone O 3 near the emission sources, these same NO X emissions eventually do react to form more ozone O 3 downwind. Photochemical m odel simulations suggest that the additional expected reductions in NO X emissions will slightly increase O 3 concentrations on days with lower O 3 concentrations in areas in close proximity to NO X sources, while at the same time decreasing the highest O 3 concentrations in outlying areas. See generally, U.S.EPA, 2014a ( section 2 .2.1 )

. At present, both the primary and secondary NAAQS use the annual fourth

- highest daily maximum 8

- hour concentration, averaged over three 3 years, as the form of the standard. An additional air quality metric, referred to as W126, is often used to asses s cumulative impact of O 3 exposure on ecosystems and vegetation. W126 is a seasonal aggregate of weighted hourly O 3 values observed between 8 am and 8 pm. As O 3 precursor emissions have decreased across the U.S., O 3 design values 12 have concurrently shown a modest downward trend

. Ozone design

12 A design value is a statistic that de scribes the air quality status of a given location relative to the level of the NAAQS.*** E.O. 12866 Review

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Page 38 of 668 values decreased by approximately 9 percent % o n average between 2000 and 2012 . Air quality model simulations estimate that peak O 3 levels will continue to improve over the next decade as additi onal reductions in O 3 precursors from power plants, motor vehicles, and other sources are realized. In addition to being affected by changing emissions, future O 3 concentrations will also be affected by climate change. Modeling studies in EPA’s Interim A ssessment (U.S. EPA, 2009b) and cited in support of the 2009 Endangerment Finding (74 FR 66,496; Dec. 15, 2009) show that, while the impact is not uniform, climate change has the potential to cause increases in summertime O 3 concentrations over substantial regions of the country, with increases tending to occur during higher peak pollution episodes in the summer, if offsetting emissions reductions are not made. Increases in temperature are expected to be the principal factor in driving any ozone increases, although increases in stagnation frequency may also contribute (Jacob and Winner, 2009). Modeling studies in EPA’s Interim Assessment (U.S. EPA, 2009b) and cited in support of the 2009 Endangerment Finding (74 FR 66,496; Dec. 15, 2009) show that, while the impact is not uniform, simulated climate change causes increases in summertime O 3 concentrations over substantial regions of the country, with increases tending to occur during higher peak pollution episodes in the summer

. These increases in O 3 pollution over broad areas of the U.S., including in the largest metropolitan areas with the worst O 3 problems, increase the risk of morbidity and mortality. Children, older adults, and people with asthma or other lung diseases , older adults, and people who are acti ve outdoors, including outdoor workers, are among the most vulnerable to these O 3 - related health effects. If unchecked, climate change has the potential to offset some of the improvements in O 3 air quality, and therefore some of the improvements in public health, that are expected from reductions in emissions of O 3 precursors.*** E.O. 12866 Review

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Page 39 of 668 Another challenging aspect of the O 3 issue is the involvement of sources of O 3 and O 3 precursors beyond those from domestic, anthropogenic sources. Modeling analyses have suggested that nationally the majority of O 3 exceedances are predominantly caused by anthropogenic emissions from within the U.S. However, observational and modeling anal yses have concluded that O 3 concentrations in some locations in the U.S. can be substantially influenced by sources that may not be suited to domestic control measures. In particular, certain high

- elevation sites in the western U.S. are impacted by a combi nation of non

- local sources like international transport, stratospheric O 3 , and O 3 originating from wildfire emissions. Ambient O 3 from these non

- local sources is collectively referred to as background O 3 . See generally section 2.4 of the Policy Assessment ( U.S. EPA , 2014c). The analyses suggest that, at these locations, there can be episodic events with substantial background contributions where O 3 concentrations approach or exceed the level of the current NAAQS (i.e., 75 ppb)

. These events are relatively infrequent and the EPA has policies that allow for the exclusion of air quality monitoring data from design value calculations when they are substantially affected by certain background influences

. Wildfires pose a direct threat to air quality and public s afety

– threats that can be mitigated through management of wildland vegetation. The use of wildland prescribed fire can influence the occurrence of catastrophic wildfires which may help manage the contribution of wildfires to background O 3 levels and peri odic peak O 3 events. Prescribed fire mimics a natural process necessary to manage and maintain fire

- adapted ecosystems and climate change adaptation, while reducing risk of uncontrolled emissions from catastrophic wildfires. Wildfire emissions may make it more challenging to m eet the NAAQS. However, t he CAA requires the
EPA to set the NAAQS at level s requisite to protect public health and welfare without regard to the source of the pollutant. API , 665 F. 2d at 1185

- 86

. The EPA may co nsider proximity to Formatted: Font: Italic*** E.O. 12866 Review

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Page 40 of 668 bac kground levels as a fa ctor in the decis ion whether and how to revise the NAAQS when considering levels within the range of reasonable values supported by the air quality criteria and judgments of the Administrator. ATA III , 283 F. 3d at 279 3 79

. It is in the implementation proce ss that states and the EPA can address how to develop effective public policy in locations in which background sources contribute substantially to high ozone levels O 3 . Section VII.F provides more detail about how background ozone O 3 can be addressed via CAA implementation provisions.
II. Rationale for Proposed Decision on the Primary Standard This section presents the Administrator’s rationale for her proposed decision to revise the existing primary O 3 standard by lowering the level of the standard to within the range of 0.065 to 0.0 70 ppm. As discussed more fully below, this rationale draws from the thorough review in the
ISA of the available scientific evidence , published through July 2011, on human health effects associated with the presence of O 3 in the ambient air. This rationale also takes into account : (1) analyses of O 3 air quality, human exposure s to O 3 , and O 3 - associated health risks, as presented and assessed in the HREA; (2) the EPA staff assessment of the most policy

- rel evant scientific evidence and exposure/risk information in the PA ; (3) CASAC advice and recommendations, as reflected in discussions of drafts of the ISA, REA , and PA at public meetings, in separate written comments, and in CASAC’s le tters to the Administr ator; and (4) public input received during the development of these documents, either in connection with CASAC meetings or separately

. Section II.A below provides an overview of the approach es used to consider the scientific eviden ce and exposure/risk information as it relates to the primary O 3 standard

. This includes summaries of the approach adopted by the Administrator in the 2008 review of the O 3 NAAQS and of the approach adopted in the PA in the current review. Section II.B summarizes the body of evidence for health effects attributable to short

- or long

- term O 3 exposures, with a focus on Formatted: Font: Italic*** E.O. 12866 Review

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Page 41 of 668 effects for which the ISA judges that there is a “causal” or a “likely to be causal ” relationship with O 3 exposure s . S ection II.C summarizes the HREA ’s quantitative estimates of O 3 exposures and health risks, including key results and uncertainties

. Section s II.D and II.E present the Administrator’s proposed conclusions on the adequacy of the current primary O 3 standard and alternative primary standards, respectively.
A. Approach In the 2008 review of the O 3 NAAQS, Administrator Stephen L. Johnson revised the level of the 8

- hour primary O 3 standard from 0.08 ppm 13 to 0.075 ppm (75 parts per billion ( ppb ) 14 ). This decision was based on his consideration of the available scientific evidence and exposure/risk information, the advice and recommendations of CASAC, and comments from the public. The Administrator placed primary emphasis on the body of available scientific evidence, while viewing the results of exp osure and risk assessments as providing supporting information. Specifically, he judged that a standard set at 75 ppb would be appreciably below the concentration in controlled human exposure studies at which adverse effects had been demonstrated at in the controlled human exposure studies available at that time (i.e., 80 ppb) , and would provide a significant increase in protection compared to the then

- current standard. T he Administrator further concluded that the body of evidence did not support setting a lower standard level, given the increasing uncertainty in the evidence at lower O 3 concentrations (U.S. EPA, 2014c, Chapter 1).

13 Due to rounding convention, the 1997 standard level of 0.08 ppm corresponded to 0.084 ppm (84 ppb). 14 The level of the O 3 standard is specified as 0.075 ppm rather than 75 ppb. However, in the PA we refer to ppb, which is most often used in the scientific literature and in the ISA, in order to avoid the confusion that could result from switching units when discussing the evi dence in relation to the standard level. Similarly, in the preamble to this notice we refer to ppb.*** E.O. 12866 Review

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Page 42 of 668 I n the current review, the EPA’s approach to informing decisions on the primary O 3 standard builds upon th e general approach us ed in the last review and reflects the broader body of scientific evidence, updated exposure/risk information, and advances in O 3 air quality modeling now available. This approach, described in detail in the PA (U.S. EPA, 2014c, section 1.3.1), is based mo st fundamentally on using the EPA’s assessment of the available scientific evidence and associated quantitative analyses to inform the Administrator’s judgments regarding a primary standard for O 3 that is “requisite” (i.e., neither more nor less stringent than necessary) to protect public health wit h an adequate margin of safety. Specifically, it is based on consideration of the available body of scientific evidence assessed in the ISA (U.S. EPA,
2013 2013 a ) , exposure and risk analyses presented in the HREA (U.S. EPA, 2014a) , advice and recommendations from CASAC (Frey, 2014 a, c ), and public comments. Based on the application of this approach, t he PA assesses and integrates the evidence and information, and re aches conclusions for the Administrator’s consideration about the range of policy options that could be supported

. The remainder of this section describes the PA’s approach to reviewing the primary
O 3 standard, and to informing the Administrator’s proposed decisions on the current and alternative standards

. As an initial matter, t he PA recognizes that the final decision to retain or revise the current primary O 3 standard is a public health policy judgment to be made by the Administrator and will draw upon the available scientific evidence for O 3 - attributable health effects and on analyses of population exposures and health risks, including judgments about the appropriate weight to assign the range of uncertainties inherent in the evidence and analyses. The PA’s general approach t o informing these public health policy judgments recognizes that the available health effects evidence reflects a continuum from relatively higher O 3 concentrations, at which*** E.O. 12866 Review

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Page 43 of 668 scientists generally agree that health effects are likely to occur, through lower concentrations, at which the likelihood and magnitude of a response become increasingly uncertain. Therefore, the conclusions in the PA reflect an interpretation of the available scientific evidence and exposure/risk information tha t , in the views of the EPA staff, neither overstates nor understates the strengths and limitations of that evidence and information. 15 This approach is consistent with the requirements of sections 108 and 109 of the CAA , as well as with how the EPA and the courts have historically interpreted the CAA

. The PA draws upon an integrative synthesis of the entire body of available scientific evidence for O 3 - related health effects, including the evidence newly available in the current review and the evidence from previous reviews, as presented in the ISA (U.S. EPA, 2013 2013 a ). C onsider ation of the scientific evidence is based fundamentally on information from controlled human exposure and epidemiologic studies, supplemented by information from animal toxicology studies. Such In the PA, s uch evidence informs the PA’s consideration of the health

15 Draft versions of the PA were subject to review by CASAC and the final PA reflects consideration of the advice received from CASAC during the review proc ess. CASAC concluded that “Overall, we find the Second Draft PA to be adequate for its intended purpose of providing a strong scientific basis for findings regarding the inadequacy of current primary and secondary ozone air quality standards” (Frey, 2014c, p. v).*** E.O. 12866 Review

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Page 44 of 668 e ndpoints and at

- risk populations 16 on which to focus the current review, and the PA’s consideration of the O 3 concentrations at which various health effects can occur. Since the 2008 review of the O 3 NAAQS, the EPA has developed formal frameworks for char acterizing the strength of the scientific evidence with regard to health effects associated with exposures to O 3 in ambient air and factors that may increase risk in some populations or lifestages. These frameworks provide the basis for robust, consistent, and transparent processes for evaluating the scientific evidence, including uncertainties in the evidence, and for drawing weight

- of

- evidence conclusions on air pollution

- related health effects and at

- risk populations. These frameworks for characterizing the strength of the scientific evidence are discussed in detail in the ISA (U.S. EPA, 2013 2013 a , Preamble; Chapter 8)

. With regard to characterization of health effects, the ISA uses a five

- level hierarchy to classify the overall weight of evidence into one of the following categories: causal relationship, likely to be a causal relationship, suggestive of a causal relationship, inadequate to infer a causal relationship, and not likely to be a causal relationship (U.S. EPA, 2013 2013 a , Preambl e Table II). In using the weight

- of

- evidence approach to inform judgments about the degree of confidence that various health effects are likely to be caused by exposure to O 3 , confidence

16 I n this review , the term “at

- risk population” is used to encompass populations or lifestages that have a greater likelihood of experiencing health effects related to exposure to an air pollutant due to a variety of factors; other terms used in t he literature include susceptible, vulnerable, and sensitive. These factors may be intrinsic, such as genetic factors, lifestage, or the presence of preexisting diseases, or they may be extrinsic, such as socioeconomic status (SES), activity pattern and ex ercise level, or increased pollutant exposures (U.S. EPA 2013, p. lxx, 8

- 1, 8

- 2). The courts and the CAA ’s legislative history refer to these at

- risk subpopulations as “susceptible” or “sensitive” populations. See, e.g., American Lung Ass’n v. EPA , 134 F. 3d 388, 389 (D.C. Cir. 1998) (“NAAQS must protect not only average health individuals, but also ‘sensitive citizens’

– children, for example, or people with asthma, emphysema, or other conditions rendering them particularly vulnerable to air pollution” (qu oting S. Rep. No. 91

- 1196 at 10). Formatted: Font: Italic, No underline*** E.O. 12866 Review

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Page 45 of 668 increases as the number of studies consistently reporting a particula r health endpoint grows and as other factors, such as biological plausibility and the strength, consistency , and coherence of evidence , increase. Conclusions about biological plausibility and about the consistency and coherence of O 3 - related health effects are drawn from the integration of epidemiologic studies with mechanistic information from controlled human exposure and animal toxicological studies, as discussed in the ISA (U.S. EPA, 2013 2013 a , EPA Framework for Causal Determination, p. 1viii). The PA p lace s the greatest weight on the health effects for which the evidence has been judged in the ISA to support a “causal” or a “likely to be causal ” relationship with O 3 exposures. The PA further consider s the evidence base assessed in the ISA with regard to the types and levels of exposure at which health effects are indicated. This consideration of the evidence , which directly informs conclusions regarding the adequacy of current or alternative standards , differs from consideration of the evidence in the ISA with regard to overarching determinations of causality. Therefore, studies that inform determinations of causality may or may not be concluded to be informative with regard to the adequacy of the curre nt or alternative standards

. 17
As with health endpoints, the ISA’s characterization of the weight of evidence for potential at

- risk populations is based on the evaluation and synthesis of evidence from across scientific di sciplines. The The ISA uses the co llective evidence to examine the coherence of effects across disciplines and to determine the biological plausibility of reported effects. Based on this approach, t he ISA characterizes the evidence for a number of “factors” that have the potential to place populations at increased risk for O 3 - related effects. The categories considered

17 For example, the PA judge s that health studies evaluating exposure concentrations near or below the level of the current standard and epidemiologic studies conducted in locations meeting the current standard are particularly informative when considering the adequacy of the public h ealth protection provided by the current standard (U.S. EPA, 2014c, Chapters 3 and 4)

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Page 46 of 668 in evaluating the evidence for these potential at

- risk factors are “adequate evidence,” “suggestive evidence,” “inadequate evidence, ” and “evidence of no effect.” These categ ories are discussed in more detail in the ISA For the “adequate evidence” category, the ISA concludes that this category is appropriate when multiple high

- quality studies show “t here is substantial, consistent evidence within a discipline to conclude that a factor results in a population or lifestage being at increased risk of air pollutant

- related health effect(s) relative to some reference population or lifestage ” (U.S. EPA, 2013, chapter 2013a, p. 8 , Table 8

- 1).

- 2). In addition, w here applicable , the “adequate evidence” category reflects a conclusion that there is coherence in the evidence across disciplines. The other categories reflect greater uncertainty in the evidence. In this review, the PA focuses on those factors for which the ISA judges there is “ adequate ” evidence of increased risk (U.S. EPA, 2013 2013a , Table 8

- 5). At

- risk populations are discussed in more detail in section 3.1.5 of the PA ( U.S. EPA, 2014 c ). ) and t hese categories are discussed in more detail in the ISA (U.S. EPA, 2013 a , chapter 8, Table 8

- 1). Using the available scientific evidence to inform conclusions on the current and alternative standards is complicated by the recognition that a population

- level th reshold has not been identified below which it can be concluded with confidence that O 3 - attributable effects do not occur (U.S. EPA, 2013 2013 a , section 2.5.4.4). In the absence of a discernible threshold, the PA’s general approach to considering the available O 3 health evidence involves characterizing confidence in the ext ent to which O 3 - attributable effects occur, and the extent to which such effects are adverse, over the ranges of O 3 exposure concentrations evaluated in controlled human exposure studies and over the distributions of ambient O 3 concentrations in locations where epidemiologic studies have been conducted. As noted above, the PA recognizes that the available health effects evidence reflects a continuum from relatively high O 3 concentrations, at which*** E.O. 12866 Review

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Page 47 of 668 scientists generally agree that adverse health effects are l ikely to occur, through lower concentrations, at which the likelihood and magnitude of a response become increasingly uncertain. Aspects of the approach used in this review to evaluate evidence from controlled human exposure and epidemiologic studies, resp ectively, are discussed below. Controlled human exposure studies provide direct evidence of relationships between pollutant exposures and human health effects (U.S. EPA, 2013 2013 a , p.lx). Controlled human exposure studies provide data with the highest le vel of confidence since they provide human effects data under closely monitored conditions and can provide exposure response relationships. Such studies are particularly useful in defining the specific conditions under which pollutant exposures can result in health impacts, including the exposure concentrations, durations, and ventilation rates under which effects can occur. As discussed in the ISA, controlled human exposure studies provide clear and compelling evidence for an array of human health effects that are directly attributable to acute exposures to O 3 per se (i.e., as opposed to O 3 and other photochemical oxidants, for which O 3 is an indicator, or other co

- occurring pollutants) (U.S. EPA, 2013 2013 a , Chapter 6). Together with animal toxicological st udies, which can provide information about more serious health outcomes as well as the effects of long

- term exposures and mode of action, controlled human exposure studies also help to provide biological plausibility for health effects observed in epidemio logic studies. The PA consider s the evidence from controlled human exposure studies in two ways. First, the PA consider s the extent to which controlled human exposure studies provide evidence for health effects following exposures to different O 3 concentrations, down to the lowest

observed

- effects levels in those studies. Second, the PA use s these studies to help e valuat e the extent to which there is confidence in health effect associations reported in epidemiologic studies*** E.O. 12866 Review

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Page 48 of 668 down through lower ambi ent O 3 concentrations, where the likelihood and magnitude of O 3 - attributable effects become increasingly uncertain. The PA consider s the range of O 3 exposure concentrations evaluated in controlled human exposure studies, including concentrations near or below the level of the current standard. The
PA consider s both group mean responses, which provide insight into the extent to which observed changes are due to O 3 exposures rather than to chance alone, and interindividual variability in responses, which pr ovides insight into the fraction of the population that might be affected by such O 3 exposures ( U.S. EPA, 2013 2013 a , section 6.2.1.1 ). When considering the relative weight to place on various controlled human exposure studies, the discussion in the PA focu ses on the exposure conditions evaluated (e.g., exercising versus resting, exposure duration); the nature, magnitude, and likely adversity of effects over the range of reported O 3 exposure concentrations; the statistical precision of reported effects; and the consistency of results across studies for a given health endpoint and exposure concentration. In addition, because controlled human exposure studies typically involve healthy individuals and do not evaluate the most sensitive individuals in the populat ion (U.S. EPA, 2013 2013 a , Preamble p. lx), when considering the implications of these studies for evaluation of the current and alternative standards , the PA also consider s the extent to which reported effects are likely to reflect the magnitude and/or severity of effects in at

- risk groups. The PA also consider s epidemiologic studies of short

- and long

- term O 3 concentrations in ambient air. Epidemiologic studies provide in formation on associations between variability in ambient O 3 concentrations and variability in various health outcomes, including lung function decrements, respiratory symptoms, school absences, hospital admissions, emergency department visits, and prematur e mortality (U.S. EPA, 2013 2013 a , Chapters 6 and 7). Epidemiologic studies*** E.O. 12866 Review

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Page 49 of 668 can inform understanding of the effects in the study population (which may include at

- risk groups) of real

- world exposures to the range of O 3 concentrations in ambient air, as well as provide evidence of associations between ambient O 3 levels and more serious acute and chronic health effects that cannot be assessed in controlled human exposure studies. For these studies, the degree of uncertainty introduced by confounding variables ( e.g., other pollutants, temperature) and other factors (e.g., effects modifiers such as averting behavior) affects the level of confidence that the health effects being investigated are attributable to O 3 exposures, alone and in combination with copollutan ts. Available epidemiologic studies have generally not indicated a d iscernible population threshold below which O 3 is no longer associated with health effects (U.S. EPA, 2013 2013 a , section 2.5.4.4). However, the currently available epidemiologic evidence indicates decreased confidence in reported concentration

- response relationships for O 3 concentrations at the lower ends of ambient distributions due to the low density of data in this range (U.S. EPA, 2013 2013 a , section 2.5.4.4). As discussed more fully in Chapter 1 of the PA (U.S. EPA, 2014c), the general approach to considering the results of epidemiologic studies within the context of the current and alternative standards focuses on characterizing the range of ambient O 3 concent rations over which studies indicate the most confidence in O 3 - associated health effects, and the concentrations below which confidence in such health effect associations becomes appreciably lower. In placing emphasis on specific epidemiologic studies, as in past reviews, the discussion in the PA focuses on the epidemiologic studies conducted in the U.S. and Canada. Such studies reflect air quality and exposure patterns that are likely more typical of the U.S. population , since studies conducted outside th e U.S. and Canada may well reflect different demographic and air*** E.O. 12866 Review

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Page 50 of 668 pollution characteristics

. 18 The PA also focuses on studies reporting associations with effects judged in the ISA (U.S. EPA, 2013 2013 a ) to be robust to confounding by other factors, including

co - occurring air pollutants. To put judgments staff conclusions about O 3 - related health effects into a broader public health context, the PA also consider s exposure and risk estimates from the HREA, which develops and applies models to estimate human expo sures to O 3 and O 3 - related health risks in urban study areas across the United States (U.S. EPA, 2014a). The HREA estimates exposures of concern, based on interpreting quantitative exposure estimates within the context of controlled human exposure study re sults; lung function risks, based on applying exposure

- response relationships from controlled human exposure studies to quantitative estimates of exposures; and epidemiologic

- based risk estimates, based on applying concentration

- response relationships draw n from epidemiologic studies to adjusted air quality. Each of these types of assessments is discussed briefly below. As in the 2008 review, the HREA estimates exposures at or above benchmark concentrations of 60, 70, and 80 ppb, reflecting exposure conce ntrations of concern based on the available health evidence. 19 Estimates of exposures of concern, defined as personal exposures while at moderate or greater exertion to 8

- hour average ambient O 3 levels, at or above these discrete benchmark concentrations provide perspective on the public health risks of O 3 - related health effects that have been demonstrated in controlled human exposure and toxicological studies . However, because of a lack of exposure

- response information across a range of exposure

18 Though the PA recognizes that a broader body of studies, including international studies, inform inform s the causal determinations in the ISA. 19 For example, see 75 F R 2945

- 2946 (January 19, 2010) and 73 FR 16441

- 16442 (March 27, 2008) discussing “exposures of concern

. ”*** E.O. 12866 Review

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Page 51 of 668 concentr ations in these studies, these risks cannot be assessed using a quantitative risk assessment. Though this analysis is conducted using discrete benchmark concentrations, information from the broad body of evidence indicates that health

- relevant exposures ar e more appropriately viewed as a continuum with greater confidence and certainty about the existence of health effects at higher O 3 exposure concentrations and less confidence and certainty at lower exposure concentrations. This approach recognizes that th ere is no sharp breakpoint within the
exposure - response relationship for exposure concentrations at and above 80 ppb down to 60 ppb. Within the context of this continuum, estimates of exposures of concern at these discrete benchmark concentrations provide some perspective on the public health impacts of O 3 - related health effects, such as pulmonary inflammation, that are plausibly linked to the more serious effects seen in epidemiologic studies but cannot be evaluated in quantitative risk assessments. They also help elucidate the extent to which such impacts may be reduced by meeting the current and alternative standards. Estimates of the number of people likely to experience exposures of concern cannot be directly translated into quantitative estimates of t he number of people likely to experience specific health effects due to individual variability in responsiveness. Only a subset of individuals can be expected to experience such adverse health effects, and at

- risk populations or lifestages, such as people with asthma or children, are expected to be affected more by such exposures than healthy adults. The HREA also generates quantitative estimates of O 3 health risks for air quality adjusted to just meet the current 20 and alternative standards

. O ne approach t o estimating O 3 health risks is to combine modeled exposure estimates with exposure

- response relationships derived from

20 For purposes of the exposure and risk estimates with adjusted air quality, the REA considered any value < 76 ppb to be “just meeting” the current 75 ppb standard (U.S. EPA, 2014a).*** E.O. 12866 Review

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Page 52 of 668 controlled human exposure studies of O 3 - induced health effects. The HREA uses this approach to estimate the occurrence of O 3 - induced lun g function decrements in at

- risk populations, including school

- age children, school

- age children with asthma, adults with asthma, and older adults. The available exposure

- response information does not support this approach for other endpoints evaluated in controlled human exposure studies (U.S. EPA, 2014a, section 2.3). The other approach used in this review to estimat e O 3 - associated health risks is to apply concentration

- response relationships derived from short

- and/or long

- term epidemiologic studies to air quality adjusted to just meet current and alternative standards . The concentration

- response relationships drawn from epidemiologic studies are based on population exposure surrogates, such as 8

- hour concentrations averaged across monitors and over more than one day (U.S. EPA,
2013 2013 a , Chapter 6). The HREA presents epidemiologic

- based risk estimates for O 3 - associated mortality, hospital admissions, emergency department visits, and respiratory symptoms (U.S. EPA, 2014a, section 2.3). These estimates are derived from the full distributions of ambient O 3 concentrations estimated for the study locations. 21 In addition, the HREA estimates mortality risks associated with various portions of distributions of short

- term O 3 concentrations (U.S. EPA, 2014a). The PA considers risk estimates based on the full distributions of ambient O 3 concentrations and, when available, estimates of the risk associated

21 In previous reviews, including the 2008 review and reconsideration, such risks were separately estimated for O 3 concentrations characterized as above policy

- relevant background concentrations. Policy

- relevant background co ncentrations were defined as the distribution of ozone O 3 concentrations attributable to sources other than anthropogenic emissions of ozone O 3 precursor emissions (e.g., VOC, CO, NO X ) in the U.S., Canada, and Mexico. The decision in this review to estimate total risk across the full range of O 3 concentrations reflects consideration of advice from CASAC (Frey and Samet, 2012b).*** E.O. 12866 Review

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Page 53 of 668 with various portions of those ambient distributions. 22 In doing so, the PA takes note of the ISA conclusions regarding confidence in linear concentration

- response relationships over distributions of ambient concentrations (see above) , and of the extent to which health effect associations at various ambient O 3 concentrations are supported by the evidence from experimental studies for effects following specific O 3 exposures . B. Health Effects Information This section outlines key info rmation contained in the ISA (U.S. EPA, 2013 2013 a , Chapters 4 to 8) and in the PA (U.S. EPA, 2014c, Chapters 3 and 4) on the known or potential effects on public health which may be expected from the presence of O 3 in the ambient air. The information highlighted here summarizes: (1) New n ew information available on potential mechanisms for health effects associated with exposure to O 3 (II.B.1); (2) the nature of effects that have been associated directly with both sh ort

- and long

- term exposure to O 3 and indirectly with the presence of O 3 in ambient air (II.B.2) ; (3) considerations related to the adversity of O 3 - attributable health effects (II.B.3) ; and (4) considerations in characterizing the public health impact of O 3 , including the identification of “at risk” populations (II.B.4)

. The decision in the 2008 rulemaking emphasize d the large number of epidemiologic studies published since the 1997 review that continued to report associations with respiratory hospital admi ssions and emergency department visits, as well as additional health endpoints, including the effects of acute (short

- term and prolonged) and chronic exposures to O 3 on lung function decrements and enhanced respiratory symptoms in asthmatic individuals, sc hool

22 In a series of sensitivity analyses, the HREA also evaluates a series of threshold models for respiratory mortality as sociated with long

- term O 3 concentrations. The PA considers these risk estimates based on threshold models, in addition to HREA core estimates based on the linear model ( U.S. EPA, 2014a, sections 3.2.3.2, 4.4.2.3). Formatted: Font: Italic*** E.O. 12866 Review

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Page 54 of 668 absences , and premature mortality

. It also emphasized controlled human exposure studies showing respiratory effects with prolonged O 3 exposures at levels below 80 ppb, changes in lung host defenses, and increased airway responsiveness, and animal toxicology studies that provided information about mechanisms of action

. The ISA (U.S. EPA, 2013 2013 a ) prepared for this review emphasizes a large number of new epidemiologic studies published since the last review on effects associated with both short

and long

- term exposures, including new epidemiologic studies about risk factors. I t also emphasize s important new information from controlled human exposure, dosimetry and toxicology studies

. Highlights of the new evidence included: (1) Two new controlled human exposure studies new since the 2008 review are now available that examine respiratory effects associated with prolonged, 6.6

- hour, O 3 exposures to levels of 72 ppb 23 and 60 ppb. These studies observed effects in healthy adults, including lung function decrements combined with respiratory symptoms at 72 ppb, and lung function decrements and pulmonary inflammation at 60 ppb. These studies

e xpand on evidence of lung function decrements with O 3 exposure at 60 ppb available in the last review, and provide new evidence of airway inflammation, a mechanism by which O 3 may cause other more serious respiratory effects (e.g., asthma exacerbations)

. (2) Recent multicity and single city epidemiologic studies continue to report associations between short

- term O 3 exposures and respiratory hospital admissions and respiratory emergency department visits. R ecent multicity studies and a multi

- continent stud y have reported consistent positive associations between short

- term O 3 exposure and total

23 As noted below, for the 70 ppb exposur e concentration , Schelegle et al. (2009) reported that the actual mean exposure concentration was 72 ppb.*** E.O. 12866 Review

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Page 55 of 668 (nonaccidental) mortality, expanding upon evidence available in the last review. They also observed associations between O 3 exposure and cardiovascular and respirator y mortality. 24 (3) Recent controlled human exposure studies reporting systemic inflammation and cardiac changes provide support for the expanded body of epidemiologic evidence for cardiovascular mortality, although l ack of coherence with epidemiologic studi es of cardiovascular morbidity remains an important uncertainty

. (4) New epidemiologic studies provide e xpanded evidence for respiratory effects associated with long

- term or repeated O 3 concentrations (e.g., seasonal average of 1

- or 8

- hour daily max conce ntrations). Recent studies demonstrate report interactions between exercise or different genetic variants and both new

- onset asthma in children and increased respiratory symptom effects in individuals with asthma ; a dditional studies of respiratory morbidity and mortality support the association between long

- term exposure to O 3 and a range of respiratory health effects

. (5) New evidence of risk factors (i.e., people with certain genetic variants related to antioxidant status or inflammation, and people with reduced intake of antioxidant nutrients) strengthens our understanding of the potential modes of action from O 3 - induced effects

. 1. Overview of Mechanisms The purpose of this section is to describe the ISA’s characterization of the key events and pathway s that contribute to health effects resulting from both short

- term and long

- term exposures

24 The consideration of ambient O 3 concentrations in the locations of these epidemiologic studies are discussed in sections II.D.1.b and II.E.4.a below, for the current standard and alternative standards, respectively.*** E.O. 12866 Review

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Page 56 of 668 to O 3 . The information in this section draws from section 5.3 of the ISA (U.S. EPA, 2013 2013 a ). Mode of action refers to a sequence of key events and processes that result in a given toxic effect. Elucidation of mechanisms provides a more detailed understanding of these key events and processes. E xperimental e vidence elucidating modes of action and/or mechanisms contribute s to our understanding of the biological plaus ibility of adverse O 3 - related health effects, including respiratory effects and effects outside the respiratory system (U.S. EPA,
2013 2013 a , Chapters 6 and 7). Figure 3.1 in the PA (U.S. EPA, 2014c) shows the current understanding of key events in the toxicity pathway of O 3 that , based on the available evidence. These key events are described briefly here and in more detail in section 3.1.1 of the PA. The initial key event is the formation of secondary oxidation products in the respiratory tract (U.S. E PA, 2013 2013 a , section 5.3). This mainly involves direct reactions with components of the extracellular lining fluid ( ELF ). Although the ELF has inherent capacity to quench (based on individual antioxidant capacity), this capacity can be overwhelmed , espec ially with exposure to elevated concentrations of O 3 . The resulting secondary oxidation products transmit signals to the epithelium, pain receptive nerve fibers and, if present, immune cells (i.e., eosinophils, dendritic cells and mast cells) involved in a llergic responses

. Thus, Thus, the available evidence indicates that the effects of O 3 are mediated by components of ELF and by the mul tiple cell types found in the respiratory tract

. Further, oxidative stress is an implicit part of this initial key event. It is well understood that secondary oxidation products initiate numerous responses at the cellular, tissue, and whole organ level of the respiratory system. These responses include the activation of neural reflexes leading to lung function decrements, airway obstruc tion, and extrapulmonary effects such as slow resting heart rate; initiation of inflammation; alteration of*** E.O. 12866 Review

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Page 57 of 668 barrier epithelial function; sensitization of bronchial smooth muscle; modification of lung host defenses; and airways remodeling (U.S. EPA, 2013 201 3 a , section 5.3.10, Figure 5

- 8). Each of these effects is discussed in more detail in section 3.1.1 of the PA (U.S. EPA, 2014c). Persistent inflammation and injury, which are observed in animal models of chronic and intermittent exposure to O 3 , are assoc iated with airways remodeling ( see Section 7.2.3 of the ISA, U.S. EPA 2013 ). Chronic intermittent exposure to O 3 has also been shown to result in effects on the developing lung and immune system. Systemic inflammation and vascular oxidative/nitrosative str ess are also key events in the toxicity pathway of O 3 . Extrapulmonary effects of O 3 occur in numerous organ systems, including the cardiovascular, central nervous, reproductive, and hepatic systems ( see Sections U.S. EPA, 2013 a, s ections 6.3 to 6.5 and
Sect ions s ections 7.3 to 7.5 of the ISA, U.S. EPA, 2013 ). Responses to O 3 exposure are variable within the population. S tudies have shown a large range of pulmonary function (i.e., spirometric) responses to O 3 among healthy young adults , while responses within an individual are relatively consistent over time. Other responses to O 3 have also been characterized by a large degree of interindividual variability. For example, a 3

- to 20

- fold difference among subjects in their studies in airways inflammation ( i.e., neutrophilia influx) following O 3 exposure has been reported (Schelegle et al., 1991 and Devlin et al., 1991, respectively)

. R eproducibility of an individual’s inflammatory response to O 3 exposure in humans , measured as sputum neutrophilia, was demon strated by Holz et al (1999) . Since individual inflammatory responses were relatively consistent across time, it was thought that inflammatory responsiveness reflected an intrinsic characteristic of the subject (Mudway and Kelly, 2000) . While the basis for the observed interindividual variability in responsiveness to O 3 is not clear, section 5.4.2 of the ISA discusses mechanisms that may underlie the variability in*** E.O. 12866 Review

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Page 58 of 668 responses seen among individuals. Certain functional genetic polymorphisms, pre

- existing cond itions or diseases, nutritional status, lifestages, and co

- exposures contribute to altered risk of
O 3 - induced effects. Experimental evidence for such O 3 - induced changes contributes to our understanding of the biological plausibility of adverse O 3 - related h ealth effects, including a range of respiratory effects as well as effects outside the respiratory system (e.g., cardiovascular effects ) (U.S. EPA, 2013 2013 a , Chapters 6 and 7).
2. Nature of Effects The health effects of O 3 are described in detail and assessed in the ISA (U.S. EPA,
2013 2013 a ). Based on this assessment, the ISA determine d that a “ causal ” relationship exists between short

- term exposure to O 3 in ambient air 25 and effects on the respiratory system and that

a “likely to be causal” relatio nship 26 exists between long

- term exposure to O 3 in ambient air and respiratory effects (U.S. EPA 2013 2013 a , pp. 1

- 6 to 1

- 7 ). As stated in the ISA, “[c]ollectively, a very large amount of evidence spanning several decades supports a relationsh i p between
expo sure to O 3 and a broad range of respiratory effects” ( ISA US. EPA, 2013a , p. 1

- 6). The ISA summarizes the longstanding body of evidence for O 3 respiratory effects as follows (U.S. EPA,
2013 2013 a , p. 1

- 5 ). ): The clearest evidence for health effects associated with exposure to O 3 is provided by studies of respiratory effects. Collectively, a very large amount of evidence spanning several decades supports a relationship between exposure to O 3 and a broad range of respiratory effects (see Section 6.2.9 and Section 7.2.8). The majority of this evidence is derived from studies investigating short

- term exposures (i.e., hours to weeks) to O 3 , although animal toxicological studies and

25 In determining that a causal relationship exists for O 3 with specifi c health effects, the EPA has concluded that “[e]vidence is sufficient to conclude that there is a causal relationship with relevant pollutant exposures” ( ISA U.S. EPA, 2013a , p. lxiv). 26 In determining a “ likely to be a causal ” relationship exists for O 3 with specific health effects, the EPA has concluded that “[e]vidence is sufficient to conclude that a causal relationship is likely to exist with relevant pollutant exposures, but important uncertainties remain” ( ISA U.S. EPA, 2013a , p. lxiv). Formatted: Space After: 0 pt*** E.O. 12866 Review

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Page 59 of 668 recent epidemiologic evidence demonstrate that long

- term exposure (i.e., mo nths to years) may also harm the respiratory system

. Additionally, the ISA determine d that the relationships between short

- term exposures to O 3 in ambient air and both total mortali t y and cardiovascular effects are likely to be causal , based on expanded evidence bases in the current review (U.S. EPA, 2013 2013 a , pp. 1

- 7 to 1

- 8). In the ISA, the EPA additionally determined that the currently available evidence for additional endpoints is “suggestive” of causal relationships between short

- term (central nerv ous system effects) and long

- term exposure (cardiovascular effects, reproductive and developmental effects, central nervous system effects and total mortality) to ambient O 3

. Consistent with emphasis in past reviews on O 3 health effects for which the evidence is strongest, in this review the EPA places the greatest emphasis on studies of health effects that have been judged in the ISA to be caused by, or likely to be caused by, O 3 exposures (U.S. EPA, 2013 2013 a , section 2. 5.2). This section discusses the evidence for health effects attributable to
O 3 exposures, with a focus on respiratory morbidity and mortality effects attributable to short

and long

- term exposures, and cardiovascular system effects (including mortality) a nd total mortality attributable to short

- term exposures. This section focuses particularly on considering the extent to which the scientific evidence available in the current review has been strengthened since the last review, and the extent to which impor tant uncertainties and limitations in the evidence from the last review have been addressed. a. Respiratory effects

– short

- term The 2006 O 3 AQCD concluded that there was clear, consistent evidence of a causal relationship between short

- term O 3 exposure and respiratory effects ( U.S. EPA, 2006a ) . This

co nclusion was substantiated by evidence from controlled h uman exposure and toxicological studies indicating a range of respiratory effects in response to short

- term O 3 exposure s , including*** E.O. 12866 Review

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Page 60 of 668 pulmonary function decrements and increases in respiratory symptoms, lung inflammation, lung permeability, and airway hyperresponsiveness. Toxicological studies provided additional evidence for O 3 - induced impairment of host defenses. Combined, these findings from experimental studies provided support for epidemiologic evid ence, in which short

- term increases in ambient O 3 concentration were consistently associated with decreases in lung function in populations with increased outdoor exposures, especially children with asthma and healthy children; increases in respiratory sym ptoms and asthma medication use in children with asthma; and increases in respiratory

- related hospital admissions and asthma

- related ED emergency department visits (U.S. EPA, 2013 2013 a , pp. 6

- 1 to 6

- 2)

. As discussed in detail in the ISA (U.S. EPA, 2013 2013 a , section 6.2.9), studies evaluated since the completion of the 2006 O 3 AQCD support and expand upon the strong body of evidence that , in the last review, indicated a causal relationship between short

- term O 3 exposure s

a nd respiratory health effects. Rece nt c ontrolled human exposure studies conducted in young, healthy adults with moderate exertion have reported FEV 1 forced expiratory volume in 1 second ( FEV 1 ) decrements and pulmonary inflammation following prolonged exposures to O 3 concentrations as low as 60 ppb , and respiratory symptoms following exposures to concentrations as low as 72 ppb

. (based on group mean responses)

. 27 Epidemiologic studies provide evidence that increases in ambient O 3 exposure s can result in are associated with lung function decremen ts, increases in respiratory symptoms, and pulmonary inflammation in children with asthma; increases in respiratory

- related hospital admissions and emergency department

27 Schelegle et al. (2009) reported a statistically significant increase in respiratory symptoms in healthy adults at a target O 3 exposure concentration of 70 ppb , averaged over the study period. For this 70 ppb target exposure concentration , Schelegle et al. (2009) reported that the actual mean exposure concentration was 72 ppb.*** E.O. 12866 Review

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Page 61 of 668 visits; and increases in respiratory mortality. Some of these studies report such assoc iations even for O 3 concentrations at the low end of the distribution of daily concentrations. R ecent epidemiologic studies report that associations with respiratory morbidity and mortality are stronger during the warm/sum mer months and remain robust after adjustment for copollutants. Recent toxicological studies reporting O 3 - induced inflammation, airway hyperresponsiveness, and impaired lung host defense continue to support the biological plausibility and modes of action for the O 3 - induced respiratory effe cts observed in the controlled human exposure and epidemiologic studies. Further support is provided by recent studies that found O 3 - associated increases in indicators of airway inflammation and oxidative stress in children with asthma (U.S. EPA, 2013 2013 a , section 6.2.9)

. Together, epidemiologic and experimental studies support a continuum of respiratory effects associated with O 3 exposure that c an result in respiratory

- related emergency department visits, hospital admissions, and/or mortality (U.S. EPA, 2 013 2013 a , section 6.2.9). Across respiratory endpoints, evidence indicates antioxidant capacity may modify the risk of respiratory morbidity associated with O 3 exposure (U.S. EPA, 2013 2013 a , section 6.2.9, p. 6

- 161 ) (section 3.1.1, above ) . The potentiall y elevated risk of populations with diminished antioxidant capacity and the reduced risk of populations with sufficient antioxidant capacity is supported by epidemiologic studies and from controlled human exposure studies . Additional evidence characterizes O 3 - induced decreases in antioxidant levels as a key event in the mode of action for downstream effects

. Key aspects of this evidence are discussed below with regard to lung function decrements; pulmonary inflammation, injury, and oxidative stress; airway hyperresponsiveness;*** E.O. 12866 Review

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Page 62 of 668 respiratory symptoms and medication use ; lung host defense; allergic and asthma

- related
responses; hospital admissions and emergency department visits; and respiratory mortal ity

. 28 i. Lung function decrements
In the 2008 review, a large number of controlled human exposure studies 29 reported O 3 - induced lung function decrements in young, healthy adults engaged in intermittent, moderate exertion following 6.6 hour exposures to O 3 concentrations at or above 80 ppb. Although two studies also reported effects following exposures to lower concentrations, an important uncertainty in the last review was the extent to which exposures to O 3 concentrations below 80 ppb result in lung funct ion decrements. In addition, in the last review epidemiologic panel studies had reported O 3 - associated lung function decrements in a variety of different populations (e.g., children, outdoor workers) likely to experience increased exposures. In the current review, additional controlled human exposure studies are available that have evaluated exposures to O 3 concentrations of 60 or 72 ppb . The available evidence from controlled human exposure and panel studies is assessed in detail in the ISA (U.S. EPA, sect ion 6.2.1) and is summarized below. Controlled exposures to O 3 concentrations that can be found in the ambient air can result in a number of lung function effects, including decreased inspiratory capacity , mild bronchoconstriction , and rapid, shallow bre athing patterns during exercise. Reflex inhibition of

28 CASAC concurred that these were “the kinds of identifiable effects on public health that are expected from the presence of ozone in the ambient air” ( Frey 2014c , p. 3 )

. 29 The controlled human exposure studies emphasized in the PA utilize only healthy adult subjects. In the near absence of controlled human exposure data for children, HREA estimates of lung function decrements are based on the assumption that children exhibit the same lung function responses following O 3 exposures as healthy 18 year olds (U.S. EPA, 2014 2014 a , section 6.2.4 and 6.5). This assumption is justified in part by the findings of McDonnell et al. (1985), who reported that children ( 8

- 11 year year s old ) experienced FEV 1 responses similar to those observed in adults ( 18

- 35 years old

. )

. Thus, the conclusions about the occurrence of lung function decrements that follow generally apply to children as well as to adults.*** E.O. 12866 Review

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Page 63 of 668 inspiration results in a decrease in forced vital capacity (FVC) and total lung capacity (TLC) and, in combination with mild bronchoconstriction, contributes to a decrease in the forced expiratory volum e in 1 second ( FEV 1 ) (U.S. EPA, 2013 2013 a , section 6.2.1.1). Accumulating evidence indicates that such effects are mediated by activation of sensory nerves, resulting in the involuntary truncation of inspiration and a mild increase in airway obstruction du e to bronchoconstriction (U.S. EPA, 2013 2013 a , section 5.3.10). Data from controlled human exposure studies show that increasing the duration of O 3 exposures and increasing ventilation rates decreases the O 3 exposure concentrations required to impair lung function. Ozone exposure concentrations well above those typically found in ambient air are required to impair lung function in healthy resting adults, while exposure to O 3 concentrations at or below those i n the ambient air have been reported to impair lung function in healthy adults exposed for longer durations while undergoing intermittent, moderate exertion (U.S. EPA, 201 3 201 3 a , section 6.2.1.1). With repeated O 3 exposures over several days, FEV 1 response s become attenuated in both healthy adults and adults with mild asthma, though this attenuation of response is lost after about a week without exposure (U.S. EPA, 2013 2013 a , section 6.2.1.1; page p . 6

- 27)

. When considering controlled human exposure studies of O 3 - induced lung function decrements , the ISA and PA evaluate both group mean changes in lung function and the interindividual variability in the magnitude of responses. An advantage of O 3 controlled human exposure studies (i.e., compared to the epidemiologic panel studies discussed below) is that reported effects necessarily result from exposures to O 3 itself. 30 To the extent studies report

30 The ISA notes that the use of filter ed air responses as a control for the assessment of responses following O 3 exposure in controlled human exposure studies serves to eliminate alternative*** E.O. 12866 Review

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Page 64 of 668 statistically significant decrements in mean lung function following O 3 exposures after controlling for other factors, these studies provide greater confidence that measured decrements are due to the O 3 exposure itself, rather than to chance alone. As discussed below, group mean changes in lung function a re often small, especially following exposures to relatively low O 3 concentrations (e.g., 60 ppb). However, even when group mean decrements in lung function are small, some individuals could experience decrements that are “clinically meaningful” ( Pellegrino et al., 2005 ; ATS, 1991 ) with respect to criteria for spirometric testing, a nd/or th at could be considered adverse with respect to public health policy decisions . See (s ee section II.B. 3 .1.3 , below

. )

. At the time of the last review, a number of controlled human exposure studies had reported lung function decrements in young, healthy adults following prolonged (6.6

- hour) exposures while at moderate exertion to O 3 concentrations at and above 80 ppb. In addition, there were two controlled human exposure studies by Adams (2002, 2006) that examined lung function effects following e xposures to 60 ppb O 3 . The EPA’s analysis of the data from the Adams (2006) study reported a small but statistically significant O 3 - induced decrement in group
mean FEV 1 following exposures of young, healthy adults to 60 ppb O 3 while at moderate exertion, w hen compared with filtered air controls (Brown , et al. , 200 8 ). 31 Further examination of the post

- exposure FEV 1 data, and mean data for other time points and other concentrations, indicated that the temporal pattern of the response to 60 ppb O 3 was generall y consistent with the

explanations other than O 3 itself in causing the measured responses ( U.S. EPA, 2013 2013a , section 6.2.1 .1). 31 Adams (2006 ) did not find effects on FEV 1 at 60 ppb to be statistically significant. In an analysis of the Adams (2006 ) data, Brown et al. (2008) showed that even after removal of potential outliers, the average effect on FEV 1 at 60 ppb was small, but highly statistically signifi cant (p < 0.002) using several common statistical tests.*** E.O. 12866 Review

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Page 65 of 668 temporal patterns of responses to higher O 3 concentra tions in this and other studies (75 FR 2950, January 19, 2010). This suggested a pattern of response following exposures to 60 ppb O 3 that was consistent with a dose

- response relationship, rather than random variability. See also State of Mississippi v. EPA , F. 3d 2013 U.S. App. LEXIS 24596 at * 28

- 29 1347 (upholding EPA’s interpretation of the Adams studies)

. Figure 6

- 1 in the ISA sum marizes the currently available evidence from multiple controlled human exposure studies evaluating group mean changes in FEV 1 following prolonged
O 3 exposures (i.e., 6.6 hours) in young, healthy adults engaged in moderate levels of physical activity (U.S. EPA, 201 3 201 3 a , section 6.2.1.1)

. With regard to the group mean changes reported in these studies, the ISA specifically notes the following (U.S. EPA, 201 3 201 3 a , section 6.2.1.1, Figure 6

- 1):
1. Prolonged exposure to 40 ppb O 3 results in a small decrease in group mean FEV 1 that is not statistically different from responses following exposure to filtered air (Adams, 2002; Adams, 2006)

. 2. Prolonged exposure to an average O 3 concentration of 60 ppb results in group mean FEV 1 decrements ranging from 1.8% to 3.6% (Adams 2002; Adams, 2006; 32 Schelegle et al., 2009; 33 Kim et al., 2011). Based on data from multiple studies, the weighted average

32 Adams (2006); (2002) both provide data for an additional group of 30 healthy subjects that were exposed via facemask to 60 ppb (square

- wave) O 3 for 6.6 hours with moderate exercise ( V ̇ E = 23 L/min per m 2 BSA). These subjects are described on page 133 of Adams (2006) and pages 747 and 761 of Adams (2002). The FEV 1 decrement may be somewhat increased due to a target V ̇ E of 23 L/min per m 2 BSA relative to other studies having the target V ̇ E of 20 L/min p er m 2 BSA. The facemask exposure is not expected to affect the FEV 1 responses relative to a chamber exposure. 33 For the 60 ppb target exposure concentration , Schelegle et al. (2009) reported that the actual mean exposure concentration was 63 ppb.*** E.O. 12866 Review

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Page 66 of 668 group mean decrement was 2.7%. In some analyses, these group mean decrements in lung function were statistically significant (B rown et al., 2008; Kim et al., 2011), while in other analyses they were not (Adams, 2006; Schelegle et al., 2009). 34

3. Prolonged exposure to an average O 3 concentration of 7 2 ppb results in a statistically significant group mean decrement in FEV 1 of about 6% (Schelegle et al., 2009). 35

4. Prolonged square

- wave exposure to average O 3 concentrations of 80 ppb, 100 ppb, or 120 ppb O 3 results in statistically significant group mean decrements in FEV 1 ranging from 6 to 8%, 8 to 14%, and 13 to 16%, respect ively (Folinsbee et al., 1988; Horstman et al., 1990; McDonnell et al., 1991; Adams, 2002; Adams, 2003; Adams, 2006)

. As illustrated in Figure 6

- 1 of the ISA, there is a smooth dose

- response curve without evidence of a threshold for exposures between 40 and 120 ppb O 3 (U.S. EPA, 201 3 201 3 a , Figure
6

- 1)

. When these data are taken together, the ISA concludes that “mean FEV 1 is clearly decreased by 6.6

- h h our exposures to 60 ppb O 3 and higher concentrations in [healthy, young adult] subjects performing moderat e exercise” (U.S. EPA, 201 3 201 3 a , p. 6

- 9). With respect to interindividual variability in lung function, in an individual with relatively “normal” lung function, with recognition of the technical and biological variability in measurements, within

- day chan ges in FEV 1 of ≥ 5% are clinically meaningful ( Pellegrino et al.,

34 Adams (2006) did not find effects on FEV 1 at 60 ppb to be statistically significant

. In an analysis of the Adams (2006) data, Brown et al. (2008) addressed the more fundamental question of whether there were statistically significant differences in responses before and after the 6.6 hour exposure period and found the average effect on FEV 1 at 60 ppb to be small, but highly statistically significant using several common statistical tests, even after removal of potential outliers. Schelegle et al. (2009) reporte d that , compared to filtered air, the largest change in FEV 1 for the 60 ppb protocol occurred after the sixth (and final) exercise period. 35 For As noted above, f

or the 70 ppb exposure group, Schelegle et al. (2009) reported that the actual mean exposure concentration was 72 ppb.*** E.O. 12866 Review

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Page 67 of 668 2005 ; ATS, 1991 ) . The ISA (U.S. EPA, 2013 2013 a , section 6.1.) focuses on individuals with >10% decrements in FEV 1 for two reasons. A 10% FEV 1 decrement is accepted by the American Thoracic Society (ATS) as an abnormal response and a reasonable criterio n for assessing exercise

- induced bronchoconstriction ( Dryden et a l., 2010 ; ATS, 2000a 2000 ) . (U.S. EPA, 2013 2013 a , section 6.2.1.1). Also, some individuals in the Schelegle et al. (2009 ) study experienced 5

- 10% FEV 1 decrements following exposure to filtered air. In previous NAAQS reviews , the EPA has made judgments regarding the potential implications for individuals experiencing FEV 1 decrements of varying degrees of severity. 36 For people with lung disease, the EPA judged that moderate functional decrements (e.g., FEV 1 decrements > 10 percent % but < 20 percent, % , lasting up to 24 hours) would likely interfere with normal activity for many individuals, and would likely result in more frequent use of medication (75 FR 2973, January 19, 2010). In previous reviews CASAC has endorsed these conclusions. In the context o f standard setting, in the last review of the O 3 NAAQS CASAC indicated that it i s appropriate to focus on the lower end of the range of moderate functional responses (e.g., FEV 1 decrements  10 percent) % ) when estimating potentially adverse lung function d ecrements in people with lung disease, especially children with asthma (Henderson, 2006c; transcript of CASAC meeting, day 8/24/06, page 149 ). More specifically, CASAC stated that “[a] 10%
decrement in FEV 1 can lead to respiratory symptoms, especially in i ndividuals with pre

- existing pulmonary or cardiac disease. For example, people with chronic obstructive pulmonary disease have decreased ventilatory reserve (i.e., decreased baseline FEV 1 ) such that a ≥ 10% decrement

36 Such judgments have been made for decrements in FEV 1 as well as for increased airway responsiveness and symptomatic responses (e.g., cough, chest pain, wheeze). Ranges of pulmonary responses and their associated potential impacts are presented in Tables 3

- 2 and 3

- 3 of the 2007 Staff Paper (U.S. EPA, 2007).*** E.O. 12866 Review

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Page 68 of 668 could lead to moderate to severe respir atory symptoms” (Samet, 2011). In this review, CASAC reiterated its support for this conclusion, stating that “[a] n FEV1 decrement of ≥10% is a scientifically relevant surrogate for adverse health outcomes for people with asthma and lung disease” (Frey, 20 14c p. 3). Therefore, in considering interindividual variability in O 3 - induced lung function decrements in the current review, the EPA also focuses on the extent to which individuals were reported to experience FEV 1 decrements of 10% or greater. 37
New stud ies (Schelegle et al., 2009; Kim et al., 2011) add to the previously available evidence for interindividual variability in the responses of healthy adults following exposures to
O 3 . Following prolonged exposures to 80 ppb O 3 while at moderate exertion, the proportion of healthy adults experiencing FEV 1 decrements greater than 10% was 17% by Adams (2006 ) , 26% by McDonnell (1996 ) , and 29% by Schelegle et al. (2009 ) . Following exposures to 60 ppb O 3 , that proportion was 20% by Adams (2002 ) , 3% by Adams (2006 ) , 16% by Sch elegle et al. (2009 ) , and 5% by Kim et al. (2011 )

. Based on Across these studies, the weighted average proportion (i.e., based on numbers of subjects in each study) of young, healthy adults with >10%
FEV 1 decrements is 25% following exposure to 80 ppb O 3 and 10% following exposure to

37 The approach to using results from controlled human exposure studies conducted in healthy adults to provide perspective on the potential public health impacts of O 3 - related respiratory health effects is discussed in section II.A above, and in sections II .C.2 and II.C.3 below

. Formatted: Font: 12 pt*** E.O. 12866 Review

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Page 69 of 668 60 ppb O 3 , for 6.6 hours at moderate exertion (U.S. EPA, 2013 2013 a , page 6

- 1 8 and 6

- 19 ). 38 , 39 The ISA notes that responses within an individual tend to be reproducible over a p eriod of several months, indicating that interindividual differences reflect differences in intrinsic responsiveness. Given this, the ISA concludes that “ “[t] hough group mean decrements are biologically small and generally do not attain statistical signifi cance, a considerable fraction ” of healthy exposed individuals experience clinically meaningful decrements in lung function ” when exposed for 6.6 hours to 60 ppb O 3 during quasi continuous , moderate exertion (U.S. EPA,
2013 2013 a , section 6.2.1.1, p. 6

- 20). As discussed above and in the ISA (U.S EPA, 2013, Section 5.3.2), secondary oxidation products formed following O 3 exposures can activate neural reflexes leading to decreased lung function. Two new quantitative models ( McDonnell et al., 2012 ; Schelegle et al., 2012 ), discussed in section 6.2.1.1 of the ISA (U.S. EPA, 2013, p. 6

- 15), included mathematical approaches to simulate the protective effect of antioxidants in the ELF at lower ambient O 3 concentrations, and include a threshold below which changes in lung function do not occur

. McDonnell et al. (2012 ) and This review has marked a n advance in the ability to make reliable quantitative predictions of the potential lung function response to ozone exposure, and

38 The ISA notes that by considering responses uncorrected for filtered air exposures, during which lung function typically improves (which would increase the size of the change, pre

- and post

- exposure), 10% is an underestimate of the proportion of healthy individuals that are likely to experience clinically meaningful changes in lung function following exposure for 6.6 hours to 60 ppb O 3 during intermittent moderate exertion (U.S. EPA, 2012, section 6.2.1.1). 39 The ISA also notes that by considering responses uncorrected for filtered air exposures, during which lung function typically improves (which would increase the size of the change, pre

- and post

- exposure), 10% is an underestimate of the proportion of healthy individuals that are likely to experience clinically meaningful changes in lung function following exposure for 6.6 hours to 60 ppb O 3 during intermittent moderate exertion (U.S. EPA, 2012, section 6.2.1.1). B ased on the data available at 60 ppb, 1% of subjects experience d decrements > 20% (also uncorrected for filtered air exposures)

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Page 70 of 668 thus to reasonably predict the degree of interindividual response of lung function to that
exposure. McDonnell et al. (2012 ) and Schelegle et al. (2012 ) developed models using data on
O 3 exposure concentrations, ventilation rates, duration of exposures, and lung function responses from a number of controlled human exposure studies. See section 6.2.1.1 of the ISA (U.S. EPA
2013 a, p. 6

- 15). The McDonnell et al. (2012 ) and Schelegle et al. (2012 ) studies analyzed large datasets to fit compartmental models that included the concept of a dose of onset in lung function response or a response threshold based upon the inhaled O 3 dose. The McDonnell et al. (2012 ) model was fit to a dataset consisting of the FE V 1 responses of 741 young, healthy adults (18

- 35 years of age) from 23 individual controlled exposure studies. Concentrations across individual studies ranged from 40 ppb to 400 ppb, 40 activity level ranged from rest to heavy exercise, duration of exposure was from 2 to 7.6 hours. The extension of the McDonnell et al. (2012 ) model to children and older adults is discussed in section 6.2.4 of the HREA (U.S. EPA a , 201 4 EPA, 201 4 a ). Schelegle et al. (2012 ) also analyzed a large dataset with substantial overlap to that used by McDonnell et al. (2012 ) . The Schelegle et al. (2012 ) model was fit to the FEV 1 responses of 220 young healthy adults (taken from a dataset of 704 individuals) from 21 individual controlled exposure studies. The r esulting empirical models can estimate the frequency distribution of individual responses for any exposure scenario as well as summary measures of the distribution such as the mean or median response and the proportions of individuals with FEV 1 decrements > 10%, 15%, and 20%. The predictions of the McDonnell and Schelegle models are consistent with the observed results from the individual studies of O 3 - induced FEV 1 decrements. Specifically, the model

40 Responses to O 3 in these studies were adjusted for responses observed following exposure to filtered air.*** E.O. 12866 Review

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Page 71 of 668 developed by McDonnell et al. (2012) predicts estimated t hat 9% of healthy exercising adults would experience FEV 1 decrements greater than 10% following 6.6 hour exposure to 60 ppb O 3 , and that 22% would experience such decrements following exposure to 80 ppb O 3 (U.S. EPA, 2013 2013 a , p. 6

- 18 and Figure 6

- 3). The model developed by 41 Schelegle et al. (2012) predicts estimated that, for a prolonged (6.6 hours) O 3 exposure with moderate, quasi

- continuous exercise, the average dose of onset for FEV 1 decrement would be reached following 4 to 5 hours of exposure to 60 pp b, and following 3 to 4 hours of exposure to 80 ppb. However, 14% of the individuals had were estimated to have a dose of onset that was less than 40% of the a verage. Those individuals would were estimated to reach their dose of onset following 1 to 2 hours of exposure to 50 to 80 ppb O 3 (U.S. EPA, 2013 2013 a , p. 6

- 16), which is consistent with the threshold FEV 1 responses reported by McDonnell et al. (2012). CASAC agreed that these models mark a significant technical advance over the exposure

response modeling approach used in the last review (Frey, 2014a) , stating that “the comparison of the MSS [McDonnell

- Stewart

- Smith] model results to those obtained with the exposure

response (E

- R) model is of tremendous importance. Typic ally, the MSS model gives results about a factor of three higher than the E

- R model for school

- aged children, which is expected because the MSS model includes responses for a wider range of exposure protocols (under different levels of exertion, lengths of exposure, and patterns of exposure concentrations ) than the E

- R model” (Frey, 2014a, p. 7) . CASAC explicitly found “the updated and expanded lung finds the MSS model to be scientifically and biologically defensible.” (Frey, 2014 a, pp. 2, 8).

41 Also consistent with the data from published studies (see above), t his model predicts that 1% of people would experience FEV 1 decrements > 20% following 6.6 hour exposure to 60 ppb O 3 .*** E.O. 12866 Review

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Page 72 of 668 As discussed above and in the ISA (U.S EPA, 2013 a , Section 5.3.2), secondary oxidation products formed following O 3 exposures can activate neural reflexes leading to decreased lung function. T he McDonnell and Schelegle models included mathematical approaches to simulat e the potential protective effect of antioxidants in the ELF at lower ambient O 3 concentrations, and include a dose threshold below which changes in lung function do not occur

. Epidemiologic studies 42 have consistently linked short

- term increases in ambient O 3 concentrations with lung function decrements in diverse populations and lifestages, including children attending summer camps, adults exercising or working outdoors, and groups with pre

existing respiratory diseases such as asthmatic children (U.S. EPA, 2013 2013 a , section 6.2.1.2).
Some of these studies reported O 3 - associated lung function decrements accompanied by respiratory symptoms 43 in asthmatic children ( Just et al., 2002 ; Mortimer et al., 2002 ; Ross et al.,
2002 ; Gielen et al., 1997 ; Romieu et al., 1997 ; Thu rston et al., 1997 ; Romieu et al., 1996 ) . In contrast, studies of children in the general population have reported similar O 3 - associated lung function decrements but without accompanying respiratory symptoms ( Ward et al., 2002 ; Gold et al., 1999 ; Linn et al., 1996 ) (U.S. EPA, 2013 2013 a , section 6.2.1.2). Several epidemiologic panel studies 44 reported that statisticall y significant associations with lung function decrements persisted at relatively low ambient O 3 concentrations. For outdoor recreation or exercise, associations were reported in analyses restricted to 1

- hour average O 3 concentrations less than 80 ppb ( Spektor et al., 1988a ; Spektor et al., 1988b ) , 60 ppb ( Brunekreef et al., 1994 ; Spektor et al. , 1988a ) , and 50 ppb ( Brunekreef et al., 1994 ) . Among outdoor

42 Unless otherwise specified, the epidemiologic studies discussed in the PA evaluate only adults. 43 Reversible loss of lung function in combination with the presence of symptoms meets the ATS definition of adversity (ATS, 2000). 44 Panel studie s include repeated measurements o f health outcomes, such as respiratory symptoms, at the individual level (U.S. EPA, 2013a, p. 1x)

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Page 73 of 668 workers, Brauer et al. (1996 ) found a robust association with daily 1

- hour max O 3 concentrations less than 40 ppb. Ulmer et al. (1997 ) found a robust association in schoolchildren with 30

- minute maximum O 3 concentrations less than 60 ppb. For 8

- hour average O 3 concentrations, associations with lung f

unction decrements in children with asthma were found to persist at concentrations less than 80 ppb in a U.S. multicity study ( Mortimer et al., 2002 ) and less than 51 ppb in a study conducted in the Netherlands ( Gielen et al., 1997 )

. Epidemiologic panel studies investigating the effects of short

- term exposure to O 3 provided information on potential confounding by copollutants such as particulate matter with a median aerodynamic diameter less than or equal to 2.5 microns ( PM 2.5 , ) , particulate matter with

a median aerodynamic diameter less than or equal to 10 microns ( PM 10 , ) , nitrogen dioxide ( NO 2 , ) , or sulfur dioxide ( SO 2 . )

. These studies varied in how they evaluated confounding. Some studies of subjects exercising outdoors indicated that ambient concentrations of copollutants such
as NO 2 , SO 2 , or acid aerosol were low, and thus not likely to confound associations observed fo r O 3 ( Hoppe et al., 2003 ; Brunekreef et al., 1994 ; Hoek et al., 1993 ) . In other studies of children with increased outdoor exposures, O 3 was consistently associated with decreases in lung function, whereas other pollutants such as PM 2.5 , sulfate, and acid aerosol individually showed variable associations across studies ( Thurston et al., 1997 ; Castillejos et al., 1995 ; Berry et al., 1991 ; Avol et al., 1990 ; Spektor et al., 1988a ) . Studies that conducted copollutant modeling generally found O 3 - associated lung function decrements to be robust (i.e., most copollutant

adjusted effect estimates fell within the 95% confidence interval ( CI ) of the single

- pollutant effect estimates) (U. S. EPA, 2013 2013 a , Figure 6

- 10 and Table 6

- 14). Most O 3 effect estimates for lung function were robust to adjustment for temperature, humidity, and copollutants such as
PM 2.5 , PM 10 , NO 2 , or SO 2 . Although examined in only a few epidemiologic studies, O 3 also*** E.O. 12866 Review

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Page 74 of 668 remained associated with decreases in lung function with adjustment for pollen or acid aerosols (U.S. EPA, 2013 2013 a , section 6.2.1.2). Several epidemiologic studies demonstrated the protective effects of vitamin E and vitamin C supplementation, and increased dietary antioxidant intake, on O 3 - induced lung function decrements ( Romieu et al., 2002 ) (U.S. EPA, 2013 2013 a , Figure 6

- 7 and Table 6

- 8). 45 These results provide support for the n ew, quantitative models ( McDonnell et al., 2012 ; Schelegle et al., 2012 ) , discussed above, which make use of the concept of oxidant stress to estimate the occurrence of lung function decrements following exposures to relatively low O 3 concentrations. In conclusion, new informa tion from controlled human exposure studies considerably strengthens the evidence and reduces the uncertainties, relative to the evidence that was available at the time of the 2008 review, regarding the presence and magnitude of lung function decrements in healthy adults following prolonged exposures to O 3 concentrations below 80 ppb.
As discussed in Section 6.2.1.1 in the ISA (U.S. EPA , 2013, p. 6

- 12), there is information available from four separate studies that evaluated exposures to 60 ppb O 3 ( Kim et al., 2011 ; Schelegle et al., 200 9 ; Adams 2002 ; 2006 ) . Although not consistently statistically significant, group mean FEV 1 decrements following exposures to 60 ppb O 3 are consistent among these studies. Moreover, as is illustrated in Figure 6

- 1 of the ISA (U.S. EPA, 2013 2013 a ) , the group
mean FEV 1 responses at 60 ppb fall on a smooth intake dose

- r esponse curve for exposures between 40 and 120 ppb O 3 . These Based on the data in these studies also indicate that, on
average , 10% of young, healthy adults experience clinically meaningful decrements in lung

45 Eviden ce from controlled human exposure studies is mixed, suggesting that supplementation may be ineffective in the absence of antioxidant deficiency ( U.S. EPA, 2013 2013a , p. 5

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Page 75 of 668 function when exposed for 6.6 hours to 60 ppb O 3 during intermittent, moderate exertion. One recent study has also reported statistically significant decrements following exposures to 72 ppb
O 3 (Schelegle et al., 2009). Predictions from newly developed quantitative models are consistent with these exper imental results. Additionally, as discussed in more detail in section 3.1 II.B .4 below, epidemiologic studies continue to provide evidence of lung function decrements in people who are active outdoors, including people engaged in outdoor recreation or exercise, children, and outdoor workers, at low ambient O 3 concentrations. While few new epidemiologic studies of
O 3 - associated lung function decrements are available in this review, previously available studies have reported associations with decrements, including at relatively low ambient O 3 concentrations. ii. Pulmonary inflammation, injury, and oxidative stress Ozone exposures result in increased respiratory tract inflammation and epithelial permeability. Inflammation is a host response to injury, and the induction of inflammation is evidence that injury has occurred. Oxidative stress has been shown to play a key role in initiating and sustaining O 3 - induced inflammation. Secondary oxidation products formed as a result of reactions between O 3 and compone nts of the ELF can increase the expression of molecules (i.e., cytokines, chemokines, and adhesion molecules) that can enhance airway epithelium permeability (U.S. EPA, 2013, Sections 2013 a , s ections 5.3.3 and 5.3.4). As discussed in detail in the ISA (U.S. EPA, 2013 2013 a , section 6.2.3), O 3 exposures can initiate an acute inflammatory response throughout the respiratory tract that has been reported to persist for at least 18

- 24 hours after exposure. Inflammation induced by exposure of humans to O 3 can have several potential outcomes: (1) inflammation induced by a single exposure (or several exposures over the course of a*** E.O. 12866 Review

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Page 76 of 668 summer) can resolve entirely; (2) continued acute inflammation can evolve into a chronic inflammatory state; (3) continued inflammation ca n alter the structure and function of other pulmonary tissue, leading to diseases such as asthma; (4) inflammation can alter the body’s host defense response to inhaled microorganisms, particularly in potentially at

- risk populations or lifestages such as t he very young and old; and (5) inflammation can alter the lung’s response to other agents such as allergens or toxins (U.S. EPA, 2013, Section 2013 a , s ection 6.2.3). Thus, lung injury and the resulting inflammation provide a mechanism by which O 3 may cause other more serious morbidity effects (e.g., asthma exacerbations). 46 In the last review, controlled human exposure studies reported O 3 - induced airway inflammation following exposures at or above 80 ppb and a nimal toxicological studies prov ided evidence for increases in inflammation and permeability in rabbits at levels as low as 100 ppb
O 3 . In the current review, the link between O 3 exposures and airway inflammation and injury has been evaluated in additional controlled human exposure studi es, as well as in recent epidemiologic studies. Controlled human exposure studies have generally been conducted in young, healthy adults or in adults with asthma using lavage (proximal airway and bronchoalveolar), bronchial biopsy, and more recently, induc ed sputum. These studies have evaluated one or more indicators of inflammation, including neutrophil 47 (PMN) influx, markers

46 CASAC also addressed this issue: “The CASAC believes that these modest changes in FEV 1 are usually associated with inflammatory changes, such as more neutrophils in the bronchoalveolar lavage fluid

. Such changes may be linked to the pathogenesis of chroni c lung disease ” (Frey, 2014 a p. 2). 47 Referred to as either neutrophils or polymorphonuclear neutrophils (or PMNs), these are the most abundant type of white blood cells in mammals. PMNs are recruited to the site of injury following trauma and are the hall mark of acute inflammation. The presence of PMNs in the lung has long been accepted as a hallmark of inflammation and is an important indicator that O 3 causes inflammation in the lungs. Neutrophilic inflammation of tissues indicates activation of the innat e immune system and requires a complex series of events, that then are normally followed by processes that clear the evidence of acute inflammation.*** E.O. 12866 Review

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Page 77 of 668 of eosinophilic inflammation, increased permeability of the respiratory epithelium, and/or prevalence of proinflammatory molecules ( U.S. EPA, 2013 2013 a , section 6.2.3.1). Epidemiologic studies have generally evaluated associations between ambient O 3 and markers of inflammation and/or oxidative stress, which plays a key role in initiating and sustaining inflammation (U.S. EPA, 2013 2013 a , section 6.2.3.2). There is an extensive body of evidence from controlled human exposure studies indicating that short

- term exposures to O 3 can cause pulmonary inflammation. A single acute exposure (1

- 4 hours) of humans to moderate concentrations of O 3 ( 200

- 600 ppb) while exercising at moderate to heavy intensities resulted in a number of cellular and biochemical changes in the lung, including inflammation characterized by increased numbers of PMNs, increased permeability of the epithelial lining of the r espiratory tract, cell damage, and production of proinflammatory molecules (i.e., cytokines and prostaglandins, U.S. EPA, 2006a b 2006a ) . A meta

- analysis of 21 controlled human exposure studies ( Mudway and Kelly,
2004 ) using varied experimental protocols (80

- 600 ppb O 3 exposures; 1

- 6.6 hours exposure duration; light to heavy exercise; bronchoscopy at 0

- 24 hours post

- O 3 exposure) reported that PMN influx in healthy subjects is linearly associated with total O 3 dose. Several studies, including one published since the last review (Alexis et al., 2010), have reported O 3 - induced increases in PMN influx and permeability following exposures at or above 80 ppb ( Alexis et al., 2010 ; Peden et al., 1997 ; Devlin et al., 1991 ), a nd eosinophilic inflammation following exposures at or above 160 ppb ( Scannell et al., 1996 ; Peden et al., 1997 ; Hiltermann et al., 1999 ; Vagaggini et al., 2002 ). In addition, one recent controlled human
exposur e study has reported O 3 - induced PMN influx following exposures of healthy adults to 60*** E.O. 12866 Review

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Page 78 of 668 ppb O 3 (Kim et al., 2011), the lowest concentration at which inflammatory responses have b een evaluated in human studies.
As with FEV 1 responses to O 3 , inflammatory responses to O 3 are generally reproducible within individuals, with some individuals experiencing more severe O 3 - induced airway inflammation than indicated by group averages ( Holz et al., 2005 ; Holz et al., 1999 )

. Unlike O 3 - induced decrements in lung function, which are attenuated following repeated exposures over

s everal days (U.S. EPA, 2013 2013 a , section 6.2.1.1), some markers of O 3 - induced inflammation and tissue damage remain elevated during repeated exposures, indicating ongoing damage to the respiratory system (U.S. EPA, 2013 2013 a , section 6.2.3.1).
Most contr olled human exposure studies have reported that asthmatics experience larger
O 3 - induced inflammatory responses than non

- asthmatics. 48 Specifically, asthmatics exposed to
200 ppb O 3 for 4

- 6 hours with exercise show significantly more neutrophils in bronchoal veolar lavage fluid (BALF) than similarly exposed healthy individuals ( Scannell et al., 1996 ; Basha et al., 1994 )

. Bosson et al. (2003 ) reported significantly greater expression of a variety of pro

inflammatory cytokines in asthmatics, compared to healthy sub jects, following exposure to
200 ppb O 3 for 2 hours. In addition, research available in the last review, combined with a recent study newly available in this review, indicates that pretreatment of asthmatics with corticosteroids can prevent the O 3 - induced inflammatory response in induced sputum, though pretreatment did not prevent FEV 1 decrements ( Vagaggini et al., 2001; 2007 ) . In contrast, Stenfors et al. (2002 ) did not detect a di fference in the O 3 - induced increases in neutrophil numbers between 15 subjects with mild asthma and 15 healthy subjects by bronchial wash at the

48 When evaluated, these studies have also reported O 3 - induced respiratory symptoms in asthmatics. Specifically, Scannell et al. (1996), Basha et al. (1994), and Vagaggini et al. (2001, 2007) reported increased symptoms in addition to inflammation.*** E.O. 12866 Review

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Page 79 of 668 6 hours postexposure time point, although the neutrophil increase in the asthmatic group was on top of an eleva ted baseline. In people with allergic airway disease, including people with rhinitis and asthma, evidence available in the last review indicated that proinflammatory mediators also cause accumulation of eosinophils in the airways (Jorres et al., 1996; Ped en et al., 1995 and 1997; Frampton et al., 1997; Hiltermann et al., 1999; Holz et al., 2002; Vagaggini et al., 2002). The eosinophil, which increases inflammation and allergic responses, is the cell most frequently associated with exacerbations of asthma ( 75 CFR 2969, January 19, 2010). 7 2 FR 37846 , July 11,
2007 ). Studies reporting inflammatory responses and markers of lung injury have clearly demonstrated that there is important variation in the responses of exposed subjects ( 75 7 2 FR 2953, January 19, 2010 37831 , July 11, 2007 ). Some individuals also appear to be intrinsically more susceptible to increased inflammatory responses from O 3 exposure (Holz et al., 2005). In healthy adults exposed to each 80 and 100 ppb O 3 , Devlin et al. (1991) observed group average increases in neutrophilic inflammation of 2.1

- and 3.8

- fold, respectively. However, there was a
20

- fold range in inflammatory responses between individuals at both concentrations. Relative to an earlier, similar study conducted at 400 ppb (Koren et al., 1989), Devlin et al. (1991) noted that although some of the study population showed little or no increase in inflammatory and cellular injury indicators analyzed after exposures to lower levels of O 3 (i.e., 80 and 100 ppb ), others had changes that we re as large as those seen when subjects were exposed to 400 ppb O 3 . The data suggest study authors concluded that as a whole , “ while the healthy population , on average, as a whole may have a small inflammatory responses following exposure response to near

- ambient*** E.O. 12866 Review

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Page 80 of 668 levels of O 3 , though ozone, there may be a sizable significant subpopulation that is very sensitive
to these low levels of O 3 . ” (Devlin et al., 1991). A number of studies report that O 3 exposures increase epithelial permeability. Increased BALF protein, suggesting O 3 - induced cha nges in epithelial permeability, has been reported at
1 hour and 18 hours postexposure ( Devlin et al., 1997 ; Balmes et al., 1996 ) . A meta

- analysis of results from 21 publications ( Mudway and Kelly, 2004 ) for varied experimental protocols (80

- 600 ppb O 3 ; 1

- 6.6 hours duration; light to heavy exercise; bronchoscopy at 0

- 24 hours post

- O 3 exposure; healthy subjects), showed that increased BALF protein is associated with total inhaled
O 3 d ose. As noted in the 2009 PM ISA (U.S. EPA, 2009a ), it has been postulated that changes in permeability associated with acute inflammation may provide increased access of inhaled antigens, particles, and other inhaled substances deposited on lung surfaces to the smooth muscle, interstitial cells, immune cells underlying the epithelium, and the blood (U.S. EPA,
2013 2013 a , sections 5.3.4, 5.3.5)

. As has been observed with FEV 1 responses, within individual changes in permeability a re correlated with changes following sequential O 3 exposures ( Que et al. , 2011) . C hanges in permeability and AHR apear to be mediated by different pathways. Animal toxicology studies have provided some support for this hypothesis (Adamson and Prieditis, 1995; Chen et al ., 2006), though these studies did not specifically evaluate O 3 exposures (U.S. EPA, 2009a ). The limited epidemiologic evidence reviewed in the 2006 O 3 AQCD ( U.S. EPA, 2006a ) demonstrated an association reported association s between short

- term increases in ambient O 3 concentrations and airways inflammation in children (1

- hour max O 3 of approximately 100 ppb). In the 2006 O 3 AQCD ( U.S. EPA, 2006a ), there was limited evidence for increases in nasal lavage levels of inflammatory cell counts and molecules relea sed by inflammatory cells (i.e., Formatted: Font: 12 pt*** E.O. 12866 Review

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Page 81 of 668 eosinophilic cationic protein, and myeloperoxidases). Since 2006, as a result of the development of less invasive methods, there has been a large increase in the number of studies assessing ambient O 3 - associated changes in airway inflammation and oxidative stress, the types of biological samples collected, and the types of indicators. Most of these recent studies have evaluated biomarkers of inflammation or oxidative stress in exhaled breath, nasal lavage fluid, or induced s putum (U.S. EPA, 2013 2013 a , section 6.2.3.2). These recent studies form a larger database to establish coherence with findings from controlled human exposure and animal studies that have measured the same or related biological markers. Additionally, results from these studies provide further biological plausibility for the associations observed between ambient O 3 concentrations and respiratory symptoms and asthma exacerbations

. A number of epidemiologic studies provide evidence that short

- term increa ses in ambient
O 3 exposure increase pulmonary inflammation and oxidative stress in children, including those with asthma ( Sienra

- Monge et al., 2004 ; Barraza

- Villarreal et al., 2008 ; Romieu et al., 2008 ; Berhane et al., 2011 )

. Multiple studi es examined and found increases in exhaled NO nitric oxide (eNO) 49 ( Berhane et al., 2011 ; Khatri et al., 2009 ; Barraza

- Villar real et al., 2008 ) . In some studies of subjects with asthma, increases in ambient O 3 concentration at the same lag were associated with both increases in pulmonary inflammation and respiratory symptoms ( Khatri et al., 2009 ; Barraza

- Villarreal et al., 2008 ) . Although more limited in number, epidemiologic studies also found associations with cytokines such as IL

- 6 or IL

- 8 ( Barraza

- Villarreal et al.,
2008 ; Sienra

- Monge et al., 2004 ) , eosinophils ( K hatri et al., 2009 ) , antioxidants ( Sienra

- Monge et al., 2004 ) , and indicators of oxidative stress ( Romieu et al., 2008 ) ( ISA, Section 6. 2.3.2, U.S.

49 Exhaled NO has been shown to be a useful biomarker for airway inflammation in large pop ulation

- based studies ( Linn et al., 2009 ) ( ISA, U.S. EPA, 2013, Section 201 3a, s ection 7.2.4)

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Page 82 of 668 EPA, 2013). 2013 a, s ection 6.2.3.2 ). Because associations with inflammation were attenuated with higher antioxidant intake in the study by Sienra

- Monge et al. (2004 ) , this study provides additional evidence that inhaled O 3 is likely to be an important source of reactive oxygen species in airways and/or may increase pulmonary inflammation via oxidative stress

- mediated mechanisms among all age groups. L imitatio ns in some recent studies have contributed to inconsistent results in adults (U.S. EPA, 2013 2013 a , section 6.2.3.2). Exposure to ambient O 3 on multiple days can result in larger increases in pulmonary inflammation and oxidative stress, as discussed in sec tion 6.2.3.2 of the ISA (U.S. EPA,
2013 2013 a ). In studies that examined multiple O 3 lags, multiday averages of 8

- hour maximum or
8

- hour average concentrations were associated with larger increases in pulmonary inflammation and oxidative stress ( Berhane et al., 2011 ; Delfino et al., 2010 ; Sienra

- Monge et al., 2004 ) , consistent with controlled human exposure (U.S. EPA, 2013 2013 a , section 6.2.3.1) and animal studies (U.S. EP A, 2013 2013 a , section 6.2.3.3) reporting that some markers of pulmonary inflammation remain elevated with O 3 exposures repeated over multiple days. Evidence from animal toxicological studies also clearly indicates that O 3 exposures result in damage and
inf lammation in the lung ( ISA, Section 5.3, U.S. EPA, 2013 2013 a, s ection 5.3 ). In the few studies that evaluated the potential for confounding, O 3 effect estimates were not confounded by temperature or humidity, and were robust to adjustment for PM 2.5 or PM 10 ( Barraza

- Villarreal et al., 2008 ; Romieu et al., 2008 ; Sienra

- Monge et al., 2004 )

. In conclusion, a relatively small number of controlled human exposure studies evaluating
O 3 - induced airway inflam mation have become available since the last review. For purposes of reviewing the current O 3 NAAQS, the most important of these recent studies reported a statistically significant increase in airway inflammation in healthy adults at moderate exertion*** E.O. 12866 Review

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Page 83 of 668 follo wing exposures to 60 ppb O 3 , the lowest concentration that has been evaluated for inflammation. In addition, a number of recent epidemiologic studies report O 3 - associated increases in markers of pulmonary inflammation, particularly in children. Thus, recen t studies continue to support the evidence for airway inflammation and injury that was available in previous reviews, with new evidence for such effects following exposures to lower concentrations than had been evaluated previously. iii. Airway hyperrespon siveness Airway hyperresponsiveness (AHR) refers to a condition in which the conducting airways undergo enhanced bronchoconstriction in response to a variety of stimuli. Airway hyperresponsiveness is an important consequence of exposure to ambient O 3 because its presence reflects a change in airway smooth muscle reactivity, and indicates that the airways are predisposed to narrowing upon inhalation of a variety of ambient stimuli including specific triggers (i.e., allergens) and nonspecific triggers ( e.g., SO 2 , and cold air). People with asthma are generally more sensitive to bronchoconstricting agents than those without asthma, and the use of an airway challenge to inhaled bronchoconstricting agents is a diagnostic test in asthma

. (U.S. EPA, 2013, sec tion 6.2.2)

. Standards for airway responsiveness testing have been developed for the clinical laboratory ( ATS, 2000 ) , although variation in the methodology for administering the broncho constricting agent may affect the results ( Cockcroft et al., 2005 ) . There is a wide range of airway responsiveness in people without asthma, and respons iveness is influenced by a number of factors, including cigarette smoke, pollutant exposures, respiratory infections, occupational exposures, and respiratory irritants. Dietary antioxidants have been reported to
attenuate O 3 - induced bronchial hyperresponsi veness in people with asthma ( Trenga et al., 2001 )

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Page 84 of 668 Evidence for airway hyperresponsiveness (AHR) following O 3 exposures is derived primarily from controlled human exposure and toxicolog ical studies (U.S. EPA, 2013 2013 a , section 6.2.2). Airway responsiveness is often quantified by measuring changes in pulmonary function following the inhalation of an aerosolized allergen or a nonspecific bronchoconstricting agent (e.g., methacholine), or following exposure to a bronchoconstricting stimulus such as cold air. In the last review, controlled human exposure studies of mostly adults (≥ 18 years of age) had shown that exposures to O 3 concentrations at or above 80 ppb increase airway responsivenes s, as indicated by a reduction in the concentration of specific (e.g., ragweed) and

non - specific (e.g., methacholine) agents required to produce a given reduction in lung function (e.g., as measured by FEV 1 or specific airway resistance) (U.S. EPA, 2013 201 3 a , section 6.2.2.1). This O 3 - induced AHR has been reported to be dose

- dependent (Horstman et al., 1990). Animal toxicology studies have reported O 3 - induced airway hyperresponsiveness AHR in a number of species, with some rat strains exhibiting hyperrespons iveness following 4

- hour exposures to O 3 concentrations as low as 50 ppb ( Depuydt et al., 1999 ) . Since the last review, there have been relatively few new controlled human exposure and animal toxicology studies of
O 3 and airway hyperresponsiveness AHR , and no new studies have evaluated exposures to O 3

conce ntrations at or below 80 ppb (U.S. EPA, 2013 2013 a , section 6.2.2.1)

. Airway hyperresponsiveness is linked with the accumulation and/or activation of eosinophils in the airways of asthmatics, which is followed by production of mucus and a late

phase asthm atic response ( 75 FR 2970, January 19, 2010)

. section II.B.4.a.ii)

. In a study of 16 intermittent asthmatics, Hiltermann et al. (1999) found that there was a significant inverse correlation between the O 3 - induced change in the percentage of eosinophils in induced sputum and the concentration of methacholine causing a 20% decrease in FEV 1 . Hiltermann et al. (1999)*** E.O. 12866 Review

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Page 85 of 668 concluded that the results point to the role of eosinophils in O 3 - induced airway hyperresponsiveness

. AHR

. Increases in O 3 - induced nonspecific airw ay responsiveness incidence and duration could have important clinical implications for children and adults with asthma, such as exacerbations of their disease

. Airway hyperresponsiveness after O 3 exposure appears to resolve more slowly than changes in F EV 1 or respiratory symptoms ( Folinsbee and Hazucha, 2000 ) . Studies suggest that
O 3 - induced AHR usually resolves 18 to 24 hours after exposure, but may persist in some individuals for longer periods ( Folinsbee and Hazucha, 1989 ) . Furthermore, in studies of repeated exposure to O 3 , changes in AHR tend to be somewhat less susceptible to attenuation with consecutive exposures than changes in FEV 1 ( Gong et al., 1997 ; Folinsbee et al., 1994 ; Kulle et al., 1982 ; Dimeo et al., 1981 ) (U.S. EPA, 2013 2013 a , section 6.2.2)

. In animal studies a
3

- day continuous exposure re sulted in attenuation of O 3 - induced airway hyperresponsiveness AHR (Johnston et al., 2005) while repeated exposures for 2 hours per day over 10 days did not (Chhabra et al., 2010), suggesting that attenuation could be lost when repeated exposures are inters persed with periods of rest (U.S. EPA, 2013 2013 a , section 6.2.2.2). As mentioned above, in addition to human subjects a number of species, including nonhuman primates, dogs, cats, rabbits, and rodents, have been used to examine the effect of O 3 exposure on airway hyperresponsiveness (see Table 6

- 14 AHR , ( U.S. EPA, 1996 ) , Table 6

- 14 ; and U.S. EPA, 2006a , Annex Table AX5

- 12, p. AX5

- 36 ) of the 1996 O 3 AQCD and Annex Table AX5

- 12 on page AX5

- 36 ( U.S. EPA, 2006a ) of the 2006 O 3 AQCD).

. A body of animal toxicology studies, including some recent studies conducted since the last review, provides support for the O 3 - induced AHR reported in humans (U.S. EPA, 2013 2013 a , section 6.2.2.2). Although most of these studies evaluated O 3 concentrations above those typically found in*** E.O. 12866 Review

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Page 86 of 668 ambient air in cities in the United States (i.e., most studies evaluated O 3 concentrations of 100 ppb or greater), one study reported that a very low exposure concentration (50 ppb for 4 hours) induced AHR in some rat strains ( Depuydt et al., 1999 ) . Additional recent rodent studies reported O 3 - induced AHR following exposures to O 3 concentrations from 100 to 500 ppb (Johnston et al., 2005; Chhabra et al., 2010; Larsen et al., 2010)

. In characterizing the relevance of these exposure concentrations, the ISA noted that a study using radiolabeled O 3 suggests that even very high O 3 exposure concentrations in rodents could be equivalent to much lower exposure concentrations in humans

. Specifically, a 2000 p pb (2 ppm) O 3 exposure concentration in resting rats was reported to be roughly equivalent to a 400 ppb exposure concentration in exercising humans (Hatch et al., 1994)

. Given this relationship, the ISA noted that animal data obtained in resting conditions could underestimate the risk of effects for humans (U.S. EPA,
2013 2013 a , section 2.4, p. 2

- 14)

. The 2006 AQCD ( U.S. EPA, 2006a , p. 6

- 34) concluded that spirometric responses to O 3 are independent of inflammatory responses and markers of epithelial injur y (Balmes et al., 1996; Blomberg et al., 1999; Torres et al., 1997). Significant inflammatory responses to O 3 exposures that did not elicit significant spirometric responses have b een reported (Holz et al., 2005 ). A recent study (Que et al., 2011) indicate s that airway hyper

- responsiveness AHR also appears to be mediated by a differing physiologic pathway. These results from controlled human exposure studies indicate that sub

- populations of healthy study subjects consistently experience larger than
average O 3 - induced lung function decrements, greater than average inflammatory responses and
p ulmonary injury as expressed by (leading to increased epithelial permeability , ) , and greater than average airway responsiveness, and that these effects AHR , are mediated by a pparently different physiologic pathways. Except for lung function decrments, we do not have*** E.O. 12866 Review

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Page 87 of 668 concentraiton concentration or exposure response informaiton information about the other, potentially more sensitive, 50 clinical endpoints (i.e., inflammation, increa sed epithelial permeability, AHR) that would allow us to quantitatively estimate the size of the population affetcted and the magnitude of their responses. In summary, a strong body of controlled human exposure and animal toxicological studies, most of wh ich were available in the last review of the O 3 NAAQS, report O 3 - induced airway hyperresponsiveness AHR after either acute or repeated exposures (U.S. EPA, 2013 2013 a , section 6.2.2.2). People with asthma often exhibit increased airway responsiveness at baseline relative to healthy controls, and they can experience further increases in responsiveness following exposures to O 3 . Studies reporting increased airway responsiveness after O 3 exposure contribute to a plausible link between ambient O 3 exposures an d increased respiratory symptoms in asthmatics, and increased hospital admissions and emergency department visits for asthma (U.S. EPA, 2013 2013 a , section 6.2.2.2). iv. Respiratory symptoms and medication use
R espiratory symptoms are associated with adve rse outcomes such as limitations in activity , and are the primary reason for people with asthma to us e quick relief medication and seek medical care . S tudies evaluating the link between O 3 exposures and such symptoms allow a direct characterization of the clinical and public health significance of ambient O 3 exposure . Controlled human exposure and toxicological studies have described modes of action through which short

- term O 3 exposure s may increase respiratory symptoms by demonstrating O 3 - induced

50 CASAC noted that “...[W]hile “w hile measures of FEV1 are quantitative and readily obtainable in humans, they are not the only measures

— and perhaps not the most sensitive measures

— of the adverse health effects induced by ozone exposure.” (Henderson, 2006 ).*** E.O. 12866 Review

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Page 88 of 668 airway hy perresponsiveness AHR ( U.S. EPA, 2013 2013 a , section 6.2.2 ) and pulmonary inflammation (U.S. EPA, 2013 2013 a , section 6.2.3 ). The link between subjective respiratory symptoms and O 3 exposures has been evaluated in both controlled human exposure and epidemiologic studies, and the link with medication use has been evaluated in epidemiologic studies. In the last review, several controlled human exposure studies reported respiratory symp toms following exposures to O 3 concentrations at or above 80 ppb. In addition, one study reported such symptoms following exposures to 60 ppb O 3 , though the increase was not statistically different from filtered air controls. Epidemiologic studies reported associations between ambient O 3 and respiratory symptoms and medication use in a variety of locations and populations, including asthmatic children living in U.S. cities. In the current review, additional controlled human exposure studies have evaluated r espiratory symptoms following exposures to O 3 concentrations below 80 ppb and recent epidemiologic studies have evaluated associations with respiratory symptoms and medication use (U.S. EPA,
2013 2013 a , sections 6.2.1, 6.2.4). In controlled human exposure studies available in the last review as well as newly available studies, s tatistically significant increases in respiratory symptoms have been consistently reported in healthy adult volunteers engaged in intermittent, moderate exertion following 6. 6 hour exposures to average O 3 concentrations at or above 72 of 80 ppb (Adams, 2003; Adams, 2006 ; Schelegle et al., 2009 ) and 72 ppb ( Schelegle et al., 2009) . Such symptoms have been reported to increase with increasing O 3 exposure concentrations, duration of exposure, and activity level ( McDonnell et al., 1999 )

. Results have been less consistent for lower exposure concentrations. A recent study by Schelegle et al. (2009) report ed a statistically s ignificant increase in respiratory symptoms in*** E.O. 12866 Review

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Page 89 of 668 healthy adults follo wing 6.6 hour exposures to an average O 3 concentration of 72 ppb , but not 60 ppb

. Kim et al. (2011) also did not find statistically significant increases in respiratory symptoms following e xposures of healthy adults to 60 ppb O 3 . Adams (2006) reported an increase in respiratory symptoms in healthy adults during a 6.6 hour exposure protocol with an average O 3 exposure concentration of 60 ppb. This increase was significantly different from ini tial respiratory symptoms, but not from filtered air controls. The findings for O 3 - induced respiratory symptoms in controlled human exposure studies , and the evidence integrated across disciplines describing underlying modes of action , provide biological plausibility for epidemiologic associations observed between short

- term increases in ambient O 3 concentration and increases in respiratory symptoms (U.S. EPA, 2013 2013 a , section 6.2.4)

. In epidemiologic panel studies of respiratory sy mptom s, data typically are collected by having subjects (or their parents) record symptoms and medication use in a diary without direct supervision by study staff. Several limitations of symptom reports are well recognized , as described in the ISA (U.S. EP A, 2013 2013 a , section 6.2.4) . Nonetheless, symptom diaries remain a convenient tool to collect individual

- level data from a large number of subjects and allow modeling of associations between daily changes in O 3 concentration and daily changes in respirato ry morbidity over multiple weeks or months. Importantly, many of the limitations in these studies are sources of random measurement error that can bias effect estimates to the null or increase the uncertainty around effect estimates (U.S. EPA, 2013, Sectio n 2013 a , s ection 6.2.4)

. B ecause respiratory symptoms are associated with limitations in activity and daily function and are the primary reason for using medication and seeking medical care, the evidence is directly coherent with the associations consistently observed between increases in ambient O 3*** E.O. 12866 Review

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Page 90 of 668 concentration and increases in asthma emergency department visits , discussed below (U.S. EPA, 2013, Section 2013 a , s ection 6.2.4)

. Most epidemiologic studies of O 3 and respiratory symptoms and medicati on use have been conducted in children and/or adults with asthma, with fewer studies, and less consistent results, in non

- asthmatic populations (U.S. EPA, 2013 2013 a , section 6.2.4)

. The 2006 AQCD ( U.S. EPA, 2006a , U.S. EPA, 2013 2013 a , section 6.2.4) conclu ded that the collective body of epidemiologic evidence indicated that short

- term increases in ambient O 3 concentrations are associated with increases in respiratory symptoms in children with asthma. A large body of

s ingle

- city and single

- region studies of asthmatic children provide s consistent evi dence for associations between short

- term increases in ambient O 3 concentrations and increased respiratory symptoms and asthma medication use in children with asthma (U.S. EPA, 2013 2013 a , Figure 6

- 12 , Table 6

- 20 , p. 79 ). Methodological differences among studies make comparisons across recent multicity studies of respiratory symptoms difficult. Because of fewer person

- days of data ( Schildcrout et al., 2006 ) or examination of 19

- day averages of ambient O 3 concentrations ( O'Connor et al.,
2008 ) , the ISA did not give greater weight to results from recent multicity studies than results from single

- city studies (U.S. EPA, 2013 2013 a , section 6.2.4.5). 51 While evidence from the few available U.S. multicity studies is less consistent ( O'Connor et al., 2008 ; Schildcrout et al., 2006 ; Mortimer et al., 2002 ) , the overall body of epidemiologic evidence with respect to the associati on betweeen exposure to O 3 and respiratory symptoms in asthmatic children remains compelling (U.S. EPA, 2013 2013 a , section 6.2.4.1). Findings from a small body of studies

51 Though, as discussed below, for other endpoints (e.g., hospital admissions, emergency department visits) the ISA focused primarily on multicity studies.*** E.O. 12866 Review

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Page 91 of 668 indicate that O 3 is also associated with increased respiratory symptoms in adults with asthma ( Khatri et al., 2009 ; Feo Brito et al., 2007 ; Ross et al., 2002 ) (U.S. EPA, 2013 2013 a , section 6.2.4.2). Available evidence indicates that O 3 - associated increases in respirator y symptoms are not confounded by temperature, pollen, or copollutants (primarily PM) (U.S. EPA, 2013 2013 a , section 6.2.4.5; Table 6

- 25 ; Romieu et al., 1996; Romieu et al., 1997; Thurston et al., 1997; Gent et al., 2003). However, identifying the independen t effects of O 3 in some studies was complicated due to the high correlations observed between O 3 and PM or different lags and averaging times examined for copollutants. Nonetheless, the ISA noted that the robustness of associations in some studies of indiv iduals with asthma, combined with findings from controlled human exposure studies for the direct effects of O 3 exposure, provide substantial evidence supporting the independent effects of short

- term ambient O 3 exposure on respiratory symptoms (U.S. EPA, 20 13 2013 a , section 6.2.4.5). Epidemiologic studies of medication use have reported associations with
1

- hour maximum O 3 concentrations and with multiday average O 3 concentrations ( Romieu et al.,
2006 ; Just et al., 2002 ) . Some studies reported O 3 associations for both respiratory symptoms and asthma medication use ( Escamilla

- Nuñez et al., 2008 ; Romieu et al., 2006 ; Schildcrout et al.,
2006 ; Jalaludin et al., 2004 ; Romieu et al., 1997 ; Thurston et al., 1997 ) while others reported associations for either respiratory symptoms or medication use ( Romieu et al., 1996 ; Rabinovitch et al., 2004 ; Just et al., 2002 ; Ostro et al., 2001 )

. In summary, both controlled human exposure and epidemiologic studies have reported respiratory symptoms attributable to short

- term O 3 exposures. In the last review, the majority of the evidence from controlled human exposure studies in young, healthy adults was for symptoms*** E.O. 12866 Review

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Page 92 of 668 following exposures to O 3 concentrations at or above 80 ppb. Although studies that have become available since the last review have not reported increased respiratory symptoms in young, healthy adults following exposures with moderate exertion to 60 ppb, one recent study did re port increased s ymptoms following exposure to 70 72 ppb O 3 . 52 As was concluded in the 2006 O 3 AQCD ( U.S. EPA, 2006a , ; U.S . EPA, 1996 ) , the collective body of epidemiologic evidence indicates that short

- term increases in ambient O 3 concentration are associated with increases in respiratory symptoms in children with asthma (U.S. EPA, 2013 2013 a , section 6.2.4). Recent studies of respiratory symptoms and medication use, primarily in asthmatic children, add to this evidence. In a smaller body of studies, increases in ambient O 3 concentration were associated with increases in respiratory symptoms in adults with asthma. v. Lung host defense The mammalian respiratory tract has a number of closely integrated defense mechanisms that, when functioning normally, provide protection fr om the potential health effects of exposures to a wide variety of inhaled particles and microbes. These defense mechanisms include mucociliary clearance, alveolobronchiolar transport mechanism, alveolar macrophages , 53 and adaptive immunity 54 (U.S. EPA, 2013 2 013 a , section 6.2.5). The previous O 3 AQCD ( U.S. EPA, 2006a ) concluded that animal toxicological studies provided evidence that acute exposure
to O 3 concentrations as low as 100 to 500 ppb can increase susceptibility to infectious diseases due to modulatio n of these lung host defenses. This conclusion was based , in large part , on

52 As noted above, for the 70 ppb target exposure concentration , Schelegle et al. (2009) reported that the actual mean exposure concentration was 72 ppb. 53 Phagocytic white blood cells within the alveoli of the lungs that ingest inhaled particles. 54 The adaptive immune system , is also known as the acquired immune syst em . Acquired immunity creates immunological memory after an initial response to a specific pathogen, leading to an enhanced response to subsequent encounters with that same pathogen.*** E.O. 12866 Review

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Page 93 of 668 animal studies of alveolar macrophage function and mucociliary clearance (U.S. EPA,
2013 2013 a , section 6.2.5). Integrating animal study resul ts with human exposure evidence , the 2006 Criteria Document concluded that available evidence indicates that short

- term O 3 exposures have the potential to impair host defenses in humans, primarily by interfering with alveolar macrophage function. Any impairment in alveolar macrophage function may lead to decreased clearance of microorganisms or nonviable particles. Compromised alveolar macrophage functions in asthmatics may increase their susceptibility to other O 3 effects, the effects of particles, and respiratory infections ( U.S. EPA, 2006a , p. 8

– 26). These conclusions were based largely on studies conducted in animals exposed for several hours up to several weeks to O 3 concentrations from 100 to 250 ppb ( Hurst et al., 1970 ; Driscoll et al., 1987 ; Coh en et al., 2002 ) . Consistent with the animal evidence, a controlled human exposure study available in the last review had reported decrements in the ability of alveolar macrophages to phagocytize yeast following exposures of healthy volunteers to O 3 concentrations of 80 and 100 ppb for 6.6

- hour hour s during moderate exercise ( Devlin et al., 1991 )

. Alveolobronchiolar transport mechanisms refers to the transport of particles deposited in the deep lung (alveoli) which may be removed either up through the respiratory tract (bronchi) by alveolobronchiolar transport or through the lymphatic system. The pivotal mechanism of alveolobronchiolar transport involves the movement of alveolar macrophage s with ingested particles to the bottom of the conducting airways

. These airways are lined with ciliated epithelial cells and cells that produce mucous, which surrounds the macrophages. The ciliated epithelial cells move the mucous packets up the resiratory tract, hence the term “mucociliary escala tor.” Although some studies show reduced tracheobronchial clearance after O 3 exposure (U.S. EPA,*** E.O. 12866 Review

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Page 94 of 668 2013 2013 a , section 6.2.5.1) , alveolar clearance of deposited material is accelerated, presumably due to macrophage influx, which in itself can be damaging. With regard to adaptive immunity, a limited number of epidemiologic studies have examined associations between O 3 exposure and hospital admissions or ED emergency department visits for respiratory infection, pneumonia, or influenza. Results have been mixed, and in some cases conflicting (U.S. EPA, 2013, Sections 2013 a , s ections 6.2.7.2 and 6.2.7.3). With the exception of influenza, it is difficult to ascertain whether cases of respiratory infection or pneumonia are of viral or bacterial etiology. A recent study that examined the association between O 3 exposure and respiratory ho spital admissions in response to an increase in influenza intensity did observe observe d an increase in respiratory hospital admissions ( Wong et al., 2009 ) , but information from toxicological studies of O 3 and viral infections is ambiguous. In summary, relatively few studies conducted since the last review have evaluated the effects of O 3 exposures on lung host defense. When the available evidence is taken as a whole, the ISA concludes that acute O 3 exposures impair the host defense capability of animals, primarily by depressing alveolar macrophage function and perhaps also by decreasing mucociliary clearance of inhaled particles and microorganisms. Coupled with limited evidence from controlled human exposure studies, this suggests that humans exposed to O 3 could be predisposed to bacterial infections in the lower respiratory tract (U.S. EPA , 2013 2013 a , section 6.2.5.5)

. vi. Allergic and asthma

- related responses Effects resulting from combined exposures to O 3 and allergens have been studied in a variety of animal species, generally as models of experimental asthma. P ulmonary function and
AHR in animal models of asthma are discussed in detail in Section 6.2.1.3 and Section 6.2.2.2,*** E.O. 12866 Review

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Page 95 of 668 respectively, in the ISA (U.S. EPA, 2013 2013 a )

. Studies of allergic and asthma

- related responses are discussed in detail in sections 5.3.6 and 6.2.6 of the ISA (U.S. EPA, 2013 2013 a ). Evidence available in the last review indicates that O 3 exposure skews immune responses
to ward an allergic phenotype and could also make airborne allergens more allergenic

. In humans,

a llergic rhinoconjunctivitis symptoms are associated with increases in ambient O 3 concentrations ( Riediker et al., 2001 ) . Controlled human exposure studies have observed O 3 - induced changes indicating allergic skewing. Airway eosinophils, which are white blood cells that participate in allergic disease and inflammation, were observed to increase in volunteers with atopy 55 and mild asthma (Peden et al., 1997)

. In a more recent study, expression of IL

- 5, a cytokine involved in eosinophil recruitment and activation, was increased in subjects with atopy but not in healthy subjects (Hernandez et al., 2010). Epidemiologic studies describe associations between eosinophils in both short

- (U.S. EPA, 2013, Sect ion 2013 a , s ection 6.2.3.2) and long

- term (U.S. EPA, 2013, Section 2013 a , s ection 7.2.5) O 3 exposure, as do chronic exposure studies in non

human primates. Collectively, findings from these studies suggest that O 3 can induce or enhance certain components of allergic inflam mation in individuals with allergy or allergic asthma. Evidence available in the last review indicates that O 3 may also increase AHR to specific allergen triggers (75 FR 2970, January 19, 2010). Two studies (Jörres et al., 1996; Holz et al. , 2002) observed increased airway responsiveness to O 3 exposure with bronchial allergen challenge in subjects with preexisting allergic airway disease

. Ozone

- induced exacerbation of airway responsiveness persists longer and attenuates more slowly than O 3 - i nduced lung function decrements and respiratory symptom responses and can have important clinical implications for

55 Atopy is a predisposition toward developing certain allergic hypersens itivity reactions. A person with atopy typically presents with one or more of the following: eczema (atopic dermatitis), allergic rhinitis (hay fever), allergic conjunctivitis, or allergic asthma.*** E.O. 12866 Review

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Page 96 of 668 asthmatics

. Animal toxicology studies indicate that O 3 enhances inflammatory and allergic responses to allergen challenge in sensitized anima ls. In addition to exacerbating existing allergic
responses, toxicology studies indicate that O 3 can also act as an adjuvant to produce sensitization in the respiratory tract. Along with its pro - allergic effects (inducing or enhancing certain components of allergic inflam mation in individuals with allergy or allergic asthma ) , O 3 could also make airborne allergens more allergenic. W hen combined with NO 2 , O 3 has been shown to enhance nitration of common protein allergens, which may incr e ase their allergenicity ( Franze et al . (

. , 2005 )

. vii. Hospital admissions and emergency departm ent visits The 2006 O 3 AQCD evaluated numerous studies of respiratory

- related emergency department visits and hospital admissions. These were primarily time

- series studies conducted in the U.S., Canada, Europe, South America, Australia, and Asia. Based on such studies, the 2006
O 3 AQCD concluded that “the overall evidence supports a causal relationship between acute ambient O 3 exposures and increased respiratory morbidity resulting in increased ED emergency department visits and [hospital admissions] during the warm season ” 56 ” ( U.S. EPA, 2006a ) . This conclusion was “strongly supported by the human clinical, animal toxicologic[al], and epidemiologic evidence for [O 3 - induced] lung function decrements, increased respiratory symptoms, airway inflammation, and airway hyperreactivity” ( U.S. EPA , 2006a )

. The results of recent studies largely support the conclusions of the 2006 O 3 AQCD (U.S. EPA, 2013 2013 a , section 6.2.7). Since the completion of the 2006 O 3 AQCD, relatively fewer studies conducted in the U.S., Canada, and Europe have evaluat ed associations between short

-

56 Epidemiologic associations for O 3 are more robust during the warm season than during cooler months (e.g., smaller measurement error, less potential confounding by copollutants). Rationale for focusing on warm season epidemiologic studies for O 3 can be found at 72 FR 37838

- 37840.*** E.O. 12866 Review

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Page 97 of 668 term O 3 concentrations and respiratory hospital admissions and emergency department visits, with a growing number of studies conducted in Asia. This epidemiologic evidence is discussed in detail in the ISA (U.S. EPA, 2013 2013 a , section 6.2.7). 57 In considering this body of evidence, the ISA focused primarily on multicity studies because they examine associations with respiratory

- related hospital admissions and emergency department visits over large geographic areas using consi stent statistical methodologies (U.S. EPA, 2013 2013 a , section 6.2.7.1). The ISA also focused on single

- city studies that encompassed a large number of daily hospital admissions or emergency department visits, included long study

durations, were conducted i n locations not represented by the larger studies, or examined population

- specific characteristics that may impact the risk of O 3 - related health effects but were not evaluated in the larger studies (U.S. EPA, 2013 2013 a , section 6.2.7.1)

. When examining the association between short

- term O 3 exposure and respiratory health effects that require medical attention, the ISA distinguishes between hospital admissions and emergency department visits because it is likely that a small percentage of respiratory emergen cy department visits will be admitted to the hospital; therefore, respiratory emergency department visits may represent potentially less serious, but more common outcomes (U.S. EPA, 2013 2013 a , section 6.2.7.1). Several recent multicity studies (e.g., Cakmak et al., 2006 ; Dales et al., 2006 ) and a multi

- continent stu dy ( Katsouyanni et al., 2009 ) report associations between short

- term O 3 concentrations and increased respiratory

- related hospital admissions and emergency department visits. These multicity studies are supported by res ults from single

- city studies also reporting consistent positive associations using different exposure assignment approaches (i.e., average of

57 The consideration of ambient O 3 concentrations in the locations of these epidemiologic studies are discussed in sections II.D.1.b and II.E.4.a below, for the current standard and alternative standards, respectively.*** E.O. 12866 Review

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Page 98 of 668 multiple monitors, single monitor, population

- weighted average) and averaging times (i.e., 1

- hour max and 8

- hour max) (U.S. EPA, 2013 2013 a , sections 6.2.7.1 to 6.2.7.5). When examining cause

- specific respiratory outcomes, recent studies report positive associations with hospital admissions and emergency department visits for asthma ( Strickland et al., 2010 ; Stieb et al., 2009 ) and COPD chronic obstructive pulmonary disease ( COPD ) ( Stieb et al., 2009 ; Medina

Ramon et al., 2006 ) , with more limited evidence for pneumonia ( Medina

- Ramon et al., 2006 ; Zanobetti and Schwartz, 2006 ) . In seasonal analyses (U.S. EPA, 2013 2013 a , Figure 6

- 19, Table
6

- 28), stronger ass ociations were reported in the warm season or summer months , when O 3 concentrations are higher, compared to the cold season, particularly for asthma ( Strickland et al.,
2010 ; Ito et al., 2007 ) and COPD ( Medina

- Ramon et al., 2006 ) . The available evidence indicates that children are at greatest risk for effects leading to O 3 - associated hospital admission s and emergency department visits ( Silverman and Ito, 2010 ; Mar and Koenig, 2009 ; Villeneuve et al.,
2007 )

. Although the collective evidence across studies indicates a mostly consistent positive association between O 3 exposure and respiratory

- related hospital admissions and ED emergency dep artment visits, the magnitude of these associations may be underestimated due to behavioral modification to the extent members of study populations modify their behavior in response to air quality forecasts , and to the extent such behavior modification increases exposure misclassification (U.S. EPA, 2013, Section 4.6.6). Studies examining the potential confounding effects of copollutants have reported that O 3 effect estimates remained relatively robust upon the inclusion of PM and gaseous pollutants in t wo - pollutant models (U.S. 2013 EPA, 2013 a , Figure
6

- 20, Table 6

- 29). Additional studies that conducted copollutant analyses, but did not present*** E.O. 12866 Review

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Page 99 of 668 quantitative results, also support these conclusions ( Strickland et al., 2010 ; Tolbert et al., 2007 ; Medina

- Ramon et al., 2006 ) (U.S. 2013 EPA, 2013 a , section 6.2.7.5). In the last review, studies had not evaluated the concentration

- response relationship between short

- term O 3 exposure and respiratory

- related hospital admissions and emergency department visits. A preliminary examination of this relationship in studies that have become available since the last review found no evidence of a deviation from linearity when examining the association between short

- term O 3 exposure and asthma hospital admissions (U.S. EPA,
2013 2013 a , page 6

- 157 , and ; Silverman and Ito, 2010 ) . In addition, an examination of the concentration

- response relationship for O 3 exposure and pediatric asthma emergency department visits found no evidence of a threshold at O 3 concentrations as low as 30 ppb (for daily maximum 8

- hour concentrations) ( Strickland et al., 2010 ) . However, in both studies there is uncertainty in the shape of the concentration

- response curve at the lower end of the distribution of O 3 concentrations due to the low density of data in this range (U.S. 2013 EPA, 2013 a , page 6

- 157). viii. Respiratory mortality The controlled human exposure, epidemiologic, and toxicological studies discussed in section 6.2 of the ISA (U.S. EPA, 1013, section 6.2 2 013 a ) provide strong evidence for respiratory morbidity effects, including ED emergency departmen t visits and hospital admissions, in response to short

- term O 3 exposures. Moreover, evidence from experimental studies indicates multiple potential pathways of respiratory effects from short

- term O 3 exposures, which support the continuum of respiratory eff ects that could potentially result in respiratory

- related mortality in adults (U.S. EPA, 1013 2 013 a , section 6.2.8). The 2006 O 3 AQCD found inconsistent evidence for associations between short

- term O 3 concentrations and respiratory mortality ( U.S. EPA,*** E.O. 12866 Review

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Page 100 of 668 2006a ) . Although some studies reported a strong positive associ ation between O 3 and respiratory mortality, additional studies reported small associations or no associations. New epidemiologic evidence for respiratory mortality is discussed in detail in section 6.2.8 of the ISA (U.S. EPA,
2013 2013 a ). The majority of re cent multicity studies have reported positive associations between short

- term O 3 exposures and respiratory mortality, particularly during the summer months (U.S. EPA, 2013 2013 a , Figure 6

- 36). Specifically, recent multicity studies from the U.S. ( Zanobetti and Schwartz, 2008b ) , Europe ( Samoli et al., 2009 ) , Italy ( Stafoggia et al., 2010 ) , and Asia ( Wong et al., 2010 ) , as well as a multi

- continent study ( Katsouyanni et al., 2009 ) , reported associations between short

- term O 3 concentrations and respiratory mortality (U.S. EPA, 2013 2013 a , Figure 6

- 37, page 6

- 259). With respect to respiratory mortality, summer

- only analyses were consistently positive and most were statistically significant. All

- year analyses had more mixed results, but most were positive

. Of the studies evaluated, only the studies by Katsouyanni et al. (2009 ) and by Stafoggia et al. (2010 ) analyzed the potential for copollutant confounding of the O 3 - respiratory mortality relationship. Based on the results of these analyses, the ISA concluded that O 3 respiratory mortality risk estimates appear to be moderately to substantially sensitive (e.g., increased or attenuated) to inclusion of PM 10 . However, in the APHENA study ( Katsouyanni et al., 2009 ) , the mostly ever y - 6th

- day sampling schedule for PM 10 in the Canadian and U.S. datasets greatly reduced their sample size and limits the interpretation of these results (U.S. EPA, 2013 2013 a , section 6.2.8). In summary, recent epidemiologic studies support and reinforce th e epidemiologic evidence for O 3 - associated respiratory hospital admissions and emergency department visits from the last review. In addition, the evidence for associations with respiratory mortality has*** E.O. 12866 Review

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Page 101 of 668 been strengthened considerably since the last review, with the addition of several large multicity studies. The biological plausibility of the associations reported in these studies is supported by the experimental evidence for respiratory effects. b. Respiratory effects

– long

- term S ince the last review, the body of evidence indicating the occurrence of respiratory effects due to long

- term O 3 exposure has been considerably strengthened. This evidence is discussed in detail in the ISA (U.S. EPA, 2013 2013 a , Chapter 7) and summarized bel ow for

new - onset asthma and asthma prevalence, asthma hospital admissions, pulmonary structure and function, and respiratory mortality. i. New

- onset asthma and asthma prevalence Asthma is a heterogeneous disease with a high degree of temporal variabilit y. The on

- set, progression, and symptoms can vary within an individual’s lifetime, and the course of asthma may vary markedly in young children, older children, adolescents, and adults. In the previous review, longitudinal cohort studies that examined asso ciations between long

- term O 3 exposures and the onset of asthma in adults and children indicated a direct effect of long

- term O 3 exposures on asthma risk in adults (McDonnell et al., 1999 , 15

- year follow

- up ; Greer et al., 1993 , 10

- year follow

- up ) and effec t modification by O 3 in children (McConnell et al., 2002). Since that review, additional studies have evaluated associations with new evidence has become available about the association between long

- term exposures to O 3 and new

- onset asthma that has increa sed , further informing our understanding of the potential gene - environment interaction and the interactions, mechanisms , and biological pathways most relevant to assessing O 3 - related effects. associated with incident asthma

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Page 102 of 668 In children, the relationship between long

- term O 3 exposure and new

- onset asthma has been extensively studied in the Children’s Health Study ( CHS ), a long

- term study that was initiated in the early 1990’s which has evaluated effects in several cohorts of children. The CHS was initially designed to examine whether long

- term exposure to ambient pollution was related to chronic respiratory outcomes in children in 12 communities in southern California. In th e CHS , new - onset asthma was classified as having no prior history of asthma at study entry with subsequent report of physician

- diagnosed asthma at follow

- up, with the date of onset assigned to be the midpoint of the interval between the interview date when asthma diagnosis was first reported and the previous interview date. The results of one study (McConnell et al., 2002) available in the previous review indicated that within high O 3 communities, asthma risk was 3.3 times greater for children who played three or more outdoor sports as compared with children who played no sports. For thi s review, as discussed in section 7.2.1.1 of the ISA (U.S. EPA 2013 , 2013 a ), r ecent studies from the CHS provide evidence for gene

- environment interactions in effects on new

onset asthma by indicating that the lower risks associated with specific genetic v ariants are found in children who live in lower O 3 communities. These studies indicate that the r isk for new

- onset asthma is related in part to genetic susceptibility, as well as behavioral factors and environmental
exposure. The onset of a chronic disease , such as asthma, is partially the result of a sequence of biochemical reactions involving exposures to various environmental agents metabolized by enzymes related to a number of different genes. Oxidative stress has been p roposed to underlie the mechanist ic hypotheses related to O 3 exposure . Genetic variants may impact disease risk directly, or modify disease risk by affecting internal dose of pollutants and other environmental agents and/or their reaction products, or by altering cellular and molecular mo des of action.*** E.O. 12866 Review

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Page 103 of 668 Understanding the relation between genetic polymorphisms and environmental exposure can help identify high

- risk subgroups in the population and provide better insight into pathway mechanisms for these complex diseases.

The CHS analyses (Islam et al., 2008 ; Islam et al

. . , 2009; Salam et al., 2009 ) have found that asthma risk is related to interactions between O 3 and variants in genes for enzymes such as heme

- oxygenase (HO

- 1), arginases (ARG1 and 2), and gluta thione S transferase P1 (GSTP1 ) . Biological plausibility for these findings is provided by evidence that these enzymes have antioxidant and/or anti

- inflammatory a ctivity and participate in well

- recognized modes of action in asthma pathogenesis. As O 3 is a source of oxidants in the airw ays, oxidative stress serves as the link among O 3 exposure, enzyme activity, and asthma. Further , several lines of evidence demonstrate that secondary oxidation products of O 3 initiate the key modes of action that mediate downstream health effects ( ISA, Se ction 5.3 , U.S. EPA, 2013 2013 a, section 5.3 ). For example, HO

- 1 responds rapidly to oxidants, has anti

- inflammatory and anti oxidant effects, relaxes airway smooth muscle, and is induced in the airways during asthma. Cross

- sectional studies by Akinbami et al. (2010 ) and Hwang et al. (2005 ) provide further evidence relating O 3 exposures with asthma prevalence. Gene

- environ ment interactions are discussed in detail in Section 5.4.2.1 in the ISA ( U.S. EPA, 2013 2013 a )

. ii. Asthma hospital admissions In the 2006 AQCD, studies on O 3 - related hospital discharges and emergency department (ED) visits for asthma and respiratory dise ase mainly looked at short

- term ( daily ) metric s . T he short

- term O 3 studies presented in section 6.2.7.5 of the ISA (U.S. EPA 2013 , 2013 a ) and discussed above in section 3.1.2.1 continue to indicate that there is evidence for increases in both hospital admissions and ED emergency department visits in children and adults related to all*** E.O. 12866 Review

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Page 104 of 668 respiratory outcomes , including asthma , with stronger associations in the warm months. New studies , discussed in section 7.2.2 of the ISA (U.S. EPA, 2013 2013 a ) also evaluated long

- term O 3 exposure metrics, providing a new line of evidence that suggests a positive exposure

- response relationship between the first hospital admission for asthma and long

- term O 3 exposu re , although the ISA cautions in attributing the associations in that study to long

- term exposures since there is potential for short

- term exposures to contribute to the observed associations

. Evidence associating long

- term O 3 exposure to first asthma hos pital admission in a positive concentration

- response relationship is provided in a retrospective cohort study (Lin et al., 2008b). This study investigated the association between chronic exposure to O 3 and childhood asthma admissions by following a birth c ohort of more than 1.2 million babies born in New York State (1995

- 1999) to first asthma admission or until 31 December 31, 2000. Three annual indicators (all 8

- h our max imum from 10:00 a.m. to 6:00 p.m.) were used to define chronic O 3 exposure: (1) mean co ncentration during the follow

- up period (41.06 ppb); (2) mean concentration during the O 3 season (50.62 ppb); and (3) proportion of follow

- up days with O 3 le vels >70 ppb. The effects of co pollutants were controlled , and i nteraction terms were used to assess potential effect modifications. A positive association between chronic exposure to O 3 and childhood asthma hospital admissions was observed , indicating that children exposed to high O 3 levels over time are more likely to develop asthma severe enough to be admitted to the hospital. The various factors were examined and differences were found for younger children (1

- 2 years),
poor neighborhoods, Medicaid/self

- paid births, geographic region and others. As shown in the ISA, Figure 7

- 3 (U.S. EPA 2013 , 201 3 a , p. 7

- 16), positive concentration

- response relationships were observed

. Asthma admissions were significantly associated with increased O 3 levels for all chronic exposure indicators.*** E.O. 12866 Review

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Page 105 of 668 In considering the relationship between long

- term pollutant exposures and chronic disease heath health endpoints, where chronic pathologies are found with acute expression of chronic disease, Künzli (2012) hypothesizes that if the associations of pollution with events are much larger in the long

- term studies, it provides som e indirect evidence that air pollution increases the pool of subjects with chronic disease, and that more acute events are to be expected to be seen for higher exposures

. The results of Lin et al (2008 a ) for first asthma hospital admission, presented in Fi gure 7

- 3 (U.S. EPA 2013 , 2013 a , p. 7

- 16), show effects estimates that are larger than those reported in a study of childhood asthma hospital admission in New York
state S tate (Silverman and Ito, 2010), discussed in section 3.1.2.1 and 3.1.2.2 above. The ISA (U.S. EPA, 2013 2013 a , p. 7

- 16) notes that this provides some support for the hypothesis that O 3 exposure may not only have triggered the events but also increased the pool of asthmatic children, but cautions in attributing the associations in the Lin et a l. (2008) study to long

- term exposures since there is potential for short

- term exposures to contribute to the observed associations

. iii. Pulmonary structure and function In the 2006 O 3 AQCD, few epidemiologic studies had investigated the effect of chro nic
O 3 exposure on pulmonary function. The definitive 8

- year follow

- up analysis of the first cohort of the CHS (U.S. EPA, 2013 2013 a , section 7.2.3.1) provided little evidence that long

- term exposure to ambient O 3 was associated with significant deficits in the growth rate of lung function in children. The strongest evidence was for medium

- term effects of extended O 3 exposures over several summer months on lung function (FEV 1 ) in children, i.e., reduced lung function growth being associated with higher ambient O 3 levels. Short

- term O 3 exposure studies presented in the ISA (U.S. EPA , 2013, Section 6.2.1.2), and above in 2013 a , section 3.1 6 .2 .1 , .2 )*** E.O. 12866 Review

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Page 106 of 668 provide a cumulative body of epidemiologic evidence that strongly supports associations between ambient O 3 exp osure and decrements in lung function among children. A later CHS study (Islam et al., 2007) included in this review (U.S. EPA, 2013 2013 a , section 7.2.3.1) also reported no substantial differences in the effect of O 3 on lung function. However, in a more

re cent CHS study, Breton et al. (2011) hypothesized that genetic variation in genes on the glutathione metabolic pathway may influence the association between ambient air pollutant exposures and lung function growth in children, and found that variation in t he GSS locus was associated with differences in risk of children for lung function growth deficits associated ambient air pollutants, including O 3 . A recent study (Rojas

- Martinez et al., 2007) of long

- term exposure to O 3, described in section 7.2.3.1 of th e ISA (U.S. EPA, 2013 2013 a , p. 7

- 19), observed a relationship with pulmonary function declines in school

- aged children where O 3 and other pollutant levels were higher (90 ppb at high end of the range) than those in the CHS. Two studies of adult cohorts pro vide mixed results where long

- term exposures were at the high end of the
range. Long

- term studies in animals allow for greater insight into the potential effects of prolonged exposure to O 3 that may not be easily measured in humans, such as structural ch anges in the respiratory tract

. Despite uncertainties, epidemiologic studies observing associations of O 3 exposure with functional changes in humans can attain biological plausibility in conjunction with long

- term toxicological studies, particularly O 3 - inh alation studies performed in non

- human primates whose respiratory systems most closely resembles resemble that of the human. An important series of studies, discussed in section 7.2.3.2 of the ISA (U.S. EPA, 2013 2013 a ), have used nonhuman primates to examine the effect of O 3 alone, or in combination with an inhaled allergen, house dust mite antigen (HDMA), on morphology and lung function. A nimals exhibit*** E.O. 12866 Review

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Page 107 of 668 the hallmarks of allergic asthma defined for humans ( NHLBI, 2007 )

. These studies and others have demonstrated changes in pulmonary function and airway morphology in adult and infant nonhuman primates repeatedly exposed to environ mentally relevant concentrations of O 3 ( U.S. EPA, 2013 2013 a , section 7.2.3.2 , 2013 ). The initial observations in adult nonhuman primates have been expanded in a series of experiments using infant rhesus monkeys repeatedly exposed to 0.5 ppm O 3 starting at 1 month of age ( Plopper et al., 2007 ; Schelegle et al. 2003 )

. The purpose of these studies was to determine if a cyclic regimen of O 3 inhalation would amplify the allergic responses and structural remodeling associated with allergic sensitization and inhalation in the infant rhesus monkey; they provide evidence of an O 3 - induced change in airway resistance and responsiveness provides biological plausibility of long

- term exposure, or r epeated short

- term exposures, to O 3 contributing to the effects of asthma in children. In addition, significant structural changes in the respiratory tract development, during which conducting airways increase in diameter and length, have been observed in infant rhesus monkeys after cyclic exposure to O 3 ( Fanucchi et al., 2006 ) . The se effects are noteworthy because of their potential contribution to airway obstruction and airway hyperresponsiveness AHR which are central features of asthma. A number of studies in both non

human primates and rodents demonstrate that O 3 exposure can increase collagen synthesis and deposition, including fibrotic

- like changes in the lung ( ISA U.S. EPA, 2013 a , section 7.2.3.2 , U.S. EPA, 2013 ). Collectively, evidence from animal studies strongly suggests that chronic O 3 exposure is capable of damaging the distal airways and proximal alveoli, resulting in lung tissue remodeling and leading to apparent irreversible changes. Poten tially, persistent inflammation and interstitial*** E.O. 12866 Review

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Page 108 of 668 remodeling play an important role in the progression and development of chronic lung disease

. Further discussion of the modes of action that lead to O 3 - induced morphological changes can be found in Section s e ction 5.3.7 of the ISA (U.S. EPA, 2013 2013 a ). Discussion of mechanisms involved in lifestage susceptibility and developmental effects can be found in Section s ection 5.4.2.4 of the ISA (U.S. EPA, 2013 2013 a ). The findings reported in chronic animal studies o ffer insight into potential biological mechanisms for the suggested association between seasonal O 3 exposure and reduced lung function development in children as observed in epidemiologic studies ( see Section U.S. EPA, 2013a, s ection 7.2.3.1). iv. Respiratory mortality A limited number of epidemiologic studies have assessed the relationship between long

term exposure to O 3 and mortality in adults. The 2006 O 3 AQCD concluded that an insufficient amount of evidence existed “to suggest a causal relationship between chronic O 3 exposure and increased risk for mortality in humans” ( U.S. EPA, 2006a ). Though total and cardio

- pulmonary mortality were considered in thes e studies, respiratory mortality was not specifically considered. In the most recent follow

- up analysis of the American Cancer Society ( ACS ) cohort (Jerrett et al., 2009), cardiopulmonary deaths were separately subdivided into respiratory and cardiovascu lar deaths, rather than combined as in the Pope et al. (2002) work. Increased O 3 exposure was associated with the risk of death from respiratory causes, and this effect was robust to the inclusion of PM 2.5 . The association between increased O 3 concentratio ns and increased risk of death from respiratory causes was insensitive to the use of different models and to adjustment for several ecologic variables considered individually. The authors reported that when seasonal averages of 1

- hour daily maximum O 3 conc entrations ranged from 33 to 104 ppb, there was no statistical deviation from a linear concentration

- response relationship between O 3 and respiratory*** E.O. 12866 Review

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Page 109 of 668 mortality across 96 U.S. cities (U.S. EPA, 2013 2013 a , section 7.7). However, the authors also evaluated th e degree to which models incorporating thresholds provided a better fit to the data

. Based on these analyses, Jerrett et al. (2009) reported “limited evidence” for an effect threshold
at an O 3 concentration of 56 ppb (p=0.06). Additionally, a recent mult icity time series study (Zanobetti and Schwartz, 2011) , which followed (from 1985 to 2006) four cohorts of Medicare enrollees with chronic conditions that might predispose to O 3 - related effects, observed an association between long

- term (warm season) exposure to O 3 and elevated risk of mortality in the cohort that had previously experienced an emergency hospital admission due to COPD. A key limitation of this study i s the inability to control for PM 2.5 , because data were not available in these cities u ntil 1999

. c. Cardiovascular effects
A relatively small number of studies have examined the potential effect of short

- term O 3 exposure on the cardiovascular system. The 2006 O 3 AQCD ( U.S. EPA, 2006a , p. 8

- 77) concluded that “O 3 directly and/or indirectly contributes to cardiovascular

- related morbidity ” , ” but added that the body of evidence was limited. This conclusion was based on a controlled human exposure study that in cluded hypertensive adult males; a few epidemiologic studies of physiologic effects, heart rate variability, arrhythmias, myocardial infar ctions, and hospital admissions; and toxicological studies of heart rate, heart rhythm, and blood pressure. More recently, the body of scientific evidence available that has examined the effect of
O 3 o n the cardiovascular system has expanded. There is an emerging body of animal toxicological evidence demonstrating that short

- term exposure to O 3 can lead to autonomic nervous system alterations (in heart rate and/or heart rate variability) and suggesting that proinflammatory signals may mediate cardiovascular effects. Interactions of O 3 with respiratory*** E.O. 12866 Review

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Page 110 of 668 tract components result in secondary oxidati on product formation and subsequent production of inflammatory mediators , which have the potential to penetrate the epithelial barrier and to initiate toxic effects systemically. In addition, animal toxicological studies of long

- term exposure to O 3 provide evidence of enhanced atherosclerosis and ischemia/reperfusion ( I/R ) injury, corresponding with development of a systemic oxidative, proinflammatory environment. Recent experimental and epidemiologic studies have investigated O 3 - related cardiovascular even ts and are summarized in Section s ection 6.3 of the ISA (U.S. EPA, 2013 , Section 6.3 2013 a )

. Overall , the ISA summarized the evidence in this review as follows (U.S. EPA, 2013 2013 a , p. 6

- 211). In conclusion, animal toxicological studies demonstrate O 3 - induc ed cardiovascular effects, and support the strong body of epidemiologic evidence indicating O 3 - induced cardiovascular mortality. Animal toxicological and controlled human exposure studies provide evidence for biologically plausible mechanisms underlying th ese O 3 - induced cardiovascular effects. However, a lack of coherence with epidemiologic studies of cardiovascular morbidity remains an important uncertainty. Controlled human exposure studies discussed in previous AQCDs have not demonstrate d any consistent extrapulmonary effects. In this review, evidence from controlled human exposure studies suggests cardiovascular effects in response to short

- term O 3 exposure ( see ISA, U.S. EPA, 2013 , Section 2013 a , s ection 6.3.1) and provides some coherence with evidence from animal toxicology studies. Controlled human exposure studies also support the animal toxicological studies by demonstrating O 3 - induced effects on blood biomarkers of systemic inflammation and oxidative stress, as well as changes in biom arkers that can indicate the potential for increased clotting following O 3 exposures. Increases and decreases in high frequency HRV heart rate variability ( HRV ) have been reported following relatively low (120 ppb during rest) and high (300 ppb with exercis e) O 3 exposures, respectively. These changes in cardiac function observed in animal and human studies provide preliminary evidence for*** E.O. 12866 Review

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Page 111 of 668 O 3 - induced modulation of the autonomic nervous system through the activation of neural reflexes in the lung ( see ISA, U.S. EPA 2013 , Section 2013 a , s ection 5.3.2). Overall, the ISA concludes that the available body of epidemiologic evidence examining the relationship between short

- term exposures to O 3 concentrations and cardiovascular morbidity is inconsistent (U.S. EPA, 2013 , Section 2013 a , s ection 6.3.2.9). Across studies, different definitions , ( i.e., ICD

- 9 diag n ostic codes ) were used for both all

- cause and cause

- specific cardiovascular morbidity ( ISA, U.S. EPA, 2013 , see 2013 a , Tables 6

- 35 to 6

- 39), which may contribute to inconsistency in results. However, within diagnostic categories, no consistent pattern of association was found with O 3 . Generally, the epidemiologic studies used nearest air monitors to assess O 3 concentratio ns, with a few exceptions that used modeling or personal exposure monitors. The inconsistencies in the associations observed between short

- term O 3 and cardiovascular disease ( CVD ) morbidities are unlikely to be explained by the different exposure assignmen t methods used ( see Section 4.6, ISA, U.S. EPA 2013 , 2013 a, section 4.6 ). The wide variety of biomarkers considered and the lack of consistency among definitions used for specific cardiovascular disease endpoints (e.g., arrhythmias, HRV) make comparisons a cross studies difficult

. Despite the inconsistent evidence for an association between O 3 concentration and CVD morbidity, mortality studies indicate a consistent positive association between short

- term O 3 exposure and cardiovascular mortality in multicity studies and in a multi

- continent study. When examining mortality due to cardiovascular disease CVD , epidemiologic studies consistently observe positive associations with short

- term exposure to O 3 . Additionally, there is some evidence for an association between long

- term exposure to O 3 and mortality , although the association between long

- term ambient O 3 concentrations and cardiovascular mortality can be*** E.O. 12866 Review

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Page 112 of 668 confounded by other pollutants as evident by a study of cardiovascular mortality that reported no

assoc iation after adjustment for PM 2.5 concentrations

. The ISA (U.S. EPA 2013 (U.S. EPA, 2013a)

. The ISA (U.S. EPA 2013 a , section 6.3.4) states that taken together, the overall body of evidence across the animal and human studies is sufficient to conclude that t here is likely to be a causal re l ationship between relevant short

- term exposures to O 3 and cardiovascular system effects. d. Total Mortality The 2006 O 3 AQCD concluded that the overall body of evidence was highly suggestive that short

- term exposure to O 3 directly or indirectly contributes to nonaccidental and cardiopulmonary

- related mortality in adults, but additional research was needed to more fully establish underlying mechanisms by which such effects occur (U.S. EPA, 2013 2013 a , p. 2

- 18)

. In building on the 2006 evidence for mortality , the ISA states the following (U.S. EPA,
2013 2013 a , p. 6

- 261).
The evaluation of new multicity studies that examined the association between short

- term O 3 exposures and mortality found evidence that supports the conclusio ns of the 2006 AQCD

. These new studies reported consistent positive associations between short

- term O 3 exposure and all

- cause ( nonaccidental ) mortality, with associations persisting or increasing in magnitude during the warm season, and provide additional support for associations between O 3 exposure and cardiovas cular and respiratory mortality. The 2006 O 3 AQCD reviewed a large number of time

- series studies of associations between short

- term O 3 exposures and total mortality including single

- and multicity studies, and
meta

- analyses. In the large U.S. multicity studies that examined all

- year data, effect estimates corresponding to single

- day lags ranged from a 0.5

- 1% increase in all

- cause (nonaccidental) total mortality per a 20 ppb (24

- hour), 30 ppb (8

- hour maximum), or 40 ppb (1

- hour maximum) increase in ambient O 3 (U.S. EPA, 2013 2013 a , section 6.6.2). Available studies reported some*** E.O. 12866 Review

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Page 113 of 668 evidence for heterogeneity in O 3 mortality risk estimates across cities and across studies. Studies that conducted seasonal a nalyses reported larger O 3 mortality risk estimates during the warm or

summer season. Overall, the 2006 O 3 AQCD identified robust associations between various measures of daily ambient O 3 concentrations and all

- cause mortality, which could not be readily

e xplained by confounding due to time, weather, or copollutants. With regard to cause

- specific mortality, consistent positive associations were reported between short

- term O 3 exposure and cardiovascular mortality, with less consistent evidence for associatio ns with respiratory mortality. The majority of the evidence for associations between O 3 and cause

- specific mortality were from single

- city studies, which had small daily mortality counts and subsequently limited statistical power to detect associations. Th e 2006 O 3 AQCD concluded that “the overall body of evidence is highly suggestive that O 3 directly or indirectly contributes to nonaccidental and cardiopulmonary

- related mortality” (U.S. EPA, 201 3 201 3 a , section 6.6.1)

. Recent studies have strengthened the body of evidence that supports the association between short

- term O 3 concentrations and mortality in adults. This evidence includes a number of studies reporting associations with nonaccidental as well as cause

- specific mortality. Multi

continent and multi city studies have consistently reported positive and statistically significant associations between short

- term O 3 concentrations and all

- cause mortality, with evidence for larger mortality risk estimates during the warm or summer months (U.S. EPA, 2013 2013 a , Figure 6

- 27; Table 6

- 42). Similarly, evaluations of cause

- specific mortality have reported consistently positive associations with O 3 , particularly in analyses restricted to the warm season (U.S. EPA, 2013 2013 a , Figure 6

- 37; Table 6

- 53). 58

58 Respiratory mortality is discussed in more detail above

.*** E.O. 12866 Review

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Page 114 of 668 In assessi ng the evidence for O 3 - related mortality, the 2006 AQCD also noted that multiple uncertainties remained regarding the relationship between short

- term O 3 concentrations and mortality, including the exten t of residual confounding by co pollutants; characteriz ation of the factors that modify the O 3 - mortality association; the appropriate lag structure for identifying
O 3 - mortality effects; and the shape of the O 3 - mortality concentration

- response function and whether a threshold exists

. Many of the studies, publis hed since the last review, have attempted to address one or more of these uncertainties. The ISA (U.S. EPA, 2013; Section 2013 a, s ection 6.6.2) discusses the extent to which recent studies have evaluated these uncertainties in the relationship between O 3 an d mortality

. In particular, recent studies have evaluated different statistical approaches to examine the shape of the O 3 - mortality concentration

- response relationship and to evaluate whether a threshold exists for O 3 - related mortality. In an analysis of the National Morbidity and Mortality Air Pollution Study ( NMMAPS ) data, Bell et al. (2006) evaluated the potential for a threshold in the O 3 - mortality relationship. The authors reported positive and statistically significant associations with mortality in a variety of restricted analyses, including analyses restricted to days with 24

- hour area

- wide average O 3 concentrations below 60, 55, 50, 45, 40, 35, and 30 ppb. In these restricted analyses O 3 effect estimates were of similar magnitude, were statisticall y significant, and had similar statistical precision. In analyses restricted to days with 24

- hour average O 3 concentrations below 25 ppb, the O 3 effect estimate was similar in magnitude to the effect estimates resulting from analyses with the higher cutoff s, but had somewhat lower statistical precision, with the estimate approaching statistical significance (i.e., based on observation of Figure 2 in Bell et al., 2006). In analyses restricted to days with lower 24

- hour average O 3 concentrations (i.e., below 20 and 15 ppb), effect estimates were similar in magnitude*** E.O. 12866 Review

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Page 115 of 668 to analyses with higher cutoffs, but with notably less statistical precision, and were not statistically significant (i.e., confidence intervals included the null, indicating no O 3 - associated
morta lity , based on observation of Figure 2 in Bell et al., 2006). Ozone was no longer positively associated with mortality when the analysis was restricted to days with 24

- hour O 3 concentrations below 10 ppb

. Given the relatively small number of days included in these restricted analyses, especially for cut points of 20 ppb and below, 59 statistical uncertainty is increased

. Bell et al. (2006) also evaluated the shape of the concentration

- response relationship between O 3 and mortality. Although the results of th is analysis suggested the lack of threshold in the O 3 - mortality relationship, the ISA noted that it is difficult to interpret such a curve because: (1) there is uncertainty around the shape of the concentration

- response curve at 24

- hour average
O 3 concentr ations generally below 20 ppb ; and (2) the concentration

- response curve does not take into consideration the heterogeneity in O 3 - mortality risk estimates across cities (U.S. EPA,
2013 2013 a , section 6.6.2.3)

. Several additional studies have used the NMMAPS dataset to evaluate the concentration

response relationship between short

- term O 3 concentrations and mortality. For example, using the same data as Bell et al. ( 2006 ) , Smith et al. ( 2009 ) conducted a subset analysis, but instead of restricting the analysis to days with O 3 concentrations below a cutoff , the authors only included days above a defined cu toff (cutoffs from 15 and 60 ppb)

. The results of this analysis were consistent with those reported by Bell et al. (2006)

. Specifically, the authors reported consistent positive associations for all cutoff concentrations up to concentrations where the tota l number of

59 For exam ple, Bell et al. (2006) reported that for analyses restricted to 24

- hour O 3 concentrations at or below 20 ppb, 73% of days were excluded on average across the 98 communities.*** E.O. 12866 Review

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Page 116 of 668 days available were so limited that the variability around the central estimate was increased (i.e., cutoff values at or above about 50 ppb) (U.S. EPA, 2013 2013 a , section 6.6.2.3). In addition, using NMMAPS data for 1987

- 1994 for Chicago, Pitts burgh, and El Paso, Xia and Tong ( 2006 ) reported evidence for a threshold around a 24

- hour average O 3 concentration of 25 ppb, though the threshold values estimated in the analysis were sometimes in the range of where data density was low (U.S. EPA, 2013 2013 a , section 6.6.2.3). Stylianou and Nicolich ( 2009 ) examined the existence of threshol ds following an approach similar to Xia and Tong ( 2006 ) using data from NMMAPS for nine major U.S. cities (i.e., Baltimore, Chicago, Dallas/Fort Worth, Los Angeles, Miami, New York, Philadelphia, Pittsburgh, and Seatt le) for the years 1987

- 2000. The authors reported that the estimated O 3 - mortality risks varied across the nine cities, with the models exhibiting apparent thresholds in the 10

- 45 ppb range for O 3 (24

- hour average). However, given the city

- to

- city variation in risk estimates, combining the city

- specific estimates into an overall estimate complicate s the interpretation of the results. Additional studies in Europe, Canada, and Asia did not report the existence of a threshold (Katsouyanni et al., 2009), with in consistent and/or inconclusive results across cities, or a non

- linear relationship in the O 3 - mortality concentration

- response curve (Wong et al., 2010)

. 3. Adversity of O 3 Effects In making judgments as to when various O 3 - related effects become regarded as adverse to the health of individuals, in previous NAAQS reviews , the EPA has relied upon the guidelines published by the American Thoracic Society (ATS) and the advice of CASAC. In 2000, the ATS published an official statement on “What Constitutes an A dverse Health Effect of Air Pollution?” (ATS, 2000), which updated and built upon its earlier guidance (ATS, 1985). The earlier guidance defined adverse respiratory health effects as “medically significant physiologic*** E.O. 12866 Review

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Page 117 of 668 changes generally evidenced by one or more of the following: (1) interference with the normal activity of the affected person or persons, (2) episodic respiratory illness, (3) incapacitating illness, (4) permanent respiratory injury, and/or (5) progressive respiratory dysfunction ” , , ” while

rec ognizing that perceptions of “medical significance” and “normal activity” may differ among physicians, lung physiologists and experimental subjects (ATS, 1985). The 2000 ATS guidance builds upon and expands the 1985 definition of adversity in several ways. T he guidance concludes that transient, reversible loss of lung function in combination with respiratory symptoms should be considered adverse

. There is also a more specific consideration of population risk (ATS, 2000). Exposure to air pollution that increases the risk of an adverse effect to the entire population is adverse, even though it may not increase the risk of any individual to an unacceptable level. For example, a po pulation of asthmatics could have a distribution of lung function such that no individual has a level associated with clinically important impairment. Exposure to air pollution could shift the distribution to lower levels that still do not bring any indivi dual to a level that is associated with clinically relevant effects. However, this would be considered to be adverse because individuals within the population would have diminished reserve function, and therefore would be at increased risk to further envir onmental insult (U.S. EPA, 2013 2013 a , p. lxxi; and 75 FR at 35526/2, J une 22, 2010 )

. The ATS also concluded that elevations of biomarkers such as cell types, cytokines and reactive oxygen species may signal risk for ongoing injury and more serious effect s or may simply represent transient responses, illustrating the lack of clear boundaries that separate adverse from nonadverse events. More subtle health outcomes also may be connected mechanistically to health effects that are clearly adverse, so that sma ll changes in physiological measures may not appear clearly adverse when considered alone, but may be part of a coherent*** E.O. 12866 Review

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Page 118 of 668 and biologically plausible chain of related health outcomes that include responses that are clearly adverse, such as mortality ( U.S. EP A, 2014c, section 3.1.2.1 , above )

. In this review, the new evidence provides further support for relationship s between O 3 exposure s and a spectrum of health effects, including effects that meet the ATS criteria for being adverse ( ATS , 1985 and 2000 ) . The ISA judgment determination that there is a causal relationship between short

- term O 3 exposure and a full range of respiratory effects, including respiratory morbidity (e.g., lung function decrements, respiratory symptoms , inflammation , hospital admissions , and emergency department visits ) and mortality , provides support for concluding that short

- term O 3 exposure is associated with adverse effects (U.S. EPA 2013 , 2013 a , section 2.5.2). Overall, including new evidence of cardiovascular system effects, the evi dence supporting an association between short

- term O 3 exposures and total ( nonaccidental , cardiopulmonary) respiratory mortality is stronger in this review (U.S. EPA 2013 , 2013 a , section 2.5.2). And the judgment of likely causal associations between long

- t erm measures of O 3 exposure and respiratory effects such as new

- onset asthma, prevalence of asthma, asthma symptoms and control, and asthma hospital a dmissions provides support for concludin g that long

- term O 3 exposure is associated with adverse effects ra nging from episodic respiratory illness to permanent respiratory injury or progressive respiratory decline (U.S. EPA 2013 , 2013 a , section 7.2.8 ).
A pplication of the ATS guidelines to the least serious category of effects related to ambient O 3 exposures, which are also the most numerous and , therefore , are also potentially important from a public health perspective, involves judgments about which medical experts on CASAC panel s and public commenters have in the past expressed diverse views. To help frame

s uch judgments, in past reviews , the EPA has defined gradations of individual functional*** E.O. 12866 Review

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Page 119 of 668 responses (e.g., decrements in FEV 1 and airway responsiveness) and symptomatic responses (e.g., cough, chest pain, wheeze), together with judgments as to the potential impact on individuals experiencing varying degrees of severity of these responses

. These gradations were used in the 1997 O 3 NAAQS review and slightly revised in the 2008 review ( U.S. EPA, 1996, p. 59; 2007, p.3

- 72; 72 FR 37849, July 11, 2007). These grada tions and impacts are summarized in Tables 3

- 2 and 3

- 3 in the 2007 O 3 Staff Paper ( U.S. EPA, 2007, pp.3

- 74 to 3

- 75). For active healthy people, including children, moderate levels of functional responses (e.g., FEV 1 decrements of ≥ 10% but < 20%, lasting 4 to 24 hours) and/or moderate symptomatic responses (e.g., frequent spontaneous cough, marked discomfort on exercise or deep breath, lasting 4 to 24 hours) would likely interfere with normal activity for relatively few sensitive individuals ( U.S. EPA, 200 7, p.3

- 72; 72 FR 37849, July 11, 2007) ; whereas large functional responses (e.g., FEV 1 decrements ≥ 20%, lasting longer than 24 hours) and/or severe symptomatic responses (e.g., persistent uncontrollable cough, severe discomfort on exercise or deep breath, lasting longer than 24 hours) would likely interfere with normal activities for many sensitive individuals ( U.S. EPA, 2007, p.3

- 72; 72 FR 37849, July 11, 2007) and , therefore , would be considered adverse under ATS guidelines

. For the purpose of estimating potentially adverse lung function decrements in active healthy people in the 2008 O 3 NAAQS review , the
CASAC panel for that review indicated that a focus on the mid to upper end of the range of moderate levels of functional responses is most appropriate ( e.g., FEV 1 decrements ≥ 15% but < 20%) (Henderson, 2006; U.S. EPA, 2007, p. 3

- 76). In this review, CASAC concurred that the “[e]stimation of FEV 1 decrements of ≥15% is appropriate as a scientifically relevant surrogate for adverse health outcomes in active healthy adults ” (Frey, 2014c, p. 3). However, for children and adults with lung disease, even moderate functional (e.g., FEV 1 decrements ≥ 10% but <*** E.O. 12866 Review

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Page 120 of 668 20%, lasting up to 24 hours) or symptomatic responses (e.g., frequent spontaneous cough, marked discomfort on exercise or with deep breath, wheeze accompanied by shortness of breath, lasting up to 24 hours) would likely interfere with normal activity for many individuals, and would likely result in additional and more frequent use of medication ( U.S. EPA, 2007 , p.3

- 72; 72 FR 37849, July 11, 2007) . For people with lung disease, large functional responses (e.g.,
FEV 1 decrements ≥ 20%, lasting longer than 24 hours) and/or severe symptomatic responses (e.g., persistent uncontrollable cough, severe discomfort on exe rcise or deep breath, persistent wheeze accompanied by shortness of breath, lasting longer than 24 hours) would likely interfere with normal activity for most individuals and would increase the likelihood that these individuals would seek medical treatment ( U.S. EPA, 2007, p.3

- 72; 72 FR 37849, July 11, 2007). In the last
O 3 NAAQS review , f

or the purpose of estimating potentially adverse lung function decrements in people with lung disease the CASAC panel indicated that a focus on the lower end of the
range of moderate levels of functional responses is most appropriate (e.g., FEV 1 decrements
≥ 10%) (Henderson, 2006; U.S. EPA , 2007 , p. 3

- 76). In addition, in the ir letter advising the Administrator on the reconsideration of the 2008 final decision, CASAC stated that “[a] 10% decrement in FEV1 can lead to respiratory symptoms, especially in individuals with pre

- existing pulmonary or cardiac disease. For example, people with chronic obstructive pulmonary disease have decreased ventilatory reserve (i.e., decreased b aseline FEV 1 ) such that a ≥10% decrement could lead to moderate to severe respiratory symptoms” (Samet, 2011 ) (section 3.1.2.1, above). ). In this review, CASAC concurred that “[a]n FEV1 decrement of ≥10% is a scientifically relevant surrogate for adverse h ealth outcomes for people with asthma and lung disease” (Frey, 2014c, p. 3).*** E.O. 12866 Review

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Page 121 of 668 In judging the extent to which these impacts represent effects that should be regarded as adverse to the health status of individuals, in previous NAAQS reviews , the EPA has also considered whether effects we re experienced repeatedly during the course of a year or only on a single occasion (U.S. EPA, 2007)

. Although some experts would judge single occurrences of moderate responses to be a nuisance, especially for healthy individua ls, a more general consensus view of the adversity of such moderate responses emerges as the frequency of occurrence increases. Thus it has been judged that repeated occurrences of moderate responses, even in otherwise healthy individuals, may be considered to be adverse since they could well set the stage for more serious illness (61 FR 65723). The CASAC panel in the 1997 NAAQS review expressed a consensus view that these “criteria for the determination of an adverse physiological
response were re asonable” (Wolff, 1995). In the review completed in 2008, estimates of repeated occurrences continued to be an important public health policy factor in judging the adversity of moderate lung function decrements in healthy and asthmatic people (72 FR 37850, July 11, 2007)

. Evidence new to this review indicates that 6.6

- hour exposures to 60 ppb O 3 during moderate exertion can result in pulmonary inflammation in healthy adults

. (based on study mean)

. As discussed in section 3.1.2 above the ISA , the initiation of inflammation can be considered as evidence that injury has occurred. Inflammation induced by a single O 3 exposure can resolve entir ely , but , as noted in the ISA (U.S. EPA, 2013a, p. 6

- 76), “ continued acute inflammation can evolve into a chronic inflam matory state (ISA, U.S. EPA, 2013, p. 6

- 76), , ” which is clearly would be adverse. Responses measured in controlled human exposure studies indicate that the range of effects elicited in humans exposed to ambient O 3 concentrations include: decreased inspiratory*** E.O. 12866 Review

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Page 122 of 668 capacity; mild bronchoconstriction; rapid, shallow breathing pattern during exercise; and symptoms of cough and pain on deep inspiration ( U.S. EPA, 2013 2013 a , section 6.2.1.1). Some
young Y oung , healthy adults exposed for 6.6 hours to O 3 concentrations ≥ 60 ppb , while engaged
in 6.6 hours of intermittent moderate exertion, develop reversible, transient decrements in lung function , . In addition, depending on the exposure concentration and the duration of exposure , young healthy adults have been shown to experience symptoms of breathing discomfort , and inflammation if minute ventilation or duration of exposure is increased sufficiently ( U.S. EPA, 2013 2013 a , section 6.2.1.1). Among healthy subjects there is considerable interindividual variability in the magnitude of the FEV 1 responses, but when data were combined across studies at 60 ppb (U.S. EPA , 2013 2013 a , pp. 6

- 17 to 6

- 18), 10% of healthy subjects had >10% FEV 1 decrements. Moreover, consistent with the f indings of the ISA (U.S. EPA , 2013 2013 a , section 6.2.1.1), CASAC concluded that “[a]sthmatic subjects appear to be at least as sensitive, if not more sensitive, than non

- asthmatic subjects in manifesting ozone

- induced pulmonary function decrements” (Frey, 2014c, p. 4). The combination of l ung function decrements and respiratory symptoms , which has been considered adverse in previous reviews, ha s been demonstrated in healthy adults following prolonged (6.6 hour) exposures , while at intermittent moderate exer tion, to 72 ppb

. For these types of effects, information from controlled human exposure studies , which provides an indication of the magnitude and thus adversity of effects at different O 3 concentrations, combined with estimates of occurrences in the popul ation from the HREA , provide information about their importance from a policy perspective.
4

. O zone - Related Impacts on Public Health Setting standards to provide appropriate public health protection requires consideration of the factors that put populations at greater risk from O 3 exposure. In order to estimate the potential for public health impacts, it is important to consider not only the adversity of the health*** E.O. 12866 Review

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Page 123 of 668 effects, but also the populations at greater risk and potential behaviors that may reduce
exposures. a. Identification of at

- risk populations and lifestages The currently available evidence expands the understanding of populations that were identified to be at greater risk of O 3 - related health effects at the time of the last review (i. e., people who are active outdoors, people with lung disease, children and older adults and people with increased responsiveness to O 3 ) and supports the identification of additional factors that may lead to increased risk (U.S. EPA , 2006, section 3.6.2; U. S. EPA, 2013, chapter 2013 a , C hapter 8). P opulations and lifestages may be at greater risk for O 3 - related health effects due to factors that contribute to the ir susceptibility and/or vulnerability to O 3 . The definitions of susceptibility and vulnerability h ave been found to vary across studies, but in most instances “susceptibility” refers to biological or intrinsic factors (e.g., lifestage, sex, preexisting disease/conditions) while “vulnerability” refers to non

- biological or extrinsic factors (e.g., socioe conomic status [SES]) (U.S. EPA, 2013 2013 a , p. 8

- 1; U.S. EPA, 2010c, 2009d)

. In some cases, the terms “at

- risk” and “sensitive” have been used to encompass these concepts more generally. In t he ISA and PA, “at

- risk” is the all

- encompassing term used to def ine groups with specific factors that increase the ir risk of O 3 - related health effects. There are multiple avenues by which groups may experience increased risk for O 3 - induced health effects. A population or lifestage 60 may exhibit greater effects than other populations or lifestages exposed to the same concentration or dose, or they may be at greater risk due to increased exposure to an air pollutant (e.g., time spent outdoors). A group with

60 Lifestages, which in this case includes childhood and older adulthood, are experienced by most people over the course of a lifetime, unlike other factors associated with at

- risk populations.*** E.O. 12866 Review

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Page 124 of 668 i ntrinsically increased risk would have some factor(s) t h at increases risk through a biological mechanism and, i n general, would have a steeper concentration

- risk relationship, compared to those not in the group . F actors that are often considered intrinsic include pre - existing asthma, genetic background , and lif estage

. A group of people could also have extrinsically increased risk, which would be through an external, non

- biological factor , such as socioeconomic status ( SES ) and diet. Some groups are at risk of i ncreased internal dose at a given exposure concentra tion, for example , because of breathing pattern s . This category would include p eople who work or exercise outdoors. Finally, there are those who might be placed at increased risk for experiencing greater exposure s by being exposed to higher O 3 concentratio n s . This would include, for example, groups of people with greater exposure to ambient O 3 due to less availability or use of home air conditioners such that they are more likely to be in locations with open windows on high O 3 days

. Some groups may be at increased risk of O 3 - re lated health effect s through a combination of factors . For example, children tend to spend more time outdoors when O 3 levels are high, and at higher levels of activity than adults, which leads to increased exposure a nd dose , and they also have biological, or intrinsic, risk factors (e.g., their lungs are still developing) (U.S. EPA, 2013 2013 a , Chapter 8 )

. An at

- risk population or lifestage is more likely to experience adverse health effects related to O 3 exposures and /or, develop more severe effects from exposure than the general population. i. People with Specific Genetic Variants
T here is ad equate evidence for populations with certain genotypes being more at

- risk than others to the effects of O 3 exposure on health (U.S. EPA, 2013 2013 a , section 8.1)

. Controlled human exposure and epidemiologic studies have reported evidence of O 3 - related increases in respiratory symptoms or decreases in lung function with variants including GSTM1,*** E.O. 12866 Review

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Page 125 of 668 GSTP1, HMOX1, and NQO1. NQO1 deficient mice were found to be resistant to O 3 - induced AHR and inflammation, providing biological plausibility for results of studies in humans. Additionally, studies of rodents have identified a number of other genes that may affect O 3 - related health out comes, including genes related to innate immune signaling and pro

- and anti

inflammatory genes, which have not been investigated in human studies

. ii. People with Asthma Previous O 3 AQCDs identified individuals with asthma as a population at increased ri sk of O 3 - related health effects. Multiple new epidemiologic studies included in the ISA have evaluated the potential for increased risk of O 3 - related health effects in people with asthma, including: lung function; symptoms; medication use; airway hyperresp onsiveness ( AHR ); ; and airway inflammation (also measured as exhaled nitric oxide fraction, or FeNO) . A study of lifeguards in Texas reported decreased lung function with short

- term O 3 exposure among both indi viduals with and without asthma; however, the d ecrease was greater among those with asthma ( Thaller et al., 2008) . A Mexican study of children ages 6

- 14 detected an association between short

- term O 3 exposure and wheeze, cough, and bronchodilator use among asthmatics but no t non

- asthmatics, although this may have been the result of a small non

- asthmatic population ( Escamilla

- Nuñez et al., 2008) . A study of modification by AHR (a n obligate condition among asthmatics) reported grea ter short

- term O 3 - associated decreases in lung function in elderly individuals with AHR, especially among those who were obese ( Alexeeff et al., 2007 )

. With respect to airway inflammation, in one study, a positive association was reported for airway inflammation among asthmatic children following short

- term O 3 exposure, but the observed association was similar in magnitude to that of non

- asthmatics ( Barraza

- Villarreal et al., 2008 ) . Similarly, a nother study of children in California reported an association between O 3*** E.O. 12866 Review

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Page 126 of 668 concentration and FeNO that persisted both among childr en with and without asthma as well as those with and without respiratory allergy ( Berhane et al., 2011 )

. Finally, Khatri et al. ( 2009 ) found no association between short

- term O 3 exposure and alt ered lung function for either asthmatic or non

- asthmatic adults, but did note a decrease in lung function among individuals with allergies

. New e vidence for difference in effects among asthmatics has been observed in studies that examined the association between O 3 exposure and altered lung function by asthma medication use. A study of children with asthma living in Detroit reported a greater association between short

- term O 3 and lung function ( i.e., FEV 1 ) for corticosteroid users compared with noncorticosteroid users ( Lewis et al., 2005 ) . Co nversely, another study found decreased lung function among noncorticosteroid users compared to users, although in this study, a large proportion of non

- users were considered to be persistent asthmatics ( Hernández

- Cadena et al., 2009 )

. Lung function was not related to short

- term O 3 exposure among corticosteroid users and

non - users in a study taking place during the winter months in Canada ( Liu et al., 2009 )

. Additionally, a study of airway inflammation reported a counterintuitive inverse association with
O 3 of similar magnitude for all groups of corticosteroid users and non

- users ( Qian et al., 2009 )

. Controlled human exposure studies that have examined the effects of O 3 on adults with asthma and healthy controls are limited. Based on studies reviewed in the 1996 and 2006 O 3 AQCDs, subjects with asthma appeared to be more s ensitive to acute effects of O 3 in terms of
FEV 1 and inflammatory responses than healthy non

- asthmatic subjects. For instance, Horstman et al. ( 1995 ) observed that mild

- to

- moderate asthmatics, on average, experienced double the
O 3 - induce d FEV 1 decrement of healthy subjects (19% versus 10%, respectively, p = 0.04)

. Moreover, a statistically significant positive correlation between FEV 1 responses to O 3 exposure*** E.O. 12866 Review

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Page 127 of 668 and baseline lung function was observed in individuals with asthma, i.e., respon ses increased with severity of disease. Minimal evidence exists suggesting that individuals with asthma have smaller O 3 - induced FEV 1 decrements than healthy subjects (3% versus 8%, respectively) ( Mudway et al., 2001 )

. However, the asthmatics in that study also tended to be older than the healthy subjects, which could partially explain their lesser response since FE V 1 responses to O 3 exposure diminish with age. Individuals with asthma also had significantly more neutrophils in the BALF (18 hours postexposure) than similarly exposed healthy individuals ( Peden et al., 1997 ; Scannell et al., 1996 ; Basha et al., 1994 )

. Furthermore, a study examining the effects of O 3 on individuals with atopic asthma and healthy controls reported that greater numbers of neutrophils, higher levels of cytokines and hyaluronan, and gre ater expression of macrophage cell

- surface markers were observed in induced sputum of atopic asthmatics compared with healthy controls ( Hernandez et al., 2010 )

. Differences in O 3 - induced epithelial cytokine expression were noted in bronchial biopsy samples from asthmatics and healthy controls ( Bosson et al., 2003 )

. Cell

- surface marker and cytokine expression results, and the presence of hyaluronan, are consistent with O 3 having greater effects on innate an d adaptive immunity in these asthmatic individuals. In addition, studies have demonstrated that O 3 exposure leads to increased bronchial reactivity to inhaled allergens in mild allergic asthmatics ( Kehrl et al., 1999 ; Jorres et al., 1996 ) and to the influx of eosinophils in individuals with pre

- existing allergic disease ( Vagaggini et al., 2002 ; Peden et al., 1995 )

. Taken together, these results point to several mechanistic pathways which co uld account for the enhanced sensitivity to O 3 in subjects with asthma ( see Section 5.4.2.2 in U.S. EPA, 2013 2013 a, section 5.4.2.2 ). As noted in the previous review (72 FR 37846, July 11, 2007) asthmatics present a differential response profile for cellular, molecular, and biochemical parameters (U.S. EPA,*** E.O. 12866 Review

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Page 128 of 668 2006a, Figure 8

– 1) that are altered in response to acute O 3 exposure. Ozone

- induced increases in neutrophils, IL

– 8 and protein were found to be significantly higher in the BAL fluid from asthmatics compared to healthy subjects, suggesting mechanisms for the increased sensitivity of asthmatics ( Basha et al. , 1994 ; McBride et al. , 1994 ; Scannell et al. , 1996 ; Hiltermann et al. , 1999 ; Holz et al. , 1999 ; Bosson et al. , 2003 ). Neutrophils, or PMNs, are the white blood cell most associated with inflammation. IL

– 8 is an inflammatory cytokine with a number of biological effects, primarily on neutrophils. The major role of this cytokine is to attract and activate neutrophils. Protein in the airways is leaked from the circulatory system, and is a marker for increased cellular permeability. Bronchial constriction following provocation with O 3 and/or allergens presents a two

phase response. The early response is mediated by release of histamine and leukotrienes that leads to contraction of smooth muscle cells in the bronchi, narrowing the lumen and decreasing the airflow. In people with allergic airway disease, including people with rhinitis and asthma, these mediators also cause accumulation of eosinophils in th e airways ( Bascom et al. , 1990 ; Jorres et al. , 1996 ; Peden et al. , 1995 and 1997; Frampton et al. , 1997a ; Michelson et al. , 1999; Hiltermann et al. , 1999 ; Holz et al. , 2002; Vagaggini et al. , 2002 ). In asthma, the eosinophil, which increases inflammation a nd allergic responses, is the cell most frequently associated with exacerbations of the disease. A study by Bosson et al. (2003 ) evaluated the difference in O 3 - induced bronchial epithelial cytokine expression between healthy and asthmatic subjects. After
O 3 exposure the epithelial expression of IL

– 5 and GM

- CSF increased significantly in asthmatics, compared to healthy subjects. Asthma is associated with Th2

- related airway response (allergic response), and IL

– 5 is an important Th2

- related cytokine. The O 3 - in duced increase in IL

– 5, and also in GM

- CSF, which affects the growth, activation and survival of eosinophils, may indicate*** E.O. 12866 Review

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Page 129 of 668 an effect on the Th2

- related airway response and on airway eosinophils. The authors reported that the O 3 - induced Th2

- related cytokine responses that were found within the asthmatic group may indicate a worsening of their asthmatic airway inflammation and thus suggest a plausible link to epidemiological data indicating O 3 - associated increases in bronchial reactivity and hospital admissio ns. The accumulation of eosinophils in the airways of asthmatics is followed by production of mucus and a late

- phase bronchial constriction and reduced airflow. In a study of 16 intermittent asthmatics, Hiltermann et al. (1999) found that there was a signi ficant inverse correlation between the O 3 - induced change in the percentage of eosinophils in induced sputum and the change in PC20, the concentration of methacholine causing a 20% decrease in FEV 1 . Characteristic O 3 - induced inflammatory airway neutrophilia at one time was considered a leading mechanism of airway hyperresponsiveness. However, Hiltermann et al. (1999) determined that the O 3 - induced change in percentage neutrophils in sputum was not significantly related to the change in PC20. These results ar e consistent with the results of Zhang et al. (1995), which found neutrophilia in a murine model to be only coincidentally associated with airway hyperresponsiveness, i.e. , there was no cause and effect relationship (U.S. EPA, 2006a, AX 6

– 26). Hiltermann e t al. (1999 ) concluded that the results point to the role of eosinophils in O 3 - induced airway hyperresponsiveness. Increases in O 3 - induced nonspecific airway responsiveness incidence and duration could have important clinical implications for asthmatics. Toxicological studies provide additional evidence of the biological basis for the greater effects of O 3 among those with asthma or AHR (U.S. EPA, 2013 2013 a , section 8.2.2) . In animal toxicological studies, an asthmatic phenotype is modeled by allergic sensitization of the respiratory tract. Many of the studies that provide evidence that O 3 exposure is an inducer of*** E.O. 12866 Review

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Page 130 of 668 AHR and remodeling utilize these types of animal models. For example, a series of experiments in infant rhesus monkeys have shown these effe cts, but only in monkeys sensitized to house dust mite allergen. Similarly, adverse changes in pulmonary function were demonstrated in mice exposed to O 3 ; enhanced inflammatory responses were in rats exposed to O 3 , but only in animals sensitized to allerge n. In general, it is the combined effects of O 3 and allergic sensitization which result in measurable effects on pulmonary function. In a pulmonary fibrosis model, exposure to O 3 for 5 days increased pulmonary inflammation and fibrosis, along with the freq uency of bronchopneumonia in rats. Thus, short

- term exposure to O 3 may enhance damage in a previously injured lung (U.S. EPA, 2013 2013 a , section 8.2.2)

. In the 2006 O 3 AQCD, the potential for individuals with asthma to have greater risk of
O 3 - related hea lth effects was supported by a number of controlled human exposure studies, evidence from toxicological studies, and a limited number of epidemiologic studies. In section 8.2.2, the ISA reports that in the recent epidemiologic literature some, but not all, studies report greater risk of health effects among individuals with asthma. Studies examining effect measure modification of the relationship between short

- term O 3 exposure and altered lung function by corticosteroid use provided limited evidence of O 3 - r elated health effects. However , recent studies of behavioral responses have found that studies do not take into account individual behavioral adaptations to forecasted air pollution levels (such as avoidance and reduced time outdoors), which may underestim ate the observed associations in studies that examined the effect of O 3 exposure on respiratory health ( Neidell and Kinney, 2010)

. This could explain some inconsistenc y observed among recent epidemiologic studies. The evidence from controlled human exposure studies provides support for increased detriments in FEV 1 and greater inflammatory responses to O 3 in individuals with asthma than in healthy individuals without a*** E.O. 12866 Review

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Page 131 of 668 history of asthma. The collective evidence for increased risk of O 3 - related health effects among individuals with asthma from controlled human exposure studies is supported by recent toxicol ogical studies which provide biological plausibility for heightened risk of asthmatics to respiratory effects due to O 3 exposure. Overall, the ISA finds there is adequate evidence for asthmatics to be an at

- risk population

. iii. Children Children are con sidered to be at greater risk from O 3 exposure because their respiratory systems undergo lung growth until about 18

- 20 years of age and are therefore thought to be intrinsically more at risk for O 3 - induced damage ( U.S. EPA, 2006a ) . It is generally recognized that children spend more time outdoors than adults, and , the refore , would be expected to have higher exposure to O 3 than adults. Children aged 11 years and older and adults have higher absolute ventilation rates than younger children aged 1

- 11 years. However, younger children have higher ventilation rates relative to their lung volumes, which tends to increase dose normalized to lung surface area. In all ages, e xercise intensity has a substantial effect on ventilation rate, high intensity activity result s in nearly double the ventilation rate for moderate activity. For more information on time spent outdoors and ventilation rate differences by age
group, see Section s ection 4. 4.1 in the ISA (U.S. EPA, 2013)

. 2013 a )

. The 1996 O 3 AQCD reported clinical evidence that children, adolescents, and young adults (< 18 years of age) appear, on average, to have nearly equivalent spirometric responses to
O 3 exposure, but have greater responses than middle

- aged and older adults ( U.S. EPA, 1996 )

. Symptomatic responses (e.g., cough, shortness of breath, pain on deep inspir ation) to O 3 exposure, however, appear to increase with age until early adulthood and then gradually decrease with increasing age ( U.S. EPA, 1996 ) . Complete lung growth and development is not achieved*** E.O. 12866 Review

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Page 132 of 6 68 u ntil 18

- 20 years of age in women and the early 20s for men; pulmonary function is at its maximum during this time as well. Recent epidemiologic studies have examined different age groups and their risk to
O 3 - related respiratory hospital admissions and emergency department (ED) visits. Evidence for greater r isk in children was reported in several studies. A study in Cyprus of short

- term O 3 concentrations and respiratory hospital admissions ( HA ) detected possible effect measure modification by age with a larger association among individuals < 15 years of age c ompared with those > 15 years of age ; the effect was apparent only with a 2

- day lag (Middleton et al., 2008) . Similarly, a Canadian study of asthma

- ED related emergency department visits reported the strongest O 3 - related associations among 5

- to 14

- year old s compared to the other age groups (ages examined 0

- 75+) ( Villeneuve et al., 2007 ) . Greater O 3 - associated risk in asthma

- related
ED emergency department visits were also reported among children (< 15 years) as compared to adults (15 to 64 years) in a study from Finland ( Halonen et al., 2009 ) . A study of New York City hospital admissions demonstrated an increase in the association between O 3 exposure and asthma

- related hospital admissions for 6

- to 18

- year olds compared to those < 6 years old and those > 18 years old ( Silverman and Ito, 2010 )

. When examining long

- term O 3 exposure and asthma HA

- related hospital admissions among ch ildren, associations were determined to be larger among children 1 to 2 years old compared to children 2 to 6 years old ( Lin et al., 2008 ) . A few studies report ed positive associations among both children and adults and no modification of the effect by age

. The evidence reported in epidemiologic studies is supported by recent toxicological studies which observed O 3 - induced health effects in immature animals. Ea rly life exposures of multiple species of laboratory animals, including infant monkeys, resulted in changes in*** E.O. 12866 Review

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Page 133 of 668 conducting airways at the cellular, functional, ultra

- structural, and morphological levels. The studies conducted on infant monkeys are most rele vant for assessing effects in children. Carey et al. ( 2007 ) conducted a study of O 3 exposure in infant rhesus macaques, whose respiratory tract closely resemble that of humans. Monkeys were exposed either acutely o r in epi sodes designed to mimi c human exposure

. All monkeys acutely exposed to O 3 had moderate to marked necrotizing rhinitis, with focal regions of epithelial exfoliation, numerous in filtrating neutrophils, and some eosinophils. The distribution, character, and severity of lesions in episodically exposed infant monkeys were similar to that of acutely exposed animals. Neither exposure protocol for the infant monkeys produced mucous cell metaplasia proximal to the lesions, an adaptation observed in adult monkeys exposed in another study ( Harkema et al., 1987 )

. Functional and cellular changes in conducting airways were common manifestations of exposure to O 3 among both the adult and infant monkeys ( Plopper et al., 2007 )

. In addition, the lung growth of the distal conducting airways in the infant monkeys was significantly stunted by O 3 and this aberrant development was persistent 6 months postexposure (Fanucchi et al., 2006)

. Age may also affect the inflammatory response to O 3 exposure. Toxicological studies reported that the difference in effects among younger lifestage test animals may be due to
age - related changes in antioxidants levels and sensitivity to oxidative stress. Further discussion of these studies may be found in section 8.3.1.1 of the ISA (U.S. EPA, 2013 2013 a , p. 8

- 18)

. The previous and recent human clinical and toxicological studies reported evidence of increased risk from O 3 exposure for younger ages, which provides coherence and biological plausibility for the findings from epidemiologic studies. Although there was some inconsistency, generally, the epidemiologic studies reported positive associations among both children and adults or just among children. The interpretation of these studies is limited by the lack of*** E.O. 12866 Review

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Page 134 of 668 consistency in comparison age groups and outcomes examin ed. However, overall, the epidemiologic, controlled human exposure, and toxicological studies provide adequate evidence that children are potentially at increased risk of O 3 - related health effects. iv. Older adults The ISA notes that o lder adults are at greater risk of health effects associated with O 3 exposure through a variety of intrinsic pathways (U.S. EPA, 2013 2013 a , section 8.3.1.2) . In addition, older adults may differ in their exposure and internal dose. Older adults were outdoors for a slightly l onger proportion of the day than adults aged 18

- 64 years. For more information on time spent outdoors by age group, see Section 4. 4 in the ISA (U.S. EPA, 2013 2013 a ) . The gradual decline in physiological processes that occur s with aging may lead to increase d risk of
O 3 - related health effects ( U.S. EPA, 2006a ) . Respiratory symptom responses to O 3 exposure appears to increase with age until early adulthood and then gradually decrease with increasin g
age ( U.S. EPA, 1996 ) ; lung function responses to O 3 exposure also decline from early adulthood (U.S. EPA, 1996). The reductions of these responses with age may put older adults at increased risk for continued O 3 exposure. In addition, older adults, in ge neral, have a higher prevalence of preexisting diseases compared to younger age groups and this may also lead to increased risk of
O 3 - related health effects (U.S. EPA, 2013 2013 a , section 8.3.1.2)

. With the number of older Americans increasing in upcoming years (estimated to increase from 12.4% of the U.S. population to 19.7% between 2000 to 2030, which is approximately 35 million and 71.5 million individuals, respectively) this group represents a large population potentially at risk of O 3 - related health ef fects ( SSDAN CensusScope, 2010a ; U.S. Census Bureau, 2010 )

. The majority of recent studies reported greater effects of short

- term O 3 exposure and mortality among older adults, which is consistent with the finding s of the 2006 O 3 AQCD. A*** E.O. 12866 Review

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Page 135 of 668 study (Medina

- Ramón and Schwartz, 2008) conducted in 48 cities across the U.S. reported larger effects among adults ≥65 years old compared to those < 65 years . F urther investigation of thi s study population revealed a trend of O 3 - related mortality risk that gets larger with increasing age starting at age 51 (Zanobetti and Schwartz, 2008 2008 a )

. A nother study conducted in 7 urban centers in Chile reported similar results, with greater effects in adults ≥65 years old (Cakmak et al., 2007)

. More recently, a study conducted in the same area reported similar associations between O 3 exposure and mortality in adults aged < 64 ye ars old and 65 to 74 years old, but the risk was increased among the older age group (Cakmak et al., 2011)

. A study performed in China reported greater effects in populations ≥45 years old (compared to 5 to 44 year olds), with statistically significant eff ects present only among those ≥65 years old (Kan et al., 2008)

. An Italian study reported higher risk of all

- cause mortality associated with increased O 3 concentrations among individuals ≥85 year old as compared to those 35 to 84 years old (Stafoggia et al ., 2010)

. The Air Pollution and Health: A European and North American Approach (APHENA) project examined the association between O 3 exposure and mortality for those <75 and ≥ 75 years of age. In Canada, the associations for all

- cause and cardiovascular

mor tality were greater among those ≥75 years old. In the U.S., the association for all

- cause mortality was slightly greater for those <75 years of age compared to those ≥75 years old in

summer - only analyses. No consistent pattern was observed for CVD mortalit y. In Europe, slightly larger associations for all

- cause mortality were observed in those <75 years old in all

- year and summer

- only analyses. Larger associations were reported among those <75years for CVD mortality in all

- year analyses, but the reverse was true for summer

- only analyses (Katsouyanni et al., 2009).*** E.O. 12866 Review

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Page 136 of 668 With respect to epidemiologic studies of O 3 exposure and hospital admissions , a positive association was reported between short

- term O 3 exposure and respiratory hospital admissions for adults ≥65 years old but not for those adults aged 15 to 64 years (Halonen et al., 2009) . In the same study, no association was observed between O 3 concentration and respiratory mortality among those ≥65 years old or those 15 to 64 years old

. No modification by age (40 to 64 year olds versus >64 year olds) was observed in a study from Brazil examining O 3 levels and COPD
ED

- related emergency department visits. Although some outcomes reported mixed findings regarding an increase in risk for older adults, recent epidemiologic studies report consistent positive associations between short

- term O 3 exposure and mortality in older adults. The evidence from mortality studies is consistent with the results reported in the 2006 O 3 AQCD and is supported by toxicological st udies providing biological plausibility for increased risk of effects in older adults. Also, older adults may be experiencing increased exposure compared to younger adults. Overall, the ISA (U.S. EPA 2013 , 2013 a ) concludes adequate evidence is available indicating that older adults are at increased risk of O 3 - related health effects

.

v. People with d iets l ower in v itamins C and E Diet was not examined as a factor potentially affecting risk in previous O 3 AQCDs, but recent studies have examined modificat ion of the association between O 3 and health effects by dietary factors. Because O 3 mediates some of its toxic effects through oxidative stress, the antioxidant status of an individual is an important factor that may contribute to increased risk of
O 3 - rela ted health effects. Supplementation with vitamins C and E has been investigated in a number of studies as a means of inhibiting O 3 - mediated damage.*** E.O. 12866 Review

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Page 137 of 668 Two e pidemiologic studies have examined effect modification by diet and found evidence that certain dietar y components are related to the effect O 3 has on respiratory outcomes

. In one recent study , the effects of fruit/vegetable intake and Mediterranean diet were examined. Increases in these food patterns, which have been noted for their high vitamins C and E and
omega - 3 fatty acid content, were positively related to lung function in asthmatic children living in Mexico City , and modified by O 3 exposure (Romieu et al., 2009) . Another study examined supplementation of the diets of asthmatic children in Mexico wit h vitamins C and E (Sienra

Monge et al., 2004). Associations were detected between short

- term O 3 exposure and nasal airway inflammation among children in the placebo group but not in those receiving the supplementation. The epidemiologic evidence is supported by controlled human exposure studies, discussed in section 8.4.1 of the ISA (U.S. EPA 2013 , 2013 a ), that have shown that the first line of defense against oxidative stress is antioxidants

- rich extracellular lining fluid (ELF) which
scavenge scavenge s free radicals and limit lipid peroxidation. Exposure to O 3 depletes antioxidant level s in nasal ELF probably due to scrubbing of O 3 ; however, the concentration and the activity of antioxidant enzymes either in ELF or plasma do not appear to be related to O 3 responsiveness

. C ontrolled studies of dietary antioxidant supplementation have demonstrated some protective effects of α

- tocopherol (a form of vitamin E) and ascorbate (vitamin C) on spirometric measures of lung function after O 3 exposure but not o n the intensity of subjective symptoms and inflammatory response s. Dietary antioxidants have also afforded partial protection to asthmatics by attenuating postexposure bronchial hyperresponsivenes s . Toxicological studies discussed in section 8.4.1 of the I SA (U.S. EPA 2013 , 2013 a ) provide evidence of biological plausibility to the epidemiologic and controlled human exposure studies

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Page 138 of 668 Overall, the ISA (U.S. EPA 2013 , 2013 a ) concludes adequate evidence is available indicating that individuals with diets lowe r in vitamins C and E are at risk for O 3 - related health effects. The evidence from epidemiologic studies is supported by controlled human exposure and toxicological studies. vi. Outdoor workers Studies included in the 2006 O 3 AQCD reported that individuals who participate in outdoor activities or work outside to be a population at increased risk based on consistently reported associations between O 3 exposure and respiratory health outcomes in these groups ( U.S. EPA, 2006a b 2006a ) . Outdoor workers are exposed to ambient O 3 concentrations fo r a greater period of time than individuals who spend their days indoors. As discussed in Section s ection 4. 7 of the ISA (U

. S

. EPA, 201 3 201 3 a ) outdoor workers sampled during the work shift had a higher ratio of personal exposure to fixed

- site monitor concen trations than health clinic workers who spent most of their time indoors. Additionally, an increase in dose to the lower airways is possible during outdoor exercise due to both increases in the amount of air breathed (i.e., minute ventilation) and a shift from nasal to oronasal breathing. The association between FEV 1 responses to O 3 exposure and minute ventilation is discussed more fully in Section s ection 6.2.3.1 of the 2006 O 3 AQCD

. (U.S. EPA, 2006a)

. Previous studies have shown that increased exposure t o O 3 due to outdoor work leads to increased risk of O 3 - related health effects, specifically decrements in lung function ( U.S. EPA, 2006a b 2006a ). The strong evidence from the 2006 O 3 AQCD , which demonstrated increased exposure, dose, and ultimately risk of O 3 - related health effects in this population , supports the conclusion that there is adequate evidence to indicate that increased exposure to O 3 through outdoor work increases the risk of O 3 - related health effects.*** E.O. 12866 Review

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Page 139 of 668 In some cases, it is difficult to determine a factor that results in increased risk of effects. For example, previous assessments have included controlled human exposure studies in which some healthy individuals demonstrate gre ater O 3 - related health effects compared to other h ealthy individuals. Interindividual variability has been observed for lung function decrements, symptomatic responses, pulmonary inflammation, AHR, and altered epithelial permeability in healthy adults expo sed to O 3 , and these results tend to be reproducible within a given individual over a period of several months indicating differences in the intrinsic responsiveness . In many cases the reasons for the variability is not clear. This may be because one or so me of the factors described above have not been evaluated in studies, or it may be that additional, unidentified factors influence individual responses to O 3 ( U.S. EPA, 2013 2013 a , section 8.5 )

. As discussed in chapter 8 of the ISA , (U.S. EPA, 2013a) , there is a lack of information regarding the extent to which some factors may increase risk from O 3 exposures. Due to this lack of information, the ISA concluded that for some factors, such as sex, SES, and obesity , there is only “suggestive” evidence of increased risk , or that for a number of factors the evidence i s inadequate to draw conclusions about potential increase in risk of effects. Overall, the factors for which the ISA concludes there is adequate evidence of increased risk for experienc ing O 3 - re lated effects were related to asthma, lifestage (children and older adults), genetic variability, dietary factors, and working outdoors. b. Size of at

- risk populations
O ne consideration in the assessment of potential public health impacts is the size of

v arious population groups for which there is adequate evidence of increased risk for health effects associated with O 3 - related air pollution exposure (U.S. EPA , 2014c, section 3.1.5.2). The factors for which the ISA judged the evidence to be “adequate” with respect to contributing to*** E.O. 12866 Review

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Page 140 of 668 increased risk of O 3 - related effects among various populations and lifestages included: asthma; childhood and older adulthood; diets lower in vitamins C and E; certain genetic variants ; and , working outdoors (U.S. EPA , 2013 2013 a , section 8.5)

. No statistics are available to estimate the size of an at

- risk population based on nutritional status or genetic variability

. With regard to asthma, Table 3

- 7 in the PA (U.S. EPA, 2014c, section 3.1.5.2) summarizes information on the pre valence of current asthma by age in the U.S. adult population in 2010 (Schiller et al. 2012; children

- Bloom et al., 2011). Individuals with current asthma constitute a fairly large proportion of the population, including more than 25 million people. Asth ma prevalence tends to be higher in children than adults. Within the U.S., approximately
8.2 % of adults have reported currently having asthma (Schiller et al., 2012) and 9.5% of children have reported currently having asthma (Bloom et al., 2011)

. 61
With re gard to lifestages, b ased on U.S. census data from 2010 (Howden and Meyer, 2011) , about 74 million people, or 2 4 % of the U.S. population , are under 18 years of age and more than 40 million people, or about 13% of the U.S. population, are 65 years of age or older

. Hence, a large proportion of the U.S. population (i.e., more than a third) is included in age groups that are considered likely to be at increased risk for health effects from ambient O 3 exposure. With regard to outdoor workers, in 2010 , approximately 11.7% of the total number of people (143 million people) employed, or about 16.8 million people, worked outdoors one or

61 As noted below (II.C.3.a.ii), asthmatics can experience large r O 3 - induced respiratory effects than non

- asthmatic, healthy adults. The responsiveness of asthmatics to O 3 exposures could depend on factors that have not been well

- evaluated such as asthma severity , the effectiveness of asthma control, or t he prevalence of medication use.*** E.O. 12866 Review

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Page 141 of 668 more day day s per week (based on worker surveys). 62 Of these , approximately 7.4% of the workforce, or about 7.8 million people, worked outdoors three or more days per week. The health statistics data illustrate what is known as the “pyramid” of effects. At the top of the pyramid, there are approximately 2.5 million deaths from all causes per year in the U.S. population, with about 250 thousand respiratory

- related deaths (CDC

- WONDER, 2008)

. For respiratory health diseases, there are nearly 3.3 million hospital discharges per year (HCUP, 2007), 8.7 million respiratory ED emergency department visits (HCUP, 2007) , 112 million ambulatory care visits (Woodwell and Cherry, 2004), and an estimated 700 million restricted activity days per year due to respiratory conditions (Adams et al., 1999). Combining small risk estimates w ith relatively large baseline levels of health outcomes can result in quite large public health impacts. Thus, even a small percentage reduction in O 3 health impacts on cardiopulmonary diseases would reflect a large number of avoided cases. c. Impacts of averting behavior The activity pattern of individuals is an important determinant of their exposure ( ISA, U.S. EPA, 2013 2013 a , section 4.4.1)

. Variation in O 3 concentrations among various microenvironments means that the amount of time spent in each locat ion, as well as the level of activity, will influence an individual’s exposure to ambient O 3 . Activity patterns vary both among and within individuals, resulting in corresponding variations in exposure across a population and over time. Individuals can red uce their exposure to O 3 by altering their behaviors,

62 The O*NET program is the nation's primary source of occupational information. Central to the project is the O*NET database, containing information on hundreds of standardized and occupation

- specific descriptors. The database, which is available to the public at no cost, is continually updated by surveying a broad range of workers from each occupation. http://www.onetcenter.org/overview.html

. http://www.onetonline.org/find/descriptor/browse/Work_Context/4.C.2 / /

. Formatted: Keep lines together*** E.O. 12866 Review

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Page 142 of 668 such as by staying indoors, being active outdoors when air quality is better, and by reducing their activity levels or reducing the time being active outdoors on high

- O 3 days (U.S. EPA, 2013 2013 a , secti on 4.4.2)

. The widely reported Air Quality Index (AQI) conveys advice to the public, and particularly at

- risk populations, on reducing short

- or prolonged

- exposures on days when ambient levels of common , criteria air pollutants (except lead), are elevated (www.airnow.gov)

. Information communicated by the AQI is based on the evidence and exposure/risk information assessed in the review of the NAAQS; it is updated and revised as necessary during the review of each standard. Proposed changes to the AQI sub

- in dex for O 3 , based on evidence and exposure/risk information assessed in this review, are discussed in section III below. The AQI describes the potential for health effects from O 3 (and other individual pollutants) in six color

- coded categories of air

- qual ity, ranging from Good (green), Moderate (yellow), Unhealthy for Sensitive Groups (orange), Unhealthy (red), and Very Unhealthy (purple), and Hazardous (maroon). Levels in the unhealthy ranges (i.e., Unhealthy for Sensitive Groups and above) come with reco mmendations about reducing exposure. Forecasted and actual AQI values for O 3 are reported to the public during the O 3 season . The AQI advisories explicitly state that children, older adults, people with lung disease, and people who are active outdoors,
may be at greater risk from exposure to O 3 . People are advised to reduce exposure depending on the predicted O 3 levels and the likelihood of risk. This advice includes being active outdoors when air quality is better, and reducing activity levels or reducing the time being active outdoors on high

- O 3 days. Staying indoors to reduce exposure is not recommended until air quality reaches the Very Unhealthy or Hazardous categories

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Page 143 of 668 Evidence of individual averting behaviors in response to AQI advisories has been fo und in several studies, including activity pattern and epidemiologic studies, especially for the at

- risk populations, such as children, older adults, and people with asthma, who are targeted by the advisories. Such effects are less pronounced in the genera l population, possibly due to the opportunity cost of behavior modification. Epidemiologic evidence from a study (Neidell and Kinney, 2010) conducted in the 1990’s in Los Angeles, CA reports increased asthma hospital admissions among children and older adu lts when O 3 alert days (1

- hour max O 3 concentration >200 ppb) were excluded from the analysis of daily hospital admissions and O 3 concentrations (presumably thereby eliminating averting behavior based on high O 3 forecasts). The lower rate of admissions obs erved when alert days were included in the analysis suggests that estimates of health effects based on concentration

- response functions If averting behavior reduces exposure to ambient O 3 , then epidemiologic studies that do not account for averting behavior may be underestimates produce effect estimates that are biased toward the null due to exposure misclassification (U.S. EPA, 2013, section 4. 4.2)

. 6.6 )

. C

. Human Exposure and Health Risk Assessments To put judgments about health effects that are adverse for individuals into a broader public health context, the EPA has developed and applied models to estimate human exposures
to O 3 and O 3 - associated health risks . Exposure and risk estimates based on such model s are presented and assessed in the HREA ( U.S. EPA, 2014a) . In reviewing the draft HREA, CASAC expressed the view that the document is “well

- written, founded based upon comprehensive analyses and adequate for its intended purpose” (Frey, 2014a, p. 1). Analyses in the HREA inform consideration of the O 3 exposures and health risks that could be allowed by the current Formatted: Font: Italic Formatted: Font: Italic*** E.O. 12866 Review

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Page 144 of 668 standard and alternative standards , and consideration of the kind and degree of uncertainties inherent in estimates of O 3 exposures and heal th risks

. The following sections discuss the air quality adjustment approach used in the HREA for exposure and health risk estimates (II.C.1) ; the approach taken to estimate exposure s, key
exposure results , and important uncertainties (II.C.2) ; and the a pproaches taken to estimate O 3 health risks, key risk results , and important uncertainties (II.C.3).
1

. Air Quality Adjustment As discussed above ( section I. E ), O 3 is formed near the Earth’s surface due to chemical interactions involving solar radiation and precursor pollutants including VOCs, NO X , CH 4 and
CO

. T he response of O 3 to changes in precursor concentrations is nonlinear

. In particular, NO X causes both the formation and destruction of O 3 . The net impact of NO X emissions on O 3 concentrations depend s on the local quantities of NO X , VOC, and sunlight , which interact in a set of complex chemical reactions

. In some areas, such as urban centers where NO X emissions typically are high, NO X leads to the net destruction of O 3 , decreasing O 3 concentrations in the immediate vicinity. This phenomenon is particularly pronounced under conditions that lead to low ambient O 3 concentrations (i.e. during cool, cloudy weather and at night when photochemical activity is limited or nonexistent)

. However, while NO X can initially destroy O 3 near emission sources, these same NO X emissions eventually react to form O 3 downwind of those sources . Photochemical m odel simulations suggest that reductions in NO X emissions will slightly increase O 3 concentrations near NO X sources on days with lower O 3 concentrations, while at the same time decreasing the highest O 3 concentrations in outlying a reas. The atmospheric chemistry that influences ambient O 3 concentrations is discussed in more detail in*** E.O. 12866 Review

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Page 145 of 668 the ISA (U.S. EPA, 2013 2013 a , Chapter 3) and the PA (U.S. EPA, 2014c, Chapter 2 ) (see also Frey, 2014a, p. 10 and 11 )

. The HREA uses a photochemical model to estimate sensitivities of O 3 to c hanges i n precursor emissions in order to estimate ambient O 3 concentrations that would just meet the current and alternative standards (U.S. EPA, 2014 a , Chapter 4)

. 63 For the 15 urban study areas

eva luated in the HREA, 64 this model

- based adjustment approach estimate s hourly O 3 concentrations at each monitor location when modeled U.S. anthropogenic precursor emissions (i.e., NO X , VOC) 65 a re reduced. T he HREA estimates air quality that just meet s the current and alternative standards for the 2006

- 2008 and 2008

- 2010 periods. 66 As discussed in Chapter 4 of the HREA (U.S. EPA, 2014a), this approach to adjusting air quality models the physical and chemical atmospheric processes that influence ambient O 3 concentrations. Compared to the quadratic rollback approach used in previous reviews, it provides more realistic estimates of the spatial and temporal responses of O 3 to reductions in precursor emissions. B ecause ambient NO X can contribute both to the f ormation and destruction of O 3 (U.S. EPA, 2014a, Chapter 4), as discussed above, the response of ambient O 3

63 The HREA uses the Comm unity Multi

- scale Air Quality ( CMAQ ) photochemical model instrumented with the higher order direct decoupled method (HDDM) to estimate O 3 concentrations that would occur with the achievement of the current and alternative O 3 standards (U.S. EPA, 2014a, Chapter 4). 64 The urban study areas assessed are Atlanta, Baltimore, Boston, Chicago, Cleveland, Dallas, Denver , Detroit, Houston, Los Angeles, New York, Philadelphia, Sacramento, St. Louis, and Washington, DC. 65 Exposure and risk analyses for most urban study areas focus on reducing U.S. anthropogenic NO X emissions alone. The exceptions are Chicago and Denver. Exposure and risk analyses for Chicago and Denver are based on reductions in emissions of both NO X and VOC (U.S. EPA, 2014a, section 4.3.3.1; Appendix 4D ). 66 These simulations are illustrative and do not reflect any consideration of specific control programs or strategies designed to achieve the reductions in emissions required to meet the specified standards. Further, these simulations do not represent predictions of when, whether, or how areas might meet the specified standards.*** E.O. 12866 Review

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Page 146 of 668 concentrations to reductions in NO X emissions is more variable than indicated by the quadratic rollback approach. This improved approach to adjustin g O 3 air quality is consistent with recommendations from the National Research Council of the National Academies (NRC, 2008). In addition, CASAC strongly supported the improved approach, stating that “the quadratic rollback approach has been replaced by a scientifically more valid Higher

- order Decoupled Direct Method (HDDM)” and that “[t] he replacement of the quadratic rollback procedure by the HDDM procedure is important and supported by the CASAC” (Frey, 2014a, pp.1 and 3). Consistent with the O 3 chemistry summarized above , in locations and time periods when
NO X is predominantly contributing to O 3 formation (e.g., downwind of important NO X sources, where the highest O 3 concentrations often occur), model

- based adjustment to the current and alternative standards decreases estimated ambient O 3 concentrations compared to recent monitored concentrations (U.S. EPA, 2014 a , section 4.3.3.2). In contrast, in locations and time periods when NO X is predominantly contributing to O 3 titration (e.g., in urban centers with high concentrations of NO X emissions, where ambient O 3 concentrations are often suppressed a nd thus relatively low 67 ), model

- based adjustment increases ambient O 3 concentrations compared to
recent monitored concentrations (U.S. EPA, 2014 a , section 4.3.3 .2 )

. ; Frey, 2014a, p. 10 )

. Within urban study areas , the overall impacts of model

- based air quality adjustment are to reduce the O 3 concentrations at the upper ends of ambient distributions and to increase the O 3 concentrations at the lower ends of those distributions (U.S. EPA, 2014 a , section 4.3.3.2, Fig ures

67 Titration is also prominent during time periods when photochemistry is limited, and ambient O 3 concentrations are relatively low, such as at night and on cool, cloudy days (U.S. EPA, 2014a, Chapter 4).*** E.O. 12866 Review

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Page 147 of 668 4

- 9 and 4

- 1 0 ). 68 Seasonal means of daily O 3 concentrations generally exhibit only modest changes upon model adjustment, reflecting the seasonal balance between daily decreases in relatively higher concentrations and increases in relatively lower concen trations (U.S. EPA,
2014 a , Figures 4

- 9 and 4

- 10 ). The resulting compression in the seasonal distributions of ambient
O 3 concentrations is evident in all of the urban study areas evaluated, though the degree of compression varies considerably across areas (U.S. EPA, 2014 a , Figures 4

- 9 and 4

- 10 ).
Th is compression in the distributions of ambient O 3 concentrations has important implications for exposure and risk estimates in urban s tudy areas . Estimates influenced largely by the upper ends of the distribution of ambient concentrations (i.e., exposures of concern and lung function risk estimates, as discussed in sections 3.2.2 and 3.2.3.1 of the PA ( U.S. EPA, 2014c ) ) decrease with adj ustment of air quality to the current and alternative standards. In contrast, seasonal risk estimates influenced by the full distribution of ambient O 3 concentrations (i.e., epidemiology

- based risk estimates, as discussed in section 3.2.3.2 of the PA ) eith er decrease or increase in response to air quality adjustment, depending on the balance between the daily decreases in high O 3 concentrations and increases in low O 3 concentrations. 69
In their review of the second draft HREA, CASAC considered this issue , i n particular noting that “reductions in nitrogen oxides emissions can lead to less scavenging of ozone and free radicals, resulting in locally higher levels of ozone” (Frey, 2014a, p. 10). CASAC

68 It is important to note that sensitivity analyses in the HREA indicate that the increases in low O 3 concentrations are smaller when NO X and VOC emissions are reduced than when only NO X emissi ons are reduced (U.S. EPA, 2014a, Appendix 4

- D , section 4.7 ). 69 In addition, because epidemiology

- based risk estimates use “area

- wide” average O 3 concentrations, calculated by averaging concentrations across multiple monitors in urban study areas (U.S. EPA, 2014c, section 3.2.3.2), risk estimates on a given day depend on the daily balance between increasing and decreasing O 3 concentrations at the individual monitors that are averaged together to calculate the “area

- wide” concentration

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Page 148 of 668 recommended that “ the EPA should identify and discuss whether and to what extent health risks in the urban core may be affected by NO X reductions or other possible strategies ” and , in particular, concluded that it would “ be of interest to learn if there would be any children or outdoor workers in the more urban area s who would experience significantly higher exposures to ozone as a result of possible changes in the ozone NAAQS” (Frey, 2014a, p. 10)

. The Consistent with this advice, t he exposure and risk implications of the spatial and temporal patterns of ambient O 3 f

ollowing air quality adjustment in urban study areas are discussed in the final HREA (U.S. EPA, 2014a, Chapter 9) and the final PA (U.S. EPA, 2014c, sections 3.2.2, 3.2.3), and are summarized below within the context of the PA ’s consideration of exposure e stimates (II. D.2.a) and risk estimates (II. D.2.b and II.D.2.c ).
2

. Exposure Assessment This section discusses the HREA assessment of human exposures to O 3 . Section II.C.2.a provides an overview of the approach used in the HREA to assessing exposures and the approach in the PA to considering exposure estimates, and summarizes key results. Section II.C.2.b summarizes the important uncertainties in exposure estimates

. a. Overview and summary of key results The exposure assessment presented in the HREA (U.S. EPA, 2014 a, Chapter 5 ) provides estimates of the number and percent of people exposed to various concentrations of ambient O 3 , while at specified exertion levels

. The HREA estimates exposures in the 15 urban study areas for four study groups, all school

- a ge children (ages 5 to 18), asthmatic school

- age children, asthmatic adults (ages 19 to 95), and all older adults (ages 65 to 95), reflecting the strong evidence indicating that these populations are at increased risk for O 3 - attributable effects (U.S.
EPA , 2013 2013 a , Chapter 8)

. An important purpose of these exposure estimates is to provide*** E.O. 12866 Review

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Page 149 of 668 perspective on the extent to which air quality adjusted to just meet the current O 3 NAAQS could be associated with exposures to O 3 concentrations reported to result in r espiratory effects. 70 Estimates of such “exposures of concern” provide perspective on the potential public health impacts of O 3 - related effects , including effects that cannot currently be evaluated in a quantitative risk assessment

. 71
In the absence of large scale exposure studies that encompass the general population, as well as at

- risk populations, modeling is the preferred approach to estimating exposures to O 3 (U.S. EPA, 2014a, Chapter 5). The use of exposure modeling also facilitates the estimation of exposures resulting from ambient O 3 concentrations differing from those present during exposure studies. In the HREA, population exposures to ambient O 3 concentrations are estimated using the
current ve rsion of the Air Pollutants Exposure (APEX) model. The APEX model simulates the movement of individuals through time and space and estimates their exposures to a given pollutant in indoor, outdoor, and in

- vehicle microenvironments ( U.S. EPA, 2014 a , section 5.1.3). APEX takes into account important factors that contribute to total human exposure to ambient
O 3 , including the temporal and spatial distribution s of people and O 3 concentrations throughout an urban area, the variation of O 3 concentrations within various microenvironment s , and the effects of exerti on on breathing rate in exposed individuals ( U.S. EPA, 2014 a , section 5.1.3 ). To the extent spatial and/or temporal patterns of ambient O 3 concentrations are altered upon model

70 In addition, the range of modeled personal exposures to ambient O 3 provide an essential input to the portion of the health risk assessment based on exposure

- response functions (for lung function decrements) from controlled human exposure studies. The health risk assessment based on exposure - response information is discussed below (II.C.3). 71 In this review, the term “exposure of concern” is defined as a personal exposure , while at moderate or greater exertion , to 8

- hour average ambient O 3 concentrations at and above specif ic benchmarks. As discussed below, b enchmarks represent exposure concentrations at which O 3 - induced health effects are known to occur, or can reasonably be anticipated to occur, in some individuals.*** E.O. 12866 Review

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Page 150 of 668 adjustment, as discussed above, exposure estimates reflect population exposures to those altered patterns. The HREA estimates 8

- hour exposures at or above benchmark concentrations of 60, 70, and 80 ppb for individual s engaged in moderate or greater exertion

. (i.e., to approximate conditions in the controlled human exposure studies on which benchmarks are based)

. Benchmarks reflect exposure concentrations at which O 3 - induced respiratory effects are known to occur in so me healthy adults engaged in moderate, intermittent exertion, based on evidence from controlled human exposure studies (U.S. EPA, 2013 2013 a , section 6.2; U.S. EPA, 2014c , section 3.1.2.1 ). The amount of weight to place on the estimates of exposures at or a bove specific benchmark concentrations depends in part on the weight of the scientific evidence concerning health effects associated with O 3 exposures at those benchmark concentration s . It also depends on judgments about the importance, from a public healt h perspective, of the health effects that are known or can reasonably be inferred to occur as a result of exposures at benchmark concentrations ( U.S. EPA, 2014c , sections 3.1.3, 3.1.5 )

. As discussed in more detail above (II.B.2) , the health evidence that supports evaluating exposures of concern at or above benchmark concentrations of 60, 70, and 80 ppb comes from a large body of controlled human exposure studies reporting a variety of respiratory effects in healthy adults. The lowest O 3 exposure concentrat ion for which controlled human exposure studies have reported respiratory effects in healthy adults is 60 ppb , (based on changes in group

mean responses ) , with more evidence supporting this benchmark concentration in the current review than in the last rev iew. In healthy adults, 6.6 hour exposures to 60 ppb O 3 have been reported to decrease lung function and to increase airway inflammation. Exposures of healthy adults to 7 2 ppb O 3 for 6.6 hours have been reported to result in larger average lung function*** E.O. 12866 Review

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Page 151 of 668 decrements, compared to 60 ppb, as well as in increased respiratory symptoms. 72 Exposures of healthy adults to 80 ppb O 3 for 6.6 hours have been reported to result in larger average lung function decrements than following exposures to 60 or 7 2 ppb , increase d and, depending on the study, to increase airway inflammation, increased increase respiratory symptoms, increased increase airways responsiveness, and decreased decrease lung host defense ( based on changes in group means) ( U.S. EPA, 2014c , section 3.1.2.1 ). In commenting on the evidence for benchmark concentrations, CASAC stated the following (Frey, 2014c, p. 6): The 80 ppb

- 8hr benchmark level represents an exposure level for which there is substantial clinical evidence demonstrating a range of ozone

- related effects including lung inflammation and airway responsiveness in healthy individuals. The 70 ppb

- 8hr benchmark level reflects the fact that in healthy subjects, decreases in lung function and respiratory symptoms occur at concentrations as low as 72 ppb a nd that these effects almost certainly occur in some people, including asthmatics and others with low lung function who are less tolerant of such effects, at levels of 70 ppb and below. The 60 ppb

- 8hr benchmark level represents the lowest exposure level at which ozone

- related effects have been observed in clinical studies of healthy individuals. Based on its scientific judgment, the CASAC finds that the 60 ppb

- 8hr exposure benchmark is relevant for consideration with respect to adverse effects on asthmatics

. In considering estimates of O 3 exposures of concern at or above be nchmarks of 60, 70, and 80 ppb , the PA focuses on modeled e xposures for school

- age children (ages 5

- 18) , including asthmatic school

- age children, which are key at

- risk populations identified in the ISA ( U.S. EPA, 2014c , section 3.1.5). The percentages of children estimated to experience exposures of concern

a re considerably larger than the percentages estimated for adult populations (i.e., approximately
3

- fold larger across urban st udy areas ) (U.S. EPA, 2014a, section 5.3.2 and Figures 5

- 5 to 5

- 8 )

. T he larger exposure estimates for children are due primarily to the larger percentage of children

72 As noted above, for the 70 ppb exposure concentration Schelegle et al. (2009) reported that the actual 6.6

- hour mean exposure concentration was 72 ppb.*** E.O. 12866 Review

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Page 152 of 668 estimated to spend an extended period of time being physically active outdoors when O 3

con centrations are elevated (U.S. EPA, 2014 a , sections 5.3.2 and 5.4.1 ). Although exposure estimates differ between children and adults, the patterns of results across the urban study areas and years are similar among all of the populations evaluated (U.S.
E PA, 2014a, Figures 5

- 5 to 5

- 8). Therefore, while the PA highlights estimates in children, including asthmatic school

- age children, it also notes that the patterns of exposures estimated for children represent the patterns estimated for adult asthmatics and older adults. Table 1 below summarizes key results from the exposure assessment. Table 1 presents estimates of the percentages and numbers of all school

- aged children estimated to experience exposures of concern when air quality was adjusted to just meet the current and alternative 8

- hour O 3 standards

. T he percentage of all school

- age children in the 15 urban study areas estimated to experience exposures of concern decline s when comparing just meeting the current standard to just meeting alternative 8

- hour O 3 standards. Substantial variability is evident across years and urban study areas , as indicated by the ranges of averaged estimates and estimates for
worst

- case years and study areas . As discussed below , the inter individual variability in responsiveness following exposures of concern means that only a subset of individuals who are exposed at and above a given benchmark concentration would actually be expected to experience respiratory effects.*** E.O. 12866 Review

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Page 153 of 668 Table 1. Summary of Estimated Exposures of Concern in All School
- age Children for the Current and Alternative O 3 Standards in Urban Study Areas Benchmark Concentration Standard

Level (ppb) Average %

Children Exposed 73 Average Number of

Children Exposed [Average Number of Asthmatic Children] 74 % Children

- Worst Year and Worst Area One or more exposures of concern per season ≥ 80 ppb 75 0

- 0.3 27,000 [3,000] 1.1

70 0

- 0.1 3,700 [300] 0.2 65 0 300 [0] 0 60 0 100 75 [0] 0 ≥ 70 ppb 75 0.6

- 3.3 362,000 [40,000] 8.1

70 0.1

- 1.2 94,000 [10,000] 3.2 65 0

- 0.2 14,000 [2,000] 0.5 60 0 1,400 [200] 0.1 ≥ 60 ppb 75 9.5

- 17 2,316,000 [246,000] 25.8

70 3.3

- 10.2 1,176,000 [126,000] 18.9 65 0

- 4.2 392,000 [42,000] 9.5 60 0

- 1.2 70,000 [8,000] 2.2 Two or more exposures of concern per season ≥ 80 ppb 75 0 600 [100] 0.1

70 0 0 [0] 0 65 0 0 [0] 0 60 0 0 [0] 0 ≥ 70 ppb 75 0.1

- 0.6 46,000 [5,000] 2.2

70 0

- 0.1 5,400 [600] 0.4 65 0 300 [100] 0 60 0 0 [0] 0 ≥ 60 ppb 75 3.1

- 7.6 865,000 [93,000] 14.4

70 0.5

- 3.5 320,000 [35,000] 9.2

73 Estimates for each urban case study area were averaged for the years evaluated in the HREA (2006 to 2010). Ranges reflect the ranges across urban study areas. Estimates smaller than 0. 05 % were rounded downward to zero (from U.S. EPA, 2014a, Tables 5

- 11 and 5

- 12). 74 Numbers of children exposed in each urban case study area were averaged over the years 2006 to 2010. These averages were then summed across urban study areas . Numbers are were rounded to nearest thousand unless otherwise indicated. Estimates smaller than 5 0 were rounded downward to zero (from U.S. EPA, 2014a, Appendix 5F Table 5F

- 5). See below for discussion of uncertainties in exposure estimates. 75 As discussed in section 4.3.3 of the HREA, the model

- based air quality adjustment approach used to estimate r isks associated with the current and alternative standards was unable to estimate the distribution of ambient O 3 concentrations in New York City upon just meeting an alternative standard with a level of 60 ppb. Therefore, for the 60 ppb standard level the numbers of children and asthmatic children reflect all of the urban study areas except New York

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Page 154 of 668 65 0

- 0.8 67,000 [7,500] 2.8 60 0

- 0.2 5,100 [700] 0.3 b

. Key u ncertainties In considering exposure estimates within the context of the current and alternative O 3 standards, t he PA also notes important unce rtainties in these estimates

. For example, d ue to variability in responsiveness, only a subset of individuals who experience exposures at or above a benchmark concentration can be expected to experience health ef fects. 76 G iven the lack of sufficient exposure

- response information for most of the health effects that informed benchmark concentrations, estimates of the number of people likely to experience exposures at or above benchmark concentrations generally cannot be translated into quantitative estimates of the number of people likely to experience specific health effects. 77 The PA views health

- relevant exposures as a continuum with greater confidence and less uncertainty about the existence of adverse health effec ts at higher O 3 exposure concentrations , and less confidence and greater uncertainty as one considers lower exposure concentrations. This view draws from the overall body of available health evidence, which indicates that as exposure concentrations increas e , the incidence, magnitude, and severity of effects increases

. Though the PA indicates less confidence in the likelihood of adverse health effects as O 3 exposure concentrations decrease, it also notes that the controlled human exposure studies that provi ded the basis for health benchmark concentrations have not evaluated at

- risk populations.
C ompared to the healthy individuals included in controlled human exposure studies, members of

76 As noted below (II.C.3.a.ii), in the case of asthmatics, responsiveness to O 3 could depend on factors that have not been well

- evaluated, such as asthma severity , the effectiveness of asthma control, or t he prevalence of medication use. 77 The exception to this is lung function decrements, as discussed below ( and in U.S. EPA, 2014c, section 3.2.3.1). Formatted: Space After: 0 pt*** E.O. 12866 Review

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Page 155 of 668 at

- risk populations (e.g., asthmatics, children) could be more likely to experience adverse effects, could experience larger and/or more serious effects , and/or could experience effects following exposures to lower O 3 concentrations

. The CASAC expressed similar views in their advice to the Administrator (Frey, 2014a, pp. 7 and 14). I n considering estimated exposures of concern (U.S. EPA, 2014c, section 3.4), the PA notes that concerns about the potential for adverse health effects, including effects in at

- risk populations must be balanced against the inc reasing uncertainty regarding the likelihood of such effects following exposures to lower O 3 concentrations. Uncertainties associated with the APEX exposure modeling also have the potential to be important (U.S. EPA, 2014a, section 5.5.2, Table 5

- 6). For example, the HREA concludes that
exposures of concern could be underestimated for some individuals who are frequently and routinely active outdoors during the warm season ( U.S. EPA, 2014a, section 5.5.2). This could include outdoor workers and children who are frequently active outdoors. The HREA specifically notes that l ong - term diary profiles (i.e., monthly, annual) do not exist for such populations, limiting the extent to which APEX outputs reflect people who follow similar daily routines resulting in hi gh exposures, over extended periods of time. In order to evaluate one dimension of the potential implications of this uncertainty for exposure estimates, the HREA reports the results of limited exposure model sensitivity analyses using subsets of activity diaries specifically selected to reflect groups spending a larger proportion of time being active outdoors during the O 3 season. When diaries were selected to mimic activity patterns performed by outdoor workers, the percent of modeled individuals estimat ed to exp erience exposures of concern were was higher than the other adult populations evaluated. The percentages of outdoor workers estimated to experience exposures of concern*** E.O. 12866 Review

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Page 156 of 668 were generally similar to the percentages estimated for children (i.e., using t he full database of diary profiles) in the worst

- case urban study area and year (i.e., urban study area and year with the largest percent of children estimated to experience exposures of concern) (U.S. EPA, 2014a, section 5.4.3.2, Figure 5

- 14). In addition , when diaries were restricted to children who did not report any time spent inside a school or performing paid work (i.e., to mimic children spending large portions of their time outdoors during the summer), the number experiencing exposures of concern in creased by approximately 30% (U.S. EPA, 2014a, section 5.4.3.1). Though these sensitivity analyses are limited to single urban study areas, and though there is uncertainty associated with diary selection approaches to mimic highly exposed populations, they suggest the possibility that some at

- risk groups could experience more frequent exposures of concern than indicated by estimates made using the full database of activity diary profiles

. In further considering activity diaries, the HREA also notes that gr owing evidence indicates that people can change their behavior in re sponse to high O 3 concentrations , reducing the time spent being active outdoors (U.S. EPA, 2014 a , section 5.4.3 .3 ). Commonly termed

“ averting behaviors, ” these altered activity patterns could reduce personal exposure concentrations. The refore, the HREA also performed limited sensitivity analyses to evaluate the potential implications of averting behavior for estimated exposures of concern. These analyses

s uggest that averting behavior could reduce the percentages of children estimated to experience exposures of concern at or above the 60 or 70 ppb benchmark concentrations by approximately 10 to 30%, with larger reductions possible for the 80 ppb benchmark ( U.S. EPA, 2014 a , Figure 5

- 1 5 ). As discussed above for other sensitivity analyses, these analyses are limited to a single urban case study area and are subject to uncertainties associated with assumptions about the prevalence and duration of averting behavi ors. However, the results suggest that exposures of*** E.O. 12866 Review

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Page 157 of 668 concern could be overestimated, pa rticularly in children (Neidell et al., , 2009; U.S. EPA, 2013, Figures 4

- 7 and 4

- 8), if the possibility for averting behavior is not incorporated into estimates

. 3

. Quan titative Health Risk Assessments
For some health endpoints, there is sufficient scientific evidence and information available to support the development of quantitative estimates of O 3 - related health risks. In the last review of the O 3 NAAQS, the quantitat ive health risk assessment estimated O 3 - related lung function decrements, respiratory symptoms, respiratory

- related hospital admissions, and nonaccidental and cardiorespiratory

- related mortality (U.S. EPA, 2007)

. In those analyses, b oth controlled human ex posure and epidemiologic studies were used for the quantitative assessment of O 3 - related human health risks

. In the current review, for short

- term O 3 concentrations , the HREA estimates lung function decrements; respiratory symptoms in asthmatics; hospital admissions and emergency department visits for respiratory causes; and all

- cause mortality (U .S. EPA, 2014a). For long

term O 3 concentrations, t he HREA estimates respiratory mortality (U.S. EPA, 2014a). 78
Estimates of O 3 - induced lung function decrements ar e based on exposure modeling, combined with exposure

- response relationships from controlled human exposure studies (U.S. EPA, 2014a, Chapter 6). Estimates of O 3 - associated respiratory symptoms ; , hospital admissions and emergency department visits ; , and mor tality are based on concentration

- response relationships from epidemiologic studies (U.S. EPA, 2014a, Chapter 7). As with the exposure assessment discussed above, O 3 - associated health risks are estimated for recent air quality and for ambient concentration s adjusted to just meet the current and alternative O 3 standards, based on 2006

- 2010

78 Estimates of O 3 - associated respiratory mortality are based on the study by Jerrett et al. (2009)

. This study used seasonal averages of 1

- hour daily maximum O 3 concentrations to estimate long

term concentrations.*** E.O. 12866 Review

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Page 158 of 668 air quality and adjusted precursor emissions. The following sections discuss the lung function risk assessment (II.C.3.a) and the epidemiology

- based morbidity and mortalit y risk assessment s (II.C.3.b) from the HREA , including important sources of uncertainty in these estimates

. a. Lung function risk assessment Section II.C.3.a.i provides an overview of the approach used in the HREA to assessing lung function risks , an over view of the approach in the PA to considering lung function risk estimates, and a summary of key results . Section II.C.3.a.ii presents a summary of key uncertainties in lung function risk estimates. i. Overview and summary of key results In the current review, the HREA estimates risks of lung function decrements in school

aged children (ages 5 to 18), asthmatic school

- aged children, and the general adult population for the 15 urban study areas . The results presented in the HREA are based o n an updated dose

threshold model that estimates FEV 1 responses for individuals following short

- term exposures to O 3 ( McDonnell et al., 201 2 ), reflecting methodological improvements since the last review ( II.B.2.a.i, above; U.S. EPA, 2014 a , section 6.2.4). The impact of the dose threshold is that O 3 - induced FEV 1 decrements result primarily from exposures on days with average ambient O 3 concentrations above about 40 ppb ( U.S. EPA, 2014a , section 6.3.1 , Figure 6

- 9 ). 79
The HREA estimates risks of moderate to large lung function decrements, defined as
FEV 1 decrements > 10%, 15%, or 20%. In evaluating these lung function risk estimates within

79 Analysis of this issue in the HREA is based on risk estimates in Los Angeles for 2006 unadjusted air quality. T he HREA shows that more than 90% of daily instances of FEV 1 decrements ≥ 10% occur when 8

- hr average ambient concentrations are above 40 ppb for this modeled scenario. The HREA notes that the distribution of responses will be different for different study areas, years, and air quality scenarios (U.S. EPA, 2014c, Chapter 6)

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Page 159 of 668 the context of considering the current and alternative O 3 standard s , the PA focuses on the percent of children estimated to experience one or more and two or more decrements > 10, 15, and 20%, noting that the percentage of asthmatic children estimated to experience such decrements is virtually indistinguishable from the percentage estimated for all children. 80 Compared to chi ldren, a small er percentage of adults were estimated to experience O 3 - induced FEV 1 decrements (U.S. EPA, 2014 a , section 6.3.1 , Table 6

- 4 ). As for exposures of concern (see above), the patterns of results across urban study areas and over the years evaluate d are similar in children and adults . Therefore, while the PA highlights estimates in children, it notes that these results are also representative of the patterns estimated for adult populations

. Table 2 below summarizes key results from the lung function risk assessment. Table 2 presents estimates of the percentages of school

- aged children estimated to experience O 3 - induced
FEV 1 decrements > 10, 15, or 20% when air quality was adjusted to just meet the c urrent and alternative 8

- hour O 3 standards. Table 2 also presents the numbers of children, including children with asthma, estimated to experience such decrements. As shown in these tables, the percentage of school

- age children in the 15 urban study areas estimated to experience O 3 - induced FEV 1 decrements declines when comparing just meeting the current standard to just meeting alternative 8

- hour O 3 standards. Substantial variability is evident across years and urban study

areas , as indicated by the ranges of averaged estimates and estimates for worst

- case years and locations.

80 Though see below for discussion of uncertainty in lung function response s of children and asthmatics.*** E.O. 12866 Review

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Page 160 of 668 Table 2 . Summary of Estimated O 3 - Induced Lung Function Decrements for the Current and Potential Alternative O 3 Standard s in Urban Case Study Areas Lung Function Decrement Alternativ e

Standard Level Average

% Children 81 Number of Children (5

to 18 years) [Number of Asthmatic Children] 82 % Children Worst Year and Area One or more decrements per season ≥ 10% 75 14

- 19 3,007,000 [312,000] 22

70 11

- 17 2,527,000 [261,000] 20 65 3

- 15 1,896,000 [191,000] 18 60 5

- 11 1,404,000 [139,000] 83 13 ≥ 15% 75 3

- 5 766,000 [80,000] 7

70 2

- 4 562,000 [58,000] 5 65 0

- 3 356,000 [36,000] 4 60 1

- 2 225,000 [22,000] 3 ≥ 20% 75 1

- 2 285,000 [30,000] 2.8

70 1

- 2 189,000 [20,000] 2.1 65 0

- 1 106,000 [11,000] 1.4 60 0

- 1 57,000 [6,000] 0.9 Two or more decrements per season ≥ 10% 75 7.5

- 12 1,730,000 [179,000] 14

70 5.5

- 11 1,414,000 [145,000] 13 65 1.3

- 8.8 1,023,000 [102,000] 11 60 2.1

- 6.4 741,000 [73,000] 7.3 ≥ 15% 75 1.7

- 2.9 391,000 [40,000] 3.8

70 0.9

- 2.4 276,000 [28,000] 3.1 65 0.1

- 1.8 168,000 [17,000] 2.3 60 0.2

- 1.0 101,000 [10,000] 1.4 ≥ 20% 75 0.5

- 1.1 128,000 [13,000] 1.5

70 0.3

- 0.8 81,000 [8,000] 1.1 65 0

- 0.5 43,000 [4,000] 0.8 60 0

- 0.2 21,000 [2,000] 0.4

81 Estimates in each urban case study area were averaged for the years evaluated in the HREA (2006 to 2010). Ranges reflect the ranges across urban study areas

. 82 Numbers of children estimated to experience decrements in each s tudy urban case study area were averaged over 2006 to 2010. These averages were then summed across urban study areas

. Numbers are rounded to nearest thousand unless otherwise indicated. 83 As discussed in section 4.3.3 of the HREA, the model

- based air quali ty adjustment approach used to estimate risks associated with the current and alternative standards was unable to estimate the distribution of ambient O 3 concentrations in New York City upon just meeting an alternative standard with a level of 60 ppb. Ther efore, for the 60 ppb standard level the numbers of children and asthmatic children reflect all of the urban study areas except New York

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Page 161 of 668 ii. Key u ncertainties As for exposures of concern discussed above, the PA also considers important uncertainties in estimates of lung function risk. In addition to the uncertainties noted for exposure estimates, the HREA identifies several key uncertainties associated with estimates of
O 3 - induced lung function decrements. An uncertainty with particular potential to impact consideration of risk estimates stems from the lack of exposure

- response information in children.
I n the near absence of controlled human exposure data for children , risk estimates are based on the assumption that children exhibit the same lung function response following O 3 exposures as healthy 18 year olds (i.e., the youngest age for which controlled human exposure data is available) (U.S. EPA, 2014a, section 6.5.3 ). This assumption i s justified in part by the findings of McDonnell et al. (1985), who reported that children ( 8

- 11 year year s old ) experienced FEV 1 responses similar to those observed in adults ( 18

- 35 years old

. )

. In addition, as discussed in the ISA (U.S. EPA, 2013 2013 a , section 6.2.1), summer camp studies of school

- aged children reported O 3 - induced lung function decrements similar in magnitude to those observed in controlled human exposure studies using adults

. In extending the risk model to children, the HREA fixes the age term in the model at its highest value, the value for age 18. This approach could result i n either over

- or underestimates of O 3 - induced lung function decrements in children, depending on how children compare to the adults used in controlled human exposure studies (U.S. EPA, 2014a, section 6.5 .3 )

. A related source of uncertainty is that the ri sk assessment estimates O 3 - induced decrements in asthmatics using the exposure

- response relationship developed from data collected from healthy individuals. Although the evidence has been mixed (U.S. EPA, 2013 2013 a , section 6.2.1.1), several studies have r eported larger O 3 - induced lung function decrements in asthmatics than in non

- asthmatics (Kreit et al., 1989; Horstman et al., 1995; Jorres et al., 1996; Alexis et al.,*** E.O. 12866 Review

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Page 162 of 668 2000). On this issue , CASAC noted that “[a]sthmatic subjects appear to be at least as se nsitive, if not more sensitive, than non

- asthmatic subjects in manifesting ozone

- induced pulmonary function decrements” ( Frey, 2014c , p. 4). To the extent asthmatics experience larger O 3 - induced lung function decrements than the healthy adults used to develop exposure - response relationships, the HREA could underestimate the impacts of O 3 exposures on lung function in asthmatics, including asthmatic children. The HREA notes that the magnitude implications of this uncertainty might have on for risk estimat es remains remain unknown at this time (U.S. EPA, 2014a, section 6.5.4 ), and could depend on a variety of factors that have not been well

- evaluated, including the severity of asthma and the prevalence of medication use

. However, the available evidence shows responses to O 3 increase with severity of asthma (Horstman et a l., 1995) and corticosteroid usage does not prevent O 3 effects on lung function decrements or respiratory symptoms in people with asthma (Vagaggini et al., 2001, 2007 ). b. Mortality and morbi dity risk assessment s As discussed above (II.B.2), epidemiologic studies provide evidence for the most serious
O 3 - associated public health outcomes (e.g., mortality, hospital admissions, emergency department visits). Section II.C.3.b.i below provid es an overview of the approach used in the HREA to assessing mortality and morbidity risks based on information from epidemiologic studies , discusses the approach in the PA to considering epidemiology

- based risk estimates, and presents a summary of key results. Section II.C.3.b.ii summarizes key uncertainties in epidemiology

- base risk estimates. i. Overview and summary of key results Risk estimates based on epidemiologic studies can provide perspective on the most serious O 3 - associated public health outcomes (e. g., mortality, hospital admissions, emergency*** E.O. 12866 Review

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Page 163 of 668 department visits) in populations that often include at

- risk groups. T he HREA estimates O 3 - associated risks in 12 urban study areas 84 using concentration

- response relationships drawn from epidemiologic studies. These concentration

- response relationships are based on “area

- wide” average O 3 concentrations. 85 The HREA estimates risks for the years 2007 and 2009 in order to provide estimates of risk for a year with generally higher O 3 concentrations (2007) and a year with generally lower O 3 concentrations (2009) (U.S. EPA, 2014 a , section 7. 1.1 )

. As in the last review of the O 3 NAAQS (U.S. EPA, 2007, pp. 2

- 48 to 2

- 54) , the PA recognize s that ambient O 3 concentrations, and therefore O 3 - associated health risks, result from precursor emissions from various types of sources. Based on the air quality modeling discussed in chapter 2 of the PA ( U.S. EPA, 2014c ) , approximately 30 to 60% of average daytime O 3 during the warm season (i.e., daily maximum 8

- hour concentrations av eraged from April to October) is attributable to precursor emissions from U.S. anthropogenic sources ( U.S. EPA, 2014c , section 2.4.4). The remainder is attributable to precursor emissions from international anthropogen ic sources and natural sources. Becaus e the HREA characterizes health risks from all
O 3 , regardless of source, risk estimates reflect emissions from U.S. anthropogenic, international anthropogenic, and natural sources.

84 The 12 urban areas evaluated are Atlanta, Baltimore, Boston, Cleveland, Denver, Detroit, Houston, Los Angeles, New York, Philadelphia, Sacramento, and St. Louis. 85 In the epidemiologic studies that provide the health basis for HREA risk assessments, conce ntration

- response relationships are based on daytime O 3 concentrations, averaged across multiple monitors within study areas. These daily averages are used as surrogates for the spatial and temporal patterns of exposures in study populations. Consistent wi th this approach, the HREA epidemiologic

- based risk estimates also utilize daytime O 3 concentrations, averaged across monitors, as surrogates for population exposures. In this notice, we refer to these averaged concentrations as “area

- wide” O 3 concentratio ns. Area

- wide concentrations are discussed in more detail in section 3.1.4 of the PA (U.S. EPA, 2014c).*** E.O. 12866 Review

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Page 164 of 668 Compared to the weight given to HREA estimates of exposures of concern and lung function risks, and the weight given to the evidence ( U.S. EPA, 2014 c , section 4.4.1), the PA places relatively less weight on epidemiologic

- based risk estimates. In doing so, the PA notes that the overall conclusions from the HREA likewise reflect l ess confidence in estimates of epidemiologic

- based risks than in estimates of exposures and lung function risks. The determination to attach less weight to the epidemiologic

- based estimates reflects the uncertainties associated with mortality and morbidity risk estimates, including the heterogeneity in effect estimates between epidemiologic study areas, the potential for epidemiologic

- based exposure measurement error, and uncertainty in the interpretation of the shape of concentration

response functions at lower O 3 concentrations (discussed below)

. The PA also notes the HREA conclusion that lower confidence should be placed in the results of the assessment of respiratory mortality risks associated with long

- term O 3 exposures, primarily because that analysis is based on only one study (even though that study is well

- designed) and because of the uncertainty in that study about the existence and level of a potential threshold in the concentration

- response function (U.S . EPA, 2014a, section 9.6). In considering the epidemiology

- based risk estimates, the PA focuses on mortality risks associated with short

- term O 3 concentrations. In doing so, in addition to noting uncertainty in estimates of respiratory mortality associat ed with long

- term O 3 , the PA notes that the patterns of estimated respiratory morbidity risks across urban study areas , over years, and for different standards are similar to the patterns of total mortality risk. The PA considers estimates of total risk ( i.e., based on the full distributions of ambient O 3 concentrations) and estimates of risk associated with O 3 concentrations in the upper portions of ambient distributions. A focus on estimates of total risks would place greater weight on the*** E.O. 12866 Review

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Page 165 of 668 possibility th at concentration

- response relationships are linear over the entire distribution of ambient O 3 concentrations , and thus on the potential for morbidity and mortality to be affected by changes in relatively low O 3 concentrations . A focus on risks associated w ith O 3 concentrations in the upper po rtions of the ambient distribution would place greater weight on the uncertainty associated with the shapes of concentration

- response curves for O 3 concentrations in the lower portions of the distribution. Given that bo th types of risk estimates could reasonably inform a decision on standard level, depending on the weight placed on uncertainties in the occurrence and the estimation of O 3 - attributable effects at relatively low O 3 concentrations, the PA consider s both type s of estimates. Key results for O 3 - associated mortality risk are summarized in Table 3 below. Table 3 presents estimates of the number of O 3 - a ssociated d eaths in urban study areas , for air quality adjusted to just meet the current and alternative standards.*** E.O. 12866 Review

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Page 166 of 668 Table 3 . Estimates of O 3 - Associated Deaths Attributable to the Full Distribution of 8
- Hour Area
- Wide O 3 Concentrations and to Concentrations at or above 20, 40, or 60 ppb O 3 (Deaths Summed Across Urban Case Study Areas) 86 Number of O 3 - Associated Deaths Summed Across Urban Case Study Areas Standard Level Total O 3 20+ ppb 40+ ppb 60+ ppb 2007 75 ppb 7,500 7, 500 5,4 00 500 70 ppb 7,200 7, 200 4, 900 240 65 ppb 6,5 00 6,5 00 2,8 00 90 60 ppb 87 6, 400 6, 400 2, 300 10 2009 75 ppb 7, 000 7,0 00 4,7 00 27 0 70 ppb 6,9 00 6, 900 4, 300 80 65 ppb 6,4 00 6,4 00 2, 600 40 60 ppb 6, 300 6, 300 2,100 10 i i

. Key Uncertainties
C ompared to estimates of O 3 exposures of concern and estimates of O 3 - induced lung function decrements (discussed above), the HREA conclusions reflect lower confidence in epidemiologic

- based risk estimates (U.S. EPA, 2014a, section 9.6 ) . In particular, the HREA highlights the heterogeneity in effect estimates between locati ons, the potential for exposure measurement errors, and uncertainty in the interpretation of the shape of concentration

- response

86 Numbers Table 3 is based on the information in Figures 7

- 2 and 7

- 3 in the HREA (U.S. EPA, 2014a). Estimates of the numbers of O 3 - associated deaths are based on concentration

- response relationships for total mortality associated with short

- term O 3 from the study by Smith et al. (2009). Estimates of the numbers O 3 - associated deaths are rounded to the nearest hundred, unless otherwise indicated. 87 As discussed in section 4.3.3 of the HREA, the model

- based air quality adjustment approach used to estimate risks associated with the current and alternative standards was unable to estimate the distribution of ambient O 3 concentrations in New York City upon just meeting an alternative standard with a level of 60 ppb. Therefore, the total number of deaths indicated for the 60 ppb standard level reflect the 60 ppb estimates for all urban study areas except New York City. For New York City, the estimated number of O 3 - associated deaths for the 6 0 ppb standard level was assumed to be equal to the number for the 65 ppb level

. Formatted: Space After: 0 pt*** E.O. 12866 Review

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Page 167 of 668 functions at lower O 3 concentrations (U.S. EPA, 2014a, section 9.6). The HREA also concludes that lower confidence should be pl aced in the results of the assessment of respiratory mortality risks associated with long

- term O 3 , primarily because that analysis is based on only one study , though that study is well

- designed, and because of the uncertainty in that study about the existence and identification of a potential threshold in the concentration

- response function (U.S. EPA, 2014a, section 9.6). 88 , 89 This section further discusses some of the key uncertainties in epidemio logic

- based risk estimates, as summarized in the PA ( U.S. EPA, 2014c , section 3.2.3.2), with a focus on uncertainties that can have particularly important implications for the Administrator’s consideration of epide miology

- based risk estimates. The PA note s that reducing NO X emissions generally reduces O 3 - associated mortality and morbidity risk estimates in locations and time periods with relatively high ambient O 3 concentrations and increases risk estimates in locations and time periods with relatively low concentrations (II.C.1 , above ) . When evaluating uncertainties in epidemiologic risk estimates, it is important to consider (1) the extent to which the O 3 response to reductions in NO X emissions appropriately represent s the trends observed in ambient O 3 following actual reductions in NO X emissions; (2) the extent to which estimated changes in risks in urban study areas are representative of the changes that would be experienced broadly across the U.S. population; and (3) the extent to which the O 3 respon se to reductions in precursor emissions could differ with

88 The CASAC also concluded that “[i]n light of the potential nonlinearity of the C

- R function for long

- term exposure reflecting a threshold o f the mortality response, the estimated number of premature deaths avoidable for long

- term exposure reductions for several levels need to be viewed with caution” (Frey, 2014a, p. 3). 89 There is also uncertainty about the extent to which mortality estimates based on the long

- term metric used in the study by Jerrett et al. (2009) (i.e., seasonal average of 1

- hour daily maximum concentrations) reflects associations with long

- term average O 3 versus repeated occurrences of elevated short

- term concentrations.*** E.O. 12866 Review

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Page 168 of 668 emissions reduction strategies that are different from those used in H REA to generate risk estimates. To evaluate the first issue, the H REA conducted a national analysis evaluating trends in monito red ambient O 3 concentrations during a time period when the U.S. experienced large

- scale reductions in NO X emissions (i.e., 2001 to 2010). Analyses of trends in monitored O 3 indicate that over such a time period, the upper end of the distribution of monito red O 3 concentrations (i.e., indicated by the 95 th percentile) generally decreased in urban and non

- urban locations across the U.S. (U.S. EPA, 2014 a , Figure 8

- 29). D uring this same time period , median O 3 concentrations decreased in suburban and rural locat ions , and in some urban locations. However , median concentrations i ncreased in some large urban centers (U.S. EPA, 2014 a , Figure 8

- 28). As discussed in the REA, and above (II.C.1), these increases in median concentrations likely reflect the increases in relatively low O 3 concentrations that can occur near important sources of NO X upon reductions in NO X emissions (U.S. EPA, 2014 a , section 8.2.3.1). These patterns of monitored O 3 during a period when the U.S. experienced large reductions in NO X emissions ar e qualitatively consistent with the modeled response s of O 3 to reductions in NO X emissions. To evaluate the second issue, the HREA conducted national air quality modeling analyses. These analyses estimated the proportion of the U.S. population living in locations where seasonal averages of daily O 3 concentrations are estimated to decrease in response to reductions in NO X emissions, and the proportion living in locations where such seasonal averages are estimated to increase. Given the close relationship b etween changes in seasonal averages of daily O 3 concentrations and changes in seasonal mortality and morbidity risk estimates, this analysis informs consideration of the extent to which the risk results in urban study areas represent the U.S. population as a whole. This representativeness analysis indicates*** E.O. 12866 Review

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Page 169 of 668 that the majority of the U

. S

. population lives in locations where reducing NO X emissions would be expected to result in decreases in warm season averages of daily maximum 8

- hour ambient O 3 concentrations

. Because the HREA urban study areas tend to underrepresent the populations living in such areas (e.g., suburban, smaller urban, and rural areas ) , risk estimates for the urban study areas are likely to understate the average reduction s in O 3 - associated mor tality and morbidity risk s that would be experienced across the U.S. population as a whole upon reducing
NO X emissions (U.S. EPA, 2014 a , section 8.2.3.2 ). To evaluate the third issue, the HREA assesse d the O 3 air quality response to reducing both NO X and VOC emissions (i.e., in addition to assessing reductions in NO X emissions alone) for a subset of seven urban study areas . As discussed in the PA ( U.S. EPA, 2014c , section 3.2.1), in most of the urban study areas the inclusion of VOC emissions reductio ns did not alter the NO X emissions reductions required to meet the current or alternative standards. 90 However, the addition of VOC reductions generally resulted in larger decreases in mid

- range O 3 concentrations (25 th to 75 th percentiles) ( US U

. S

. EPA, 2014 a, Appendix 4 D , section 4.7). 91 In addition, in all seven of the urban study areas evaluated, the increases in low O 3 concentrations were smaller for the NO X /VOC scenarios than the NO X alone scenarios ( US U

. S

. EPA, 2014a, Appendix 4 D , section 4.7). This was most apparent for Denver, Houston, Los Angeles, New York, and Philadelphia . Given the impacts on total risk estimates of increases in low O 3 concentrations,

90 The exceptions are Chicago and Denver, for which the HREA risk estimates are based on reductions in both NO X and VOC (U.S. EPA, 2014a, section 4.3.3.1). Emissions of NO X and VOC were reduced by equal percentages, a scenario not likely to reflect the optima l combination for reducing risks. 91 This was the case for all of the urban study areas evaluated, with the exception of New York (U.S. EPA, 2014a, Appendix 4

- D , section 4.7 ).*** E.O. 12866 Review

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Page 170 of 668 these results suggest that in some locations optimized emissions reduction strategies could result in larger reductions in O 3 - associated mortality and morbidity than indicated by HREA estimates.
S ection 7.4 of the HREA also highlights some additional uncertainties associated with epidemiologic

- based risk estimates ( U.S. EPA, 2014 a ). This section of the HREA identifies and discusses sources of uncertainty and p resents a qualitative evaluation of key parameters that can introduce uncertainty into risk estimates (U.S. EPA, 2014 a , Table 7

- 4) . For several of these parameters , the HREA also presents quantitative sensitivity analyses (U.S. EPA, 2014 a , sections 7.4.2 and 7.5.3). Of the uncertainties discussed in Chapter 7 of the HREA , those related to the application of concentration

- response functions from epidemiologic studies can have particularly important implications for consideration of epidemiology

- based risk estimates , as discussed below

. An important uncertainty is the shape of concentration

- response functions at low ambient
O 3 concentrations (U.S. E PA, 2014 a , Table 7

- 4). 92 Consi stent with the ISA conclusion that there is no discernible population threshold in O 3 - associated health effects, the HREA estimates epidemiology

- based mortality and morbidity risks for entire distributions of ambient O 3 concentrations, based on the assumpt ion that concentration

- response relationships remain linear over those distributions. In addition, in recognition of the ISA conclusion that certainty in the shape of O 3 concentration

- response functions decreases at low ambient concentrations, the HREA als o estimates total mortality associated with various ambient O 3 concentrations. The PA considers both types of r isk estimates, recognizing greater public health concern for adverse O 3 - attributable effects at higher ambient O 3 concentrations (which drive hig her exposure

92 A related uncertainty is the existence, or not, of a threshold. The HREA addr esses this issue for long

- term O 3 by evaluating risks in models that include potential thresholds (II.D.2.c).*** E.O. 12866 Review

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Page 171 of 668 concentrations, section 3.2.2 of the PA ( U.S. EPA, 2014c ) ), as compared to lower concentrations. A related uncertainty is that associated with the public health importance of the increases in relatively low O 3 concentrations following air quality adjustment. This uncertainty relates to the assumption that the concentration response function for O 3 is linear, such that that total risk estimates are equally influenced by decreasing high concentrations and increas ing low concentrations, when the increases and decreases are of equal magnitude. Even on days with increases in relatively low area

- wide average concentrations, resulting in increases in estimated risks, some portions of the urban study areas could experie nce decreases in high O 3 concentrations. To the extent adverse O 3 - attributable effects are more strongly supported for higher ambient concentrations (which are consistently reduced upon air quality adjustment) , t he impacts on risk estimates of increasing l ow O 3 concentrations reflect an important source of uncertainty. The HREA also notes important uncertainties associated with using a concentration

response relationship developed for a particular population in a particular location to estimate health risk s in different populations and locations (U.S. EPA, 2014 a , Table 7

- 4). As discussed above, concentration

- response relationships derived from epidemiologic studies reflect the spatial and temporal patterns of population exposures during the study. The HREA applies concentration

- response relationships from epidemiologic studies to adjusted air quality in study

areas that are different from, and often larger in spatial extent than, the areas used to generate the relationships. This approach ensures the inclusi on of the actual nonattainment monitors that often determine the magnitude of emissions reductions for the air quality adjustments throughout the urban study areas . This approach also allows the HREA to estimate patterns of health risks more*** E.O. 12866 Review

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Page 172 of 668 broadly across a larger area, including a broader range of air quality concentrations and a larger population. The HREA notes that it is not possible to quantify the impacts of this uncertainty on risk estimates in most urban case study locations, though the HREA notes that mortality e ffect estimates for different portions of the New York City CBSA

- core based assessment statistical

area ( CBSA ) vary by a factor of almost 1 0 (U.S. EPA, 2014 a , section 7.5.3). An additional, related uncertainty is that associated with applying concentration

- response functions from epidemiologic studies to adjusted air quality. Concentration

- response functions from the O 3 epidemiologic studies used in the HREA are based on associations between day to day variation in “area

- wide” O 3 conce ntrations (i.e., averaged across multiple monitors) and variation in health effects. Epidemiologic studies use these area

- wide O 3 concentrations, which reflect the particular spatial and temporal patterns of ambient O 3 present in study locations, as
surrog ates for the pattern of O 3 exposures experienced by study populations. To the extent adjusting O 3 concentrations to just meet the current standard results in important alterations in the spatial and/or temporal patterns of ambient O 3 , there is uncertainty in the appropriateness of applying concentration

- response functions from epidemiologic studies (which necessarily reflect a different air quality distribution than the modelled distribution) to estimate health risks associated with adjusted O 3 air quality. In particular, this uncertainty could be important to the extent that (1) factors associated with space modify the effects of O 3 on health or (2) spatial mobility is a key driver of individual

- level exposures. Although the impact of this uncertainty on
ri sk estimates cannot be quantified (U.S. EPA, 2014 a , Table 7

- 4), it has the potential to become more important as model adjustment results in larger changes in spatial and temporal patterns of ambient O 3 concentrations across urban study areas

.*** E.O. 12866 Review

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Page 173 of 668 The use of a national concentration

- response function to estimate respiratory mortality associated with long

- term O 3 is a source of uncertainty. Risk estimates generated in sensitivity analyses using region

- specific effect estimates differ substantially from the core estimates based on a single national

- level effect estimate (U.S. EPA, 2014a; Table 7

- 14). Furthermore, the risk estimates generated using the regional effect estimates display considerable variability across urban study areas (U.S. EPA, 2014a; Table 7

- 14), reflecting the substantial variability in the underlying effect estimates (see Jerrett et al., 2009, Table 4). While the results of the HREA sensitivity analyses evaluating this uncertainty point to the potential for regional heterogeneity in the long

- ter m risk estimates, the relatively large confidence intervals associated with regional effect estimates resulted in the HREA conclusion that staff does not have confidence in the regionally based risk estimates themselves. Finally, the HREA does not quantif y any reductions in risk that could be associate d with reductions in the ambient concentrations of pollutants other than O 3 , resulting from control of
NO X . For example , as discussed in chapter 2 of the PA ( U.S. EPA, 2014c ) , NO X emissions contribute to ambient NO 2 , and NO X and VOCs can contribute to secondary formation of PM 2.5 constituents, including ammonium sulfate (NH 4 SO 4 ), ammonium nitrate (NH 4 NO 3 ), and organic carbon (OC). Therefore, at some times and in some locations, con trol strategies that would reduce NO X emissions (i.e., t o meet an O 3 standard) could reduce ambient concentrations of NO 2 and PM 2.5 , resulting in health benefits beyond those directly associated with reducing ambient O 3 concentrations. In issuing its advic e, CASAC likewise noted the potential reductions in criteria pollutants other than ozone as a result of NOx reductions, and the resulting potential public health benefits (Frey, 2014a, pp. 10 and 11).
D

. Conclusions on the Adequacy of the Current Primary Standard Formatted: Font: Italic Formatted: Font: Italic*** E.O. 12866 Review

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Page 174 of 668 The initial issue to be addressed in the current review of the primary O 3 standard is whether, in view of the advances in scientific knowledge and additional information, the existing standard should be revised. In evaluating whether it is approp riate to retain or revise the current standard, the Administrator ’s considerations build upon those in the 2008 review, including consideration of the broader body of scientific evidence and exposure and health risk information

now available , as summarized above (II.A to II.C)

. I n developing conclusions on the adequacy of the current primary O 3 standard , t he Administrator take s into account both evidence

- based and quantitative exposure

- and risk

- based considerations. Evidence

- based considerations include the assessment of evidence from controlled human exposure, animal toxicological, and epidemiologic studies for a variety of health endpoints. The Administrator focuses on health endpoints for which the evidence is strong enough to support a "causal" or a “ likely to be causal” relationship, based on the ISA's integrative synthesis of the entire body of evidence. The Administrator's c onside ration of quantitative exposure and risk information draws from the results of the exposure and risk
assessments presente d in the HREA

. The Administrator's consideration of the evidence and exposure/risk information is informed by the considerations and conclusions presented in the PA (U.S. EPA, 2014c)

. T he purpose of the PA is to help "bridge the gap" between the scientif ic and technical information assessed in the ISA and HREA, and the policy decisions that are required of the Administrator (U.S. EPA, 2014c, Chapter 1)

. T he PA's evidence

- based and exposure

- /risk

- based considerations and conclusions are summarized below in sections II.D.1 to II.D. 3

. CASAC advice to the Administrator and public commenter views are summarized in section II.D. 4

. Section II.D.5*** E.O. 12866 Review

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Page 17 5 of 668 presents the Administrator’s proposed conclusions concerning the adequacy of the public health protection provided b y the current standard , and her proposed decision to revise that standard

. 1

. Summary of Evidence

- Based Considerations in the PA In considering the available scientific evidence, t he PA evaluates the O 3 concentrations in health effects studies ( U.S. EPA, 2014c , section 3.1.4). Specifically, the PA characterize s the extent to which effects have been reported for the O 3 exposure concentrations evaluated in controlled human exposure studies and over the distributions of ambient O 3 concentrations in locations where epidemiologic studies have been conducted. The se considerations, as they relate
to the adequacy of the current standard, are presented in detail in section 3.1.4 of the PA (U.S. EPA, 2014c) and are summarized briefly belo w for controlled human exposure and epidemiologic panel studies (II.D.1.a), epidemiologic studies of short

- term O 3 exposures (II.D.1.b), and epidemiologic studies of long

- term O 3 exposures (II.D.1.c). Section II.D.1.d summarizes the PA conclusions based on consideration of the scientific evidence. a. Concentrations in controlled human exposure and panel studies The evidence from controlled human exposure studies and panel studies is assessed in section 6.2 of the ISA (U.S. EPA, 2013 2013 a ) and is summarize d in section 3.1.2 of the PA ( U.S. EPA, 2014c ). As discussed above (II.B), c ontrolled human exposure studies have generally been conducted with young, healthy adults, and have evaluated exposure durations less than 8 hours. P anel studies have evaluated a w ider range of study populations, including children, and have generally evaluated associations with O 3 concentrations averaged over several hours ( U.S. EPA, 2013 2013 a , section 6.2.1.2 ). 93

93 The PA focuses on panel studies that used on

- site monitoring, and that are highlighted in the ISA for the extent to which monitored ambient O 3 concentrations reflect exposure concentrations in their study populations ( U.S. EPA, 2013 2013a , section 6.2.1.2).*** E.O. 12866 Review

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Page 176 of 668 As summarized above (II.B) , a large number of controlled human exposure studies have reported lung function decrements, respiratory symptoms, airway inflammation, airway hyperresponsiveness AHR , and/or impaired lung host defense in young, healthy adults engaged in moderate, intermitte nt exertion, following 6.6

- hour O 3 exposures. These studies have consistently reported such effects following exposures to O 3 concentrations of 80 ppb or greater. Available In addition to lung function decrements, available studies have also evaluated most of these effects (i.e., lung function decrements, respiratory symptoms , or airway inflammation ) following exposures to O 3 concentrations below 75 ppb

. Table 3

- 1 in the PA highlights the group mean results of individual controlled human exposure studies tha t have evaluated exposures of healthy adults to O 3 concentrations below 75 ppb ( U.S. EPA, 2014c )

. The studies included in Table 3

- 1 of the PA indicate a combination of lung function decrements and respiratory symptoms following 6.6 hour exposures to O 3 concentrations as low as 72 ppb, 94 and lung function decrements and airway inflammation following 6.6 hour exposures to O 3 concentrations as low as 60 ppb

. (based on group means)

. The PA also notes consistent results in some panel studies of O 3 - associate d lung function decrements

. In particular , the PA notes that epidemiologic panel studies in children and adults consistently indicate O 3 - associated lung function decrements when on

- site monitored concentrations were below 75 ppb, with although the evidence becoming becom es less consistent at lower O 3 concentrations (U.S. EPA, 2014c, section 3.1.4.1). 95

94 As noted above, for the 70 ppb exposure concentration Schelegle et al. (2009) reported that the actual 6.6

- hour mean exposure concentration was 72 ppb. 95 As indicated in the PA (U.S. EPA, 2014c, Table 3

- 2), key O 3 p anel studies evaluated averaging periods ranging from 10 minutes to 12 hours.*** E.O. 12866 Review

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Page 177 of 668 Thus, controlled human exposure studies and panel studies have reported respiratory effects in adults and children following exposures to O 3 concentrations bel ow 75 ppb

. (albeit

over shorter averaging periods than the 8 hour averaging time of the current O 3 standard)

. The PA notes that s uch impairments in respiratory function have the potential to be adverse, based on ATS guidelines for adversity and based on ad vice from CASAC ( Frey, 2014c , pp. 5 and 6 ) ( U.S. EPA, 2014c , section 3.1.3). In addition, the PA notes that if they become serious enough, these respiratory effects could lead to the types of clearly adverse effects commonly reported in O 3 epidemiologic studies (e.g., respiratory emergency department visits, hospital admissions). Therefore, the PA concludes that the respiratory effects experienced following exposures to O 3

co ncentrations lower than 75 ppb could be adverse in some individual s, particularly if experienced by members of at

- risk populations (e.g., people with asthma , children). 96 b. Concentrations in epidemiologic studies

– short

- term The PA also considers distributions of ambient O 3 concentrations in locations where epidemiolo gic studies have evaluated O 3 - associated hospital admissions, emergency department visits, and/or mortality ( U.S. EPA, 2014c , section 3.1.4.2)

. When considering epidemiologic studies within the context of the current standard, the PA emphasize s those studi es conducted in the U.S. and Canada. Such studies reflect air quality and exposure patterns that are likely more typical of the U.S. population than the air quality and exposure patterns reflected in studies conducted outside the U.S. and Canada ( U.S. EPA, 2014c , section 1.3.1.2)

. 97 The PA also

96 These effects were reported in healthy individuals. Consistent with past CASAC advice (Samet, 2011 ; Frey, 2014a, p. 14; Frey, 2014c, p. 7 ), it is a reasonable inference that the effects would be greater in magnitude and potential severity for at

- risk groups. See National Environmental Development Ass’n Clean Air Project v. EPA, 686 F. 3d 803, 811 (D.C. Cir. (2012) (making this point). 97 Nonetheless, the PA recognizes the importance of all studies, including international studies, in the ISA’s assessment of the weight of the evidence that informs causality determinations. Formatted: Space After: 0 pt*** E.O. 12866 Review

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Page 178 of 668 emphasizes studies reporting associations with effects judged in the ISA to be robust to confounding by other factors, including co

- occurring air pollutants. In addition to these factors, the PA consider s the statisti cal precision of study results, the extent to which studies report associations in at

- risk populations, and the extent to which the biological plausibility of associations at various ambient O 3 concentrations is supported by controlled human exposure and/o r animal toxicological studies. T hese considerations help inform the range of ambient O 3 concentrations over which the evidence indicates the most confidence in O 3 - associated health effect s, and the range of concentrations over which confidence in such ass ociations is appreciably lower. This section summarizes the PA conclusions regarding the extent to which health effect associations have been reported for ambient O 3 concentrations likely to have met the current O 3 standard. Section II.D.1.b.i summarizes PA analyses an d conclusions based on analyses evaluating the extent to which epidemiologic studies have reported health effect associations in locations that would likely have met the current O 3 standard . Section II .D.1.b.ii summarizes PA conclusions based on analyses evaluating the O 3 air quality in locations where epidemiologic studies have characterized confidence intervals around cut point analyses or concentration

response functions. Section II.D.1.b.iii summari zes the important uncertainties in these analyses. i. Associations in locations likely meeting current standard The PA considers the extent to which U.S. and Canadian epidemiologic studies have reported associations with mortality or morbidity in locatio ns that would likely have met the
current O 3 standard during the study period ( U.S. EPA, 2014c , section 3.14.2). Addressing this issue can provide important insights into the extent to which O 3 - health effect associations are present for distributions of ambient O 3 concentrations that would be allowed by the current*** E.O. 12866 Review

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Page 179 of 668 standard. To the extent associations are reported in study areas that would have met the current standard, those associations indicate that the current standard could allo w the types of clearly adverse O 3 - associated effects reported in epidemiologic studies (e.g., mortality, hospital admissions, emergency department visits). 98 In considering these analyses, the PA also notes that the lack of such associations does not indica te that the current standard would prevent O 3 - associated health effects. Rather, the lack of health effect associations in locations meeting the current standard indicates increasing increas ed uncertainty in the extent to which O 3 - associated health effects would persist upon reducing O 3 precursor emissions in order to meet the
current that standard. The PA identifies U.S. and Canadian studies of respiratory hospital admissions, respiratory emergency department visits, and mortality (total, respiratory, card iovascular) from the ISA (U.S. EPA, 2013 2013 a , Tables 6

- 28, 6

- 42, and 6

- 53, and section 6.2.8; U.S. EPA, 2014c , Appendix 3D). Analysis of study area air quality indicates that the large majority of epidemiologic study areas evaluated would have violated the current standard during study periods ( U.S. EPA, 2014c , Appendix 3 D). However, the PA notes that a single

- city study conducted in Seattle, a location that would have met the current standard over the entire study period , reported positive and statistic ally significant associations with respiratory emergency department visits in children and adults (Mar and Koenig, 2009). The PA also notes four Canadian multicity studies that reported positive and statistically significant associations with respiratory m orbidity or mortality, and for which the majority of study cities would have met the

98 See ATA III , 283 F.3d at 370 ( EPA justified in revising NAAQS when health effect associations are observed in epidemiologic studies at levels allowed by the NAAQS ). ) ; State of Mississippi v. EPA , 744 F. 3d at 1345 (same). Formatted: Space After: 0 pt*** E.O. 12866 Review

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Page 180 of 668 current standard over the entire study periods (Cakmak et al., 2006; Dales et al., 2006; Katsouyanni et al., 2009; Stieb et al., 2009). 99 The PA concludes that the single

- city study by Mar and Koenig (2009) indicates the presence of associations with mortality and morbidity for an ambient distribution of O 3 that would have met the current standard (U.S. EPA, 2014c, section 3.1.4.2). T he PA notes that interpretation of the air quality concentrations in the multicity study locations evaluated in this review is complicated by uncertainties in the extent to which multicity effect estimates can be attributed to ambient O 3 in the majority of locations, which would have met the cu rrent standard,
versus O 3 in the smaller number of locations that would have violated the standard. While acknowledging this uncertainty in interpreting air quality in multicity studies, the PA notes that multicity effect estimates in the four studies cite d above are largely influenced by locations meeting the current standard (i.e., given that most study areas would have met this standard). Therefore, the PA concludes that Canadian multicity studies, in addition to the single

- city study in Seattle, suggest confidence in the presence of associations with mortality and morbidity for ambient distributions of O 3 that would have met the current standard (U.S. EPA, 2014c, section 3.1.4.2). ii. Air quality associated with cut point analyses and c oncentration

- respo nse functions The PA also considers the extent to which additional epidemiologic studies of mortality or morbidity, specifically those conducted in locations that would have violated the current standard, can inform consideration of adequacy of the current standard ( U.S. EPA, 2014c ,

99 In addition, a study by Vedal et al. (2003) was included in the 2006 CD AQ CD ( U.S. EPA, 2006a ). This study reported positive and statistically significant associations with mortality in Vancouver during a time period when the study area would have met the c urrent standard (U.S. EPA, 2007). This study was not assessed in the ISA in the current review (U.S. EPA, 2013 2013 a ).*** E.O. 12866 Review

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Page 181 of 668 section 3.1.4.2). In doing so, the PA notes that health effect associations reported in epidemiologic studies are influenced by the full distributions of ambient O 3 concentrations, including concentrations below the level of the current standard. The PA focuses on studies that have explicitly characterized O 3 health effect associations, including confidence in those associations, for various portions of distributions of ambient O 3 concentrations.
T he U.S. multicity study by Bell et al. (2006) reported health effect associations for air quality subsets restricted to ambient O 3 concentrations below one or more predetermined cut points . In these analyses, effect estimates were based only on the s ubsets of days contributing to averaged O 3 concentrations below cut point s ranging from 5 to 60 ppb ( see Figure 2 in Bell et al.,
2006 , Figure 2 ). 100 The PA notes that s uch “cut point” analyses can provide information on the magnitude and statistical precision of effect estimates for defined distributions of ambient concentrations, which may in some cases includ e distributions that would meet the current standard (U.S. EPA, 2014c, section 3.1.4.2)

. T he cut points below which confidence intervals become notably wider depend in large part on data density and, therefore, cut point analyses provide insight into the ambient concentrations below which the available air quality information becomes too sparse to support conclusions about the nature of concentra tion

- response relationships with a high degree of confidence (U.S. EPA, 2014c, section 3.1.4.2).
T he PA considers the extent to which the cut

- point analyses reported by Bell et al. (2006) indicate health effect associations for distributions of ambient O 3 concentrations that would likely have met the current standard

. The PA particularly focuse s on t he lowest cut

- point for which the association between O 3 and mortality was reported to be statistically significant ( i.e.,

100 In the published study, 2

- day rolling averages of 24

- hour average O 3 concentrations were calculated in each study location (based on av eraging across monitors in study locations with multiple monitors).*** E.O. 12866 Review

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Page 182 of 668 30 ppb, based on visual inspection of Figure 2 in the published study). Based on the O 3 air quality concentrations that met the criteria for inclusion in the 30 ppb cut point analysis, 95% of study areas had 3

- year averages of annual 4 th highest daily maximum 8

- hour O 3 concentration at or below 75 ppb over the entire study period (U.S. EPA, 2014c, section 3.1.4.2, Table 3

- 6). Though there are important uncertainties in this analysis, as discussed below, the PA concludes that these results suggest that the large majority of air qualit y distributions that provided the basis for the positive and statistically significant association with mortality at the 30 ppb cut point would likely have met the current O 3 standard. The PA also analyzes air quality for studies that have reported confi dence intervals around concentration

- response functions over distributions of ambient O 3 concentrations ( U.S. EPA, 2014c , section 3.1.4.2)

. Confidence intervals around concentration

- response functions can provide insights into the range of ambient concentr ations over which the study indicates the most confidence in the reported health effect associations (i.e., where confidence intervals are narrowest), and into the range of ambient concentrations below which the study indicates that uncertainty in the natu re of such associations becomes notably greater (i.e., where confidence intervals become markedly wider). As with cut point analyses, t he concentrations below which confidence intervals become markedly wider are intrinsically related to data density, and d o not

ne cessarily indicate the absence of an association. The PA focuses on two U.S. single

- city studies that have reported confidence intervals around concentration

- response functions ( Silverman and Ito, 2010 ; Strickland e t al., 2010)

. Based on the publ ished analyses, the PA identifies the range s of ambient O 3 concentrations over which the se studies indicate the highest degree of confidence in the reported linear concentration

- response functions (U.S. EPA, 2014c, section 3.1.4.2) . F or the lower end s of the se*** E.O. 12866 Review

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Page 183 of 668 ranges , air quality analyses in the PA indicate that o ver 99% of days had maximum 8

- hour O 3 concentrations (i.e., from highest monitors in study locations) at or below 75 ppb. For comparison, the annual 4 th highest daily maximum 8

- hour O 3 concent ration generally corresponds to the 98 th or 99 th percentile of the seasonal distribution, depending on the length of the O 3 season. The PA concludes that these analyses of air quality data from the study locations evaluated by Silverman and Ito (2010) an d Strickland et al. (2010) indicate a relatively high degree of confidence in reported statistical associations with respiratory health outcomes on days when virtually all monitored 8

- hour O 3 concentrations were 75 ppb or below (U.S. EPA, 2014c, section 3. 1.4.2) . Though these analyses do not identify true design values, the presence of O 3 - associated respiratory effects on such days provides insight into the types of health effects that could occur in locations with maximum ambient O 3 concentrations at or below the level of the
current standard

. iii. Important Uncertainties The In considering the above evidence within the context of developing overall conclusions on the current and potential alternative standards, the PA also notes that there are takes i nto account important uncertainties associated with in these analyses of air quality in locations of epidemiologic studies. For example , t he study areas. These uncertainties are summarized in this section. The PA’s consideration of the evidence, including th e associated uncertainties, in reaching conclusions on the current and potential alternative standards is summarized in sections II.D.3 (current standard) and II.E.4 .b (potential alternative standards) below

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Page 184 of 668 The PA notes that while multicity studies generally have greater statistical power and geographic coverage than single

- city studies , there is often greater uncertainty in conclusions about the extent to which multicity effect estimates reflect associations with air quality meeting the current stan dard (U.S. EPA, 2014c, section 1.3.1.2.1). This is particularly the case for the multicity studies evaluated in this review with some study locations meeting the current standard and others violating that standard. Specifically f or the four Canadian multic ity studies discussed above, t he PA notes that interp retation of air quality information is complicated by uncertainties in the extent to which multicity effect estimates can be attributed to ambient O 3 in the majority of locations, which would have met th e current standard, versus O 3 in the smaller number of locations that would have violated the standard. The PA also notes important uncer tainties in multicity studies that evaluate the potential for thresholds to exist, as was done in the study by Bell e t al. (2006). Specifically, the ISA highlights the regional heterogeneity in O 3 health effect associations as a factor that could obscure the presence of thresholds, should they exist, in multicity studies (U.S. EPA, 2013 2013 a , sections 2.5.4.4 and 2.5.4.5). The ISA notes that community characteristics (e.g., activity patterns, housing type, age distribution, prevalence of air conditioning) could be important contributors to reported regional heterogeneity (U.S. EPA, 2013 2013 a , section 2.5.4.5). Given this heterogeneity, the ISA concludes that “a national or combined analysis may not be appropriate to identify whether a threshold exists in the O 3 - mortality [concentration

- response] relationship” (U.S. EPA, 2013 2013 a , p. 2

- 33). Th is represents an important source of uncertainty when characterizing confidence in reported concentration

- response relationships over distributions of ambient O 3 concentrations, based on multicity studies. The PA notes that t his uncertainty becomes increas ingly important when interpreting concentration

- response*** E.O. 12866 Review

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Page 185 of 668 relationships at lower ambient O 3 concentrations, particularly those concentrations corresponding to portions of distributions where data density decreases notably (U.S. EPA, 2014c, section 3.1.4.2)

. An other important uncertainty , related specifically to the PA analysis of cut points by Bell et al. (2006) , is that EPA staff was unable to obtain the air quality data used to generate the
cut

- point analyses in the published study (U.S. EPA, 2014c, sect ion 3.1.4.2) . Therefore, the analyses in the PA identified 2

- day averages of 24

- hour O 3 concentrations in study locations using the air quality data available in AQS, combined with the published description of study area definitions. A n important uncertain ty in this approach i s the extent to which the PA appropriately recreate d the cut

- point analyses in the published study (U.S. EPA, 2014c, section 3.1.4.2)

. An uncertainty that applies to epidemiologic studies in general is the extent to which reported h ealth effects are caused by exposures to O 3 itself, as opposed to other factors such as

co - occurring pollutants or pollutant mixtures. T he PA notes that this uncertainty becomes an increasingly important consideration as health effect associations are evaluated at lower ambient
O 3 concentrations. In particular, there is increasing uncertainty as to whether the observed associations remain plausibly related to exposures to ambient O 3 , rather than to the broader mix of air pollutants present in the ambien t air. In considering the potential importance of this uncertainty at the relatively low ambient O 3 concentrations that are the focus of the PA analyses, the PA notes that Silverman and Ito (2010) and Strickland (2010) reported O 3 health effect association s in co

- pollutant models, 101 providing support for associations with O 3 itself (U.S.

101 In addition, Bell et al. (2006) reported that, based on a previous study (Bell et al., 2004), associations with mortality were robust to the inclusion of PM 10 in the model.*** E.O. 12866 Review

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Page 186 of 668 EPA, 2014c, section 3.1.4.2). The PA also concludes that air quality analyses indicate c oherence with the results of experimental studies (i.e., in which the study design di ctates that exposures to
O 3 itself are res ponsible for reported effects) , and are consistent with the occurrence of O 3 - attributable respiratory hospital admissions and emergency department visits, even when virtually all monitored concentrations were below the level of the current standard (U.S. EPA, 2014c, section 3.1.4.2, Tables 3

- 4, 3

- 5)

.

c. Concentrations in e pidemi ologic s tudies

– long

- term The PA also considers the extent to which epidemiologic studies employing longer

- term ambient O 3 concentration metrics inform our understanding of the air quality conditions associated with O 3 - attributable health effects, and specifically inform consideration of the extent to which such effects could occur under air quality conditions meeting the cur rent standard ( U.S. EPA, 2014c , section 3.1.4.3). Unlike for the studies of short

- term O 3 discussed above, the available U.S. and Canadian epidemiologic studies evaluating long

- term ambient O 3 concentration metric s have not been conducted in locations likely to have met the current 8

- hour
O 3 standard during the study period , and have not reported concentration

- response functions that indicate confidence in health effect associations at O 3 concentrations meeting the current standard ( U.S. E PA, 2014c , section 3.1.4.3 )

. Therefore, although these studies contribute to understanding of health effects associated with long

- term or repeated exposures to ambient O 3 , consideration of study area air quality does not inform consideration of the extent to which those health effects may be occurring in locations that me e t the current standard. d. PA conclusions based on consideration of the evidence As discussed above (II.D.1.a to II.D.1.c), in considering the available scientific evidence , including as sociated uncertainties, as it relates to the degree of public health protection provided*** E.O. 12866 Review

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Page 187 of 668 by the current primary O 3 standard, the PA evaluates the extent to which health effects have been reported for the O 3 exposure concentrations evaluated in controlled h uman exposure studies and over the distributions of ambient O 3 concentrations in locations where epidemiologic studies have been conducted. The PA concludes that (1) t he evidence from controlled human exposure studies provides strong support for the occurr ence of adverse respiratory effects following exposures to O 3 concentrations below the level of the current standard and that (2) e pidemiologic studies provide support for the occurrence of adverse respiratory effects and mortality under air quality condit ions that would likely meet the current standard. In further considering the public health protection provided by the current standard, the PA next considers the results of exposure and health risk assessments.
2

. Summary of Exposure

- and Risk

- Based Considerations in the PA In order to further inform judgments about the potential public health implications of the
current O 3 NAAQS, the PA considers the exposure and risk assessments presented in the HREA ( U.S. EPA, 2014c , section 3.2). Overviews of the se exposure and risk assessments, including summaries of key results and uncertainties , are provided in section II.C ab ove. This section summarizes key observations from the PA related to the adequacy of the current O 3 NAAQS, based on consideration of the HREA exposure assessment (II.D.2.a), lung function risk assessment (II.D.2.b), and mortality/morbidity risk assessments (II.D.2. c)

. a. Exposure assessment

– k ey observations As discussed above (II.C.2) , t he exposure assessment provides estimates of the nu mber and percent of people who would experience exposures of concern at or above benchmark concentrations of 60, 70, and 80 ppb. B enchmarks reflect exposure concentrations at which O 3 - induced respiratory effects are known to occur in some healthy adults en gaged in moderate,*** E.O. 12866 Review

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Page 188 of 668 intermittent exertion, based on evidence from controlled human exposure studies ( U.S. EPA, 2014c , section 3.1.2.1; U.S. EPA, 2013 2013 a , section 6.2).
T he PA focuses on exposure estimates in children. C ompared to re cent (i.e., unadjusted) air quality, the PA notes that adjusting air quality to just meet the current O 3 NAAQS consistently reduces the estimated occurrence of exposures of concern in children (U.S. EPA, 2014a , Appendix 5 F ). When averaged over the years ev aluated in the HREA, reductions of up to about 70% were estimated . These reductions in estimated exposures of concern , relative to unadjusted air quality, reflect the consistent reductions in the highest ambient O 3 concentrations upon model adjustment to j ust meet the current standard ( U.S. EPA, 2014c , section 3.2.1; U.S. EPA, 2014 a , Chapter 4). Such reductions in estimated exposures of concern are evident throughout urban study areas , including in urban cores and in surrounding areas (U.S. EPA,
2014 a , Appe ndix 9A). Based o n Figures 3

- 7 to 3

- 10 in the PA ( U.S. EPA, 2014c ) , and the asso ciated details described in the HREA (U.S. EPA , 2014a, Chapter 5), the PA further highlights key observations with regard to exposures of concern in children that are estimated to be allowed by the current standard. These key observations are summarized below for exposures of concern > 60, 70, and 80 ppb. For exposures of concern at or above 60 ppb, the PA highlights the following key observations : for air qua lity adjusted to just meet the current standard : (1) On average over the years 2006 to 2010, the current standard is estimated to allow approximately 10 to 18% of children in urban study areas to experience one or more
exposure s of concern at or above 60 ppb. Summing across urban study areas , these percentages correspond to almost 2.5 million children experiencing approximately 4*** E.O. 12866 Review

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Page 189 of 668 million exposures of concern at or above 60 ppb during a single O 3 season . Of these children, almost 250,000 are asthmatic s . 102 (2) On av erage over the years 2006 to 2010, the current standard is estimated to allow approximately 3 to 8% of children in urban study areas to experience two or more exposures of concern to O 3 concentrations at or above 60 ppb. Summing across the urban study area s , these percentages correspond to almost 900,000 children (including almost 90,000 asthmatic children) estimated to experience at least two O 3 exposure concentrations at or above 60 ppb during a single O 3 season. (3) In the worst

- case years (i.e., those with the largest exposure estimates ) , t he current standard is estimated to allow approximately 1 0 to 25% of children to experience o ne or

more exposure s of concern at or above 60 ppb, and approximately 4 to 14% to experience two or more exposures of concern at or above 60 ppb. For exposures of concern at or above 70 ppb, the PA highlights the following key observations : for air quality adjusted to just meet the current standard : (1) On average over the years 2006 to 2010, the current standard is estimated to allow up to approximately 3 % of children in urban study areas to experience o ne or more exposure s of concern at or above 7 0 ppb. Summing across urban study areas , almost 400,000

c hildren (including almost 4 0,000 asthmatic children ) are estimated to experience O 3 exposure concentrations at or above 7 0 ppb during a single O 3 season. 103

102 As discussed above (II.C.2.b), due to variability in responsiveness, only a subset of individuals who experience exposures at or above a benchmark concentration can be expected to experience adverse health effects. 103 As discussed above (II.C.2.b), due to variability in responsiveness, only a subset of individuals who experience exposures at or above a benchmark concentration can be expected to experience adverse health effects.*** E.O. 12866 Review

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Page 190 of 668 (2) On average over the years 2006 to 2010, the current standard is estimated to allow less than 1% of c hildren in urban study areas to experience two or more exposures of concern
to O 3 concentrations at or above 70 ppb. (3) In the worst

- case years , t he current standard is estimated to allow approximately 1 to 8 % of children to experience o ne or more exposure s of concern at or above 70 ppb, and up to approximately 2% to experience two or more exposures of concern, at or above 7 0 ppb. For exposures of concern at or above 80 ppb , the PA highlights the observation that t he current standard is estimated to allow about 1% or fewer children in urban study areas to experience exposures of concern at or above 80 ppb, even in years with th e highest exposure estimates. b. L ung function risk assessment

– key o bservations As discussed above (II.C.3.a) , the HREA estimates risks of moderate to large lung function decrements (i.e., FEV 1 decrements > 10%, 15%, or 20%) in school

- aged children (ages 5 to 18), asthmatic school

- aged children, and the general adult population for 15 urban study

areas . As for exposures of concern, the PA focus es on lung function risk estimates in children (including children with asthma). Compared to risks associated with recent air quality, risk estimates for air quality just meeting the current standard are consistently smaller across urban study areas (U.S. EPA, 2014 a , Appendix 6 B ). When averaged over the years evaluated in the HREA, risk reductions of up to about 40 % were estimated compared to recent air quality. These reductions reflect the consistent decreases in relatively high ambient O 3 con centrations upon adjustment to just meet the current standard (U.S. EPA, 2014a, Chapter 4). Such reductions in estimated lung function risks are evident throughout urban study areas , including in urban cores and in surrounding areas (U.S. EPA, 2014, Appendix 9A).*** E.O. 12866 Review

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Page 191 of 668 Based on Figures 3

- 11 to 3

- 14 in the PA ( U.S. EPA, 2014c ) , and the associated details described in the HREA (U.S. EPA , 2014a, chapter 6), the PA highlights key observations with regard to lung function risks estimated in children for air qual ity adjusted to just meet the current standard. These key observations are presented below for FEV 1 decrements > 10, 15, and 20%

. With regard to decrements > 10%, the PA highlights the following key observations : for air quality adjusted to just meet the current standard : (1) On average over the years 2006 to 2010, the current standard is estimated to allow approximately 1 4 to 19 % of children in urban study areas to experience one or more lung function decrements > 10% . Summing across urban study areas , this correspond s to approximately 3 million children experiencing 15 million O 3 - induced lung function decrements > 10% during a single O 3 season . Of these children, about 30 0,000 are asthmatic s . (2) On average over the years 2006 to 2010, the current standard is estimated to allow approximately 7 to 12% of children in urban study areas to experience two or more O 3 - induced lung function decrements > 10%. Summing across the urban study areas , this corresponds to almost 2 million children (inc luding almost 200,000 asthmatic children) estimated to experience two or more O 3 - induced lung function decrements greater than 10% during a single O 3 season. (3) In the worst

- case years , the current standard is estimated to allow approximately 17 to 23 % of ch ildren in urban study areas to experience one or more lung function decrements

> 10% , and approximately 10 to 14% to experience two or more O 3 - induced lung function decrements > 10%

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Page 192 of 668 With regard to decrements > 15%, the PA highlights the following key ob servations for air quality adjusted to just meet the current standard : (1) On average over the years 2006 to 2010, the current standard is estimated to allow approximately 3 to 5 % of children in urban study areas to experience one or more lung function decrem ents > 15% . Summing across urban study areas , this correspond s to approximately 800,000 children (including approximately 8 0,000 asthmatic children ) estimated to experience at least one O 3 - induced lung function decrement > 15% during a single O 3 season. (2) On average over the years 2006 to 2010, the current standard is estimated to allow approximately 2 to 3% of children in urban study areas to experience two or more O 3 - induced lung function decrements > 15%. (3) In the worst

- case years, the current standard is estimated to allow approximately 4 to 6 % of children in urban study areas to experience one or more lung function decrements > 15% , and approximately 2 to 4% to experience two or more O 3 - induced lung function decrements > 15%

. With regard to decrements > 20%, the PA highlights the following key observations : for air quality adjusted to just meet the current standard : (1) On average over the years 2006 to 2010, the current standard is estimated to allow approximately 1 to 2 % of children in urban study areas to experience one or more lung function decrements > 20% . Summing across urban study areas , this correspond s to approximately 300,000 children (including approximately 3 0,000 asthmatic children ) estimated to experience at least one O 3 - induced lung function decrement > 20% during a single O 3 season.*** E.O. 12866 Review

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Page 193 of 668 (2) On average over the years 2006 to 2010, the current standard is estimated to allow less than 1% of children in urban study areas to experience two or more O 3 - induced lung function decrement s > 20%. (3) In the worst

- case years , the current standard is estimated to allow approximately 2 to 3 % of children to experience one or more lung function decrements > 20% , and less than 2% to experience two or more O 3 - induced lung function decrements > 20%

. c. Mortality and morbidity risk assessment s

– key observations As discussed above (II.C.3.b), r isk estimates based on epidemiologic studies can provide perspective on the most serious O 3 - associated public health outcomes (e.g., mortality, hospital admissio ns, emergency department visits) in populations that often include at

- risk groups. T he HREA estimates such O 3 - associated risks in 12 urban study areas 104 using concentration

response relationships drawn from epidemiologic studies. These concentration

- response relationships are based on “area

- wide” average O 3 concentrations. 105 The HREA estimates risks for the years 2007 and 2009 in order to provide estimates of risk for a year with generally higher
O 3 concentrations (2007) and a year with generally lower O 3 concentrations (2009) (U.S. EPA, 2014a, section 7. 1.1 )

.

104 The 12 urban areas evaluated are Atlanta, Baltimore, Boston, Cleveland, Den ver, Detroit, Houston, Los Angeles, New York, Philadelphia, Sacramento, and St. Louis. Morbidity endpoints were evaluated in subsets of these areas, based on availability of appropriate studies (U.S. EPA, 2014a, Chapter 7). 105 In the epidemiologic studies that provide the health basis for HREA risk assessments, concentration

- response relationships are based on daytime O 3 concentrations, averaged across multiple monitors within study areas. These daily averages are used as surrogates for the spatial and temp oral patterns of exposures in study populations. Consistent with this approach, the HREA epidemiologic

- based risk estimates also utilize daytime O 3 concentrations, averaged across monitors, as surrogates for population exposures. In this notice, these aver aged concentrations are referred to as “area

- wide” O 3 concentrations. Area

- wide concentrations are discussed in more detail in section 3.1.4 of the PA (U.S. EPA, 2014c).*** E.O. 12866 Review

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Page 194 of 668 In considering these estimates, the PA notes that HREA conclusions reflect somewhat lower confide nce in epidemiologic

- based risk estimates than in estimates of O 3 exposures of concern and O 3 - induced lung function decrements (U.S. EPA, 2014a, section 9.6 ). In particular, the HREA highlights the unexplained heterogeneity in effect estimates between loca tions, the potential for exposure measurement errors, and uncertainty in the interpretation of the shape of concentration

- response functions at lower O 3 concentrations (U.S. EPA, 2014a, section 9.6). The HREA also concludes that lower confidence should be placed in the results of the assessment of respiratory mortality risks associated with long

- term O 3 exposures, primarily because that analysis is based on only one study, though that study is well

- designed, and because of the uncertainty in that study abou t the existence and identification of a potential threshold in the concentration

- response function (U.S. EPA, 2014a, section 9.6). These and other uncertainties are considered in the PA in reaching conclusions on the current and alternative standards (U.S. EPA, 2014c, sections 3.4, 4.6). Key observations from the PA are summarized below for mortality and morbidity risks associated with air quality adjusted to simulate just meeting the current O 3 NAAQS

. These include key observations for estimates of total ( nonaccidental ) mortality associated with short

term O 3 concentrations, respiratory morbidity associated with short

- term O 3 concentrations, and respiratory morta lity associated with long

- term O 3 concentrations ( U.S. EPA, 2014c , section 3.2.3.2). With rega rd to total mortality or morbidity associated with short

- term O 3 , the PA notes the following for air quality adjusted to just meet the current standard : (1) When air quality was adjusted to the current standard for the 2007 model year (the year with generally “higher” O 3 - associated risks), 10 of 12 urban study areas exhibited either*** E.O. 12866 Review

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Page 195 of 668 decreases or virtually no change in estimates of the number of O 3 - associated deaths (U.S. EPA, 2014a, Appendix 7B). Increases were estimated in two of the urban study areas (Houston , Los Angeles) 106 (U.S. EPA, 2014 a , Appendix 7B). 107 (2) In focusing on total risk, the current standard is estimated to allow thousands of O 3 - associated deaths per year in the urban study areas . In focusing on the risks associated with the upper portions of distributions of ambient concentrations (area

- wide concentrations > 40, 60 ppb), the current standard is estimated to allow hundreds to thousands of O 3 - associated deaths per year in the urban study areas

. (3) The current standard is estimated to allow tens to thousands of O 3 - associated morbidity events per year (i.e., respiratory

- related hospital admissions, emergency department visits, and asthma exacerbations)

.

106 As discussed above (II.C.1), in locations and time periods when NO X is predominantl y contributing to O 3 formation (e.g., downwind of important NO X sources, where the highest O 3 concentrations often occur), model

- based adjustment to the current and alternative standards decreases estimated ambient O 3 concentrations compared to recent moni tored concentrations (U.S. EPA, 2014a, section 4.3.3.2). In contrast, in locations and time periods when NO X is predominantly contributing to O 3 titration (e.g., in urban centers with high concentrations of NO X emissions, where ambient O 3 concentrations ar e often suppressed and thus relatively low), model

- based adjustment increases ambient O 3 concentrations compared to recent monitored concentrations (U.S. EPA, 2014a, section 4.3.3.2). Changes in epidemiology

- based risk estimates depend on the balance betwe en the daily decreases in high O 3 concentrations and increases in low O 3 concentrations following the model

- based air quality adjustment

. Commenting on this issue, CASAC noted that “controls designed to reduce the peak levels of ozone (e.g., the 4 th highest annual MDA8) may not be effective at reducing lower levels of ozone on more typical days and may actually increase ozone levels on days where ozone concentrations are low” (Frey 2014a, p. 2). CASAC further noted that risk results “suggest that t he ozone

- related health risks in the urban cores can increase for some of the cities as ozone NAAQS alternatives become more stringent. This is because reductions in nitrogen oxides emissions can lead to less scavenging of ozone and free radicals, resultin g in locally higher levels of ozone” (Frey 2014c, p. 10). 107 For the 2009 adjusted year (i.e., the year with generally lower O 3 concentrations), changes in risk were generally smaller than in 2007 (i.e., most changes about 2% or smaller). Increases were es timated for Houston, Los Angeles, and New York City.*** E.O. 12866 Review

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Page 196 of 668 With regard to r espiratory mort ality associated with long

- term O 3 , the PA notes the following : for air quality adjusted to just meet the current standard : (1) Based on a linear concentration

- response function, the current standard is estimated to allow thousands of O 3 - associated respirator y deaths per year in the urban study areas

. (2) Based on threshold models, HREA sensitivity analyses indicate that the number of respiratory deaths associated with long

- term O 3 concentrations could potentially be considerably lower (i.e., by more than 75% if a threshold exists at 40 ppb, and by about 98% if a threshold exists at 56 ppb) ( U.S. EPA, 2014a, Figure 7

- 9 )

. 108
3

. CASAC Advice Following the 2008 decision to revise the primary O 3 standard by setting the level at 0.075 ppm (75 ppb), CASAC strongly questioned whether the standard met the requirements of the CAA. In September 2009, EPA announced its intention to reconsider the 2008 standards, issuing a notice of proposed rulemaking i n January 2010 (FR 75 2938). Soon after, EPA solicited CASAC review of that proposed rule and in January 2011 solicited additional a dvice. This proposal was based on the scientific and technical record from the 2008 rulemaking, including public comments an d CASAC advice and recommendations. As further described above (I.C), in the fall of 2011 EPA did not revise the standard as part of the reconsideration process but

108 R isk estimates for respiratory mortality associated with long

- term O 3 exposures are based on the study by Jerrett et al. (2009) (U.S. EPA, 2014a, Chapter 7). As discussed above (II.B.2.b.iv) and in th e PA (U.S. EPA, 2014c, section 3.1.4.3), Jerrett et al. (2009) reported that when seasonal averages of 1

- hour daily maximum O 3 concentrations ranged from 33 to 104 ppb, there was no statistical deviation from a linear concentration

- response relationship be tween O 3 and respiratory mortality across 96 U.S. cities ( U.S. EPA, 2013 2013a , section 7.7). However, the authors reported “limited evidence” for an effect threshold at an O 3 concentration of 56 ppb (p=0.06). In communications with EPA staff (Sasser, 2014) , the study authors indicated that it is not clear whether a threshold model is a better predictor of respiratory mortality than the linear model, and that “considerable caution should be exercised in accepting any specific threshold.”*** E.O. 12866 Review

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Page 197 of 668 decided to defer decisions on revisions to the ozone standards to the next periodic review, which was already underway. Accordingly, in this section we describe CASAC’s advice related to the 2008 final decision and the subsequent reconsideration, as well as its advice on this current review of the O 3 NAAQS that was initiated in September 2008. In April 2008, the members of the CASAC Ozone Review Panel sent a letter to EPA stating “[I]n our most

- recent letters to you on this subject

— dated October 2006 and March
2007

— the CASAC unanimously recommended selection of an 8

- hour average Ozone NAAQS with in the range of 0.060 to 0.070 parts per million [60 to 70 ppb] for the primary (human health

- based) Ozone NAAQS” (Henderson, 2008). The letter continued: The CASAC now wishes to convey, by means of this letter, its additional, unsolicited advice with reg ard to the primary and secondary Ozone NAAQS

. In doing so, the participating members of the CASAC Ozone Review Panel are unanimous in strongly urging you or your successor as EPA Administrator to ensure that these recommendations be considered during the n ext review cycle for the Ozone NAAQS that will begin next year ... numerous medical organizations and public health groups have also expressed their support of these CASAC recommendations’ ... [The CASAC did] not endorse the new primary ozone standard as being sufficiently protective of public health

. The CASAC

— as the EPA ’s statutorily

- established science advisory committee for advising you on the national ambient air quality standards

— unanimously recommended decreasing the primary standard to within the range of 0.060

– 0.070 ppm [60 to 70 ppb]

. It is the Committee’s consensus scientific opinion that your decision to set the primary ozone standard above this range fails to satisfy the explicit stipulations of the Clean Air Act that you ensure an adequate margin o f safety for all individuals, including sensitive populations. In response to EPA’s solicitation of advice on the EPA’s proposed rulemaking as part of the reconsideration, CASAC conveyed support (Samet, 2010). CASAC fully supports EPA’s proposed range of 0.060

– 0.070 parts per million (ppm) for the 8

- hour primary ozone standard. CASAC considers this range to be justified by the scientific evidence as presented in the Air Quality Criteria for Ozone and Related Photochemical Oxidants (March 2006) and Review of the National Ambient Air Quality Standards for Ozone: Policy Assessment of Scientific and Technical Information, OAQPS Staff Paper (July 2007). As stated in our letters of October 24, 2006, March 26, 2007 and April 7, 2008 to former Administrator Steph en L. Johnson, CASAC unanimously recommended selection*** E.O. 12866 Review

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Page 198 of 668 of an 8

- hour average ozone NAAQS within the range proposed by EPA (0.060 to 0.070 ppm). In proposing this range, EPA has recognized the large body of data and risk analyses demonstrating that retention of the current standard would leave large numbers of individuals at risk for respiratory effects and/or other significant health impacts including asthma exacerbations, emergency room visits, hospital admissions and mortality. In response to EPA’s request for additional advice on the reconsideration in 2011, CASAC reaffirmed their conclusion that “the evidence from controlled human and epidemiological studies strongly supports the selection of a new primary ozone standard within the 60

– 70 ppb range for a n 8

- hour averaging time” (Samet, 2011, p ii). As requested by EPA, CASAC’s advice and recommendations were based on the scientific and technical record from the 2008 rulemaking. In considering the record for the 2008 rulemaking, CASAC stated the following to summarize the basis for their conclusions (Samet, 2011, pp. ii to iii). (1) The evidence available on dose

- response for effects of ozone shows associations extending to levels within the range of concentrations currently experienced in the United States. (2) T here is scientific certainty that 6.6

- hour exposures with exercise of young, healthy, non

- smoking adult volunteers to concentrations ≥ 80 ppb cause clinically relevant decrements of lung function. (3) Some healthy individuals have been shown to have clinically relevant responses, even at 60 ppb. (4) Since the majority of clinical studies involve young, healthy adult populations, less is known about health effects in such potentially ozone sensitive populations as the elderly, children and those with cardiopulmonary disease

. For these susceptible groups, decrements in lung function may be greater than in healthy volunteers and are likely to have a greater clinical significance.*** E.O. 12866 Review

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Page 199 of 668 (5) Children and adults with asthma are at increased risk of acute exacerbations on or shortly after days when elevated ozone concentrations occur, even when exposures do not exceed the NAAQS concentration of 75 ppb. (6) (5) Large segments of the population fall into what EPA terms a “sensitive population group,’’ i.e., those at increased risk because they are more intrinsically susceptible (children, the elderly, and individuals with chronic lung disease) and those who are more vulnerable due to increased exposure because they work outside or live in areas that are more polluted than the mean levels in the ir communities. With respect to evidence from epidemiologic studies, CASAC stated “while epidemiological studies are inherently more uncertain as exposures and risk estimates decrease (due to the greater potential for biases to dominate small effect estim ates), specific evidence in the literature does not suggest that our confidence on the specific attribution of the estimated effects of ozone on health outcomes differs over the proposed range of 60

- 70 ppb” (Samet, 2011, p.10). Following its review of the second draft PA in the current review, which considers an updated scientific and technical record since the 2008 rulemaking, CASAC concluded that “there is clear scientific support for the need to revise the standard” ( Frey, 2014c , p. ii). In particular, CASAC noted the following ( Frey, 2014c , p. 5): [T]he scientific evidence provides strong support for the occurrence of a range of adverse respiratory effects and mortality under air quality conditions that would meet the current standard. Therefore, CASAC unanimously recommends that the Administrator revise the current primary ozone standard to protect public health. In supporting these conclusions, CASAC judged that the strongest evidence comes from controlled human exposure studies of respiratory effects. The Committee*** E.O. 12866 Review

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Page 200 of 668 specifically noted that “the combination of decrements in FEV 1 together with the statistically significant alterations in symptoms in human subjects exposed to 72 ppb ozone meets the American Thoracic Society’s definition of an adver se health effect” (Frey, 2014c, p. 5). CASAC further judged that “if subjects had been exposed to ozone using the 8

- hour averaging period used in the standard, adverse effects could have occurred at lower concentration ” and that “ the level at which adverse effects might be observed would likely be lower for more sensitive subgroups, such as those with asthma ” (Frey, 2014c, p. 5). With regard to lung function risk estimates based on information from controlled human exposure studies, CASAC concluded that “e stimation of FEV1 decrements of ≥15% is appropriate as a scientifically relevant surrogate for adverse health outcomes in active healthy adults, whereas an FEV1 decrement of ≥10% is a scientifically relevant surrogate for adverse health outcomes for people with asthma and lung disease” (Frey, 2014c, p. 3). The Committee further concluded that “[a]sthmatic subjects appear to be at least as sensitive, if not more sensitive, than non

- asthmatic subjects in manifesting O 3 - induced pulmonary function decrements” ( Frey, 2014c, p. 4). In considering estimates of the occurrence of these decrements in urban study areas , CASAC specifically noted that the current standard is estimated to allow 11 to 22% of school age children to experience at least one day with an FEV 1 d ecrement > 10 %. While CASAC judged that controlled human exposure studies of respiratory effects provide the strongest evidence supporting their conclusion on the current standard, the Committee judged that there is also “ sufficient scientific evidence based on epidemiologic studies for mortality and morbidity associated with short

- term exposure to ozone at the level of the current standard” ( Frey, 2014c , p. 5). In support of the biological*** E.O. 12866 Review

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Page 201 of 668 plausibility of the associations reported in these epidemiologic studies, CASAC noted that “[r]ecent animal toxicological studies support identification of modes of action and, therefore, the biological plausibility associated with the epidemiological findings” ( Frey, 2014c , p. 5). Consistent with the advice of CASAC, several public commenters supported revising the primary O 3 standard to provide increased public health protection. In considering the available evidence as a basis for their views, these commenters generally noted that the health evidence is stronger in the current review than in past reviews , with new evidence for effects attributable to short

- and long

- term exposures, and new evidence for effects at lower O 3 exposure concentrations. Other public commenters opposed considering revised standards. These commenters discussed a variety of reasons for their views. A number of commenters expressed the view that EPA should not lower the level of the standard because a lower level would be clo ser to background O 3 concentrations. In addition, several commenters challenged the interpretation of the evidence presented in the ISA. With respect to the risk assessment, several commenters expressed the view that the EPA should only estimate risks abov e O 3 background concentrations, or above threshold concentrations. Some commenters also expressed the view that, based on the mortality and morbidity risk estimates in the HREA, there is little to no difference between the risks estimated for the
current O 3 standard and the risks estimated for revised standards with lower levels. These commenters concluded that the HREA and PA have not shown that the public health improvements likely to be achieved by a revised O 3 standard would be greater than the improvem ents likely to be achieved by the current standard.*** E.O. 12866 Review

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Page 202 of 668 4. Policy Assessment Conclusions on the Current Standard As an initial matter, the PA concludes that reducing precursor emissions to achieve O 3 concentrations that meet the current standard will provide important improvements in public health protection. This initial conclusion is based on (1) the strong body of scientific evidence indicating a wide range of adverse health outcomes attributable to exposures to O 3 concentrations commonly found in the ambient air and (2) estimates indicating decreased occurrences of O 3 exposures of concern and decreased health risks upon meeting the current standard, compared to recent air quality. In particular, the PA concludes t hat s trong support for this initial conclusion is provided by controlled human exposure studies of respiratory effects, and by quantitative estimates of exposures of concern and lung function decrements based on information in these studies. Analyses in th e HREA estimate that the percentages of children (i.e., all children and children with asthma) in urban study areas experiencing exposures of concern, or experiencing abnormal and potentially adverse lung function decrements, are consistently lower for air quality that just meets the current O 3 standard than for recent air quality. The HREA estimates such reductions consistently across the urban study areas evaluated and throughout various portions of individual urban study areas , including in urban cores a nd the portions of urban study areas surrounding urban cores. These reductions in exposures of concern and O 3 - induced lung function decrements reflect the consistent decreases in the highest O 3 concentrations following reductions in precursor emissions to meet the current standard. Thus, populations in both urban and non

- urban areas*** E.O. 12866 Review

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Page 203 of 668 would be expected to experience important reductions in O 3 exposures and O 3 - induced lung function risks upon meeting the current standard. 109
The PA further concludes that s uppor t for this initial conclusion is also provided by estimates of O 3 - associated mortality and morbidity based on application of concentration

response relationships from epidemiologic studies to air quality adjusted to just meet the current standard. These es timates, which are based on the assumption that concentration

- response relationships are linear over entire distributions of ambient O 3 concentrations, are associated with uncertainties that complicate their interpretation ( II.C.3 ). However, risk estimates for effects associated with short

- and long

- term O 3 exposures, combined with the HREA’s national analysis of O 3 responsiveness to reductions in precursor emissions and the consistent reductions estimated for the highest ambient O 3 concentrations, suggest that O 3 - associated mortality and morbidity would be expected to decrease nationwide following reductions in precursor emissions to meet the current O 3 standard.
R eductions in O 3 precursor emissions (i.e., NO X ) could also increase public health protection by reducing the ambient concentrations of pollutants other than O 3 . For example, in their advice on the second draft HREA CASAC acknowledged the potential for ambient NO 2 concentrations to be affected by changes in NO X emissions (Frey, 2014a, p. 10) . Consi stent with this, the PA notes that NO X emissions contribute to ambient NO 2 , and that NO X and VOCs can contribute to secondary formation of PM 2.5 constituents, including ammonium sulfate (NH 4 SO 4 ), ammonium nitrate (NH 4 NO 3 ), and organic carbon (OC). Therefor e, at some times and in some locations, control strategies that would reduce NO X emissions (i.e., to meet an O 3 standard) could

109 As discussed above (II.C.1), CASAC recommended that the EPA evaluate how health risks in urban centers, as well as outside urban centers, change upon reducing NO X emissions, given the varying impacts of NO X emissions reductions on ambient O 3 concentration s.*** E.O. 12866 Review

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Page 204 of 668 reduce ambient concentrations of NO 2 and PM 2.5 , resulting in health benefits beyond those directly associated with reducing ambi ent O 3 concentrations. After reaching the initial conclusion that meeting the current primary O 3 standard will provide important improvements in public health protection, and that it is not appropriate to consider a standard that is less protective than t he current standard, the PA considers the adequacy of the public health protection that is provided by the current standard

. In considering the available scientific evidence, exposure/risk information, advice from CASAC , (II.D.4, below) , and input from the public, the PA reaches the conclusion that the a vailable evidence and information clearly call into question the adequacy of public health protection p rovided by the current primary standard. In reaching this conclusion, the PA notes th at evidence from controlled human exposure studies provides strong support for the occurrence of adverse respiratory effects following exposures to O 3 concentrations below the level of the current standard. Epidemiologic studies provide support for the occ urrence of adverse respiratory effects and mortality under air quality conditions that would likely meet the current standard. In addition, based on the analyses in the HREA, the PA concludes that the exposures and risks projected to remain upon meeting th e current standard are indicative of risks that can reasonably be judged to be important from a public health perspective. Thus, the PA concludes that the evidence and information provide strong support for giving consideration to revising the current prim ary standard in order to provide increased public health protection against an array of adverse health effects that range from decreased lung function and respiratory symptoms to more serious indicators of morbidity (e.g., including emergency department vi sits and hospital admissions), and mortality. In consideration of all of the above, the PA draws the conclusion that it is appropriate for the*** E.O. 12866 Review

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Page 205 of 668 Administrator to consider revision of the current primary O 3 standard to provide increase d public health protecti on . 4. CASAC Advice Following the 2008 decision to revise the primary O 3 standard by setting the level at 0.075 ppm (75 ppb), CASAC strongly questioned whether the standard met the requirements of the CAA. In September 2009, the EPA announced its intention to reconsider the 2008 standards, issuing a notice of proposed rulemaking in January 2010 (75 FR 2938). Soon after, the EPA solicited CASAC review of that proposed rule and in January 2011, solicited addit ional advice. This proposal was based on the scientific and technical record from the 2008 rulemaking, including public comments and CASAC advice and recommendations. As further described above (I.C), in the fall of 2011, the EPA did not revise the standar d as part of the reconsideration process but decided to defer decisions on revisions to the O 3 standards to the next periodic review, which was already underway. Accordingly, in this section we describe CASAC’s advice related to the 2008 final decision and the subsequent reconsideration, as well as its advice on this current review of the O 3 NAAQS that was initiated in September 2008. In April 2008, the members of the CASAC Ozone Review Panel sent a letter to EPA stating “[I]n our most

- recent letters to you on this subject

— dated October 2006 and March
2007

— the CASAC unanimously recommended selection of an 8

- hour average Ozone NAAQS with in the range of 0.060 to 0.070 parts per million [60 to 70 ppb] for the primary (human health

- based) Ozone NAAQS” (Henderson, 2008). The letter continued: The CASAC now wishes to convey, by means of this letter, its additional, unsolicited advice with reg ard to the primary and secondary Ozone NAAQS

. In doing so, the participating members of the CASAC Ozone Review Panel are unanimous in strongly urging you or your successor as EPA Administrator to ensure that these recommendations be considered during the n ext review cycle for the Ozone NAAQS that will begin next year ... numerous medical organizations*** E.O. 12866 Review

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Page 206 of 668 and public health groups have also expressed their support of these CASAC recommendations’ ... [The CASAC did] not endorse the new primary ozone standard as being sufficiently protective of public health

. The CASAC

— as the EPA ’s statutorily

- established science advisory committee for advising you on the national ambient air quality standards

— unanimously recommended decreasing the primary standard to within the range of 0.060

– 0.070 ppm [60 to 70 ppb]

. It is the Committee’s consensus scientific opinion that your decision to set the primary ozone standard above this range fails to satisfy the explicit stipulations of the Clean Air Act that you ensure an adequate margin o f safety for all individuals, including sensitive populations. In response to the EPA’s solicitation of advice on the EPA’s proposed rulemaking as part of the reconsideration, CASAC conveyed support (Samet, 2010). CASAC fully supports EPA’s proposed range of 0.060

– 0.070 parts per million (ppm) for the 8

- hour primary ozone standard. CASAC considers this range to be justified by the scientific evidence as presented in the Air Quality Criteria for Ozone and Related Photochemical Oxidants (March 2006) and Re view of the National Ambient Air Quality Standards for Ozone: Policy Assessment of Scientific and Technical Information, OAQPS Staff Paper (July 2007). As stated in our letters of October 24, 2006, March 26, 2007 and April 7, 2008 to former Administrator S tephen L. Johnson, CASAC unanimously recommended selection of an 8

- hour average ozone NAAQS within the range proposed by EPA (0.060 to 0.070 ppm). In proposing this range, EPA has recognized the large body of data and risk analyses demonstrating that reten tion of the current standard would leave large numbers of individuals at risk for respiratory effects and/or other significant health impacts including asthma exacerbations, emergency room visits, hospital admissions and mortality. In response to EPA’s req

uest for additional advice on the reconsideration in 2011, CASAC reaffirmed their conclusion that “the evidence from controlled human and epidemiological studies strongly supports the selection of a new primary ozone standard within the 60

– 70 ppb range f

or an 8

- hour averaging time” (Samet, 2011, p ii). As requested by the EPA, CASAC’s advice and recommendations were based on the scientific and technical record from the 2008 rulemaking. In considering the record for the 2008 rulemaking, CASAC stated the fo llowing to summarize the basis for their conclusions (Samet, 2011, pp. ii to iii).*** E.O. 12866 Review

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Page 207 of 668 (7) (6) The evidence available on dose

- response for effects of O 3 shows associations extending to levels within the range of concentrations currently experienced in the United Stat es. (8) (7) There is scientific certainty that 6.6

- hour exposures with exercise of young, healthy, non

- smoking adult volunteers to concentrations ≥ 80 ppb cause clinically relevant decrements of lung function. (9) (8) Some healthy individuals have been shown to have clini cally relevant responses, even at 60 ppb. (10) (9) Since the majority of clinical studies involve young, healthy adult populations, less is known about health effects in such potentially ozone sensitive populations as the elderly, children and those with cardiopulm onary disease

. For these susceptible groups, decrements in lung function may be greater than in healthy volunteers and are likely to have a greater clinical significance. (10) Children and adults with asthma are at increased risk of acute exacerbations on or sh ortly after days when elevated O 3 concentrations occur, even when exposures do not exceed the NAAQS concentration of 75 ppb. (11) Large segments of the population fall into what the EPA terms a “sensitive population group,’’ i.e., those at increased risk becaus e they are more intrinsically susceptible (children, the elderly, and individuals with chronic lung disease) and those who are more vulnerable due to increased exposure because they work outside or live in areas that are more polluted than the mean levels in their communities.*** E.O. 12866 Review

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Page 208 of 668 With respect to evidence from epidemiologic studies, CASAC stated “while epidemiological studies are inherently more uncertain as exposures and risk estimates decrease (due to the greater potential for biases to dominate small effect estimates), specific evidence in the literature does not suggest that our confidence on the specific attributi on of the estimated effects of ozone on health outcomes differs over the proposed range of 60

- 70 ppb” (Samet, 2011, p.10). Following its review of the second draft PA in the current review, which considers an updated scientific and technical record since the 2008 rulemaking, CASAC concluded that “there is clear scientific support for the need to revise the standard” ( Frey, 2014c , p. ii). In particular, CASAC noted the following ( Frey, 2014c , p. 5): [T]he scientific evidence provides strong support for the occurrence of a range of adverse respiratory effects and mortality under air quality conditions that would meet the current standard. Therefore, CASAC unanimously recommends that the Administrator revise the current primary ozone standard to protect publi c health. 110 In supporting these conclusions, CASAC judged that the strongest evidence comes from controlled human exposure studies of respiratory effects. The Committee specifically noted that “the combination of decrements in FEV 1 together with the statistically significant alterations in symptoms in human subjects exposed to 72 ppb ozone meets the American Thoracic Society’s definition of an adverse health effect” (Frey, 2014c, p. 5). CASAC further judged that “if subjects had bee n exposed to ozone using the 8

- hour averaging period used in the standard, adverse effects could have occurred at lower concentration ” and that “ the level at which adverse effects might be

110 CASAC provided similar advice in their letter to the Administrator on the REA, stating that “The CASAC finds that the current primary NAAQS for ozone is not protective of human health and needs to be revised” (Frey, 2014a, p. 15 ).*** E.O. 12866 Review

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Page 209 of 668 observed would likely be lower for more sensitive subgroups, such a s those with asthma ” (Frey, 2014c, p. 5). With regard to lung function risk estimates based on information from controlled human exposure studies, CASAC concluded that “estimation of FEV1 decrements of ≥15% is appropriate as a scientifically relevant surr ogate for adverse health outcomes in active healthy adults, whereas an FEV1 decrement of ≥10% is a scientifically relevant surrogate for adverse health outcomes for people with asthma and lung disease” (Frey, 2014c, p. 3). The Committee further concluded t hat “[a]sthmatic subjects appear to be at least as sensitive, if not more sensitive, than non

- asthmatic subjects in manifesting O 3 - induced pulmonary function decrements” (Frey, 2014c, p. 4). In considering estimates of
the occurrence of these decrements in urban study areas , CASAC specifically noted that the current standard is estimated to allow 11 to 22% of school age children to experience at least one day with an FEV 1 decrement > 10 % (Frey, 2014c, p. 7)

. Although CASAC judged that controlled human exposure studies of respiratory effects provide the strongest evidence supporting their conclusion on the current standard, the Committee judged that there is also “ sufficient scientific evidence based on epidemiologic s tudies for mortality and morbidity associated with short

- term exposure to ozone at the level of the current standard” ( Frey, 2014c , p. 5). In support of the biological plausibility of the associations reported in these epidemiologic studies, CASAC noted th at “[r]ecent animal toxicological studies support identification of modes of action and, therefore, the biological plausibility associated with the epidemiological findings” ( Frey, 2014c , p. 5). Consistent with the advice of CASAC, several public commente rs supported revising the primary O 3 standard to provide increased public health protection. In*** E.O. 12866 Review

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Page 210 of 668 considering the available evidence as a basis for their views, these commenters generally noted that the health evidence is stronger in the current review than in past reviews , with new evidence for effects attributable to short

- and long

- term exposures, and new evidence for effects at lower O 3 exposure concentrations. Other public commenters opposed considering revised standards. These commenters discussed a variety of reasons for their views. A number of commenters expressed the view that the EPA should not lower the level of the standard because a lower level would be closer to background O 3 concentrations. In addition, several commenters challenged the interpretation of the evidence presented in the ISA. With respect to the risk assessment, several commenters expressed the view that the EPA should only estimate risks above O 3 background concentrations, or above threshold concentrations. Some commenters also expressed the view that, based on the mortality and morbidity risk estimates in the HREA, there is little to no difference between the risks estimated for the curre nt O 3 standard and the risks estimated for revised standards with lower levels. These commenters concluded that the HREA and PA have not shown that the public health improvements likely to be achieved by a revised O 3 standard would be greater than the impr ovements likely to be achieved by the current standard. 5 . Administrator’s Proposed Conclusions Concerning the Adequacy of the Current Standard This section discusses the Administrator’s proposed conclusions related to the adequacy of the public health pr otection provided by the current primary O 3 standard, resulting in her proposed decision to revise that standard. These proposed conclusions, and her proposed decision, are based on the Administrator’s consideration of the available scientific evidence,*** E.O. 12866 Review

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Page 211 of 668 exposure/risk information, the comments and a dvice of CASAC, and public input received thus far, as summarized below. As an initial matter, the Administrator concludes that reducing precursor emissions to achieve O 3 concentrations that meet the current primary O 3 standard will provide important impr ovements in public health protection, compared to recent air quality. In reaching this initial conclusion, she notes the discussion in section 3.4 of the PA (U.S. EPA, 2014c), summarized above ( II.D. 4 3 ). In particular, the Administrator notes that this ini tial conclusion is supported by (1) the strong body of scientific evidence indicating a wide range of adverse health outcomes attributable to exposures to O 3 at concentrations commonly found in the ambient air lower than the level of current standard and ( 2) estimates indicating decreased occurrences of O 3 exposures of concern and decreased O 3 - associated health risks upon meeting the current standard, compared to recent air quality. Thus, she concludes that it would not be appropriate in this review to cons ider a standard that is less protective than the current standard. 111 After reaching the initial conclusion that meeting the current primary O 3 standard will provide important improvements in public health protection, and that it is not appropriate to consi der a standard that is less protective than the current standard, the Administrator next considers the adequacy of the public health protection that is provided by the current standard . In doing so, the Administrator first notes that studies evaluated sinc e the completion of the 2006 O 3 AQCD support and expand upon the strong body of evidence that, in the last review, indicated a causal relationship between short

- term O 3 exposures and respiratory health effects. This is the

111 W hile not analyz ed quantitatively, consistent with CASAC advice (Frey, 2014a, p. 10), the Administrator notes that reductions in O 3 precursor emissions (e.g., NO X ; VOC) to achieve O 3 concentrations that meet the current standard could also increase public health protectio n by reducing the ambient concentrations of pollutants other than O 3 (i.e., PM 2.5 , NO 2 ).*** E.O. 12866 Review

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Page 212 of 668 strongest causality finding possi ble under the ISA’s hierarchical system for classifying weight of evidence for causation. Together, experimental and epidemiologic studies support conclusions regarding a continuum of O 3 respiratory effects ranging from small reversible changes in pulmonar y function, and pulmonary inflammation, to more serious effects that can result in respiratory

- related emergency department visits, hospital admissions, and premature mortality.
Recent animal toxicolog y studies support descriptions of modes of action for t he se respiratory effects and augment support for biological plausibility for the role of O 3 in reported effects

. With regard to mode of action, evidence indicates that antioxidant capacity may modify the risk of respiratory morbidity associated with O 3 exposure , and that the inherent capacity to quench (based on individual antioxidant capacity) can be overwhelmed, especially with exposure to elevated concentrations of O 3 . In addition, b ased on the consistency of findings across studies and evidence for the coherence of results from different scientific disciplines, strong evidence indicates that certain populations are at increased risk of experiencing O 3 - related effects , including the most severe effects. These include populations and lifestages identif ied in previous reviews (i.e., people with asthma, children, older adults , outdoor workers ) and populations identified since the last review (i.e., people with certain genotypes related to antioxidant and/or anti

- inflammatory status ; people with reduced in take of certain antioxidant nutrients , such as Vitamins C and E). The Administrator further notes that evidence for adverse respiratory health effects attributable to long

- term , or repeated short

- term, O 3 exposures is much stronger than in previous review s, and the ISA concludes that there is “likely to be” a causal relationship between such O 3 exposures and adverse respiratory health effects (the second strongest causality finding)

. Uncertainties related to the extrapolation of data generated by rodent to xicology studies to the*** E.O. 12866 Review

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Page 213 of 668 understanding of health effects in humans have been reduced by studies in non

- human primates and by recent epidemiologic studies. The evidence available in this review includes new epidemiologic studies using a variety of designs an d analysis methods , conducted by different research groups in different locations , evaluating the relationship s between long

- term O 3 exposures and measures of respiratory morbidity and mortality. New evidence supports associations between long

- term O 3 expo sure s and the development of asthma in children, with several studies reporting interactions between genetic variants and such O 3 exposure s . S tudies also report associations between long

- term O 3 exposures and asthma prevalence, asthma severity and control, respirato ry symptoms among asthmatics, and respiratory mortality. In considering the O 3 exposure concentrations reported to elicit respiratory effects, the Administrator agrees with the conclusions of the PA and with the advice of CASAC (Frey, 2014c) tha t controlled human exposure studies provide the most certain evidence indicating the occurrence of health effects in humans following exposures to specific O 3 concentrations. In particular, as discussed further in section II.E.4.d below, she notes that the effects reported in controlled human exposure studies are due solely to O 3 exposures, and interpretation of study results is not complicated by the presence of co

- occurring pollutants or pollutant mixtures (as is the case in epidemiologic studies). Theref ore, she places the most weight on information from these controlled human exposure studies. In considering the evidence from controlled human exposure studies, the Administrator first notes that these studies have reported a variety of respiratory effect s in healthy adults following exposures to O 3 concentrations of 60, 72, 112 or 80 ppb, and higher. The largest

112 As noted above, for the 70 ppb target exposure concentration , Schelegle et al. (2009) reported that the actual mean exposure concentration was 72 ppb.*** E.O. 12866 Review

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Page 214 of 668 respiratory effects, and the broadest range of effects, have been studied and reported following exposures of healthy adults to 80 ppb O 3 or higher, with most exposure studies conducted at these higher concentrations. She further notes that recent evidence includes c ontrolled human exposure stud ies reporting the combination of lung function decrements and respiratory symptoms in healthy adults engaged in intermittent, moderate exertion following 6.6 hour exposures to concentrations as low as 72 ppb , and lung function decrements and pulmonary inflammation following exposures to O 3 concentrations as low as 60 ppb

. As discussed below,

c ompared to the evid ence available in the last review, these studies have strengthened support for the occurrence of abnormal and adverse respiratory effects attributable to short

- term exposures to O 3 concentrations below the level of the current standard

. 113 T he Administrator concludes that such exposures to O 3 concentrations below the level of the current standard are potentially important from a public health perspective , given the following: (1) The combination of lung function decrements and respiratory symptoms reported to occur in healthy adults following exposures to 72 ppb O 3 or higher, while at moderate

exer tion, meet ATS criteria for an adverse response. In specifically considering the 72 ppb exposure concentration, CASAC noted that “the combination of decrements in FEV 1 together with the statistically significant alterations in symptoms in human subjects exposed to 72 ppb ozone meets the American Thoracic Society’s definition of an adverse health effect” (Frey, 2014c, p. 5). (2) With regard to 60 ppb O 3 , CASAC agreed that “a level of 60 ppb corresponds to the lowest exposure concentration demonstrated to result in lung function decrements large

113 Cf. State of Misisssippi . 744 F.3d 1350 (“Perhaps more studies like the Adams studies will yet reveal that the 0.060 ppm level produces significant adverse decrements that simply cannot be attributed to normal variation in lung function.”).*** E.O. 12866 Review

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Page 215 of 668 enough to be judged an abnormal response by ATS and that could be adverse in individuals with lung disease” (Frey, 2014c, p. 7). CA SAC further noted that “a level of 60 ppb also corresponds to the lowest exposure concentration at which pulmonary inflammation has been reported” (Frey, 2014c, p. 7). (3) The controlled human exposure studies reporting these respiratory effects were conducte d in healthy adults, while at

- risk groups (e.g., children, people with asthma) could experience larger and/or more serious effects. In their advice to the Administrator, CASAC concurred with this reasoning ( Frey, 2014a, p. 14; Frey, 2014c, p. 5). (4) These re spiratory effects are coherent with the serious health outcomes that have been reported in epidemiologic studies evaluating exposure to O 3 (e.g., respiratory

- related hospital admissions, emergency department visits, and mortality).
As noted above , t he Adm inistrator’s proposed conclusions regarding the adequacy of the current primary O 3 standard place a large amount of weight on the results of controlled human exposure studies. In particular, given the combination of lung function decrements and respiratory symptoms following 6.6 hour exposures to O 3 concentrations as low as 72 ppb, and given CASAC advice regarding effects at 72 ppb along with ATS adversity criteria, she concludes that there is strong the evidence in this review supporting support s the occurre nce of adverse respiratory effects following exposures to O 3 concentrations lower than the level of the current standard. 114 As discussed b elow, t he Administrator further considers information from

114 The u se of evidence from controlled human exposure studies conducted in healthy adults to characterize the potential for adverse effects, including in at

- risk groups such as children and asthmatics, is discussed in sections II.C.2 and II.C.3.a, above. CASAC advice on this issue i s discussed in sections II.D.4 and II.E.4.c.*** E.O. 12866 Review

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Page 216 of 668 the broader body of controlled human exposure studies within the context of quantitative estimates of exposures of concern and O 3 - induced FEV 1 decrements. In addition to controlled human exposure studies, the Administrator also considers what the available epidemiologic evidence indicates with regard to the adequacy of the public health protection provided by the current primary O 3 standard. 115 She notes that recent epidemiologic studies provide support, beyond that available in the last review, for associations between short

term O 3 exposures and a wide range of adverse respiratory outcomes (including respiratory

related hospital admissions, emergency department visits, and mortality) and with total mortality.
As sociations with morbidity and mortality are stronger during the warm or summer months , and remain ro bust after adjustment for copollutants. In considering information from epidemiologic studies within the context of her conclusions on the adequacy of the current standard, the Administrator considers the extent to which available studies support the occurrence of O 3 health effect associations with air quality likely to be allowed by the current standard. In doing so, she places the most weight on air quality analyses in locations of single

- city studies of short

- term O 3 , as discussed in more detail in section II.E.4.d below. 116 In particular, she notes that a U.S. single

- city study reported

115 As noted above, she places less weight on information from epidemiologic studies than on information from controlled human exposure studies. 116 As discussed in section II.E.4.d of this preamble , this judgment applies specifically to epidemiologic studies of short

- term O 3 concentrations where multicity effect estimates are presented, based on combining the effect estimates from multiple individual cities , and where individual city effect estimates are not prese nted (as is the case for key multicity studies analyzed in the PA). Because these reported multicity effect estimates do not allow health effect associations to be disaggregated by individual city, it is not possible to assign the health effect association to the air quality in any one study location, or to the air quality in a subset of locations. In contrast, for epidemiologic studies of long

- term concentrations, where multicity effect estimates are based on comparisons across cities, different judgments have been made with regard to the utility of multicity studies ( see, e.g. 78 FR 3086 at 3103/2) (January 15, 2013) (and see discussion below of study by Jerrett et al., (2009)).*** E.O. 12866 Review

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Page 217 of 668 associations with respiratory emergency department visits in children and adults in a location that would likely have met the current O 3 standard over the entire study period (Mar and Koenig, 2009). In addition, even in some single

- city study locations where the current standard was likely not met (i.e., Silverman and Ito, 2010; Strickland et al., 2010), the Administrator notes PA analyses indicating that reported conce ntration

- response functions and available air quality data support the occurrence of O 3 - health effect associations on subsets of days with ambient O 3 concentrations below the level of the current standard (II.D.1). Compared to single

- city studies, the Administrator notes additional uncertainty in interpreting the relationships between air quality in individual study cities and health effects based on m ulticity analyses (discussed further in sections II.D.1 and II.E.4.d). While such uncertainties limit the extent to which the Administrator bases her conclusions on air quality in locations of multicity epidemiologic studies, she does note that O 3 associat ions with respiratory morbidity or mortality have been reported in several multicity studies when the majority of study locations (though not all study locations) would likely have met the current O 3 standard. When taken together, the Administrator reaches the conclusion that single

- city epidemiologic studies and associated air quality information support the occurrence of O 3 - associated hospital admissions and emergency department visits for ambient O 3 concentrations likely to have met the current standard , and that air quality analyses in locations of multicity studies provide some support for this conclusion for a broader range of effects (i.e., including mortality)

. Beyond her consideration of the scientific evidence, the Administrator also considers the results of the HREA exposure and risk analyses in reaching initial conclusions regarding the adequacy of the current primary O 3 standard. In doing so, as noted above, she focuses primarily on exposure and risk estimates based on information from controlle d human exposure studies*** E.O. 12866 Review

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Page 218 of 668 (i.e., exposures of concern and O 3 - induced lung function decrements ) . She places relatively less weight on epidemiologic

- based risk estimates, noting that the overall conclusions from the HREA likewise reflect less confidence in es timates of epidemiologic

- based risks than in estimates of exposures and lung function risks (U.S. EPA, 2014, section 9.6). Consistent with the conclusions in the PA, her determination to attach less weight to the epidemiologic

- based risk estimates reflects her consideration of key uncertainties, including the heterogeneity in effect estimates between locations, the potential for exposure measurement errors, and uncertainty in the interpretation of the shape of concentration

- response functions for O 3 concent rations in the lower portions of ambient distributions (U.S. EPA, 2014, section 9.6) (II.D.2). In particular, she concludes that lower confidence should be placed in the results of the assessment of respiratory mortality risks associated with long

- term O 3 exposures, primarily because that analysis is based on only one study (even though that study is well

- designed) and because of the uncertainty in that study about the existence and level of a potential threshold in the concentration

- response function (U.S. EPA, 2014a, section 9.6) (II.D.2). 117 With regard to estimates of exposures of concern, the Administrator considers the extent to which the current standard provides protection against exposures to O 3 concentrations at or above 60, 70, and 80 ppb , noting C ASAC advice that 60 ppb “is an appropriate exposure of concern for asthmatic children” (Frey, 2014c, p. 8). She further notes that while single exposures of concern could be adverse for some people, particularly for the higher benchmark concentrations (70, 80 ppb) where there is stronger evidence for the occurrence of adverse effects (discussed further in II.E.4.d, below), she becomes increasingly concerned about the

117 CASAC also called into question the extent to which it is appropriate to pl ace confidence in risk estimates for respiratory mortality (Frey, 2014a, p. 11). Formatted: Space After: 0 pt*** E.O. 12866 Review

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Page 219 of 668 potential for adverse responses as the frequency of occurrences increases. 118 In particular, she notes that r epeated occurrences of the types of effects shown to occur following exposures of

concern can have potential ly adverse outcomes . For example, repeated occurrences of airway inflammation could potentially result in the induction of a chronic inflammatory state ; alter ed pulmonary structure and function, leading to diseases such as asthma; alter ed lung host defense

res ponse to inhaled microorganisms; and alter ed lung response to other agents such as allergens or toxins (U.S. EPA, 2013, Section 2013 a , s ection 6.2.3). Thus, the Administrator notes that the types of lung injury shown to occur following exposures to O 3 concentrations from 60 to 80 ppb, particularly if experienced repeatedly, provide a mode of action by which O 3 may cause other

more serious effects (e.g., asthma exacerbations). Therefore, the Administrator places the most weight on estimates of two or more exposures of concern (i.e., as a surrogate for the occurrence of repeated exposures), though she also considers estimates of one o r more , particularly for the 70 and 80 ppb benchmarks

. Consistent with CASAC advice (Frey, 2014c), the Administrator focuses on children in these analyses of O 3 exposures, noting that estimates for all children and asthmatic children are virtually indisti nguishable (in terms of the percent estimated to experience exposures of concern). Though she focuses on children, she also recognizes that exposures to O 3 concentrations at or above 60 or 70 ppb could be of concern for adults. As discussed in the HREA and PA , ( and II.C.2.a, above) , the patterns of exposure estimates over years and across urban study areas , across years, and across air quality scenarios are similar in adults with asthma,

118 Not all people who experience an exposure of concern will experience an adverse effect (even members of at

- risk population s ). For most of the endpoints evaluated in control led human exposure studies (with the exception of O 3 - induced FEV 1 decrements, as discussed below) , the number of those experiencing exposures of concern who will experience adverse effects cannot be reliably quantified.*** E.O. 12866 Review

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Page 220 of 668 older adults, all children, and children with asthma, though smaller percentages of adult populations are estimated to experience exposures of concern than children and children with asthma. Thus, the Administrator recognizes that the exposure patterns for children across years and , urban study areas , and air quality scenarios are indicative of the exposure patterns in a broader group of at

- risk populations that also includes asthmatic adults and older adults. As illustrated in Table 1 (above), the Administrator notes that if the 15 urban study areas evaluated in the HREA were to just meet the current O 3 standard, fewer than 1% of children in those areas would be estimated to experience two or more exposures of concern at or above 70 ppb, though approximately 3 to 8% of chi ldren, including approximately 3 to 8% of asthmatic children, would be estimated to experience two or more exposures of concern to O 3 concentrations at or above 60 ppb 119 (based on estimates averaged over the years of analysis). To provide some perspective o n these percentages, the Administrator notes that they correspond to almost 900,000 children in urban study areas, including about 90,000 asthmatic children , estimated to experience two or more exposures of concern at or above 60 ppb . Nationally, if the

cu rrent standard were to be just met the number of children experiencing such exposures would be larger. In the worst

- case year and location (i.e., year and location with the largest exposure estimates), the Administrator notes that over 2% of children are e stimated to experience two or more exposures of concern at or above 70 ppb and over 14% are estimated to experience two or more exposures of concern at or above 60 ppb. Although, as discussed above and in section II.E.4.d, the Administrator is less concer ned about single occurrences of exposures of concern, she notes that even single occurrences can

119 Almost no children in those areas would be estimated to experience two or more exposures of co ncern at or above 80 ppb.*** E.O. 12866 Review

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Page 221 of 668 cause adverse effects in some people, particularly for the 70 and 80 ppb benchmarks. Therefore, she also considers estimates of one or more exposures of concer n. As illustrated in Table 1 (above), if the 15 urban study areas evaluated in the HREA were to just meet the current O 3 standard, fewer than 1% of children in those areas would be estimated to experience one or more exposures of concern at or above 80 ppb (based on estimates averaged over the years of analysis). However, approximately 1 to 3% of children, including 1 to 3% of asthmatic children, would be estimated to experience one or more exposures of concern to O 3 concentrations at or above 70 ppb and ap proximately 10 to 17% would be estimated to experience one or more exposures of concern to O 3 concentrations at or above 60 ppb. In the worst

- case year and location, the Administrator notes that over 1% of children are estimated to experience one or

more e xposures of concern at or above 80 ppb, over 8% are estimated to experience one or more exposures of concern at or above 70 ppb, and about 26% are estimated to experience one or more exposures of concern at or above 60 ppb. In addition to estimated exposu res of concern, the Administrator also considers HREA estimates of the occurrence of O 3 - induced lung function decrements. In doing so, she particularly
notes CASAC advice that “ estimation of FEV 1 decrements of ≥ 15% is appropriate as a scientifically relev ant surrogate for adverse health outcomes in active healthy adults, whereas an
FEV 1 decrement of ≥ 10% is a scientifically relevant surrogate for adverse health outcomes for people with asthma and lung disease ” (Frey, 2014c, p. 3)

. The Administrator notes that while single occurrences of O 3 - induced lung function decrements could be adverse for some people, as discussed above (II.B.3), a more general consensus view of the potential adversity of such decrements emerges as the frequency of occurrence s increases . Therefore, the Administrator focuses primarily on the estimates of two or more O 3 - induced lung function decrements.*** E.O. 12866 Review

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Page 222 of 668 When averaged over the years evaluated in the HREA, the Administrator notes that the current standard is estimated to allow abou t 1 to 3% of children in the 15 urban study areas (corresponding to almost 400,000 children) to experience two or more O 3 - induced lung function decrements > 15%, and to allow about 8 to 12% of children (corresponding to about 180,000 asthmatic children 120 ) t o experience two or more O 3 - induced lung function decrements > 10%. Nationally, larger numbers of children would be expected to experience such O 3 - induced decrements if the current standard were to be just met. The current standard is also estimated to all ow about 3 to 5% of children in the urban study areas to experience one or more decrements > 15% and about 14 to 19% of children to experience one or more decrements > 10%. In the worst

case year and location, the current standard is estimated to allow 4% of children in the urban study areas to experience two or more decrements > 15% (and 7% to experience one or more such decrements) and 14% of children to experience two or more decrements > 10% (and 22% to experience one or more such decrements). In furth er considering the HREA results, the Administrator considers the epidemiology

based risk estimates. As discussed above, compared to the weight given to HREA estimates of exposures of concern and lung function risks, she places relatively less weight on epi demiology

based risk estimates. In giving some consideration to these risk estimates, the Administrator notes estimates of total risk s (i.e., based on the full distributions of ambient O 3 concentrations) and risk s associated with O 3 concentrations in the u pper portions of ambient distributions. The Administrator notes that estimates of total risks are based on the assumption that concentration

-

120 As noted above, CASAC concluded that “an FEV1 decrement of ≥10% is a scientifically relevant surrogate for adverse health outcomes f or people with asthma and lung disease” (Frey, 2014c, p. 3) and that such decrements “could be adverse for people with lung disease” (Frey, 2014c, p. 7).*** E.O. 12866 Review

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Page 223 of 668 response relationships remain linear over the entire distributions of ambient O 3 concentrations. With regard to tot al risks, she notes that the HREA estimates thousands of O 3 - associated hospital admissions, emergency department visits, and deaths per year for air quality conditions associated with just meeting the current standard in the 12 urban study areas (II.C.3)

. However, the Administrator also notes the increasing uncertainty associated with the shapes of concentration

- response curves for O 3 concentrations in the lower portions of ambient distributions. She particularly notes that there is less certainty in the s hape of concentration

response functions for area

- wide O 3 concentrations at the lower ends of warm season distributions (i.e., below about 20 to 40 ppb depending on the O 3 metric, health endpoint, and study population) (U.S. EPA, 2013 2013 a , section 2.5.4.4) . The Administrator further notes the evidence from controlled human exposure studies, which provide the strongest support for O 3 - induced effects following exposures to O 3 concentrations corresponding to the upper portions of typical ambient distri butions (i.e., 60 ppb and above). Therefore, the Administrator judges it appropriate to focus on risks associated with O 3 concentrations in the upper po rtions of ambient distributions

. Even when considering only area - wide O 3 concentrations from the upper p ortions of seasonal distributions, the Administrator notes that the current standard is estimated to allow hundreds to thousands of O 3 - associated deaths per year in urban study areas (II.C.3)

. A lthough the Administrator note s the HREA conclusions indicati ng somewhat less confidence in estimates of O 3 - associated mortality and morbidity risks , compared to estimates of exposures of concern and risk of lung function decrements , she conclude s that the general magnitude of mortality and morbidity risk estimates suggests the potential for a substantial number of O 3 - associated deaths and adverse resp iratory events to occur nationally, even when the current standard is met. She especially notes that t his is the case based on the risks associated*** E.O. 12866 Review

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Page 224 of 668 with the upper ends of distributions of ambient O 3 concentrations, where she has the greatest confidence in O 3 - attributable effects

. In addition to the evidence and exposure/risk information discussed above, the Administrator also takes note of the CASAC advice in the curren t review and in the 2010 proposed reconsideration of the 2008 decision establishing the current standard. As discussed in more detail above, the current CASAC “finds that the current NAAQS for ozone is not protective of human health” and “unanimously recom mends that the Administrator revise the current primary ozone standard to protect public health” (Frey, 2014 2014c , p. 6). Consistent with this advice from the current CASAC, in commenting on the proposed reconsideration, the 5). T he prior CASAC O 3 Panel als o likewise recommended revision of the current standard to one with a lower level. This earlier recommendation was based entirely on the evidence and information in the record for the 2008 standard decision, which, as discussed above, has been substantially strengthened in the current review (Samet, 2011; Samet, 2012). In consideration of all of the above, the Administrator proposes that the current primary
O 3 standard is not adequate to protect public health, and that it should be revised to provide increa sed public health protection. This proposed decision is based on the Administrator’s initial conclusions that the available evidence and exposure and risk information clearly call into question the adequacy of public health protection provided by the curre nt primary standard and, therefore, that the current standard is not requisite to protect public health with an adequate margin of safety . With regard to the evidence , she specifically notes that (1) controlled human exposure studies provide strong support for the occurrence of adverse respiratory effects following exposures to O 3 concentrations below the level of the current standard (i.e., as low as 72 ppb) , and that (2) single

- city epidemiologic studies provide support for the occurrence of*** E.O. 12866 Review

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Page 225 of 668 adverse respiratory effects under air quality conditions that would likely meet the current standard , with multicity studies providing some support for this conclusion for a broader range of effects (i.e., including mortality) . Courts have repeatedly held that thi s type of evidence justifies an Administrator’s conclusion that it is “appropriate” (within the meaning of section 109 (d)(1) of the Act CAA ) to revise a primary NAAQS to provide further protection of public health. 121 In addition, based on the analyses in th e HREA, the Administrator initially concludes that the exposures and risks projected to remain upon meeting the current standard can reasonably be judged to be important from a public health perspective. Thus, she reaches the proposed conclusion that the e vidence and information, together with CASAC advice based on their consideration of that evidence and information, provide strong support for revising the current primary standard in order to increase public health protection against an array of adverse ef fects that range from decreased lung function and respiratory symptoms to more serious indicators of morbidity (e.g ., including emergency department visits and hospi tal admissions), and mortality. The Administrator solicits comment on her proposed decisio n to revise the current primary O 3 NAAQS, including on her considerations and proposed conclusions based on the scientific evidence, exposure/risk information, and CASAC advice. In doing so, she recognizes that some have expressed alternative approaches to viewing th e evidence and information, including alternative approaches to viewing , evaluating, and weighing important uncertainties. In some cases, these alternative approaches have le d some public commenters to recommend retaining the current standard

. G iven these alternative views , in addition to proposing to revise the current primary O 3 standard, the Administrator also solicits comment on the option of

121 See e.g. State of Mississippi , 744 F. 3d at 13435 1345 ; American Farm Bureau , 559 F. 3d at 525

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Page 226 of 668 retaining that standard

. solicits comment on the option of retaining that standard . In doing so, she also solicits comment on the potential approaches to viewing the scientific evidence and exposure/risk information that could support a conclusion that the current standard is requisite to protect public health with an adequate margin of safety.
E. Conclusions on the Elements of the Primary Standard Having reached the proposed conclusion that the currently available scientific evidence and exposure/risk information call into question the adequacy of the current O 3 standard, the Administrator next co nsiders the range of alternative standards supported by that evidence and information. Consistent with her consideration of the adequacy of th e current standard, the Administrator's proposed conclusions on alternative standards are informed by the availabl e scientific evidence assessed in the ISA, exposure/risk information presented and assessed in the HREA, the evidence

- based and exposure

- /risk

- based considerations and conclusions in the PA, CASAC advice, and input from members of the public. The sections below discuss the evidence and exposure/risk information, CASAC advice and public input, and the Administrator's proposed conclusions , for the major elements of the NAAQS: indicator (II.E.1), averaging time (II.E.2), form (II.E.3), and level (II.E.4).
1. Indicator In the last review, the EPA focused on O 3 as the most appropriate indicator for a standard meant to provide protection against ambient photochemical oxidants. In this review, while the complex atmospheric chemistry in which O 3 plays a key role h as been highlighted, no alternatives to O 3 have been advanced as being a more appropriate indicator for ambient photochemical oxidants. More specifically, the ISA noted that O 3 is the only photochemical oxidant (other than NO 2 ) that is routinely monitored and for which a comprehensive database Formatted: Font: 12 pt*** E.O. 12866 Review

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Page 227 of 668 exists ( ISA U.S. EPA, 2013a, section 3.6). Data for other photochemical oxidants (e.g., PAN,
H 2 O 2 , etc.) typically have been obtained only as part of special field studies. Consequently, no data on nationwide patterns of occurrence are available for these other oxidants; nor are extensive data available on the relationships of concentrations and patterns of these oxidants to those of O 3 ( ISA U.S. EPA, 2013a, section 3.6). In its review of the second draft PA, CASAC
state d “The indicator of ozone is appropriate based on its causal or likely causal associations with multiple adverse health outcomes and its representation of a class of pollutants known as photochemical oxidants” ( Frey, 2014c , p. ii). In addition, the PA not es that meeting an O 3 standard can be expected to provide some degree of protection against potential health effects that may be independently associated with other photochemical oxidants, even though such effects are not discernible from currently availab le studies indexed by O 3 alone ( U.S. EPA, 2014c , section 4.1). That is, since the precursor emissions that lead to the formation of O 3 generally also lead to the formation of other photochemical oxidants, measures leading to reductions in population exposu res to O 3 can generally be expected to lead to reductions in population exposures to other photochemical oxidants. In considering this information , and CASAC’s advice, the Administrator reaches the proposed conclusion that O 3 remains the most appropriate i ndicator for a standard meant to provide protection against photochemical oxidants. 122
2. Averaging Time

122 The D.C. Circuit upheld the use of O 3 as the indicator for photochemical oxidants based on these same considerations. American Petroleum Inst. v. Costle , 665 F. 2d 1176, 1186 (D.C. Cir. 1981). Formatted: Space After: 0 pt*** E.O. 12866 Review

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Page 228 of 668 The EPA established t he current 8

- hour averaging time 123 for the primary O 3 NAAQS in 1997 (62 FR 38856). The decision on averaging time in that review was based on numerous controlled human exposure and epidemiologic studies reporting associations between 6 to 8 hour
O 3 concentrations and adverse respiratory effects ( 62 FR 38861 ) . It was also noted that a standard with a max 8

- hour averaging time is likely to provide substantial protection against respiratory effects associated with 1

- hour peak O 3 concentrations. Similar conclusions were reached in the last O 3 NAAQS review and thus, the 8

- hour averaging time was retained in 2008.
In reaching a proposed con clusion on averaging time in the current review, the Administrator considers the extent to which the available evidence continue s to support the appropriateness of a standard with an 8

- hour averaging time . Specifically, the Administrator considers the exte nt to which the available information indicates that a standard with the current
8

- hour averaging time provides appropriate protection against short

- and long

- term O 3 exposures.

a. Short

- term As an initial consideration with respect to the most appropria te averaging time for the O 3 NAAQS, the Administrator notes that the strongest evidence for O 3 - associated health effects is for respiratory effects following short

- term exposures. More specifically, the Administrator notes the ISA conclu sion that the evide nce is “sufficient to infer a caus al relationship ” between short

term O 3 exposures and respiratory effects. The ISA also judges that for short

- term O 3 exposures , the evidence indicate s “likely to be causal” relationships with both cardiovascular effects and mortality ( U.S. EPA, 2013 2013 a , section 2.5.2) . Therefore, as in past reviews, the strength of the

123 This 8

- hour averaging time reflects daily max 8

- hour average O 3 concentrations.*** E.O. 12866 Review

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Page 229 of 668 available scientific evidence provides strong support for a standard that protects the public health against short

- term exposures to O 3 . In first consi dering the level of support available for specific short

- term averaging times, the Administrator note s the evidence available from controlled h uman exposure studies. As discussed in more detail in chapter 3 of th e PA, substantial health effects evidence fr om controlled human exposure studies demonstrates that a wide range of respiratory effects (e.g., pulmonary function decrements, increases in respiratory symptoms, lung inflammation, lung permeability, decreased lung host defense, and airway hyperresponsiv eness AHR ) occur in healthy adults following 6.6 hour exposures to O 3 (U.S. EPA 2013 , 2013 a , section 6.2.1.1). Compared to studies evaluating shorter exposure durations (e.g., 1

- hour), studies evaluating 6.6 hour exposures in healthy adults have reported respiratory effects at lower O 3 exposure concentrations and at more moderate levels of exertion. The Administrator a lso note s the strength of evidence from epidemiologic studies that have evaluated a wide variety of populations (e.g., including at

- risk l ifestages and populations, such as children and people with asthma, respectively). A number of different averaging times are used in O 3 epidemiologic studies, with the most common being the max 1

- hour concentration within a 24

- hour period (1

- hour max), the max 8

- hour average concentration within a 24

- hour period (8

- hr max), and the 24

- hour average. These studies are summarized above and assessed in detail in chapter 6 of the ISA (U.S. EPA, 2013 2013 a ). Limited evidence from time

- series and panel epidemiologi c studies comparing risk estimates across averaging times does not indicate that one exposure metric is more consistently or strongly associated with respiratory health effects or mortality, though the ISA notes some evidence for “smaller O 3 risk estimates when using a 24

- hour average exposure metric” (U.S. EPA 2013 , 2013 a , section 2.5.4.2; p. 2

- 31). For*** E.O. 12866 Review

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Page 230 of 668 single

- and multi

- day average O 3 concentrations, lung function decrements were associated with
1

- hour max, 8

- hour max, and 24

- hour average ambient O 3 conce ntrations, with no strong difference in the consistency or magnitude of association among the averaging times (U.S. EPA 2013 , 2013 a , p. 6

- 71). Similarly, in studies of short

- term exposure to O 3 and mortality, Smith et al. (2009) and Darrow et al. (2011) ha ve reported high correlations between risk estimates calculated using 24

- hour average, 8

- hour max, and 1

- hour max averaging times (U.S. EPA 2013 , 2013 a , p. 6

- 253). Thus, the Administrator notes that the epidemiologic evidence alone does not provide a stron g basis for distinguishing between the appropriateness of 1

- hour, 8

- hour, and 24

- hour averaging times. Considering the health information discussed above, the Administrator concludes that an
8

- hour averaging time remains appropriate for addressing health effects associated with short

term exposures to ambient O 3 . An 8

- hour averaging time is similar to the exposure periods evaluated in controlled human exposure studies, including recent studies that provide evidence for respiratory effects following exposu res to O 3 concentrations below the level of the current standard. In addition, epidemiologic studies provide evidence for health effect associations with
8

- hour O 3 concentrations, as well as with 1

- hour and 24

- hour concentrations. As in previous reviews, t he Administrator notes that a standard with an 8

- hour averaging time (combined with an appropriate standard form and level) would also be expected to provide substantial protection against health effects attributable to 1

- hour and 24

- hour exposures (e.g., 62 FR 38861, July 18, 1997). This conclusion is consistent with the advice received from CASAC that “ the current 8

- hour averaging time is justified by the combined evidence from epidemiologic and clinical studies ” ( Frey, 2014c , p. 6 ). b. Long

- term*** E.O. 12866 Review

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Page 231 of 668 The ISA concludes that the evidence for long

- term O 3 exposures indicates that there is “likely to be a causal relationship” with respiratory effects ( US U

. S

. EPA, 2013 2013 a , chapter 7). Thus, in this review the Administrator also consider s the extent to whi ch currently available evidence and exposure/risk information suggests that a standard with an 8

- hour averaging time can provide protection against respiratory effects associated with longer term exposures to ambient O 3 . In considering this issue in the last review of the O 3 NAAQS, the Staff Paper noted that “b ecause long

- term air quality patterns would be improved in areas coming into attainment with
an 8

- hr standard, the potential risk of health effects associated with long

- term exposures would be reduc ed in an y area meeting an 8

- hr standard” (U

. S

. EPA, 2007 , p. 6

- 57) . In the current review, the PA further evaluate s this issue, with a focus on the long

- term O 3 metrics reported to be associated with mortality or morbidity in recent epidemiologic studies. As discussed in section 3.1.3 of the PA ( U.S. EPA, 2014c , section 4.2) , much of the recent evidence for such associations is based on studies that defined long

- term O 3 in terms of seasonal averages of daily maximum 1

- hour or 8

- hour c oncentrations

. As an initial consideration, the Administrator notes the risk results from the HREA for respiratory mortality associated with long

- term O 3 concentrations. These HREA analyses indicate that as air quality is adjusted to just meet the current 8

- hour standard, most urban study

areas are estimated to experience reduction s in respiratory mortality associated with long

- term O 3 concentrations based on the seasonal averages of 1

- hour daily max imum O 3 concentrations evaluated in the study by Jerrett et al. (2009) ( U.S. EP A, 2014 a , chapter 7 ). 124 A s air quality is

124 Though the Administrator also notes important uncertainties associated with these risk estimates, as discussed above (II.C.3.b)

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Page 232 of 668 adjusted to meet low er alternative standard levels, for standards based on 3

- year averages of the annual fourth

- highest daily max imum 8

- hour O 3 concentrations, respiratory mortality risk s are estimated to be reduced further in urban study areas . This analysis indicates that an O 3 standard with an 8

- hour averaging time, when coupled with an appropriate form and level, can reduce respiratory mortality reported to be associate d with long

- ter m O 3 concentrations. In further considering the study by Jerrett et al. (2009), the Administrator notes the PA comparison of long

- term O 3 concentrations following model adjustment in urban study areas (i.e., adjusted to meet the current and alternative 8

- hour standards) to the concentrations present in study cities that provided the basis for the positive and statistically significant association with respiratory mortality . As indicated in Table 4

- 3 of the PA ( U.S. EPA, 2014c , section 4.2) , this compariso n suggests that a standard with an 8

- hour averaging time can decrease seasonal averages of 1

- hour daily max imum O 3 concentrations , and can maintain those O 3 concentrations below the seasonal average concentration where the study indicates the most confiden ce in the reported concentration

- response relationship with respiratory mortality ( U.S. EPA, 2014c , sections 4.2 and 4.4.1). The Administrator also notes that the HREA conducted analyses evaluating the impacts of reducing regional NO X emissions on the se asonal averages of daily maximum 8

- hour O 3 concentrations. Seasonal averages of 8

- hour daily max O 3 concentrations reflect long

- term metrics that have been reported to be associated with respiratory morbidity effects in several
recent O 3 epidemiologic studies (e.g., Islam et al., 2008; Lin et al., 2008; Salam et al., 2009). The HREA analyses indicate that the large majority of the U

. S

. population lives in locations where reducing NO X emissions would be expected to result in decreases in s easonal averages of daily
max 8

- hour ambient O 3 concentrations (U.S. EPA, 2014 a , chapter 8). Thus, consistent with the*** E.O. 12866 Review

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Page 233 of 668 respiratory mortality risk estimates noted above, this analysis suggests these analyses suggest that reductions in O 3 precursor emissions in order to meet a standard with an 8

- hour averaging time would also be expected to reduce the long

- term O 3 concentrations that have been reported in recent epidemiologic studies to be associated with respiratory morbidity. c. Administrator’s proposed con clusion on averaging time Taken together, the Administrator notes that the analyses summarized above indicate that a standard with an 8

- hour averaging time, coupled with the current 4 th high form and an appropriate level , would be expected to provide appr opriate protection against the short

- and long

- term O 3 concentrations that have been reported to be associated with respiratory morbidity and mortality. The CASAC agreed with this conclusion, stating that “[t]he current 8

- hour averaging time is justified b y the combined evidence from epidemiologic and clinical studies” and that “[t]he 8

- hour averaging window also provides protection against the adverse impacts of long

- term ozone exposures, which were found to be “likely causal” for respiratory effects and
p remature mortality” ( Frey, 2014c , p. 6). Therefore, considering the available evidence and exposure risk information, and CASAC’s advice, the Administrator proposes to retain the current
8

- hour averaging time, and not to set an additional standard with a different averaging time.
3. Form The “form” of a standard defines the air quality statistic that is to be compared to the level of the standard in determ i ning whether an area attains that standard. The fo remost consideration in selecting a form is the adequacy of the public health protection provided by the combination of the form and the other elements of the standard. In this review , the Administrator

co nsiders the extent to which the available evidence and/or information continue to support the*** E.O. 12866 Review

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Page 234 of 668 appropriateness of a standard with the current form , defined by the 3

- year average of annual 4 th

- highest 8

- hour daily max imum O 3 concentrations

. The EPA established the current form of the primary O 3 NAAQS in 1997 (62 FR 38856). Prior to that time, the standard had a “1

- expected

- exceedance” form. 125 An advantage of the
current concentration

- based form recognized in the 1997 review is that such a form bet ter reflects the continuum of health effects associated with increasing ambient O 3 concentrations. Unlike an expected exceedance form, a concentration

- based form giv es proportionally more weight to years when 8

- hour O 3 concentrations are well above the level of the standard than years when 8

- hour O 3 concentrations are just above the level of the standard. 126 It was judged appropriate to give more weight to higher O 3 concentrations, given that available health evidence indicated a continuum of effects associated with exposures to varying concentrations of O 3 , and given that the extent to which public health is affected by exposure to ambient O 3 is related to the actual magnitude of the O 3 concentration, not just whether the concentration is above a spec ified level. During the 1997 review, the EPA considered a range of alternative “concentration

- based” forms, including the second

- , third

- , fourth

- and f ifth

- highest daily max max imum 8

- hour concentrations in an O 3 season. The fourth

- highest daily max max im um was selected,

125 For a standard with a 1

- expected

- exceedance form to be met at an air quality monitoring site, the fourth

- highest air quality value in 3 years, given adjustments for missing data, must be less than or equal to the level of the standard. 126 As discussed (6 1 FR 65731 ) , this is because with an exceedance

- based form, days on which the ambient O 3 concentration is well above the level of the standard are given equal weight to those days on which the O 3 concentration is just above the standard (i.e., each day is counted as one exceedance), even though the public health impact of such days would be v ery different. With a concentration

- based form, days on which higher O 3 concentrations occur would weigh proportionally more than days with lower O 3 concentrations since the actual concentrations are used directly to calculate whether the standard is met o r violated. Formatted: Space After: 0 pt*** E.O. 12866 Review

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Page 235 of 668 recognizing that a less restrictive form (e.g., fifth highest) would allow a larger percentage of sites to experience O 3 peaks above the level of the standard, and would allow more days on which the level of the standard may be exceeded wh en the site attains the standard (62 FR 38856). Consideration was also given to setting a standard with a form that would provide a margin of safety against possible but uncertain chronic effects, and would provide greater stability to ongoing control programs. 127 A more restr ictive form was not selected, recognizing that the differences in the degree of protection afforded by the alternatives were not well enough understood to use any such differences as a basis for choosing the most restrictive forms (62 FR 38856). In the 2 008 review, the EPA additionally considered the potential value of a percentile

based form. In doing so, the EPA recognized that such a statistic is useful for comparing datasets of varying length because it samples approximately the same place in the dist ribution of air quality values, whether the dataset is several months or several years long. However, the EPA concluded that a percentile

- based statistic would not be effective in ensuring the same degree of public health protection across the country. Spe cifically, a percentile

- based form would allow more days with higher air quality values in locations with longer O 3 seasons relative to places with shorter O 3 seasons. Thus, in the 2008 review , the EPA concluded that a form based on the nth

- highest max imum O 3 concentration would more effectively ensure that people who live in areas with different length O 3 seasons receive the same degree of public health protection.

127 See American Trucking Assn’s v. EPA , 283 F. 3d 355, at 374

- 75 ( D.C. Cir. 2002) ( less stable implementation programs may be less effective, and therefore the EPA can consider programmatic stability in determining the form of a NAAQS). Formatted: Font: Italic*** E.O. 12866 Review

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Page 236 of 668 Based on analyses of forms specified in terms of an nth

- highest concentration (n ranged
fr om 3 to 5), advice from CASAC, and public comment, 128 the Administrator concluded that a 4th

- highest daily max imum should be retained (73 FR 16465 , March 27, 2008 ). In reaching this decision, t he Administrator recognized that “there is not a clear health

- bas ed threshold for selecting a particular nth

- highest daily maximum form of the standard” and that “the adequacy of the public health protection provided by the combination of the level and form is a foremost consideration” (73 FR 16475 , March 27, 2008 ). Bas ed on this, the Administrator judged that the existing form (4th

- highest daily maximum 8

- hour average concentration) should be retained, recognizing the increase in public health protection provided by combining this form with a lower standard level (i.e., 75 ppb). The Administrator also recognized that it is important to have a form that provides stability with regard to implementation of the standard. In the case of O 3 , for example, he noted the importance of a form insulated from the impacts of the meteorological events that are conducive to O 3 formation. Such events could have the effect of reducing public health protection, to the extent they result in frequent shifts in and out of attainment due to meteorological conditions. The Administrator note d that such frequent shifting could disrupt an area’s ongoing implementation plans and associated control programs (73 FR 16474 , March 27,
2008 ). In his final decision, the Administrator judged that a “ 4 th high form “ provides a stable target for implementi ng programs to improve air quality” (73 FR 16475 , March 27, 2008 ).

128 In the 2008 review, one group of commenters expressed the view that the standard was not adequate and supported a more health

- protective form (e.g., a second

- or third

- highest daily max form). Another group of commenters expressed the view that the standard was adequate and did not provide any views on alternative forms that would be appropriate should the Administrator consider revisions to the standard. The Administrator considered the protection afforded by the combination of level and form in revising the sta ndard in 2008 to 75 ppb, as a 3

- year average of the annual fourth

- highest daily max 8

- hour concentrations (73 FR 16475 , March 27, 2008 ). Formatted: Font color: Auto*** E.O. 12866 Review

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Page 237 of 668 In the current review, the Administrator consider s the extent to which newly available information provides support for the current form. In so doing, she takes note of the conclusions of prior reviews summarized above. She recognize s the value of an nth

- high statistic over that of an expected exceedance or percentile

- based form in the case of the O 3 standard, for the reasons summarized above. The Administrator additionally take s note of t he importance of stability in implementation to achieving the level of protection specified by the NAAQS . Specifically, she
note s that to the extent areas engaged in implementing the O 3 NAAQS frequently shift from meeting the standard to violating the standard, it is possible that ongoing implementation plans and associated control programs could be disrupted, thereby re ducing public health protection

. In light of this, wh ile giving foremost consideration to the adequacy of public hea lth protection provided by the combination of all elements of the standard, including the form, the Administrator considers particularly findings from prior reviews with regard to the use of the nth

- high metric. As noted above, the 4 th

- highest daily max imu m was selected in recognition of the public health protection provided by this form, when coupled with an appropriate averaging time and level, and recognizing that such a form can provide stabilit y for implementation programs. The Administrator concludes that t he currently available evid ence and information do not call into question these conclusions from previous reviews. In reaching this conclusion, the Administrator notes that CASAC concurred that the O 3 standard should be based on the fourth highest, d aily maximum 8

- hour average value (averaged over three 3 years), stating that this form

“ provides health protection while allowing for atypical meteorological conditions that can lead to abnormally high ambient ozone concentrations which, in turn, provides programmatic stability ” ( Frey, 2014c , p. 6 ). Thus , a standard with the current 4 th high form, coupled with a level lower than 75 ppb as discussed below, would be expected to increase public health protection relative*** E.O. 12866 Review

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Page 238 of 668 to the current standard while continuin g to provide stability for implementation programs. Therefore, the Administrator proposes to retain the current 4 th

- highest daily max imum form for
an O 3 standard with an 8

- hour averaging time and a revised level, as discussed below. 4. Level The Administrator next considers the extent to whic h alternative levels below 75 ppb could provide greater protection than the current primary standard against short

- and long

- term exposures to O 3 in ambient air , for a standard based on the 3

- year average of the annual 4 th highest daily maximum 8

- hour O 3 concentration . In doing so, she particularly notes the evidence

- based and exposure - /risk

- based considerations in the PA, which take into account the experimental and epidemiologic evidence as assessed in the I SA; quantitative estimates of O 3 exposure s and health risks in at

- risk populations provided by the HREA; uncertainties and limitations associated with this evidence and information; CASAC advice ; and public input ( U.S. EPA, 2014c , sections 4.4 and 4.5)

. Section II.E.4.a below summarize s the PA’s approach to considering the scientific evidence and the exposure/risk information related to level of the primary standard

. Section II.E.4.b presents the PA’s conclusions on alternative primary O 3 standard levels. Section II.E.4.c summarizes CASAC advice on the level of the primary standard, and public input received thus far. Section II.E.4.c presents the PA’s conclusions on alternative primary O 3 standard levels. Section II.E.4.d presents the Administrator’s prop osed conclusions

on primary O 3 standard levels

. a. PA approach to considering the evidence and information related to alternative levels of the primary standard The PA's approach to reaching conclusions on alternative standard levels focuses on the evide nce from controlled human exposure and epidemiologic studies, as assessed in the ISA*** E.O. 12866 Review

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Page 239 of 668 (U.S. EPA, 2013 2013 a ), and the exposure and health risk analyses presented in the HREA (U.S. EPA, 2014a). This approach is discussed in detail in Chapter s 1 and 4 of the PA (U.S. EPA, 2014c, section s 1.3 , 4.6 ), and is summarized below. As an initial matter, the PA notes that controlled human exposure studies provide the most certain evidence indicating the occurrence of health effects in humans following exposures to spe cific O 3 concentrations. Consistent with this , CASAC concluded that “the scientific evidence supporting the finding that the current standard is inadequate to protect public health is strongest based on the controlled human exposure studies of respiratory effects” (Frey,
2014 2014 c , p. 5). As discussed above and in section 3.1.2.1 of the PA (U.S. EPA, 2014c), controlled human exposure studies have reported a variety of respiratory effects in healthy adults following exposures to O 3 concentrations of 60, 72, 129 or 80 ppb, and higher. Given the evidence for respiratory effects from controlled human exposure studies, the PA considers the extent to which standards with revised levels would be estimated to protect at

risk populations against exposures of concern t o O 3 concentrations at or above the health benchmark concentrations of 60, 70, and 80 ppb (i.e., based on HREA estimates of one or more and two or more expo sures of concern). In doing so, the PA notes the CASAC conclusion that (Frey, 2014c, p. 6): The 80 ppb

- 8hr benchmark level represents an exposure level for which there is substantial clinical evidence demonstrating a range of ozone

- related effects including lung inflammation and airway responsiveness in healthy individuals. The 70 ppb

- 8hr benchmark leve l reflects the fact that in healthy subjects, decreases in lung function and respiratory symptoms occur at concentrations as low as 72 ppb and that these effects almost certainly occur in some people, including asthmatics and others with low lung function who are less tolerant of such effects, at levels of 70 ppb and below. The 60 ppb

- 8hr benchmark level

129 As noted above, for the 70 ppb exposure concentration Schelegle et al. (2009) reported that the actual 6.6

- hour mean exposure concentration was 72 ppb.*** E.O. 12866 Review

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Page 240 of 668 represents the lowest exposure level at which ozone

- related effects have been observed in clinical studies of healthy individuals. T he PA also notes that, d ue t o individual variability in responsiveness, only a subset of people who experience exposures at or above the three benchmark concentration s can be expected to experience associated health effects , and that available data are not sufficient to quantify that subset of people for most of the endpoints that have been evaluated in controlled human exposure studies (i.e., with the exception of FEV 1 decrements)

. The PA views the health effects evidence as a continuum with greater confidence and less u ncertainty about the occurrence of adverse health effects at higher O 3 exposure concentrations , and less confidence and greater uncertainty as one considers lower exposure concentrations (U.S. EPA, 2014c, section 3.2.2 , p. 3

- 101 ). While there is greater uncertainty regarding the occurrence of adverse health effects at lower concentrations, the PA also notes that the controlled human exposure studies that provided the basis for benchmark concentrations have not evaluated responses in populations at the
gre atest risk from exposures to O 3 (e.g., children, people with asthma). Compared to the healthy people included in most controlled human exposure studies, members of at

- risk populations and lifestages are at greater risk of experiencing adverse effects. Thus , the effects reported in healthy adults at each of the benchmark concentrations may underestimate effects in these at

- risk groups.
I n considering the health evidence within the context of drawing conclusions on alternative standard levels , the PA balance s concerns about the potential for adverse health effects, especially in at

- risk populations, with the increasing uncertainty regarding the likelihood of such effects following exposures to lower O 3 concentrations. With respect to the lung function decrem ents that have been evaluated in controlled human exposure studies, the PA consider s the extent to which standards with revised levels*** E.O. 12866 Review

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Page 241 of 668 would be estimated to protect healthy and at

- risk populations against O 3 - induced lung function decrements large enough to be adverse in some people (based on quantitative risk estimates in the HREA)

. As discussed in section 3.1.3 of the PA (U.S. EPA, 2014c) and section II.B.3 above , although some experts would judge single occurrences of moderate responses to be a nuisance, especially for healthy individuals, a more general consensus view of the adversity of moderate lung function decrements emerges as the frequency of occurrence increases. Repeated occurrences of moderate responses, even in otherwise healthy individuals, may be considered to be adverse, since they could well set the stage for more serious illness ( 61 73 FR 65723 16448 ). In reaching conclusions on alternative standard levels, the PA consider s the extent to which standards with revised levels would be estimated t o protect healthy and at

- risk populations against one or more, and two or more, moderate (i.e., FEV 1 decrements ≥ 10% and ≥ 15%) and large (i.e., FEV 1 decrements ≥ 20%) lung function decrements

. In evaluating the epidemiologic evidence within the context of drawing conclusions on alternative standard levels , the PA consider s the extent to which available studies have reported associations with emergency department visits, hospital admissions, and/or mortality in locations that would likely have met altern ative standards with levels below 75 ppb. In evaluating the epidemiologic evidence in this way, the PA considers both multicity and single

- city studies, recognizing the strengths and limitations of each. In particular , while single

- city studies are more
li mited than multicity studies in terms of statistical power and geographic coverage, conclusions linking air quality in a specific area with health effect associations in that same area can be made with greater certainty for single

- city studies (i.e., compa red to multicity studies reporting only multicity effect estimates).*** E.O. 12866 Review

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Page 242 of 668 The PA also considers the epidemiologic evidence within the context of epidemiology

based risk estimates

. Compared to the weight given to HREA estimates of exposures of concern and lung function risks (sections 4.4.2.1 and 4.4.2.2, above), , and the weight given to the evidence (section 4.4.1), , the PA places relatively less weight on epidemiologic

- based risk estimates. In doing so, the PA notes that the overall conclusions from the HREA likewise reflect less confidence in estimates of epidemiologic

- based risks than in estimates of exposures and lung function risks. The determination to attach less weight to the epidemiologic

- based estimates reflects the uncertainties associated with morta lity and morbidity risk estimates, including the heterogeneity in effect estimates between locations, the potential for exposure measurement errors, and uncertainty in the interpretation of the shape of concentration

- response functions at lower O 3 concentr ations (U.S. EPA, 2014a, section 9.6). The HREA also concludes that lower confidence should be placed in the results of the assessment of respiratory mortality risks associated with long

- term O 3 exposures, primarily because that analysis is based on only o ne study (even though that study is well

- designed) and because of the uncertainty in that study about the existence and level of a potential threshold in the concentration

- response function (U.S. EPA, 2014a, section 9.6). In considering the epidemiology

- based risk estimates, the PA focuses on the extent to which potential alternative O 3 standards with levels below 75 ppb are estimated to reduce the risk of O 3 - associated mortality. 130 As discussed for the current standard (II.D.2.c), the PA considers estimates of total risk (i.e., based on the full distributions of ambient O 3

130 Differences in estimated respiratory morbidity risks between alternative standard levels are similar to the differences estimated for total mortality associated with short

- term O 3 concentrations. Formatted: Not Superscript/ Subscript*** E.O. 12866 Review

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Page 243 of 668 concentrations) and estimates of risk associated with O 3 concentrations in the upper portions of ambient distri butions. b

. CASAC Advice The PA recognizes that decisions regarding the weight to place on various types of evidence, exposure/risk information, and associated uncertainties reflect public health policy judgments that are ultimately left to the Administrator. To help inform those judgments with regard to the range of alternative primary O 3 standard levels appropriate for consideration, CASAC has provided advice to the Administrator based on their reviews of draft versions of the
O 3 ISA, HREA, and PA. This section summarizes the advice provided by CASAC regarding alternative standard levels, as well as the views expressed at the CASAC meetings by public commenters. This section includes CASAC advice from the reconsideration of the 2008 final decisi on on the level of the standard, as well as CASAC advice received during the current review as it pertains to alternative standards. Consistent with its advice in 2008, CASAC reiterated during the reconsideration its support for an 8

- hour primary O 3 stand ard with a level ranging from 60 to 70 ppb, combined with the current indicator, averaging time, and form. Specifically, in response to EPA’s
solicitation of CASAC advice during the reconsideration, the CASAC letter (Samet 2010) to the Administrator stated : CASAC fully supports EPA’s proposed range of 0.060

– 0.070 parts per million (ppm) for the 8

- hour primary ozone standard. CASAC considers this range to be justified by the scientific evidence as presented in the Air Quality Criteria for Ozone and Related Photochemical Oxidants (March 2006) and Review of the National Ambient Air Quality Standards for Ozone: Policy Assessment of Scientific and Technical Information, OAQPS Staff Paper (July 2007). Similarly, in response to EPA’s request for additional advice on the reconsideration in 2011, CASAC reaffirmed its conclusion that “the evidence from controlled human and*** E.O. 12866 Review

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Page 244 of 668 epidemiologic studies strongly supports the selection of a new primary ozone standard within the
60

– 70 ppb range for an 8

- hour averaging time” (Samet, 2011). CASAC further concluded that this range “ would provide little margin of safety at its upper end” (Samet, 2011, p. 2).
In the current review of the Second Draft PA , CASAC concurred with staff’s conclusions that it is appropriate to con sider retaining the current indicator (O 3 ), averaging time (8

- hour average) and form ( three

- year average of the 4th highest maximum daily 8

- hour average

. With regard to level, CASAC stated the following (Frey, 2014 c , p. ii to iii ): The CASAC further concl udes that there is adequate scientific evidence to recommend a range of levels for a revised primary ozone standard from 70 ppb to 60 ppb. The CASAC reached this conclusion based on the scientific evidence from clinical studies, epidemiologic studies, and animal toxicology studies, as summarized in the Integrated Science Assessment (ISA), the findings from the exposure and risk assessments as summarized in the HREA, and the interpretation of the implications of these sources of information as given in the S econd Draft PA. The CASAC acknowledges that the choice of a level within the range recommended based on scientific evidence [i.e., 70 to 60 ppb] is a policy judgment under the statutory mandate of the Clean Air Act. The CASAC advises that, based on the sci entific evidence, a level of 70 ppb provides little margin of safety for the protection of public health, particularly for sensitive subpopulations. Thus, our policy advice is to set the level of the standard lower than 70 ppb within a range down to 60 ppb , taking into account your judgment regarding the desired margin of safety to protect public health, and taking into account that lower levels will provide incrementally greater margins of safety. The public commenters who expressed the view that the curr ent primary O 3 standard is not adequate (II.D. 4) also submitted comments that supported revising the level of the primary
O 3 standard

. Several of these commenters expressed the view that the level should be revised to the lower end of the range of 70 to 60 ppb , or in some cases to a level below 60 ppb

. These commenters often placed a large amount of emphasis on evidence from controlled human exposure studies for respiratory effects following exposures to 60 ppb O 3 .*** E.O. 12866 Review

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Page 245 of 668 In addition, as discussed ab ove (II.D.4 ), some public c ommenters expressed the view that revision of the current standard is not necessary. Consistent with their view that it would not be appropriate to revise the current standard, these commenters did not provide any provisional vie ws on alternative levels below 75 ppb that would be appropriate for consideration.

c . PA conclusions on alternative O 3 standard levels Using the approach discussed above to consider the scientific evidence and exposure/risk information, CASAC advice , (II .E.4.c, below) , and public comments, the PA reaches the conclusion that it is appropriate for the Administrator to consider alternative primary O 3 standard levels from 70 to 60 ppb. The basis for this conclusion is discussed in detail in sections 4.4.1 and 4.4.2 of the PA (U.S. EPA, 2014c), and is summarized below. With regard to controlled human exposure studies , the PA considers the lowest O 3 exposure concentrations at which various effects have been evaluated and statistically significant effects reported. The PA also consider s the potential for reported effects to be adverse, including in at

- risk populations and lifestages

. As discussed in section 3.1 .2.1 of the PA (U.S. EPA, 2014c), controlled human exposure studies provide evidence of respiratory symptoms combined wit h lung function decrements (an adverse response based on ATS criteria) in healthy adults following 6.6 hour exposures to O 3 concentrati ons as low as 72 ppb , and evidence of potentially adverse lung function decrements and airway inflammation following 6.6 hour exposures to O 3 concentrations as low as 60 ppb.
A lthough some studies show that respiratory symptoms also develop during exposu res to 60 ppb O 3 , the increase in symptoms has not been reported to reach statistical significance by the end of the 6.6 hour exposure period (Adams , 2006; Schelegle et al

. . , 2009). Thus, while significant increases in respiratory symptoms combined with lung function decrements have not*** E.O. 12866 Review

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Page 246 of 668 been reported following exposures to 60 ppb O 3 , this combination of effects is likely to occur to some degree in healthy adults with 6.6

- hour exposures to concentrations below 7 2 ppb, and also are more likely to occur with longer (i.e., 8

- hour ) exposures. 131 In addition, p ulmonary inflammation, particularly if experienced repeatedly, provides a mechanism by which O 3 may cause other more serious respiratory morbidity effects (e.g., asthma exa cerbations) and possibly extrapulmonary effects. As discussed in section 3.1.2.1 of the PA (U.S. EPA, 2014c) , the physiological effects reported in controlled human exposure studies down to 60 ppb O 3 have been linked to aggravation of asthma and increased susceptibility to respiratory infection, potentially leading to increased medication use, increased school and work absences, increased visits to doctors’ offices and emergency departments, and increased hospital admissions. With regard to the lowest exp osure concentration shown to cause respiratory effects (i.e., 60 ppb), 132 the PA notes that m ost controlled human exposure studies have not evaluated O 3

c oncentrations below 60 ppb. Therefore, 60 ppb does not necessarily reflect an exposure concentration below which effects such as lung function decrements and airway inflammation no longer occur. This is particularly the case given that controlled human exposure studies w ere conducted in healthy adults, while people with asthma, including asthmatic children, are likely to be more sensitive to O 3 - induced respiratory effects. With regard to the lowest exposure

131 In addition, CASAC observed that, “adverse health effects in young healthy adults occur with exposures to 72 ppb of ozone for 6.6 hours” and that “[i] t is the judgment of CASAC that if subjects had been exposed to ozone using the 8

- hour averaging period u sed in the standard, adverse effects could have occurred at [a] lower concentration. Further, in our judgment, the level at which adverse effects might be observed would likely be lower for more sensitive subgroups, such as those with asthma” (Frey, 2014 20 14 c , p. 5). 132 As discussed above (II.B.2), p rolonged 6.6 exposure to 40 ppb O 3 has been shown to result in a small decrease in group mean FEV 1 that is not statistically different from responses following exposure to filtered air (Adams, 2002; Adams, 2006)

. Formatted: Normal*** E.O. 12866 Review

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Page 247 of 668 concentration shown to cause respiratory effects (i.e., 60 ppb), 133 the PA notes that m ost controlled human exposure studies have not evaluated O 3 c oncentrations below 60 ppb. Therefore, 60 ppb does not necessarily reflect an exposure concentration below which effects such as lung function decrements and airway inflammation no longer occur. Thi s is particularly the case given that controlled human exposure studies w ere conducted in healthy adults, while people with asthma, including asthmatic children, are likely to be more sensitive to O 3 - induced respiratory effects. In support of this, some ep idemiologic panel studies, which can include members of at

- risk groups such as children and outdoor workers, have found respiratory effects at ambient concentrations lower than 60 ppb (U.S. EPA, 2014c, section 3.1.2.1).

With regard to other O 3 - induced effects, the PA note s that airway hyperresponsiveness AHR and impaired lung host defense capabilities have been reported in healthy adults engaged in moderate exertion following exposures to O 3 concentrations as low as 80 ppb, the lowest concentration evaluated for these effects. As discussed in section 3.1.2.1 of the PA (U.S. EPA, 2014c) , these physiological effects have been linked to aggravation of asthma and increased susceptibility to respi ratory infection, potentially leading to increased medication use, increased school and work absences, increased visits to doctors’ offices and emergency departments, and increased hospital admissions. These are all indicators of adverse O 3 - related morbidi ty effects, which are consistent with, and provide plausibility for, the adverse morbidity effects and mortality effects observed in epidemiolog ic studies.

133 As discussed above (II.B.2), p rolonged 6.6 exposure to 40 ppb O 3 has been shown to result in a small decrease in group mean FEV 1 that is not statistically different from responses following exposure to filtered air (Adams, 2002; Adams, 2006)

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Page 248 of 668 Based on consideration of the above evidence, the PA conclude s that available controlled human exp osure studies support a level no higher than considering alternative O 3 standard levels from 70 to 60 ppb as the upper end of the range for consideration in the current review. In reaching this conclusion, the PA note s that 70 ppb is just below the O 3 expos ure concentration reported to result in lung function decrements and respiratory symptoms in healthy adults (i.e., 72 ppb), a combination of effects that meet ATS criteria for an adverse response. In addition, while 70 ppb is well below the 80 ppb exposure concentration shown to cause potentially adverse respiratory effects such as airway hyperresponsiveness AHR and impaired host

- defense capabilities, these effects have not been evaluated at exposure concentrations below 80 ppb and there is no reason to beli eve that 80 ppb represents a threshold for such effects. The PA further conclude s t hat the evidence from controlled human exposure studies 134 supports considering alternative O 3 standard levels at least as low as 60 ppb. Potentially In addition, potentially adverse lung function decrements and pulmonary inflammation have been demonstrated to oc cur in healthy adults at 60 ppb . Thus, 60 ppb is a short

- term exposure concentration that may be reasonably concluded to elicit adverse effects in at

- risk groups. Pulm onary inflammation, particularly if experienced repeatedly, provides a mechanism by which O 3 may cause other more serious respiratory morbidity effects (e.g., asthma exacerbations) and possibly extrapulmonary effects. As discussed in section 3.1.2.1 of th e PA (U.S. EPA, 2014c) , the physiological effects reported in controlled human exposure studies down to 60 ppb O 3 have been linked to aggravation of asthma and increased susceptibility to respiratory infection,

134 As discussed in sections 3.1.2.1 and 4.4.1 of the PA (U.S. EPA, 2014c) , panel studies also provide supporting evidence for these conclusions.*** E.O. 12866 Review

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Page 249 of 668 potentially leading to increased medication u se, increased school and work absences, increased visits to doctors’ offices and emergency departments, and increased hospital admissions.
The PA further note s that the range of alternative levels from 70 to 60 ppb is supported by evidence from epidemiol ogic studies and by exposure and risk estimates from the HREA. This evidence and exposure/risk information indicate that a level from anywhere in the range of 70 to 60 ppb would be expected to result in important public health improvements over the
current standard. In particular, compared to the current standard a revised standard with a level from 70 to 60 ppb would be expected to ( 1 ) more effectively maintain short

- and long

- term O 3 concentrations below those present in the epidemiologic studies that rep orted significant O 3 health effect associations in locations likely to have met the current standard ; (2) reduce the occurrence of exposures of concern to O 3 concentrations that result in respiratory effects in healthy adults ( at or above 60 , 70, and 80 ppb); (3) reduce the occurrence of moderate

- to

- large
O 3 - induced lung function decrements ; and ( 4 ) reduce the risk of O 3 - ass ociated mortality and morbidity, p articularly the risk associated with the upper portions of the distributions of ambient
O 3 concentr ations. The PA also notes that the range of levels from 70 to 60 ppb corresponds to the range of levels recommended for consideration by CASAC, based on the available evidence and information (Frey, 2014 a; Frey, 2014c ). In reaching a conclusion on whethe r it is appropriate to consider alternative standard levels below 60 ppb, the PA note s the following: (1) While controlled human exposure studies provide evidence for O 3 - induced respiratory effects following exposures to O 3 concentrations as low as 60 ppb, th ey do not provide evidence for adverse effects following exposures to lower concentrations. On this issue, CASAC concurred that 60 ppb O 3 is an appropriate and justifiable scientifically based*** E.O. 12866 Review

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Page 250 of 668 lower bound for a revised primary standard, based upon findings of “adverse effects, including clinically significant lung function decrements and airway inflammation, after exposures to 60 ppb ozone in healthy adults with moderate exertion (Adams , 2006; Schelegle et al., 2009; Brown et al

. . , 2008; Kim et al., 2011), with limited evidence of adverse effects below 60 ppb” (Frey, 2014 2014 c , p. 7). (2) Based on the HREA results, meeting an O 3 standard with a level of 60 ppb would be expected to almost eliminate exposures of concern to O 3 concentrati ons at or above 60 ppb. To the extent lower exposure concentrations may result in adverse health effects in some people, a standard level of 60 ppb would be expected to also reduce exposures to
O 3 concentrations below 60 ppb. (3) U.S. and Canadian epidemiolog ic studies have not reported O 3 health effect associations based primarily on study locations likely to have met a standard with a level of 60 ppb. (4) In all of the urban study areas evaluated, a standard with a level of 60 ppb would be expected to maintain long

- term O 3 concentrations below those where a key study indicates the most confidence in a linear concentration

- response relationship with respiratory mortality. Beyond the above considerations, the PA also note s the HREA estimates indicating that
meet ing an O 3 standard with a level of 60 ppb would result in important reductions in the risk of
O 3 - induced lung function decrements and O 3 - associated mortality and morbidity. Although some risk is estimated to remain based on these metrics, even with a level of 60 ppb, the PA concludes that there is decreasing confidence in further public health improvements with levels below 60 ppb . The PA reaches this conclusion because, as noted above, at a level of 60 ppb virtually no one in the population would be expected to experience exposures of concern a t or above 60 ppb,*** E.O. 12866 Review

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Page 251 of 668 and because epidemiologic studies have not reported O 3 health effect associations based primarily on study locations likely to have met a standard with a level of 60 ppb. Given all of the above considerations the PA concludes that, compared to standards with levels from 70 to 60 ppb, the extent to which standards with leve ls below 60 ppb could result in further public health improvements becomes notably less certain. Therefore, the PA conclude s that it is not appropriate in this review to consider standard levels below 60 ppb. The range of levels from 70 to 60 ppb corresp onds to the range of levels recommended for The following sections summarize the PA’s consideration by CASAC, based on the available evidence and information (Frey, 2014). While CASAC further offered what it characterized as “policy advice” to set the leve l below 70 ppb, based on margin of safety considerations, the Committee acknowledged that “the choice of a level within the range recommended based on scientific evidence [i.e., 70 to 60 ppb] is a policy judgment under the statutory mandate of the Clean Ai r Act” (Frey, 2014). Therefore, the PA conclusions on the appropriate range for alternative primary O 3 standard levels are consistent with CASAC conclusions that of the scientific evidence and exposure/risk information supports consideration of levels from 70 to 60 ppb, and that the ultimate identification of a standard that protects public health with an adequate margin of safety will reflect policy judgments that are explicitly reserved for the Administrator (section 1 .2.1). The following sections summarize the specific scientific evidence and exposure/risk information as they relate to revised specifically relate d to potential alternative O 3 standards with levels from the upper (70 ppb) ( II.E.4. b c .i), middle (65 ppb) ( II.E.4. b c .ii), and lower (60 ppb) ( II.E.4. b c .iii) portions of the range of 70 to 60 ppb. Key exposure/risk information considered in the PA is summarize d in Tables 4 and 5 , below (from U.S. EPA, 2014c, Tables 4

- 4 and 4

- 5)

.*** E.O. 12866 Review

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Page 252 of 668 Formatted: Space After: 0 pt, Line spacing: Double, Tab stops: 0.5", Left*** E.O. 12866 Review

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Page 253 of 668 Table 4 . Summary of Estimated Exposures of Concern for Potential Alternative O 3 Standard Levels of 70, 65, and 60 ppb in Urban Case Study Areas 135

Benchmark Level Alternative

Standard Level (ppb) Average

% Children Exposed 136 Number of

Children (5 to 18 years) [ Number of Asthmatic C hildren] 137 , 138 Average %

Reduction from Current Standard 139 % Children

-

Worst Year and Worst Area One or more exposures of concern per season ≥ 70 ppb 70 0.1

- 1.2 94,000 [10,000] 73 3.2

65 0

- 0.2 14,000 [2,000] 95 0.5 60 0 140 1,400 [200] 141 100 0.1
≥ 60 ppb 70 3.3

- 10.2 1,176,000 [126,000] 46 18.9 65 0

- 4.2 392,000 [42,000] 80 9.5 60 0

- 1.2 70,000 [8,000] 96 2.2 Two or more exposures of concern per season ≥ 70 ppb 70 0

- 0.1 5,400 [600] 95 0.4

65 0 300 [100] 100 0 60 0 0 [0] 100 0 ≥ 60 ppb 70 0.5

- 3.5 320,000 [35,000] 61 9.2

65 0

- 0.8 67,000 [7,500] 92 2.8 60 0

- 0.2 5,100 [700] 100 0.3

135 All alternative standard level s evaluated in the HREA were effective at limiting exposures of concern at or above 80 ppb (U.S. EPA, 2014c, Figures 4

- 1 to 4

- 4 ) . Therefore, Table 4 focuses on exposures of concern at or above the 70 and 60 ppb benchmark concentrations. 136 Estimates for each urban case study area were averaged for the years evaluated in the HREA (2006 to 2010). Ranges reflect the ranges across urban study areas

. 137 Numbers of children exposed in each urban case study area were averaged over the years 2006 to 2010. These averages were then summed across urban study areas. Numbers are rounded to nearest thousand unless otherwise indicated. 138 As noted in section II.C.3.a.ii, the responsiveness of asthmatics to O 3 exposures could depend on factors that have not been well

- evaluated such as asthma severity , the effectiveness of asthma cont rol, or t he prevalence of medication use. 139 Percent reductions in each urban study area were calculated and averaged across areas. 140 Estimates smaller than 0. 05 % were rounded to zero. 141 As discussed in section 4.3.3 of the HREA (U.S. EPA, 2014a) , the model

- based air quality adjustment approach used to estimate risks associated with the current and alternative standards was unable to estimate the distribution of ambient O 3 concentrations in New York City upon just meeting an alternative standard with a level of 60 ppb. Therefore, for the 60 ppb standard level the numbers of children and asthmatic children reflect all of the urban study areas except New York. Formatted Table

Formatted Table*** E.O. 12866 Review

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Page 254 of 668 Table 5 . Summary of Estimated Lung Function Decrements for Potential Alternative O 3 Standard Levels of 70, 65, and 60 ppb in Urban Case Study Areas Lung Function Decrement Alternative

Standard Level Average %

Children 142 Number of Children (5

to 18 years) [ Number of Asthmatic C hildren] 143 , 144 Average % Reduction from Current Standard % Children

Worst Year and Area One or more decrements per season ≥ 10% 70 11

- 17 2,527,000 [261,000] 15 20

65 3

- 15 1,896,000 [191,000] 31 18 60 5

- 11 1,404,000 [139,000] 145 45 13 ≥ 15% 70 2

- 4 562,000 [58,000] 26 5

65 0

- 3 356,000 [36,000] 50 4 60 1

- 2 225,000 [22,000] 67 3 ≥ 20% 70 1

- 2 189,000 [20,000] 32 2.1

65 0

- 1 106,000 [11,000] 59 1.4 60 0

- 1 57,000 [6,000] 77 0.7

Two or more decrements per season ≥ 10% 70 5.5

- 11 1,414,000 [145,000] 17 13

65 1.3

- 8.8 1,023,000 [102,000] 37 11 60 2.1

- 6.4 741,000 [73,000] 51 7.3 ≥ 15% 70 0.9

- 2.4 276,000 [28,000] 29 3.1

65 0.1

- 1.8 168,000 [17,000] 54 2.3 60 0.2

- 1.0 101,000 [10,000] 71 1.4 ≥ 20% 70 0.3

- 0.8 81,000 [8,000] 34 1.1

65 0

- 0.5 43,000 [4,000] 66 0.8 60 0

- 0.2 21,000 [2,000] 83 0.4

142 Estimates in each urban case study area were averaged for the years evaluated in the HREA (200 6 to 2010). Ranges reflect the ranges across urban study areas

. 143 Numbers of children estimated to experience decrements in each study urban case study area were averaged over 2006 to 2010. These averages were then summed across urban study areas

. Numbers are rounded to nearest thousand unless otherwise indicated. 144 As noted in section II.C.3.a.ii, the responsiveness of asthmatics to O 3 exposures could depend on factors that have not been well

- evaluated such as asthma severity , the effectiveness of asthma control, or t he prevalence of medication use. 145 As discussed in section 4.3.3 of the HREA (U.S. EPA, 2014a) , the model

- based air quality adjustment approach used to estimate risks associated with the current and alternative standards was unable to estimat e the distribution of ambient O 3 concentrations in New York City upon just meeting an alternative standard with a level of 60 ppb. Therefore, for the 60 ppb standard level the numbers of children and asthmatic children reflect all of the urban study areas except New York.*** E.O. 12866 Review

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Page 255 of 668 i. PA consideration of an O 3 standard level of 70 ppb
As noted above, The PA notes that a level of 70 ppb is below the lowest O 3 exposure concentration that has been reported to elicit a range of respiratory effects that includes airway hyperresponsiveness AHR and decreased lung host defense, in addition to lung function decrements, airway inflammation, and respiratory symptoms (i.e., 80 ppb). A level of 70 ppb is also below the lowest exposure concentration at which the combined occurrence of respiratory symptoms and lung function decrements have been reported (i .e., 72 ppb), a combination judged adverse by the ATS ( U.S. EPA, 2014c, section 3.1.3). A level of 70 ppb is above the lowest exposure concentration demonstrated to result in lung function decrements large enough to be judged an abnormal response by ATS an d above the lowest exposure concentration demonstrated to result in pulmonary inflammation (i.e., 60 ppb). Compared to the current standard, the HREA estimates that a revised O 3 standard with a level of 70 ppb would reduce exposures of concern to O 3 concentrations of 60, 70, and 80 ppb in urban study areas , with such a standard level estimated to be most effective at limiting exposures at or above the higher health benchmark concentrations and at limiting multiple occurrences of such exposures. On av erage over the years 2006 to 201 0, for a standard with a level of 70 ppb , up to about 1% of children (i.e., ages 5 to 18) are estimated to experience e xposures of concern at or above 70 ppb (73% reduction, compared to current standard), and far less than 1 % are estimated to experience two or more such exposures (95% reduction, compared to current standard). In the worst

- case location and year (i.e., location and year with the largest exposure estimate), about 3% of children are estimated to experience one o r more exposures of concern at or above 70 ppb, and less than 1% are estimated to experience two or more. Far less than 1% of*** E.O. 12866 Review

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Page 256 of 668 children are estimated to experience exposures of concern at or above the 80 ppb benchmark concentration, even i n the worst

- case y ear (Table 4, above ). 146 As noted above, CASAC advised the EPA that 60 ppb is an appropriate exposure of

concern with respect to adverse effects on people with asthma, including children (Frey, 2014,
p 2014 c , p p . 6 , and 8)

. For a n O 3 standard with a level of 70 ppb , a bout 3 to 10% of children , including asthmatic children, are estimated to experience one or more exposure s of concern at or above 60 ppb in a single O 3 season. Compared to the current standard, this reflects about a 46%

r eduction, on average across the urban study areas

. A bout 1% to 4% of children are estimated to experience two or more exposure s of concern at or above 60 ppb (approximately 60% reduction, compared to current standard). I n the worst

- case location and year, for a standard set at 70 ppb, about 1 9% of children are estimated to experience one or more exposures of concern at or above 60 ppb, and 9 % are estimated to experience two or more such exposures (Table 4, above)

. Compared to the current standard, the HRE A estimates that a revised O 3 standard with a level of 70 ppb would also reduce O 3 - induced lung function decrements in children. A level of 70 ppb is estimated to be most effective at limiting the occurrences of moderate and large lung function decrements (i.e., FEV 1 decrements ≥ 15% and ≥ 20% , respectively ) , and at limiting multiple occurrences of O 3 - induced decrements

. On average over the years 2006 to 2010, for a standard with a level of 70 ppb , about 2 to 4% of children in the urban study areas are estimated to experience one or more moderate O 3 - induced lung function decrements (i.e., FEV 1 decrement
≥ 15% ), which would be of concern for healthy people , and about 1 to 2.5% of children are

146 As noted above, due to interindividual variability, children (or adults) exposed at these levels will not necessarily experience health effects; the information available for some health effects is not sufficient to quantify the numbers of children in the urban study areas who might experience these effects.*** E.O. 12866 Review

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Page 257 of 668 estimated to experience two or more such decrements (approx imately 30% reduction, compared to the current standard) . In the worst

- case location and year , up to 5 % of children are estimated to experience one or more O 3 - induced lung function decrements ≥ 15%, and up to 3 % are estimated to experience two or more such decrements. For a standard set at 70 ppb , about 2% or fewer children are estimated to experience large O 3 - induced lung function decrements (i.e., FEV 1 decrement ≥ 20% ), and about 1% or fewer children are estimated to experience two or more such decrements , even in the worst

- case years and locations (Table 5 , above )

. On average over the years 2006 to 2010, for an O 3 standard set at 70 ppb , a bout 11 to 1 7% of children in the urban study areas are estimated to experience one or more moderate O 3 - induced lung function decrements (i.e., FEV 1 decrement ≥ 10% ), which could be adverse for people with lung disease. This reflects an average reduction of about 15 %, compared to the current standard. A bout 6 to 11% of children are estimated to experience two or more su ch decrements (17% reduction, compared to current standard). In the worst

- case location and year , for a standard set at 70 ppb , a bout 20 % of children in the urban study areas are estimated to experience one or more O 3 - induced lung function decrements ≥ 10%, and 1 3 % are estimated to experience two or more such decrements (Table 5 , above ). Compared to the current standard, a revised standard with a level of 70 ppb would also more effectively maintain short

- term ambient O 3 concentrations below those pres ent in the epidemiologic studies that reported significant O 3 health effect associations in locations likely to have met the current standard. In particular, the single

- city study by Mar and Koenig (2009) reported positive and statistically significant ass ociations with respiratory emergency department visits in children and adults in a location that likely would have met the current O 3 standard over the entire study period but violated a revised s tandard with a level of 70 ppb or below. None of*** E.O. 12866 Review

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Page 258 of 668 the single

- city studies evaluated in section 4.4.1 of the PA (U.S. EPA, 2014c) provide evidence for O 3 health effect associations in locations meeting a standard with a level of 70 ppb or below. While this analysis does not provide information on the extent to which the reported O 3 - associated emergency department visits would persist upon meeting an O 3 standard with a level of 70 ppb, or on the extent to which standard levels below 70 ppb could further reduce the incidence of such emergency department visits, 147 it sugg ests that a revised O 3 standard with a level at or below 70 ppb would require reductions in the ambient O 3 concentrations that provided the basis for the health effect associations reported by Mar and Koenig

. (2009)

. As discussed above, compared to single

- city studies, there is greater uncertainty in linking air quality concentrations from individual study cities to multicity effect estimates . With regard to the multicity studies in this review , the PA note s that Dales et al. (2006) reported signific ant associations with respiratory hospital admissions based on air quality in 11 Canadian cities, most of which would likely have met the current standard over the entire study period , but violated a revised standard with a level of 70 ppb or below over at least part of th at period (Table
4

- 1). This analysis suggests that while although the current standard would allow the ambient O 3 concentrations in most of the study locations that provided the basis for the association with hospital admissions, a revised O 3 standard with a level at or below 70 ppb would require reductions in those ambient O 3 concentrations. As with the study by Mar and Koenig , (2009) , this analysis does not provide information on the extent to which the reported O 3 - associated hospital admi ssions would persist upon meeting an O 3 standard with a level of 70 ppb, or on the

147 Put another way, one cannot infer from this analysis the extent to which effects would occur at O 3 concentrations b elow those observed in the study.*** E.O. 12866 Review

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Page 259 of 668 extent to which standard levels below 70 ppb could further reduce the incidence of such hospital admissions. 148 With regard to long

- term O 3 concentrations, the PA evaluates the long

- term O 3 metrics reported to be associated with mortality or morbidity in recent epidemiologic studies (e.g., seasonal averages of 1

- hour or 8

- hour daily max concentrations) . Compared to the current standard, a revised standard with a level of 70 ppb would be expected to reduce the risk of respiratory mortality associated with long

- term O 3 concentrations, based on information from the study by Jerrett et al. (2009), though the PA notes the HREA conclusion, discussed above, that lower confidence sho uld be placed in respiratory mortality risk estimates based on this study (U.S. EPA, 2014a, section 9.6). In addition, a standard with a level of 70 ppb would be expected to more effectively maintain long

- term O 3 concentrations below those where the study by Jerrett et al. (2009) indicates the most confidence in the reported association with respiratory mortality. 149 Specifically, air quality analyses indicate this to be the case in 9 out of the 12 urban study areas for a level of 70 ppb, compared to 6 out of 12 areas for the current standard. Finally, a revised standard with a level of 70 ppb would be expected to reduce long

- term O 3 concentrations based on the types of metrics that have been reported in recent epidemiologic

148 In addition, for the other multicity studies identified in Table 4

- 1 of the PA (Cakmak et al., 2006; Stieb et al., 2009; Katsouyanni et al., 2009), and for the study by Bell et al. (2006) (for the 30 ppb cut point) (Table 4

- 2 of the PA ), the majority of s tudy locations would likely have met a standard with a level of 70 ppb

. (U.S. EPA, 2014c)

. 149 As discussed in section 3.1.4.3 of the PA (U.S. EPA, 2014c) , the study by Jerrett et al. (2009) suggests notably decreased confidence in the reported linear conce ntration

- r esponse function for long

- term O 3 concentrations in the first quartile (i.e., at or below about 53 ppb), given the widening in confidence intervals for lower concentrations; the fact that most study cities contributing to the linear function had O 3 concentrations in the highest three quartiles, accounting for approximately 72% of the respiratory deaths in the cohort (based on Table 2 in the published study); and the limited evidence presented in the published study for a threshold at or near 56 pp b.*** E.O. 12866 Review

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Page 260 of 6 68 studies to be associated with respi ratory morbidity (i.e., seasonal averages of daily maximum 8

- hour concentrations). In further considering the potential implications of epidemiology studies for alternative standard levels, the PA note s estimates of total mortality associated with short

- term O 3 concentrations. 150 As discussed above, the PA consider s estimates of total risk (i.e., based on the full distributions of ambient O 3 concentrations) and estimates of risk associated with O 3 concentrations in the upper portions of ambient distribution s. With regard to total risk the PA
notes that, when summed across urban study areas , a standard with a level of 70 ppb is estimated to reduce the number of deaths associated with short

- term O 3 concentrations by about 4% (2007) and 2% (2009), compared to t he current standard. 151 Based on a national modeling analysis, the majority of the U.S. population would be expected to experience reductions in such risks upon reducing precursor emissions. Compared to the total risk estimates noted above, an O 3 standard with a level of 70 ppb is estimated to be more effective at reducing the number of deaths associated with short

- term O 3 concentrations at the upper ends of ambient distributions. Specifically, for area - wide O 3 concentrations at or above 40 ppb , a standard with a level of 70 ppb is estimated to reduce the number of deaths associated with short

- term O 3 concentrations by about 10% compared to the current standard. In addition, for area - wide concentrations at or above 6 0 ppb , a standard with a

150 As discussed above, compared to the weight given to the evidence and to HREA estimates of exposures of concern and lung function risks, we place the PA places relatively less weight on epidemiologic

- based risk estimates. 151 A standard with a level of 70 ppb is also estimated to reduce respiratory mortality associated with long

- term O 3 concentrations in urban study areas . However, given uncertainties associated with these risk estimates, as discussed above, we give the PA give s them limited weight.*** E.O. 12866 Review

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Page 261 of 668 level of 70 ppb i s estimated to reduce O 3 - associated deaths by about 50% to 70% ( U.S. EPA, 2014c, Figure 4

- 13). The PA noted that in providing the advice that 70 ppb is an appropriate upper bound for consideration, CASAC advised that a level of 70 ppb would provide littl e margin of safety for protection of public health, particularly for sensitive subpopulations (Frey, 2014 2014 c , p. 8). In particular, CASAC stated that: At 70 ppb, there is substantial scientific certainty of a variety of adverse effects, including decrea se in lung function, increase in respiratory symptoms, and increase in airway inflammation. Although a level of 70 ppb is more protective of public health than the current standard, it may not meet the statutory requirement to protect public health with an adequate margin of safety (Frey, 2014 2014 c , p.8). 152 However, the c ommittee also acknowledged that “the choice of a level within the range recommended based on scientific evidence [i.e., 70 to 60 ppb] is a policy judgment under the statutory mandate of the Clean Air Act” (Frey, 2014). 2014 c, pp. ii and 8 ). In summary, compared to the current standard, the PA concludes that a revised O 3 standard with a level of 70 ppb would be expected to (1) reduce the occurrence of exposures of
concern to O 3 concentrations that result in respiratory effects in healthy adults ( at or above 60 and 70 pp b) by about 45 to 95%, almost eliminating the occurrence of multiple exposures at or above 70 ppb; (2) reduce the occurrence of moderate

- to

- large O 3 - induced lung function decrements ( FEV 1 decrements > 10, 15, 20%) by about 15 to 35%, most effectively limiting the occurrence of multiple decrements and decrements > 15, 20%; (3) more effectively maintain short

- and long

- term O 3 concentrations below those present in the epidemiologic studies that reported significant O 3 health effect associations in locations likely to have met the current

152 Also see Frey (2014c, p. ii).*** E.O. 12866 Review

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Page 262 of 668 standard ; 153 and ( 4 ) reduce the risk of O 3 - associated mortality and morbidity, particularly the risk associated with the upper portions of the distributions of ambient O 3 c oncentrations. ii. PA consideration of an O 3 standard level of 65 ppb The PA also considers a standard with a level of 65 ppb. A level of 65 ppb is well below 80 ppb, an O 3 exposure concentration that has been reported to elicit a range of respiratory ef fects that includes airway hyperresponsiveness and decreased lung host defense, in addition to lung function decrements, airway inflammation, and respiratory symptoms. A standard level of 65 ppb is also below the lowest exposure concentration at which the combined occurrence of respiratory symptoms and lung function decrements has been reported (i.e., 72 ppb), a combination judged adverse by the ATS ( U.S. EPA, 2014c, section 3.1.3). A level of 65 ppb is above the lowest exposure concentration demonstrated t o result in lung function decrements large enough to be judged an abnormal response by ATS, where statistically significant changes in group mean responses would be judged to be adverse by ATS, and which the CASAC has indic a ted could be adverse in people w ith lung disease (i.e., 60 ppb). A level of 65 ppb is also above the lowest exposure concentration at which pulmonary inflammation has been reported in healthy adults (i.e., 60 ppb). Compared to the current standard and a revised standard with a level of 70 ppb, the HREA estimates that a standard with a level of 65 ppb would reduce exposures of concern to the range of O 3 benchmark concentrations analyzed (i.e., 60, 70, and 80 ppb). The HREA estimates that meeting a standard with a level of 65 ppb would el iminate exposures of concern at or above 80 ppb in the urban study areas . Such a standard is estimated to allow far less than 1% of

153 E pidemiologic studies also provide some evidence for O 3 health effect associations in locations likely to have met a standard with a level of 70 ppb, as discussed below for lower standard levels.*** E.O. 12866 Review

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Page 263 of 668 children in the urban study areas to experience one or more exposures of concern at or above the 70 ppb benchmark level, eve n in the worst

- case years and locations, and is estimated to eliminate the occurrence of two or more exposures at or above 70 ppb ( Table 4, above ). In addition, for a standard with a level of 65 ppb , b etween 0 and about 4 % of children (including asthmatic children) in urban study areas are estimated to experience e xposures of concern at or above 6 0 ppb , which CASAC has indicated is an appropriate exposure of concern for people with asthma, including children. This reflects an 80% reduct ion (on average across areas), relative to the current standard. L ess than 1 % of children are estimated to experience two

or more e xposures of concern at or above 6 0 ppb (> 90% reduction, compared to current standard). In the worst

- case location and year, about 10% of children are estimated to experience one or more exposures of concern at or above 60 ppb, with about 3% estimated to experience two or more such exposures ( Table 4, above ). Compared to the current standard and a revised standard with a level of 70 ppb, the HREA estimates that a standard with a level of 65 ppb would also further reduce the occurrence of O 3 - induced lung function decrements. For a level of 65 ppb, about 4% of ch ildren , or less, are estimated to experience moderate O 3 - induced FEV 1 decrements ≥ 15% (50% reduction, compared to current standard), even considering the worst

- case location and year. A bout 2% of children , or less, are estimated to experience two or more such decrements. Only about 1% of children , or less, are estimated to experience large O 3 - induced lung function decrements (i.e.,
FEV 1 decrement ≥ 20% ) , even in the worst

- case year and location

. In addition , for a standard with a level of 65 ppb , a bout 3 to 15% of children are estimated to experience one or more moderate O 3 - induced lung function decrements (i.e., FEV 1 decrement ≥ 10% ), which CASAC has indicated could be adverse for people with lung disease.*** E.O. 12866 Review

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Page 264 of 668 This reflects an aver age reduction of about 30 %, relative to the current standard. A bout 1 to 9% of children in the urban study areas are estimated to experience two or more such decrements (37% reduction, compared to current standard). In the worst

- case location and year , for a standard set at 65 ppb , u p to about 18 % of these children are estimated to experience one or more moderate O 3 - induced lung function decrements ≥ 10%, and up to 11 % are estimated to experience two or more such decrements

. With regard to O 3 epidemiologic studies, the PA notes that , compared to a standard with a level of 70 ppb, a revised standard with a level of 65 ppb would more effectively be expected
to maintain short

- term ambient O 3 concentrations below those present in some of the epide miologic studies study locations that provided the basis for reported significant O 3 health effect associations in locations and that were likely to have met the current a revised standard with a level of 70 ppb

. In particular, Katsouyanni et al. (2009) rep orted statistically significant associations with mortality based on air quality in 12 Canadian cities, most of which would likely have met a standard with a level of 70 ppb over the entire study period but violated a revised standard with a level of 65 pp b or below over at least part of th at period ( U.S. EPA, 2014c, Table 4

- 1). This analysis suggests that while although the current standard or a standard with a level of 70 ppb would allow the ambient O 3 concentrations in most of the study locations that provided the basis for the association with mortality in this study, a revised O 3 standard with a level at or below 65 ppb would require reductions in those ambient O 3 concentrations. As discussed above f

or a level of 70 ppb, this analysis does not provide information on the extent to which O 3 - associated mortality would persist upon meeting an O 3 standard with a level of 65 ppb,*** E.O. 12866 Review

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Page 265 of 668 or on the extent to which standard levels below 65 ppb could further reduce th e incidence of this mortality. 154 With regard to long

- term O 3 concentrations, as for 70 ppb (above) the PA evaluates the long

- term O 3 metrics reported to be associated with mortality or morbidity in recent epidemiologic studies (e.g., seasonal averages of 1

- hour or 8

- hour daily max concentrations)

. Compared to the current standard or a revised O 3 standard with a level of 70 ppb, a revised standard with a level of 65 ppb would be expected to further reduce the risk of respiratory mortality associated with lon g - term O 3 concentrations, based on information from the study by Jerrett et al. (2009). 155 In addition, a standard with a level of 65 ppb would be expected to more effectively maintain long

- term O 3 concentrations below those where the study by Jerrett et al. (2009) indicates the most confidence in the reported association with respiratory mortality. Specifically, air quality analyses indicate this to be the case in 10 out of the 12 urban study areas for a level of 65 ppb, compared to 6 out of 12 areas for the current standard and 9 out of 12 for a standard with a level of 70 ppb ( U.S. EPA, 2014c, Table 4

- 3). Finally, a revised standard with a level of 65 ppb would be expected to further reduce long

- term O 3 concentrations based on the types of metrics that have been reported in recent epidemiologic studies to be associated with respiratory morbidity (i.e., seasonal averages of daily maximum 8

- hour concentrations).

154 For the other multicity studies identified in Table 4

- 1 of the PA (Cakmak et al., 2006; Stieb et al., 2009; Katsouyanni et al., 2009 (for hospital admissions)), and for the study by Bell et al. (2006) (for the 30 ppb cut point) (Table 4

- 2 of the PA ), the majority of study locations would have met a standard with a level of 65 ppb

. (U.S. EPA, 2014c)

. 155 Though as discussed above, the PA notes the lower confidence we place place d in these risk results (U.S. EPA, 2014a, section 9.6). Formatted: Keep lines together*** E.O. 12866 Review

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Page 266 of 668 In further considering the potential implications of epidemiology studies for alternative standar d levels, the PA notes estimates of total mortality associated with short

- term O 3 . 156 As discussed above, the PA considers estimates of total risk (i.e., based on the full distributions of ambient O 3 concentrations) and estimates of risk associated with O 3 concentrations in the upper portions of ambient distributions. With regard to total risk the PA notes that, when summed

across urban study areas , a standard with a level of 65 ppb is estimated to reduce the number of deaths associated with short

- term O 3 e xposures by about 13% (2007) and 9% (2009), compared to the current standard. 157 For area - wide concentrations at or above 40 ppb , a standard level of 65 ppb is estimated to reduce O 3 - associated deaths by almost 50% compared to the current standard, when summ ed across urban study areas . For area - wide concentrations at or above 6 0 ppb , a standard level of 65 ppb is estimated to reduce O 3 - associated deaths by more than 80% ( U.S. EPA, 2014c, Figure 4

- 13). In summarizing CASAC’s advice regarding a standard with a level of 65, the PA noted CASAC’s conclusion that an alternative standard with a level of 65 ppb would further reduce , though not eliminate, the frequency of lung function decrements > 15% and w ould lead to lower frequency of short

- term premature mortali ty (i.e., compared to a standard with a level of 70 ppb) (Frey, 2014 2014 c , p. 8). In summary, compared to a standard with a level of 70 ppb, the PA concludes that a revised standard with a level of 65 ppb would be expected to further reduce O 3 exposures and

156 As discussed above, comp ared to the weight given to the evidence and to HREA estimates of exposures of concern and lung function risks, the PA places relatively less weight on epidemiologic

- based risk estimates. 157 A standard with a level of 65 ppb is also estimated to reduce res piratory mortality associated with long

- term O 3 concentrations in urban study areas . However, given uncertainties associated with these risk estimates, as discussed above, we give them limited weight.*** E.O. 12866 Review

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Page 267 of 668 health risks. In particular, a standard with a level of 65 ppb is estimated to (1) reduce the occurrence of exposures of concern by about 80 to 100% , compared to the current standard , decreasing exposures at or above 60 ppb and almost elimin ating exposures at or above 70 and 80 ppb; (2) reduce the occurrence of FEV 1 decrements > 10, 15, and 20% by about 30 to 65%,

c ompared to the current standard ; (3) more effectively maintain short

- and long

- term O 3 concentrations below those present in the epidemiologic studies that reported significant O 3 health effect associations in locations likely to have met the current standard ; 158 and (4) further reduce the risk of O 3 - asso ciated mortality and morbidity , particularly the risk associated with the
upper p ortion of the distribution of ambient O 3 concentrations. iii. PA consideration of an O 3 standard level of 60 ppb The PA also c onsider s a standard with a level of 60 ppb. A level of 60 ppb is well below the O 3 exposure concentration that has been reported to elicit a wide range of potentially adverse respiratory effects in healthy adults (i.e., 80 ppb). A level of 60 ppb is also below the lowest concentration where the combined occurrence of respiratory symptom s and lung function decrements was observed, a combination judged adverse by the ATS (i.e., 72 ppb , discussed in section 3.1.3). ). A level of 60 ppb corresponds to the lowest exposure concentration demonstrated to result in lung function decrements that ar e large enough to be judged an abnormal response by ATS, that meet ATS criteria for adversity based on a downward shift in the distribution of FEV1, and that the CASAC indicated could be adverse in people with lung disease. A level of 60 ppb also correspon ds to the lowest exposure concentration at which pulmonary inflammation has been reported in a single c ontrolled human exposure study

.

158 Though epidemiologic studies also provide evidence for O 3 health effect associations in locations likely to have met a standard with a level of 65 ppb, as discussed below for a level of 60 ppb.*** E.O. 12866 Review

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Page 268 of 668 Based on the HREA analyses of O 3 exposures of concern, a standard with a level of 60 ppb is estimated to eliminate expo sures of concern at or above the 70 and 80 ppb benchmark concentrations and t o be more effective than the higher standard levels at limiting expos ures of concern at or above 60 ppb

. On average over the years 2006 to 2010, for a standard with a level of 60 ppb , between 0 and about 1 % of children , including asthmatic children, in urban study

areas are estimated to experience e xposures of concern at or above 6 0 ppb , which CASAC indicated is an appropriate exposure of concern for asthmatic children. This reflec ts a 96% reduction (on average across areas), compared to the current standard. V irtually no children are estimated to experience two or more e xposures of concern at or above 6 0 ppb . In the worst

- case location and year, about 2% of children are estimated t o experience exposures of concern at or above 60 ppb, with far less than 1% estimated to experience two or more such exposures ( Table 4, above ). Based on the HREA analyses of O 3 - induced lung function decrements, a standard with a level of 60 ppb would be expected to be more effective than a level of 65 or 70 ppb at limiting the occurrence of O 3 - induced lung function decrements. For a standard with a level of 60 ppb , about 2% of children , or less, in the urban study areas are estimated to expe rience one or more moderate O 3 - induced FEV 1 decrements ≥ 15% (almost 70% reduction, compared to current standard), and about 1% or less are estimated to experience two or more such decrements (3% in the location and year with the largest estimates)

. A bout 1% of children, or less, are estimated to experience large O 3 - induced lung function decrements (i.e., FEV 1 decrement ≥ 20% ) , even in the
worst

- case locations and year (Table 5 , above )

. In addition , for a standard with a level of 60 ppb , a bout 5 to 11% of children in the urban study areas are estimated to experience one or more moderate O 3 - induced lung function*** E.O. 12866 Review

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Page 269 of 668 decrements that CASAC indicated could be adverse for people with lung disease (i.e., FEV 1 decrements ≥ 10% ). This reflects an average reduction of about 45 %, compared to the current standard. A bout 2 to 6% of children in these areas are estimated to experience two or more such decrements (51% reduction, compared to current standard). In the worst

- case location and year, for a standard set at 60 ppb , up to about 13 % of children are estimated to experience one or more moderate O 3 - induced FEV 1 decrements ≥ 10%, and 7 % are estimated to experience two or more such decrements (Table 5 , above ). With regard to O 3 epidemiologic studies , the PA notes that , compared to a standard with a level of 65 or 70 ppb, a revised standard with a level of 60 ppb would more effectively be expected to maintain short

- term ambient O 3 concentrations below those present in some of the epidemiologic studies study locations th at provided the basis for reported significant O 3 health effect associations in locations and that were likely to have met the current a revised standard with a level of 70 or 65 ppb

. Specifically, in all of the U.S. and Canadian epidemiologic studies evalu ated, the majority of study cities had ambient O 3 concentrations that would likely have violated a standard with a level of 60 ppb. Thus, none of the U.S. and Canadian epidemiologic studies analyzed provide evidence for O 3 health effect associations when t he majority of study locations would likely have met a standard with a level of 60 ppb ( U.S. EPA, 2014c, Tables 4

- 1 and 4

- 2). As discussed above, while this analysis does not provide information on the extent to which the O 3 - associated morbidity or mortali ty would persist upon meeting an O 3 standard with a level of 60 ppb, it suggests that a revised O 3 standard with a level of 60 ppb would require reductions in the ambient O 3 concentrations that provided the basis for those health effect associations.*** E.O. 12866 Review

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Page 270 of 668 With regard to long

- term O 3 concentrations, compared to the current standard or a revised
O 3 standard with a level of 65 or 70 ppb, a revised standard with a level of 60 ppb would be expected to further reduce the risk of respiratory mortality associated w ith long

- term O 3 concentrations, based on information from the study by Jerrett et al. (2009). 159 In addition, a standard with a level of 60 ppb would be expected to more effectively maintain long

- term O 3 concentrations below those where the study by Jerrett et al. (2009) indicates the most confidence in the reported association with respiratory mortality. Specifically, air quality analyses indicate this to be the case in all of the urban study areas evaluated at a level of 60 ppb, compared to 6 out of 12 are as for the current standard, 9 out of 12 for a standard with a level of 70 ppb, and 10 out of 12 for a standard with a level of 65 ppb ( U.S. EPA, 2014c, Table 4

- 3). Finally, a revised standard with a level of 60 ppb would be expected to further reduce long

- term O 3 concentrations based on the types of metrics that have been reported in recent epidemiologic studies to be associated with respiratory morbidity (i.e., seasonal averages of daily maximum 8

- hour concentrations). In further considering the potenti al implications of epidemiology studies for alternative standard levels, the PA notes estimates of total mortality associated with short

- term O 3 concentrations. 160 As discussed above, the PA consider s estimates of total risk (i.e., based on the full distribu tions of ambient O 3 concentrations) and estimates of risk associated with O 3 concentrations in the upper portions of ambient distributions. With regard to total risk the PA

159 Though as discussed above, the PA notes the lower confidence we place in these risk results (U.S. EP A, 2014a, section 9.6). 160 As discussed above, compared to the weight given to the evidence and to HREA estimates of exposures of concern and lung function risks, we place relatively less weight on epidemiologic

based risk estimates.*** E.O. 12866 Review

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Page 271 of 668 notes that, when summed across urban study areas , a standard with a level of 60 ppb is estimated to reduce the number of deaths associated with short

- term O 3 exposures by about 15% (2007) and 11% (2009), compared to the current standard ( U.S. EPA, 2014c, Figure 4

- 13). 161 For area wide concentrations at or above 40 ppb , a standard with a level set at 60 ppb is estimated to reduce O 3 - associated deaths by almost 60% compared to the current standard. For area - wide concentrations at or above 6 0 ppb , a standard level of 60 ppb is estimated to reduce O 3 - associated deaths by over 95% c omp ared to the current standard

. In summarizing CASAC’s advice, the PA notes CASAC’s statement that, relative to the current standard, or alternative O 3 standards with levels of 65 or 70 ppb: The frequency of lung function decrements and premature mortality from short

term exposure to ozone decreases even further when the alternative standard is lowered to 60 ppb (Frey, 2014, p.8). CASAC also concluded that “the recommended lower bound of 60 p pb would certainly offer more public health protection than levels of 70 ppb or 65 ppb and would provide an adequate margin of safety” (Frey, 2014, p. ii). In summary, compared to a standard with a level of 65 or 70 ppb, the PA concludes that a revised standard with a level of 60 ppb would be expected to further reduce O 3 exposures and health risks

. In particular, a standard with a level of 60 ppb is estimated to (1) reduce the

occu rrence of exposures of concern by about 95 to 100%, compared t o the current standard, almost eliminating exposures at or above 60 ppb; (2) reduce the occurrence of FEV 1 decrements

> 10, 15, and 20% by about 45 to 85% , compared to the current standard; (3) more effectively maintain short

- and long

- term O 3 concentratio ns below those present in the epidemiologic

161 A standard with a le vel of 60 ppb is also estimated to reduce respiratory mortality associated with long

- term O 3 concentrations in urban study areas . However, given uncertainties associated with these risk estimates, as discussed above, we give the PA gives them limited weight

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Page 272 of 668 studies that reported significant O 3 health effect associations in locations likely to have met the current standard ; 162 and (4) further reduce the risk of O 3 - asso ciated mortality and morbidity , particularly the ri sk associated with the upper portion of the distribution of ambient O 3 concentrations

.

c. CASAC Advice The PA recognizes that decisions regarding the weight to place on various types of evidence, exposure/risk information, and associated uncertainties ref lect public health policy judgments that are ultimately left to the Administrator. To help inform those judgments with regard to the range of alternative primary O 3 standard levels appropriate for consideration, CASAC has provided advice to the Administrator based on their reviews of draft versions of the
O 3 ISA, HREA, and PA. This section summarizes the advice provided by CASAC regarding alternative standard levels, as well as the views expressed at the CASAC meetings by public commenters. This section includes CASAC advice from the reconsideration of the 2008 final decision on the level of the standard, as well as CASAC advice received during the current review as it pertains to alternative standards. Consistent with its advice in 2008, CASAC r eiterated during the reconsideration its support for an 8

- hour primary O 3 standard with a level ranging from 60 to 70 ppb, combined with the current indicator, averaging time, and form. Specifically, in response to the EPA’s solicitation of CASAC advice du ring the reconsideration, the CASAC letter (Samet, 2010) to the Administrator stated: CASAC fully supports EPA’s proposed range of 0.060

– 0.070 parts per million (ppm) for the 8

- hour primary ozone standard. CASAC considers this range to be

162 As discussed above, these studies do not provide information on the extent to which O 3 health effect associations would persist following reductions in ambient O 3 concentrations in order to meet a standard with a level of 60 ppb.*** E.O. 12866 Review

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Page 273 of 668 justified by t he scientific evidence as presented in the Air Quality Criteria for Ozone and Related Photochemical Oxidants (March 2006) and Review of the National Ambient Air Quality Standards for Ozone: Policy Assessment of Scientific and Technical Information, OAQPS S taff Paper (July 2007). Similarly, in response to the EPA’s request for additional advice on the reconsideration in 2011, CASAC reaffirmed its conclusion that “the evidence from controlled human and epidemiologic studies strongly supports the selection of a new primary ozone standard within the
60

– 70 ppb range for an 8

- hour averaging time” (Samet, 2011). CASAC further concluded that this range “ would provide little margin of safety at its upper end” (Samet, 2011, p. 2).
In the current review of the Secon d Draft PA , CASAC concurred with staff’s conclusions that it is appropriate to consider retaining the current indicator (O 3 ), averaging time (8

- hour average) and form ( 3

- year average of the 4th highest maximum daily 8

- hour average

. With regard to level, CASAC stated the following (Frey, 2014 c , p p . ii to iii ): The CASAC further concludes that there is adequate scientific evidence to recommend a range of levels for a revised primary ozone standard from 70 ppb to 60 ppb. The CASAC reached this conclusion ba sed on the scientific evidence from clinical studies, epidemiologic studies, and animal toxicology studies, as summarized in the Integrated Science Assessment (ISA), the findings from the exposure and risk assessments as summarized in the HREA, and the int erpretation of the implications of these sources of information as given in the Second Draft PA. The CASAC acknowledges that the choice of a level within the range recommended based on scientific evidence [i.e., 70 to 60 ppb] is a policy judgment under the statutory mandate of the Clean Air Act. The CASAC advises that, based on the scientific evidence, a level of 70 ppb provides little margin of safety for the protection of public health, particularly for sensitive subpopulations. Thus, our policy advice is to set the level of the standard lower than 70 ppb within a range down to 60 ppb, taking into account your judgment regarding the desired margin of safety to protect public health, and taking into account that lower levels will provide incrementally great er margins of safety. The public commenters who expressed the view that the current primary O 3 standard is not adequate (II.D. 3) also submitted comments that supported revising the level of the primary*** E.O. 12866 Review

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Page 274 of 668 O 3 standard

. Several of these commenters expressed th e view that the level should be revised to the lower end of the range of 70 to 60 ppb , or in some cases to a level below 60 ppb

. These commenters often placed a large amount of emphasis on evidence from controlled human exposure studies for respiratory eff ects following exposures to 60 ppb O 3 . In addition, as discussed above (II.D.3 ), some public c ommenters expressed the view that revision of the current standard is not necessary. Consistent with their view that it would not be appropriate to revise the current standard, these commenters did not provide any provisional views on alternative levels below 75 ppb that would be appropriate for consideration. d. Administrator’s proposed conclusions on level This section discusses the Administrator’s proposed conclusions on the level of the primary O 3 standard. In conjunction with her proposed decisions to retain the current indicator, averaging time, and form (II.E.1 to II.E.3, above), the Administrator proposes to revise the level of the primary O 3 s tandard to within the range of 65 to 70 ppb. In doing so, she is mindful that the selection of a primary O 3 standard that is requisite to protect public health wit h an adequate margin of safety requires judgment s based on an interpretation of the scientific evidence and exposure/risk information that neither overstate s nor understate s the strength s and limitations of that evidence and information, nor the appropriat e inferences to be drawn therefrom

. 163 The rationale supporting the Administrator's proposed conclusions on alternative standard levels is discussed below.

163 As discussed above (I.B), in addressing the requirement for an adequate margin of safety the EPA considers such factors as the nature and severity of the health effects, the size of sensitive population(s) at risk, and the kind and degree of the uncertain ties that must be addressed. The selection of any particular approach for providing an adequate margin of safety is a policy choice left specifically to the Administrator’s judgment. See Lead Industries Association v. EPA , 647 F.2d at 1161

- 62; State of Mis sissippi , 744 F. 3d at 1353.*** E.O. 12866 Review

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Page 275 of 668 The Administrator’s proposed conclusions on alternative standard levels build upon her proposed concl usion that the overall body of scientific evidence and exposure/risk information call into question the adequacy of public health protection af forded by the current primary O 3 standard , particularly for at

- risk populations and lifestages (II.D.5). These pr oposed conclusions are based on consideration of the scientific evidence assessed in the ISA (U.S. EPA, 2013 2013 a );
t he results of the exposure and risk assessments in the HREA (U.S. EPA, 2014a); the evidence

based and exposure

- /risk

- based considerations and conclusions in the PA (U.S. EPA, 2014c); CASAC advice and recommendations, as reflected in CASAC’s letters to the Administrator and
in public discussions of drafts of the ISA, HREA, and PA ; and public input received during the development of these docu ments

. In reaching proposed conclusions on alternative levels for the primary O 3 standard, the Administrator considers the extent to which various alternatives would be expected to protect the public, including at

- risk populations, against the wide range of adverse health effects that have been linked with short

- or long

- term O 3 exposures. At

- risk populations include people with asthma; children and older adults ; people who are activ e outdoors, including outdoor workers ; people with certain genetic variant s; and people with reduced intake of certain nutrients. As was the case for her consideration of the adequacy of the current primary O 3 standard (II.D.5) , the Administrator places the greatest weight on the results of controlled human exposure studies and on exposure and risk analyses based on information from these studies. In doing so, she notes that controlled human exposure studies provide the most certain evidence indicating the occurrence of health effects in humans following exposures to specific O 3 concentrations. The effects reported in these studies are due solely to O 3 exposures, and interpretation of study results is not complicated by the presence of co

- occurring pollutants or pollutant mixtures (as is*** E.O. 12866 Review

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Page 276 of 668 the case in epidemiologic studies). She fu rther notes the CASAC judgment that “the scientific evidence supporting the finding that the current standard is inadequate to protect public health is strongest based on the controlled human exposure studies of respirat ory effects” (Frey,
2014 2014 c , p. 5). Consistent with this emphasis, the HREA conclusions reflect relatively greater confidence in the results of the exposure and risk analyses based on information from controlled human exposure studies (i.e., exposures of concern and risk of lung fun ction decrements) than the results of epidemiology

- based risk analyses, given the greater uncertainties in the epidemiology

- based risk estimates (U.S. EPA, 2014a, section 9.6). For all of these reasons, the Administrator has the most confidence in using th e information from controlled human exposure studies to reach proposed conclusions on alternative standard levels. In considering the evidence from controlled human exposure studies, the Administrator first notes that these studies have reported a variety of respiratory effects in healthy adults following exposures to O 3 concentrations of 60, 164 72, 165 or 80 ppb, and higher. The largest respiratory effects, and the broadest range of effects, have been studied and reported following exposures of healthy adults to 80 ppb O 3 or higher, with most exposure studies conducted at these higher concentrations. Exposures of healthy adults to O 3 concentrations of 80 ppb or higher have been reported to decrease lung function, increase airway inflammation, increase respirato ry symptoms, result in airway hyperresponsiveness, and decrease lung host defenses (II.B.2).

164 As discussed above (II.B.2), exposures to 60 ppb O 3 have been evaluated in studies by Adams ( 2002 , 2006), Schelegle et al ., . ( 2009 , ), and Kim et al. ( 2011 ). In the study by Schelegle, f or the 60 ppb target exposure concentration , study authors reported that the actual mean exposure concentration was 63 ppb. 165 As noted above, for the 70 ppb target exposure concentration , Schelegle et al. (2009) reported that the actual mean exposure concentration was 72 ppb.*** E.O. 12866 Review

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Page 277 of 668 Most of these effects have also been shown in healthy adults following exposures to O 3 concentrations lower than 80 ppb, with generally smaller effects following exposures to lower concentrations. In particular, the T he Administrator notes that O 3 exposure concentrations as low as 72 ppb have been shown to both decrease lung function and increase respiratory symptoms (Schelegle et al., 2009), a combination that meet s the ATS criteria for an adverse response. In considering effects at 72 ppb, CASAC likewise noted that “ the combination of decrements in
FEV 1 together with the statistically significant alterations in symptoms in human subjects exposed to 72 ppb ozone mee ts the American Thoracic Society’s definition of an adverse health effect” (Frey, 2014c, p. 5). With regard to lower exposure concentrations, although the Administrator notes that the combination of statistically significant increases in respiratory symptoms and decrements in lung function decrements has not been reported , 166 the Administrator notes that

. More specifically, she notes that respiratory symptoms have been evaluated foll owing 6.6

- hour exposures to average O 3 concentrations of 60 ppb O 3 have been shown to decrease lung function in several studies and, in one study ( (Adams, 2006; Kim et al., 2011 ), to ) and 63 ppb (Schelegle et al., 2009 ) and that none of these studies repor ted a statistically significant increase airway inflammation (II.B.2)

. in respiratory symptoms, compared to filtered air controls. 167 Based on this evidence, the Administrator reaches the initial conclusion that the results of controlled human exposure studi es strongly support setting the level of a revised O 3 standard no

166 More s pecifically, the Administrator notes that respiratory symptoms have been evaluated following 6.6

- hour exposures to average O 3 concentrations of 60 ppb (Adams, 2006; Kim et al., 2011) and 63 ppb (Schelegle et al., 2009 ). None of these studies reported a sta tistically significant increase in respiratory symptoms, compared to filtered air controls, though Adams (2006) report ed a significant i ncrease in symptoms , compared to initial symptoms. 167 However, following exposures to 60 ppb O 3 , several studies have observed decreases in lung function and one study (Kim et al., 2011) observed an increase in airway inflammation (II.B.2).*** E.O. 12866 Review

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Page 278 of 668 higher than 70 ppb. In reaching this initial conclusion, the Administrator places a large amount of weight on the importance of setting the level of the standard well below 80 ppb, the O 3 exposure concentration shown in healthy adults to result in the broadest range of respiratory effects, and below 72 ppb, the lowest O 3 exposure concentration shown in healthy adults to result in the adverse combination of respiratory symptoms and lung fun ction decrements. In further considering the potential public health implications of a standard with a level of 70 ppb, the Administrator also considers the extent to which such a standard would be expected to limit population exposures to the broader ran ge of O 3 concentrations reported in controlled human exposure studie s to cause respiratory effects. Given the range of effects reported following exposures to 80 ppb O 3 , and the evidence for the adverse combination of lung function decrements and respirato ry symptoms in healthy adults following exposures as low as 72 ppb, the Administrator concludes that there is strong the evidence in this review supporting support s the occurrence of adverse respiratory effects for exposures to O 3 con centrations at or above 72 ppb.
T he Administrator has decreasing confidence that adverse effects will occur following exposures to O 3 concentrations below 72 ppb. In particular, compared to O 3 exposure concentrations at or above 72 ppb, she has less confidence that adverse effe cts will occur following exposures to O 3 concentrations as low as 60 ppb. In reaching this conclusion, she notes that , as discussed above, statistically significant increases in respiratory symptoms, combined with lung function decrements, have not been reported following exposures to 60 or 63 ppb O 3 , though several studies have evaluated the potential for such effects. Although she has decreasing confidence in the occurrence of adverse effects following exposures to O 3 concentrations below 72 p pb, the Administrator note s the CASAC judgment that*** E.O. 12866 Review

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Page 279 of 668 the adverse combination of lung function decrements and respiratory symptoms “almost certainly occur in some people ” following exposures to lower concentrations (Frey, 2014c, p. 6)

. In particular, when co mmenting on the extent to which the study by Schelegle et al. (2009) suggests the potential for adverse effects following O 3 exposures below 72 ppb, CASAC judged that: [I] f subjects had been exposed to ozone using the 8

- hour averaging period used in the standard [i.e., Rather r ather than the 6.6 hour exposures evaluated in the study] , adverse effects could have occurred at lower concentration. Further, in our judgment, the level at which adverse effects might be observed would likely be lower for more sens itive subgroups, such as those with asthma [i.e., compared to the healthy adults evaluated in the study] (Frey, 2014c, p. 5). Though CASAC did not provide advice as to how far below 72 ppb adverse effects would likely

occur , the Administrator agrees that s uch effects could occur following exposures at least somewhat below 72 ppb

. Based on the evidence and CASAC advice noted above, when considering the extent to which a standard with a level of 70 ppb would be expected to limit population exposures to the broader range of O 3 concentrations shown to cause respiratory effects, the Administrator considers the extent to which such a standard would be expected to limit the occurrence of O 3 exposures of concern at or ab ove 60, 70, and 80 ppb

. 168 In doing so, she notes that an O 3 standard established at a particular level can provide protection against a range of exposure concentrations, including concentrations below the standard level. This is because the degree of protection provided by any NAAQS is due to the c ombination of all of the elements of the

168 As for with her consideration of the current standard (II.D.5), the Ad ministrator focuses on estimated exposures of concern in children , including asthmatic children , noting the HREA analyses indicating that exposures of concern occur in a larger percentage of children than adults (given that a larger percentage of children are estimated to spend an extende d period of time being physically active outdoors when O 3 concentrations are elevated) (II.C.2). To the extent alternative standards provide an appropriate degree of protection for children, she judges that those standards will also protect adult populatio ns (including at

- risk adult populations).*** E.O. 12866 Review

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Page 280 of 668 standard (i.e., indicator, averaging time, form, level). In the case of the 4 th maximum form of the
O 3 NAAQS, which the Administrator is proposing to retain in the current review (II.E.3), the large majority of days in areas that meet the standard will have 8

- hour O 3 concentrations below the level of the standard. In considering exposures of concern at or above 60, 70, and 80 ppb, the Administrator judges that the evidence supporting the occurrence of adverse respira tory effects is strongest for exposures at or above the 70 and 80 ppb benchmarks. While the Administrator has less confidence that adverse effects will occur following exposures to O 3 concentrations as low as 60 ppb, she notes the possibility for adverse e ffects following such exposures given that (1) CASAC has indicated the moderate lung function decrements (i.e., FEV 1 decrements ≥ 10%) that occur in some healthy adults following exposures to 60 ppb O 3 , which are large enough to be judged an abnormal respo nse by ATS, could be adverse to people with lung disease (II.B.3), and that (2) airway inflammation has been reported following exposures as low as 60 ppb O 3 . She also takes note of CASAC advice that the occurrence of exposures of concern at or above 60 pp b is an appropriate consideration for people (including children) with asthma (Frey, 2014c, p. 6).
D ue to interindividual variability in responsiveness , the Administrator further notes that not every occurrence of an exposure of concern will result in an adverse effect. 169 R epeated occurrences of some of the effects demonstrated following exposures of concern could increase the likelihood of adversity. For example, as discussed in the ISA (U.S. EPA, 2013 2013 a , Section 6.2.3), repeated occurrences of airway inflammation could lead to the induction of a chronic

169 F or most of the effects demonstrated in controlled human exposure studies (e.g., airway inflammation , airway hyperresponsiveness AHR , decreased lung host defense , respiratory symptoms ) the available data are not sufficient to quantify the number of people who would experience adverse effects due to O 3 exposures.*** E.O. 12866 Review

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Page 281 of 668 inflammatory state ; alter ed pulmonary structure and function, leading to diseases such as asthma; alter ed lung host defense response to inhaled microorga nisms, particularly in potentially at

- risk populations such as the very young and old ; and alter ed lung response to other agents such as allergens or toxins . The Administrator notes that the types of lung injury that can occur following exposures of concer n, particularly if experienced repeatedly, provide a plausible mode of action by which O 3 may cause other more serious effects. Therefore, the Administrator is most concerned about protecting at

- risk populations against repeated occurrences of exposures of

concern. Based on the above considerations, the Administrator focuses on the extent to which a revised standard would be expected to protect populations from experiencing two or more O 3 exposures of concern (i.e., as a surrogate for repeated exposures). While she emphasizes the importance of limiting two or more exposures and reducing their occurrence, compared to the current standard, s he balances this emphasis by noting that (1 ) not all exposures of concern will result in adverse effects; (2) she has le ss confidence in the occurrence of adverse effects at the 60 ppb benchmark than at the 70 or 80 ppb benchmarks; and (3) the NAAQS are not meant to be

zero - risk standards

. 170 Therefore, in using estimates of exposures of concern to inform her decisions on alt ernative standard levels, the Administrator judges that it would not be appropriate
to set a standard intended to eliminate all exposures of concern for all benchmarks , particularly the 60 ppb benchmark. Her consideration of specific estimates of exposures of concern is discussed below. As illustrated in Table 1 (above), the Administrator notes that, in urban study areas, a revised standard with a level of 70 ppb would be expected to eliminate the occurrence of two or

170 State of Mississippi , 744 F. 3d at 1343.*** E.O. 12866 Review

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Page 282 of 668 more exposures of concern to O 3 concen trations at and above 80 ppb and to virtually eliminate the occurrence of two or more exposures of concern to O 3 con centrations at and above 70 ppb,

even in the worst

- case urban study area and year . For the 70 ppb benchmark, this reflects about a 95% reduc tion in the occurrence of two or more exposures of concern, compared to the current standard (Table 4). Though the Administrator acknowledges greater uncertainty with regard to the occurrence of adverse effects following exposures of concern at or above 6 0 ppb, she notes that a revised standard with a level of 70 ppb would also be expected to protect the large majority of children in the urban study areas (i.e., about 96% to more than 99% of children in individual urban study areas) from experiencing two o r more exposures of concern at or above 60 ppb. Compared to the current standard, this represents a reduction of more than 60% in the occurrence of two or more exposures of concern (Tables 1 and 4). Based on the above information, the Administrator conclu des that a revised O 3 standard with a level of 70 ppb would be expected to virtually eliminate the occurrence of two or more O 3 exposures of concern for the 70 and 80 ppb benchmarks, and to substantially reduce the occurrence of two or more O 3 exposures of concern for the 60 ppb benchmark, compared to the current standard. Although the Administrator is less concerned about single occur rences of exposures of

concern , she acknowledges that even single exposures to O 3 concentrations at or above b enchmark concentrations (particularly for the 70 and 80 ppb benchmarks) could potentially result in adverse effects. To the extent this may be the case, the Administrator notes that a standard with a level of 70 ppb would also be expected to (1) virtually eliminate all occurrences of exposures of concern at or above 80 ppb, even in the worst

- case year and location and (2)*** E.O. 12866 Review

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Page 283 of 668 achieve important reductions, compared to the current standard, in the occurrence of one or more exposures of concern at or above 70 and 60 ppb (i.e., about a 70% reduction for the 70 ppb benchmark and almost a 50% reduction for the 60 ppb benchmark) (Tables 1 and 4). In further evaluating the potential public health impacts of a standard with a level of 70 ppb, the Administrator also cons iders the HREA estimates of O 3 - induced lung function decrements . To inform her consideration of these decrements , the Administrator takes note of CASAC advice that “estimation of FEV 1 decrements o f > 15% is appropriate as a scientifically relevant surrogat e for adverse health outcomes in active healthy adults, whereas an FEV 1 decrement of > 10% is a scientifically relevant surrogate for adverse health outcomes for people with asthma and lu ng disease” (Frey, 2014 2014 c , p. 3). Consistent with this advice, she considers estimates of the occurrence of O 3 - induced FEV 1 decrements > 10 and 15% as surrogates for the occurren ce of adverse health outcomes. While these surrogates provide perspective on the potential for the occurrence of adverse respiratory effects fo llowing O 3 exposures, the Administrator agrees with the conclusion in past reviews that a more general consensus view of the adversity of moderate responses emerges as the frequency of occurrence increases (61 FR 65722

- 3) (Dec, 13, 1996). Specifically, she concludes that not every estimated occurrence of an O 3 - induced FEV 1 decrement will be adverse and that repeated occurrences of moderate responses, even in otherwise healthy individuals, may be considered to be adverse since they could set the stage for more serious illness. Therefore, the Administrator becomes increasingly concerned about the potential for adversity as the fre quency of occurrences increases and, a s a result, s he focuses primarily on estima tes of two or more O 3 - induced FEV 1 decrements (i.e., as a surrogate for repeated exposures)

.*** E.O. 12866 Review

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Page 284 of 668 Given the above considerations, the Administrator does not believe it would be appropriate to set a standard that is intended to eliminate all O 3 - induced FEV 1 dec rements. She notes that this is consistent with CASAC advice, which did not include a recommendation to set the standard level low enough to eliminate all O 3 - induced FEV 1 decrements > 10 or 15% (Frey, 2014c). Rather, the Administrator considers the extent to which a standard with a level of 70 ppb would be expected to protect the population from experiencing O 3 - induced FEV 1 decrements > 10 and 15%, including the extent to which such a standard would be expected to achieve reductions in the occurrence of O 3 - induced FEV 1 decrements, relative to the current standard. 171
T he Administrator notes that a revised O 3 standard with a level of 70 ppb is estimated to protect about 98 to 99% of children in urban study areas from experiencing two or more O 3 - induced FEV 1 d ecrements > 15%, and about 89 to 94% from experiencing two or more decrements > 10%. 172 Compared to the current standard, these estimates represent decreases in the occurrence of two or more O 3 - induced decrements of about 29 and 17%, respectively (Tables
2 a nd 5). Although the Administrator is less concerned about the public health implications of single O 3 - induced lung function decrements, she also gives some consideration to estimates of
one or more O 3 - induced FEV 1 decrements. In particular, she notes that a revised standard with a level of 70 ppb is estimated to reduce the occurrence of one or more O 3 - induced decrements,

171 The Administrator additionally notes that, unlike exposures of concern, the variability in lung function ris k estimates across urban study areas is often greater than the differences in risk estimates between various standard levels (Table 2, above). Given this, and the resulting considerable overlap between the ranges of lung function risk estimates for differe nt standard levels, while although the Administrator has confidence in the lung function risk estimates themselves, she views them as providing a more limited basis than exposures of concern for distinguishing between the degree of public health protection provided by alternative standard levels. 172 I n the worst

- case year and location, a standard with a level of 70 ppb is estimated to protect about 97% of children in urban study areas from experiencing two or more O 3 - induced FEV 1 decrements > 15%, and about 87% from experiencing two or more decrements > 10%.*** E.O. 12866 Review

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Page 285 of 668 compared to the current standard, by about 26% (for decrements > 15%) and 15% (for decrements > 10%) (Tables 2 and 5). Given all of the a bove information, the Administrator concludes that a revised standard with a level of 70 ppb would be expected to provide substantial protection against O 3 exposures of concern (for benchmark concentrations of 60, 70, 80 ppb) and O 3 - induced lung function d ecrements, and would be expected to result in important reductions in the occurrence of such exposures and decrements, compared to the current standard. This is particularly the case for estimates of two or more occurrences of exposures of concern and lung function decrements. In next considering the additional protection that would be expected from standard levels below 70 ppb, the Administrator evaluates the extent to which a standard with a level of 65 ppb would be expected to further limit O 3 exposures of concern and O 3 - induced lung function decrements. In addition to eliminating almost all exposures of concern to O 3 concentrations at or above 80 and 70 ppb, even in the worst

- case years and locations, the Administrator notes that a revised st andard with a level of 65 ppb would be expected to protect more than 99% of children in urban study areas (and 100% of children in some urban study areas) from experiencing two or more exposures of concern at or above 60 ppb. Compared to the current standa rd, this represents about a 95% reduction in the occurrence of two or more exposures of concern for the 60 ppb benchmark (Tables 1 and 4). In addition, the Administrator notes that a revised standard with a level of 65 ppb is estimated to reduce the occurr ence of one or more exposures of concern for the 60 ppb benchmark by about 80%, compared to the current standard (Tables 1 and 4). With regard to O 3 - induced lung function decrements, the Administrator notes that an O 3 standard with a level of 65 ppb is es timated to protect about 98% to more than 99% of children*** E.O. 12866 Review

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Page 286 of 668 from experiencing two or more O 3 - induced FEV 1 decrements > 15%, even considering the
worst

- case year and location, and about 91 to 99% from experiencing two or more decrements > 10% (89% in worst

- ca se year and location). These estimates reflects reflect reductions, compared to the current standard, of about 54 and 37%, respectively. A revised standard with a level of 65 ppb is also estimated to reduce the occurrence of one or more lung function decrem ents > 15 and 10%, compared to the current standard, by about 50 and 31%, respectively. Taken together, the Administrator initially concludes that the evidence from controlled human exposure studies, and the information from quantitative analyses that dra w upon these studies (i.e., exposures of concern, O 3 - induced FEV 1 decrements), provide strong support for standard levels from 65 to 70 ppb. In particular, she bases this conclusion on the fact that such standard levels would be well below the O 3 exposure concentration shown to result in the widest range of respiratory effects (i.e., 80 ppb), and below the lowest O 3 exposure concentration shown to result in the adverse combination of lung function decrements and respiratory symptoms (i.e., 72 ppb) . A standa rd with a level from 65 to 70 ppb would also be expected to result in important reductions, compared to the current standard, in the occurrence of O 3 exposures of concern for all of the benchmarks evaluated (i.e., 60, 70, and 80 ppb) and in the risk of O 3 - induced lung function decrements > 10 and 15%. In further considering the evidence and exposure/risk information, the Administrator considers the extent to which the epidemiologic evidence, and the quantitative risk estimates based on information from ep idemiologic studies, also provide support for standard levels from 65 to 70 ppb. In doing so, as in her consideration of the adequacy of the current O 3 standard, the Administrator focuses on epidemiologic studies of respiratory

- related hospital admissions, emergency d epartment visits, and mortality

. These considerations are discussed below.*** E.O. 12866 Review

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Page 287 of 668 T he Administrator first considers the extent to which available epidemiologic studies have reported associations between short

- term O 3 concentrations and emergency depa rtment visits, hospital admissions, and/or mortality in locations that would likely have met alternative standards w ith levels from 65 to 70 ppb (U.S. EPA, 2014c, section 4.4.1). In evaluating the epidemiologic evidence in this way, the Administrator place s the most weight on single

- city studies of short

- term O 3 concentrations, recognizing that there were no multicity studies for which air quality data indicated that all cities included in the analyses would likely have met alternative standard levels. In p articular, she notes that while single

- city studies are more limited than multicity studies in terms of statistical power and geographic coverage, conclusions linking air quality in a given city with health effect associations in that same city can be made with greater certainty for single

- city studies of short

- term O 3 , compared to health effect associations aggregated across multiple cities in multicity studies. In particular, the Administrator notes considerable uncertainty in linking multicity effect est imates (aggregated across multiple cities) for short

- term O 3 with the air quality for subsets of study locations (rather than all locations) likely to have met an alternative standard. 173

173 In recognizing that multicity studies are often emphasized over single

- city studies for purposes of making weight of evidence judgments ( U.S. EPA, 2013 2013a ) , the Administrator’s judgme nt in this case applies specifically to interpreting air quality analyses for epidemiologic studies of short

- term O 3 concentrations where multicity effect estimates are aggregated across cities, and where individual city effect estimates are not presented (as is the case for the key O 3 studies analyzed in the PA, with the exception of the study by Stieb et al. (2009) where none of the city

- specific effect estimates for asthma emergency department visits were statistically significant). Because reported mult icity effect estimates do not allow health effect associations to be disaggregated by individual city, it is not possible to assign the multicity health effect association to the air quality in any one study location, or to the air quality in a particular subset of locations. In contrast, for epidemiologic studies of long

- term concentrations, where multicity effect estimates are based on comparisons across cities, different judgments have been made by EPA with regard to the utility of multicity studies (s e e, e.g. 78 FR 3086 at 3103/2 ) ( , January 15, 2013) (and see discussion below of study by Jerrett et al., 2009).*** E.O. 12866 Review

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Page 288 of 668 Given the above, the Administrator notes analyses in the PA (U.S. EPA , 2014c, section 4.4.1) indicating that a revised standard with a level of 65 or 70 ppb would be expected to maintain short

- term ambient O 3 concentrations below those present in the locations of all of the single

- city studies analyzed. As discussed in the PA (U.S. EPA, 2014c, section 4.4.1), this includes several single

- city studies conduc ted in locations that would have violated the current standard, and the single

- city study by Mar and Koenig (2009) that reported positive and statistically significant ass ociations with respiratory emergency department visits with children and adults in a location that likely would have met the current standard over the entire study period but that would likely not have met a revised standard with a level of 70 ppb or below

. Thus, the Administrator notes that, while the current standard would allow the ambient O 3 concentrations that provided the basis for the health effect associations reported by Mar and Koenig , (2009) , a revised O 3 standard with a level at or below 70 ppb would require reductions in those ambient O 3 concentrations. While the Administrator acknowledges uncertainty in the extent to which the reported O 3 - associated emergency department visits could be further reduced b y standard levels below 65 or 70 ppb, she concludes that this analysis indicates that a revised standard with a level at least as low as 70 ppb would result in improvements in public health, beyond the protection provided by the current standard, in the lo cations of the single

- city epidemiologic studies that reported significant health effect associations. As discussed above, the Administrator notes the greater uncertainty in interpreting air quality in locations of multicity epidemiologic studies of short

- term O 3 for the purpose of evaluating alternative standard levels (II.D.1 and U.S. EPA, 2014c, section 4.4.1). Therefore, she places less weight on these studies than on the single

- city studies noted above. Despite this uncertainty, she notes that PA anal yses s uggest that standard levels of 65 or 70 ppb would more*** E.O. 12866 Review

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Page 289 of 668 effectively maintain short

- term require additional reductions, beyond those required by the current standard, in ambient O 3 concentrations below those present in se veral of the epidemiologic stud ies study locations that reported provided the basis for statistically significant
O 3 health effect associations with morbidity or mortality in locations likely to have met the current standard . For example, she notes that Dales et al. (2006) reported signi ficant associations with respiratory hospital admissions based on air quality in 11 Canadian cities, most of which would likely have met the current standard over the entire study period (i.e., seven cities) but would have violated a standard with a level of 70 ppb or below over at least part of th at period ( U.S. EPA, 2014c, Table 4

- 1). She further notes that Katsouyanni et al. (2009) reported statistically significant associations with mortality based on air quality in 12 Canadian cities, most of which would likely have met the current standard (i.e., eight study cities) and a standard with a level of 70 ppb (i.e., seven study cities) over the entire study period , but would have violated a standard with a level of 65 ppb over at lea st part of th at period ( U.S. EPA, 2014c, Table 4

- 1). While most of the other multicity epidemiologic studies evaluated also suggest that a level from 65 to 70 ppb would result in public health improvements, compared to the current standard, the Administrat or acknowledges that several multicity epidemiologic studies reported
O 3 health effect associations when the majority of study cities would likely have met standards with levels from 65 to 70 ppb. However, given the important uncertainties in interpreting the air quality in these multicity studies, the Administrator places limited weight on them overall, relative to the single

- city studies noted above (and relative to the information based on controlled human exposure studies). With regard to long

- term O 3 concentrations, the Adminis trator considers the long

- term O 3 metrics reported to be associated with mortality or morbidity in recent epidemiologic studies*** E.O. 12866 Review

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Page 290 of 668 (e.g., seasonal averages of 1

- hour or 8

- hour daily max concentrations) . Compared to the current stand ard, she notes that analyses in the PA (U.S. EPA, 2014c, section 4.4.1) suggest a re vised standard with a level of 65 or 70 ppb would more effectively maintain long

- term O 3 concentrations below those where the multicity study by Jerrett et al. (2009) indic ates the most confidence in the reported association with respiratory mortality (II.B.2, II.D.1). Based on additional information from the study by Jerrett et al. (2009), the Administrator also notes HREA analyses indicating that a revised standard with a level of 65 or 70 ppb would be expected to reduce the risk of respiratory mortality associated with long

- term O 3 concentrations (though she also notes important uncertainties with these risk estimates, as described below). Finally, she notes analyses in th e HREA suggesting that a rev ised standard with a level of 65 or 70 ppb would be expected to reduce long

- term O 3 concentrations, defined in terms of O 3 metrics similar to the long

- term metrics that have been reported in recent epidemiologic studies to be as sociated with respiratory morbidity (i.e., seasonal averages of daily maximum 8

- hour concentrations). Given the above evidence and information, the Administrator concludes that a revised 8

- hour standard with a level from 70 to 65 ppb could increase public health protection, compared to the current standard, against effects associated with long

- term O 3 exposures. In further evaluating information from epidemiologic studies, the Administrator also considers the HREA’s epidemiology

- based risk estimates of morbidity and mortality associated with short

- term O 3 (U.S. EPA, 2014a). Compared to the weight given to the evidence from controlled human exposure studies, and to HREA estimates of exposures of concern and lung function risks, she places relatively less weight on epidemiology

- based risk estimates. In doing so, she notes that the overall conclusions from the HREA likewise reflect relatively less confidence in estimates of epidemiology

- based risks than in estimates of exposures of concern*** E.O. 12866 Review

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Page 291 of 668 and lung function risks. As discussed above (II.C.3.b), this is based on the greater uncertainties associated with mortality and morbidity risk estimates, including the heterogeneity in effect estimates between locations, the potential for exposure measurement errors, and u ncertainty in the interpretation of the shape of concentration

- response functions at lower O 3 concentrations. The Administrator further notes the HREA conclusion that lower confidence should be placed in the results of the assessment of respiratory mortali ty risks associated with long

- term O 3 exposures, primarily because that analysis is based on only one study (even though that study is well

- designed) and because of the uncertainty in that study regarding the existence and identification of a potential thr eshold in the concentration

- response function (U.S. EPA, 2014a, section 9.6). In considering epidemiology

- based risk estimates, the Administrator focuses on the extent to which potential alternative O 3 standards are estimated to reduce the risk of mortali ty associated with short

- term exposures to O 3 , noting the similar patterns of risk across urban study

areas and air quality scenarios for respiratory morbidity endpoints (II.C.3) . Given the uncertainties in epidemiology

- based risk estimates , the Administra tor focuses on the general magnitudes of risk changes es timated for standard levels of 65 and 70 ppb , compared to the current standard, rather than placing a large amount of weight on the absolute estimates of O 3 - associated deaths. In doing so, she notes t he CASAC conclusion that “[a]lthough the estimates
for short

- term exposure impacts are subject to uncertainty, the data supports a conclusion that there are meaningful reductions in mean premature mortality associated with ozone levels lower than the curre nt standard” (Frey, 2014a, p. 10). She further notes that, as discussed above (II.C.3.b), the HREA risk estimates for urban study areas are likely to understate the average*** E.O. 12866 Review

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Page 292 of 668 reductions in O 3 - associated mortality and morbidity risks that would be experienced across the U.S. population as a whole upon meeting standards with lower levels. The Administrator’s primary focus is on risks associated with O 3 concentrations in the upper portions of ambient distributions, given the greater uncertainty associated with the shapes of concentration

- response curves for O 3 concentrations in the lower portions of ambient distributions. 174 The Administrator further notes that experimental studies provide the strongest evidence for O 3 - induced effects following exposures to O 3 con centrations corresponding to the upper portions of typical ambient distributions. In particular, as discussed above, she notes controlled human exposure studies showing respiratory effects following exposures to O 3

c oncentrations at or above 60 ppb (II.B)

. In considering risks associated with O 3 concentrations in the upper portions of ambient distributions, the Administrator focuses on area

- wide O 3 concentrations at or above 40 ppb and 60 ppb. For area - wide O 3 concentrations at or above 40 ppb , the Admini strator notes that re vised standards with levels of 65 70 or 70 65 ppb are estimated to reduce the number of premature deaths associated with short

- term O 3 concentrations by about 10% and almost 50%, respectively, compared to the current standard. 175 In additi on, for area - wide concentrations at or above 6 0 ppb , revised standards are estimated to reduce O 3 - associated premature deaths by about 50% to 70%

174 The ISA conclu des that there is less certainty in the shape of concentration

- response functions for area

- wide O 3 concentrations at the lower ends of warm season distributions (i.e., below about 20 to 40 ppb) ( U.S. EPA, 2013 2013a , section 2.5.4.4)

. 175 For area

- wide O 3 concentrations at or above 40 ppb, r eductions in estimated premature deaths are disproportiona tely l arger with the 65 ppb standard level than with the 70 ppb standard level

. This results from the larger air quality adjustments required to meet the 65 ppb level. Across urban study areas, t he additional reductions required to meet 65 ppb result in many few er days with area

- wide O 3 concentrations at or above 40 ppb and, therefore, many fewer O 3 - associated deaths for area

- wide concentrations at or above 40 ppb (U.S. EPA, 2014a, Figures 7

- 2 and 7

- 3)

. Formatted: Space After: 0 pt*** E.O. 12866 Review

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Page 293 of 668 for a standard level of 70 ppb, and by more than 80% for a standard level of 65 ppb. 176 Risk reductions are smaller when total risks are considered (II.C.3.b). Given all of the above evidence, exposure/risk information, and advice from CASAC, the Administrator propose s to revise the level of the current primary O 3 standard to within the ra nge of 65 to 70 ppb. She concludes that a standard with a level from within this range could reasonably be judged to be requisite to protect public health with an adequate margin of safety, based on her consideration of the evidence and information discuss ed above. In reaching this conclusion, the she particularly notes that a level from anywhere within this range would be below the lowest O 3 exposure concentration shown to result in the adverse combination of respiratory symptoms and lung function decrement s (i.e., 72 ppb), would be expected to maintain ambient O 3 concentrations below those in locations where single

- city studies assessed in the ISA have reported statistically significant O 3 health effect associations, and would be expected to result in impor tant reductions in O 3 exposures and health risks, compared to the current standard.
T he Administrator notes that the determination of what constitutes an adequate margin of safety is expressly left to the judgment of the EPA Administrator. She further note s that in evaluating how particular standards address the requirement to provide an adequate margin of safety, the Administrator must consider such factors as the nature and severity of the health effects, the size of sensitive population(s) at risk, and the kind and degree of the uncertainties that must be addressed

. (I.B, above)

. Consistent with past practice and long

- standing judicial precedent, she takes the need for an adequate margin of safety into account as an integral part of

176 Though only a relatively small number of days in urban study areas had area

- wide O 3 concentrations at or above 60 ppb.*** E.O. 12866 Review

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Page 294 of 668 her decision

- making o n the appropriate level, averaging time, form, and indicator of the standard. 177 The Administrator notes that the NAAQS are not designed to be zero

- risk or background standards, and that the sizeable risk reductions that are estimated in the HREA to be asso ciated with standard levels of 65 or 70 ppb represent substantial improvements in public health for important segments of the population, including at

- risk groups such as children and people with asthma. W hile the Although any rationale supporting a decisio n to set a specific level within the range of 65 to 70 ppb would discuss the full body of evidence and information, the Administrator notes that certain aspects of this evidence and information could be particularly important in distinguishing between the approp riateness of a level closer to 65 ppb versus a level closer to 70 ppb. 178 For example, a level at or near 65 ppb could be judged requisite to protect public health with an adequate margin of safety to the extent the Administrator places greater weight on the importance of: (1) setting the level of the standard well below the lowest O 3 exposure concentration shown to result in the adverse combination of respiratory symptoms and lung function decrements, particularly given that 8

- hour exposures could res ult in effects at lower concentrations than indicated in 6.6 controlled human exposure studies and that members of at risk populations could experience more serious effects than the healthy subjects evaluated in these studies ; (2) eliminating almost all exposures of concern (even single exposures occurrences )

177 See, e.g. NRDC v. EPA , 902 F. 2d 962, 973

- 74 (D.C. Cir. 1990). 178 Although this discussion refers to suppo rting rationale for a level of 65 ppb or 70 ppb, the Administrator is proposing the entire range between 65 and 70 ppb. The Administrator notes that al though neither the PA nor CASAC reached conclusions or provided advice on a standard set at a specific level between 65 ppb and 70 ppb, there is nothing in either the evidence, exposure/ris k information, or CASAC advice that would preclude such a standard level.*** E.O. 12866 Review

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Page 295 of 668 at or above 70 and 80 ppb, even in worst

- case years and locations; ( 3 2 ) almost eliminating the occurrence of two or more exposures of concern at or above 60 ppb; ( 4 3 ) achieving additional reductions in O 3 - induced FEV 1 decrements, beyond those achieved with a level of 70 ppb ( 5 4 ) maintaining ambient concentrations below those in locations of si ngle

- city studies and more effectively doing so for multicity studies (i.e., more effec tively than 70 ppb); and ( 6 5 ) achieving substantial reductions, compared to a standard with a level of 70 ppb, in mortality associated with the upper portion of the distribution of ambient O 3 concentrations, despite uncertainties in risk estimates.
In con trast, a level at or near 70 ppb could be judged requisite to protect public health with an adequate margin of safety to the extent the Administrator places a greater amount of weight (i.e., greater than for 65 ppb) on the importance of: (1) setting the le vel of the standard just below the lowest O 3 exposure concentration shown to result in the adverse combination of respiratory symptoms and lung function decrements (i.e., 72 ppb), given increasing uncertainty in the extent to which adverse effects occur fo llowing lower exposure concentrations; (2 greater than for 65 ppb) on the importance of: (1 ) almost eliminating the occurrence of two or more exposures of concern at or above 70 and 80 ppb, even in the worst

- case year and location; ( 3 2 ) substantially reduci ng, but not eliminating, the occurrence of two or more exposures of concern at or above 60 ppb, noting conclusions regarding increasing uncertainty in adverse effects for the 60 ppb benchmark; ( 4 3 ) reducing, but not eliminating, the occurrence of one or more exposures of concern, noting that not all exposures of concern result in adverse effects; ( 5 4 ) maintaining ambient O 3 concentrations below those in locations of single

- city epidemiologic studies, and uncertainties in analyses of air quality in multici ty study locations; and ( 6 5 ) recognizing uncertainties in epidemiology

- based risk estimates.*** E.O. 12866 Review

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Page 296 of 668 In considering CASAC advice on the range of standard levels, the Administrator first notes CASAC’s conclusion that there is adequate scientific evidence to consid er a range of levels for a primary standard that includes an upper end at 70 ppb. For the reasons discussed above, she agrees with this advice. She also notes CASAC’s conclusion that while CASAC concluded that a standard at with a level of 70 ppb “may not me et the statutory requirement to protect public health with an adequate margin of safety” (Frey, 2014c, p. 8). 8) , it further acknowledged that

“ the choice of a level within the range recommended based on scientific evidence is a policy judgment under the st atutory mandate of the Clean Air Act” (Frey, 2014c, p. ii)

. While she agrees with CASAC that it is appropriate to consider levels below 70 ppb, as reflected in her range of proposed levels from 65 to 70 ppb , for the reasons discussed above she also concludes that a standard level as high as 70 ppb , which CASAC concluded could be supported by the scientific evidence, could reasonably be judged to be requisite to protect public health with an adequate margin of safety. The Administrator has also consi dered the appropriateness of standard levels below 65 ppb. In doing so, she notes the conclusions of the PA and the advice of CASAC that it would be appropriate for her to consider standard levels as low as 60 ppb. In particular, she notes that a decision to set the primary O 3 standard level at 60 ppb would place a large amount of weight on the potential public health importance of virtually eliminating even single occurrences of exposures of concern at and above 60 ppb , though controlled human exposure stu dies have not reported the adverse combination of respiratory symptoms and decrements in lung function following exposures to 60 ppb O 3 ; on the potential public health importance of providing substantially greater protection (i.e., than that provided by a level of 65 ppb) against further reducing the occurrence of moderate to large O 3 - induced lung function decrements ; > 10 and*** E.O. 12866 Review

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Page 297 of 668 15%; on analyses of ambient O 3 concentrations in locations of multicity epidemiologic studies, despite uncertainties in linking multi city effect estimates for short

- term O 3 with air quality in individual study cities; and on epidemiology

- based risk estimates, despite the important uncertainties in those estimates. As However, as discussed more fully above, given the uncertainties associa ted with such estimates, the adversity of exposures to 60 ppb O 3 , particularly single occurrence of such exposures; uncertainties associated with air quality analyses , in locations of multicity epidemiologic studies; and assumptions uncertainties in epidemiology

based risk estimates, particularly uncertainties in the shape of the concentration

- response functions at lower O 3 concentrations and uncertainties associated with the heterogeneity in O 3 effect estimates across locations , the Administrator do es not agree that it is appropriate to place significant weight on these factors

. or to use them to support the appropriateness of standard levels below 65 ppb. C ompared to O 3 standard levels from 65 to 70 ppb, the Administrator concludes that the extent t o which standard levels below 65 ppb could result in further public health improvements becomes notably less certain. Therefore, she concludes that it is not appropriate to propose standard levels below 65 ppb

. 179
T he Administrator acknowledges that her pro posed range of 65 to 70 ppb does not include the lower portion of the range supported by CASAC. In reaching the conclusion that this is appropriate, she focuses on CASAC’s rationale for levels as low as 60 ppb. In particular, she notes the following CASAC advice : (Frey, 2014c, p. 7) : The CASAC concurs that 60 ppb is an appropriate and justifiable scientifically based lower bound for a revised primary standard. This is based upon findings of adverse effects, including clinically significant lung function decrements and airway inflammation, after exposures to 60 ppb ozone in healthy adults with

179 Al though, as discussed below, she solicits comment on standard levels as low as 60 ppb.*** E.O. 12866 Review

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Page 298 of 668 moderate exertion (Adams 2006; Schelegle et al., 2009; Brown et al

. . , 2008; Kim et al., 2011), with limited evidence of adverse effects below 60 ppb. In considering this advice, the Administrator notes that CASAC focused on the importance of limiting exposures to O 3 concentrations as low as 60 ppb. As discussed above, the Administrator agrees with this advice. In particular, she notes that standard s within the propos ed range of 65 to 70 ppb would be expected to substantially limit the occurrence of exposures of
concern to O 3 concentrations at or above 60 ppb, particularly the occurrence of two or more
exposures. 180 When she further considers that not all exposures of co ncern lead to adverse effects, and that the NAAQS are not meant to be zero

- risk or background standards, the Administrator judges that alternative standard levels below 65 ppb are not needed to further reduce such exposures. Therefore, her the Administrator ’s initial conclusion is that standard levels below 65 ppb would be more than requisite to protect public health with an adequate margin of safety. In reaching this initial conclusion, the Administrator acknowledges that alternative approaches to viewing the available scientific evidence and exposure/risk information, and to viewing the uncertainties inherent in that evidence and information, could lead one to reach a different conclusion. In particular, as noted above, she recognizes that levels as low as 60 ppb could potentially be supported, to the extent substantial weight is placed on the public health importance of estimates of one or more occurrences of exposures of concern at or above 60 ppb and O 3 - induced lung function decrements > 10%; analyses of ambient O 3 concentrations in locations of multicity epidemiologic studies; and epidemiology

- based estimates of total risk. This

180 In fact , as noted above (Table 4) , a standard with a level of 70 ppb would be expected to limit m ultiple occurrences of exposures of concern at or above the 60 ppb benchmark to as low as 0.5% in urban case study areas (and as low as 0% for a standard with a level of 65 ppb).*** E.O. 12866 Review

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Page 299 of 668 approach would also place a large amount of weight on the possibility that at

- risk groups would experience adv erse effects at lower levels than the benchmarks derived from clinical studies conducted using healthy adult subjects

. , despite the fact that these studies have not reported a statistically significant increase in respiratory symptoms , combined with lung f unction decrements , following exposures to 60 ppb

. 181 Such an approach to viewing the evidence and exposure/risk information would place very little weight on the uncertainties in these estimates and analyses. In some cases, elements of this approach have be en supported by p ublic
commenters , leading some commenters to recommend setting the level of the primary O 3 standard at least as low as 60 ppb

. In recognition of such an alternative approach to viewing the evidence and information, in addition to proposing to set the level of the O 3 standard from 65 to 70 ppb, the Administrator solicits comment on alternative standard levels below 65 ppb, and as low as 60 ppb. In doing so, the Administrator reiterates that t he CAA does not require the establishment of a pri mary NAAQS at a zero

- risk level or at background concentration levels, but rather at a level that reduces risk sufficiently so as to protect public health with an adequate margin of safety (I.A).
F

. Proposed Decision on the Primary Standard For the reasons discussed above, and taking into account information and assessments presented in the 20 13 ISA, 2014 HREA and integration of this information and assessments into staff conclusions in the 2014 PA, the advice and recommendations of CASAC, and public comments received during the development of these documents , the Administrator proposes to

181 More specifically, as discussed above, respiratory symptoms have b een evaluated following 6.6

- hour exposures to average O 3 concentrations of 60 ppb (Adams, 2006; Kim et al., 2011) and 63 ppb (Schelegle et al., 2009) . N one of these studies reported a statistically significant increase in respiratory symptoms, co mpared to filtered air controls

. Formatted: Font: Italic Formatted: Font: Italic*** E.O. 12866 Review

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Page 300 of 668 retain the current indicator, averaging time and form of the primary O 3 standard, and to set a new level for the 8

- hour primary O 3 standard

. Specifically, the Admin istrator proposes to set the level of the 8

- hour primary O 3 standard to within a the range of 65 to 70 ppb. The proposed 8

- hour primary standard would be met at an ambient air monitoring site when the 3

- year average of the annual fo u rth

- highest daily maximu m 8

- hour average O 3 concentration is less than or equal to the level of the revised standard that is promulgated. Thus, the Administrator proposes to set a standard with a level within this range. For the reasons discussed above, the Administrator also sol icits comment on setting the level of the primary O 3 standard below 65 ppb, and as low as 60 ppb.
III. Communication of Public Health Information Information on the public health implications of ambient concentrations of criteria pollutants is currently ma de available primarily through EPA's Air Quality Index (AQI) program

. The current Air Quality Index AQI has been in use since its inception in 1999 (64 FR 42530). It provides accurate, timely, and easily understandable information about daily levels of poll ution (40 CFR 58.50). It is designed to tell individual members of the public how clean or unhealthy their air is, whether health effects might be a concern, and, if so, measures individuals can take to reduce their exposure to air pollution. The AQI focus es on health effects individuals may experience within a few hours or days after breathing unhealthy air. The AQI establishes a nationally uniform system of indexing pollution concentrations for O 3 , carbon monoxide, nitrogen dioxide, particulate matter and sulfur dioxide. The AQI converts pollutant concentrations in a community's air to a number on a scale from 0 to 500. Reported AQI values enable the public to know whether air pollution concentrations in a particular location are characterized as good (0

- 50), moderate (51

- 100), unhealthy for sensitive groups (101

- 150),*** E.O. 12866 Review

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Page 301 of 668 unhealthy (151

- 200), very unhealthy (201

- 300), or hazardous ( 300 30 1

- 500). The AQI index value of 100 typically corresponds to the level of the short

- term NAAQS for each pollutant. For the current O 3 NAAQS, an 8

- hour average concentration of 75 ppb corresponds to an AQI value of 100. An AQI value greater than 100 means that a pollutant is in one of the unhealthy categories (i.e., unhealthy for sensitive groups, unhealthy, very unhea lthy, or hazardous) on a given day; an AQI value at or below 100 means that a pollutant concentration is in one of the satisfactory categories (i.e., moderate or good). An additional consideration in s electing breakpoints is for each category to span at le ast a 15 ppb range to allow for more accurate forecasting. Decisions about the pollutant concentrations at which to set the various AQI breakpoints, that delineate the various AQI categories, draw directly from the underlying health information that suppor ts the NAAQS review. The Agency recognizes the importance of revising the AQI in a timely manner to be consistent with any revisions to the NAAQS. Therefore EPA is proposing conforming changes to the AQI, in connection with the Agency's proposed decision on revisions to the O 3 NAAQS if revisions to the primary standard are promulgated. These conforming changes would include setting the 100 level of the AQI at the same level as the revised primary O 3 NAAQS and also making adjustments based on health informa tion from this NAAQS review to AQI breakpoints at the lower end of each range (i.e., AQI values of 50, 150, 200 and 300). The EPA does not propose to change the level at the top of the index (i.e., AQI value of 500) that typically is set equal to the Signi ficant Harm Level (40 CFR 51.16), which would apply to state contingency plans. The EPA is proposing to revise the AQI for O 3 by setting an AQI value of 100 equal to the level of the revised O 3 standard

. (65

- 70 ppb)

. The EPA is also proposing to revise th e*** E.O. 12866 Review

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Page 302 of 668 following breakpoints: an AQI value of 50 to 50 within a range from 49

- 54 ppb; an AQI value of 150 to 85 ppb; an AQI value of 200 to 105 ppb, and an AQI value of 300 to 200 ppb. All these levels are averaged over 8 hours. The EPA is proposing to set an AQI value of 50, the breakpoint between the good and moderate categories, at 50 ppb. This level is well 15 ppb below the value of the proposed standard, i.e. to within a range from 49 to 54 ppb. The EPA is taking comment on wh at level within this range to select, recognizing that there is no health message for either at

risk or healthy populations in the good category. Thus, the level selected should be below the lowest concentration (i.e., 60 ppb) that has been shown in contro lled human exposure studies of healthy adults 182 to cause moderate lung function decrements (i.e., FEV 1 decrements ≥ 10%, which could be adverse to people with lung disease ) ) , large lung function decrements (i.e., FEV 1 decrements ≥ 20%) in a small proportion of people, and airway inflammation in some people.

. 183 The EPA is proposing to set an AQI value of 150, the breakpoint between the unhealthy for sensitive groups and unhealthy categories, at 85 ppb. At this level, controlled human exposure studies of health y adults indicate that up to 25% of exposed people are likely to have moderate lung function decrements (i.e., 25% have FEV 1 decrements ≥ 10%; 12% have FEV 1 decrements ≥ 15%) and up to 7% are likely to have large lung function decrements (i.e., FEV 1 decrem ents ≥ 20%) (McDonnell et al., 2012; Figure 7). Large lung function decrements would likely interfere with normal activity for many healthy people. For people with lung disease, large lung function decrements would likely interfere with normal activity for most individuals people and would increase the likelihood that these individuals they would seek medical treatment ( U.S. EPA, 2007,

182 Effects would likely be greater in people with asthma. 183 Exposures to 50 ppb have not been evaluated experimentally, but are estimated to potentially affect only a small proportion of healthy adults and with only a half to a third of the moderate to large lung function decrements observed at 60 ppb (McDonnell et al., 2012; Figure 7).*** E.O. 12866 Review

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Page 30 3 of 668 p.3

- 72; 72 FR 37849 378 50 , July 11, 2007). The EPA is proposing to set an AQI value of 200, the breakpoint between the unhealthy and very unhealthy categories, at 105 ppb. At this level, controlled human exposure studies of healthy adults indicate that up to 38% of exposed people are likely to have moderate lung function decrements (i.e., 38% have FEV 1 decrements ≥ 10%;
22 % have FEV 1 decrements ≥ 15%) and up to 13% are likely to have large lung function decrements (i.e., FEV 1 decrements ≥ 20%). The EPA is proposing to set an AQI value of 300, the breakpoint between the very unhealthy and hazardous categories, at 200 ppb. At this level, controlled human exposure studies of healthy adults indicate that up to 25% of exposed people individuals are likely to have large lung function decrements (i.e., FEV 1 decrements ≥ 20%), which would interfere with daily activities for many of t hem

. Large lung function decrements would interfere with daily activities for most healthy people with lung disease, and likely cause many of th em to seek medical attention

. Effects would likely be greater in people with asthma. Table 6. Proposed AQI Break points AQI Category Index Values Existing Breakpoints (ppb, 8

- hour average) Proposed Breakpoints

(ppb, 8

- hour average)
Good 0

- 50 0

- 59 0

- 50

– (49 to 54) Moderate 51

- 100 60

- 75 51 (5 0 to 55)

- (65 to 70) Unhealthy for Sensitive Groups 101

- 150 76

- 95 (66 to 71)

- 85 Unhealthy 151

- 200 96

- 115 86

- 105 Very Unhealthy 201

- 300 116

- 374 106

- 200 Hazardous 301

- 400 375

- 201

-

401

- 500 In selecting breakpoints to propose, an additional consideration was for each category to span at least a 15 ppb range to allow for more accurate forecasting

. EPA believes that the proposed breakpoints reflect an appropriate balance between reflecting the health evidence that is the basis for the proposed primary O 3 standard and providing category rang es that are large Formatted Table*** E.O. 12866 Review

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Page 304 of 668 enough to be forecasted accurately, so that the new AQI for O 3 can be implemented more easily in the public forum for which the AQI ultimately exists. However, the EPA recognizes that some have expressed alternative approaches to viewing the evidence and information and solicits comment on these proposed revisions to the AQI. With respect to reporting requirements (40 CFR Part 58, §58.50), EPA proposes to revise 40 CFR Part 58, §58.50 (c) to require the AQI reporting requirements to be based on the latest available census figures, rather than the most recent decennial U.S. census

. This change is consistent with our current practice of using the latest population figures to make monitoring requirements more responsive to changes in popula tion

. IV. Rationale for Proposed Decision on the Secondary Standard This section presents the rationale for the Administrator’s proposed decisions regarding the need to revise the current secondary O 3 NAAQS and the appropriate revisions to the standard, in cluding her proposed decisions that the current secondary standard is not requisite to protect public welfare and should be revised to provide additional public welfare protection. The Based on her consideration of the full body of welfare effects evidence and related analyses, the Administrator proposes to conclude that ambient O 3 concentrations in terms of a W126 index value, averaged across three consecutive years, within the range from 13 ppm

- hrs to 17 ppm

- hrs would provide the requisite protection agai nst known or anticipated adverse effects to the public welfare. To achieve In considering policy options for achieving that level of air quality, the Administrator has further considered the full body of information, including air quality analyses that rel ate ambient O 3 concentrations in terms of a three

- year average W

- 126

- based metric and in terms of the form and averaging time for the current standard. Based on this consideration, the Administrator proposes to revise the level of the current secondary sta ndard to within the range*** E.O. 12866 Review

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Page 305 of 668 proposed for the primary standard of of 0.065 to 0.070 ppm

. to achieve the appropriate air quality

. As discussed more fully below, this proposal is based on a thorough review, in the ISA, of the latest scientific information on O 3 - induced environmental effects. This proposed decision also takes into account: (1) staff assessments in the PA of the most policy

- relevant information in the ISA and WREA analyses of air quality, exposure, and ecological risks and associated ecosystem s ervices; ( 2 ) CASAC advice and recommendations ; and , ( 3 ) public comments received during the development of these documents, either in connection with CASAC meetings or separately

. This proposed decision draws on the ISA’s integrative synthesis of the ent ire body of evidence, published through July 2011, on environmental effects associated with the presence of
O 3 and related photochemical oxidants in the ambient air. As summarized in section IV.B below , this body of evidence addresses the range of environm ental responses associated with exposure to ambient levels of O 3 ( U.S. EPA, 2013 2013 a , ISA chapters 9

- 10), and includes more than four hundred new studies that build on the extensive evidence base from the last review. This rationale also draws upon the results of quantitative exposure and risk assessments, summarized in section IV.C below . Section IV.D presents the Administrator’s proposed decisions on the adequacy of the current secondary standard (section IV.D.3) drawing on both evidence

- based and exposure/risk

- based considerations in the PA (section IV.D.1) and advice from CASAC (sectio n IV.D.2). Proposed conclusions on alternative standards are summarized in section IV.E. A. Approach In evaluating whether it is appropriate to retain or revise the current secondary O 3 standard, the Administrator adopts an approach in this review that b uilds upon the general*** E.O. 12866 Review

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Page 306 of 668 approach used in the 2008 review 184 and reflects the broader body of scientific evidence now available, updated exposure/risk information, advances in O 3 air quality modeling, and air monitoring information. This review of the standard also considers the July 2013 remand of the secondary standard by the U.S. Court of Appeals for the D.C. Circuit, such that the proposed decision described herein incorporates the EPA’s response to this remand. The Administrator’s decisions in the 2008 re view were based on an integration of information on welfare effects associated with exposure to O 3 , judgments on the adversity and public welfare significance of key effects, and judgments as to wh at standard would be requisite to protect public welfare. T hese considerations were informed by air quality and related analyses, quantitative exposure and risk assessments, and qualitative assessment of impacts that could not be quantified. As a result of the 2008 review, the Administrator concluded the then

- curr ent secondary standard did not provide the requisite public welfare protection and it was revised. The current secondary standard is 75 pp b based on the annual fourth

- highest daily maximum 8

- h ou r average concentration, averaged over three consecutive years , which is identical to the current primary standard . In 2008, the Administrator considered the then

- available monitoring data with regard to relationships between the revised primary standard and degree of protection of public welfare from cumulative seas onal O 3 exposures, expressed in terms of the W126 exposure index (described in section IV.B.1 below) , and decided to revise the secondary standard to be equal to the revised primary standard (73 FR 16499

- 16500 , March 27, 2008 ). In remanding the 2008 decisi on on the secondary standard back to the EPA (described in section I.C above) , the U.S. Court of Appeals for the D.C. Circuit determined that EPA did not specify what level of

184 T he 2008 revision of the O 3 secondary standard, the proposed reconsideration of the 2008 decision, and the 2013 cour t decision on the 2008 revision of the secondary standard are summarized in section I.C above

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Page 307 of 668 air quality was requisite to protect public welfare from adverse public welfare effects or explain why any such level would be requisite. Mississippi , 744 F.3d at 272

- 7 3. In addition to reviewing the most recent scientific information as required by the CAA, this rulemaking responds to the remand and fully explains the Administrator’s proposed conclusions as to the level of air quality requisite to protect public welfar e from known or anticipated effects. Our general approach in considering the scientific information available in this review involves consideration of the integrative synthesis of the entire body of available scientific evidence in the ISA (U.S. EPA, 2013 2 013 a ), including information on biologically relevant exposure indices , exposure/risk and air quality modeling analyses presented in the WREA (U.S. EPA, 2014 b ) , staff analyses in the PA; advice and recommendations from CASAC (Frey, 2014 b , c) , and public co mments. We note that in drawing conclusions on the secondary standard, the final decision to retain or revise the standard is a public welfare policy judgment to be made by the Administrator

. The Administrator’s final decision will draw upon the available scientific evidence for O 3 - attributable welfare effects and on analyses of exposures and public welfare risks based on impacts to vegetation, ecosystems and their associated services, as well as judgments about the appropriate weight to place on the range of uncertainties inherent in the evidence and analyses

. Such judgments in the context of this review include: the weight to place

on the evidence of specific vegetation

- related effects estimated to result across a range of cumulative seasonal concentratio n - weighted O 3 exposures; the weight to give associated uncertainties, including those related to the variability in occurrence of such effects in areas of the U.S. , especially areas of particular public welfare significance ; and , judgments on the extent
to which such effects in such areas may be considered adverse to public welfare

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Page 308 of 668 As provided in the CAA, section 109(b)(2), the secondary standard is to “specify a level of air quality the attainment and maintenance of which in the judgment of the Administ rator

... is requisite to protect the public welfare from any known or anticipated adverse effects associated with the presence of such air pollutant in the ambient air.” E ffects on welfare include, but are not limited to, “ effects on soils, water, crops, ve getation, 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 ” (CAA section 302(h)). A s recognized in the last review, t he secondary standard is not meant to protect against all known or anticipated O 3 - related effects, but rather those that are judged to be adverse to the public welfare (73 FR 1649 6, March 27, 2008 ). Thus, th e level of prot ection from known or anticipated adverse effects to public welfare that is requisite for the secondary standard is a public welfare policy judgment to be made by the Administrator. In the current review, the Administrator’s judgment is informed by c onclusi ons drawn with regard to adversity of effects to public welfare in decisions on secondary O 3 standards in past reviews

. In the 2008 decision, the Administrator concluded that the degree to which O 3 effects on vegetation should be considered to be adverse to the public welfare depends on the intended use of the vegetation and the significance of the vegetation to the public w elfare, and also applied this concept beyond the species level to the ecosystem level (73 FR 16496 , March 27, 2008 ). In so doing, the Administrator took note of “a number of actions taken by Congress to establish public lands that are set aside for specific uses that are intended to provide benefits to the public welfare, including lands that are to be protected so as to conserve the sc enic value and the natural vegetation and wildlife within such areas, and to leave them unimpaired for the enjoyment of future generations” (73 FR 16496, March 27, 2008). The notice for the 2008 decision further*** E.O. 12866 Review

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Page 309 of 668 noted that [s]uch public lands that are prot ected areas of national interest include national parks and forests, wildlife refuges, and wilderness areas” (73 FR 16496, March 27, 2008). 185 , 186 The Administrator additionally recognized that “States, Tribes and public interest groups also set
aside areas th at are intended to provide similar benefits to the public welfare, for residents on State and Tribal lands, as well as for visitors to those areas” ( 73 FR 16496, March 27, 2008 ). The Administrator took note of the “ clear public interest in and value of mai ntaining these areas in a condition that does not impair their intended use and the fact that many of these lands contain
O 3 - sensitive species ” (73 FR 16496, March 27, 2008). Similarly , in judgments of adversity to public welfare in the 2010 proposed recon sideration, the Administrator proposed to place the highest priority and significance on vegetation and ecosystem effects to sensitive species that are known to or are likely to occur in federally protected areas such as national parks and other Class
I ar eas, 187 or on lands set aside by states, tribes and public interest groups to provide similar benefits to the public welfare (75 FR 3023

- 24 , January 19, 2010 ).

185 For example, the National Park Service Organic Act of 1916 established the National Park Service (NPS) and, in describing the role of the NPS with regard to “F ederal areas known as national parks, monuments, and reservations”, stated that the “fundamental purpose” for these Federal areas “is to conserve the scenery and the natural and historic objects and the wild life therein and to provide for the enjoyment of the same in such manner and by such means as will leave them unimpaired for the enjoyment of future generations .” 16 U.S.C. § 1. 186 As a second example, the Wilderness Act of 1964 defines designated “wilderness areas” in part as areas “protected and manage d so as to preserve [their] natural conditions” and requires that these areas “shall be administered for the use and enjoyment of the American people in such manner as will leave them unimpaired for future use and enjoyment as wilderness, and so as to prov ide for the protection of these areas, [and] the preservation of their wilderness character ...” 16 U.S.C. § 1131 (a). 187 As defined by section 162 of the CAA, Class I areas include all international parks, national wilderness areas which exceed 5,000 acres in size, national memorial parks which exceed 5,000 acres in size, and national parks which exceed six thousand acres in size, provided the park or wilderness area was in existence on August 7, 1977, as well as other areas designated as Class I consistent with that section of the Act. The current Class I areas are specified at 40 CFR part 81.*** E.O. 12866 Review

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Page 310 of 668 In the current review, our c onsideration of the scientific evidence for effects on vegetation is based fundamentally on using information from controlled chamber studies, free air methodologies, and field

- based observational, survey and gradient studies. Such evidence, discussed below, informs consideration of welfare endpoints and at

- risk species and ecosystems on which to focus the current review, and consideration of the ambient O 3 conditions under which various welfare effec ts are known or anticipated to occur. As in past reviews, we recognize that the available evidence has not provided identifica tion of a thres hold in exposure or ambient O 3 concentrations below which it can be concluded with confidence that O 3 - attributable effects on vegetation do not occur , when considering the broad range of O 3 - sensitive plant species growing within the U.S and the array of effects. This is due in part to the fact that research shows that there is variability in sensitivity between and within species and that numerous factors, i.e., chemical, physical, biological, and genetic, can influence the direction and
magn itude of the studied effect (U.S. EPA, 2013 2013 a , section 9.4.8). In the absence of evidence for a discernible threshold, the general approach to considering the available O 3 welfare effects evidence involves characterizing the confidence in conclusions re garding O 3 - attributable vegetation effects over the ranges of cumulative seasonal O 3 exposure values evaluated in chamber studies and in field studies in areas where O 3 - sensitive vegetation are known to occur, as well as characterizing the extent to whic h these effects can be considered adverse at the plant level and beyond

. With this approach, we consider the evidence for O 3 affecting other ecosystem components (such as soils, water, and wildlife) and their associated goods and services, through its effect s on vegetation , as well as the associated uncertainties

. O ur general approach further recognizes the complexity of judgments to be made regarding the identification of particular vegetation effects as welfare effects and regarding the*** E.O. 12866 Review

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Page 311 of 668 point that known or anticipated vegetation

- related effects become adverse to the public welfare. For example, in addition to the magnitude of the ambient concentrations, the species present , their sensitivity to O 3 , and their public welfare importance are also essential considerations in drawing conclusions regarding the significance of public welfare impact. Taking this into account, we recognize the existence of a continuum from relatively higher ambient O 3 concentrations and conditions, in areas with sensitive species and public welfare significance, for which there might be general agreement that effects on public welfare are likely to occur, through lower concentrations at which the degree to which public welfare might be expected to be affected becomes increasingly u ncertain.
T he evidence base for this review, summarized in section IV.B below, includes quantitative information across a broad array of vegetation effects (e.g., growth impairment during seedling, sapling and mature tree growth stages, visible foliar inj ury, and yield loss in annual crops) and across a diverse set of exposure m ethods from laboratory and field studies. While considering the full breadth of information available, we place greater weight on U.S. studies due to the often species

- , site

- , and climate

- specific nature of O 3 - related vegetation
responses , and particularly emphasize those studies that include O 3 exposures that fall within the range of those likely to occur in the ambient air. We additionally recognize differences across different st udy types in what information they provide

. (U.S. EPA, 2013a, section 9.2.6)

. For example, because conditions can be controlled in laboratory studies, responses in such studies may be less variable and smaller differences may be easier to detect. However, the control control led conditions may limit the range of responses or incompletely reflect pollutant bioavailability, so they may not reflect responses that would occur in the natural environment. Alternatively, field data can provide important information for assessments of multiple stressors*** E.O. 12866 Review

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Page 312 of 668 or where site

- specific factors significantly influence exposure. They are also often useful for analyses of larger geographic scales and higher levels of biological organization. However, because most depending on the t ype of field study, many field study conditions cannot may not be controlled, which can make variability is expected to be higher and differences harder to detect. The In some field studies (e.g., gradient studies), t he presence of confounding factors can al so make it difficult to attribute observed effects to specific stressors. In developing quantitative exposure and risk assessments for this review, summarized in section IV.C below, we have place d greatest emphasis on studies that have evaluated plant

res ponse over multiple exposure levels and developed exposure

- response (E

- R) relationships that allow the estimation of plant responses over the range of O 3 exposures pertinent to judgments on the current and potential alternative standards. In considering th e information from these assessments, we f

ocus particularly on the quantitative risks related to three types of O 3 effects on vegetation and associated ecosystem services: visible foliar injury, biomass loss in trees , and crop yield loss. These risks were assessed in a range of analyses primarily involving national

scale air quality scenarios developed using model adjustments and interpolation methods. We consider particularly the national scale assessments for these scenarios, while recognizing the uncertainties with regard to the conditions they represent. With regard to the appropriate characterization of exposure s associated with ambient O 3 concentrations, as in the 2008 and 1997 reviews, we continue to recognize t he relevance of cumulative, seasonal, concentration

- weighted exposures for assessing vegetation effects. More specifically, in the 2008 review, the EPA concluded and the CASAC agreed that the W126 cumulative exposure metric was the most appropriate to use to evaluate both the adequacy of the current secondary standard and the appropriateness of any potential revisions. As discussed in*** E.O. 12866 Review

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Page 313 of 668 section IV.B.1 below , the information available in this review continues to support the use of such a metric and it is used in considering potential public welfare impacts in the sections below. B. Welfare Effects Information 1. Nature of Effects and Biologically Relevant Exposure Metric This section describes the nature of O 3 - induced welfare effects, including the nature of
t he exposures that drive the biological and ecological responses (U.S. EPA, 2013 2013 a , chapter 9). Ozone’s phytotoxic effects were first identified on grape leaves in a study published in 1958 (Richards et al., 1958). In the almost fifty years that have fol lowed, extensive research has been conducted both in and outside of the U.S. to examine the impacts of O 3 on plants and their associated ecosystems, since “of the phytotoxic compounds commonly found in the ambient air,
O 3 is the most prevalent, impairing c rop production and injuring native vegetation and ecosystems more than any other air pollutant” (U.S. EPA, 1989, 1996 a ). As was established in prior reviews, O 3 can interfere with carbon gain (photosynthesis) and allocation of carbon within the plant. As a result of decreased carbohydrate availability, fewer carbohydrates are available for plant growth, reproduction, and/or yield. For seed

- bearing plants, these r eproductive effects will culminate in reduced seed production or yield (U.S. EPA, 1996a, pp. 5

- 28 and 5

- 29)

. Recent studies, assessed in the ISA, together with this longstanding and well

- established literature on O 3 - related vegetation effects, further con tribute to the coherence and consistency of the vegetation effects evidence. As described in the ISA, a variety of factors in natural environments can either mitigate or exacerbate predicted O 3 - plant interactions and are recognized sources of uncertainty a nd variability. These include: 1) multiple genetically influenced determinants of O 3 sensitivity; 2) changing sensitivity to O 3 across vegetative growth*** E.O. 12866 Review

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Page 314 of 668 stages; 3) co

- occurring stressors and/or modifying environmental factors (U.S. EPA, 2013 2013 a , section 9.4.8). Among the studies of vegetation effects, the ISA recognizes controlled chamber studies as the best method for isolating or characterizing the role of O 3 in inducing the observed plant effects, and in assessing plant response to O 3 at the finer sca les (U.S. EPA, 2013 2013 a , sections 9.2 and 9.3). Recent controlled studies have focused on a variety of plant responses to O 3 including the underlying mechanisms governing such responses. These mechanisms includ e : 1) reduced carbon dioxide uptake due to st omatal closure (U.S. EPA, 2 013 2 013 a , section 9.3.2.1); 2) the upregulation of genes associated with plant defense, signaling, hormone synthesis and secondary metabolism (U.S. EPA, 2 013 2 013 a , section 9.3.3.2); 3) the down regulation of genes related to phot osynthesis and general metabolism (U.S. EPA, 2 013 2 013 a , section 9.3.3.2); 4) the loss of carbon assimilation capacity due to declines in the quantity and activity of key proteins and enzymes (U.S. EPA, 2013 2013 a , section 9.3.5.1); and 5) the negative impacts on the efficiency of the photosynthetic light reactions (U.S. EPA, 2013 2013 a , section 9.3.5.1). As described in the ISA, these new studies “have increased knowledge of the molecular,
biochemical and cellular mechanisms occurring in plants in response to O 3 ”, adding “to the understanding of the basic biology of how plants are affected by oxidative stress...” (U.S. EPA,
2013 2013 a , p. 9

- 11). The ISA further conclude s that controlled studies “have clearly shown that exposure to O 3 is causally linked to visible foliar injury, decreased photosynthesis, changes in reproduction, and decreased growth” in many species of vegetation (U.S. EPA, 2 013 2 013 a , p. 1

- 15). Such effects at the plant scale can also be linked to an ar ray of effects at larger spatial scales. For example, recent field studies at larger spatial scales, together with previously*** E.O. 12866 Review

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Page 315 of 668 available evidence, support the controlled exposure study results and indicate that “ambient O 3 exposures can affect ecosystem pro ductivity, crop yield, water cycling, and ecosystem community composition” (U.S. EPA, 2013 2013 a , p. 1

- 15; Chapter 9, section 9.4). The current body of O 3 welfare effects evidence confirms th e conclusions reached in the last review on the nature of O 3 - induc ed welfare effects and is sum marized in the ISA as follows (U.S. EPA,
2013 2013 a , p. 1

- 8)

. The welfare effects of O 3 can be observed across spatial scales, starting at the subcellular and cellular level, then the whole plant and finally, ecosystem

- level pro cesses. Ozone effects at small spatial scales, such as the leaf of an individual plant, can result in effects along a continuum of larger spatial scales. These effects include altered rates of leaf gas exchange, growth, and reproduction at the individual p lant level, and can result in broad changes in ecosystems, such as productivity, carbon storage, water cycling, nutrient cycling, and community composition. Based on its assessment of this extensive body of science, the ISA determine s that, with respect to vegetation and ecosystems, a causal relationship exists between exposure to O 3 in ambient air and visible foliar injury effects on vegetation, reduced vegetation growth, reduced productivity in terrestrial ecosystems, reduced yield a nd quality of agricultural crops and alteration of below

- ground biogeochemical cycles 188 (U.S. EPA, 2013 2013 a , Table 1

- 2). In consideration of the evidence of O 3 exposure and alterations in stomatal performance, “which may affect plant and stand transpiratio n and therefore possibly affecting hydrological cycling,” the ISA concludes that “[a]lthough the direction of the response differed among studies ,” the evidence is sufficient to conclude a likely causal relationship between O 3 exposure and the altera tion o f ecosystem water cycling (U.S. EPA, 2013 2013a , section 2.6.3). The ISA also

188 Based on studies focused on O 3 - associated alterations in quality and quantity of carbon input to soil, microbial communi t y composition, and carbon and nutrient cycling, the ISA concludes that t he evidence is sufficient “ to infer that there is a causal relationship between O 3 exposure and the alteration of below

- ground biogeochemical cycles” (U.S. EPA, 2013 2013 a , pp. 2

- 41 to 2

- 42). Formatted: Font: Not Italic*** E.O. 12866 Review

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Page 316 of 668 concludes that the evidence is sufficient to conclude a likely causal relationship between O 3 exposure and the alteration of community composition of some terrestrial ecosystems ( U.S. EPA, 2013 2013a , section 2.6.5)

. Related to the effects on vegetation growth, productivity and, to some extent, below

- ground biogeochemical cycles, the ISA additionally determine s that a likely causal relationship exists between exposures to O 3 in amb ient air and reduced carbon sequestration (also termed carbon storage) 189 in terrestrial ecosystems (U.S. EPA, 2013 2013a , p. 1

- 10 and section 2.6.2)

. Modeling studies available in this review consistently found negative impacts of O 3 on carbon sequestration, although the severity of impact was influenced by “multiple interactions of biological and environmental factors” (U.S. EPA, 2013 2013a , p. 2

- 39)

. The ISA notes that “[t]he suppression of ecosystem [carbon] sinks results in more [carbon dioxide] accumulation in the atmosphere” and that a recent study has suggested that “the indirect radiative forcing caused by O 3 exposure through lowering the ecosystem [carbon] sink could have an even greater impact on global warming than the dire ct radiative forcing of O 3 ” (U.S. EPA, 2013 2013a , p. 2

- 39). With regard to direct radiative forcing, however, the ISA makes a stronger causality conclusion that the evidence supports a causal relationship between changes in tropospheric O 3 concentrations a nd radiative forcing 190 (U.S. EPA, 2013 2013a , section 2.7.1). There are, however, “large uncertainties in the magnitude of the radiative forcing estimate attributed to tropospheric O 3 , making the impact of tropospheric O 3 on climate more uncertain than the e ffect of the longer

- lived greenhouse gases ” (U.S. EPA, 2013 2013a , p. 2

- 47)

. In this

189 The terms sequestration and storage are used somewhat interchangeably in the ISA and other documents in this review. 190 Radiative forcing by a greenhouse gas or aerosol is a metric used to quantify the change in balance between radiation coming i nto and going out of the atmosphere caused by the presence of that substance

. For example, a reduction in outgoing infrared radiation has been associated with O 3 by satellite data (U.S. EPA, 2013 2013 a , p. 2

- 47).*** E.O. 12866 Review

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Page 317 of 668 regard, the ISA observes that “ radiative forcing does not take into account the climate feedbacks that could amplify or dampen the actual surface temperature response ,” tha t “[q] uantifying the change in surface temperature requires a complex climate simulation in which all important feedbacks and interactions are accounted for ” and that “[t] he modeled surface temperature response to a given radiative forcing is highly uncert ain and can vary greatly among models and from region to region within the same model ” (U.S. EPA, 2013 2013a , p. 2

- 47)

. Even with these uncertainties, the ISA notes that “ global climate models indicate that tropospheric O 3 has contributed to observed changes in global mean and regional surface temperatures ” and as a

r esult of such evidence presented in climate modeling studies, concludes that there is likely to be a causal relationship between changes in tropospheric O 3 con centrations and effects on climate (U.S. EPA, 2013 2013a , p. 2

- 47). The ISA additionally notes, however, that “[i]mportant uncertainties remain regarding the effect of tropospheric O 3 on future climate change” (U.S. EPA, 2013 2013a , p. 10

- 31). Given the stro ng evidence base, and findings of causal or likely causal relationships with
O 3 in ambient air, including the quantitative assessments of relationships between O 3 exposure and occurrence and magnitude of effects, we give a primary focus to three main areas of effects

. The three main areas, for which the evidence is summarized in more detail below, are : 1) impacts on tree growth, productivity and carbon storage (section IV.B.1.b) ; 2) crop yield loss (section IV.B.1.c) ; and 3) visible foliar injury (section I V.B.1.a)

. Consideration of these three areas includes, as appropriate, consideration of evidence of associated effects at larger scales, including ecosystems, and on associated ecosystem services

. With regard to biologically based indices of exposure perti nent to O 3 effects on vegetation, the ISA states the following (U.S. EPA, 2013 2013 a , p. 2

- 44)

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Page 318 of 668 The main conclusions from the 1996 and 2006 O 3 AQCDs [Air Quality Criteria Documents] regarding indices based on ambient exposure remain valid. These key conclusions can be restated as follows: ozone effects in plants are cumulative; higher O 3 concentrations appear to be more important than lower conc entrations in eliciting a response; plant sensitivity to O 3 varies with time of day and plant development stage; [and] quantifying exposure with indices that cumulate hourly O 3 concentrations and preferentially weight the higher concentrations improves the explanatory power of exposure/response models for growth and yield, over using indices based on mean and peak exposure values. The long

- standing body of available evidence upon which these conclusions are based provides a wealth of information on aspects of O 3 exposure that are important in influencing plant response. Specifically, a variety of “factors with known or suspected bearing on the
exposure - response relationship, including concentration, time of day, respite time, frequency of peak occurrence, p lant phenology, predisposition, etc.,” have been identified (U.S. EPA,
2013 2013 a , section 9.5.2). In addition, the importance of the duration of the exposure and the relatively greater importance of higher concentrations over lower concentrations in determ ining plant response to O 3 have been consistently well documented (U.S. EPA, 2013 2013 a , section 9.5.3). Much of this evidence was assessed in the 1996 Criteria Document (CD) AQ CD (U.S. EPA, 1996 a ), while more recent work substantiating this evidence is assessed in the subsequent
2006 CD AQ CD and 2013 ISA

. Understanding of the biological basis for plant response to O 3 exposure led to the development of a large number of “mathematical approaches f or summarizing ambient air quality information in biologically meaningful forms for O 3 vegetation effects assessment purposes” (U.S. EPA, 2013 2013 a , section 9.5.3), including those that cumulate exposures over some specified period while weighting higher c oncentrations more than lower (U.S. EPA,
2013 2013 a , section 9.5.2) . As with any summary statistic, these exposure indices retain information on some, but not all, characteristics of the original observations. The 1996
CD AQ CD contained an extensive review of the published literature on different types of Formatted: Font: Not Italic*** E.O. 12866 Review

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Page 319 of 668 exposure - response metrics, including comparisons between metrics, from which the 1996 Staff Paper built its assessment of forms appropriate to consider in the context of the s econdary NAAQS review. The result of these assessments was a decision by the EPA to focus on cumulative, concentration

- weighted indices, which were recognized as the most appropriate biologically based metrics to consider in this context, with attention gi ven primarily to two cumulative, concentration

- weighted index forms: SUM06 and W126. 191 In both the 1997 and 2008 reviews, the EPA concluded that the risk to vegetation comes primarily from cumulative exposures to O 3 over a season or seasons 192 and focused on metrics intended to characterize such exposures: SUM06 (61 FR 65716 , December 13, 1996 ) and W126 (72 FR 37818 , July 11, 2007 ) in the 1997 and 2008 reviews, respectively. Although in both reviews the policy decision was made to set the secondary standard t o be identical to a revised primary standard (with an 8

- hour averaging time), the Administrator, in both cases, also concluded, consistent with CASAC advice, that a cumulative, seasonal index was the most biologically relevant way to relate exposure to pla nt growth response (62 FR 38856 , July 18, 1997; 73 FR 16436 , March 27, 2008; 75 FR 2938 , January 19, 2010 ). T his approach for characterizing O 3 exposure concentrations that are biological ly relevant with regard to potential vegetation effects received stro ng support from CASAC in the last review and again in this

191 The SUM06 index is a threshold

- based appr oach described as the sum of all hourly O 3 concentrations greater or equal to 0.06 ppm observed during a specified daily and seasonal time window (U.S. EPA, 2013 2013 a , section 9.5.2). The W126 index is a non

- threshold approach described as the sigmoidally weighted sum of all hourly O 3 concentrations observed during a specified daily and seasonal time window, where each hourly O 3 concentration is given a weight that increases from zero to one with increasing concentration (U.S. EPA, 2013 2013 a , section 9.5.2)

. 192 In describing the form as “seasonal”, the EPA is referring generally to the growing season of O 3 - sensitive vegetation, not to the seasons of the year (i.e., spring, summer, fall, winter).*** E.O. 12866 Review

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Page 320 of 668 review, including strong support for use of such a metric as the form for the secondary standard (Henderson, 2006, 2008; Samet, 2010; Frey, 2014 c ). An alternative to using ambient exposure duratio ns and concentrations to predict plant response has been developed in recent years, primarily in Europe, i.e., flux models. While “some researchers have claimed that using flux models can be used {sic} to better predict vegetation responses to O 3 than expo sure - based approaches” because flux models estimate the ambient O 3 concentration that actually enters the leaf (i.e., flux or deposition) (U.S. EPA, 2013 2013 a , p. 9

- 114) , it is important to note that “[f]lux calculations are data intensive and must be carefully implemented” (U.S. EPA, 2013 2013 a , p. 9

- 114). Further, the ISA state s , “[t]his uptake

- based approach to quantify the vegetation impact of O 3 requires inclusion of those factors that control the diurnal and seasonal O 3 flux to vegetation (e.g., climate patterns, species and/or vegetation

type factors and site

- specific factors)” (U.S. EPA, 2013 2013 a , p. 9

- 114). In addition to these data requirements, e ach species has different amounts of internal d etoxification potential that may protect species to differing degrees. The lack of detailed species

- and site

- specific data required for flux modeling in the U.S. and the lack of understanding of detoxification processes have continued to make this techniq ue less viable for use in vulnerability and risk assessments at the national scale in the U.S. (U.S. EPA, 2013 2013 a , section 9.5.4). Therefore, consistent with the ISA conclusions regarding the appropriateness of considering cumulative exposure indices that preferentially weight higher concentrations over lower for predicting O 3 effects of concern based on the long

- established conclusions and long

standing supporting evidence described above, and in light of continued CASAC support, we continue to focus on cumulative concentration

- weighted indices as the most biologically relevant metrics for consideration of O 3 exposures eliciting vegetation

- related effects. Such a metric has*** E.O. 12866 Review

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Page 321 of 668 an “explanatory power” that is improved “over using indices based on mean and p eak exposure values” (U.S. EPA, 2013 2013 a , section 2.6.6.1, p. 2

- 44). In this review as in the last review, we use the W126 cumulative, seasonal metric (U.S. EPA, 2013 2013 a , sections 2.6.6.1 and 9.5.2) for consideration of the effects evidence and in the e xposure and risk analyses in the WREA.
T he subsections below summarize key aspects of the welfare effects information for O 3 - elicited visible foliar injury (section IV.B.1.a), effects on forest tree growth, productivity and carbon storage (section IV.B.1. b) and reductions in crop yie ld (section IV.B.1.c), as well as associated effects. a. Visible Foliar Injury Visible foliar injury resulting from exposure to O 3 has been well characterized and documented over several decades of research on many tree, shrub , herbaceous, and crop species (U.S. EPA, 2013 2013 a , p. 1

- 10; U.S. EPA, 2006 a , 1996 a , 1984 198 6 , 1978). Additionally, O 3 - induced visible foliar injury symptoms on certain plant species, such as black cherry, yellow

poplar and common milkweed, are considered diagnostic of exposure to O 3 based on the consistent association established with experimental evidence (U.S. EPA, 2013 2013a , p. 1

- 10). The significance of O 3 injury at the leaf and whole plant levels depends on an array of factors, and therefore, it is d ifficult to quantitatively relate visible foliar injury symptoms to vegetation effects such as individual tree growth, or effects at population or ecosystem levels (U.S. EPA,
2013 2013 a , p. 9

- 39). The ISA notes that visible foliar injury “is not always a re liable indicator of other negative effects on vegetation” (U.S. EPA, 2013 2013 a , p. 9

- 39). Factors th at influence the significance to the leaf and whole plant include the amount of total leaf area affected, age of plant, size, developmental stage , and degre e of functional redundancy among the existing leaf area (U.S. EPA, 2013a, section 9.4.2). Visible foliar injury by itself is an indication of*** E.O. 12866 Review

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Page 322 of 668 phytotoxicity due to O 3 exposure, which occurs only when sensitive plants are exposed to elevated O 3 concentration s in a predisposing environment, a major aspect of which is the lack of drought conditions during the year such injury is assessed (U.S. EPA, 2013 2013 a , section 9.4.2)

. Recent research continues to build and substantiate the is consistent with previous

c onclusions and findings drawn from several decades of research on many tree, shrub, herbaceous, and crop species (U.S. EPA, 2013, 2006, 1996, 1984, 1978) that O 3 - induced visible foliar injury symptoms are well characterized and considered diagnostic on certain bioindicator plant species. Diagnostic usage for these plants has been verified experimentally in exposure

response studies, using exposure methodologies such as continuous stirred tank reactors (CSTRs), , open - top chambers (OTCs), and free

- air fumi gation c arbon d ioxide (and ozone)

e nrichment (FACE). Although there remains a lack of robust exposure

- response functions that would allow prediction of visible foliar injury severity and incidence under varying air quality and environmental conditions, “ ex perimental evidence has clearly established a consistent association of the presence of visible foliar injury symptoms with O 3 exposure, with greater exposure often resulting in greater and more prevalent injury ” (U.S. EPA, 2013 2013a , section 9.4.2, p. 9

- 4 1). The research newly available in this review includes: 1) controlled exposure studies conducted to test and verify the O 3 sensitivity and response of potential new bioindicator plant species; 2) multi

- year field surveys in several National Wildlife Refu ges (NWR) documenting the presence of foliar injury in valued areas; and 3) ongoing data collection and assessment by the U.S. Forest Service’s Forest Health Monitoring Forest Inventory and Analysis ( USFS FHM/FIA ) program, including multi

- year trend analys is (U.S. EPA, 2 013 2 013 a , section 9.4.2). These recent studies, in combination with the entire body of available evidence, thus form the basis for the ISA determinations of a causal relationship between ambient O 3 exposure and*** E.O. 12866 Review

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Page 323 of 668 the occurrence of O 3 - induced v isible foliar injury on sensitive vegetation across the U.S. (U.S. EPA, 2 013 2 013 a , p. 9

- 42). Recently available evidence confirms the evidence available in previous reviews that visible foliar injury can occur when sensitive plants are exposed to elevated O 3 concentrations in a predisposing environment (i.e., adequate soil moisture) (U.S. EPA, 2013 2013 a , section 9.4.2). Recent evidence also continues to support previous findings that indicate d the occurrence of visible foliar injury at cumulative ambient O 3 exposures previously examined

. With regard to evidence from controlled exposure studies, a recent study , using continuously stirred tank reactor (CSTR) chambers , evaluated the occurrence of O 3 characteristic visible foliar injury symptoms on 28 species of plants that were suspected of being O 3 sensitive and most of which grow naturally throughout the northeast and midwest U

. S

. , including in national parks and wilderness areas (U.S. EPA, 2013 2013 a , section 9.4.2.1 ; Kline et al., 2008). Across the 28 tested species, t he study reported O 3 - induced responses in 12, 20, 28 and 28 species at the 30, 60, 90 and 120 ppb exposure concentrations , 193 respectively ; the plants were exposed for 7 hours per each weekday over 21 to 29 summer days (Kline et al., 2008). A string of recently published multi

- year field studies provide a compl e mentary line of field

- based evidence by documenting the incidence of visible foliar injury symptoms on a variety of O 3 - sensitive species over multiple years and across a range of cumu lative, seasonal exposure values in several eastern and midwestern NWRs (U.S. EPA, 2 013 2 013 a , section 9.4.2.1; Davis and Orendovici, 2006; Davis, 2007a, b; Davis, 2009). Some of these studies also included

193 Two of the target exposure levels, 30 and 60 ppb, fall below t he level of the current standard (75 ppb) , although the exposures were average concentrations for 7

- hour exposures across durations shorter than a month. Because the form of the current standard targets peak concentrations in a season, an area that just m eets the current standard can be expected to have mean concentrations well below that level due to variability in ambient O 3 concentrations

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Page 324 of 668 information regarding soil moisture stress using t he Palmer Drought Severity Index (PDSI). While environmental conditions and species varied across the four NWRs, visible foliar injury was documented to a varying degree at each site. By far the most extensive field

- based dataset of visible foliar injury incidence is that obtained by the USFS FHM/FIA biomonitoring network program. A trend analysis of data from the sites located in the Northeast and North Central U.S. for the 16 year period from 1994 through 2009 (Smith, 2012) describes evidence of visible foliar injury occurrence in the field as well as some insight into the influence of changes in air quality and soil moisture on visible foliar injury and the difficulty inherent in predicting foliar injury response under different air quality/soil moisture scenarios (Smith, 2012; U.S. EPA, 2 013 2 013 a , section 9.2.4.1). Study results showed that incidence and severity of foliar injury were dependent on local site conditions for soil moisture availability and O 3 exposure . Overall, there was a declining trend i n the incidence of visible foliar injury as peak O 3 concentrations declined , although the study additionally indicated that moderate O 3 exposures continued to cause visible foliar injury at sites throughout the region (U.S. EPA, 2013 2013a , p. 9

- 40) . In a similar assessment of the USFS FHM/FIA data in the West, six years (2000 to 2005) of biomonitoring data , during a period where a large proportion of California sites did not meet the current standard, indicated O 3 - related visible foliar injury in 25

- 37% of biosites in California (Campbell et al., 2007; U.S. EPA,
2 013 2 013 a , section 9.4.2.1). 194 These recent studies provide additional evidence of O 3 - induced visible foliar injury in many areas across the U.S. and augment the EPA’s understanding of O 3 - related vis ible foliar injury and of factors , such as soil moisture, that influence associations between O 3 exposures or concentrations and visible foliar injury.

194 S ee: http://www.epa.gov/airtrends/values.html.*** E.O. 12866 Review

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Page 325 of 668 b. Effects on Forest Tree Growth, Productivity and Carbon Storage Ozone has been shown to affect a num ber of important U.S. tree species with respect to growth, productivity, and carbon storage. Ambient O 3 concentrations have long been known to cause decreases in photosynthetic rates and plant growth. As discussed in the ISA, research published since the 2 006 AQCD substantiates prior conclusions regarding O 3 - related effects on forest tree growth, productivity and carbon storage. The ISA states, “previous O 3 AQCDs concluded that there is strong evidence that exposure to O 3 decreases photosynthesis and growth in numerous plant species” and that “[s]tudies published since the 2008 review support those conclusions” (U.S. EPA, 2013 2013 a , p. 9

- 42). The available studies come from a variety of different study types that cover an array of different species, effects endpoints, levels of biological organization and exposure methods and durations. The O 3 - induced effects at the plant scale may translate to the ecosystem scale, with changes in productivity and carbon storage. As stated in the ISA, “[s] tudies conducted during the past four decades have demonstrated unequivocally that O 3 alters biomass allocation and plant reproduction ” (U.S. EPA, 2013 2013a , p. 1

- 10). The previously available strong evidence for trees includes robust E

- R functions for seedling relative biomass loss (RBL) 195 in 11 species developed under the National Health and Environmental Effects Research Laboratory

- Western Ecology Division program. This series of experiments used open - top

- chambers (OTC) OTC s to study seedl ing growth response for a single growing season under a variety of O 3 exposures (ranging from near background to well above current ambient concentrations) and growing conditions (U.S. EPA, 2 013 2 013 a , section 9.6. 2;

195 These functions for RBL estimate reduction in a year’s growth a s a percentage of that expected in the absence of O 3 (U.S. EPA, 2013 2013a , section 9.6.2; U.S. EPA, 2014b, section 6.2).*** E.O. 12866 Review

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Page 326 of 668 Lee and Hogsett, 1996). T he evidence from these studies shows that there is a wide range in sensitivity across the studied species in the seedling growth stage over the course of a single growing season, with some species being extremely sensitive and others being very insensitive over the ra nge of cumulative O 3 exposures studied (U.S. EPA, 2014c, Figure 5

- 1). At the other end of the organizational spectrum, field

- based studies of species growing in natural stands have compared observed plant response across a number of different sites and/or years when exposed to varying ambient O 3 exposure conditions only . For example, a study conducted in forest stands in the southern Appalachian Mountains during a period when O 3 concentrations exceeded the current standard found that the cumulative effects of O 3 decreased seasonal stem growth (measured as a change in circumference) by 30

- 50 percent for most of the examined tree species (i.e., tulip poplar, black cherry, red maple, sugar maple) in a high O 3 year in comparison to a low
O 3 year ( U.S. EPA, 2013 2 013a , section 9.4.3.1; McLaughlin et al., 2007a). The study also reported that high ambient O 3 concentrations can increase whole

- tree water use and in turn reduce late

- season streamflow (McLaughlin et al., 2007b; U.S. EPA, 2013 2013 a , p. 9

- 43)

. The magnitude of O 3 impact on ecosystem productivity and on forest composition can
vary among plant communities based on several factors including: the type of stand or community in which the sensitive species occurs (e.g., single species versus mixed can opy), the role or position of the species in the stand (e.g., dominant, sub

- dominant, canopy, understory), the sensitivity of co

- occurring species and environmental factors (e.g., drought and other factors). For example, O 3 has been found to ha ve little im pact on white fir, but to greatly reduce growth of ponderosa pine in southern California , and cause decreased net primary production of
most forest types in the Mid

- Atlantic region, although only small impacts on spruce

- fir forest ( U.S. EPA, 2013 2013a , section 9.4.3.4).*** E.O. 12866 Review

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Page 327 of 668 As noted above, long

- standing evidence has demonstrated that O 3 alters biomass allocation and plant reproduction (U.S. EPA, 2013 2013 a , section 9.4.3) . S everal studies published since the 2006 O 3 AQCD further demonstrate that O 3 can alter reproductive processes in herbaceous and woody plant species , such as the timing of flowering and the number of flowers, fruits and seeds , in herbaceous and woody plant species (U.S. EPA, 2013a, section 9.4.3.3). Further, l imited evidence in previous reviews reported that vegetation effects from a single yea r of exposure to elevated O 3 could be observed in the following year. For example, growth affected by a reduction in carbohydrate storage in one year may result in the limitation of growth in the fo llowing year

. S uch “carry

- over” effects have been documented in the growth of some tree seedlings and in roots (U.S. EPA, 2013 2013 a , section 9.4.8; Andersen, et al., 1997). In the current review, additional field

- based evidence expands the EPA’s understand ing of the consequences of single and multi

- year O 3 exposures in subsequent years. A number of studies were conducted at a planted forest at the Aspen Free

- Air Carbon Dioxide Enrichment ( FACE ) site in Wisconsin. These studies, which occurred in a field set ting ( more similar to natural forest stands than OTC studies ) , observed tree growth responses when grown in single or two species stands within 30

- m diameter rings and exposed over a period of ten years to existing ambient conditions and elevated O 3 concen trations . Some studies indicate the potential for carry

- over effects , such as those showing that the effects of O 3 on birch seeds (reduced weight, germination, and starch levels) could lead to a negative impact on species regeneration in subsequent years, and that the effect of reduced aspen bud size might have been related to the observed delay in spring leaf development. These effects suggest that elevated O 3 exposures have the potential to alter carbon metabolism of overwintering buds, which may have sub sequent effects in the following year (Darbah, et al., 2008, 2007; Riikonen et al., 2008; U.S. EPA, 2013 2013 a , section*** E.O. 12866 Review

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Page 328 of 668 9.4.3). Other studies found that, in addition to affecting tree heights, diameters, and main stem volumes in the aspen community, elevate d O 3 over a 7

- year study period was reported to increase the rate of conversion from a mixed aspen

- birch community to a community dominated by the more tolerant birch, leading the authors to conclude that elevated O 3 may alter intra

- and inter

- species comp etition within a forest stand (U.S. EPA, 2013 2013 a , section 9.4.3 ; Kubiske et al., 2006; Kubiske et al., 2007). These studies confirm earlier FACE results of aspen growth reductions from a 6

- 7 year exposure to elevated O 3 and of cumulative biomass impacts associated with changes in annual production in studied tree communities ( U.S. EPA,
2013 2013a , section 9.4.3; King et al., 2005). In addition to individual studies, recent meta

- analyses have quantitatively analyzed the effect of O 3 on trees across large numbers of studies. In particular, a recent meta

- analysis of 55 peer reviewed studies from the past 40 years indicates a negative relationship between O 3 concentrations in the northern hemisphere during that period and stomatal conductance and photosynthesis, which decrease s growth (U.S. EPA, 2013 2013 a , section 9.4.3.1; Wittig et al.,
2007 )

. In this analysis, y ounger trees (less than 4 years) were affected less by O 3 than older trees (U.S. EPA, 2013 2013 a , section 9.4.3.1; Witti g, et al., 2007). A second meta

- analysis that quantitatively compiled 263 peer - reviewed studies “ demonstrates the coherence of O 3 effects across numerous studies and species that used a variety of experimental techniques, and these results support the conclusion of the previous AQCD that exposure to O 3 decreases plant growth ” (U.S. EPA, 2013 2013a , p. 9

- 43) . Other meta

- analyses have examined the effect of O 3 exposure on root growth and generally found that O 3 exposure reduced carbon allocated to roots (U.S. EPA, 2013 2013 a , pp. 9

- 45 to 9

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Page 329 of 668 As noted above, robust E

- R functions have been developed for 11 tree species (black cherry, Douglas fir, loblolly pine, ponderosa pine, quaking aspen, red alder, red maple, sugar maple, tulip poplar, Virginia pine, white pine) from the extensive evidence base of O 3 – induced growth effects that was also available and relied upon in the previous rev iew. While the species for which robust E

- R functions have been developed represent only a small fraction (0.8 percent) of the total number of native tree species in the contiguous U.S. (1,497), this small subset includes eastern and western species, decid uous and coniferous species, and species that grow in a variety of ecosystems and represent a range of tolerance to O 3 (U.S. EPA, 2 013 2 013 a , section 9.6.2; U.S. EPA, 2014b, section 6.2, Figure 6

- 2, Table 6

- 1). Each of these species were studied in OTCs, with most species studied multiple times under a wide range of exposure and/or growing conditions, with separate E

- R functions developed for each combination of species , exposure condition and growing condition scenario. These species

- specific composite E

- R functions have been successfully used to predict the biomass loss response from tree seedling species over a range of cumulative exposure c onditions (U.S. EPA, 2013 2013a , section 9.6.2)

. The 11 robust composite E

- R functions available in the last review , as well as the E

- R for eastern cottonwood (derived from a field study in which O 3 and climate conditions were not controlled) , are described in the ISA and graphed in the WREA to illustrate the predicted responses of these species over a wide range of cumulative exposures (U.S. EPA, 2014b, section 6.2, Table 6

- 1 and Figure 6

- 2 ; U.S. EPA, 2 013 2 013 a , section 9.6.2)

. For some of these species , th e E

- R function is based on a single study (e.g., red maple), while for other species there were as many as 11 studies available (ponderosa pine). In total, the E

- R functions developed for these 12 species (the 11 with robust composite E

- R functions plus ea stern cottonwood) reflect 52 tree seedling studies

. A stochastic analysis in WREA, summarized in section IV.C below, indicates the potential for*** E.O. 12866 Review

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Page 330 of 668 within species variability to contribute appreciably to estimates for each species. Consideration of biomass lo ss estimates in the PA and in discussions below, however, is based on conventional method and focuses on estimates for the 11 species for which the robust datasets from OTC experiments are available, in consideration of CASAC advice. 196 c. Crop Yield Loss The “ detrimental effect of O 3 on crop production has been recognized since the 1960s ” (U.S. EPA, 2 013 2 013 a , p. 1

- 10, section 9.4.4). The On the whole, th e newly available scientific information has added more support for prior conclusions regarding O 3 cr op yield loss. On the whole, this evidence supports previous conclusions that exposure to O 3 decreases growth and yield of crops. The ISA describes average crop yield loss reported across a number of recently published meta

- analy ses that have been publishe d recently for soybean , wheat, rice, semi

- natural vegetation, potato, bean and barley (U.S. EPA, 2 013, section 9.4.4.1). Further, identifies several new exposure studies continue to show decreasing that support prior findings for a variety of
crops of decreased yield and biomass in a variety of crops with increased O 3 exposure (U.S. EPA, 2 013 2 013 a , section 9.4.4.1, Table 9

- 17). Studies ha ve also “ linked increasing O 3 concentration to decreased photosynthetic rates and accelerated aging in leaves, which are related to yield ” and described effects of O 3 on crop quality, such as nutritive quality of grasses,

macro - and micronutrient concentrations in fruits and vegetable crops and cotton fiber quality ( U.S. EPA, 2013a, p. 1

- 10, s ection 9.4.4). The findings of the newly available studies d o not change the basic understanding of O 3 - related crop yield loss since the last review and little

196 The CASAC cautioned EPA against placing too much emphasis on the eastern cottonwood data, stating that while the cottonwood data are important results, they are not as strong as those from other experiments that developed E

- R functions based on controlled O 3 exposure in OTCs ; they are from a single gradient study that did not control for O 3 and climati c conditions and that show s they show extreme sensitivity to O 3 compared to other studies (Frey, 2014c, p. 10).*** E.O. 12866 Review

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Page 331 of 668 additional information is available in this review on factors that influence associations between
O 3 levels and crop yield l oss (U.S. EPA, 2 013 2 013 a , section 9.4.4.). The new evidence has strengthened support for previously established E

- R functions for 10 crops (barley, field corn, cotton, kidney bean, lettuce, peanut, potato, grain sorghum, soybean and winter wheat), reducing two important areas of uncertainty, especially for soybean. The established E

- R functions were developed from OTC

- type exper iments (U.S. EPA, 2013 2013a , section 9.6.3; U.S. EPA, 2014b, section 6.2; U.S. EPA, 2014c, Figure 5

- 4)

. In this review, the ISA included an analysis comparing OTC data from for soybean from the National Crop Loss Assessment Network ( NCLAN ) with field

- based data for soybean from SoyFACE ( Soybean Free Air Concentration Enrichment ) studies ( U.S. EPA, 2013 2013a , section 9.6.3. 2 1 ). 197 Yield loss in soybean from O 3 exposure at the SoyFACE field experiment was reliably predicted by soybean E

- R functions developed in from NCLAN . This finding indicates that the average response of soybean yield to O 3 exposure has not changed in current cultivars (U.S. EPA, 2013, Section 9.6) , data, demonstrating a robustness of the E

- R functions developed in with NCLAN data to predict relative yield loss from O 3 exposure and supporting the use of these functions . A second area of uncertainty that was reduced is that regarding the application of the NCLAN E

- R functions, developed in the 1980s, to more recent cultivars currentl y growing in the field. R ecent studies , especially those focused on soybean, provide little evidence that crops are becoming more tolerant of O 3 (U.S. EPA, 2006a; U.S. EPA, 2 013 2 013 a ). A meta

- analysis of 53 studies

197 The NCLAN program, which was undertaken in the early to mid

- 1980s, assessed multiple U.S. crops, locations, and O 3 exposure levels, using cons istent methods, to provide the largest, most uniform database on the effects of O 3 on agricultural crop yields (U.S. EPA 1996 1996 a ; U.S. EPA, 2006 2006 a ; U.S. EPA, 2013 2013 a , sections 9.2, 9.4, and 9.6, Frey, 2014c, p. 9)

. The SoyFACE experiment was a chamberless (or free

- air) field

- based exposure study conducted in Illinois that was conducted from 2001

– 2009 (U.S. EPA, 2013 2013 a , section 9.2.4)

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Page 332 of 668 found consistent deleterious effects of O 3 exposures on soybean from studies published between 1973 and 2001 ( Morgan et al. , 2003). Further, Betzelberger et al. (2010) utilized the SoyFACE facility to compare the impact of elevated O 3 concentrations across 10 soybean cultivars to investigate intr aspecific variability of the O 3 response , finding that t he E

- R functions derived for these 10 current cultivars were similar to the response functions derived from the NCLAN studies conducted i n the 1980s (Heagle, 1989 ). ), “ suggesting there has not been an y selection for increased tolerance to O3 in more recent cultivars ” (U.S. EPA, 2013a, p. 9

- 59)

. Additionally, the ISA comparisons of NCLAN and SoyFACE data referenced above “ confirm that the response of soybean yield to O 3 exposure has not changed in curre nt cultivars” (U.S. EPA, 2013 a , p. 9

- 59 ; section 9.6.3.1 ). Thus, the evidence available in the current review has reduced uncertainties in two areas with regard to the use of E

- R functions for soybean crop yield loss

. During past O 3 NAAQS reviews, there we re very few studies that estimated O 3 impacts on crop yields at large geographical scales (i.e., regional, national or global). Recent modeling studies of the historical impact of O 3 concentrations historically found that increased O 3 in the past generally reduced crop yield, but the impacts varied across regions and crop species (U.S. EPA, 2013, Section 9.4.4.1). The , with the largest O 3 - induced crop yield losses were estimated to

occur have occu rr ed in high

- production areas that had been exposed to elevate d O 3 concentrations, such as the Midwest and the Mississippi Valley regions of the U.S. Among (U.S. EPA, 2013 a , Section 9.4.4.1). Among affected crop species, the estimated yield loss for wheat and soybean were higher than rice and maize (i.e., field corn)

. Additionally, satellite and ground

based O 3 measurements have assessed soybean yield loss caused by estimated to result from O 3 over the continuous area of Illinois, Iowa, and Wisconsin and found reduced soybean yield, ,*** E.O. 12866 Review

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Page 333 of 668 finding a relationship which correla tes well with the previous results from FACE

- and OTC

- type experiments (U.S. EPA, 2 013 2 013 a , section 9.4.4.1). Thus, the recent scientific literature in the ISA support s consistent with the conclusions of the 1996 and 2006 CDs , the current ISA concludes that O 3 concentrations in ambient air can reduce the yield of major commodity crops in the U.S. and focuses on use of crop E

- R functions based on OTC experiments to characterize the quantitative relationship between ambient O 3 concentrations and yield loss (U.S. EPA, 2 013 2013 a , section 9.4.4). In the PA, as summarized in sections IV.D and IV.E below, relative yield loss (RYL) is estimated for 10 different crops using the individual E

- R functions described in the WREA 198 (U.S. EPA, 2014b, section 6.2; U.S.
EPA , 2014c, section 6.3).
2

. Potential Impacts on Public Welfare The magnitude of a public welfare impact or the degree to which it may be considered adverse is dependent upon the nature and severity of the specific welfare or ecological effect, the

use or s ervice (and value) of the affected ecosystem and the relevance and significance of that

use 199 to the public welfare. In the preamble of the 2012 final notice of rulemaking on the secondary standards for oxides of nitrogen and sulfur (NOx/SOx) , the EPA stated that “[a]n evaluation of adversity to the public welfare might consider the likelihood, type, magnitude, and

198 These functions for RYL estimate reduction in a year’s growth as a percent age of that expected in the absence of O 3 (U.S. EPA, 2013 2013a , section 9.6.2; U.S. EPA, 2014b, section 6.2). 199 Ecosystem services have been defined as “the benefits that people obtain from ecosystems” (U.S. EPA, 2013 2013 a , Preamble, p. 1xxii; UNEP, 2003) and thus are an aspect of the use of a type of vegetation or ecosystem

. Similarly, a definition used for the purposes of EPA benefits assessment s states that ecological goods and services are the ‘‘outputs of ecological functions or processes that directl y or indirectly contribute to social welfare or have the potential to do so in the future” and that “[s]ome outputs may be bought and sold, but most are not marketed’’ (U.S. EPA, 2006b).*** E.O. 12866 Review

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Page 334 of 668 spatial scale of the effect, as well as the potential for recovery and any uncertainties relating to these conditions” (77 FR 20232 , April 3 , 2012 ). The EPA additionally stated that “[c]onceptually, changes in ecosystem services may be used to aid in characterizing a known or anticipated adverse effect to public welfare” (77 FR 20232 , April 3, 2012 )

. 200 Potential public welfare impacts associa ted with ecosystems and associated services have a range of dimensions, including spatial, temporal, and social, and these likely will vary depending on the type of effect being characterized. For example, ecosystems can cover a range of spatial scales, an d the services they provide can accrue locally or be distributed more broadly, such as when crops are sold and eaten locally and/or also sold in regional, national and world markets. Accordingly, impacts can be localized or more widely distributed. Further , ecosystem services can be realized over a range of temporal scales from immediate up to long er term. The size of the societal unit receiving benefits from ecosystem services can also vary dramatically. For example, a national park can provide direct recr eational services to the thousands of visitors that come each year, but also provide an indirect value to the millions who may not visit but receive satisfaction from knowing it exists and is preserved for the future (U.S. EPA, 2014b, chapter 5, section 5. 5.1)

. As recognized in the last review, judgments regarding adverse effects to the public welfare depend on the intended use for and significance of the affected vegetation, ecological

200 Ecosystem services analyses were one of the tools used in that revi ew to inform the decisions made with regard to adequacy and as such, were used in conjunction with other considerations in the discussion of adversity to public welfare (77 FR 20241).*** E.O. 12866 Review

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Page 335 of 668 receptors, ecosystems and resources to the public welfare (73 FR 1649 6 , March 27, 2008 ). 201 For example, a number of different types of locations provide services of special significance to the public welfare. As emphasized in previous O 3 NAAQS decisions, and summarized in section IV.A above, Class I areas and other parks hav e been afforded special federal protection to preserve services that provide for the enjoyment of these resources for current and future generations . Surveys have indicated that Americans rank as very important the existence of the resource, the option or availability of the resource and the ability to bequest or pass on to future generations ( USDA, 2010)

. These and other services provided by Class I areas and other areas that have been afforded special protection can flow in part or entirely from the veget ation that grows there. Aesthetic value and outdoor recreation depend on the perceived scenic beauty of the environment. Many outdoor recreation activities directly depend on the scenic value of the area, in particular scenic viewing, wildlife

- watching, hi king, and camping (U.S. EPA, 2014b, chapters 5 and 7). Further, analyses have reported that the American public values

– in monetary as well as nonmonetary ways

– the protection of forests from air pollution damage. In fact , s tudies that have assessed will ingness

- to

- pay for spruce

- fir forest protection in the southeastern U.S. from air pollution and insect damage have found that values held by the survey respondents for the more abstract services (existence, option and bequest) were greater than those for recreation or other services (U.S. EPA, 2014b, Table 5

- 6; Haefele et al., 1991 ; Holmes and Kramer, 1995). There are several potential public welfare impacts related to the three main categories of
O 3 effects on vegetation (i.e., effects on tree growth , pro ductivity and carbon storage; crop yield

201 As noted in section IV.A above, i n judgments regarding public welfare significance in the last review, emphasis was placed on vegetation and ecosystem effects to sensitive species that are known to or are likely to occur in federally protected areas such as national parks and other Class I areas, or on lands set aside by states, tribes and public interest groups to provide similar benefits to the public welfare (73 FR 16496, March 27, 2008; 75 FR 3023

- 24, January 19, 2010)

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Page 336 of 668 loss; and , visible foliar injury , as described in section IV.B.1 above) and their associated ecosystem services. At the same time, these three categories of effects differ with regard to aspects important to judging their public welfare significance. Judgments regarding crop yield loss, for example, depend on considerations related to the heavy management of agriculture in the U.S., while judgments regarding the other categories of effects generally relate to conside rations regarding forested areas

. For example, while both tree growth

- related effects and visible foliar injury have the potential to be significant to the public welfare through impacts in Class I and other protected areas, they differ in how they might be significant and with regard to the clarity of the data which describes the relationship between the effect and the services potentially affected. With regard to effects on tree growth, reduced growth is associated with e ffects on an array of ecosystem services including reduced productivity , altered forest and forest community (plant, insect and microbe) composition, reduced carbon storage and altered water cycling (U.S. EPA, 2013 2013a , Figure 9

- 1, sections 9.4.1.1 and 9.4.1.2; U.S. EPA, 2014b, section 6.1). For example, forest or forest community composition can be affected through O 3 effects on growth and reproductive success of sensitive species in the community, with the extent of compositional changes dependent on factors such as competitive interac tions (U.S. EPA, 2013 2013a , sections 9.4.3 and 9.4.3.1). D epending on the type and location of the affected ecosystem, services benefitting the public in other ways can be affected as well

. For example, other services valued by people that can be affected by reduced tree growth, productivity and carbon storage include aesthetic value, food, fiber, timber, other forest products, habitat, recreational opportunities, climate and water regulation, erosion control, air pollution removal, hydrologic and fire regi me stabilization ( U.S. EPA 2013 2013a , sections 9.4.1.1 and 9.4.1.2; U.S. EPA, 2014b, section 6.1,*** E.O. 12866 Review

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Page 337 of 668 Figure 6

- 1, section 6.4, Table 6

- 13). Further, impacts on some of these services (e.g., forest or forest community composition) may be considered of greater public welfare significance when occurring in Class I or other protected areas. Consideration of the magnitude of tree seedling growth effects that might cause or contribute to adverse effects for trees, forests, forested ecosystems or the public welfare is complicated by aspects of , or limitations in , the available information. For example, the evidence on tree seedling growth effects, d eriving from the E

- R functions for 11 species, provides no clear threshold or breakpoint in the response to O 3 exposure. Additionally, there are no established relationships between magnitude of tree seedling growth reduction and forest ecosystem impacts

a nd, as noted in section IV.B.1.b above, other factors can influence the degree to which O 3 - induced growth effects in a sensitive species affect forest and forest community composition and other ecosystem service flows from forested ecosystems . These includ e: 1) the type of stand or community in which the sensitive species is found (i.e., single species versus mixed canopy); 2) the role or position the species has in the stand (i.e., dominant, sub

- dominant, canopy, understory); 3) the O 3 sensitivity of the o ther co

- occurring species (O 3 sensitive or tolerant); and 4) environmental factors , such as soil moisture and others

. The lack of such established relationships complicates judgments as to the extent to which different amounts of tree seedling growth would be significant to the public welfare and thus an important consideration in the level of protection for the secondary standard. During the 1997 review of the secondary standard, views related to this issue were provided by a 1996 workshop of 16 then

- lead ing scientists in the context of discussing their views for a secondary O 3 standard (Heck and Cowling, 1997). In their consideration of tree growth effects as an indicator for forest ecosystems and crop yield reduction as an indicator of*** E.O. 12866 Review

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Page 338 of 668 agricultural syste ms, the workshop participants identified annual percentages, of RBL for forest tree seedlings and RYL for agricultural crops, considered important to their judgments on the standard. With regard to forest ecosystems and seedling growth effects as an indica tor, the participants selected a range of 1

- 2% RBL per year “to avoid cumulative effects of yearly reductions of 2% .” With regard to crops, they indicated an interest in protecting against crop yield reductions of 5% RYL yet noted uncertainties surroundin g such a percentage which led them to identifying 10% RYL for the crop yield endpoint (Heck and Cowling, 1997). The workshop report provides no explicit rationale for the percentages identified (2% RBL and 5% or 10% RYL); nor does it describe their connect ion to ecosystem impacts of a specific magnitude or type and judgments on significance of the effects for public welfare, e.g., taking into consideration the intended use and significance of the affected vegetation ( Heck and Cowling, 1997). Thus, in both t he 1997 and 2008 reviews, EPA’s consideration of tree growth effects and effects on crop yield, in recognizing In recognition of the complexity of assessing the adversity of those tree growth effects and effects on crop yield in the broader context of public welfare, the EPA’s consideration of those effects in both the 1997 and 2008 reviews extended beyond the consideration of various benchmark responses for the studied species . With , and with regard to
crops, EPA additionally recognized the heavy took note of the ir extensive management of agricultural systems which poses an additional complication. ( 62 FR 38856, July 18, 1997; 73 FR 16436, March 27, 2008). While, as noted above, public welfare benefits of forested lands can be pa rticular to the type of area in which the forest occurs, some of the potential public welfare benefits associated with forest ecosystems are not location dependent. A potentially extremely valuable ecosystem service provided by forested lands and for which the ISA concludes a likely causal relationship*** E.O. 12866 Review

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Page 339 of 668 with O 3 in ambient air is c arbon storage , a regulating service that is “of paramount importance for human society” (U.S. EPA, 2013 2013a , section 2.6.2.1 and p. 9

- 37 ) . T h e service of carbon storage is potentia lly important to the public welfare no matter in what location the sensitive trees are growing, or what their intended current or future use. In other words, the benefit exists as long as the tree is growing, regardless of what additional functions and ser vices it provides.
An other example of locations potentially vulnerable to O 3 - related impacts but not necessarily identified for such protection might be forested lands, both public and private, where trees are grown for timber production, particularly whe re they are dominated by a single timber species stand that is sensitive to O 3 , such as p onderosa pine. Further, forests in urbanized areas provide a number of services that are important to the public in those areas, including air pollution removal, cooli ng of the heat island effect, and beautification ( U.S. EPA, 2014b, section 6.6.2 and Appendix 6D; Akbari, 2002). 202 The presence of O 3 - sensitive trees in such areas may place them at risk from elevated O 3 exposures, contributing to potential impacts on important services provided by urban forests (U.S. EPA, 2014b, sections 6.6.2 and 6.7). There are many other tree species, such as species used in the USFS biomonitoring network, and various ornamental and a gricultural species (i.e., Christmas trees, fruit and nut trees) that provide ecosystem services that may be judged important to the public welfare but whose vulnerability to impacts from O 3 on tree growth, productivity and carbon storage has not been quan titatively characterized (U.S. EPA, 2014b, Chapter 6; Abt Associates, 1995). As noted above, in addition to tree growth

- related effects, O 3 - induced visible foliar injury also has the potential to be significant to the public welfare through impacts in Clas s I and other similarly protected areas. Visible foliar injury is a visible bioindicator of O 3 exposure in species

202 For example, see http://www.fs.fed.us/research/urban/environmental

- justice.php

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Page 340 of 668 sensitive to this effect, with the injury affecting the physical appearance of the plant. Accordingly v isible foliar injury surveys are used by federal land managers as tools in assessing potential air quality impacts in Class I areas. These surveys may focus on plant species that have been identified as potentially sensitive air quality related values ( AQRVs ) due to their sensitivity
to O 3 - ind uced foliar injury (USFS, NPS, FWS, 2010). An AQRV is defined by the National Park Services as a “resource, as identified by the FLM for one or more Federal areas that may be adversely affected by a change in air quality” and the resource “may include visi bility or a specific scenic, cultural, physical, biological, ecological, or recreational resource identified by the FLM for a particular area” ( USFS, NPS, USFWS, 2010). 203 No criteria have been established, however, regarding a level or prevalence of visible foliar injury considered to be adverse to the affected vegetation, and, a s noted in section IV.B.1.a above, there is not a clear relationship between visible foliar injury and other effects, such as reduced growth and productivity. Thus, key consideration s with regard to public welfare significance of this endpoint have related to qualitative consideration of the plant’s aesthetic value in protected forested areas. Depending on the extent and severity, O 3 - induced visible foliar injury might be expect e d to have

203 The identification, monitoring and assessment of AQRVs with regard to an adverse effect is an a pproach used for assessing the potential for air pollution imp acts from pending permit actions in Class I areas ( USFS, NPS, USFWS, 2010). An adverse impact is recognized by the National Park Service as one that results in diminishment of the Class I areas’s national significance or the impairment of the ecosystem str ucture or funct i oning, as well as impairment of the quality of the visitor experience ( USFS, NPS, USFWS, 2010). Federal land managers (FLMs) make such adverse impact determinations on a case

- by

- case basis, using technical and other information which they p rovide for consideration by permitting authorities. The National Park Services has developed a document describing an overview of approaches related to assessing projects under the National Environmental Policy Act and other planning initiatives affecting the National Park System ( http://www.nature.nps.gov/air/Pubs/pdf/AQGuidance_2011

- 01

- 14.pdf ).*** E.O. 12866 Review

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Page 341 of 668 the potential to impact the public welfare in scenic and/or recreational areas during the growing season, particularly in areas with special protection, such as Class I areas

. The ecosystem services most likely to be affected by O 3 - induced visible foliar injury (some of which are also recognized above for tree growth

- related effects) are cultural services, including aesthetic value and outdoor recreation. In addition, several tribes have indicated that many of the species identified as O 3 - sensitive (including bioindicator species) are culturally significant (U.S. EPA, 2014c, Table 5

- 1). The geographic extent of protected areas that may be vulnerable to such public welfare effects of O 3 is potentially appreciable. Sixty six species that

occur on U.S. National Park Service ( NPS ) and U

. S

. Fish and Wildlife Service lands 204 have been identified as sensitive to O 3 - induced visible foliar injury and some also have particular cultural importance to some tribes (U.S. EPA, 2014c, Table 5

- 1 and Appendix 5

- A; U.S. EPA, 2014b, section 6.4.2). N ot all species are equally sensitive to O 3 , however, and quantitative relationships between O 3 exposure and other important effects , such as seedling growth reduction, are only available for a subset of the 66, as described in section IV.B.1. above. A diverse array of ecosystem services has been identified for these twelve species (U.S. EPA, 2014c, Table 5

- 1). Two of the species in this group that are relative ly more sensitive with regard to effects on growth are the p onderosa p ine and q uaking a spen (U.S. EPA, 2014b, section 6.2), the ranges for which overlap with many lands that are protected or preserved for enjoyment of current and future generations (consistent with the discussion above on Class I and other protected areas) , including such lands located in the west and southwest regions of the U.S.

204 See http://www2.nature.nps.gov/air/Pubs/pdf/flag/NPSozonesensppFLAG06.pdf*** E.O. 12866 Review

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Page 342 of 668 where ambient O 3 concentrations and associated cumulative seasonal exposures can be highest (U.S. EPA, 2014c, Appendix 2B). 205 With regard to agriculture

- related effects such as crop yield loss, , the EPA has recognized other complexities, stating that the degree to which O 3 impacts on vegetation that could occur in areas and on species that are already heavily managed to obtain a particular output (such as commodity crops or commercial timber production) would impair the intended use at a level that might be judged adverse to the public welfare has been less clear ( 73 FR 16497, March 27, 2008; 75 FR 3024 ; January 19, 2010 ). We note that while having sufficient crop yields is of high public welfare value, important commodity crops are typically heavily managed to produce optimum yields. In light of all of the inputs that go into achieving these yields, such as fertilizer, herbicides, pesticides, and irrigation, it is difficu lt to determine at what point O 3 - induced yield loss creates an adverse impact for the producer in the way of requiring increased inputs in order to maintain the desired yields. Moreover, based on the economic theory of supply and demand, increases in crop yields would be expected to result in lower prices for affected crops and their associated goods, which would primarily benefit consumers. Given these competing impacts on producers and consumers, it is unclear how to consider these effects in terms of pot ential adversity to the public welfare (U.S. EPA, 2014c, sections 5.3.2 and 5.7). When agricultural impacts or vegetation effects in other areas are contrasted with the emphasis on forest ecosystem effects in Class I and similarly protected areas, it can be seen that the Administrator has in past reviews judg ed the significance to the public welfare of O 3 - induced effects on sensitive vegetation growing within the U.S. to differ depending on the nature of the

205 Basal area for resident species in national forests and parks are available in files accessible at: http://www.fs.fed.us/foresthealth/technology/nidrm2012.shtml*** E.O. 12866 Review

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Page 343 of 668 effect, the intended use of the sensitive plants or ecosystems, and the types of environments in which the sensitive vegetation and ecosystems are located, with greater significance ascribed to areas identified for specific uses and benefits to the public welfare , such as Class I areas, than to areas fo r which such uses have not been established. In summary , several considerations are recognized as important to judgments on the public welfare significance of the array of effects of different O 3 exposure conditions on vegetation. While t here are complexit ies associated with the consideration of the magnitude of key vegetation effects that might be concluded to be adverse to ecosystem s and associated services, there are numerous locations where O 3 - sensitive tree species are present that may be vulnerable to impacts from O 3 on tree growth, productivity and carbon storage and their associated ecosystems and services. It is not possible to generalize across all studied species regarding which cumulative exposures are of greatest concern, however, as this

can va ry by situation due to differences in exposed species sensitivity, the importance of the observed or predicted O 3 - induced effect, the role that the species plays in the ecosystem, the intended use of the affected species and its associated ecosystem and se rvices, the presence of other co

- occurring predisposing or mitigating factors, and associated uncertainties and limitations. These factors contribute to the complexity of the Administrator’s judgments regarding the adversity of known and anticipated effect s to the public welfare. C. Exposure and Risk Assessment Information The WREA characterized ambient O 3 exposure and its relationship to tree biomass loss, crop yield loss, and visible foliar injury and the associated ecosystem services 206 in national

- scale and case study analyses. The WREA also qualitatively assessed impacts to some ecosystem

206 In its review of drafts of the WREA and PA, the CASAC conveyed support for analyses and cons iderations of ecosystem services that may be affected by O 3 exposures (Frey, 2014b, 2014c).*** E.O. 12866 Review

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Page 344 of 668 services, including impacts on the hydrologic cycle, pollination regulation, and fire regulation; commercial non

- timber forest products and insect damage; and aesthetic and non

- use values. I n the quantitative analyses , the WREA characterized effects associated with exposures to O 3 in ambient air using the W126 metric. The following sections summarize the analyses and adjustment approach used to develop the O 3 concentrati ons used as inputs to the vegetation risk analyses for tree biomass and crop yield loss , and the analyses, including key results and uncertainties, for tree seedling growth, productivity, carbon storage and associated ecosystem services (section IV.C.2); c rop yield loss (section IV.C.3); and visible foliar injury (section IV.C.4). 1. Air Quality Analyses The WREA evaluate d O 3 exposure and risks for several national

- scale air quality scenarios: recent conditions (2006 to 2008) , 207 just meeting the current secondary standard, and just meeting alternative W126 index values of 15 ppm

- hrs, 11 ppm

- hrs, and 7 ppm

- hrs , using
3 three

- year averages ( USEPA U.S. EPA , 2014b, chapter 4)

. For each of these scenarios, three

year average W126 index values were estimated at e ach 12 km by 12 km grid cell in a national

scale spatial surface. Additionally, some analyses were based on single

- year surfaces. 208 The method for creating the five scenarios generally involved two steps ( summarized in Table 5

- 4 of the PA ) . The first is de rivation of the average W126 index value (across the three years) at each monitor location. This value is based on unadjusted O 3 concentrations from

207 Certain visible foliar injury analyses assessed recent conditions from 2006 to 2010 on an annual basis. 208 An analysis using data from USFS FHM/FIA O 3 biomonitorin g sampling sites ( “biosites” ) and a screening

- level assessment in 214 national parks were done using national

- scale spatial surface s of unadjusted O 3 concentrations (in terms of the W126 index) created for each year from 2006 through 2010 using the VNA int erpolation technique (U.S. EPA, 2014b, section 4.3.2, Appendix 4A).*** E.O. 12866 Review

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Page 345 of 668 monitoring data for recent conditions and adjusted concentrations for the four other scenarios. Concentrati ons were adjusted based on model predicted relationships between O 3 and U.S.

- wide emissions reductions in oxides of nitrogen (NOx) . The adjusted air quality do es not represent an optimized control scenario that just meets the current standard (or target W1 26 index values for other scenarios), but rather characterize s one potential distribution of air quality across a region when all monitor locations meet the standard (U.S. EPA, 2014b, section 4.3.4.2 ). The development of adjusted concentrations was done fo r each of nine regions independently (see U.S. EPA, 2014b, section 4.3.4.1). In the second step, national

- scale spatial surfaces (W126 index values for each 12 km x 12 km grid cell used ini in the air quality model ) were created using the monitor

- location v alues and the Voronoi Neighbor Averaging (VNA) spatial interpolation technique (details on the VNA technique are presented in U.S. EPA, 2014b, Appendix 4A).
In the dataset used to create the recent conditions scenario , the 3 three

- year average W126 index v alues at the monitor locations (before application of the VNA technique) ranged from below 5 ppm

- hrs to 48.6 ppm

- hrs (U.S. EPA, 2014b, Figure 4

- 4 and Table 4

- 3). In the nine modeling regions, the maximum 3 three

- year average W126 index values at monitor loc ations ranged from 48.6 ppm

- hrs in the W est region down to 6.6 ppm

- hrs in the N orthwest region. 209 After adjust ment of the monitor location concentrations to just meet the current standard in each region (using relationships described above) , the region

- specific maximum three

- year average W126 values range d from 18.9 ppm

- hrs in the W est region to 2.6 ppm

- hrs in the N ortheast region (U.S. EPA, 2014b, Table 4

- 3). With the next step, creation of the national surface of air

209 The regions referenced here and also with regard to monitoring data analyses described in section IV.D.4 below are NOAA climate regions, as shown in Figure 2B

- 1 of the PA.*** E.O. 12866 Review

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Page 346 of 668 quality values at grid cell centroids, the highest values were reduced, such that all t he three

- year average W126 index values were below 15 ppm

- hrs across the national surface with the exception of a very small area of the S outhwest region (near Phoenix) where average W126 ind ex values w ere just above 15 ppm

- hrs. Thus, it can be seen that application of the VNA interpolation method to estimate W126 index values at the centroid of every 12 x 12 km 2 grid cell rather than only at each monitor location results in a lowering of the highest values. Because the W126 estimates generated for the different air quality scenarios assessed are inputs to the vegetation risk analyses for tree biomass and crop yield loss, and also used in the foliar injury analyses, any uncertainties in the air quality analyses are propagated into the those analyses (U.S. EPA, 2014b, section 8.5). The WREA identified sources of uncertainty for the W126 estimates for each air quality scenario and qualitatively characterized the magnitude of uncertainty and potent ial for directional bias ( U.S. EPA, 2014b, T able 4

- 5). As discussed in Chapter 4 and 8 of the WREA, an important large uncertainty in the analyses is the assumed response of the W126 concentrations to emissions reductions needed to meet the existing standa rd (U.S. EPA, 2014b, section 8.5.1). Any approach to characterizing O 3 air quality over broad geographic areas based on concentrations at monitor locations will convey inherent uncertainty. The model

- based adjustments are based on U.S.

- wide emissions reduc tions in NOx and characterize only one potential distribution of air quality across a region when all monitor*** E.O. 12866 Review

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Page 347 of 668 locations meet the standard (U.S. EPA, 2014b, section 4.3.4.2). 210 Additionally, the surface is created from the three

- year average at the monitor l ocations, rather than creating a surface for each year and then averaging across years at each grid cell; the potential impact of this on the resultant estimates is considered in the WREA (U.S. EPA, 2014b, Appendix 4A). An additional uncertainty related t o the W126 index value estimates for each air quality scenario comes from the creation of a national W126 surface using the VNA technique to interpolate recent air quality measurements of O 3 . In general, spatial interpolation techniques perform better in a reas where the O 3 monitoring network is denser. Therefore, the W126 index values estimated in the rural areas in the West, Northwest, Southwest, and West North Central with few or no monitors ( U.S. EPA, 2014b, Figure 2

- 1) are more uncertain than those esti mated for areas with dense r monitoring. Further, this interpolation method generally under

predicts underpredicts higher 12

- h ou r W126 exposures. Due to the important influence of higher exposures in determining risks to plants, the potential for the VNA interpolation approach to underpredict higher W126 exposures could result in an underestimation of risks to vegetation in

some ar eas. Underestimation of the highest W126 index values for the current standard scenario is an additional impact of the interpolation method that is important to consider.
2

. Tree Seedling Growth, P roductivity, Carbon S torage and Associated Ecosystem Servi ces

210 The WREA analyses used U.S.

- wide NOx emissions reductions to simulate air quality that independently in each region would just meet the existing standard and the three W126 scenarios

. The NOx emissions reductions were determined such that the highest monitor w ithin each region would just meet the target level. In this way, the adjustment results in broad regional reductions in O 3 and includes reductions in O 3 at some monitors that were already meeting or below the target level. Thus, the adjustments performed to develop a scenario meeting a target level at the highest monitor in each region did result in substantial reduction below the target level in some areas of the region. This result at the monitors already well below the ta rget indicates an uncertainty with regard to air quality expected from specific control strategies that might be implemented to meet a particular target level

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Page 348 of 668 For the WREA assessments related to tree growth, productivity, carbon storage and associated ecosystem services, the sections below provide an overview of the analyses along with the key results (section IV.C.2.a) and summarize the key uncertainties ( section IV.C.2.b).

a. Overview and Summary of Key Results The assessments to estimate the exposures and risks for tree seedling growth, productivity, and carbon storage reflect a range of spatial scales ranging from the county scale up to the national park , urban area, and national scales. For the air quality scenarios described above, the WREA applied the species

- specific E

- R functions to develop estimates of O 3 - associated RBL , productivity, carbon storage and associated ecosystem services (U.S. EPA, 2014b , Chapter 6). Some analyses also apply the median across species E

- R function s . The WREA examined multiple approaches for characterizing the median tree response to
O 3 exposure based on the 11 robust E

- R functions for tree seedlings from the OTC research and the E

- R function for eastern cottonwood (U.S. EPA, 2014b, section 6.2.1.2 and Figure 6

- 5). For some species, only one study was available (e.g., red maple), and for other species there were as many as 11 studies available (e.g., ponderosa pine). To ill ustrate the effect of within

- species variability associated with the E

- R data available on estimates for a median response across the 12 species, the WREA performed a stochastic sampling analysis involving multiple iterations of random selection of E

- R fun ctions from the studies available for each of the 12 species. This analysis produced median values at each cumulative exposure level that were higher than medians derived by two conventional, deterministic methods (U.S. EPA, 2014 b , section 6.2.1.2 and Figu re 6

- 5)

. 211 For example , the median seasonal W126 index value for which a two percent

211 These methods were calculating a median using the composite functions and calculating a media n using all tree seedling studies available.*** E.O. 12866 Review

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Page 349 of 668 biomass loss is estimated in seedlings for the studied species ranges from approximately 7 ppm hrs using the conventional methods up to 14 ppm

- hrs when derived by the stoch astic method

. Although the stochastic method provides some illustration of the effect of within

– species variability, we focus on the conventional approach that gives equal weight to each studied species , calculating the median response based on the composite E

- R functions , consistent with CASAC advice (Frey, 2014b ) ). The WREA estimates indicate substantial heterogeneity in plant responses to O 3 , both within species, between species, and across regions of the U.S. Th e tree species known to be O 3 - sensitive tree species are different in the eastern and western U.S. and the eastern U.S. has far

more such species. Ozone exposure and risk is somewhat easier to assess in the eastern U.S. because of the availability of more data and the greater number of species to analyze. In addition, there are more O 3 monitors in the eastern U.S. but fewer national parks (U.S. EPA, 2014b, chapter 8). In consideration of CASAC advice, the WREA derived RBL and weighted RBL (wRBL) estimates s eparately with and without the eastern cottonwood

. The results summarized here are for the analyses that exclude cottonwood. 212 The WREA reported RBL estimates relative to a benchmark of 2% RBL for tree seedling s, as well as relative to other percent RBL

va lues. The 2% RBL benchmark was considered based on CASAC advice that stated that “ focus on a 2% loss level for trees

... is appropriate. ” (Frey, 2014b, p. 6 ). The main WREA analyses for

212 The C ASAC advised that the eastern cottonwood response data “receive too much emphasis” in a draft version of the PA, explaining that these “results are from a gradient study that did not control for ozone and climatic conditions and show extreme sensitivity to ozone compared to other studies” and that “[a] lthough they are important results, they are not as strong as those from other experiments that developed E

- R functions based on controlled ozone exposure” ( Frey, 2014b, p. 10). Formatted: Subscript*** E.O. 12866 Review

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Page 350 of 668 effects related to tree growth, productivity and carbon storage are summ arized below, with the key findings for each. Relative biomass loss nationally was estimated for each of the 12 studied species from the composite E

- R functions for each species described above and information on the distribution of those species across th e U.S. (U.S. EPA, 2014b, section 6.2.1.3 and Appendix 6A). As one example of a tree species near the median of the studied species, relative biomass loss estimates (reduced growth) for ponderosa pine in the current standard air quality scenario are below t wo percent for most areas where this species is found but estimates of RBL for this species in some areas of the southwest fall above two percent biomass loss (U.S. EPA, 2014b, Figure 6

- 8). Maximum estimates of RBL for all areas where ponderosa pine is fou nd decrease to just over three percent and just over two percent for the 15 and 7 ppm

- hrs scenarios, respectively (U.S. EPA, 2014b, Table 6

- 6). To provide an indication of ecosystem

- level impacts, weighted estimates of RBL (wRBL) were also developed for ea ch grid cell nationwide. This is estimated from the species

- specific E

R functions and a weighting approach based on information on prevalence of the studied species across the U.S. (i.e., the proportion of the total basal area modeled by USFS across all s pecies for which data were available). An overall wRBL value for each grid cell is generated by summing the wRBL values for each studied tree species found within that grid cell. The wRBL is intended to be an indication of the potential magnitude of the ec ological effect that could occur in some ecosystems. In general, the higher the wRBL is in a given ecosystem, the larger the potential ecological effect. (U.S. EPA, 2014b, section 6.8, Table 6

- 25). For the national

- scale analysis, the WREA presents the per cent of total basal area with wRBL greater than 2%. The estimates for the weighted biomass loss analysis reflecting the 11*** E.O. 12866 Review

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Page 351 of 668 tree species with robust E

- R functions are as follows (U.S. EPA, 2014b, Table 6

- 25):

 For the current standard scenario, the percent of total basal area that exceeds a two percent wRBL is 0.2 percent.

 For the W126 scenarios of 15, 11 and 7 ppm

- hrs, t he percent of total basal area that exceeds a two percent wRBL is 0.2 percent, 0.1 percent, and less than 0.1 percent respect ively (U.S. EPA, 2014b, Table 6

- 25). In the wRBL analysis for Class I areas, the number of Class I areas with wRBL greater than 2% is estimated for the grid cells located in the 145 of the 156 Class I areas for which data were available (U.S.EPA, 2014b, T able 6

- 26).

 For the current standard scenario , t wo of the 145 assessed Class I areas have weighted RBL values above two percent (U.S. EPA, 2014b, Table 6

- 26).

 For the W126 scenarios of 15, 11 and 7 ppm

- hrs, t he re are two, two and one Class I area with w RBL above two percent , respectively

. In the county analysis, the WREA estimated the n umber of U.S. counties in which any of the studied tree species is estimated to experience more than two percent RBL, the number of species affected, and the number of co unties for which the median of the species

- specific functions exceeds two percent RBL. In addition to the estimates based on all 12 studied species and also the 11 species with the exclusion of eastern cottonwood (in response to CASAC advice) , a dditional e stimates were developed without black cherry to show contribution of that sensitive species to the multi

- species estimates (U.S. EPA, 2014b, Table 6

- 7).

 In the current standard scenarios, 66% of the 3,109 assessed counties are estimated to have at least on e of the 11 species (excluding cottonwood) with an RBL greater than two percent, with three counties having three species exceeding two percent. The median*** E.O. 12866 Review

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Page 352 of 668 RBL (across the species present) is above two percent in 239 counties. T he maximum number of species in any one county with an RBL greater than two percent is three (excluding cottonwood). (U.S. EPA, 2014b, Table 6

- 7).

 For the 15, 11 and 7 ppm

- hrs scenarios, the proportion of 3,109 counties with one or more species with an RBL above two percent decrease s to 61 percent, 59 percent, and 58 percent, respectively. For the 7 ppm

- hrs scenario, the median RBL is above two percent in six percent of the counties (U.S. EPA, 2014b, Table 6

- 7).

 The county RBL estimates are appreciably influenced by black cherry, a v ery sensitive species that is widespread in the Eastern U.S. For 1,805 of the 1,929 counties estimated to have at least one species with an RBL greater than two percent when air quality is meeting the current standard , only black cherry exceeds this level of RBL. If black cherry is excluded, the median RBL for the 10 remaining species decreases . For the median RBL values, 203 of the 239 counties estimated to have a median RBL above two percent when air quality is meeting the current standard are because of the presence of black cherry (U.S. EPA, 2014b, Table 6

- 7). Additionally, the WREA estimated r elative yield loss in timber production and associated changes in consumer and producer/farmer economic surplus using E

- R functions for tree seedlings to calculate relative yield loss (equivalent to relative biomass loss) across full tree lifespans and through modeling of the resulting market

- based welfare effects. Becaus e the forestry and agriculture sectors are related and trade

- offs occur between the sec tors, the WREA calculated the resulting market

- based welfare effects of O 3 exposure in the forestry and*** E.O. 12866 Review

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Page 353 of 668 agriculture sectors on consumer and producer surplus. 213 Because demand for most forestry and agricultural commodities is not highly responsive to changes in price, producer surplus (i.e., producer gains) often declines . T hese declines can be more than offset by changes in consumer surplus gains from lower prices , but, in some cases, lower prices reduce producer gains more than can be offset by consumer sur plus (U.S. EPA, 2014b, Appendix 6B, Table and B

- 9)

.

 In the current standard scenario, e stimates of the relative yield loss for timber production are below one percent other than in the Southwest, Southeast, Central, and South regions (U.S. EPA, 2014b, sect ion 6.3, Table 6

- 9) (see U.S. EPA, 2014b, Table 6

- 8 for clarification on region names). The highest yield loss occurs in upland hardwood forests in the South Central and Southeast regions at over three percent per year and in Corn Belt hardwoods at just ov er two percent loss per year (U.S. EPA, 2014b, section 6.3, Table 6

- 9).

 For the 15 and 11 ppm

- hrs scenarios, r elative yield loss estimate s for timber production are above one percent in parts of the Southeast, Central, and South regions and above two
perc ent in parts of the Southeast and Central U.S.

 For the 7 ppm

- hrs scenario , relative yield loss estimates for timber production are above one percent in the Southeast and South regions (U.S. EPA, 2014b, section 6.3, Table 6

- 9).

213 The WREA used the Forest and Agricultural Sector Optimization Model with Greenhouse Gases (FASOMGHG). FASOMGHG is a national

- scale model that provides a complete representation of the impacts of meeting alternative standards on the U.S. forest and agricultural sectors. FASOMGHG simulates the allocation of land over time to competing activities in both the forest and agricultural sectors. FASOMGHG results include multi

- period, multi

- commodity results over 60 to 100 years in 5

- year tim e intervals when running the combined forest

agriculture version of the model.*** E.O. 12866 Review

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Page 354 of 668 The WREA also estimated impa cts on tree growth and two ecosystem services provided by urban trees: removal of air pollutants and carbon storage. The estimates of the tons of carbon monoxide, nitrogen dioxide, ozone and sulfur dioxide removed are for a 25

- year period in five urban ca se study areas: Baltimore, Syracuse, the Chicago region, Atlanta, and the urban areas of
Tennes see (U.S. EPA, 2014b, section 6.7). 214

 Estimates for all five urban case study areas indicate increased pollutant removal of O 3 , nitrogen dioxide, carbon monoxide , and sulfur dioxide in the current standard scenario (U.S. EPA, 2014b, sections 6.7). The results for the 15 ppm

- hrs scenario were very similar to those for meeting the current standard. For the 11 and 7 ppm

- hrs scenarios, all five case study areas indica te smaller additional increases in air pollutant removal beyond moving from current conditions to the current standard (U.S. EPA, 2014b, sections 6.7). The WREA estimated carbon storage related to O 3 - induced biomass loss in forests and agricultural crops nationally and also in forests in five urban areas using the FASOMGHG and i

Tree models noted above (U.S. EPA, 2014b, section 6.6). Ozone effects on tree growth affects the climate regulation service provided by ecosystems by reducing carbon sequestration and storage (U.S. EPA, 2013 2013a , section 9.4.3.4; U.S. EPA, 2014b, chapter 6, section 6.6).
Because O 3 exposure affects photosynthesis and CO 2 uptake by trees, forests sequester less carbon and thus more carbon stays in the atmosphere. In the model used t o calculate national

level impacts to forests and agriculture from O 3 - related biomass loss, carbon sequestration reflects carbon in standing (live and dead) trees, forest soils, the forest understory vegetation,

214 The WREA used the i

- Tree model for the urban case studies. i

- Tree is a peer

- reviewed suite of software tools provided by USFS. Formatted: Space Before: 0 pt*** E.O. 12866 Review

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Page 355 of 668 forest floor including litter and large wood y debris, and wood products both in use and in landfills (U.S. EPA, 2014b, chapter 6, Appendix 6B, section 2.7.1).

 Over 30 years for the national

- scale analysis , carbon storage in the forestry sector estimated for the current standard scenario is just over 89 ,000 million metric tons of CO 2 equivalents (MMtCO 2 e) ; this is 11,840 more MMtCO 2 e storage associated with the reduced O 3 - related growth impact from meeting the current standard as compared with recent conditions

. 215 The estimates of carbon storage in the agricultural sector are much smaller (i.e., 8,469 MMtCO 2 e for the current standard scenario which is 606 MMtCO 2 e more than the recent conditions scenario) (U.S. EPA, 2014b, section 6.6.1 and Appendix 6B). The forestry sector carbon storage estimated for each of the three W126 scenarios is just slightly greater than that estimated for the current standard

. As a percentage of the current standard estimate, the three scenario estimates are less than 0.1% (13 MMtCO 2 e ), ju st under 1% (593 MMtCO 2 e ) and under 2% (1,600 MMtCO 2 e ) f or the 15, 11 and 7
ppm - hrs scenarios, respectively (U.S. EPA, 2014b, Table s 6

- 1 9 and B

- 10 ).

 Estimates of the effects of avoided O 3 - related biomass loss on carbon sequestration in forests in the five urban area case studies indicate the potential for an increase in carbon sequestration of somewhat more than one MMtCO 2 e for the current standard scenario compared to the recent conditions estimate (U.S. EPA, 2014b, section 6.6.2 and Appendix 6D). The addi tional increases in O 3 - related carbon sequestration estimated

across the five case studies for the three W126 scenarios are relatively small (U.S. EPA,

215 One MMtCO 2 e is equivalent to 208,000 passenge r vehicles or the electricity to run 138,000 homes for 1 year as calculated by the EPA Greenhouse Gas Equivalencies Calculator (updated September 2013 and available at http://www.epa.gov/cleanenergy/energy

resources/calculator.html). Formatted: Subscript*** E.O. 12866 Review

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Page 356 of 668 2014b, section 6.6.2 and Appendix 6D). Although not discussed in detail here, the WREA also describes qualitative assessments for some ecosystem services that may be affected by O 3 effects on tree growth and productivity , such as commercial non

- timber forest products and recreation (U.S. EPA, 2014b, section 6.4), aesthetic and non

- use values (U.S. EPA, 201 4b, section 6.4), increased susceptibility to insect attack and fire damage (U.S. EPA, 2014b, sections 5.3 and 5.4, respectively). Other ecological effects that are causally or likely causally associated with O 3 exposure , such as effects on terrestrial pro ductivity, the water cycle, the biogeochemical cycle, and community composition (U.S. EPA, 2 013 2 013 a , Table 9

- 19) , were not quantitatively addressed in the WREA due to a lack of sufficient quantitative information. b. Key Uncertainties The WREA identified several key limitations and uncertainties in the biomass loss assessments for trees, which may have a large impact on both overall confidence and confidence in individual analyses. Key uncertainties that affect the assessment of impacts on ecosystem servi ces at the national and case

- study scales, as well as across species, U.S. geographic regions and future years , include those associated with the interpolated and adjusted O 3 concentrations used to estimate W126 exposures in the air quality scenarios, the available seedling E

- R functions, combining effects across sensitive species, the effects of compounding over time, and modeling impacts of biomass loss on timber harvesting and urban air pollutant removal. With regard to the robust seedling E

- R functions, the WREA provided some characterization of the variability of individual study results and the impact of that on estimates of W126 index values that might elicit different percentages of biomass loss in tree seedlings (U.S. EPA, 2014b, section 6.2.1.2). E ven though the evidence shows that there are additional Formatted: Space Before: 0 pt*** E.O. 12866 Review

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Page 357 of 668 species affected by O 3 - related biomass loss, the WREA only has E

- R functions available to quantify this loss for 12 tree species. This limited information only allows a partial characterization of the O 3 - related biomass loss impacts in trees associated with recent O 3 index values and with just meeting the existing and potential alternative secondary standards. In addition, there are uncertainties inherent in these E

- R functions, including the extrapola tion of relative biomass loss rates from tree seedlings to adult trees and information regarding within

species variability. The overall confidence in the E

- R function varies by species based on the number of studies available for that species. Some specie s have low within

- species variability (e.g., many agricultural crops) and high seedling/adult comparability (e.g., aspen), while other species do not (e.g., black cherry). The uncertainties in the E

- R functions for biomass loss and in the air quality analy ses are propagated into the analysis of the impact of biomass loss on ecosystem services, including provisioning and regulating services (U.S. EPA, 2014b, Table 6

- 27). The WREA characterizes the direction of potential influence of E

- R function uncertainty as unknown, yet its magnitude as high, concluding that further studies are needed to determine how accurately the assessed species reflect the larger suite of O 3 - sensitive tree species in the U.S. (U.S. EPA, 2014b, Table 6

- 27). Another uncertainty associat ed with interpretation of the WREA biomass loss

- related estimates concerns the potential for underestimation of compounding of growth effects across multiple years of varying concentrations. Though tree biomass loss impacts were estimated using air quality scenarios of 3 three

- year average W126 index values, the WREA also conducted an analysis to compare the impact of using a variable compounding rate based on yearly variations in W126 exposures to that of using a W126 index value averaged across three years . The WREA compared the compounded values for an example species occurring in the eastern U.S. and*** E.O. 12866 Review

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Page 358 of 668 another example species occurring in the western U.S . In both examples, one species (tulip polar and ponderosa pine , respectively ) and one climate region whe re that species occurred (Southeast and Southwest regions , respectively ) were chosen and air quality values associated with just meeting the existing standard of 75 ppb were used. Within each region, the WREA analysis used both the W126 index value at each monitor in the region for each year and the three

- year average W126 index value using the method described in Chapter 4 of the WREA . The results show that the use of the three

- year average W126 index value may underestimate RBL values slightly (U.S. EPA, 2014b, section 6.2.1.4 and Figure 6

- 14). In both regions, the three

- year average W126 index value is sometimes above and sometimes b elow the individual year W126 index value. The WREA recognize s uncertainty regarding the extent to which the subset of studied tree species encompass the O 3 sensitive species in the U.S. and the extent to which it represents U.S. vegetation as a whole (U. S. EPA, 2013a, pp. 9

- 123 to 9

- 125; U.S. EAP EPA , 2014b, Table
6

- 27)

. There are also uncertainties associated with estimating the national scale ecosystem

- level impacts using wRBL

. For example the wRBL estimates are likely biased low as there may be other unstudied O 3 - sensitive tree species in some areas that are also being affected at those levels , although this analysis does not take into account the effects of competition, which could further affect forest biomass loss. Uncertainties are recognized i n t he national

- scale analyses of timber production, agricultural harvesting, and carbon sequestration, for which the WREA used the FASOMGHG model

. These uncertainties include those associated with the functions for carbon sequestration, the assumptions made regarding proxy species where there are insufficient data , and the non W126 E

- R functions for three crops. The FASOMGHG model does not include agriculture and*** E.O. 12866 Review

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Page 359 of 668 forestry on public lands, changes in exports due to O 3 into international trade projections, or
f orest adaptation. Despite the inherent limitations and uncertainties, the WREA concludes that the FASOMGHG model reflects reasonable and appropriate assumptions for a national

- scale assessment of changes in the agricultural and forestry sectors due to chan ges in vegetation biomass associated with O 3 exposure (U.S. EPA, 2014b, sections 6.3, 6.5, 6.6, and 8.5.2 , and Table 6

- 27 ). In the case study analyses of five urban areas, the WREA used the i

- Tree model, which includes an urban tree inventory for each are a and species

- specific pollution removal and carbon sequestration functions. However, i

- Tree does not account for the potential additional VOC emissions from tree growth, which could contribute to O 3 formation. Uncertainties are also recognized with regard to the base inventory of city trees, the functions used for air pollutant removal and for carbon storage (U.S. EPA, 2014b, sections 6.6.2 and 6.7, and Table 6

- 27). Despite the inherent limitations and uncertain ties, the WREA concludes that the i

- Tree model reflects reasonable and appropriate assumptions for a case study assessment of pollution removal and carbon sequestration for changes in biomass associated with O 3 exposure (U.S. EPA, 2014b, sections 6.6.2, 6. 7, and 8.5.2).
3

. Crop Yield Section IV.C.3.a below provides an overview of the assessments performed in the WREA to estimate the exposures and risks for crop yield, as well as the key results

. Section IV.C.3.b summarizes the key uncertainties.

a. Overview and Summary of Key Results The WREA conducted two analyses to estimate O 3 impacts related to crop yield, including annual yield losses estimated for 10 commodity crops grown in the U.S. with E

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Page 360 of 668 functions and how these losses affect producer and consumer economic surpluses (U.S. EPA, 2014b, sections 6.2, 6.5). Summary estimates for crop yield loss related effects in the WREA are presented relative to a 5% yield loss benchmark based on consideration of CASAC ’s recommendation to consider a benchmark of 5% for median crop yield loss and to consider 5% yield loss for individual crop species. In addition, other benchmarks levels are considered in the WREA (e.g. 10% and 20%). The WREA derived estimates of crop RYL estimates nationally and in a county

- sp ecific analysis

. Crop

- specific estimates of O 3 - related RYL nationally were derived for each of the air quality scenarios from the 10 E

- R functions for crops described above combined with information regarding crop distribution (U.S. EPA, 2014b, section 6. 5). The WREA also reported crop RYL results at the county

- level , as well as the number of crop

- producing counties with greater than five percent RYL (U.S. EPA, 2014b, section 6.5.1, Appendix 6B).

 The largest reduction in O 3 - induced crop yield loss and yield changes occurs when moving from the recent conditions scenario to the current standard scenario (U.S. EPA, 2014b, section 6.5). Among the major commercial crops, winter wheat and soybeans are more sensitive to ambient O 3 l evels than other crops.

 In the current standard scenario, n o counties have RYL estimates at or above 5% (U.S. EPA, 2014b, section 6.5). 216

216 In the air quality s cenario for the current standard, a monitor that already met the current standard but was located within the same region as another monitor that was above the current standard would have had its concentration adjusted downward. This is due to the fact that concentrations were adjusted independently for each region , applying reductions to all monitors within the region, such that all monitors located within a region meet the standard (U.S. EPA, 2014b, section 4.3.4.2).*** E.O. 12866 Review

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Page 361 of 668 The WREA also estimated O 3 - related crop impacts on producer and consumer surplus. 217
These are nati onal

- scale estimates of the effects of yield loss on agricultural harvesting, which supply provisioning services of food and fiber for each of the air quality scenarios. Overall effect on agricultural yields and producer and consumer surplus depends on (1) the ability of produ cers/farmers to substitute other crops that are less O 3 sensitive, and (2) the responsiveness, or elasticity, of demand and supply (U.S. EPA, 2014b, section 6.5).

 Estimates of consumer surplus, or consumer gains, were generally higher in the current standa rd scenario in the agricultural sector because higher productivity under lower O 3 concentrations increased total yields and reduced market prices (U.S. EPA, 2014b, Table s 6

- 17 and 6

- 18). Combined gains in producer and consumer surplus for forestry and agri culture were essentially unchanged for the 15 ppm

- hrs scenario, but annualized gains increased by $21 million beyond the current standard scenario for the 11 ppm

- hrs scenario and $231 million for the 7 ppm

- hrs scenario. In some cases, lower prices reduce
p roducer gains more than can be offset by higher yields (U.S. EPA, 2014b, Table 6

- 18).

 Because demand for most agricultural commodities is not highly responsive to changes in price, producer surplus or producer gains often declined. For agricultural welfare , annualized combined consumer and producer surplus gains were estimated to be $2.6
trillion in 2010 for the current standard scenario (U.S. EPA, 2014b, Table 6

- 1 7 ). b. Key Uncertainties

217 Welfare economics focuses on the opt imal allocation of resources and goods and how those allocations affect total social welfare

. Total welfare is also referred to as economic surplus, which is the overall benefit a society, composed of consumers and producers, receives when a good or service is bought or sold, given a quantity provided and a market price

. Economic surplus is divided into two parts: consumer and producer surplus (U.S. EPA, 2014 2014 b , p. ES

6)

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Page 362 of 668 The WREA discusses multiple areas of uncertainty associated with the crop yield loss estimates, including those associated with the model

- based adjustment methodology as well as those associated with the projection of yield loss using the FASOMGHG model at the estimated
O 3 concentrations (U.S. EPA, 2014b, Table 6

- 27, secti on 8.5). Because the W126 estimates generated in the air quality analyses are inputs to the vegetation risk analyses for crop yield loss, any uncertainties in the air quality analyses are propagated into the those analyses (U.S. EPA, 2014b, Table 6

- 27, sec tion 8.5). Therefore, the air quality scenarios in the crop yield analyses have the same uncertainties and limitations as in the biomass loss analyses (summarized above), including those associated with the model

- based adjustment methodology (U.S. EPA, 201 4b, section 8.5).
4

. Visible Foliar Injury Section IV.C.4.a below provides an overview of the assessment in the WREA of O 3 - related visible foliar injury and associated ecosystem services impacts , as well as the key results

. Section IV.C.4.b summarizes the key uncertainties.

a. Overview and Summary of Key Results The WREA presents a number of analyses of O 3 - related visible foliar injury and associated ecosystem services impacts (U.S. EPA, 2014b, Chapter 7). An initial analysis using USFS FHM/FIA biosite dat a included the development of benchmark criteria reflecting different prevalences of visible foliar injury at different W126 exposures and soil moisture conditions. These criteria were then used in a screening

- level characterization of the potential risk o f foliar injury incidence in 214 national parks and a case study assessment of three national parks, which also provides limited characterization of the associated ecosystem services. In the biosite data analysis, the WREA used the biomonitoring site data from the USFS*** E.O. 12866 Review

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Page 363 of 668 FHM/FIA Network (USFS, 2011), 218 associated soil moisture data during the sample years, and national surfaces of ambient air O 3 concentrations based on spatial interpolation of monitoring data from 2006 to 2010 to calculate the proportion of b iosites with any visible foliar injury. The proportion of biosites metric is derived by first ordering the data (across biosites and sample years) by W126 index value estimated for that biosite and year. Then for each W126 index value, the proportion of bi osites is calculated with any foliar injury for all observations at or below that W126 index value. (U.S. EPA, 2014b, section 7.2). This analysis indicates that the proportion of biosites showing the presence of any foliar injury increases rapidly from zer o to about 20 percent at relatively low W126 index values

. Specifically: (1) the proportion of biosites exhibiting foliar injury rises rapidly at with increasing W126 index values below approximately 10 ppm

- hrs (W126 < 10.46 ppm

- hrs), and (2) there is relati vely little change in the proportions above th is proportion with increasing W126 index values of above approximately 10 ppm

- hrs (W126 >10.46
ppm - hrs). The data for biosites during normal moisture years are very similar to the dataset as a whole, with an overall proportion of close to 18 percent for presence of any foliar injury. Among the biosites with a relatively wet season, the proportion of biosites showing injury is much higher and the relationship with annual W126 index value is much steeper. Much l ower proportions of biosites show injury with relatively dry seasons (U.S. EPA, 2014b, section 7.2.3, Figures 7

- 10), consistent with the ISA finding that many studies have shown that dry periods tend to decrease the incidence and severity of O 3 - induced vis ible foliar injury (U.S. EPA, 2013 2013a , section 9.4.2) . While these analyses indicate the potential for foliar injury to occur under conditions that meet the current standard, the extent of foliar injury that might be expected under such

218 Data were not available for several western states (Montana, Idaho, Wyomi ng, Nevada, Utah, Colorado, Arizona, New Mexico, Oklahoma, and portions of Texas).*** E.O. 12866 Review

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Page 364 of 668 conditions is unc lear from these analyses. The national

- scale screening

- level assessment in 214 parks employed benchmark criteria developed from the above analysis. 219 , 220 For example, annual O 3 concentrations corresponding to a W126 index value of 10.46 ppm

- hrs represents the O 3 exposure concentration where the slope of exposure

- response relationship changes for FHM biosites , with the percentage of biosites showing injury remaining relatively constant for higher W126 index values . The WREA refers to this as the “base scenario” benchmark. The W126 benchmarks across this and the other four scenarios range from 3.05 ppm

- hrs ( foliar injury observed at five percent of biosites, normal moisture) up to 24.61 ppm

- hrs ( foliar injury observed at 10 percent of biosites, dry). For the

scen ario of 10 percent biosites with injury, W126 index values were approximately 4, 6, and 25
ppm - hrs for wet, normal and dry years, respectively. The national

- scale screening

- level assessment applied these benchmarks to 42 parks with O 3 monitors and a total of 214 parks with
O 3 exposure estimated from the interpolated national O 3 surfaces for individual years from 2006 to 2010 (U.S. EPA, 2014b, Appendix 7A and section 7.3).

 Based on NPS lists, 95 percent of the 214 parks in th is screening

- level assessment

219 The parks assessed in the WREA include lands managed by the NPS in the continental U.S., which includes National Parks, Monuments, Seashores, Scenic Rivers, Historic Parks , Battlefields, Reservations, Recreation Areas, Memorials, Parkways, Military Parks, Preserves, and Scenic Trails. 220 This analysis considered the approach in Kohut (2007), which assessed the risk of O 3 - induced visible foliar injury on O 3 bioindicators (i.e ., O 3 - sensitive vegetation) in 244 parks managed by the NPS. Consistent with advice from CASAC (Frey and Samet, 2012a), however, the WREA modified the approach used by Kohut (2007) to apply the W126 metric alone. The WREA applied different foliar injury be nchmarks in this assessment after further investigation into the benchmarks applied in Kohut (2007), which were derived from biomass loss rather than visible foliar injury. Kohut cited a threshold of 5.9 ppm

- hrs for highly sensitive species from Lefohn (19 97), which was based on the lowest W126 estimate corresponding to a 10 percent growth loss for black cherry. For soil moisture, Kohut (2007) qualitatively assessed whether there appeared to be an inverse relationship between soil moisture and high O 3 expos ure. Formatted: Subscript Formatted: Subscript Formatted: Subscript

Formatted: Subscript*** E.O. 12866 Review

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Page 365 of 668 con tain at least one vegetation species sensitive to O 3 - induced foliar injury ( U.S. NPS, 2003, 2006).

 In the current standard scenario, n one of the 214 parks had O 3 concentrations estimated to exceed the annual benchmark of a W126 index value above 10.46 ppm - hrs (U.S. EPA, 2014b, section 7.3. 3.3 ). The case study analys e s focused on Great Smoky Mountains National Park (GRSM ), Rocky Mountain National Park (ROMO), and Sequoia and Kings Canyon National Parks (SEKI). Information on visitation patterns, recreati onal activities and visitor expenditures was considered. For example, visitor spending in 2011 exceeded $800 million, $170 million and $97 million dollars in GRSM, ROMO and SEKI, respectively. In each park, the percent cover of species sensitive to foliar injury was estimated and the overlap between recreation areas within the park and elevated W126 concentrations was described. (U.S. EPA, 2014b, section 7.4).

 In the current standard scenario, the three

- year average W126 index values were at or below 7 ppm

- hrs in all areas of two of the three parks (GRSM and SEKI). Three

- year average W126 index values were below 7 ppm

- hrs in a little more than half of the area of the third park (ROMO) and between 7 and 11 ppm

- hrs in the remainder of the park (U.S. EPA, 2014b , section 7.4).

 For the 15, 11 and 7 ppm

- hrs scenarios , all areas of the three specific national parks evaluated ( GRSM, SEKI, and ROM O) had three

- year average W126 index value s at or below 7 ppm

- hrs , well below the 10.46 ppm

- hrs benchmark. However, the ext ent of foliar injury that might be expected under these scenarios is unclear from these analyses. Although not discussed in detail here, the WREA also describes qualitative assessments for some of the ecosystem services most likely to be affected by O 3 - ind uced foliar injury such as*** E.O. 12866 Review

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Page 366 of 668 cultural services, including aesthetic value and outdoor recreation. Aesthetic value and outdoor recreation depend on the perceived scenic beauty of the environment. Many outdoor recreation activities directly depend on the sceni c value of the area, in particular scenic viewing, wildlife

watching, hiking, and camping. These activities and services are of significant importance to public welfare as they are enjoyed by millions of Americans every year and generate millions of dollar s in economic value (U.S. EPA, 2014b, Chapters 5 and 7). Although data are not available to explicitly quantify O 3 effects on ecosystem services, the WREA includes several qualitative analyses. b. Key Uncertainties Uncertainties associated with these analy ses are discussed in the WREA, sections 7.5 and 8.5.3, and in WREA Table 7

- 24 , and also summarized in the PA (e.g., U.S. EPA, 2014c, section 6.3) . As discussed in the WREA (section 8.5.3), evaluating soil moisture is more subjective than evaluating O 3 expo sure because of its high spatial and temporal variability within the O 3 season, and there is considerable subjectivity in the categorization of relative drought. The WREA generally concludes that the spatial and temporal resolution for the soil moisture data is likely to underestimate the potential for foliar injury to occur in some areas. In addition, there is lack of a clear threshold for drought below which visible foliar injury would not occur. In general, low soil moisture reduces the potential for foliar injury, but injury could still occur, and the degree of drought nec essary to reduce potential injury is not clear. Studies in the ISA provide additional information regarding the role of soil moisture in influencing visible foliar injury response, (U.S. EPA, 2 013 2 013 a , section 9.4.2). These studies confirm that adequate s oil moisture creates an environment conducive to greater visible foliar injury in the presence of O 3 than drier conditions. As stated in the ISA, “[a] major modifying factor for O 3 - induced visible foliar injury is the*** E.O. 12866 Review

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Page 367 of 668 amount of soil moisture available to a plant during the year that the visible foliar injury is being assessed ... because lack of soil moisture generally decreases stomatal conductance of plants and, therefore, limits the amount of O 3 entering the leaf that can cause injury” (U.S. EPA,
2013 2013 a , p. 9

- 39). As a result, “many studies have shown that dry periods in local areas tend to decrease the incidence and severity of O 3 - induced visible foliar injury; therefore, the incidence of visible foliar injury is not always higher in years and areas wit h higher O 3 , especially with co

occurring drought (Smith, 2012; Smith et al., 2003)” (U.S. EPA, 2013 2013 a , p. 9

- 39). This “...partial ‘protection’ against the effects of O 3 afforded by drought has been observed in field experiments (Low et al., 2006) and mod eled in computer simulations (Broadmeadow and Jackson, 2000)” (U.S. EPA, 2013 2013 a , p. 9

- 87). In considering the extent of any protective role of drought conditions, however, the ISA also notes that other studies have shown that “drought may exacerbate the effects of O 3 on plants (Pollastrini et al., 2010; Grulke et al., 2003)” and that “[t]here is also some evidence that O 3 can predispose plants to drought stress (Maier

- Maercker, 1998)”. Accordingly, the ISA concludes that “the nature of the response is la rgely species

specific and will depend to some extent upon the sequence in which the stressors oc cur” (U.S. EPA, 2013 2013a , p. 9

- 87). Due to the absence of biosite injury data in the Southwest region and limited biosite data in the West and West North Cent ral regions, the W126 benchmarks for foliar injury that the WREA developed and applied in the national park screening assessment may not be applicable to these regions. The WREA applied the benchmarks from the national

- scale analysis to a screening

- level a ssessment of 214 national parks and case studies of three national parks. Therefore, uncertainties in the foliar injury benchmarks are propagated into the se analyses

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Page 368 of 668 Other uncertainties associated with these analyses include uncertainty associated with o ur understanding of the number and sensitivity of O 3 sensitive species, uncertainties associated with spatial assignment of foliar injury biosite data to 12 km x 12 km grid cells, and uncertainties associated with O 3 exposure data of vegetation and recreat ional areas within parks (U.S. EPA, 2014b, Table 7

- 22). There are also important uncertainties in the estimated O 3 concentrations for the different air quality scenarios evaluated (U.S. EPA, 2014b, section 8.5), as discussed earlier in this section. These uncertainties only apply to the national park case studies because these are the only foliar injury analyses that rely on the air quality scenarios, but any uncertainties in the air quality analyses are propagated into those analyses. The WREA identifies additional uncertainties that are associated with the national park case studies. Specifically, there is uncertaint y inherent in survey estimates of participation rates, visitor spending/economic impacts, and willingness

- to

- pay. These surveys potentially double

- count impacts based on the allocation of expenditures across activities but also potentially exclude other ac tivities with economic value. In general, the national level surveys apply standard approaches, which minimize potential bias. Other sources of uncertainty are associated with the mapping, including park boundaries, vegetation species cover, and park ameni ties, such as scenic overlooks and trails. In general, the WREA concludes that there is high confidence in the park mapping (U.S. EPA, 2014b, Table 7

- 24). D. Conclusions on Adequacy of the Current Secondary Standard The initial issue to be addressed in the current review of the secondary O 3 standard is whether, in view of the currently available scientific evidence, exposure and risk information and air quality analyses, discussed in the PA, the existing standard should be revised. In drawing*** E.O. 12866 Review

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Page 369 of 668 conclusions on adequacy of the current O 3 secondary standard, the Administrator has taken into account both evidence

- based and quantitative exposure

- and risk

- based considerations, and advice from CASAC. Evidence

- based considerations draw upon the EPA’s assessment and
i ntegrated synthesis of the scientific evidence from experimental and field studies evaluating welfare effect s related to O 3 exposure, with a focus on policy

- relevant considerations, as discussed in the PA. Air quality analyses inform these considerations w ith regard to cumulative, seasonal exposures occurring in areas of the U.S. that meet the current standard. Exposure

- and risk

- based considerations draw upon EPA assessments of risk of key welfare effects, including
O 3 effects on forest growth, productiv it y , carbon storage, crop yield and visible foliar injury, expected to occur in model

- based scenarios for the current standard, with appropriate consideration of associated uncertainties. The following sections describe consideration of the evidence and the exposure/risk information in the PA and advice received from CASAC, as well as the comments received from various parties, and the Administrator’s proposed conclusions regarding the adequacy of the current secondary standard. 1. Evidence

- and Exposure/Risk

- Based Considerations in the Policy Assessment Staff assessments in the PA focus on the policy

- relevant aspects of the assessment and integrative synthesis of the currently available welfare effects evidence in the ISA, analyses of air quality relationship s with exposure metrics of interest, the exposure and risk assessments in the WREA , comments and advice of CASAC and public comment on drafts of the PA, ISA and
WREA. T he PA describes evidence

- and exposure/risk

- based considerations and presents staff

conc lusions for the Administrator to consider in reaching her proposed decision on the current standard. The focus of the initial PA conclusions is consideration of the question: Does the*** E.O. 12866 Review

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Page 370 of 668 currently available scientific evidence and exposure/risk information, as reflected in the ISA and WREA, support or call into question the adequacy and/or appropriateness of the protection afforded by the current secondary O 3 standard? The PA’s general approach to informing judgments by the Administrator recognizes that
the a vailable welfare effects evidence demonstrates a range of O 3 sensitivity across studied plant species and documents an array of O 3 - induced effects that extend from lower to higher levels of biological organization. These effects range from those affecting cell processes and individual plant leaves to effects on the physiology of whole plants, as well as the range from species effects and effects on plant communities to effects on related ecosystem processes and services. Given this evidence, the PA notes th at it is not possible to generalize across all studied species regarding which cumulative exposures are of greatest concern, as this can vary by situation due to differences in exposed species sensitivity, the importance of the observed or predicted O 3 - ind uced effect, the role that the species plays in the ecosystem, the intended use of the affected species and its associated ecosystem and services, the presence of other co

- occurring predisposing or mitigating factors, and associated uncertainties and limit ations

. Therefore, in developing conclusions in the PA, staff takes note of the complexity of judgments to be made by the Administrator regarding the adversity of known and anticipated effects to the public welfare and are mindful that the Administrator’s ultimate judgments on the secondary standard will most appropriately reflect an interpretation of the available scientific evidence and exposure/risk information that neither overstates nor understates the strengths and limitations of that evidence and in formation (U.S. EPA, 2014c, section 5.7)

. In considering the estimates of exposures and risks for air quality scenarios assessed in the WREA, the PA: 1) evaluates the weight of the scientific evidence concerning vegetation*** E.O. 12866 Review

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Page 371 of 668 effects associated with those O 3 exposures; 2) considers the importance, from a public welfare perspective, of the O 3 - induced effects on sensitive vegetation and associated ecosystem services that are known or anticipated to occur as a result of exposures in the assessed air quality

sce narios; and, 3) recognizes that predictions of effects associated with any given O 3 exposure may be mitigated or exacerbated by actual conditions in the environment (i.e., co

- occurring modifying environmental and genetic factors). When considering WREA analyses that involve discrete exposure levels or varying levels of severity of effects, the PA’s approach recognizes that the available welfare effects evidence demonstrates a wide range in O 3 sensitivities across studied plant species. The PA additionall y considers the uncertainties associated with this information. As an initial matter, the PA recognizes that the CAA does not require that a secondary standard be protective of all effects associated with a pollutant in the ambient air, but rather those

co nsidered adverse to the public welfare (as described in section IV.B.2 above). In considering the extent to which it may be appropriate to consider particular welfare effects adverse, the PA applies a paradigm used in past reviews. As discussed in section IV.B.2 above, this paradigm recognizes that the significance to the public welfare of O 3 - induced effects on sensitive vegetation growing within the U.S. can vary depending on the nature of the effect, the intended use of the sensitive plants or ecosystems, and the types of environments in which the sensitive vegetation and ecosystems are located. Accordingly, any given O 3 - related effect on vegetation and ecosystems (e.g., biomass loss, crop yield loss, visible foliar injury) may be judged to have a differen t degree of impact on the public welfare depending, for example, on whether that effect occurs in a Class I area, a city park, or commercial cropland. In the last review, the Administrator took note of actions taken by Congress to establish public lands th at are set aside*** E.O. 12866 Review

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Page 372 of 668 for specific uses that are intended to provide benefits to the public welfare, including lands that are to be protected so as to conserve the scenic value and the natural vegetation and wildlife within such areas for the enjoyment of futur e generations (73 FR 16497, March 27, 2008) . Such public lands that are protected areas of national interest include national parks and forests, wildlife refuges, and wilderness areas (73 FR 16497, March 27, 2008). The PA notes that effects occurring in su ch areas would likely have the highest potential for being classified as adverse to the public welfare, given the expectation of preserving these areas to ensure their intended use is met (U.S. EPA, 2014c, section 5.1). In considering uses of vegetation an d forested lands, the paradigm also includes consideration of impacts to ecosystem goods and services. In summary, the paradigm considered in the PA, consistent with the discussion in section IV.B.2 above, integrates the concepts of: 1) variability in publ ic welfare significance given intended use and value of the affected entity, such as individual species; 2) relevance of associated ecosystem services to public welfare; and 3) variability in spatial, temporal, and social distribution of ecosystem services associated with known and anticipated welfare effects

. Further, the PA recognizes that there is no bright

- line rule delineating the set of conditions or scales at which known or anticipated effects become adverse to public welfare. With respect to the s cientific evidence, the PA takes note of the longstanding evidence base that demonstrates O 3 - induced effects that occur across a range of biological and ecological scales of organization, as described in the ISA and summarized in section IV.B.1 above (U.S. EPA, 2013 2013a , p. 1

- 8). Many of the recent studies evaluated in this review have focused on and further increased our understanding of the molecular, biochemical and physiological mechanisms that explain how plants are affected by O 3 in the absence of ot her stressors (U.S. EPA, 2013 2013a , section 9.3). These recent studies, in combination with the extensive and long

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Page 373 of 668 standing evidence, have further strengthened the coherence and consistency of the entire body of research since the last review

. Consistent with conclusions in the 2006 CD AQCD , the ISA determined that a causal relationship exists between O 3 exposure and visible foliar injury on sensitive vegetation, reduced plant growth, reduced productivity in terrestrial ecosystems, reduced yield and quality of agricultural crops and alteration of below

- ground biogeochemical cycles (U.S. EPA, 2013 2013a , Table 1

- 2 and section 2.6)

. The relationship between O 3 exposures and reduced carbon sequestration in terrestrial ecosystems, alteration of terrestrial
ecosy stem water cycling and alteration of terrestrial community composition was concluded to be likely causal (U.S. EPA, 2013 2013a , Table 1

- 2)

. The PA recognizes that consistent with conclusions drawn in the last review, the currently available evidence base also strongly supports that effects on vegetation are attributable to cumulative seasonal O 3 exposures. Moreover, on the basis of the entire body of evidence in this regard, the ISA concludes that “quantifying exposure with indices that cumulate hourly O 3 concentrations and preferentially weight the higher concentrations improves the explanatory power of exposure/response models for growth and yield, over using indices based on mean and peak exposure values” (U.S. EPA, 2013 2013a , p. 2

- 44). Accordingly, as i n other recent reviews, the evidence continues to provide a strong basis for concluding that it is appropriate to judge impacts of O 3 on vegetation, related effects and services, and the level of public welfare protection achieved, using a cumulative, seas onal exposure metric, such as the W126

- based metric. In this review, as in the last review, the CASAC concurs with this conclusion (Frey, 2014c, p. iii). Thus, based on the consistent and well

- established evidence described above, the PA concludes that the most appropriate and biologically relevant way to relate O 3 exposure to plant growth, and to determine what would be adequate protection for public welfare effects*** E.O. 12866 Review

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Page 374 of 668 attributable to the presence of O 3 in the ambient air is to characterize exposures in terms of a cumulative seasonal form, and in particular the W126 metric. In considering the current standard with regard to protection from the array of O 3 - related effects recognized in this review, the PA first considers effects related to forest tree growth, productivity and carbon storage, effects for which the ISA concludes the evidence supports a causal or likely causal relationship with exposures to O 3 in ambient air (U.S. EPA, 2014c, sections 5.2 and 5.7). In so doing, the PA notes that while changes in b iomass affect individual tree species, the overall effect on forest ecosystem productivity depends on the composition of forest stands and the relative sensitivity of trees within those stands. In considering the evidence for these effects and the extent t o which they might be expected to occur under conditions that meet the current secondary standard, the PA focused particularly on RBL estimates for the 11 species for which robust E

- R functions have been developed. The PA recognized that recent studies, su ch as multiple

- year exposures of aspen and birch, have provided additional evidence on tree biomass or growth effects associated with multiple year exposures in the field, including the potential for cumulative and carry

- over effects. For example, findings from these studies indicate that effects of O 3 on birch seeds (reduced weight, germination, and starch levels) could lead to a negative impact on species regeneration in subsequent years and may have the potential to alter carbon metabolism of overwinteri ng buds, potentially affecting growth in the following year. Other studies have reported that multiple

- year exposures reduced tree size parameters in an aspen community, and increased the rate of conversion from a mixed aspen

- birch community to a community dominated by the more tolerant birch, such that elevated O 3 may alter intra

- and inter

- species competition within a forest stand (U.S. EPA, 2013 2013 a , section 9.4.3; U.S. EPA, 2014c, section 5.2). In giving particular attention to tree seedling biomass lo ss estimates, the PA*** E.O. 12866 Review

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Page 375 of 668 notes that CASAC “concurs that biomass loss in trees is a relevant surrogate for damage to tree growth that affects ecosystem services such as habitat provision for wildlife, carbon storage, provision of food and fiber, and pollution r emoval” (Frey, 2014c, p. 10)

. In evaluating the current evidence and exposure/risk information associated with tree growth, productivity and carbon storage, with regard to the adequacy of public welfare protection afforded by the current standard, the P A consider s the evidence of vegetation and welfare impacts in areas of the U.S. likely to have met the current standard. With regard to O 3 effects on tree growth, productivity and carbon storage and associated ecosystems and services, the PA focuses on rel ative biomass loss estimates based on the OTC

- based E

- R functions, noting that analyses newly performed in this review have reduced the uncertainty associated with using
OTC E

- R functions to predict tree growth effects in the field (U.S. EPA, 2014c, sectio n 5.2.1; U.S. EPA, 2013 2013a , section 9.6.3.2). In focusing on RBL estimates, the PA recognized that comparison to an array of benchmarks would be informative to considerations of significance to public welfare

. Included in this array were RBL values of 2% and 6% given emphasis by CASAC (Frey, 2014c). In considering the RBL estimates for different O 3 conditions associated with the current standard, the PA focused first on the median of the species

- specific (composite) E

- R functions. In so doing, the PA ta kes note of CASAC’s comments that a 6% median RBL is “unacceptably high”,*** E.O. 12866 Review

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Page 376 of 668 and that the 2% median RBL is an important benchmark to consider (Frey, 2014c). 221 Based on the summary of RBL estimates in the PA, the PA notes that the median species RBL estimate is at or below 2% for W126 exposure index values less than or equal to 7 ppm

- hrs (U. S. EPA, 2014c, Table 6

- 1 and Appendix 5C)

. The median species RBL is at or above 6% for W126 index values of 19 ppm

- hrs and higher. In recognition of the significance of welfare effects in Class I areas, the PA gives appreciable weight to consideration of the occurrence of O 3 concentrations associated with the potential for RBL estimates above benchmarks of interest in Class I areas that meet the current standard. Based on air quality data for the period from 1998 to 2012, the PA focused consideration on 22 Class I areas , in w hich during one or more three

- year periods the air quality met the current standard and the 3 three

- year average W126 index value was at or above 15 ppm

hrs ( see Table 7 below, drawn from U.S. EPA, 2014c, Table 5

- 2). Across these 22 Class I areas , the highe st single

- year W126 index values for these three

- year periods ranged from 17.4 to 29.0
ppm - hrs. In 2 0 of the areas, distributed across eight states (AZ, CA, CO, KY, NM, SD, UT, WY) and four regions ( W est, S outhwest, W est N orth C entral and C entral), this ra nge was 19.1 to 29.0
ppm - hrs, exposure values for which the corresponding median species RBL estimates equal or exceed 6%, which CASAC has termed “unacceptably high”. R ecogniz ing that in any given year, other environmental factors can influence the extent to which O 3 may have the impact predicted

221 The CASAC provided several comments related to 2% RBL for tree seedlings both with regard to its use in summarizing WREA results and with regard to consideration of the potential significance of vegetation effects, as summarized in sections IV.D.2 a nd IV.E. 3 . In identifying 2% as an important benchmark, CASAC referenced the 1996 workshop sponsored by the Southern Oxidant s Study g roup at which, as noted in section IV.B.2 above, participants identified annual percentages of tree seedling growth reducti on and crop yield loss they considered important to their judgments on a secondary standard . T he workshop report provides no explicit rationale for the percentages identified or specification with regard to number or proportion of species for which such pe rcentages should be met (Heck and Cowling, 1997).*** E.O. 12866 Review

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Page 377 of 668 by the E

- R functions, the PA looked beyond single year occurrences of such magnitudes of W126 index values. For example, focusing on the highest three

- year periods that include these highest annual values for 21 ar eas, the PA notes that in 10 areas (across five states in the W est and S outhwest regions), the three

- year average W126 values ( for the highest three

- year period that includes these annual values) are at or above 19 ppm - hrs , ranging up to 22. 5 ppm - hrs ( for which the median species RBL estimate is above 7%). This indicates that the W126 value above 19 ppm

- hrs is not simply a single year in a period of lower years, but that in these cases there were sustained higher values that contributed to a 3 three

- year W126 also above 19 ppm

- hrs. In terms of the highest three

- year values observed (regardless of single

- year values), the PA additionally notes that the highest three

- year average W126 index value (during periods meeting the current standard) was at or above 19 (ranging up to 22.5 ppm

- hrs) in 1 1 areas, distributed among five states in the W est and S outhwest regions (U.S. EPA, 2014c, Table 5

- 2 , Appendix 5B)

.

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Page 378 of 668 Table 7 . O 3 

### Concentrations in Class I Areas During Period From 1998 to 2012 that Met the Current Standard and Where Three
- year Average W126 Index Value was at or Above 15 ppm
- hrs

Class I Area State / County Design Value (ppb)* 3
- year Average W126

(ppm
- hrs)* (# ≥ 19 ppm

- hrs, range) Annual W126 (ppm
- hrs)* (# ≥ 19 ppm

- hrs, range) Number of 3
- year Periods Bandelier Wilderness Area QA, DF, PP NM / Sandoval 70

- 74 15.8

- 20.8 (2, 20.0

- 20.8) 12.1

- 25.3 (4, 19.2

- 25.3) 8 Bridger Wilderness Area QA, DF WY / Sublette 69

- 72 15.1

- 17.4 9.9

- 19.2 (1, 19.2) 5 Canyonlands National Park QA, DF, PP, UT / San Juan 69

- 73 15.0

- 20.5 (2, 19.8

- 20.5) 9.9

- 24.8 (5, 19.3

- 24.8) 9 Carlsbad Caverns National Park PP NM / Eddy 69 15.0

- 15.3 8.6

- 26.7 (1, 26.7) 3 Chiricahua National Monument DF, PP AZ / Cochise 69

- 73 15.7

- 18.0 13.2

- 21.6 (2, 19.3

- 21.6) 7 Grand Canyon National Park QA, DF, PP AZ / Coconino 68

- 74 15.3

- 22.2 (7, 19.2

- 22.2) 11.3

- 26.7 (7, 19.8

- 26.7) 12 John Muir Wilderness Area QA, DF, PP CA / Inyo 71

- 72 16.5

- 18.6 10.1

- 25.8 (2, 23.9

- 25.8) 3 Lassen Volcanic National Park DF, PP CA / Shasta 75 15.3 13.6

- 18.7 1 Mammoth Cave National Park BC, C, LP, RM, SM, VP, YP KY / Edmonson 74 15.9 12.5

- 22.5 (1, 22.5) 1 Mesa Verde National Park DF CO / Montezuma 67

- 73 15.5

- 21.0 (2, 19.0

- 21.0) 10.7

- 23.6 (4, 19.7

- 23.6) 10 Mokelumne Wilderness Area DF, PP CA / Amador 74 17.6 14.8

- 22.6 (1, 22.6) 1 Petrified Forest National Park AZ / Navajo 70 15.7 12.9

- 19.2 (1, 19.2) 1 Pinnacles National Monument CA / San Benito 74 15.1 13.1

- 17.4 1 Rocky Mountain National Park QA, DF, PP CO / Boulder 73

- 75 15.1

- 19.3 (1, 19.3) 9.5

- 25.1 (5, 20.7

- 25.1) 6 CO / Larimer 74 15.0

- 18.3 8.1

- 25.8 (3, 19.1

- 25.8) 3 Saguaro National Park DF, PP AZ / Pima 69

- 74 15.4

- 18.9 11.0

- 23.1 (3, 20.0

- 23.1) 6 Sierra Ancha Wilderness Area DF, PP AZ / Gila 72

- 75 17.9

- 22.4 (3, 20.2

- 22.4) 14.8

- 27.5 (4, 20.3

- 27.5) 4 Superstition Wilderness Area PP AZ / Maricopa 75 22.4 (1, 22.4) 14.5

- 28.6 (2, 27.4

- 28.6) 1 AZ / Pinal 73

- 75 18.7

- 22.5 (2, 20.8

- 22.5) 14.8

- 29.0 (3, 22.6

- 29.0) 3 Weminuche Wilderness Area QA, DF, PP CO / La Plata 70

- 74 15.0

- 19.1 (1, 19.1) 10.9

- 21.0 (2, 20.8

- 21.0) 5 West Elk Wilderness Area QA, DF CO / Gunnison 68

- 73 15.6

- 20.1 (1, 20.1) 12.9

- 23.9 (3, 21.1

- 23.9) 8 Wind Cave National Park QA, PP SD / Custer 70 15.4 12.2

- 20.6 (1, 20.6) 1 Yosemite National Park QA, DF, PP CA / Tuolumne 73

- 74 20.7

- 20.8 (2, 20.7

- 20.8) 19.7

- 22.1 (4, 19.7

- 22.1) 2 Zion National Park QA, DF, PP UT / Washington 70

- 73 17.8

- 21.1 (2, 20.3

- 21.1) 14.9

- 24.2 (5, 19.3

- 24.2) 4 Formatted: Table title-NPR Formatted: Left: 1"

Formatted Table Formatted: Font: Times New Roman Formatted: Font: Times New Roman

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Page 379 of 668 *Based on data from http://www.epa.gov/ttn/airs/airsaqs/detaildata/downloadaqsdata.htm

. W126 values are truncated after first decimal place. Superscript letters refer to species present for which E

- R functions have been developed

. QA=Quaking Aspen, BC=Black Cherry, C=Cottonwood, DF=Douglas Fir, LP=Loblolly Pine, PP=Ponderosa Pine, RM=Red Maple, SM=Sugar Maple, VP=Virginia Pine, YP=Yellow (Tulip) Poplar

. Sources include USDA

- NRCS (2014, http://plants.usda.gov ), USDA

- FS (2014, http://www.fs.fed.us/foresthealth/technology/nidrm2012.shtml ) UM

- CFCWI (2014, http://www.wilderness.net/printFactSheet.cfm?WID=583 ) and Phillips and Comus (2000). Formatted: Default Paragraph Font, Font: (Default) Times New Roman, 12 pt
Formatted: Default Paragraph Font, Font: (Default) Times New Roman, 12 pt Formatted: Default Paragraph Font, Font: 12 pt Formatted: Default Paragraph Font, Font: (Default) Times New Roman, 12 pt Formatted: Font: Times New Roman*** E.O. 12866 Review

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Page 380 of 668 In considering the data analysis for 2 2 Class I areas described above, the PA additionally consider s the species

- specific RBL estimates for quaking aspen and ponderosa pine, two tree species that are found in many of these 22 area s and have a sensitivity to O 3 exposure that places them near the middle of the group for which E

- R functions have been establ ished (U.S. EPA, 2014c, sections 5.2 and 5.7). In the Class I areas where ponderosa pine is present, the highest single year W12 6 index values ranged from 18.7 to 29.0 ppm

- hrs and the highest 3 three

- year average W126 values in which these single year value s we re represented ranged from 15 to 22.5
ppm - hrs, with these three

- year values above 19 ppm

- hrs in eight areas across five states . The
p onderosa p ine RBL estimates for 29 and 22.5 ppm

- hrs are approximately 12% and 9%, respectively (U.S. EPA, 2014c, Append ix 5C). In Class I areas where quaking aspen is present, the highest single year W12 6 i ndex values ranged from 19.2 to 26.7 ppm

- hrs and the highest
3 three

- year average W126 values in which these single year values we re represented ranged from 15.0 to 22.2 ppm - hrs, with these three

- year values above 19 ppm

- hrs in eight areas across five states. The quaking aspen RBL estimates for 26.7 and 22.2 ppm

- hrs are approximately 16% and 13%, respectively (U.S. EPA, 2014c, Appendix 5C). The PA describes the above obse rvations, particularly in light of advice from CASAC, summarized in section IV.D.2 below, as evidence of the occurrence in Class I areas during periods where the current standard is met of cumulative seasonal O 3 exposures of a magnitude for which the tree growth impacts indicated by the estimated median species RBL might reasonably be concluded to be important to public welfare (U.S. EPA, 2014c, sections 5.2.1 and 5.7)

. In considering the WREA analyses of effects on tree growth and associated ecosystem

se rvices in the air quality scenario for the current standard, the PA first takes note of the potential Formatted: Left: 1"*** E.O. 12866 Review

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Page 381 of 668 for the interpolation method used in creating the national surface of O 3 concentrations for the air quality scenarios to underestimate the higher W126 val ues such that W126

- based exposures would be expected to be somewhat higher than those included in each scenario (U.S. EPA, 2014b, pp. 5

- 31 to 5

- 32). While recognizing this, the PA considers results of the WREA analyses for the current standard scenario and the 11 species of trees, for which robust E

- R functions are available. These results indicate that O 3 can impact growth of these species across the U.S

. , as well as an array of associated ecosystem services provided by forests , including timber production , carbon storage and air pollution removal (U.S. EPA, 2014b, sections 6.2

- 6.8; U.S. EPA, 2014c, section 5.2). With regard to WREA analyses of ecosystem services, the PA notes that the national

scale analysis of O 3 impacts on carbon storage indicates appreciably more storage in the air quality scenario for the current standard (approximately 11,000 MMtCO 2 e, over 30 years) compared to the scenario for recent, higher O 3 conditions (U.S. EPA, 2014b, Appendix 6B, Table B

- 10). The PA additionally considers the WREA estimates of tree growth and ecosystem services provided by urban trees over a 25

- year period for five urban areas based on case

- study scale analyses that quantified the effects of biomass loss on carbon storag e and pollution removal (U.S. EPA, 2014b, sections 6.6.2 and 6.7; U.S. EPA, 2014c, sections 5.2 and 5.7). The urban areas included in this analysis represent diverse geography in the Northeast, Southeast, and Central regions, although they do not include a n urban area in the western U.S. Estimates of the effects of O 3 - related biomass loss on carbon sequestration indicate the potential for an increase of somewhat more than a MMtCO 2 e for the current standard scenario as compared to the recent conditions scena rio (U.S. EPA, 2014b, section 6.6.2 and Appendix 6D; U.S. EPA, 2014c, sections 5.2 and 5.7). The PA also notes the WREA estimates of increased pollution removal in*** E.O. 12866 Review

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Page 382 of 668 the current standard scenario as compared to the scenario for recent conditions (U.S. EPA,
2 014b, section 6.6.2; U.S. EPA, 2014c, section 5.2.2). In considering the significance of these WREA analyses of risks for the associated ecosystem services for timber production, air pollution removal, and carbon sequestration, the PA takes note of the lar ge uncertainties associated with these analyses (see U.S. EPA, 2014b, Table 6

- 27), and the potential for these findings to underestimate the response at the national scale. While noting the potential usefulness of considering predicted and anticipated impa cts to these services in assessing the extent to which the current information supports or calls into question the adequacy of the protection afforded by the current standard, the PA also notes that staff places limited weight on the absolute magnitude of the risk results for these ecosystem service endpoints due to the identification of significant associated uncertainties (U.S. EPA, 2014c, sections 5.2 and 5.7). In reaching conclusions regarding support for the adequacy of the current secondary standard provided by the currently available information on O 3 - induced effects on trees and associated services, the PA takes note of: 1) the robust evidence supporting the causal relationship between cumulative O 3 exposures and effects on tree growth and producti vity, and information from model simulations supporting the determination of a likely causal relationships for carbon storage in terrestrial ecosystems (U.S. EPA, 2013 2013 a , sections 2.6.2.1 and 9.4.3); 2) the tree seedling E

- R functions evidence, which ha s been strengthened and demonstrates variability in sensitivity to O 3 across species; 3) estimates of median species RBL at or above 6% associated with W126

- based exposure levels in several areas when O 3 concentrations were at or below the current standard ; 4) growth effects estimates associated with exposure concentrations in several Class I areas based on O 3 concentrations from 1998

- 2012 that were at or below the*** E.O. 12866 Review

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Page 383 of 668 current standard; 5) evidence that impacts from single year exposures can carry over to the

s ubsequent year and/or cumulate over multiple years with repeated annual exposures; 6) evidence from recent mechanistic studies and field based studies that support earlier findings from OTC studies; and 7) WREA analyses indicating that O 3 - induced biomass l oss can impact ecosystem services provided by forests, including timber production, carbon storage, and air pollution removal, even when air quality is adjusted to just meet the current standard

. Given the above, and noting CASAC views (described in secti on IV.D.2 below), the PA concludes that the current evidence and exposure/risk information call into question the adequacy of public welfare protection afforded by the current standard from the known and anticipated adverse effects associated with O 3 - induc ed impacts on tree growth, productivity and carbon storage, including the associated ecosystem services assessed in this review. Therefore, the PA concludes that it is appropriate to consider revision of the secondary standard to provide increased protecti on. With respect to crops, the PA takes note of the extensive and long

- standing evidence on the detrimental effect of O 3 on crop production, which continues to be confirmed by newly available evidence (U.S. EPA, 2013 2013a , section 9.4.4; U.S. EPA, 2014c, sections 5.3 and 5.7). The PA additionally notes that recent studies have highlighted the effects of O 3 on crop quality, such as through decreases in the nutritive quality of grasses, and in the macro

- and micro

- nutrient concentrations in fruits and vegeta ble crops (U.S. EPA, 2013 2013a , section 9.4.4; U.S. EPA, 2014c, section 5.3). Further, the PA notes that there has been little published evidence that crops are becoming more tolerant of O 3 , taking note particularly of the ISA analyses of data from cultivars used in NCLAN studies, and yield data for modern cultivars from SoyFACE which confirm that the average response of soybean yield to O 3 exposure has not changed in current cultivars (U.S. EPA, 2006a; U.S. EPA, 2013, section 9.6.3; U.S. EPA, 2014c, section 5.3). The*** E.O. 12866 Review

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Page 384 of 668 PA further takes note of a recent analysis of satellite and ground

- based O 3 measurements to assess yield loss associated with ambient O 3 concentrations during the 2002 through 2006 growing seasons over the continuous tri

- state area of I llinois, Iowa, and Wisconsin. This analysis found that O 3 concentrations contributed to reduced soybean yield, which correlates well with the previous results from FACE

- and OTC

- type experiments (U.S. EPA, 2013, section 9.4.4.1). 2013a, section 9.6.3; U.S. EPA, 2014c, section 5.3). In consideration of the currently available evidence for O 3 effects on crops, the PA concludes that the recently available evidence, as assessed in the ISA, continues to support the conclusions of the 1996 and 2006 CDs that ambien t O 3 concentrations can reduce the yield of major commodity crops in the U.S, and that the currently available evidence continues to support the use of the E

- R functions developed for 10 crops from OTC experiment data. Further, the PA recognizes that impor tant uncertainties have been reduced regarding the exposure

- response functions for crop yield loss, especially for soybean, the second

- most planted field crop in the U.S., 222 with the ISA generally reporting consistent results across exposure techniques and across crop varieties (U.S. EPA, 2013 2013a , section 9.6.3.2)

. With regard to consideration of the quantitative impacts of O 3 on crop yield, the PA considers RYL estimates for O 3 conditions associated with the current standard

. As in the case of the PA c onsiderations of RBL estimates for tree seedlings, the PA recognized CASAC comments, which described greater than 5% RYL for the median crop species as “unacceptably high” and 5% RYL for the median crop species as adverse, while noting the opportunities to alter management of annual crops (Frey, 2014c, pp. iii and 14)

. T he PA notes that staff analyses of recent monitoring data (2009

- 2011) indicate that O 3 concentrations in multiple agricultural areas

222 See http://www.ers.usda.gov/topics/crops/soybeans

- oil

- crops/background.as px .*** E.O. 12866 Review

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Page 385 of 668 in the U.S. that meet the current standard correspond to W126 index levels above 12 ppm

- hrs, a value for which soybean RYL estimates are greater than 5%. In particular, the PA notes that while the design values for two counties in the Midwest met the current standard in 2009

- 2011, both had a maximum annual W126 of 19 ppm

- hrs (in 2011) for which the soybean annual RYL estimate, based on the E

- R function, is 9%. 223 In considering the evidence and exposure/risk

- based information for effects on crops, the PA notes the CASAC comments regarding the use of crop yields as a surrogate for consideration of public welfare impacts, in which it noted that “[c]rops provide food and fiber services to humans” and that “[e]valuation of market

- based welfare effects of O 3 exposure in forestry and agricultural sectors is an appropriat e approach to take into account damage that is adverse to public welfare” (Frey, 2014c, p. 10; U .S. EPA, 2014c, section 5.7)

. The PA additionally notes, however, as recognized in section IV.B.2 above that the determination of the point at which O 3 - induced crop yield loss becomes adverse to the public welfare is still unclear, given that crops are heavily managed with additional inputs that have their own associated markets and that benefits can be unevenly distributed between producers and consumers. The P A further notes that to the extent protection is provided by the current standard with regard to impacts on trees, protection may also be provided for commodity crops (U.S. EPA, 2014c, sections 5.3 and 5.7)

. In reaching conclusions regarding support prov ided for the adequacy of the current secondary standard by the currently available information on O 3 - related crop effects, the PA

223 The monitoring data reflect observations in locations that meet the current standard. The WREA analysis that assessed crop yield loss used a model

- developed air quality scenario to reflect air quality associated with the current standard (as described in section IV.C.1 above). In so doing, adjustments are made to create air quality that me ets the standard and when the highest monitor in an area is adjusted downward to meet the standard, concentrations at nearby monitors that already meet the standard are also reduced.*** E.O. 12866 Review

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Page 386 of 668 notes: (1) the clear and robust evidence supporting the support for a causal relationship between cumulative O 3 exposures and effects on crop yields and quality (U.S. EPA, 2013 2013a , section 9.4.4); (2) the evidence supporting E

- R functions for 10 crops, which has been strengthened in this review and which demonstrates variability in sensitivity to O 3 across specie s; (3) evidence from recent mechanistic studies and field based studies supporting earlier findings from OTC studies; (4) evidence that crops, and in particular soybean, have not become more toler ant of O 3 (U.S. EPA, 2013 2013 a , section 9.6.3, 9.4.4.1); and , ( 5) WREA analysis results indicating that
O 3 - induced crop yield loss can impact producer and consumer surpluses and the interaction between agriculture and timber production. With regard to visible foliar injury, the PA recognizes the long

- standing evid ence that has established that O 3 causes diagnostic visible injury symptoms on studied bioindicator species and that soil moisture is a major confounding effect that can decrease the incidence and severity of visible foliar injury under dry conditions and vice versa (U.S. EPA, 2014c, sections 5.4 and 5.7). As at the time of the last review, the most extensive dataset regarding visible foliar injury incidence across the U.S. is that collected by the U.S. Forest Service (USFS) Forest Health Monitoring/Forest Inventory and Analysis (FHM/FIA) Program , which has documented incidence of visible foliar injury in both the eastern and western U.S

. Evidence available in the current review includes studies using controlled exposures as well as multi

- year field surveys . In addition to supporting prior conclusions, the newly available studies also address some uncertainties identified in the last review, such as the influence of soil moisture on visible injury development (U.S. EPA, 2013 2013a , section 9.4.2). As stated i n the ISA, “many studies have shown that dry periods in local areas tend to decrease the incidence and severity of O 3 - induced visible foliar injury; therefore, the incidence of visible foliar injury is not always higher in years*** E.O. 12866 Review

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Page 387 of 668 and areas with higher O 3 , e specially with co

- occurring drought” (U.S. EPA, 2013 2013a , p. 9

- 39). The ISA additionally concludes, however, that “the nature of the response is largely species

specific and will depend to some extent upon the sequence in which the stressors occur” (U.S. EPA, 2013 2013a , p. 9

- 87). As recognized in the PA, this area of uncertainty complicates characterization of the potential for visible foliar injury and its severity or extent of occurrence for any given air quality conditions and thus complicates identific ation of air quality conditions that might be expected to provide a specific level of protection from this effect (U.S. EPA, 2014c, sections 5.4 and 5.7)

. Information available in this review indicates the occurrence of visible foliar injury in some Clas s I areas during times when O 3 concentrations met or would be expected to meet the current standard (U.S. EPA, 2014c, sections 5.4.1 and 5.7). In noting this occurrence in Class I areas, the PA notes it has particular public welfare significance in light o f direction from Congress that these areas merit a high level of protection (U.S. EPA, 2014c, sections 5.1, 5.4.1 and 5.7). T he PA also notes that visible foliar injury surveys are used by the federal land managers to assess potential O 3 impacts in Class I areas (USFS, NPS, FWS, 2010)

. Given this focus on visible foliar injury, the PA concludes that such O 3 - induced impacts have the potential to impact the public welfare in scenic and/or recreational areas on an annual basis. Visible foli ar injury is associated with important cultural and recreational ecosystem services to the public, such as scenic viewing, wildlife

- watching, hiking, and camping, that are of significance to the public welfare and enjoyed by millions of Americans every yea r, generating millions of dollars in economic value (U.S. EPA, 2 014b, section 7.1). In addition, several tribes have indicated that many of the O 3 - sensitive species (including bioindicator species) are culturally significant (U.S. EPA, 2014c, Table 5

- 1). W ith respect to agricultural species, such visible effects of O 3 exposure*** E.O. 12866 Review

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Page 388 of 6 68 can affect the market value of certain crops and ornamentals for which leaves are the product, such as spinach (U.S. EPA, 20 06b 20 06a , p . AX

- 9

- 189 )

. The PA additionally notes CASAC

co mments that “visible foliar injury can impact public welfare by damaging or impairing the intended use or service of a resource”, including through “visible damage to ornamental or leafy crops that affects their economic value, yield, or usability; visible damage to plants with special cultural significance; and visible damage to species occurring in natural settings valued for scenic beauty or recreational appeal” (Frey, 2014c, p. 10). With regard to the exposure and risk

- based information, the PA takes no te of the WREA analyses of the nationwide dataset (2006

- 2010) for USFS/FHM biosites, including the observation that the proportion of biosites with injury varies with soil moisture conditions and O 3 W126 index values (U.S. EPA, 2014b, Chapter 7, Figure 7

- 1 0; U.S. EPA, 2014c, section 5.4.2). These analyses indicate that the proportion of biosites showing visible foliar injury incidence increases steeply with W126 index values up to approximately 10 ppm

- hrs, with little difference in incidence across higher W 126 index levels. The screening

- level assessment of national parks indicated that risk of visible foliar injury is likely to be lower in most national parks after simulating just meeting the current standard , although visible foliar injury would likely con tinue to occur at lower O 3 exposures, including some sensitive species growing in National Parks and other Class I areas that may provide important cultural ecosystem services to the public. The PA also notes the WREA recognition that many of the outdoor recreational activities which directly depend on the scenic value of the area are of significant importance to public welfare as they are enjoyed by millions of Americans every year and generate millions of dollars in economic value (U.S. EPA, 2014b, Chapt er 5, Chapter 7).*** E.O. 12866 Review

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Page 389 of 668 In reaching conclusions regarding support for the adequacy of the current secondary standard provided by the currently available information on O 3 - induced visible foliar injury, the PA took note of: (1) the evidence for many species of n ative plants, including trees, that have been observed to have visible foliar injury symptoms in both OTC and field settings, some of which have also been identified as bioindicators of O 3 exposure by the USFS; (2) the finding that visible foliar injury in cidence can occur at very low cumulative exposures, but due to confounding by soil moisture and other factors, it is difficult to predictively relate a given O 3 exposure to plant response; (3) information indicating the occurrence of visible foliar injury in some Class I areas under air quality conditions expected to meet the current standard; and, (4) WREA analyses, based on USFS biosite data, indicating a relationship of the proportion of biosites showing visible foliar injury incidence with W126 index va lues below approximately 10
ppm - hrs (U.S. EPA, 2014c, section 5.7)

. The PA additionally recognizes a lack of guidance for federal land managers regarding what spatial scale or degree of severity of visible foliar injury is considered sufficient to trigge r protective action for O 3 sensitive AQRVs. Further, there does not appear to be any consensus in the literature in this regard, and CASAC, while identifying benchmarks to consider for percent biomass loss and yield loss for tree seedlings and commodity cr ops, respectively, did not provide a similar recommendation for this endpoint. Likewise, as in previous reviews, the ISA notes the difficulty in relating visible foliar injury symptoms to other vegetation effects such as individual plant growth, stand grow th, or ecosystem characteristics (U.S. EPA, 2013 2013a , section 9.4.2, p.
9

- 39) and further notes that the full body of evidence indicates that there is wide variability in this endpoint, such that although evidence shows visible foliar injury can occur und er very low cumulative O 3 concentrations, “...the degree and extent of visible foliar injury development*** E.O. 12866 Review

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Page 390 of 668 varies from year to year and site to site..., even among co

- members of a population exposed to similar O 3 levels, due to the influence of co

- occurring envi ronmental and genetic factors” (U.S. EPA, 2013 2013a , section 9.4.2, p. 9

- 38)

. Given the above, and taking note of CASAC views, the PA recognizes visible foliar injury as an important O 3 effect which, depending on severity and spatial extent, may reasonab ly be concluded to be of public welfare significance, especially when occurring in nationally protected areas. While noting the uncertainties associated with describing the potential for visible foliar injury and its severity or extent of occurrence for an y given air quality conditions, the PA notes the occurrence of O 3 - induced visible foliar injury in areas, including federally protected Class I areas that meet the current standard, and suggests it may be appropriate to consider revising the standard to ac hieve greater protection, while recognizing that the degree to which
O 3 - induced visible foliar injury would be judged important and potentially adverse to public welfare is uncertain (U.S. EPA, 2014c, section 5.7). With regard to other welfare effects, fo r which the ISA determined a causal or likely causal relationships with O 3 in ambient air, such as alteration of ecosystem water cycling and changes in climate, the PA concludes there are limitations in the available information which affect our ability to consider potential impacts of air quality conditions associated with the current standard. In reaching conclusions on options for the Administrator’s consideration, the PA indicates that the final decision to retain or revise the current secondary O 3 stan dard is a public welfare policy judgment to be made by the Administrator, based on her judgment as to what level of air quality would be requisite (i.e., neither more nor less stringent than necessary) to protect the public welfare from any known or antici pated adverse effects. This final decision will*** E.O. 12866 Review

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Page 391 of 668 draw upon the available scientific evidence for O 3 - attributable welfare effects and on quantitative analyses of vegetation and ecosystem exposures and associated risks to vegetation, ecosystems and their asso ciated services, and judgments about the appropriate weight to place on the range of uncertainties inherent in the evidence and analyses. In making this decision, the Administrator will need to weigh the importance of these effects and their associated eco system services in the overall context of public welfare protection. Based on the considerations described in the PA and summarized here, the PA concludes that the currently available evidence and exposure/risk information call into question the adequacy of the public welfare protection provided by the current standard and provides support for considering potential alternative standards to achieve increased public welfare protection, especially for sensitive vegetation and ecosystems in federally protected Class I and similar ly protected areas. In this conclusion, staff give s particular weight to the evidence indicating the

occurrence in Class I areas that meet the current standard of cumulative seasonal O 3 exposures associated with estimates of tree growt h impacts of a magnitude that may reasonably be considered important to public welfare

. 2. CASAC Advice Beyond the evidence

- and exposure/risk

- based considerations in the PA discussed above, the EPA’s consideration of the adequacy of the current secondary standard also takes into account the advice and recommendations of CASAC

. In its advice offered in the current review, based on the updated scientific and technical record since the 2008 rulema king, the CASAC stated that they “support the conclusion in the Second Draft PA that the current secondary standard is not adequate to protect against current and anticipated welfare effects of ozone on vegetation” (Frey, 2014c, p. iii) and that the PA*** E.O. 12866 Review

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Page 392 of 668 “ cl early demonstrates that ozone

- induced injury may occur in areas that meet the current standard” (Frey, 2014c, p. 12). The Panel further stated “[w]e support EPA’s continued emphasis on Class I and other protected areas” (Frey, 2014c, p. 9). Additionally, t he CASAC indicated support for the concept of ecosystem services “as part of the scope of characterizing damage that is adverse to public welfare” and “concurs that trees are important from a public welfare perspective because they provide valued services to humans, including aesthetic value, food, fiber, timber, other forest products, habitat, recreational opportunities, climate regulation, erosion control, air pollution removal, and hydrologic and fire regime stabilizatio n” (Frey, 2014c, p. 9). Similar to comments from CASAC in the last review, including comments on the proposed reconsideration, t he current CASAC also endorsed the PA discussions and conclusions on biologically relevant exposure metrics and the focus on the W126 index accumulated over a 12

- hour period (8am

– 8pm) over the three

- month summation period of a year resulting in the maximum value (Frey, 2014c, p. iii)

. In addition, CASAC stated that “relative biomass loss for tree species, crop yield loss, and visible foliar injury are appropriat e surrogates for a wide range of damage that is adverse to public welfare” (Frey, 2014c, p. 10). With respect to relative biomass loss for tree species, CASAC states that it is appropriate to “include levels that aim for not greater than 2% RBL for
the med ian tree species” and that a media n tree species RBL of 6% is “unacceptably high." With respect to crop yield loss, CASAC points to a benchmark of 5%, stating that a crop RYL for median species over 5% is “unacceptably high ” (Frey, 2014c, p. 13). 3. Admini strator’s Proposed Conclusions on Adequacy of the Current Standard In considering the adequacy of the current secondary O 3 standard, the Administrator has considered the assessment of the current evidence in the ISA , findings of the WREA, including*** E.O. 12866 Review

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Page 393 of 668 associ ated limitations and uncertainties, considerations and staff conclusions and associated rationales presented in the PA, views expressed by CASAC, and public comments

. In taking into account the information discussed above with regard to the nature of O 3 - related effects on vegetation , the Administrator has taken particular note of: the PA analysis of the magnitude of tree seedling growth effects (biomass loss) estimated for different cumulative, seasonal, concentration

- weighted exposures in terms of the W126 metric; the monitoring analysis in the PA of W126 exposures occurring in locations where the current standard is met, including those locations in C lass I areas, and associated estimates of tree seedling growth effects; the analyses in the W REA illust rating the geographic distribution of tree species for which E

- R functions are available and relative differences estimated for O 3 - related growth impacts across areas of the U.S. for the air quality scenarios , taking into account the identified potential f or the WREA’s scenario for the current standard to underestimate the highest W126

- based O 3 values that would be expected to occur. As an initial matter, the Administrator recognizes the appropriateness and usefulness of the W126 metric, as described in se ctions IV.B.1 and IV.D.1 above, in evaluating O 3 exposures of potential concern for vegetation effects. In so doing, the Administrator additionally notes support conveyed by CASAC for such a use for this metric. With regard to considering the adequacy of p ublic welfare protection provided by the current secondary standard, the Administrator focuses first on welfare effects related to reduced native plant growth and productivity in terrestrial ecosystems, taking note of the ISA conclusion of a causal relatio nship between O 3 in the ambient air and these effects. In considering the assessment of the information available in this review with regard to O 3 effects on vegetation growth and productivity, the Administrator takes note of the evidence from OTC studies of the*** E.O. 12866 Review

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Page 394 of 668 effects of O 3 exposure on tree seedling growth that support robust E

- R functions for 11 tree seedling species, and the characterization of growth effects across these species for different cumulative seasonal concentration

- weighted exposures using t he W126 metric. Reductions in growth of sensitive species, as recognized in section IV.B above, have the potential to result in effects on ecosystem productivity, as well as, on forest and forest community composition. The Administrator takes particular no te of the evidence, described in section IV.D.1 above, of the occurrence in Class I areas during periods where the current standard is met of cumulative seasonal O 3 exposures for which median species RBL estimates are of a magnitude that CASAC has termed “ unacceptably high .” In so doing, the Administrator also takes note of a number of actions taken by Congress to establish public lands that are set aside for specific uses intended to provide benefits to the public welfare, including lands that are to be pr otected so as to conserve the scenic value and the natural vegetation and wildlife within such areas for the enjoyment of future generations

. Such public lands that are protected areas of national interest include national parks and forests, wildlife refu ges, and wilderness areas (many of which have been designated Class I areas). 224
W hile recognizing the variability in the various environmental factors that can influence the occurrence and severity of the effect of ambient O 3 concentrations on vegetation in different locations, the Administrator concludes that the information referenced above including the currently available, extensive evidence base and also factors affecting the significance of impacts to public welfare, as well as WREA estimates regarding the potential for occurrence of impacts important to public welfare, provides an appropriate b asis to inform a conclusion as to whether

224 As noted in section IV.A above, Congress has established areas such as national parks and wilderness areas with specific purposes including the preservation of the areas for future generations, and has identified many of those areas as Class I areas

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Page 395 of 668 the current standards provide adequate protection against O 3 - related vegetation effects on public welfare

. With regard to the results of the monitoring analysis, the Administrator takes note of the PA conclusions that the impacts on tree growth ( and the potential for associated ecosystem effects ) estimated for W126 values found to occur in C lass I areas when meeting the current standard are reasonably concluded to be important from a public welfare standpoint in terms of both the magnitude of the vegetation effects and the significance to public welfare of such effects in such areas, calling into question the adequacy of the current secondary standard

. The Administrator also recognizes t he causal relationship s between O 3 in the ambient air and visible foliar injury, reduced yield and quality of agricultural crops and alteration of below

grou nd biogeochemical cycles associated with effects on growth and productivity. As to visible foliar injury, the Administrator takes note of the complexities and limitations in the evidence base regarding characterizing air quality conditions with respect to the magnitude and extent of risk for visible foliar injury

. She additionally recognizes the challenges of associated judgments with regard to adversity of such effects to public welfare

. In taking note of the conclusions with regard to crops, s he recogni zes the complexity of considering adverse O 3 impacts to public welfare due to the heavy management common for achieving optimum yields and market factors that influence associated services and additionally takes note of the PA conclusions that placing emph asis on the protection afforded to trees inherently also recognizes a level of protection afforded for crops

. Based on her consideration of the conclusions in the PA , and with particular weight given to PA findings pertaining to tree growth

- related effects , as well as with consideration of CASAC’s conclusion that the current standard is not adequate, the Administrator pro poses to conclude that the current standard is not requisite to protect public welfare from known or*** E.O. 12866 Review

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Page 396 of 668 anticipated effects and that revision is needed to provide increased public welfare protection, especially for sensitive vegetation and ecosystems in federally protected Class I areas and in other areas providing similar public welfare benefits. T he Administrator further conclude s that the scientific evidence and quantitative analyses on tree growth

- related effects provide strong support for consideration of alternative standards that would provide increased public welfare protection beyond that afforded by the current O 3 secondary standard. She further notes that a revised standard would provide increased protection for other growth

- related effects, including for carbon storage and for areas for which it is more difficult to determine public welfare significance, as recognized in s ection IV.B.2 above, as well other welfare effects of O 3 , including visible foliar injury and crop yield loss.
In giving particular focus to tree growth

- related effects of O 3 on public welfare, the Administrator additionally recognizes that there are alte rnative approaches to viewing the evidence and information, including alternative approaches to viewing, evaluating, and weighing important uncertainties. In some cases, these alternative approaches have been expressed by public commenters, leading some pu blic commenters to recommend retaining the current standard. Given these alternative views, in addition to proposing to revise the current secondary standard, the Administrator also solicits comment on the option of retaining the standard without revision

. E. Consideration of Alternative Secondary Standards Given her proposed conclusion that the current secondary standard is inadequate, the Administrator has then considered what revisions to the standard may be appropriate, focusing on revisions to the key standard elements of indicator, form, averaging time, and level. On the basis of the strength and coherence of the vegetation effects evidence indicating a cumulative,*** E.O. 12866 Review

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Page 397 of 668 seasonal, concentration

- weighted metric as the most appropriate approach for judging pot ential impacts of and protection from O 3 in ambient air, the Administrator judges that it is appropriate to consider revisions to the secondary standard that reflect this understanding and to use such a metric in identifying an appropriate level of protect ion and considering the protection afforded by potential alternative standards. The Administrator also judges that the current averaging time and form may also provide protection to vegetation when set at an appropriate level. Therefore, the Administrator considered whether revision to the level of the current secondary standard might provide sufficient protection to also achieve the level of air quality that is determined requisite to protect the public welfare. The sections below address the indicator fo r the secondary standard (section IV.E.1), consideration of a cumulative, seasonal exposure

- based standard in the PA (section IV.E.2), CASAC advice and public input (section IV.E.3), analyses of air quality in the PA and subsequent to the PA (section IV.E. 4) and the Administrator’s proposed conclusions regarding an alternative secondary standard (section IV.E.5) 1. Indicator In the last review of the air quality for O 3 and other photochemical oxidants and of the O 3 standard, as in other prior reviews, the EPA focused on a standard for O 3 as the most appropriate surrogate for ambient photochemical oxidants. Ozone is a long

- established surrogate for ambient photochemical oxidants, among which it is by far the most widely studied with regard to effects on welf are and specifically on vegetation. The information available in this review adds to the understanding of the atmospheric chemistry for photochemical oxidants an d O 3 in particular (as described in the ISA, sections 3.2 and 3.6, and summarized in section 2.2 in the PA ). The 1996 Staff Paper noted that the database on vegetation effects is generally considered to raise concern*** E.O. 12866 Review

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Page 398 of 668 at levels found in the ambient air for O 3 an d, therefore, control of ambient O 3 levels has previously been concluded to provide the best means of controlling other photochemical oxidants of potential welfare concern (U.S. EPA, 1996b, p. 277). In the current review, while the complex atmospheric chem istry in which O 3 plays a key role has been highlighted, no alternatives to O 3 have been advanced as being a more appropriate surrogate for ambient photochemical oxidants. Ozone continues to be the only photochemical oxidant ( other than nitrogen dioxide ) t hat is routinely monitored and for which a comprehensive database exists (U.S. EPA, 2013 2013 a , section 3.6). Thus, the Administrator concludes that ozone is the appropriate indicator and proposes to continue to use O 3 as indicator for a secondary standard that is intended to address effects associated with exposure to O 3 , alone and in combination with related photochemical oxidants. In so doing, the Administrator recognizes that measures leading to reductions in ecosystem exposures to O 3 will also reduce e xposures to other photochemical oxidants. 2. Consideration of a Cumulative, Seasonal Exposu re - based Standard in the Policy Assessment
I n recognition of the extensive evidence supporting a cumulative, seasonal exposure index as a biologically relevant metri c for assessing potential for O 3 effects on vegetation , discussed in sections IV.B.1 above, as well as advice from CASAC in the current and last O 3 NAAQS reviews, summarized in sections IV.D.3 above and IV.E.3 below, the PA focused its consideration of alt ernative standards on a revised secondary standard based on a cumulative, seasonal, concentration

- weighted form. The PA consider ed the currently available information that has been critically analyzed and characterized in the ISA, the risk and exposure inf ormation presented in the WREA, and CASAC advice and public comment w ith regard to support for*** E.O. 12866 Review

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Page 399 of 668 consideration of options for alternative standards that might be expected to provide increased protection from ambient O 3 exposures over the current standard

. a. Form and Averaging Time In considering potential forms for a revised secondary standard, the PA considers the characterization of the evidence in the ISA, summarized in section IV.B.1 above, including the ISA conclusion that exposure indices that cumula te and differentially weight the higher hourly average concentrations over a season and also include the mid

- level values , such as the W126 index, offer the most scientifically defensible approach for characterizing vegetation response to ambient O 3 and co mparing study findings, as well as for defining indices for vegetation protection (U.S. EPA, 2013 2013 a , section 2.6.6.1)

. The PA additionally considers CASAC advice in the current review, as well as that from the last review, all of which provided support for such a form. Thus, in considering alternative forms of a revised standard , the PA conclude s that it is reasonable and appropriate to consider a cumulative, concentration

- weighted form to provide protection against cumulative, seasonal exposures to O 3 that are known or anticipated to harm sensitive vegetation or ecosystems. The PA recognizes that s uch a metric is specifically designed to focus on the kind of O 3 exposures that have been shown to cause harm to vegetation and states that it would have a distinct advantage over the form of the current standard in characterizing air quality conditions potentially of concern for vegetation and in more directly demonstrating that the des ired degree of protection against those conditions was being achieved (U. S. EPA, 2014c, sections 6.2 and 6.6)

. With regard to the appropriate index for a cumulative seasonal form, the PA considers the evidence and background for a number of different cumulative concentration weighted indices that have been developed and evalu ated in the scientific literature and in past NAAQS reviews in*** E.O. 12866 Review

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Page 400 of 668 terms of their ability to predict vegetation response and their usefulness in the NAAQS context (U.S. EPA, 2006 2006 a , pp. 9

- 11 to 9

- 15 and pp. AX9

- 159 to AX9

- 187; U.S. EPA, 2007, pp. 7

- 15 to 7

- 16 )

. While these various forms have different strengths and limitations, the PA notes the ISA conclusion that the W126 index , described in section IV.B.1 above, has some important advantages over other non

- sigmoidally weighted cumulative indices , includin g its lack of a cut

off in its weighting scheme which allows fo r cumulation of lower O 3 concentrations (U.S. EPA,
2013 2013 a , section 9.5; U.S. EPA, 2014c, sections 6.2 and 6.6)

. Additionally, the W126 metric adds increasing weight to hourly concentrations from about 40 ppb to about 100 ppb, which is an important feature because “as hourly concentrations become higher, they become increasingly likely to overwhelm plant defenses and are known to be more detrimental to vegetation” (U.S. EPA, 2013 2013 a , p. 9

- 104). The PA additionally take s note of CASAC advice in the current and last review that concurred with a focus on the W126 form (Frey, 2014c, p. iii ; Henderson, 2006; Samet, 2010). Based on the considerations summarized here, the PA conclude s that the W126 index is the most appropriate cumulative seasonal form to consider in the context of the secondary O 3 NAAQS review

. The PA next considers the exposure periods

– diurnal and seasonal

– over which the W126 index would be summed in any given year. T he currently available information continues to provide support for a definition of the diurnal period of interest as the 12

- hour period from 8:00 am to 8:00 pm , which the EPA identified in past reviews as appropriately capturing the diurnal window with m ost relevance to the photosynthetic process (U.S. EPA, 2013 2013 a , section 9.5.3 ; 72 FR 37900 , July 11, 2007 )

. The CASAC has generally supported th is 12

- hour daylight period as well (Frey, 2014c ; Henderson, 2006, 2007)

. Based on these considerations, the PA conclude s that the 12

- hour daylight window (8:00 am to 8:00 pm) represents the portion*** E.O. 12866 Review

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Page 401 of 668 of the diurnal exposure period that is most relevant to predicting or inducing plant effects related to photosynthesis and growth and thus is an appropriate diurnal p eriod to use in conjunction with a W126 cumulative metric (U.S. EPA, 2014c, sections 6.2 and 6.6) . With regard to a seasonal period of interest, the current evidence base continues to provide support for a seasonal period with a minimum duration of three m onths, as described more fully in the ISA and considered in the PA (U.S. EPA, 2013 2013 a , section 9.5.3; U.S. EPA, 2014c, sections 6.2 and 6.6). The CASAC has also indicated support for such a th ree month period (Frey, 2014c ; Samet, 2010; Henderson , 2006). The PA thus concludes that it is appropriate to identify the seasonal W126 index value as that derived from the consecutive 3

- month period within the O 3 season with the highest W126 index value

. The PA a dditionally consider s the period of time o ver which a cumulative seasonal
W126

- based standard should be evaluated , considering the support for both a single year form and a form averaged over three years ( U.S. EPA, 2014c , pp. 6

- 29 through 6

- 33 )

. T he PA consider s the evidence of effects associated with single year and multiple year exposures as well as their potential public welfare significance. The PA also consider s comments from CASAC, including their comment in the current review that “[t]he CASAC does not recommend the use
of a three

- year aver aging period” and that they “favor a single

- year period for determining the highest three

- month summation which will provide more protection for annual crops and for the anticipated cumulative effects on perennial species” (Frey, 2014c, p. iii)

. The PA c onsidered O 3 - induced effects that can occur with a single year’s exposure, including visible foliar injury, growth reduction in annual and perennial species and yield loss in annual crops (U.S. EPA, 2014c, section 6.3). While recognizing that there are a n umber of O 3 - induced effects that have the potential for public welfare significance within the annual*** E.O. 12866 Review

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Page 402 of 668 timeframe , the PA also notes the uncertainties associated with these effects that complicate consideration of the level of appropriate protection on an an nual basis for such effects in ord er to protect the public welfare from known or anticipated adverse effects , and thus recognizes the possibility that a multiple

- year form could be considered to provide a more consistent target level of protection for cert ain effects (U.S. EPA, 2014c, pp. 6

- 29 to 6

- 31). With regard to visible foliar injury, the ISA notes that “the degree and extent of visible foliar injury development varies from year to year and site to site ... even among co

- members of a population exposed to similar O 3 levels, due to the influence of co

- occurring environmental and genetic factors” (U.S. EPA,
2013 2013a , p. 9

- 38; U.S. EPA, 2014c, p. 6

- 30). Additionally, the PA takes note of the difficulty and complexity shown by the WREA analyses with regard to identifying W126 index values that would provide consistent protection on an annual basis given likely fluctuations in annual O 3 and soil moisture conditions (U.S. EPA, 2014c, p. 6

- 30). The PA additionally notes evidence of some O 3 effects on perennial species that may result from a single season’s elevated O 3 exposures, such as reduced bud size or starch content, which may have the potential for some “carry over” of effects on plant growth or reproduction in the subsequent season. Another effect where s uch potential for “carry over” has been noted with elevated O 3 exposure is reduction in below

- ground carbohydrate reserves which can impair growth in subsequent seasons ( U.S. EPA, 2014c, pp. 6

- 30 to 6

- 31; U.S. EPA, 2013 2013 a , pp. 9

- 43 to 9

- 44 and p. 9

- 86). The PA notes that the occurrence of such annual effects of elevated O 3 exposures over multiple years may contribute to a potential to be compounded, increasing the potential for effects at larger scales (e.g., population, ecosystem). In the PA, staff note s that multiple consecutive years of critical O 3 exposures might be expected to result in larger impacts*** E.O. 12866 Review

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Page 403 of 668 on forested areas than intermittent occurrences of such exposures due to the potential for compounding or carry

- over effects on tree growth (U.S. EPA, 2014c, pp. 6

- 29 to 6

- 31). In light of the above summarized considerations for potential compounding of carry

- over effects, the PA conclude s that the public welfare significance of the effects that can occur as a result of three

- year O 3 exposures are potentially greater than those associated with a single year of such exposure. Thus, to the extent that the focus for public welfare protection to be afforded by the secondary O 3 standard is on long

- term effects that occur in sensitive tree species in natural forested ecosystems, including federally protected areas such as Class I areas or on lands set aside by States, Tribes and public interest groups to provide similar benefits to the public welfare, the PA concludes that a standard with a form that evaluates the cumulative seasonal index across multiple years might be considered to provide a more appropriate match to the nature of O 3 - related effects on vegetation upon which the secondary O 3 standard is focused

. In considering such forms, t he PA focuses on one that ave rages the W126 index values across three years (U.S. EPA, 2014c, section 6.2). With regard to single

- year and three

- year forms, the PA considers a WREA analysis that examined the extent to which cumulative RBL across a three

- ye ar period might be underestimated when each year’s RBL is derived from the three

- year average W126 index value versus each single

- year W126 index value for each of three years (in which no other influence on plant growth is presumed to change). This analys is indicates that use of th e 3 three

- year average may lead to an underestimation , although of relatively small magnitude (U.S. EPA, 2014b, section 6.2.1.4). The PA notes that this limited analysis does not account for moisture levels and other environmental factors that could affect plant growth and that vary from year to year. W hen considering an appropriate level for a form that averages W126 index values across three years,*** E.O. 12866 Review

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Page 404 of 668 the PA also recognizes the importance of considering the extent to which the cumul ative effect of diff erent average W126 exposures across the three

- year period would be judged adverse (U.S. EPA, 2014c, p. 6

- 31). Although single

- year W126 index values were not separately analyzed in th e PA analysis of recent monitor ing data, the data ind icate appreciable variation in cumulative, seasonal O 3 concentrations among monitor locations meeting different levels of a standard of the current form (U.S. EPA 2014c, section 6.Appendix 2B)

. Therefore, a standard with an annual form would have the cumulative seasonal index values be at or lower than the level of the standard in all years and, noting the inter

- annual observed variability in seasonal W126 index values, could be appreciably below the standard level in some years. For a standard with a form that averages the cumulative seasonal index values across three consecutive years, the annual seasonal index value could be above the level in some years, but would have to be below it in others within the

same 3 three

- year period, thus restricting the air quality for a given area to have no more than two years out of three with a W126 index value above the standard level, and depending on magnitude of each year’s index, potentially having no more than one. In its consideration of one year as compared to three year forms, the PA also considers implications with regard to stability of air quality programs that implement the NAAQS (U.S. EPA, 2014c, pp. 6

- 31 to 6

- 32)

. The PA notes that a standard bas ed on a single year W126 index would be expected to have a less stability relative to a standard based on a form that averages seasonal indices across three consecutive years, given the potential for large year

- to

- year variability in annual W126 index valu es in areas across the country. Thus, a three

- year evaluation period can contribute to greater public welfare protection by limiting year

- to

- year disruptions in ongoing control programs that would occur if an area was frequently shifting in*** E.O. 12866 Review

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Page 405 of 668 and out of atta inment due to extreme year

- to

- year variations in meteorological conditions. This greater stability in air quality management programs would thus facilitate achievement of the protection intended by a standard. Such considerations of stability often receive particular weight in NAAQS reviews, such as those resulting in selection of the form for the current O 3 primary and secondary standards (62 FR 38856, July 18, 1997), as well as the primary standards for nitrogen dioxide ( 75 FR 6474 , February 9, 2010) and sulfur dioxide ( 75 FR 35520 , June 22, 2010). See also ATA III , 283 F. 3d at 374

- 75 (recognizing programmatic stability as a legitimate consideration in the NAAQS standard

- setting process). Thus, to the extent that emphasis continues to be placed on protect ing against effects associated with multi

- year exposures and maintaining more year

- to

- year stability of public welfare protection, the PA conclude s that it is appropriate to consider a secondary standard form that is an average of the seasonal W126 index v alues across three consecutive years. The PA conclude s that such a form might be appropriate for a standard intended to achieve the desired level of protection from longer

- term effects, including those associated with potential compounding , and that such a form might be concluded to contribute to greater stability in air quality management programs, and thus, greater effectiveness in achieving the desired level of publ ic welfare protection, than that might result from a single year form (U.S. EPA, 2014c,

se ction 6.6). The PA additionally recognized that to the extent the Administrator finds it useful to consider the public welfare protection that might be afforded by a revised primary standard, this is appropriately judged by evaluating the impact of attain ment of such a revised primary standard
on O 3 exposures in terms of the cumulative seasonal W126

- based exposure index. b. Level Formatted: Font: Not Italic*** E.O. 12866 Review

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Page 406 of 668 In considering an appropriate range of levels to consider for a W126

- based standard, the
PA notes that , due to the variability in the importance of the associated ecosystem services provided by different species at different exposures and in different locations, as well as differences in associated uncertainties and limitations, both the species present and their public welfare significance , in addition to the magnitude of the ambient concentrations, are essential considerations in drawing conclusions regarding the significance or magnitude of public welfare impact. Therefore, in development of the PA conclu sions, staff took note of the complexity of judgments to be made by the Administrator regarding the adversity of known and anticipated effects to the public welfare and recognized that the Administrator’s ultimate judgments on the secondary standard will m ost appropriately reflect an interpretation of the available scientific evidence and exposure/risk information that neither overstates nor understates the strengths and limitations of that evidence and information. As described in section IV.D.1 above, th e PA employed a paradigm, which has evolved over the course of the O 3 and other secondary NAAQS reviews , t o assist in putting the available science and exposure/risk information into the public welfare context (U.S. EPA, 2014c, section 5.1). This paradigm recognizes that the significance to the public welfare of O 3 - induced effects on sensitive vegetation growing within the U.S. can vary depending on the nature of the effect, the intended use of the sensitive plants or ecosystems, and the types of environmen ts in which the sensitive vegetation and ecosystems are located. Accordingly, any given O 3 - related effect on vegetation and ecosystems (e.g., biomass loss, crop yield loss, visible foliar injury) may be judged to have a different degree of impact on or sig nificance to the public welfare depending, for example, on whether that effect occurs in a Class I area, a city park, or commercial cropland. This approach also includes consideration of impacts to ecosystem goods and services , which are*** E.O. 12866 Review

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Page 407 of 668 an important categ ory of public welfare effects with an obvious relationship to consideration of intended use (73 FR 16492 , March 27, 2008 ). In considering potential levels for an alternative standard based on the W126 metric, the
PA focus ed primarily on impacts on tree gr owth , crop yield loss , and visible foliar injury , as well as impacts on the associated ecosystem services, while taking note of the uncertainties and limitations associated with several key aspects of this information. In addition to uncertainties related to the WREA air quality scenarios and assessments summarized in section IV.C above, the PA also recognized uncertainties associated with the evidence underlying the tree seedling and crop E

- R functions (U.S. EPA, 2014c, section 6.3). These include u ncertai nties regarding intra

- species variability due to the different numbers of studies that exist for different species so that the weight of evidence is not the same for each species. Those species with more than one study show variability in response and E

- R functions. The potential variability in less well

studied species is, however, unknown (U.S. EPA, 2013 2013a , pp. 9

- 123 to 9

- 125; U.S. EPA, 2014b, section 6.2.1.2, and Table 6

- 27). The PA also recognizes uncertainty regarding the extent to which tree seedling E

- R functions can be used to represent mature trees since seedling sensitivity has been shown in some cases to not reflect mature tree O 3 sensitivity in the same species and uncertainty in the relationship of O 3 effects on tree seedlings (e.g., re lative biomass loss) in one or a few growing seasons to effects that might be expected to accrue over the life of the trees extending into adulthood (U.S. EPA, 2013 2013a , section 9.6 and pp. 9

- 52 to 9

- 53; U.S. EPA, 2014b, sections 6.2.1.1, 6.2.1.4 and Tabl es 6

- 5 and 6

- 27)

. With respect to tree growth, the PA gave primary consideration to relative biomass loss estimates derived from the E

- R functions, described in section IV.B.1.b above and in the PA , while also considering WREA risk/exposure estimates rel ated to this effect (U.S. EPA, 2014c,*** E.O. 12866 Review

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Page 408 of 668 section 6.4). The PA takes note of the different index value estimates presented in Table 6

- 1 of PA (Table 8 below) with regard to the number of s tudied species below different response benchmarks, as well as with reg a rd to the median response. The PA additionally considers the WREA estimates regarding: (1) percent of assessed geographic area exceeding 2% weighted relative biomass (U.S. EPA, 2014c, Table 6

- 2); (2) number of assessed Class I areas with tree seedling weig hted relative biomass loss estimates below 2% (U.S. EPA, 2014c, Table 6

- 3); and (3) the percent median biomass loss across counties for different air quality scenarios (U.S. EPA, 2014c, Table 5

- 5). The PA further notes other WREA estimates for effects on e cosystem services related to public welfare, such as carbon sequestration and air pollutant removal. With respect to crop yield loss, the PA notes the summary of RYL estimates for individual crop species and for the median across species (Table 8 ), and the WREA risk/exposure estimates (U.S. EP A , 2014 b , Section 6.3). The PA also notes information available on visible foliar damage to species occurring in areas preserved for their natural character , such as federal Class I areas, and the analyses in the WREA evaluating biosite data and several benchmarks of injury (U.S. EPA, 2014b, section 5.4.2 )

. Table 8. Tree Seedling Biomass Loss and Crop Yield Loss Estimated for O 3 Exposure over a Season

W126 value for exposure period Tree seedling RBL A Crop RYL C

Median Value Individual Species Median Value Individual Species 21 ppm

- hrs Median species w.

6.8% loss B < 2% loss: 3/11 species

< 5% loss: 5/11 species < 10% loss: 7/11 species < 15% loss: 10/11 species >40% loss: 1/11 species Median species w. 7.7 % loss D < 5% loss: 4/10 species

>5,<10% loss: 3/10 species >10,<20% loss: 3/10 species 19 ppm

- hrs Median species w.

6.0% loss B < 2% loss: 3/11 species

<5% loss: 5/11 species < 10% loss: 7/11 species < 15% loss: 10/11 species >30% loss: 1/11 species Median species w. 6.4 % loss D < 5% loss: 5/10 s pecies

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Page 409 of 668 17 ppm

- hrs Median species w.

5.3% loss B < 2% loss: 5/11 species

<5% loss: 5/11 species < 10% loss: 9/11 species < 15% loss: 10/11 species >30% loss: 1/11 species Median species w. 5.1 % loss D < 5% loss: 5/10 species

>5, <10% loss: 3/10 species >10,<20% loss: 2/10 species 15 ppm - hrs Median species w.

4.5% loss B < 2% loss: 5/11 species

< 5% loss: 6/11 species < 10% loss: 10/11 species >30% loss: 1/11 species Median species w. < 5% loss D < 5% loss: 6/10 species

>5, <10% loss: 4/10 species

13 ppm - hrs Median species w.

3.8% loss B < 2% loss: 5/11 species

<5% loss: 7/11 species <10% loss: 10/11 species >20% loss: 1/11 species Median species w. < 5% loss D < 5% loss: 6/10 species

>5, <10% loss: 4/10 species

11 ppm - hrs Median species w.

3.1% loss B < 2% loss: 5/11 species

< 5% loss: 8/11 species < 10% loss: 10/11 species >20% loss: 1/11 species Median species w. < 5% loss D < 5% loss: 9/10 species

>5, <10% loss: 1/10 species

9 ppm - hrs Median species w

.

2.4% loss B < 2% loss: 5/11 species

< 5% loss: 10/11 species >20% loss: 1/11 species Median species w. < 5% loss D < 5% loss: all species

7 ppm - hrs Median species w.

< 2% loss B < 2% loss: 7/11 species

< 5% loss: 10/11 species >15% loss: 1/11 species Median species w. < 5% loss D < 5% loss: all species

A Estimates are based on the 11 E

- R functions for tree seedlings described in WREA, Appendix 6F and discussed in the PA, section 5.2.1, with the exclusion of cottonwood in consideration of CASAC comments on differences of that study from the other controlled E

- R studies (Frey, 2014b, 2014c). B This is the median of the composite E

- R functions for 11 tree species from the WREA, Appendix 6F (discussed in the PA, section 5.2.1)

. C Estimates here are based on the 10 E

- R functions for crops (from the PA, Appendix 6F and section 5.3.1). D This median value is the median of the composite E

- R functions for 10 crops from WREA, A ppendix 6F (also discussed in the PA, section 5.3.1). Given the wide variation in sensitivity of studied tree species to O 3 - induced relative biomass loss , the PA focused consideration on both median species values and individual species responses and RBL estimates for a given range of W126 index values

. In this consideration, the PA took note of CASAC’s advice regarding RBL levels, specifically their emphasis on a benchmark of median relative tree biomass loss at or be low 2% and their view that a 6% median relative biomass loss is “unacceptably high

. ” The median tree species RBL estimate is at or below 2% only at the lowest W126 level assessed, 7 ppm

- hrs

. A t incrementally higher W126 index level s , the median RBL is als o incrementally higher , so that at W126 index values of 9, 11, Formatted: Font: Times New Roman

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Page 410 of 668 13, 15, 17 and 19 ppm - hrs , the median RBL increases to 2.4%, 3.1%, 3.8%, 4.5%, 5.3% and 6.0%, respectively

. Thus , the median species biomass loss is below 6%, the level characterized by the CA SAC as unacceptably high, across the W126 range of 7 to 17 ppm

- hrs, for which it varies from approximately 2% to approximately 5%. Given this finding, the PA discussion of a range of levels appropriate to consider focuses on this range. In focusing on this range , the PA considers the full array of CASAC advice with regard to interpretation of the evidence and exposure/risk information on vegetation

- related effects of O 3 , as well as the role of the Administrator’s judgments in identifying the level of air qu ality that is requisite to protect public welfare from adverse effects, as noted in section IV.A above. 225
The PA recognizes that public welfare judgments may reasonably be informed by a range of biomass loss benchmarks , in contexts of considering both medi an RBL estimates and RBL estimates for individual species

. Accordingly, in considering individual tree species estimates, the PA notes the value of additionally characterizing the RBL estimates in comparison to higher loss levels such as 10% or 15%.
For e very W126 value over the full range from 7 to 17 ppm

- hrs, the RBLs for each of 5 five species is less than 2% (Table 8), which is the lower benchmark that CASAC identified for tree species

. Accordingly, the PA focused attention on the remaining 6 six more sensitive studied species (i.e., eastern white pine, aspen, tulip poplar, ponderosa pine, red alder, and black cherry)
to evaluate the protection against tree seedling biomass loss at different W126 levels within the

225 In the context of the O 3 standard, such judgments include: the weight to g ive the evidence of specific vegetation

- related effects estimated to result across a range of cumulative seasonal concentration

- weighted O 3 exposures; the weight to give associated uncertainties, including those related to the variability in occurrence of such effects in specific areas of U.S. , such as those of particular public welfare significance ; and , judgments on the extent to which such effects in such areas may be considered adverse to public welfare.*** E.O. 12866 Review

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Page 411 of 668 range from 17 to 7 ppm

- hrs

. At a W126 i ndex value of 17 ppm

- hrs, one of these six species (red alder) has a RBL estimate below 6% , while at the W126 index value of 7 ppm

- hrs, five of these six species have RBLs below 6% (eastern white pine, aspen, tulip poplar, ponderosa pine, red alder). Taken together with the more tolerant species, the proportion of the studied tree species with RBLs below 6% are 6 of 11, 7 of 11, 8 of 11, and 10 of 11 at W126 index values of 17, 15, 13, and 11 ppm

- hrs, respectively. With regard to other , higher, RBL benchma rk levels and estimates for all 11 species, the PA notes that 9 of 11 studied tree species have a predicted RBL below 10% at the W126 level of 17 ppm

- hrs, while 10 of 11 species have a predicted RBL below 10% for W126 levels of 15 to 7
ppm - hrs. In addition , 10 of 11 studied tree species have a predicted RBL below 15% for W126 levels of 17 to 7 ppm

- hrs. The PA notes that the RBL estimates for black cherry, the most sensitive of the 11 species, remain above 15% for W126 index values across the range from 17 t o 7 ppm

- hrs , making unclear the extent to which black cherry estimates might inform consideration of different W126 exposures within this range (U.S EPA, 2014c, section 6.6 and Table 6

- 1; U.S. EPA, 2014b, section 6.2 and Appendix 6A). While recognizing the limitations and uncertainties associated with the WREA air quality scenarios with regard to their representation of conditions just meeting different 3 three

- year average W126 index values (as summarized in section IV.C.1 above), inclu ding the potential underestimation of the highest O 3 concentrations, the PA additionally considers several WREA RBL analyses (U.S. EPA, 2014c, section 6.3)

. In t he WREA characteriz ation of the number of counties where the median RBLs were greater than 2% , 7 % of the counties have median RBLs
g reater than 2% in the 15 and 11 ppm

- hrs W126 scenario s, as compared to 8% for the current standard (U.S. EPA, 2014c, Table 5

- 5; U.S. EPA, 2014b, Table 6

- 7). The percentage is 6 %*** E.O. 12866 Review

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Page 412 of 668 inthe in the 7 ppm

- hrs W126 scenario . Of the 221 counties ( 7 % of counties) estimated to have a median RBL above 2% for the 15 ppm

- hrs scenario , 203 of those counties have a RBL greater than 2% because of the presence of black cherry

. (U.S. EPA, 2014c, section 6.3). In considering the potential magnitude of the ecosystem impact of O 3 - related biomass effects on tree growth , the PA additionally focused on the WREA estimates of weighted RBL for the W126 air quality scenarios (U.S. EPA, 2014 b , section 6.8). For the current standard and the three W126 scenarios, the percent of total assessed ar ea having weighted RBL greater than 2% was 0.2%, 0.2%, 0.1% and <0.1%, respectively (U.S. EPA, 2014c, Table 6

- 2; U.S. EPA 2014b, Table 6

- 25). In giving p articular attention to estimates for Class I areas , the PA notes that f or all four scenarios , the WREA estimates indicate weighted RBL greater than 2% in one or two of the 145 assessed nationally protected Class I areas (U.S. EPA, 2014c, sections 6.3 and 6 .6)

. In considering potential impacts on ecosystem services related to reductions in O 3 effects on tree growth, the PA particularly recognize s that impacts on climate regulation can reasonably be concluded to be potentially significant from a public welf are perspective . In additionally recognizing that carbon sequestration has been identified as a potentially important tool for managing anthropogenic impacts on climate , the PA considers the WREA estimates of potential increases in forestry carbon storage for ambient O 3 reductions in the th ree W126 air quality scenarios (U.S. EPA, 2014c, section s 6.3 and 6.6; U.S. EPA, 2014b, section 6.6.1). The WREA estimates additional forestry carbon storage potential of 13, 593 and 1,600 MMtCO 2 e (over 30 years) for the W 126 scenarios of 15, 11 and 7 ppm

- hrs, respectively, as compared to the current standard (U.S. EPA, 2014b , Table 6

- 18). Compared to the absolute estimate for the current standard scenario (approximately 89,000 MMtCO 2 e , over 30 years), hese these amounts represent*** E.O. 12866 Review

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Page 413 of 668 additional storage of less than 0.1 %, just under 1% and under 2% f or the 15, 11 and 7 ppm

- hrs scenarios, respectively (U.S. EPA, 2014b, section 6.6.1 and Appendix 6B). The PA additionally consider s the WREA estimates for five urban are as of ho w reduced growth of O 3 - sensitive trees in urban forests may affect air pollutant removal (U.S. EPA, 2014b, sections 6.6.2 and 6.7 and Appendix 6D). As with the national estimates, e stimates for all five case study areas indicate generally small dif ferences between the current standard and the three W126 scenarios (U.S. EPA, 2014c, Table 6

- 5)

. The PA additionally notes significant uncertainties and limitations associated with WRE A estimates related to carbon sequestration and air pollution removal ( U.S. EPA, 2014b, Table 6

- 27; U.S. EPA, 2014c, sections 6.3 and 6.6 ) , some of which are summarized in section IV.C.2.b above. The PA recognizes that , as with consideration of other pertinent evidence and exposure/risk information, the Administrator’s
consid eration of WREA estimates for these ecosystem services will involve judgments regarding the appropriate weight to place on such uncertainties as well as the potential impacts to the public welfare of the estimates

. The PA additionally considers the biomas s effects of O 3 on crops estimated for different W126 index values across the range identified above. For this consideration, the PA focuses on the 10 crops for which robust E

- R functions have been established, as described in section IV.B.1 above: barley, lettuce, field corn, grain sorghum, peanut, winter wheat, field cotton, soybean, potato and kidney bean (U.S. EPA, 2013 2013a ; U.S. EPA, 2014b, section 6.5 and Figure 6

- 3 ). In evaluatin g this information, the PA t akes note of CASAC’s comment regardi ng significance of 5% for median crop relative yield loss (RYL). The PA finds that the median crop RYL is at or below 5% for all W126 index values from 7 to 17 ppm

- hrs and observes that this finding makes it unclear to what extent this information informs consideration of levels within*** E.O. 12866 Review

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Page 414 of 668 this range. The RBL estimates for half of the ten individual species are below 5% RYL at 17
ppm - hrs

. The number of the ten individual crops with RYL below 5% is six for W126 values of 15 and 13 ppm

- hrs, nine for a W126 value of 11 ppm

- hrs and ten for W126 levels of 9 and 7
ppm - hrs. Recognizing that different crops are likely to have different values or importance to public welfare, the PA also considers the RYL estimates across the W126 range for individual species

. For exam

ple, less than 5% yield loss was estimated for soybeans at W126 index value s at and below 12 ppm

- hrs , while five crops are more O 3 tolerant . The RYL estimates for four of the five (barley, lettuce, field corn, and grain sorghum) are below 1% for all W126 values across the range from 7 to 17 ppm

- hrs , and the RYL estimates for the fifth, peanut, are below 4% RYL

across th is range. The RYL estimates for the other four studied crops are below 5% for W126 index values at or below 15 ppm

- hrs ( winter wheat ) , 13 p pm - hrs ( cotton ) , 9 ppm

- hrs ( kidney bean ) and 7 ppm

- hrs ( potato )

. In considering these RYL estimates, the PA recognizes that they do not reflect the influence of the heavy management of agricultural crops that is common in the U.S. and so cannot be easily interpreted with regard to potential public welfare significance

. In light of the median RYL estimates of approximately 5% or lower for W126 index values at and below 17
ppm - hrs, the PA gives less emphasis to consideration of crop RYL, while noting that th is information indicates that a secondary standard revised to provide additional protection for vegetation with attention to tree growth, would be expected to also provide additional protection to crops over that provided by the current standard (U.S. EPA, 2014c, section 6.6)

. The PA also considers the evidence and exposure/risk information with regard to visible foliar injury and the extent to which that might inform consideration of potential alternative*** E.O. 12866 Review

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Page 415 of 668 secondary standards appropriate for the Administrator to consider. Specif ically, the PA notes the findings of the WREA analyses of the nationwide USFS/FHM biosite dataset (2006

- 2010) that while soil moisture conditions influence the proportion of biosites with O 3 - related visible foliar injury, as described in section IV.B.1.a a bove, the proportion of such sites increases appreciably with increasing W126 index values up to approximately 10 ppm

- hrs, while relatively little or no change in incidence of injury is seen with O 3 exposures at higher W126 index values (U.S. EPA 2014 b , Ch apter 7, Figure 7

- 10). The PA additionally notes that v isible foliar injury has been identified by the federal land managers as a diagnostic tool for informing conclusions regarding potential O 3 impacts on potentially s ensitive AQRVs (USFS, NPS, FWS, 2010) , which the PA conclude s indicate s that such O 3 - induced impacts might be considered to have the potential to impact the public welfare in scenic and/or recreational areas during years they occur

. The PA was unable, however, to identify any guidance for f ederal land managers regarding at what spatial scale or what degree of severity visible foliar injury might be sufficient to trigger protective action based on this potential impact on AQRV s . The PA states that there does not appear to be consensus in the literature regarding severity of visible foliar injury and risks to plant functions or services, additionally noting that CASAC, while identifying percent biomass loss and yield loss benchmarks for tree seedlings and commodity crops, respe ctively, did not provide any benchmark or criteria for consideration of O 3 impacts related to this endpoint. Further , as in previous reviews, the ISA concludes visible foliar injury is not always a reliable indicator of other negative effects on vegetation , making it difficult to relat e visible foliar injury symptoms to other vegetation effects such as individual plant growth, stand growth, or ecosystem characteristics (U.S. EPA, 2013 2013 a , section 9.4.2, p. 9

- 39) . Additionally, although evidence shows visi ble foliar injury can occur under very low cumulative O 3 exposures ,*** E.O. 12866 Review

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Page 416 of 668 “...the degree and extent of visible foliar injury development varies from year to year and site to site..., even among co

- members of a population exposed to similar O 3 levels, due to the
infl uence of co

- occurring environmental and genetic factors” (U.S. EPA 2013 2013 a , section 9.4.2, p. 9

- 38). Thus, while the PA recognize s visible foliar injury as an important O 3 effect which, depending on severity and spatial extent may reasonably be concluded to be of public welfare significance, most particularly in nationally protected areas such as Class I areas, it additionally recognizes the appreciable variability in this endpoint , which poses challenges to giving it primary emphasis in identifying poten tial alternative standard levels

. On the basis of all the considerations described above, including the evidence and exposure/risk analyses, and advice from CASAC, the PA conclude s that a range of W126 index values appropriate for the Administrator to consider in identifying a secondary standard that might be expected to provide the requisite protection to the public welfare from any known or anticipated adverse effects, extends fro m 7 to 17 ppm

- hrs. The PA note s , however, the role of judgments by the Administrator in such decisions , as recognized above. In selecting th is range, the PA primarily consider s the evidence

- and exposure/risk

- based information for cumulative seasonal O 3 ex posures represented by W126 index values (including those represented by the WREA average W126 scenarios) associated with biomass loss in studied tree species, both in and outside areas that have been afforded special protections. The PA recognizes that tr ee biomass loss can be an indicator of more significant ecosystem

- wide effects which might reasonably be concluded to be significant to public welfare. For example, when biomass loss occurs over multiple years at a sufficient magnitude, it is linked to som e level of effects on an array of ecosystem

- level processes, such as nutrient and water cycles, changes in above and below ground communities, carbon storage and air pollution removal, that benefit the public*** E.O. 12866 Review

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Page 417 of 668 welfare (U.S. EPA, 2014 c , Figure 5

- 1). In focus ing on tree biomass effects, the PA gave emphasis to CASAC’s judgment that a 6% median RBL is unacceptably high, and that the 2% median RBL is an important benchmark to consider . The PA notes that for the lower W126 value of 7 ppm

- hrs that the median tree species biomass loss is at or below 2% and that for the upper value of 17 ppm

- hrs that the median tree biomass loss is below 6%

. 226 In considering the stability and potential for associated greater public welfare protection offered by a three

- year form, as well as based on the recognition that in any given year in the environment, other environmental factors can influence the extent to which O 3 may have the impact predicted by the E

- R functions on which much of the range discussion above focuses, the PA gave careful consideration to the support for consideration of potential alternative W126 based standards with levels in the range identified above (17 ppm

- hrs to 7 ppm

- hrs) with a three

year average form. Thus, the PA concludes that in staff’s view, the evide nce - and exposure/risk

- based information relevant to tree biomass loss and the associated ecosystem services important to the public welfare support consideration of a W126

- based secondary standard with index values within the range of 7 to 17 ppm

- hrs , and a form averaged over three years

. In reaching this conclusion , the PA gave particular consideration to the importance of considering the lasting or
carry - over effects that can derive from single year exposures of perennial plants, recognizing the importan ce of considering the available evidence and exposure/risk based information related to such effects, as well as associated uncertainties. The PA additionally recognize d that there is limited information to discern differences in the level of protection afforded for cumulative

226 We note that a W126 index value of 19 ppm

- hrs i s estimated to result in a median RBL value of 6%, as shown in Table 2 above.*** E.O. 12866 Review

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Page 418 of 668 growth

- related effects by potential alternative W126

- based standards of a single year form as compared to a three

- year average form. Lastly, the PA recognizes the role of policy judgments required of the Admi nistrator with regard to the public welfare significance of identified effects, the appropriate weight to assign the range of uncertainties inherent in the evidence and analyses , and, ultimately, in identifying the requisite protection for the secondary O 3 standard. Examples of areas where the Administrator’s judgments would be expected include those stemming from
consideration of the effects associated with longer

- term conditions and the role that year

- to

- year exposure variability may play in associated pu blic welfare impacts , as well as the objectives for consideration of tree species biomass loss estimates in relationship to identified benchmarks (e.g

. . , 2% or greater)

. The PA also concludes that, to the extent the Administrator finds it useful to consi der the public welfare protection that might be afforded by a revised primary standard, this is appropriately judged through the use of a cumulative seasonal W126

- based exposure metric , a metric considered appropriate for evaluating impacts on vegetation

. For example, comparison of the air quality conditions (expressed in terms of W126 exposures) expected to result from a revised primary standard to the W126

- based exposures concluded to provide requisite public welfare protection would thus inform a judgme nt of whether a secondary standard set identical to a revised primary standard would be expected to achieve the appropriate level of air quality

. The PA notes that s uch a comparison would be in terms of a metric considered appropriate for evaluating impact s on vegetation which inform conclusions on public welfare impacts. The PA further conclude s that the drawing of conclusions with regard to the public welfare protection afforded by such a standard should entail consideration of the air quality conditions likely to be achieved in terms of the cumulative seasonal W126

- based metric described above.*** E.O. 12866 Review

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Page 419 of 668 Accordingly, the PA describes several analyses of air quality data that might inform such consideration (U.S. EPA, 2014c, section 6.4), and notes the importance o f taking into account associated uncertainties, including those associated with the limited monitor coverage in many rural areas, such as those in the W est and S outhwest regions and at high elevation sites. Additional such analyses, based on more recent O 3 monitoring data, have been developed since the completion of the PA

. All of these analyses are summarized in section IV.E.4 below. In reaching conclusions on appropriate policy options for a revised secondary standard the Administrator has considered the findings of these analyses, as described in section IV.E.5 below.
3 . CASAC Advice Beyond the evidence

- and exposure /risk

- based considerations in the PA discussed above, the EPA’s consideration of a revised secondary standard also takes into account the a dvice and recommendations of CASAC . The EPA also considered public comments received to date, some of which urge d the consideration of a secondary standard with a cumulative seasonal form using the W126 metric and a level within the range of 7 to 15 ppm

- hr s or in the low end of this
range, 227 while others have urged retaining the existing form and averaging time due to their view of a lack of new information to support a distinct secondary standard

. In advice offered on a revised secondary standard in the cu rrent review , similar to advice in the last review, including advice offered on the 2010 proposed reconsideration, the CASAC recommended “ retaining the current indicator (ozone) but establishing a revised form of the secondary standard to be the biological ly relevant W126 index accumulated over a 12

- hour

227 Public comment received thus far in this review are in the docket EPA

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- 2008

- 0699, ac cessible at www.regulations.gov

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Page 420 of 668 period (8 a. m.

– 8 p.m.) over the 3

- month summation period of a single year resulting in the maximum value of W126” (Frey, 2014c, p. iii)

. With regard to the level, the CASAC recommended that “ that the lev el associated with this form be within the range of 7 ppm

- hrs to 15 ppm

- hrs to protect against current and anticipated welfare effects of ozone ” and that “ CASAC does not support a level higher than 15 ppm

- hrs ” (Frey, 2014c, p. iii)

. The CASAC additionally stated that “[i]n reaching its scientific judgment regarding the indicator, form, summation time, and range of levels for a revised secondary standard, the CASAC has focused on the scientific evidence for the identification of the kind and extent of adverse effects on public welfare , ” while also acknowledging “ that the choice of a level within the range recommended based on scientific evidence is a policy judgment under the statutory mandate of the Clean Air Act ” ( Frey, 2014c , p. iii)

. In providing advice on a range for the secondary standard, the CASAC noted a W126 index value for which the median tree species RBL estimate was 6 percent , and the median crop species RBL estimate w as over 5 percent, stating that “[t] hese levels are unacceptably high” ( Frey, 2014c , p. iii)

. 228 In addition, regarding consideration of relative biomass loss benchmarks for tree seedlings, the CASAC state d that “[a] 2% biomass loss is an appropriate scientifically based value to consider as a benchmark of adverse impact for l ong - lived perennial species such as trees, because effects are cumulative over multiple years” (Frey, 2014c, p. 14). In so stating, the CASAC referenced findings for biomass loss in aspen exposed to elevated O 3 over seven

228 The CASAC made this comment while focusing on Tabl e 6

- 1 in the second draft PA and the entry for 17 ppm

- hrs. That table was revised for inclusion in the final PA in consideration of CASAC comments on the E

- R function for eastern cottonwood, such that the RBL estimates for 17 ppm

- hrs in the final table (s ee Table 2 above) are below the values CASAC viewed as “unacceptably high”.*** E.O. 12866 Review

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Page 421 of 668 years, citing Wittig et al., 2009. 229 The CASAC additionally pointed to the report of the 1996 workshop sponsored by the Southern Oxidants Study group (Heck and Cowling, 1997, noted in section IV.B.2 above) which described a general consideration of 1

- 2% per year growth reduction in making j udgments the group identified as appropriate for the endpoint of growth effects in trees, without providing an explicit rationale for the identified percentages (Frey, 2014c, p. 14). The CASAC also commented that “it is appropriate to identify a range of l evels of alternative W126

- based standards that includes levels that aim for not greater than 2% RBL for the median tree species” (Frey, 2014c, p. 14). The CASAC noted that the “ level of 7 ppm

- hrs is the only level analyzed for which the relative biomass lo ss for the median tree species is less than or equal to 2 percent ” indicating that 7 ppm was appropriate lower bound for the recommended range (Frey, 2014c, p. 14). With regard to consideration of effects on crops, the CASAC, as noted above, described medi an species RYL over 5% yield loss as “unacceptably high.” The CASAC further noted that “[c]rop loss appears to be less sensitive than these other indicators, largely because of the CASAC judgment that a 5% yield loss represents an adverse impact, and in pa rt due to more opportunities to alter management of annual crops” ( Frey, 2014c , p. 14). The CASAC acknowledge d that “ the choice of a level within the range recommended based on scientific evidence is a policy judgment under the statutory mandate of the Cle an Air
Act ”, while further providing its own policy recommendation s , including the following (Frey, 2014c, p. iii).

229 The way in which the statement pointing to the aspen seven

- year biomass loss value from Wittig et al (2009) relates to CASAC’s view with regard to 2%, however, is unclear as the original source for this finding (cited in Wittig et al., 2009) indicates yearly relative biomass loss values during this seven year exposure that are each well above 2%, and, in fact, are all above 20% (King, et al., 2005).*** E.O. 12866 Review

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Page 422 of 668 [T]he CASAC advises that a level of 15 ppm

- hrs for the highest 3

- month sum in a single year is requisite to protect crop yield loss, but tha t lower levels provide additional protection against crop yield loss. Furthermore, there are specific economically significant crops, such as soybeans, that may not be protected at 15 ppm - hrs but would be protected at lower levels. A level below 10 ppm

- hrs is required to reduce foliar injury. A level of 7 ppm

- hrs is protective of relative biomass loss for trees and offers additional protection against crop yield loss and foliar injury. Therefore, 7 ppm

- hrs is protective of ecosystem services. Thus, lower le vels within the recommended range offer a greater degree of protection of more endpoints than do higher levels within the range. Additionally, in regard to consideration of form, the CASAC note d that “[i]f, as a policy matter, the Administrator prefers to base the secondary standard on a three

- year averaging period for the purpose of program stability, then the level of the standard should be revised downward such that the level for the highest three

- month summation in any given year of the three

- year peri od would not exceed the scientifically recommended range of 7 ppm

- hrs to 15 ppm

- hrs ” (Frey, 2014c, pp. iii and iv)

. In related manner, the CASAC noted that a three

- year average W126 level of 13 ppm

- hrs may be appropriate depending on consideration of year

- to

- year variability and such policy considerations (Frey, 2014c, p. iv). Lastly, in comments recognizing uncertainties associated with the evidence and exposure and risk analyses, the CASAC stated that “ there is sufficient scientific evidence, and suffici ent confidence in the available research results, to support the advice we have given above for this review cycle of the primary and secondary standards” ( Frey, 2014c , p. iv).
4

. Air Quality Analyses As described in section II.D. above, the PA conclude s with regard to the primary standard that it is appropriate for the Administrator to consider revis ion of the level to within t he range of 60 to 70 ppb. In consideration of this conclusion for the primary standard , although the PA also concludes it is appr opriate to consider a revised secondary standard with a cumulative, seasonal , concentration

- weighted form, the PA recognized that, it may be practical to consider the extent Formatted: Font: Not Italic*** E.O. 12866 Review

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Page 423 of 668 to which a revised secondary standard in the form of the primary current secondary standard might be expected to also reduce and provide protection from cumulative seasonal exposures of

concern , noting that, f

or example, if a clear and robust relationship was found to exist between 8

- hour daily peak O 3 concentrations and cumulative, seas onal exposures, the averaging time and form of the current standard might be concluded to have the potential to be effective as a surrogate (U.S. EPA, 2014c, section 6.4)

. Therefore, the PA evaluated w hat the available information indicated with regard to control of cumulative O 3 exposures that might be afforded by alternative secondary stand ards with the averaging time and form of the current standard (a 3 three

- year average of 4 th highest 8

- hour average concentrations) . The available information a ddressin g this point includes a “focus study” in the ISA, and several air quality analyses described in the PA, chapters 2, 5 and 6 and Appendix 2b. 230 Additionally, a similar air quality analysis performed with more recent monitoring data is now available and is also described here.
T he focus study described in the ISA examined the diel variability in O 3 concentrations in six rural areas between 2007 an d 2009 (U.S. EPA, 2013 2013 a , pp. 3

- 131 to 3

- 133). The ISA reported that “[t]here was considerable variability in the diel patterns observed in the six rural focus areas” with the three mountainous eastern sites exhibiting a “generally flat profile with
lit tle hourly variability in the median concentration and the upper percentiles , ” while the three western rural areas demonstrated a “clear diel pattern to the hourly O 3 data with a peak in concentration in the afternoon similar to those seen in the urban are as , ” which was especially obvious at the San Bernardino National Forest site, 90 km east of Los Angeles at an elevation of

230 This information and analyses were included in the second draft PA (U.S. EPA, 2014d 2014j ), reviewed by CASAC in early 2014, and drafts of the ISA, reviewed by CASAC earlier in the review. Formatted: Superscript*** E.O. 12866 Review

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Page 424 of 668 1,384 meters (U.S. EPA, 2013 2013 a , p. 3

- 132). Thus, while the western sites that are influenced by upwind urban plumes may have incre ased cumulative seasonal values coincident with increased daily 8

- hour peak O 3 concentrations, this analysis indicates that, in sites without such an urban influence (the eastern sites in this analysis), such a relationship does not occur (U.S. EPA, 2013 20 13 a , section 3.6.3.2). Thus, the lack of such a relationship indicates that in some locations, O 3 air quality patterns can lead to elevated cumulative, seasonal O 3 exposures without the occurrence of elevated daily maximum 8

- hour average O 3 concentrations (U.S. EPA, 2013 2013 a , section 3.6.3.2). Further, staff notes that the prevalence and geographic extent of such locations is unclear, since as in the last review, there continue to be relatively fewer monitors in the w est ern U.S. , including in high elevatio n remote sites. In considering the findings of this analysis, the PA additionally recognized, however, that the cumulative seasonal values for the eastern rural sites, where cumulative seasonal O 3 concentrations appear to be relatively less related to dail y maximum 8

- hour concentrations, are lower in general than those of the western, urban

- influenced sites. In addition to the focus study described in the ISA (U.S. EPA, 2013 2013 a , section 3.6.3.2), the PA consider s additional analyses of air quality monitoring data. For example, Chapter 2 of the PA characterized recent monitoring data o f O 3 air quality in rural areas. While approximately 80 percent of the O 3 monitoring network is urban focused, about 120 rural monitors are divided among CASTNET, NCore , and portable O 3 monitors (POMs) sites ( U.S. EPA, 2014c, Chapter 2, pp. 2

- 2 to 2

- 3, Figure 2.1). Specifically, as stated in C hapter 2 of the PA, “[a]lthough rural monitoring sites tend to be less directly affected by anthropogenic pollution
sources than u rban sites, rural sites can be affected by transport of O 3 or O 3 precursors from upwind urban areas and by local anthropogenic sources such as motor vehicles, power*** E.O. 12866 Review

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Page 425 of 668 generation, biomass combustion, or oil and gas operations” (U.S. EPA, 2013 2013 a , section
3. 6.2.2). In addition, O 3 tends to persist longer in rural than in urban areas due to lower rates of chemical scavenging in non

- urban environments. At higher elevations, increased O 3 concentrations can also result from stratospheric intrusions (U.S. EPA, 201 3 2013 a , sections 3.4, 3.6.2.2). As a result, O 3 concentrations measured in some rural sites can be higher than those measured in nearby urban areas (U.S. EPA, 2013 2013 a , section 3.6.2.2) and the ISA concludes that “cumulative exposures for humans and vegetation in rural areas can be substantial, and often higher than cumulative exposures in urban areas” (U.S. EPA, 2013 2013 a , p. 3

- 120). These known differences between urb an and rural sites suggest that there is the potential for an inconsistent relationship between 8

- hour daily peak O 3 concentrations and cumulative, seasonal exposures in those areas. However, the PA also notes that reductions in NOx emissions that occur in urban areas to attain primary standards would also have the effect of reducing downwind, rural concentrations over the season (U.S. EPA, 2014c, section 6.4). In addition, as was done in both the 1997 and 2008 reviews, the PA analyzed relationships betwee n O 3 levels in terms of the current averaging time and form and a W126 cumulative form, based on recent air quality data. One analysis in the PA describes the W126 index values and current standard design values at each monitor for two periods: 2001

- 2003 a nd 2009

- 2011 (e.g., U.S. EPA, 2014c, Appendix 2B, Figures 2B

- 2 and 2B

- 3). This shows that between the two periods, during which broad scale O 3 precursor emission reductions occurred,
O 3 concentrations in terms of both metrics were reduced. There is a fairl y strong, positive degree of correlation between the two metrics ( U.S. EPA, 2014c, Appendix 2B). 231 Focusing only on the

231 Appendix 2B in the PA additionally observes that the program impl emented for reducing precursor emissions, especially NOx, appears to have been an effective strategy for lowering both design values and W126 index values.*** E.O. 12866 Review

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Page 426 of 668 latter dataset (2009

- 2011), it can be seen that at monitors just meeting the current standard ( 3 three

- year average fourth

- highest daily m aximum 8

- hour average concentration equal to 0.075 ppm), W126 index values (in this case 3 three

- year averages) varied from less than 3 ppm

- hrs to approximately 20 ppm

- hrs ( U.S. EPA, 2014c, Appendix 2B, Figure 2B

- 3b). At sites with a
3 three

- year average fou rth

- highest daily maximum 8

- hour average concentration at or below a potential alternative primary standard level of 70 ppb, 3 three

- year W126 index values were above 17 ppm

- hrs at no monitors, above 15 ppm

- hrs at one monitor, and above 13 ppm

- hrs at 8 moni tors in the West and Southwest NOAA climate regions

. At sites with a 3 three

- year average fourth

- highest daily maximum 8

- hour average concentration at or below a potential alternative primary standard level of 65 ppb, 3 three

- year W126 index values were above 1 1 ppm - hrs at no monitors, above 9 ppm - hrs at three monitors, and above 7 ppm

- hrs at 9 monitors (distributed across five regions) . The majority of these nine monit oring sites are located in the West and
S outhwest regions and i nclude the states of Arizona, California, Colorado, Nevada, New Mexico, and Utah. At sites with a 3 three

- year average fourth

- highest daily maximum 8

- hour average concentration at or below a potential alternative primary standard level of 60 ppb,
3 three

- yea r W126 index values were at or below 7 ppm

- hrs at all monitors (U.S. EPA, 2014c, Figure 2B

- 3b).
An other analysis in Chapter 2 of the PA presents the data for sets of rec ent 3 three

- year periods back to 2006

- 2008 and indicates that among the counties with O 3 concentrations that met the current standard, the number of counties with 3 three

- year W126 index values above 15 ppm

hrs ranges from fewer than 10 to 24 ( U.S. EPA, 2014c, Appendix 2B, Figure 2B

- 9). In general during this longer period, W126 index values a bove 15 ppm

- hrs and meeting the current standard were predominantly in Southwest region. As the first analysis in Appendix 2B of the PA (for the*** E.O. 12866 Review

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Page 427 of 668 2001

- 2003 and 2009

- 2011 perio ds) indicates, monitors in the west West and s outhwest S outhwest tend to have higher W126 index values relative to their design values than do monitors in other regions. This pattern is noteworthy because the southwest S outhwest region has a less dense monitoring network than regions in the eastern U.S. (see U.S. EPA, 2014c, Figure 2

- 1), so that the extent to which this pattern occurs throughout these regions is uncertain.
An additional air quality analysis was performed for this review that is documented in a technical memorandum (Wells, 2014). This analysis examines the r el ationships between O 3 levels in terms of the primary form and averaging time for the current standard design value (the
“4 th max” metric) and a 3 three

- year average, W126

- based metric. The first part of the analyses focus on the air quality values for the mos t recent 3 three

- year period, 2011

- 2013. Based on this information, it can be seen that at monitors just meeting the current standard ( 3 three

- year average fourth

- highest daily maximum 8

- hour average concentration equal to 0.075 ppm), W126 index values (in t his case 3 three

- year averages) varied from less than 3 ppm

- hrs to up to 23 ppm

hrs (Figure 5a ). At sites with a 3 three

- year average fourth

- highest daily maximum 8

- hour average concentration at or below a level of 70 ppb (566 monitors distributed across all regions of the U.S.) , 3 three

- year W126 index values were above 17 ppm

- hrs at no monitors, above 15
ppm - hrs at 4 monitor s , and above 1 3 ppm - hrs at 16 monitors (1% of the monitors in full dataset and less than 3% in this group)

. These 16 monitors are located in the S outhwest (15 monitors) and West North Central NOAA climate regions and include the states of Arizona, Colorado, New Mexico, Utah and Wyoming. A t sites with a 3 three

- year average fourth

- highest daily maximum 8

- hour average concentration at or below a level of 65 ppb (220 monitors distributed*** E.O. 12866 Review

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Page 428 of 668 across all regions of the U.S. 232 ) , 3 three

- year W126 index values were above 1 1 ppm - hrs at no monitors, above 7 ppm

- hrs at 15 monitors. The se 15 monitoring sites are predomina ntly located in the West North Central and Southwest regions

. At all sites with a 3 three

- year average fourth

highest daily maximum 8

- hour average concentration at or below a level of 60 ppb, 3 three

- year W126 index values were at or below 7 ppm

- hrs (Wells, 2014, Figure 5b)

. Further analysis in the technical memorandum focused on a comparison of monitors with

a 3 three

- year average fourth

- highest daily maximum 8

- hour average concentration at or below a level of 70 ppb and a 3 three

- year W126 index values above 13 ppm - hrs for sets of 3 three

- year periods between 2001

- 2003 and 2011

- 2013 (Wells, 2014 , Figure 8). This analysis found that the number of sites meeting 70 ppb while exceeding 13 ppm

- hrs has remained relatively constant over the past decade, with these sites consistently being limited to a small number in the
west West and southwest Southwest . In addi tion, the number of sites meeting both 70 ppb and 13
ppm - hrs has increased over time, while the number of sites exceeding both 70 ppb and 13 ppm

hrs has decreased by a similar amount. The second part of the analysis in the technical memorandum focused on t rends in the

r elationships between O 3 levels in terms of the primary standard design value 4 th high metric and

a 3 three

- year average W126 metric, starting with the 2001

- 2003 period and ending with the
2011

- 2013 period. Based on analysis of 729 monitors, tre nds in both the primary standard design value 4 th high metric and the 3 three

- year average, W126 metric showed decreasing values between 2001

- 2003 and 2011

- 2013. In addition, the amount of year

- to

- year variability in the two metrics tended to decrease over t ime with decreasing O 3 concentrations, especially for the W126

232 This memo utilizes the same regional specifications as are used in the PA and WREA (e.g., U.S. EPA , 2014c, Appendix 2B, Figure 2B

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Page 429 of 668 metric. Most sites in the e astern U.S. and California saw large, widespread decreases in both the primary standard design value 4 th high metric and the 3 three

- year average W126 metrics over the past decade as a result of regional NOx control p rograms. In the inter

- mountain w est, where control programs have been more localized, the decreases observed in the primary standard design value 4 th high metric and 3 three

- year average W126 metrics were typi cally much smaller in magnitude, with a small numbe r of sites showing significant increases

. As part of this analysis, regional comparisons were included on the relative changes in the r elationships between O 3 levels in terms of the primary standard design value 4 th high metric and a 3 three

- year average W126 metrics metric between the periods of 2001

- 2003 and 2011

- 2013. Figure 12 in the technical memorandum shows that a positive, linear relationship persists within each region between the changes in primary s tandard design value 4 th high and 3 three

- year average W126 metrics . Nationally, the 3 three

- year average W126 metric decreased by approximately 0.7 ppm

- hrs per unit ppb decrease in the primary standard design value 4 th high metric. In addition, the southwest S outhwest and west West regions, which have the greatest potential for sites to measure elevated cumulative, seasonal O 3 exposures without the occurrence of elevated daily maximum 8

- hour average O 3 concentrations , exhibited the greatest response in W126 valu e change per unit change in primary design value 4 th high metric ( Wells, 2014 , Table 6). The technical memorandum concludes that the primary standard design value 4 th high metric and a 3 three

- year average W126 metric are highly correlated, as are the relative changes in these two metrics over the past decade. In this way, the technical memorandum concludes that that future control programs designed to help meet a revised primary O 3 standard based on the*** E.O. 12866 Review

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Page 430 of 668 3 three

- year average of the 4 th highest daily maximum 8

- hour concentration are expected to also result in decreases in the values of a 3 three

- year average W126 metric

. The above information suggests that depending on the level for a standard of the current averaging time and form, the current form and averaging time of the secondary standard can be expected to achieve control of cumulative seasonal O 3 exposures , providing air quality that may meet specific three

- year average W126 index values . As discussed above, w e recognize limitations in the dataset and associated analyses, including those related to monitor coverage, which may contribute uncertainties to conclusions related to the relationships described. With respect to monitor coverage, the current O 3 monitori ng network is urban focused, with fewer monitors in some parts of the country, particular rural areas of the s outhwestern and w estern U.S. Because of this, there are potential uncertainties in the extent to which the monitoring information discussed above represents air quality patterns and relationships that would occur in areas without monitors

. There is some information suggesting that there is a potential for inconsistencies in the relationship between W126 measures of seasonal O 3 concentrations and the fourth highest peak O 3 concentration s assessed by the current standard averaging time and form , but the available data suggest that air quality in areas meeting a primary standard standard of the current form and averaging time with a level in the range of 65 to 70 ppb would also meet

a three

- year W126 index value falling in the range of 13 to 17 ppm - hrs, and that to the extent areas need to take action to attain a primary standard in the range of 65 to 70 ppb, those actions*** E.O. 12866 Review

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Page 43 1 of 668 would also improve air quality a s measured by the W126 metric. 233 To the extent to which the monitoring data can be expected to describe future relationships in air quality, we acknowledge potential uncertainties in specifying future air quality but note that these uncertainties are limite d by the fact that the data analysis includes over a decade of O 3 measurements, with similar patterns and trends observed in air quality over this period of time. 5. Administrator’s Proposed Conclusions In considering what revisions to the secondary standard are appropriate, the Administrator has drawn on the ISA conclusions regarding the weight of the evidence for a range of welfare effects associated with O 3 in ambient air, and associated areas of uncertainty; quantitative risk and exposure analyses in the WREA for different adjusted air quality scenarios and associated limitations and uncertainties; staff evaluations of the evidence, exposure/risk information and air quality information in the PA; additional air quality analyses of relationships bet ween air quality metrics based on form and averaging time of the current standards and a cumulative seasonal exposure index; and CASAC advice; and, public comments received thus far in the review. As described in section IV.E.1 above, the Administrator co ncludes it is appropriate to continue to use O 3 as the indicator for a secondary standard intended to address adverse effects to public welfare associated with exposure to O 3 alone and in combination with related photochemical oxidants. In this review, no alternatives to O 3 have been advanced as being a

233 EPA notes that areas can be expected to have air quality at least as good as that specified by the primary standard, so to the extent there are inconsistencies between fourth highest peak concentrations and W126 values such that some areas meeting a standard of 0.065 to 0.070 ppm might be well below the range of 13 to17 ppm

- hours, those inconsistencies are less relevant to consideration of the appropriate form and level for the secondary standard.

Formatted: Footnote Text-NPR*** E.O. 12866 Review

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Page 432 of 668 more appropriate surrogate for ambient photochemical oxidants

. Thus, as is the case for the primary standard (discussed above in section II.E.1), the Administrator proposes to continue to
use O 3 as the indi cator for a standard that is intended to address effects associated with exposure
to O 3 alone and in combination with related photochemical oxidants. In so doing, the Administrator recognizes that measures leading to reductions in ecosystem exposures to O 3 would also be expected to reduce exposures to other photochemical oxidants. The Administrator has next considered the array of information with regard to identifying policy options for a revised secondary standard for O 3 that in her judgment would provide appropriate protection for public welfare effects associated with O 3 in ambient air. This information includes ISA conclusions, WREA analysis findings, staff considerations and conclusions in the PA and CASAC advice, as well as the Administrator’s conclus ions in the last review, with regard to a biologically relevant exposure metric for O 3 vegetation

- related effects. The information also includes PA conclusions and CASAC advice with regard to key aspects of the definition of such a metric, as summarized in section IV.E.2 and IV.E.3 above. Additionally, the Administrator has considered findings of staff evaluations in the PA with regard to potential impacts on vegetation and forested ecosystems associated with a range of values for such a metric and identifi ed uncertainties and limitations of such information, as summarized in section IV.E.2 above. Additionally important to her deliberations here are findings of air quality analyses of relationships between the W126

- based exposure metric and levels of a stand ard of the same form and averaging time as the current standards, as described in section IV.E.4 above. Based on consideration of this array of information, as described below, the Administrator has drawn conclusions with regard to policy options for a rev ised secondary standard. In drawing conclusions on such options, she recognizes that the Act does not require that NAAQS be set at*** E.O. 12866 Review

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Page 433 of 668 zero - risk or background levels, but rather at levels that reduce risk sufficiently to protect public welfare from adverse eff

ects. As an initial matter, the Administrator recognizes the longstanding evidence, described in the ISA, of O 3 effects on vegetation and associated terrestrial ecosystems

. Further, in reaching a proposed conclusion on the appropriate form and averaging time for a revised secondary standard that would provide increased protection against vegetation

- related effects on public welfare, the Administrator takes note of the conclusions drawn in the ISA, the PA and by CASAC in this review that the scientific evi dence continues to demonstrate the cumulative nature of O 3 - induced plant effects and the need to give greater weight to higher concentrations, as summarized in sections IV.B.1, IV.D.1, IV.D.2, IV.E.2.a and IV.E.3 above. Based on these considerations, the A dministrator concurs with the CASAC that a cumulative, seasonal, concentration

- weighted exposure

- based form and averaging time provides the most direct link between O 3 in ambient air and O 3 - related effects on vegetation. The Administrator further concludes that in judging the extent of public welfare protection that might be afforded by a revised standard, it is appropriate to use a cumulative , seasonal concentration

- weighted metric

. In identifying a cumulative, seasonal, concentration

- weighted metric for u se in judging public welfare protection, the Administrator gives weight to the PA conclu sions regarding consider ation of a revised secondary standard in terms of the cumulative, seasonal, concentration

- weighted form, the W126 index . As described in section IV.B.1 above, the ISA has recognized the strengths strength of the W126 index in its weighting of potential potentially damaging O 3 concentrations that contribute contributes to the advantages it offers over other weighted cumulative indices. The Administrator notes the PA conclusions regarding the W126 metric, specifically use of the three consecutive month period within the O 3 season with the*** E.O. 12866 Review

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Page 434 of 668 maximum index value as the seasonal period over which to cumulate hourly O 3 exposures and
t he cumulation of daily exposures for the 12

- hour period from 8:00 am to 8:00 pm. The Administrator additionally takes note of CASAC support for consideration of the W126 index defined in this way and concludes it is appropriate to use the cumulative season al W126

- based metric derived in this way

. In further considering the PA conclusions regarding a revised secondary standard in terms of the W126 index , the Administrator takes note of considerations in the PA of a three

year or single

- year evaluation peri od. Such considerations include the variability in ambient air
O 3 concentrations from year to year, as well as variability and uncertainties related to environmental factors that influence the occurrence and magnitude of O 3 - related effects. The Administrat or additionally notes the PA observation of greater significance for effects associated with multiple

- year exposures. Based on these and related considerations described in the PA (and summarized in section IV.E.2 above), the Administrator, in identifying a metric for use in judging public welfare protection afforded, agrees with the PA conclusion that it is appropriate to consider a form that averages W126 index values across three consecutive years , and to do so in conjunction with identification of level s for such a form that might be judged to provide the appropriate degree of public welfare protection from O 3 effects across multiple years. In so doing, the Administrator takes note of the ISA conclusions regarding the role of environmental factors in var iability associated with effects of ambient air O 3 and the year

- to

- year variability commonly observed in such environmental factors. Further, the Administrator also recognizes uncertainties associated with determining the degree of vegetation impacts for a nnual effects that would be adverse to public welfare. Even in the case of annual crops, the assessment of public welfare significance is unclear for the reasons discussed below related to agricultural practices.*** E.O. 12866 Review

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Page 435 of 668 The considerations identified here lead the Administrator to conclude it is appropriate to use an index averaged across three years. In reaching this conclusion regarding a three

- year average metric, the Administrator has considered CASAC comments that it favors a W126

- based secondary standard with a single year form and that its recommended range of levels relates to such a form. The Administrator concurs with CASAC that it is important to consider impacts associated with a single year that may be of a magnitude concluded to represent an adverse ef fect on public welfare. The Administrator further concludes that such an occurrence can be addressed through use of a three

- year average metric, chosen with consideration of the relevant factors. As noted above, the Administrator gives consideration to the variabilities, as well as the uncertainties, associated with single year and multiple year impacts. Based on all of these considerations, the Administrator recognizes greater confidence in judgments related to public welfare impacts based on a three

- year average metric. Thus, based on all of the above, the Administrator proposes, for purposes of judging the extent of public welfare protection that might be afforded by a revised standard and whether it meets the appropriate level of protection, to use the a verage W126 index value across three years, with each year’s value identified as that for the three

- month period yielding the highest seasonal value and with daily O 3 exposures within a three

- month period cumulated for the 12

- hour period from 8:00 am to 8: 00 pm. In reaching a conclusion on the appropriate range of W126 index values that describe the
O 3 conditions expected to provide the requisite protection of public welfare, the Administrator has given careful consideration to the following: (1) the nature and degree of effects of O 3 to the public welfare, including what constitutes an adverse effect; (2) the strengths and limitations of*** E.O. 12866 Review

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Page 436 of 668 the evidence that is available regarding known or anticipated adverse effects from cumulative, seasonal exposures, and its usefulness in informing selection of a proposed range; and (3) CASAC’s views regarding a range of W126 levels appropriate to consider, as well as on the strength of the evidence and its adequacy to inform a range of levels. In this consideration, the Administrator recognizes that the choice of a range of W126 index values (and the form of the W126 i ndex) that might be expected to provide protection of the public welfare from any known or anticipated adverse effects requires judgments about the interpretation of the evidence and other information, such as the quantitative analyses of air quality monit oring, exposure and risk, that neither overstates nor understates the strengths and limitations of the evidence and information nor the appropriate inferences to be drawn as to risks to public welfare. The CAA does not require that a secondary standard be protective of all effects associated with a pollutant in the ambient air but rather those considered adverse to the public welfare (as described in section IV.B.2 above). The Administrator additionally recognizes that there is not a bright line clearly dir ecting the choice of a range of W126 index values and that the choice of what is appropriate is a public welfare policy judgment entrusted to the Administrator. In determining the range of three

- year average W126 index values that might be expected to pro vide the appropriate level of public welfare protection, the Administrator first considers the nature and degree of effects of O 3 on the public welfare. The Administrator recognizes that the significance to the public welfare of O 3 - induced effects on sensi tive vegetation growing within the U.S. can vary, depending on the nature of the effect, the intended use of the sensitive plants or ecosystems, and the types of environments in which the sensitive vegetation and ecosystems are located. Any given O 3 - relate d effect on vegetation and ecosystems (e.g., biomass loss, visible foliar injury), therefore, may be judged to have a different degree of impact on the public*** E.O. 12866 Review

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Page 437 of 668 depending, for example, on whether that effect occurs in a Class I area, or a residential or

comm ercial setting. The Administrator notes that such a distinction is supported by CASAC advice in this review. In her judgment, like those of the Administrator in the last review, it is appropriate that this variation in the significance of O 3 - related vegeta tion effects should be taken into consideration in making judgments with regard to the level of ambient O 3 concentrations that is requisite to protect the public welfare from any known or anticipated adverse effects. As a result, the Administrator conclude s that of those known and anticipated O 3 - related vegetation and ecosystem effects identified and discussed in this notice, particular significance should be ascribed to those that occur on sensitive species that are known to or are likely to occur in feder ally protected areas such as Class I areas 234 or on lands set aside by States, Tribes and public interest groups to provide similar benefits to the public welfare, for residents on those lands, as well as visitors to those areas. Likewise, the Administrator also notes that the same known or anticipated O 3 - induced effects occurring in other areas may call for less protection. For example, the maintenance of adequate agricultural crop yields is extremely important to the public welfare and is currently achieve d through the application of intensive management practices. With respect to commercial production of commodities, the Administrator notes that judgments about the extent to which O 3 - related effects on commercially managed vegetation are adverse from a pub lic welfare perspective are particularly difficult to reach, given that the extensive management of such

234 For example, the Wilderness Act of 1964 defines designated ‘‘wilderness areas’’ in part as areas “protected and managed so as to preserve [their] natural conditions” and requires that these areas ‘‘shall be administered for the use and enjoyment of the Am erican people in such manner as will leave them unimpaired for future use and enjoyment as wilderness, and so as to provide for the protection of these areas [and] the preservation of their wilderness character

. ’’ 16 U.S.C. §1131(a ).*** E.O. 12866 Review

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Page 438 of 668 vegetation (which, as CASAC noted, may reduce yield variability) may also to some degree mitigate potential O 3 - related effects. The management practice s used on these lands are highly variable and are designed to achieve optimal yields, taking into consideration various environmental conditions. In addition, changes in yield of commercial crops and timber may affect producers and consumers differently, f urther complicating the question of assessing overall public welfare impacts. Thus, the Administrator concludes that agricultural crops do not have same need for additional protection from the NAAQS as forested ecosystems and, while research on agricultura l crop species remains useful in illuminating mechanisms of action and physiological processes, information from this sector on O 3 - induced effects is considered less useful in informing judgments on what level(s) would be sufficient but not more than neces sary to protect the public welfare

. The CASAC identified a crop RYL benchmark of 5% for the median species and indicated they found higher percentages unacceptably high. Although the Administrator has not drawn a conclusion with regard to this specific be nchmark, the Administrator finds the public welfare impacts associated with crop yield loss to be less significant , a less important consideration in this review for the reasons discussed above here, including the extensive management of crop yields and the dynamics of agricultural markets , and thus is not focusing on crop yield loss in selecting a revised standard. She notes, h owever, the PA finding that median species crop RYL estimates for W126 index values in the PA identified
range (17 to 7 ppm

- hrs) fall below the 5% benchmark emphasized by CASAC for this endpoint. The Administrator a lso notes that a standard revised to increase protection for forested ecosystems would also be expected to provide some increased protection for agricultural crops. The Admi nistrator also recognizes that O 3 - related effects on sensitive vegetation can occur in other areas that have not been afforded special Federal f ederal protections, ranging from*** E.O. 12866 Review

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Page 439 of 668 effects on vegetation growing in managed city parks and residential or commercial settings, such as ornamentals used in urban/suburban landscaping or vegetation grown in land use categories that are heavily managed for commercial production of commodities such as timber. For vegetation used for residential or commercial ornamental purposes, the Administrator believes that there is not adequate information at this time to establish a secondary standard based specifically on impairm ent of these categories of vegetation, but notes that a secondary standard revised to provide protection for sensitive natural vegetation and ecosystems would likely also provide some degree of protection for such vegetation. Based on the above, the Admini strator finds that the type of information most useful in informing the selection of an appropriate range of protective levels is appropriately focused on information regarding exposures and responses of sensitive trees and other native species known

or an ticipated to occur in protected areas such as Class I areas or on lands set aside by States, Tribes and public interest groups to provide similar benefits to the public welfare, for residents on those lands, as well as visitors to those areas. With regard to the available evidence, the Administrator finds the coherence and strength of the weight of evidence from the large body of available literature compelling. This evidence addresses a broad array of O 3 - induced effects on a variety of tree species across a range of growth stages (i.e., seedlings, saplings and mature trees) using diverse field

- based (e.g., free air, gradient and ambient) and OTC exposure methods. The Administrator gives particular attention to the effects related to native tree growth and productivity, recognizing their relationship to a range of ecosystem services, including forest and forest community composition

. With regard to selection of the values for use with the W126 index for the purpose of identifying a range of O 3 conditions e xpected to provide the appropriate level of protection from*** E.O. 12866 Review

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Page 440 of 668 vegetation effects of particular concern, the Administrator, as an initial matter, takes note of the PA conclusion that, with regard to a target level of protection for a revised standard, it is

a ppropriate to give consideration to a range of levels from 17 ppm

- hrs to 7 ppm - hrs, expressed in terms of the W126 index averaged across three consecutive years

. As summarized in section IV.E.2.b above, this PA conclusion draws heavily on considerations re lated to estimates of tree seedling growth impacts (in terms of relative biomass loss) associated with a range of W126

- based index values developed from the robust E

- R functions for 11 tree species. This conclusion also gives weight to CASAC comments as to an unacceptably high magnitude of relative biomass loss (6%) for the median species and a magnitude of median relative biomass loss on which to focus considerations (2%). The Administrator takes particular note of the CASAC view of a median species RBL of 6% as unacceptably high. In considering the basis for the range of W126 index levels identified by the PA, for which 17 ppm

- hrs is the upper end, the Administrator considers the CASAC advice, including their view that a 6% median tree seedling species RBL is unacceptably high, their consideration of Table 6

- 1 in the second draft PA which indicated such a RBL estimate for a W126 index value of 17 ppm

- hrs, and their consequent lack of support for levels higher than 15 ppm

- hrs (Frey, 2014c, p. iii; U.S. EPA 2 014d 2014 j , Table 6

- 1)

. Revisions As noted in section IV.E.3 above, revisions to this table in the final PA, made in consideration of CASAC comments on the study supporting the E

- R function for eastern cottonwood have resulted in changes to the median speci es RBL estimates such that the median is below 6% for a W126 index value of 17 ppm

- hrs (U.S. EPA, 2014c, Table 6

- 1), and thus, not of a magnitude that CASAC described as unacceptably high. In fact, the median species RBL estimate for a W126 index value of 17 ppm

hrs in this table in the final PA (5.3%) is nearly identical to the median species estimate for 15*** E.O. 12866 Review

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Page 441 of 668 ppm - hrs (the value corresponding to the upper end of the CASAC

- identified range) in the second draft PA (5.2%) (U.S. EPA, 2014c, Table 6

- 1; U.S. EPA, 2014d 2014 j , Table 6

- 1). The Administrator additionally takes note of the PA observations that the number and proportion of individual species with RBL estimates at or below 2%, a benchmark given emphasis by CASAC, do not vary across W126 index values from 17 ppm

- hrs down to 9 ppm

hrs (as seen in Table 8 above), providing little distinction with regard to the significance of growth impacts for exposures across this large portion of the PA range. The Administrator also notes the CASAC recommendation regarding a lowering of the level with consideration of a three

- year average index; however, the Administrator’s judgments on a three

- year average index, as described above, focus on confidence in conclusions that might be drawn with regard to single as compared to multiple year impacts. For example, the Administrator, while recognizing the strength of the evidence with regard to quantitative characterization of O 3 effects on growth of tree seedlings and crops, in addition to noting the additional difficulties for assessing welfare impacts of crops, takes note of the uncertainty associated with drawing conclusions with regard to the extent to which small percent red uctions in annual growth contribute to adverse effects on public welfare and the role of annual variability in environmental factors that affect plant responses to O 3 . Moreover, as explained above, the Administrator concludes that concerns related to the p ossibility of a singly unusually damaging year can be addressed through use of a three

- year average metric, chosen with consideration of the relevant factors. Accordingly, she judges it appropriate to include 17 ppm

- hrs, without adjustment, in the range of three

- year average W126 index values appropriate to consider in determining what secondary standard will provide air quality associated with the appropriate level of public welfare protection. She thus judges it appropriate to focus on a range for three

- y ear average W126 levels with 17 ppm

- hrs at*** E.O. 12866 Review

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Page 442 of 668 the upper end. In so doing, she additionally notes CASAC’s recognition that , within a scientifically appropriate range, the choice of levels is a public policy judgment by the Administrator

. In turning to consid eration of the low end for the W126 index range, the Administrator considers the full range of W126 levels identified in the PA with regard to the evidence and exposure/risk

- based information, and associated uncertainties, identified in the PA, as well as CASAC advice. The Administrator notes the CASAC policy view regarding protection provided for trees and associated ecosystem services from a W126 index value of 7 ppm

- hrs, which is based on the W126 index value for which the median species estimate falls b elow 2% RBL. The Administrator recognizes, however, as noted above, the greater uncertainty associated with the extent to which estimates of benefits in terms of ecosystem services and reduced effects on vegetation at lower O 3 exposures might be judged sig nificant to the public welfare. The Administrator additionally notes the results of the EPA’s quantitative exposure and risk assessments for the air quality scenarios for W126 levels at and below 11 ppm

- hrs, including the relatively small additional benef its and increased uncertainty with the ecosystem services estimates in these lower W126 scenarios. With regard to the PA evaluation of RBL estimates, the Administrator, while noting the PA observations of similarity in the number of species with less than 2% RBL across the W126 range from 17 to 9 ppm

- hrs, as stated above, additionally notes PA observations of a similar number of studied species with RBL estimates below 5% for W126 index values of 13 and 11 ppm

- hrs. Thus, to the extent that weight is given t o the importance of 5% RBL for individual species, both W126 index values are observed to provide RBL estimates below this benchmark.*** E.O. 12866 Review

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Page 443 of 668 With regard to considerations of O 3 effects beyond biomass loss in tree seedlings, the Administrator takes note of the la ck of new quantitative E

- R relationships for larger trees growing in the field that would help inform consideration of a standard level within the lower part of PA range. Thus, the Administrator recognizes that important uncertainties remain in interpretin g the quantitative O 3 - related growth effects for tree seedlings assessed in OTC studies for the purpose of characterizing long

- term growth effects, and other more subtle but important effects on sensitive tree species, natural forests, and forested ecosyst ems in the broader context of protection of public welfare. Additionally, while the Administrator notes that there is evidence that O 3 - related visible foliar injury can occur at such lower levels (below a W126 index value of 13 ppm

- hrs), she recognizes, as summarized in sections IV.C.3.c and IV.D.1 above, the significant challenges in jud ging the extent to which such effects should be considered adverse to public welfare, in light of the variability and the lack of clear quantitative relationship with othe r effects on vegetation, as well as the lack of established criteria or objectives that might inform consideration of potential public welfare impacts related to this vegetation effect. Thus, in the Administrator’s judgment, focus on a 3 three

- year average W126 index value below 13 ppm

- hrs would not give sufficient attention to the important uncertainties and limitations inherent in the currently available scientific evidence and in the quantitative assessments conducted for the current review

. Taking into account the uncertainties that remain in interpreting the evidence, the Administrator observes that the likelihood of obtaining benefits to public welfare decreases with a standard set below a level of 13 ppm

- hrs, while the likelihood of requiring reducti ons in ambient concentrations that go beyond those that are needed to reduce adverse impacts to public welfare increases.*** E.O. 12866 Review

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Page 444 of 668 Based on the above considerations and based on the entire body of evidence and information currently available, the Administrator iden tifies the range of three

- year average W126 index values extending from 13 to 17 ppm

- hrs as appropriate to consider in identifying the ambient O 3 concentrations that would provide the appropriate level of public welfare protection. In so doing, the Adminis trator notes CASAC recognition that a three

- year average W126 level of 13 ppm

- hrs may be appropriate depending on consideration of year

- to

- year variability and policy considerations. Thus, based on the discussion above, and with consideration of CASAC advi ce on these issues, the Administrator proposes that ambient O 3 concentrations resulting in cumulative seasonal O 3 exposures of a level within the range from 13 ppm

- hrs to 17 ppm

- hrs, in terms of a W126 index averaged across three consecutive years, would p rovide the requisite protection against known or anticipated adverse effects to the public welfare. The EPA solicits comments on levels within this range

. The Administrator next turns to consideration of policy options for a revised secondary standard th at would provide this level of protection

. The Administrator takes note of staff conclusions that it is appropriate to consider a revised secondary standard in terms of the cumulative, seasonal, concentration

- weighted form, the W126 index

. Further, she g ives extensive consideration to CASAC advice to set such a secondary standard. Such a standard, as mentioned above, would be directly linked to O 3 exposures to which vegetation are most responsive and thus might be expected to provide some confidence that such exposures of concern would be controlled. In considering different policy options for a revised secondary standard, the Administrator finds it useful to consider what can be concluded from the available information with regard to relationships between air quality characterized in terms of the current form and*** E.O. 12866 Review

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Page 445 of 668 averaging time and also in terms of the W126 metric. She has considered particularly what such analyses and relationships indicate with regard to the extent to which W126

- based O 3 concentrations m ay be controlled by a revised secondary standard set identical to a revised primary standard (in the range identified in section II.F above)

. In so doing, she considers the air quality analyses in the PA and also the analyses of more recent air quality da ta summarized in the EPA technical memo (described in section IV.E.4 above), focusing particularly on analyses examining the W126

- based O 3 exposure achieved in locations found to meet potential alternative standards within the range of primary standards pr oposed in section II.F above. Findings from these analyses of recent O 3 measurements and trends in the relationship between the primary current standard and the W126 metrics were substantially similar for the various time periods examined over the past decade. There is some information suggesting that there is a potential for inconsistencies in the relationship between W126 measures of seasonal O 3 concentratio ns and the fourth highest peak O 3 concentration s assessed by the current standard averaging time and form , but the available data suggest that air quality in areas meeting a primary standard in the range of 65 to 70 ppb would also meet a three

- year W126 in dex value falling in the range of 13 to 17 ppm

- hrs, and that to the extent areas need to take action to attain a standard in the range of 0.0 65 to 0.0 70 pp m , those actions would also improve air quality as measured by the W126 metric. The Administrator als o recognizes that the relatively lesser density of monitors in rural areas, including in areas of the west West and southwest Southwest NOAA climatic regions currently meeting the current standard where O 3 W126 index values are generally higher, makes uncert ain the degree to which a revised level for the current standard would provide the appropriate degree of protection for vegetation

- related effects on public welfare in these areas. The Administrator takes note of the PA finding, referenced in section*** E.O. 12866 Review

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Page 446 of 668 IV.D. 3 above, that reductions in NOx emissions that occur in urban areas to attain primary standards would also have the effect of reducing downwind, rural concentrations over the season. Thus, while the potential for underprotection may exist, depending on the specific levels chosen, the extent of such areas and of such a risk is not clear. Based on the most recent period of monitoring data, the Administrator notes that in all areas in which the O 3 concentrations would have met a primary standard with a revise d level of 70 ppb (which includes over 500 monitors distributed across all regions of U.S), the three

- year average W126 index values are at or below 17 ppm

- hrs. In the same areas, only 16 monitors (or less than 3 % of all monitors in this group, all but one of which is located in the southwest S outhwest region ) had three

- year average W126 index value s above 13 ppm

- hrs. She further notes that in all areas in which the O 3 concentrations would have met a primary standard with a revised level of 65 ppb (which inc ludes 220 monitors distributed across all regions of U.S), the three

- year average W126 index values are at or below 13 ppm

- hrs. In considering these findings regarding cumulative seasonal O 3 exposures in areas that would have met a primary standard with a revised level within the proposed range, the Administrator also takes note of the high correlation observed between the design value for the current secondary (and primary) standard and valu es for the three

- year average, W126 metric, as well as the high correlation in the relative changes in these two metrics based on air quality analyses of O 3 measurements from over the past decade. This finding supports a conclusion that the air quality ana lyses indicate that future control programs designed to reduce O 3 concentrations to help meet a revised primary O 3 standard that retains the current form and averaging time ( 3 three

- year average of the 4th highest daily maximum 8

- hour concentration) would a lso be expected to result in reductions in three

- year average, W126 index values. Further,*** E.O. 12866 Review

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Page 447 of 668 she notes the conclusion from the air quality analysis that the southwest Southwest and west West regions, which have the greatest potential for sites to measure eleva ted cumulative, seasonal O 3 exposures without the occurrence of elevated daily maximum 8

- hour average O 3 concentrations, exhibited the greatest response in W126 index value change per unit change in primary design value. metric based on the current standar d form and averaging time

. While recognizing the limitations of such analyses in projections of future air quality patterns, the Administrator also notes that the time period over which the analyses focused involved emissions control programs to achieve O 3 reductions such that their findings would be expected to be informative of further similar control activities, such as those to meet a revised standard with a lower level, in the future

. Based on the findings from these analyses, the Administrator finds it appropriate to consider the policy option of revising the retaining the form and averaging time of the current secondary standard and revising the level to within a the range identical of 65 to the proposed range for the primary standard 70 ppb . In such c onsideration, the Administrator first notes her proposed conclusion that the requisite protection from known or anticipated adverse effects to public welfare may be achieved by cumulative, seasonal, concentration

- weighted O 3 concentrations characterized in terms of a W126 index value that falls within the range from 13 to 17 ppm

- hrs

. Her final decision on the W126 index value in this range that affords the requisite protection will be based on a series of judgments, as described above. Given the focus
on t ree seedling growth effects in identifying this range, such judgments will include the weight to give the evidence of specific vegetation

- related effects estimated to result from W126 index values within this range, including the objectives for considerati on of tree species biomass loss estimates in relationship to identified benchmarks (e.g., median species RBL of 2% and greater),*** E.O. 12866 Review

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Page 448 of 668 the weight to give associated uncertainties, including those related to the variability in occurrence of such effects in forest ed areas, the associated ecosystem services including those of particular public welfare significance, and judgments on the extent to which such effects in forested areas may be considered adverse to public welfare. This final decision will also take into account judgments with regard to the weight to give the evidence and quantitative analyses, and associated uncertainties , related to other effects of O 3 (summarized in section s IV.C , IV.D.1 and
IV.E.2 above) , particularly including those for which the ISA conclude s causal or likely causal relationships with O 3 exposures. As noted above, a standard that provides the appropriate level of protection for growth effects would also be expected to provide additional protection for other effects including visible foliar injury, crops and carbon storage. The Administrator notes th at based on the above analyses, the proposed range of levels for a revised primary standard provide air quality, in terms of three

- year average W126 index values, of a range at or below the range which the Administrator has identified for consideration wit h regard to the requisite public welfare protection. Thus, depending on final judgments on revisions to the primary standard and the requisite protection for the secondary standard, a revised secondary standard identical to the revised primary standard may provide sufficient protection for public welfare. Therefore, the Administrator proposes to retain the current averaging time and form of the secondary standard and revise the level to within the range proposed for the primary standard of 65 to 70 ppb

. In r eaching such a conclusion, the Administrator recognizes that such a strengthening of the secondary standard would be expected to provide significant additional protection for public welfare, including effects related to vegetation and associated ecosystem services (and others discussed above), over that afforded by the current secondary standard

.*** E.O. 12866 Review

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Page 449 of 668 Thus, based on her consideration of the full range of information as described above, the Administrator judges that ambient O 3 concentrations in terms of a three

- year average W126 index value within the range extending from 13 ppm

- hrs to 17 ppm

- hrs would provide requisite public welfare protection. She further judges that it would be appropriate to achieve that level of air quality by retaining the existing averag ing time and form, and revising the level to within the
range proposed for the primary standard. of 65 to 70 ppb. In recognition of CASAC’s recommendation and the PA conclusion with regard to a distinct secondary standard, the Administrator additionally sol icits comment on the policy option of revising the form and averaging time for the secondary standard to a W126 index value, averaged across three years, with each year’s value identified as that for the three

- month period yielding the highest seasonal val ue and with daily O 3 exposures within a three

- month period cumulated for the 12

- hour period from 8:00 am to 8:00 pm, and a level within the range from 13 ppm

- hrs to 17 ppm

- hrs

. F. Proposed Decision on the Secondary Standard The Administrator proposes to revise the level of the current secondary standard within the range proposed for the primary standard of 0.065 to 0.070 ppm

. The EPA solicits comments on this proposed revision of the secondary standard. Further, the EPA solicits comments on the proposed conclusion that air that air quality in terms of a W126 index value, averaged across three consecutive years, within the range of 1 3 ppm - hrs to 17 ppm

- hrs would provide requisite protection against known or anticipated adverse effects to the public welfare. Additionally, the EPA solicits comments on alternative values for a three

- year average W126 index for such a purpose within the range extending below 13 ppm

- hrs down to 7 ppm

- hrs. The EPA also solicits comments on the alternative approach of revising the secondary standard to a cumulative, seasonal, concentration

- weighted form, the W126 index based on the*** E.O. 12866 Review

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Page 450 of 668 three consecutive month period within the O 3 season with the maximum index value, with daily exposures cumulated for the 12

- hour period from 8:00am to 8: 00pm and with a form that averages seasonal W126 values across three consecutive years and a level within the range of 13 to 17 ppm

- hrs. The EPA additionally solicits comments on such a distinct secondary standard with a level within the range extending be low 13 ppm

- hrs down to 7 ppm

- hrs. Further, the EPA solicits comments on retaining the current secondary standard , without revision

. , along with the alternative views of the evidence that would support retaining the current standard

. V. Appendix U : Interpretation of the Primary and Secondary NAAQS for O 3 A. Background The EPA is proposing to create Appendix U to 40 CFR p art 50 to reflect the proposed revisions to the primary and secondary national ambient air quality standards ( NAAQS ) for

ozone ( O 3 ) discussed in previous sections of this preamble. The proposed Appendix U explains the computations necessary for determining when the proposed primary and secondary O 3 NAAQS are met at an ambient air quality monitoring site, similar to Appendix P to 40 CF R part 50 which deals with revisions to interpretation of the O 3 NAAQS promulgated in 2008. Specifically, the proposed Appendix U addresses data selection requirements (s ection V.B), data reporting and data handling requirements (s ection V.C), and data comp leteness requirements. The EPA is proposing to maintain the data completeness requirements from the previous O 3 NAAQS. Given that the EPA is soliciting public comment on a distinct secondary standard based on the W126 metric, section V.D of this preamble contains a discussion o f additional data handling requirements that would be adopted in Appendix U in the event that the Administrator decides to set a distinct secondary standard based on public comments received. Formatted: Normal, Line spacing: Double Formatted: Font color: Red Formatted: Font: Italic Formatted: Font: Italic*** E.O. 12866 Review

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Page 451 of 668 The proposed Appendix U also provide s spe cific requirements for the handling of data affected by exceptional events in accordance with 40 CFR 50.14. Section V.E of this preamble addresses O 3 - specific deadlines related to the flagging and submission of demonstrations for exceptional event data for the proposed O 3 NAAQS.
B. Data Selection Requirements The EPA is proposing to clarify which data are to be used in comparisons with the NAAQS. First, the EPA proposes to maintain the existing regulatory requirements that only O 3 data collected by a feder al reference method spe cified in Appendix D to 40 CFR p art 50, or an equivalent method designated in accordance with 40 CFR p art 53, and meeting all applicable monitoring requirements listed in 40 CFR p art 58, are eligible for comparison to the proposed O 3 NAAQS

. Second, the EPA is proposing in Appendix U that O 3 design values are to be calculated on a site

- level basis. Past practice has been to calculate a design value for each individual O 3 monitor. However, t his practice could be viewed as inconsistent with the stated purpose of the previous ozone O 3 data handling appendix, which is to determine “ whether the national 8

- hour primary and secondary ambient air quality standards for ozone (O 3 ) specified in §50.15 are met at an ambient O 3 air quality monitoring site

. ” (40 CFR part 50, appendix Appendix P, section 1 (emphasis added ).) )). Given the level of consistency in the measurement data obtained across the various federal reference and equivalent O 3 monitoring instruments currently in operation 235 , (U .S. EPA, 2013a, section 3.5.2.1) , the EPA believes that it would be appropriate to combine data across O 3 monitors operating at the same site. Therefore, the EPA is proposing an analytic

235 See Final Integrated Science Assessment for Ozone and Related Photochemical Oxidants (EPA 600/R

- 10/076F, Feb. 2013), section 3.5.2.1 Formatted: Font: Italic*** E.O. 12866 Review

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Page 452 of 668 approach for combining data collected from multiple O 3 monitors at a site in order to obtain a single set of hourly O 3 concentration data for each site. The proposed approach allows the monitoring agencies to designate one monitor as the “primary monitor” for each site. In the absence of a primary monitor des ignation, the primary monitor would default to the monitor with the most complete hourly dataset in each year. Once a primary monitor has been determined for the site, missing hourly O 3 concentrat ions for the primary monitor would be substituted from any o ther monitors at the site. In the event of three or more monitors operating at the same site, missing hourly O 3 concentrat ions for the primary monitor would be substituted with hourly values averaged across the other monitors. The EPA notes that at the tim e of this proposal, there were approximately 20 sites operating two monitors simultaneously, and no O 3 sites operating three or more monitors simultaneously. This proposed approach for combining data across monitors at a site is consistent with the existin g approach described in Appendix N to Part 50 for the PM 2.5 NAAQS. The EPA invites public comment on the scientific validity of combining data across O 3 monitors, and the merits of the proposed approach for combining data across multiple O 3 monitors at a s ite. Third, the EPA proposes to maintain t he existing practice of combining data from nearby monitoring sites in order to determine a valid design value, known as a “site combination”. Site combinations typically involve situations where sites have been re placed or relocated a short distance away , and the monitoring agency wishes to combine the data from the two sites in order to maintain a continuous data record . The EPA regional offices have approved over 100 site combinations for O 3 since the promulgatio n of the 1997 O 3 NAAQS revisions

. The EPA has maintained records of approved site combinations, but these records are not easily accessible by the public

.*** E.O. 12866 Review

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Page 453 of 668 The EPA proposes to replace the current procedure for approving O 3 site combinations with a more form al procedure in Appendix U , which would require allow s tates to submit site combination requests to the appropriate Regional Administrator. Site combinations may be approved by the Regional Administrator, after he or she has determined that the measured air quality concentrations do not differ substantially between the two sites. In order to make this determination, the Regional Administrator may request a dditional information from the s tates, including detailed information on the locations and distance betw een the two sites, levels of ambient concentrations measured at the two sites, and local emissions or meteorology data. In order to improve transparency, the EPA will make records of all approved site combinations available in their Air Quality System (AQS ) database , and will update design value calculations in AQS so that approved site combinations are implemented

. The EPA invites public comment on the merits of the proposed process for approving site combinations in order to obtain valid design values for the O 3 NAAQS.
C. Data Reporting and Data Handling Requirements The EPA is proposing to maintain the requirement that hourly O 3 concentration data be reported in parts per million (ppm) to three decimal places. Any decimal digits reported beyond three dec imal digits will be truncated, consistent with past practice (40 CFR part 50, appendix Appendix P, section 2.1) and the typical measurement uncertainty associated with most
O 3 monitoring instruments. The proposed Appendix U clarifies that hourly O 3 concentr ations are to be reported in Local Standard Time (LST), consistent with how the values are currently stored in AQS. The EPA is proposing to maintain the existing procedures for calculating moving 8

- hour averages from the hourly O 3 data (40 CFR part 50, ap pendix Appendix P, section 2.1) , with one Formatted: Font: Italic*** E.O. 12866 Review

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Page 454 of 668 minor exception. In instances where fewer than six hourly O 3 concentrations are available during
an 8

- hour period (i. e. less than 75% completeness), the EPA is pro posing to substitute zero (i.e. 0.000 ppm) instead o f one half of the O 3 monitoring instrument’s minimum detectable limit (MDL) for the missing concentration values to determine if the resulting 8

- hour average is greater than the level of the NAAQS. The purpose of this “data substitution test” is to identif y any 8

- hour periods that do not meet the requirements for a valid 8

- hour average, but have reported concentrations that are so high that the NAAQS is exceeded even when substituting low values for the missing concentrations. The EPA believes that a consta nt substitution value of zero is preferable to 1/2 MDL, which may vary across O 3 monitoring instruments. The MDL value for most O 3 monitoring instruments is 0.005 ppm, and the 1/2 MDL value is 0.002 ppm (with truncation); thus , in practice , the difference is slight. The EPA notes that a value of zero micrograms per cubic meter (ug/m 3 ) is used in data substitution tests for 24

- hour average PM 2.5 concentrations, as specified in Appendix N to 40 CFR p art 50. The EPA invites public comment

on th e merits of using zero instead of 1/2 MDL for the 8

- hour average data substitution test. The EPA is proposing new procedures for determining daily maximum 8

- hour average
O 3 concentrations. Past practice allows for daily maximum 8

- hour average O 3 concentrat ions from two consecutive days to have some hours in common (40 CFR part 40, appendix 50, Appendix P, section 2.1) . One implication of this is that an O 3 site may be counted as having exceeded the NAAQS on two distinct days based on two 8

- hour periods havin g up to seven 7 hours in common. Theoretically, this could result in an annual fourth

- highest value greater than the NAAQS based on high overnight O 3 concentrations occurring only twice during the year. The EPA performed an analysis based on ambient O 3 concentration data from 2006 200 4
to 2011 [ insert reference to docketed memo, once it is available ] , 201 3 (Wells, 2014b) , which*** E.O. 12866 Review

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Page 455 of 668 showed that at least one instance of overlapping daily maximum 8

- hour averages occurred at
97 9 9.5 % of O 3 sites during that time p eriod. Overlapping daily maximum 8

- hour averages were infrequent at most sites, but in some cases , these values occurred quite regularly (up to 60 times per year). Overlapping daily maximum 8

- hour averages contributed to additional exceedances of the propo sed O 3 NAAQS at 9% of sites for a level of 0.070 ppm, and at 14 % of sites for a level of 0. 070 ppm, and at 23 % of sites for a level of 0. 065 ppm. In addition, 15 8 % of sites had overlapping daily maximum 8

- hour averages which contributed to a higher annual 4 th fourth

highest daily maximum value in one or more years , resulting in higher design values at 2 to 3% of sites for a given 3

- year period . Finally, the analysis showed that O 3 sites located in non

- urban areas affected by long

- range transport, especially those sites at higher elevations, were most likely to have additional exceedances of the proposed O 3 NAAQS due to the occurrence of overlapping daily maximum 8

- hour averages. Based on this analysis, the EPA initially concludes that overlapping daily maxim um 8

- hour averages are more likely to contribute to additional exceedances of the O 3 NAAQS as the level of the standard is lowered . T herefore, the EPA is proposing a new procedure for determining daily maximum 8

- hour average O 3 concentrations for the propo sed NAAQS that is based on 17 consecutive 8

- hour periods in each day, beginning with the 8

- hour period from 7:00 AM to 3:00 PM, and ending with the 8

- hour period from 11:00 PM to 7:00 AM. Given that 8

- hour averages are stored in the beginning hour of each period, this corresponds to the 8

- hour averages from 7:00 AM to 11:00 PM. The rationale for the proposed approach is twofold. First, it avoids any possibility of “double counting” exceedances of the NAAQS based on 8

- hour periods with one or more hours in c ommon, while continuing to make use of all of the hourly concentration data, and keeping the*** E.O. 12866 Review

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Page 456 of 668 calculations simple and straightforward. Second, it is more consistent with the physical processes involved in the formation and transport of ground

- level ozone O 3 . Specifically, the chemical reactions involved in the formation of new ground

- level ozone O 3 require sunlight. Therefore, it is appropriate to begin the “ ozone O 3 day” at sunrise, which for simplicity is assumed to be 7:00 AM LST. Similarly, any daily maximu m 8

- hour averages occurring after sunset are assumed to be caused by transport of ozone O 3 molecules which originated before sunset . Therefore, it is appropriate to end the “ ozone O 3 day” with the 8

- hour period beginning at 11:00 PM and ending
at 7:00 AM.
In order to accommodate the above proposed approach to the hours considered in an

“ ozone O 3 day”, the EPA is also proposing to modify the requirement for determining whether a daily maximum 8

- hour average O 3 concentration is valid for assessing compliance wit h the NAAQS (40 CFR part 50, appendix Appendix P, section 2.1)

. The proposed Appendix U requires valid 8

- hour averages for 13 of the 17 8

- hour periods in a day in order to determine a valid daily maximum value. The requirement of 13 valid 8

- hour averages was chosen because 13/17 is the smallest ratio greater than 75%, which is cons istent with the long standing requirement of 75% data completeness for daily and annual NAAQS

- related statistics. In addition, the EPA is proposing to maintain the existing provision allowing daily maximum 8

- hour averages greater than the level of the NAAQ S to be considered valid (40 CFR part 50, appendix Appendix P, section 2.1)

. The EPA invites public comment on the merits of the proposed procedure for determining daily maximum 8

- hour average O 3 concentrations, and the merits of the proposed daily validity criteria. Finally, the EPA has included additional language in the proposed Appendix U codifying existing data handling procedures for the previous O 3 NAAQS. First, the proposed Appendix U*** E.O. 12866 Review

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Page 457 of 668 maintains the provision that hourly O 3 concentrations approved und er 40 CFR 50.14 as having been affected by exceptional events are to be counted as missing or unavailable when calculating
8

- hour averages, and that these concentrations are to be included when determining whether the daily validity criteria have been met for a given day. Effectively, this means that it is possible for
an 8

- hour period affected by exceptional events to lack sufficient data to determine an 8

- hour average, yet the 8

- hour period may still be counted toward meeting the daily validity criteria. Second, the proposed Appendix U maintains the existing practice of including monitored days outside of the O 3 monitoring season when determining the annual fourth

- highest daily maximum value. Finally, the proposed Appendix U maintains the existing practice of using only daily maximum 8

- hour average values for days where the daily validity criteria have been met when determining the annual fourth

- highest daily maximum value.
D. Considerations for the Possibility of a Distinct Secondary Standard Given that th e EPA is soliciting public comment on setting a distinct secondary O 3 NAAQS based on the W126 index, the EPA is including a discussion on the data handling requirements for a distinct secondary standard. In the event that the Administrator decides to set

a distinct secondary O 3 standard based on the W126 index, the EPA will adopt data handling requirements for the secondary standard similar to those proposed during the reconsideration of the 2008 O 3 NAAQS in 2010 (see 75 FR 30 49

- 3052 , January 19, 2010 ).
Two changes would need to be made to the data handling provisions for the secondary standard proposed in 2010 in order to provide consistency with what the EPA is proposing for the primary standard in Appendix U. First, the secondary standard design value (i. e. the 3

- year average of the annual W126 index) would be truncated after the decimal point, instead of being rounded to the nearest whole number. Second, paragraph 4(c)(ii) would be modified to read: Formatted: Font: Italic*** E.O. 12866 Review

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Page 458 of 668 “If one or more months during the ozone monitoring seaso ns of three consecutive years has less than 75% data completeness, the three years shall nevertheless be used in the computation of a valid design value for the site, if, after adjusting the monthly W126 index values for the months with less than 75% data completeness by a factor of 4/3, the resulting design value is greater than the level of the standard.”
E

. Exceptional Event

s Information Submission Schedule
States 236 are responsible for identifying air quality data that they believe warrant special consideration, including data affected by exceptional events. States identify such data by flagging (making a notation in a designated field in the electronic data record) s pecific values in the Air Quality System ( AQS ) database. States flag the data and submit supporting documentation showing that the data have been affected by exceptional events if they wish the EPA to consider excluding the data in regulatory decisions, in cluding determining whether or not an area is attaining the proposed new revised O 3 NAAQS , if a different standard is finalized

. All states and areas of Indian country that include areas that could exceed or contribute to an exceedance of any revised O 3 NAA QS in a nearby area and could therefore be designated as nonattainment for the proposed O 3 NAAQS have the potential to be affected by this rulemaking. Therefore, this action applies to all states; to local air quality agencies to which a state has delegated relevant responsibilities for air quality management including air quality monitoring and data analysis; and to tribal air quality agencies , where appropriate. The “Treatment of Data Influenced by Exceptional Events; Final Rule” (72 FR 13560,
Ma rch 22, 2007), known as the Exceptional Events Rule and codified at 40 CFR 50.1, 50.14 and

236 R eferences to “state” are meant to include state, local and tribal agencies responsible for preparing and submitting exceptional event documentation as identified in the Exceptional Events Rule

. (72 FR 13560, March 22, 2007)

.*** E.O. 12866 Review

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Page 459 of 668 51.930 , contains generic deadlines for a state to submit to the EPA specified information about exceptional events and associated air pollutant concentration data. U nder this generic flagging schedule in 40 CFR 50.14(c)(2)( iii ) , a state must initially notify the EPA that data have been affected by an event by July 1 of the calendar year following the year in which the event occurred. This is done by flagging the data in AQS and providing an initial event description. According to the generic demonstration schedule in 40 CFR 50.14(c)( 3 )( i ) , t he state must also, after notice and opportunity for public comment, submit a demonstration to justify any claim within 3 years af

ter the quarter in which the data were collected. This section of the regulation also states that if the EPA must make a regulatory decision based on the data , the state must submit all information to the EPA no later than 1 year before the decision is to be made. These generic deadlines in the Exceptional Events Rule apply to data influencing redesignation efforts or other regulatory decisions made by the EPA after the EPA promulgates initial area designations for a new or revised NAAQS

. However, these sam e generic deadlines in the Exceptional Events Rule may not work well with the timing of the initial area designation process and schedule under a new or re vised NAAQS. Until the EPA promulgates the level and form of the NAAQS, a state does not know whether the criteria for excluding data (which are tied to the level and form of the NAAQS) were met for a given event. In some cases, the generic deadlines, especially the deadlines for flagging some rele vant data, may have already passed by the time the EPA promulgates the new or revised NAAQS. This scheduling constraint could result in the EPA ’s being unable to consider whether an exceptional event has affected the data relied on for initial area designa tions and further result in an area being designated nonattainment based on data that might have been excluded as having been influenced by an exceptional event if the EPA had been able to consider it during the designation process. For this reason, the EP A*** E.O. 12866 Review

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Page 460 of 668 has historically undertaken rulemaking as part of the NAAQS promulgation process to adjust the generic deadlines in sections 50.14(c)(2)( iii) and 50.14(c)( 3 )( i ) of the Exceptional Events Rule to accommodate the initial area designation process and schedu le under a new or re vised NAAQS. The Exceptional Events Rule at section 50.14(c)(2)(vi) indicates “when EPA sets a NAAQS for a new pollutant or revises the NAAQS for an existing pollutant, it may revise or set a new schedule for flagging exceptional event data, providing initial data descriptions and providing detailed data documentation in AQS for the initial designations of areas for those NAAQS.” As indicated in this proposal, the The EPA intends to issue its final action promulgating a revised O 3 NAAQS o r determining determine that it is not necessary to do so in October 2015. The CAA provides requirements regarding the schedule for initial area designations. Section 107(d)(1) of the C AA states that, “By such date as the Administrator may reasonably requi re, but not later than 1 year after promulgation of a new or revised national ambient air quality standard for any pollutant under section 109, the Governor of each state shall

... submit to the Administrator a list of all areas (or portions thereof) in the S tate , designating ”

... ” those areas as nonattainment, attainment, or unclassifiable. 237 N o later than 120 days prior to promulgating designations, the EPA is r equired to notify states of any intended modifications to their designation recommendations as the EPA may deem necessary

. Section 107(d)(1)(B)(i) further provides, “Upon promulgation or revision of a NAAQS, the Administrator shall promulgate the designations of all areas (or portions thereof)

... as expeditiously as practicable, but in no case later than 2 years from the date of promulgation

. Such period may be extended for

237 While the CAA says “designating” with respect to the Governor’s letter, in the full context of the CAA section it is cle ar that the Governor actually makes a recommendation.*** E.O. 12866 Review

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Page 461 of 668 up to one year in the event the Administrator has insufficient information to promulgate the designations .” As described in more detail in section VII.C of this proposal, the EPA inten ds to complete designations for any revised O 3 NAAQS promulgated in 2015 following the standard
2

- year process. The EPA is required by Court Order to take final action for this O 3 NAAQS review no later than October 1, 2015. The EPA does not intend to estab lish a date earlier than the 1 year submission period provided in CAA section 107(d)(4 ) of the CAA ; ) ; thus, state Governors (and tribes, if they choose) would be required to submit their initial designation recommendations for any revised NAAQS no later th an 1 year after promulgation ( i.e., by October 1, 2016 , if the EPA promulgates a revised NAAQS on October 1, 2015 )

. State Governors (and tribes, if they choose) would likely use air quality data from the years 201 3 to 201 5 as the basis for their recommendations

. The EPA would notify states and tribes of intended modifications to their recommendations no later than June 2017 and the EPA would promulgate
i nitial designations for any revised NAAQS in October 2017. We anticipate that the EPA’s
notific ation of intended modifications and the final designations would be based on air quality data from the years 201 4 to 201 6, because air quality data from 2016 is required to be certified by the state no later than May 1, 2017, and thus would be available fo r consideration for purposes of initial area designations by October 2017

. As indicated above, and as explained in additional detail in section VII.C of this preamble, section 107(d)(1)(B) of the CAA allows the Administrator to extend the designations sche dule for up to 1 year in the event the Administrator has insufficient information to promulgate the designations for a newly promulgated NAAQS. If the EPA were to determine that it is necessary to extend the schedule for designating areas for a revised O 3 NAAQS promulgated (promulgation in October 2015 ) from 2017 to 2018, then it is possible that air*** E.O. 12866 Review

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Page 462 of 668 quality data from 2017 could be considered for designations. This could raise concerns about whether influences from exceptional events in 2017 could be investi gated and submitted by the state and reviewed by the EPA in sufficient time for consideration during the designation
process. For purposes of initial designations, where the EPA considers the most recent air quality monitoring data in a relatively quick t imeframe, the EPA is proposing revisions to the flagging and data submission schedule in 40 CFR 50.14 applicable to the initial area designations process

. Th e proposed exceptional events schedul e is based on following a standard 2 year designation
process . However, because the CAA also provides for a 3

- year process in the event the Administrator has insufficient information to promulgate the designations for a newly promulgated NAAQS within 2 years and provides for the promulgation of designations as “exp editiously as practicable,” which could include accelerat ing the designations schedule ahead of the 2

- year schedule , the proposed exceptional event schedule also includes provisions for both an accelerated designations process and a 3

- year process. If th e EPA were to pursue a designations schedule other than a 2

- or 3

- year process, the EPA would notify the State s tate Governors of th e intended date for final designations through notification letters, guidance and/or Federal Register notices

. These proposed revised exceptional event scheduling provisions would, if promulgated, apply to submission of information supporting claimed exceptional events affecting pollutant data for initial area designations under any new or revised NAAQS, including any revised O 3 NAAQS promulgated in October 2015. The general data flagging deadlines in the Exceptional Events Rule at 40 CFR 50.14(c)(2)(iii) and the general schedule for submission of demonstrations at 40 CFR 50.14(c)(3)(i) would continue to apply to re gulatory decisions other*** E.O. 12866 Review

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Page 463 of 668 than those related to the initial area designations process under a new or revised NAAQS. The EPA believes these proposed revisions to the exceptional events scheduling provisions will provide adequate time for states to review the impact of determine whether data have been influenced by an exceptional events on any revised standards event , to notify the EPA by flagging the relevant data and providing an initial description in AQS, and to submit documentation to support claims for exceptional events. Therefore, using the authority provided in CAA section 319(b)(2), the EPA proposes to modify the schedule for data flagging and submission of demonstrations for exceptional events data considered fo r initial area designations as by replacing the deadlines and information in Table 1 in 40 CFR 50.14 with the deadlines and information presented in Table 9. The EPA is also providing Table 10 to illustrate how the proposed schedule might apply to the desig nations process for any revised O 3 NAAQS promulgated in October 2015 or to designations processes for future new or revised NAAQS. The EPA invites comment on these proposed changes, shown in Table 9, to the exceptional event data flagging and documentation submission deadlines for future new or revised NAAQS, including any revised O 3 NAAQS promulgated in 2015. Table 9. Pr oposed Schedule for Exceptional Event Flagging and Documentation Submission for Data to be Used in Initial Area Designations Exceptional Event / Regulatory

Action Exceptional Event Deadline Schedule d

Exceptional event data flagging and initial description deadline for data years 1, 2 and 3 a 3. a If state and tribal initial designation recommendations for the new/revised NAAQS are due August through January, then the flagging and initial description deadline will be the July 1 prior to the recommendation deadline. If state and tribal recommendations for the new/revised NAAQS are due February through July, then the flagging and initial d escription deadline will be the January 1 prior to the recommendation deadline

. Formatted: Line spacing: single*** E.O. 12866 Review

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Page 464 of 668 Exceptional event demonstration submittal deadline for data years 1, 2 and 3 a 3. a No later than the date that state and tribal recommendations are due to EPA

.

Exceptional event data flagging, initial description, and exceptional event demonstration submittal deadline for data year 4 b and potential data year 5 c 5. c By the last day of the month that is 1 year and 7 months after promulgation of a new or revised NAAQS, unless ei ther option a or b applies. a. If the EPA follows a 3

- year designation schedule, the deadline is 2 years and 7 months after promulgation of a new or revised NAAQS. b. I f the EPA notifies the state/tribe via Federal Register notice, letter or guidance that it intends to complete the initial area designations process according to a schedule other than a 2

- year or 3

- year timeline, the deadline is 5 months prior to the date of specified for final designations decisions in such EPA notification

. a Where data years 1, 2, and 3 are those years expected to be considered in state and tribal recommendations

. b Where data year 4 is the additional year of data that the EPA may consider when it makes final area designations for the new/revised NAAQS under the standard designations schedule.

c Where data year 5 is the additional year of data that the EPA may consid er when it makes final area designations for the new/revised NAAQS under an extended designations schedule. d The date by which air agencies must certify their ambient air quality monitoring data in AQS is annually on May 1 of the year following the year o f data collection. The EPA cannot require air agencies to certify data prior to this date. In some cases, however, air agencies may choose to certify a prior year's data in advance of May 1 of the following year, particularly if the EPA has indicated its i ntent to promulgate final designations in the months of May, June, July or August. Exceptional event flagging, initial description, and demonstration deadlines for “early certified” data will follow the deadlines for “year 4” and “year 5” data.

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Page 465 of 668 Table 10. Examples by Month of How the Proposed Revised Schedule for Exceptional Event Flagging and Documentation Submission for Data to be Used in Initial Area Designations Would Apply Month of NAAQS Promulgation, State and Tribal Recommendation, and Final Designations Exceptional Event / Regulatory Action Exceptional Event Deadline Schedule c Oct Nov Dec Jan Feb Mar Apr May d Jun d Jul d Aug d Sep Oct Oct 2015 Nov

2015 Dec

2015 Jan

2016 Feb

2016 Mar

2016 Apr

2016 May

2016 Jun

2016 Jul

2016 Aug

2016 Sep

2016 Oct

2016

Exceptional event data flagging and initial description deadline for data years 1, 2, and 3 a 3. a If state and tribal recommendations for

the new/revised NAAQS are due August through January, then the flagging and initial description deadline will be the July 1 prior to the recommendation deadline. If state and tribal recommendations for the new/revised NAAQS are d ue Feb through July, then the flagging and initial description deadline will be the January 1 prior to the recommendation deadline

. July 1, 2016 (data years 2013, 2014, 2015) July 1,

2016 (data years 2013, 2014, 2015) July 1,

2016 (data years 2013, 2014, 2015) July 1,

2016 (data years 2013, 2014, 2015) Jan 1,

2017 (data years 2013, 2014, 2015) Jan 1,

2017 (data years 2013, 2014, 2015) Jan 1,

2017 (data years 2013, 2014, 2015) Jan 1,

2017 (data years 2013, 2014, 2015) Jan 1,

2017 (data years 2014, 201 5, 2016) Jan 1,

2017 (data years 2014, 2015, 2016) July 1,

2017 (data years 2014, 2015, 2016) July 1,

2017 (data years 2014, 2015, 2016) July 1,

2017 (data years 2014, 2015, 2016)
Exceptional event demonstration submittal deadline for data year s 1, 2, and 3 a 3. a No later than the date that state and

tribal recommendations are due to EPA

. by Oct 2016 (data years 2013, 2014, 2015) by Nov

2016 (data years 2013, 2014, 2015) by Dec

2016 (data years 2013, 2014, 2015) by Jan

2017 (data years 2013, 201 4, 2015) by Feb

2017 (data years 2013, 2014, 2015) by Mar

2017 (data years 2013, 2014, 2015) by Apr

2017 (data years 2013, 2014, 2015) by May

2017 (data years 2013, 2014, 2015) by June

2017 (data years 2014, 2015, 2016) by July

2017 (data years 2014, 2015, 2016) by Aug

2017 (data years 2014, 2015, 2016) by Sep

2017 (data years 2014, 2015, 2016) by Oct

2017 (data years 2014, 2015, 2016) AQS Q&A and data certification Annually on May 1 of the year

following the year of data collection May 1 May 1 M ay 1 May 1 May 1 May 1 May 1 May 1 May 1 May 1 May 1 May 1 May 1

Exceptional event data flagging, initial description, and exceptional event demonstration submittal deadline for data year 4 b and potential data year 5 c 5. c By the last day of the month that is 1

year and 7 months after promulgation of a new or revised NAAQS, unless either option a or b applies. a. If the EPA follows a 3 year designation schedule, the deadline is 2 years and 7 months after promulgation of a new or revised NAAQS. b. If the EPA notifies the state/tribe via Federal Register notice, letter or guidance that it intends to complete the initial area designations process according to a schedule other than a 2

- year or 3

- year timeline, the deadline is 5 months prior to the da te of specified for final designations decisions in such EPA notification

. by May 31, 2017 (data year 2016) by June

30, 2017 (data year 2016) by July

31, 2017 (data year 2016) by Aug

31, 2017 (data year 2016 and potentia lly 2017) by Sep

30, 2017 (data year 2016 and potentia lly 2017) by Oct

31, 2017 (data year 2016 and potentia lly 2017) by Nov

30, 2017 (data year 2016 and potentia lly 2017) by Dec

31, 2017 (data year 2016 and potentia lly 2017) by Jan

31, 2018 (data year 2017) by Feb

28/29, 2018 (data year 201 7) by Mar

31, 2018 (data year 2017) by Apr

30, 2018 (data year 2017) by May

31, 2018 (data year 2017) State & Tribal Recommendations to EPA Oct 2016 Nov

2016 Dec

2016 Jan

2017 Feb

2017 Mar

2017 Apr

2017 May

2017 June

2017 July

2017 Aug

2017 Sep

2017 Oct

2017

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Page 466 of 668 EPA notifies States/Tribes of intended modifications to recommendations (RAs send 120
- day letters) June 2017 July

2017 Aug

2017 Sep

2017 Oct

2017 Nov

2017 Dec

2017 Jan

2018 Feb

2018 Mar

2018 Apr

2018 May

2018 June

2018 Administrator Promulgates Final Designations Oct 2017 Nov

2017 Dec

2017 Jan

2018 Feb

2018 Mar

2018 Apr

2018 May

2018 June

2018 July

2018 Aug

2018 Sep

2018 Oct

2018

a - Where data years 1, 2, and 3 are those years expected to be considered in state and tribal recommendations

. b

- Where data year 4 is the additional year of data that the EPA may consider when it makes final area designations for the new/ revised NAAQS

. c - W here data year 5 is the additional year of data that the EPA may consider when it makes final area designations for the new/revised NAAQS under an extended designations schedule. d

- The date by which air agencies must certify their ambient air quality monitoring data in AQS is annually on May 1 of the year following the year of data co llection. The EPA cannot require air agencies to certify data prior to this date. In some cases, however, air agencies may choose to certify a prior year's data in advance of May 1 of the following year, particularly if the EPA has indicated its intent to promulgate final designations in the months of May, June, July or August. Exceptional event flagging, initial description, and demonstra tion deadlines for "early certified" data will follow the deadlines for "year 4" and “year 5” data

.



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Page 467 of 668 Additionally, in conjunction with proposing exceptional event schedules related to implementing any revised O 3 standards, the EPA is also proposing to remove obsolete regulatory language F This section presents the rationale for the Administrator’s proposed decision s regarding the need to revise the current secondary O 3 NAAQS This section presents the rationale fo r the Administrator’s proposed decision s regarding the need to revise the current secondary O 3 NAAQS associated with exceptional event schedules for historical standards. The EPA expects to propose additional revisions to the Exceptional Events Rule in a fu ture notice and comment rulemaking effort and will solicit public comment on other, non

- schedule related, aspects of the Exceptional Events Rule at that time.
VI. Ambient Monitoring Related to Proposed O zone O 3 Standards A. Background The EPA is proposing to: revise the state

- by

- state O 3 monitoring seasons; revise the PAMS monitoring requirements; revise the Federal Reference Method ( FRM ) for measuring O 3 ; and revise the Federal Equivalent Method ( FEM ) testing requirements. The EPA is also proposing to make additional minor changes to the FEM testing requirements for NO 2 and particulate matter in part 53 as discussed below

. The EPA is proposing to extend the length of the required O 3 monitoring season in some
states to be appropriate for the O 3 NAAQS revisio n finalized in 2008, as well as a final revised
O 3 standard, if a revision is finalized in 2015

. The EPA is proposing to make changes to the PAMS monitoring requirements in 40 CFR part 58, Appendix D section 5. Section VI.C of this preamble provides background on the current PAMS monitoring requirements, recent efforts to re

- evaluate the current PAMS requirements, and a summary of the proposed PAMS requirement revisions.*** E.O. 12866 Review

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Page 468 of 668 The EPA is proposing to revise the FRM to establish a new, additional technique f or measuring O 3 in the ambient air. This new technique is based on Nitric Oxide nitric oxide

chemiluminescence (NO

- CL) methodology. Because of the similarity of this new chemiluminescence technique to the existing ethylene

- chemiluminescence (ET

- CL) methodol ogy, the EPA proposes that it be incorporated into the existing O 3 FRM, using the same calibration procedure. Appendix D of 40 CFR part 50 would be revised to include both the original ET

- CL as well as the new NO

- CL methodology. A minor change is proposed to the existing O 3 FRM calibration procedure, which would be applicable to both of the chemiluminescence FRM methodologies. The proposed change in section 4.5.2.3 of the calibration procedure in appendix D provides for more flexibility in the range of the linearity
test. The only substantial changes proposed to the requirements of 40 CFR part 53 are in Tables B

- 1 and B

- 3 of s ubpart B. Table B

- 1 has b een updated in recent years with regard to FRM and FEM methods for SO 2 (74 F R 64877 ; , December 8, 2009) and CO (76 FR 54294 ; , August 31, 2011) to be more consistent with current analyzer performance capabilities. Similar changes to Table B

- 1 are proposed here for methods for O 3 . M odest changes to Table B

- 3 would add new interferent test concentrations specifical ly for NO

- CL analyzers, adding a test for NO 2 . Also , the table would clarify that the existing test concentrations apply to ethylene

chemiluminescence ET

- CL O 3 analyzers. In addition, the EPA is making minor additional changes to part Part 53 including: conf orming changes to the FEM testing requirements in Table B

- 1 and Figure B

- 5 for NO 2 ; extending the period of time for the Administrator to take action on a request for modification of*** E.O. 12866 Review

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Page 469 of 668 a FRM or FEM from 30 days to 90 days; and removing an obsolete provision for manufacturers to submit Product Manufacturing Checklists for certain PM monitors. B. Revisions to the Length of the Required Ozone O 3 Monitoring Seasons Unlike the ambient monitoring requirements for other criteria pollutants that mandate
year - round mon itoring, O 3 monitoring is currently only required during the seasons of the year that are conducive to O 3 formation. These seasons vary in length from place to place as the conditions that determine conducive to the likely O 3 formation of O 3 (i.e., seasonal ly

- dependent factors such as ambient temperature, strength of solar insolation, and length of day) differ by location. 238 In some locations, conditions conducive to O 3 formation are limited to a few the summer months of the year. For example, in states with colder climates such as Montana and South Dakota, the currently required O 3 monitoring season is 4 four months long . However, in other states with warmer climates such as California, Nevada, and Arizona, the currently required O 3 monitoring season for most sites continues all 12 months of the year is year

- round

. 239
Based on the O 3 NAAQS revision that was finalized in 2008 , as well as the proposed NAAQS revisions discussed elsewhere in this rulemaking, the EPA has determined that
l engthening of the O 3 monitorin g season s may be appropriate . A mbient O 3 concentrations could approach or exceed the level of the 2008 NAAQS as well as the proposed NAAQS more frequently and during more months of the year

. As noted later in this section, a related issue is the status of any currently effective Regional Administrator

- granted waiver approvals to O 3 monitoring seasons, and the impact of the proposed changes to monitoring season requirements

238 See 40 CFR part 58 Appendix D, section 2.5 4.1 , Table D

- 3 for a table of required O 3 seasons. 239 Certain states, such as California and Arizona, have approved shorter seasons for a subset of O 3 sites, based on Regional Administrator review and approval (see 40 CFR part 58, Appendix D, section 4.1(i) for the waiver authority). Formatted: Subscript*** E.O. 12866 Review

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Page 470 of 668 on such waiver approvals. For the reasons explained below, EPA is proposing to revoke any existing waivers

. As appropriate, areas could seek new waivers so that monitoring agencies and the EPA can evaluate the length of monitoring seasons in consideration of the 2008 NAAQS and the final 2015 O 3 standard, if it is revised. , as well as the proposed NAAQS , more frequently and during more months of the year

. The EPA has done an analysis to address the issue of whether extensions of currently required monitoring seasons are appropriate in light of the proposed NAAQS. 240 In the (Rice, 2014)

. In th i s analysis, we determined the number of days where one or more monitors had a daily maximum 8

- hour O 3 average equal to or above 0.060 ppm in the months outside the currently

required state O 3 monitoring season using data from monitors that collected O 3 data year

- round in 2010

- 201 3

. 241 Although we refer to these days as “exceedance days” in the analysis, this
threshold is actually a conservative benchmark that is at a level below those proposed for the revised NAAQS. We find that this level, taking into co nsideration reasonable uncertainty, serves

as an appropriate indicator of ambient conditions that may be conducive to the formation of O 3 concentrations that approach or exceed the 2008 NAAQS or the proposed 8

- hour average range of 0.065 to 0.070 ppm

. 242 Alt hough we refer to these days as “exceedance days” in the analysis,
this 0.060 ppm threshold is simply a conservative benchmark that is below the levels proposed for the revised NAAQS. Proposals for revising each state’s required monitoring season are based

240 Memo to docket to be prepared regarding documentation of O 3 Monitoring Season Analysis for the Proposed Rule

. 241 Approximately 800 O 3 monitors are currently operated year

- round, representing greater than 50 percent % of the total O 3 monitoring network of about 1500 monitors . They include monitors that are mandated to operate year

- round due t o the required O 3 season an d other monitors that are voluntarily operated year

- round by states and other organizations including EPA

- operated monitors at Clean Air Status and Trends Network ( CASTNET ) sites. 242 A n 8

- hour concentration of 0.060 ppm also corresponds to the threshold def ining the current AQI breakpoint between the Good and Moderate indicator level ( 40 CFR part 58, appendix G ).*** E.O. 12866 Review

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Page 471 of 668 on the observed “ exceedance days equal to or above ” where the 8

- hour average daily maximum
was ≥ 0.060 ppm level in and surrounding the state. The EPA considered a number of factors including out

- of

- season “ exceedance days ” either before or after the cu rrent O 3 monitoring season, the pattern of “ exceedance days ” in the out

- of

- season months, and regional consistency. We note that year - to

- year variability occurs in seasonal O 3 patterns based on vary year - to

- year due primarily to highly variable and unpredictable meteorological conditions which can support conducive to the formation of early or late season elevated O 3 concentrations in some years and not others. Given the impracticality of forecasting such variations in seasonal weather patterns, t he The EPA believes it is important that O 3 monitors operate during all periods when there is a reasonable possibility of ambient levels approaching the level of the proposed NAAQS. The EPA reviewed the year

- round , O 3 data for 2010 through 2013 . A year

- roun d monitor was identified as “ year - round ” if it had at least 20 daily observations in all 12 months, for at least 1 year of the 4 year period. During the 2010

- 2013 data period, all states operated a portion of their monitoring network outside of their requi red O 3 monitoring season and reported the data to the EPA Air Quality System (AQS). The EPA’s analysis found the frequency of observed

“ exceedance days ” of daily maximum 8

- hour average O 3 readings of at least ≥ 0.060 ppm to be quite high in several states across the country in months outside of the current ly required monitoring season. A total of 4 2 4 3 states experienced at least 1 one “ exceedance day ” outside of the the ir current O 3 season; 2 1 states had “ exceedance days ” only b efore the required monitoring season; 4 states had “ exceedance days ” only after the required monitoring season ; and 17 1 8 states had “ exceedance days ” both before and after the required monitoring season. In some cases, the frequency of “ exceedance days ” be fore the current O 3 season was high, with 4 four*** E.O. 12866 Review

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Page 472 of 668 states (South Dakota, Colorado, Wyoming, and Utah) experiencing between 31 and 122 230 out

of

- season “ exceedance days ” from 2010 to 201 3 at monitors operating year

- round. 243
B asing O 3 monitoring season requirements on the goal of ensuring monitoring when ambient O 3 levels approach or exceed the level of the proposed NAAQS supports established monitoring network objectives described in Appendix D of part P art 58, including the requiremen t to provide air pollution data to the general public in a timely manner 244 and to support comparisons of an area's air pollution levels against the NAAQS. The EPA believes that these exceedance s frequency of “exceedance day s ” in which daily maximum of 8

- hour O 3 levels are observed to be greater than or equal to a threshold level that approaches the level of the proposed NAAQS of 0.060 ppm i n months outside the currently required O 3 monitoring season support support s the proposed lengthening of the O 3 m onitoring season requirements for certain
states.
T he operation of O 3 monitors during periods of time when ambient levels approach or exceed the level of the proposed NAAQS ensures that persons unusually sensitive to O 3 are alerted t o potential levels of health concern allowing them to take precautionary measures. The majority of O 3 monitors in the U.S. report to AIRNOW, 245 as well as to state

- operated websites and auto mated phone reporting systems. These programs support many objective s including real

time air quality reporting to the public, O 3 forecasting programs, and the verification of real

- time air quality forecast models.

243 Colorado, South Dakota, Utah, and Wyoming. 244 Public reporting requirements are detailed in 40 CFR part 58 Appendix G, Uniform Air Quality Index (AQI) and Daily Reporting. 245 See http://airnow.gov/*** E.O. 12866 Review

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Page 473 of 668 The specific proposed changes to the required state O 3 monitoring seasons are detailed in the proposed change s to Table D

- 3 of 40 CFR part 58 , Appendix D (O 3 Monitoring Season by
S tate). Although 4 2 4 3 states had at least one exceedance day outside the current monitoring season, changes are proposed for only 3 3 of those states. These proposed changes would entail

a n incre ase of 1 month for 24 23 states (Connecticut, Delaware, District of Columbia, Idaho, Illinois , Indiana , Iowa, Kansas, Maryland, Massachusetts, Minnesota, Missouri, Nebraska, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rh ode Island, South Carolina, Northern Texas, Virginia, and West Virginia) , an increase of 1.5 one and one half months for Wisconsin , an increase of 2 two months for 3 four states ( Indiana, Michigan, Montana, and North Dakota) , an increase of 4 four months for F lorida and South Dakota , an increase of 5 five months for Colorado, and an increase of 7 seven months for Utah. For Wyoming, we are proposing to add 3 three months at the beginning of the season and remove 1 one month at the end of the season, resulting in a net increase of 2 two months. O 3 Ozone season requirements are currently split by Air Quality Control Region (AQCR) in Louisiana and Texas. Included in the
state

- by

- state accounting is the proposal to lengthen the required season in the no rthern part of Texas (AQCR 022, 210, 211, 212, 215, 217, and 218) by 1 one month. S outhern Texas O 3 monitors in AQCRs 106, 153, 213, 214, and 216 would remain on a year

- round schedule. In some states with limited available data and few exceedance days outside the current season, proposed changes were made by considering regional consistency and using supporting information from the surrounding states; these changes were all minor, involving the proposed addition of 1 month to th e current required season in Iowa, Missouri, Rhode Island, and West Virginia.*** E.O. 12866 Review

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Page 474 of 668 The EPA solicits comment on the proposed changes to the required O 3 monitoring

seasons. We note that EPA Regional Administrators have previously approved certain deviations from the required O 3 monitoring seasons through rulemakings

. 246 (64 FR 3028, January 20, 1999; 67 FR 57332, September 10, 2002; and 69 FR 52836, August 30, 2004). The current ambient monitoring rule, in paragraph 4.1(i) of 40 CFR part 58 Appendix D (71 FR 61319 ; , October 17, 2006 ) , allows the EPA Regional Administrators to approve changes to the O 3 monitoring season without rulemaking. The EPA is retaining the rule language allowing such deviations from the required O 3 monitoring seasons in the proposed revision to p aragraph 4.1( i ) of 40 CFR part 58, Appendix D. The proposed changes to O 3 monitoring season requirements, if finalized, will revoke previous Regional Administrator

- granted waiver approvals. As appropriate, monitoring agencies could seek new waivers. Po st

- final rule requests submitted along with relevant supporting information by states for monitoring season waivers from the revised requirements will be reviewed by Regional Administrators using, at a minimum, occurrences of the moderate Air Quality Index ( AQI ) level , the frequency of out

- of

- season O 3 NAAQS exceedances , and regional consistency. Any deviations based on the Regional Administrator’s waiver of requirements must be described in the state’s annual monitoring network plan and updated in the AQS. Current regulations permit O 3 monitors located at NCore multi

- pollutant stations to be counted toward meeting minimum network monitoring requirements. The NCore network requirements were promulgated in the October 17, 2006 (71 FR 61318 6131 7 ) revisions to ambient monitoring regulations in order to build a long

- term, nationwide network that supports multiple objectives including air quality trends analyses, model evaluation, ecosystem studies,

246 64 FR 3028, 67 FR 57332, 69 FR 52836*** E.O. 12866 Review

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Page 475 of 668 and assessment of transport between urban and rural areas. In the 2006 rulemaking, the EPA did not propose a different O 3 monitoring season for NCore stations. NCore stations are required to operate a full suite of gaseous and particulate matter monitors as well as basic meteorology to support the objectives. Given the potential value of NCore data to support year

- round scientific studies, the EPA believes that it is appropriate to require O 3 monitors at NCore stations to be o perated on a year - round basis

. Accordingly, the EPA proposes that the required monitoring seaso n for NCore stations be January through December regardless of the length of the required O 3 monitoring season for the remainder of the SLAMS (State and Local Air Monitoring Stations) monitors within a state. The EPA has estimated the cost of the proposed changes to the O 3 seasons. The results are detailed in the EPA ICR # 2313.03 and summarized in Section VIII.B., “Paperwork Reduction Act”. The estimated cost is $1,668,433 which is about 7% of the total average annual cost of $24,115,182 for the national O 3 monitoring network. This estimate is based on the current requirements in 40 CFR part 58 and the proposed requirements in this rule. We note however, that greater than 50% of the monitors are currently operated year

- round due to existing requirements, as well as other monitors that are voluntarily operated year

- round by the states. Taking into consideration the number of year

- round O 3 monitors that are operated due to existing requirements, as well as on a discretionary basis by states, the incremental cost of these proposed changes is reduced from $1,668,433 to approximately $230,000, which is less than 1% of the total average annual cost of the national O 3 monitoring network. Considering the timing of this proposal and the final rule making (court ordered deadline of October 1, 2015) and associated burden on state/local monitoring agencies, we propose that implementation of the revise d O 3 seasons become effective at SLAMS (including NCore sites)*** E.O. 12866 Review

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Page 476 of 668 on January 1, 2017

. The EPA is proposing to add paragraph 58.13 (g) of 40 CFR part 58 to require that monitors operating under the requirements of section 4.1 of 40 CFR part 58, Appendix D oper ate on the applicable required O 3 monitoring seasons effective January 1, 2017 as listed in Table D

- 3 of appendix D to this part. We solicit comment on whether the revised

seasons could be implemented beginning January 1, 2016 for all monitors or for a sub set of monitors, such as those currently operating year

- round or on a schedule that corresponds to the proposed ozone O 3 season. If we determine, based on any such comments that implementation could occur earlier in such cases, we could proceed to final ac tion requiring earlier implementation. C. Revisions to the Photochemical Assessment Monitoring Stations (PAMS) Network Design Section 182 (c)(1) of the CAA required the EPA to promulgate rules for enhanced monitoring of O 3 , NO x oxides of nitrogen , and volatile organic compounds (VOC) VOCs for nonattainment areas classified as serious (or above) to obtain more comprehensive and representative data on O 3 air pollution. In addition, Section 185 B of the CAA required the EPA to work with the National Academy of Sciences (NAS) to conduct a study on the role of O 3 precursors in tropospheric O 3 formation and control. In 1992, the NAS issued the report entitled , “Rethinking the Ozone Problem in Urban and Regional Air Pollution ” (National Academy of Sciences, 1992 ” , ( NAS , 199 1 ). In response to the CAA requirements and the reco mmendations of the NAS report, o n February 12, 1993 (58 FR 8452), the EPA revised the ambient air quality surveillance regulations to require Photochemical Assessment Monitoring Stations (PAMS ) PAMS in each O 3 Formatted: Font: Italic*** E.O. 12866 Review

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Page 477 of 668 nonattainment area classified as serious, severe, or extreme (“PAMS areas ”). 247 As noted in EPA’s Technical Assistance Document (TAD) for Sampling and Analysis of Ozone
Precursors , 248 (U.S. EPA, 1998), the current objectives of the PAMS program are to: 1) pr ovide a speciated ambient air database which is both representative and useful in evaluating control strategies and understanding the mechanisms of pollutant transport by ascertaining ambient profiles and distin guishing among various individual volatile organic compounds ( VOC s); VOC s; 2) p rovide local, current meteorological and ambient data to serve as initial and boundary condition information for photochemical grid models ; 3) provide a representative, speciated ambient air database which is characteristic of source emission impacts to be used in analyzing emissions inventory issues and corrobor ating progress toward attainment; 4) provide ambient data measurements which would allow later preparation of unadjusted and a djusted pollutant trends reports; 5) provide additional measurements of selected criteria pollutants for attainment/nonattainment decisions and to construct NAAQS maintenance plans ; and 6) provide additional measurements of selected criteria and non

- criteria pollutants to be used for evaluating population exposure to air toxics as well as criteria pollutants

. The original PAMS requirements called for two to five PAMS sites per PAMS area depending on the PAMS area’s population. Four types of PAMS sites were identified including upwind (Type 1), maximum precursor emission rate (Type 2), maximum O 3 (Type 3), and extreme downwind (Type 4) sites. Each PAMS site was required to measure O 3 , nitrogen oxide (NO), nitrogen dioxide (NO 2 ), N O, NO 2 , speciated VOCs, selected carbonyl compounds, and

247 Additional information on the O 3 designation process can be obt ained at EPA’s O 3 designations webpage at http://www.epa.gov/groundlevelozone/designations/ 248 Technical Assistance Document (TAD) for Sampling and Analysis of Ozone Precursors, USEPA, 1998*** E.O. 12866 Review

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Page 478 of 668 sele cted meteorological parameters. In addition, upper air meteorological monitoring was required at one site in each PAMS area.
In the October 17, 2006 monitoring rule ( 71 FR 61236 61267 ), the EPA re vised the PAMS requirements to only require two PAMS sites per PAMS area

. 249 The intent of the revision was to “allow PAMS monitoring to be more customized to local data needs rather than meeting so many specific requirements common to all subject O 3 nonatta inment areas; the PAMS changes would also give s tates the flexibility to reduce the overall size of their PAMS
programs

— within limits

— and to use the associated resources for other types of monito ring they consider more useful.” In addition to reducing the number of required sites per PAMS area, the 2006 revisions also limited the requirement for carbonyl measurements (specifically formaldehyde, acetaldehyde, and acetone) to areas classified as serious or above for the 8

- hour
O 3 standard. This change was mad e in recognition of carbonyl sampling issues which were believed to cause significant uncertainty in the measured concentrations. Twenty

- two areas were classified as serious or above O 3 non - attainment nonattainment at the time the PAMS requirements were promulgated in 1993. On July 18, 1997 (62 FR 38856), the EPA revised the averaging time of the O 3 NAAQS from a 1

- hour averaging period to an 8

- hour averaging period. On June 15, 200 5 (70 FR 44470), the EPA revoked the 1

- hour standard in most areas of the c ountry , ; however, PAMS requirements were identified as requirements that had to be retained in the anti

- backsliding provisions 250 included in that action. Therefore, PAMS requirements continue to be applicable to areas that were classified as serious or abov e non attainment nonattainment for the 1

- hour O 3 standard as of June 15, 2004. Currently, 25 areas are

249 A One Type 2 site and either a Type 1 or a Type 3 site are currently required. 250 Refer to 40 CFR part 51.905 Formatted: Footnote Text-NPR*** E.O. 12866 Review

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Page 479 of 668 subject to the PAMS requirements with a total of 75 sites. As will be discussed in detail later, the current PAMS sites are concentrated in the North East and California with relatively limited coverage in the rest of the country

. 251 (Cavender, 2014). As discussed above, t he first PAMS sites began operation in 1994, and have been in operation for over 20 years. Many changes have occurred during those times th at time that have changed the O 3 problem in the U

. S

. as well as our understanding of it. The O 3 standard has been revised multiple times since the PAMS program was first implemented. On July 18, 1997, the EPA revised the O 3 NAAQS to a level of 0.08 parts per million (ppm), with a form based on the
3

- year average of the annual fourth

- highest daily maximum 8

- hour average O 3 concentration. On March 28, 2008, the EPA revised the O 3 standard to a level of 0.075 ppm, with a form based on the 3

- year average of th e annual fourth

- highest daily maximum 8

- hour average O 3 concentration (73 FR 16436).

. On March 28, 2008 (73 FR 16436), the EPA revised the O 3 standard to a level of 0.075 ppm, with a form based on the 3

- year average of the annual fourth

- highest daily maxim um 8

- hour average O 3 concentration. These changes in the level and form of the O 3 NAAQS, along with notable decreases in O 3 levels in most parts of the U

. S

. , ha ve changed the landscape of the O 3 problem in the U.S

. At the time of the first round of designations for the 8

- hour standard (June 15, 2005), only 5 five areas were classified as serious or above for the 8

- hour standard as compared to 2 2 areas that were classified as serious or above for the 1

- hour standard. 252 While the number of serious and above areas decreased, the number of non attainment nonattainment areas remained nearly the same. In addition to the change in the

251 Figure 1, Cavender 2014, “Network Design Considerations for the PAMS Network”, to be added to the docket. 252 PAMS requirements continue to apply to all areas classified as serious or above as of June 15, 2005 due to anti

- backsliding provisions of 40 CFR 51.905.*** E.O. 12866 Review

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Page 480 of 668 landscape of O 3 non - attainment issues , much of the equipment used at PAMS sites is old and in need of replacement. New technologies have been developed since the inception of the PAMS program th at should be considered for use in the network. For these reasons, the EPA determined that it would be appropriate to re

- evaluate the PAMS program and assoc iated requirements in light of current O 3 issues.
In 201 1 , (U.S. EPA, 2011c) , the EPA initiated an effort to re

- evaluate the PAMS requirements in light of changes in the needs of PAMS data users and the improvements in monitoring technology. The EPA consulted with the Clean Air Science Advisory Committee (CASAC), CASAC’s, Air Monitoring and Methods Subcommittee (AMMS) to seek advice on potential revisions to the technical and regulatory aspects of the PAMS program; including changes to required measure ments and associated network design requirements. The EPA also requested advice on appropriate technology, sampling frequency, and overall program objectives in the context of the most recently revised O 3 NAAQS and changes to atmospheric chemistry that hav e occurred over the past 10

- 15 years in the significantly impacted areas. The CASAC AMMS met on May 16 and May 17, 2011, and provided a report with their advice on the PAMS program on September 28, 2011

. 253 (U.S. EPA, 2011c). In addition, the EPA met multipl e times with the N ational Association of Clean Air Agencies (NA CAA ) Monitoring Steering Committee (MSC) to seek advice on the PAMS program. The MSC includes monitoring experts from various State state and local agencies actively engaged in ambient air monit oring and many members of the MSC have direct experience with running PAMS sites. Specific As discussed in more detail in the appropriate sections below, the EPA took into consideration advice obtained

253 CASAC Review of EPA’s Photochemical Assessment Monitoring Stations (PAMS) Network Re

- engineering Pro

ject; to be added to the Docket.*** E.O. 12866 Review

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Page 481 of 668 from the CASAC AMMS and the MSC that was considered in making the proposed in proposing changes to the PAMS requirements is discussed in the appropriate sections below

. Based on the findings of the PAMS evaluation and the consultations with the CASAC AMMS and NACAA MSC, the EPA is proposing to revise several a spects of the PAMS monitoring requirements including c hanges in 1) network design, 2) VOC sampling, 3) c arbonyl sampling, 4) n itrogen oxides sampling, and 5) u pper air meteorology measurements

. The following paragraphs describe the changes being proposed i ncluding the rationale for the proposed changes. Timing and other implementation issues associated with these proposed changes are discussed at the end of this section.
1. Network Design

. As discussed above, the current PAMS network design calls for two sites (a Type 2, and a Type 1 or Type 3) per PAMS area. In their report , (U.S EPA, 2011c), the CASAC AMMS f ound

“ that the existing uniform national network design model for PAMS is outdated and too resource intensive, ” and recommend ed “that greater flexib ility for network design and implementation of the PAM S program be transferred to state and local monitoring agencies to allow monitoring, research and data analysis to be better tailored to the specific needs of each O 3 problem area. ” While stating that t he current PAMS objectives were appropriate, the AMMS report also stated that “ objectives may need to be revised to include both a national and regional focus because national objectives may be different from regional objectives. ” The NACAA MSC also advise d the EPA that the existing PAMS requirements were too prescriptive and may hinder state efforts to collect other types of data that were more useful in understanding their local O 3 problems. The EPA agrees with CASAC that the PAMS objectives include both local and national objectives, and believes that the current PAMS network design is no longer suited for meeting Formatted: No underline*** E.O. 12866 Review

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Page 482 of 668 either sets of objectives. As part of the PAMS evaluation, it was determined that at the national level the primary use of the PAMS data has be en to evaluate photochemical model performance. Due to the locations of the current PAMS areas and the current network design, existing PAMS sites are clustered along the n orth e ast and w est coasts leading to significant redundancy in these areas and very l imited coverage th r oughout the remainder of the count r y . 254 (Cavender, 2014)

. The resulting uneven spatial coverage greatly limits the value of the PAMS data for evaluation of model performance. CASAC (U.S. EPA, 2011c) noted the spatial coverage issue and advised that EPA should consider requiring PAMS measurements in areas in addition to “ areas classified as serious and above for the O 3 NAAQS to improve spatial coverage. ” The EPA also agrees with CASAC and the NACAA th at the PAMS requirements should be revised to provide monitoring agencies greater flexibility in meeting local objectives. The EPA is proposing changes to the network design requirements that we believe will better serve both national and local objectives . The EPA is proposing a two part network design. The first part of the design includes a network of fixed sites (“ ( required PAMS sites ”) ) intended to support O 3 model development and the tracking of trends of important O 3 precursor concentrations. The se cond part of the network design includes monitoring agency directed

“ Enhanced Monitoring Plans ” which allow monitoring agencies the needed flexibility to implement additional monitoring capabilities to suit the needs of their area. To implement the fixed site portion of the network design, the EPA is proposing to require PAMS measurements at any existing NCore site in an O 3 non - attainment area (either based on the 2008 O 3 NAAQS or the 2015 O 3 NAAQS The EPA considered a number of options

254 Figure 1, Cavender 2014, “Network Design Considerations for the PAMS Network”, to be added to the docket.*** E.O. 12866 Review

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Page 483 of 668 to revise the fixed site portion of the network design (Cavender, 2014). An initial option considered was to require all NCore sites to make PAMS measurements regardless of O 3 attainment status. This option would take advantage of the existing NCore infrastructure and would r esult in a relatively wide geographic distribution of sites. However, it was noted that this option would place some PAMS measurements in areas with relatively low O 3 levels and would also result in a network of approximately 80 required sites, which would strain existing resources with a somewhat larger network than the current situation, and could make it difficult to also implement the desired state

- directed Enhanced Monitoring Plans . The second option considered was to require only NCore sites in O 3 nonattainment areas to collect PAMS measurements. This option would provide the benefits discussed above for collecting PAMS measurements at existing NCore sites. This option would also reduce the total number of sites required and focus efforts in areas with higher, non

- attaining, levels of O 3 . The final option considered would add a population limit in addition to the consideration of O 3 attainment status at NCore sites. An illustration of this example would be a PAMS requirement that applied only to NCo re sites in O 3 nonattainment areas with a population greater than a given threshold, for example, Core Based Statistical Areas with 1,000,000 people or more. This approach would continue the current practice of focusing PAMS resources in areas of elevated O 3 readings with an additional consideration that measurements in these larger population areas would be sufficient to characterize O 3 formation on a national basis. After considering the above options as well as the comments of CASAC and NACAA, the EPA be lieves that an approach focused primarily on the use of the existing NCore sites in O 3 nonattainment areas provides an appropriate balance to the consideration of O 3 levels as well as population, noting that a majority of NCore sites are already located in the larger urban areas of*** E.O. 12866 Review

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Page 484 of 668 each state. Accordingly, the EPA is proposing to require PAMS measurements at any existing NCore site in an O 3 nonattainment area (either based on the 2008 O 3 NAAQS or the 2015 O 3 NAAQS if finalized ) in lieu of the current PAMS n etwork design requirements. 255 The NCore network is a multi

- pollutant monitoring network consisting of 80 sites (63 urban, 17 rural) and is intended to support multiple air quality objectives including the development and model evaluation of photochemical mo dels (including both PM 2.5 and O 3 models), and the tracking of regional precursor trends. NCore sites are sited in typical neighborhood scale locations which are more suitable than source impacted locations for evaluation of grid models typical of current photochemical models and tracking of trends in pre

- cursor concentrations. The EPA believes NCore sites are well suited for O 3 model development and evaluation. The proposal to require PAMS measurements at existing NCore sites in O 3 non attainment nonattainment areas would replace the existing PAMS network design. 256 This change would keep roughly the same number of required PAMS sites while improving spatial
coverage . 257 (Cavender, 2014). Based on the range of the O 3 NAAQS being proposed today and

curr ent O 3 design value estimates (based on 2011

- 2013 air quality data), the number of required sites is estimated to be between 48 and 65 , which compares to 50 c urrently required sites, and 75

255 Although enhanced monitoring for ozone O 3 , oxides of nitrogen, and VOCs is specifically required for areas classified at least serious for the ozone O 3 NAAQS by section 182(c)(1) of the CAA, the EPA has concluded that requiring enhanced monitoring for all ozone O 3 nonattainment areas is appropriate for the purposes of monitoring ambient air quality and better understanding ozone O 3 pollution. 256 While the EPA is proposing to replace the multi

- site design, monitoring agencies would be encouraged to identify the type of PAMS site the NCore site represen ts. In most cases, NCore sites would likely be classified as either a Type 2 or Type 3 site. In limited situations , rural NCore sites might be subject to these proposed requirements, in which case, these sites would likely be either Type 1 or Type 4 sites. 257 Figure 2, Cavender 2014, “Network Design Considerations for the PAMS Network” , to be added to the docket.*** E.O. 12866 Review

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Page 485 of 668 currently operating sites. Potential redundancy in the existing ne twork would be reduced while important network coverage in the south east South east and mid

- west Midwest would be added. The improved spatial coverage will also improve the EPA’s ability to track trends in precursor concentrations regionally. The EPA notes th at in limited situations, an O 3 non attainment nonattainment area may not have an NCore site and in those cases, the area would only be subject to the requirement for a n Enhanced Monitoring Plan as discussed in more detail below . The EPA believes that the network coverage provided by existing NCore sites in O 3 non attainment nonattainment areas would be adequate for the national PAMS objectives discussed above, and that requiring PAM S sites , in addition to Enhanced Monitoring Plan s, in those O 3

non - attainment nonattainment areas without NCore sites would not substantially improve the network coverage. In addition to the reduction in the number of required sites, the T he EPA notes that the proposed network design change would provide significant cost efficiencies. By adding PAMS measurements to existing NCore sites, the PAMS network would be taking advantage of existing infrastructure and measurements currently being collected at NCore sites. NCore sites already have the larger, clima te

- controlled shelters that are necessary to operate the automated gas chromatographs (“auto

- GCs”) used to collect speciated VOCs. In addition, existing NCore sites currently collect data on many of the required PAMS measurements including O 3 , carbon

monox ide ( CO ), , total reactive nitrogen (NO y ), and meteorological measurements including wind speed and direction, temperature, and relative humidity

. While the EPA believes these proposed changes will result in fixed network cost savings

on an for the overall network on a national basis, individual monitoring agencies may see either an increase or a decrease in burden as a result of these proposed changes. Many*** E.O. 12866 Review

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Page 486 of 668 monitoring Monitoring agencies in O 3 non - attainment nonattainment areas who are not currently affected by the existing PAMS requirements would be required to add PAMS measurements to their existing NCore sites, while several monitoring agencies with existing PAMS sites would not be required to continue PAMS monitoring i f these proposed requirements are promulgated. 258 As discussed later in this preamble, the EPA is proposing a staggered compliance schedule for the proposed PAMS requirements in recognition of the need for capital investment and staff training at these sites

. The EPA recognizes that in limited situations , existing NCore sites may not be the most appropriate locations for making PAMS measurements. For example, an existing PAMS site in
an O 3 non - attainment nonattainment area may be sited at a different location than the existing NCore site. In this case, it may be appropriate to continue monitoring at the existing PAMS site to support ongoing research and to maintain trends information. To account for these situations, the EPA is also proposing to provide the EP A Regional Administrator the authority to approve an alternative location for a required PAMS sites where appropriate

. The EPA seeks comment on the proposed addition of PAMS measurements at NCore sites in O 3 non - attainment areas, and the removal of current multi

- site PAMS network design requirements. The EPA seeks comment on the network design revision proposed above, the requirement for PAMS measurements at NCore sites in O 3 nonattainment areas, and the removal of current multi

- site PAMS network design re quirements. The EPA also solicits comment on whether, instead of requiring PAMS measurements at all NCore sites in nonattainment areas, we should instead adopt one of the other options discussed above, for example, using both

258 Monitoring agencies would be able to seek approval to shut down non

- required PAMS sites at their discretion pursuant to the requirements detaile d in 40 CFR part 58.14 for O 3 and NO x monitors

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Page 487 of 668 attainment status and populati on thresholds, that may result in a fixed PAMS monitoring network that is either smaller or larger than what will result from the proposed requirement. The second part of the proposed PAMS network design includes monitoring agency directed enhanced O 3 monitoring activities intended to provide data needed to understand an area’s specific O 3 issues

. To implement this part of the PAMS network design , the EPA is proposing to add a requirement for states with O 3 non - attainment nonattainment areas to develop

a a n “ Enhanced Monitoring Plan .” These Enhanced Monitoring Plans, which are to be submitted as part of their required Annual Monitoring Network Plan , (40 CFR 58.10), would be reviewed and approved by the EPA Regional Administrator as part of the annual plan review process

. The purpose of the Enhanced Monitoring Plan is to improve monitoring for ambient concentrations of O 3 , NO x /NO y , VOC VOCs , and meteorology. The goal of the Enhanced Monitoring Plan is to allow monitoring agencies flexibility in determining a nd collecting the data they need to understand their O 3 problems , consistent with this purpose and the advice obtained from the CASAC AMMS and the NACAA MSC

. Types of activities that might be included in the state directed Enhanced Monitoring Plan include (but are not limited to) additional PAMS sites (e.g., upwind or downwind sites), additional O 3 and NO x monitoring, ozonesondes or other aloft
measurements, rural measurements, mobile PAMS sites, additional meteorological
measurements, and episodic or intensive studies. The intent of this part is to allow monitoring agencies flexibility in determining and collecting the data they need to understand their O 3 problems , consistent with the advice obtained from the CASAC AMMS and the NACAA MSC

. The savings from a smaller less costly fixed network of required PAMS sites would be available for re

- investment in the development and implementation of the proposed Enhanced Monitoring Plans

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Page 488 of 668 2. Speciated VOC Measurements

. Measurement of speciated VOCs important to O 3 formation is a key aspect of the PAMS
program. Currently, the existing PAMS requirements allow for a number of options in measuring speciated VOCs at PAMS sites which include 1) h ourly measurements using an auto

- GC, 2)

e ight 3

- hour samples daily usin g canisters, or 3) o ne morning and one afternoon sample with a 3

- hour or less averaging time daily using canisters plus continuous Total Non t otal n on - methane Hydrocarbon h ydrocarbon (TNMHC) measurements. The EPA believes that the options provided for VOC me asurement measurement s limit the comparative value of the data being collected, and is proposing to require instead require that all required PAMS sites to measure and report hourly speciated VOCs using an auto GC

. More complete and consistent speciated VOC data nationally would better help meet certain objectives of the PAMS program described above (e.g., a speciated ambient air database useful in evaluating control strategies, analyzing emissions inventory issues, corroborating progress toward attainment, and evaluating population exposure to air toxics). Furthermore, as noted by the CASAC AMMS, h ourly VOC data are “ particularly useful in evaluating air quality models and performing diagnostic emission attribution studies. These data can be provided on a near real

- time basis and presented along with other precursor species (e.g., oxides of nitrogen and carbon monoxide) collected over similar averaging times. ” L onger time

- averaged data are of significantly lower valu e for model evaluation. 259 In addition, creating consistent monitoring requirements across the network will provide better data for analyzing regional trends and spatial patterns.

259 Data of longer than a one 1

- hour average are often not used in model evaluations due to the complexity of trying to accommodate non

- hourly averaged data. Formatted: No underline*** E.O. 12866 Review

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Page 489 of 668 At the time the original PAMS requirements were promulgated, the canister opt ions were included because the EPA recognized that the technologies necessary to measure hourly average speciated VOCs concentrations were relatively new and may not have been suitable for broad network use. At that time, gas chromatographs designed for la boratory use were equipped with
auto

- samplers designed to “trap” the VOC compounds from a gas sample, and then “purge” the compounds onto the GC column. The EPA did not believe that auto

- GCs were universally appropriate due to the technical skill and effor t necessary at that time to properly operate an auto

GC. While the basic principles of auto

- GC technology have not changed, the hardware and software of modern auto

- GCs are greatly improved over that available at the time of the original PAMS requirements

. Based on advice from the CASAC AMMS, the EPA has initiated an evaluation of current auto

- GCs potentially suitable for use in the PAMS network. Based on the preliminary results, the EPA believes that typical NCore site operators, with appropriate training , will have the skill necessary to operate a modern auto

- GC successfully

. Considering the advances in auto

- GC technology, the added value obtained from hourly data , and the proposed move of PAMS measurements to NCore sites in O 3 non - attainment nonattainment areas, the EPA is proposing to require hourly speciated VOC sampling at all PAMS sites. The EPA notes that this proposed requirement would effectively prevent the use of canisters to collect speciated VOCs at the required PAMS sites. However, canister sam pling may continue to be an appropriate method for collecting speciated VOCs at other locations as part of the proposed Enhanced Monitoring Plans. While the EPA believes that the proposed transition to hourly speciated VOC sampling is the appropriate stra tegy to take advantage of improved technology and to broaden the utility of*** E.O. 12866 Review

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Page 490 of 668 collected data, we are also mindful of the additional rigidity that the proposed mandatory use of
auto

- GCs may have for monitoring agencies, especially those that have experience w ith and have established effective and reliable canister sampling programs. Therefore, the EPA is requesting comment on the proposed requirement for hourly VOC sampling as well as the range of alternatives that might be appropriate in lieu of a strict req uirement. Such alternatives could range from a more formal process where monitoring agencies could request a Regional Administrator

- granted waiver from the hourly VOC requirements through the Annual Monitoring Network Plan process to collect canister

- base d speciated VOC data, to a more flexible set of alternatives where canister sampling could be retained based on each monitoring agency’s evaluation of programmatic needs as well as their own logistical and technical capabilities.
3. Carbonyl Sampling

. Carbonyls include a number of compounds important to O 3 formation that cannot currently be measured using the auto

- GCs or canisters used at PAMS sites to measure speciated
VOCs. 260 The current method for measuring carbonyls in the PAMS program is Compendium Method TO

- 11A

. 261 (U.S. EPA, 1999). In this method , carbonyl compounds are adsorbed and converted into stable hydrazones using dinitrophenylhydrazine (DNPH) cartridges. These cartridges are then analyzed for the individual carbonyl compounds using liquid chr omatography

260 Carbonyls compounds including formaldehyde and acetaldehyde are difficult to analyze by GC with Flame Ionization Detectors (FID). Both of these compounds in their free state, do not respond well to FID detectors. GC analysis is difficult due to the chemic al composition of these compounds, increased polarity and their inherently low boiling points. 261 “ Determination of Formaldehyde in Ambient Air Using Adsorbent Cartridge Followed by High Performance Liquid Chromatography (HPLC) ” (EPA 1996), to be added to t he docket

. Formatted: No underline*** E.O. 12866 Review

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Page 491 of 668 (LC) techniques. Three carbonyls ( formaldehyde, acetaldehyde, and acetone ) are currently required to be measured in the PAMS program

- formaldehyde, acetaldehyde, and acetone

. In 2006 , the EPA revised the PAMS requirements such that carbonyl sa mpling was only required in areas classified as serious or above non - attainment nonattainment for O 3 under the 8

- hour O 3 standard which effectively reduced the applicability of carbonyl sampling to a few areas in California. This change was made in recognit ion that there were a number of issues with Method TO

- 11A that raised concerns with the uncertainty in the carbonyl data being collected. These issues include interferences (humidity and O 3 ) and breakthrough (i.e., overloading of the DNPH cartridge) at hig h concentrations. While solutions for these issues have been investigated , these improvements have not been incorporated into Method TO

- 11A. A recent evaluation of the importance of VOCs and carbonyls to O 3 formation determined that carbonyls, especially formaldehyde, are very important to O 3 formation

. 262 (Cavender, 2013). CASAC AMMS (U.S. EPA, 2011c) also noted the importance of carbonyls stating that “ There are many compelling scientific reasons to measure carbonyls. They are a very important part of O 3 chemistry almost everywhere .” Due to the importance of carbonyls to understanding O 3 chemistry, the EPA believes the need for carbonyl data outweighs the concerns over the uncertainty in the data. Therefore , the EPA is proposing to require all required PAMS sites to measure the carbonyls formaldehyde, acetaldehyde, and acetone. In addition, EPA is investigating alternatives to further reduce uncertainties in carbonyl data as described below. To improve the car

bonyl data that would be collected at required PAMS sites (and National Air Toxics Trends Station, or NATTS sites which are also currently measuring

262 Cavender, 2013 “Revisions to the Photochemical Assessment Monitoring Stations Compound Target List”, to be added to the docket.*** E.O. 12866 Review

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Page 492 of 668 carbonyls), the EPA has undertaken an effort to improve carbonyl sampling and analysis methods to reduce th e uncertainty in carbonyl data. This effort will lead to improvements to the current Method TO

- 11A by incorporating solutions to sampling and analysis issues that have been identified since Method TO

- 11A was finalized in 1996 1999 , such as the inclusion of an O 3 scrubber in the sampling system to reduce the interference from oxidants such as O 3 . Also as part of this effort, the EPA is investigating alternative cartridge materials that have been identified in the literature as a replacement for DNPH that may have better collection efficiency with fewer interferences.
4. Nitrogen Oxides Sampling

. It is well known that n itr ic o xide ( NO ) and n itrogen dioxide ( NO 2 ) play important roles
in O 3 formation

. 263 (U.S. EPA, 2011a, Section 3.2.2)

. Under the current network design, Type 2 PAMS sites are required to measure nitrogen oxides ( NO x , ( which by definition is the sum of NO and NO 2 ), and Types 1, 3, and 4 sites are required to measure total reactive nitrogen ( NO y ) which by definition include s NO, NO 2 , and other oxidized nitrogen compounds (NO z ). NCore sites are also currently required to measure NO y but are not required to measure NO 2 . In conventional NO x analyzers, NO 2 is determined as the difference between the measured NO and NO x concentr ations. However, due to the non

- selective reduction of oxidized nitrogen compounds by the molybedenum converter used in conventional NO x monitors, the
NO 2 measurement made by conventional NO x monitors can be biased high due to the varying

263 See ISA section 3.2.2. Formatted: No underline*** E.O. 12866 Review

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Page 493 of 668 presence of NO z compounds that may be reported as NO 2 . 264 The unknown bias from the NO z compounds is undesir able when attempting to understand O 3 chemistry. Improvements in reactive nitrogen measurements have been made since the original PAMS requirements were promulgated that allow for improved NO 2 measurements. Selective photolytic converters have been developed that are not significantly biased by NO z compounds

. 265 (Ryerson et al., 2000). Monitors using photolytic converters are commercially available and have been approve d as FEMs for the measurement of NO 2 . In addition, methods that directly read NO 2 have been developed that allow for very accurate readings of NO 2 without some of the issues inherent to the “difference method” used in converter based NO x analyzers.
However , these direct reading NO 2 analyzers generally do not provide a n NO estimate, and would need to be paired with a converter

- based NO x monitor or NO y monitor in order to also
measure NO. As discussed above, the EPA is propo sing to change the PAMS network de sign such that PAMS measurements would be required at existing NCore sites in O 3 non attainment nonattainment areas. NCore sites currently are required to measure NO and NO y . NCore sites are not currently required to measure NO 2 . Due to the importance of accurate NO 2 data to the understanding of O 3 formation, the EPA is proposing to require NO 2 measurements at required PAMS sites. Since existing NCore sites currently measure NO y , either a direct reading
NO 2 analyzer or a photolytic

- converter NO x analyzer s h ould be used to meet the proposed

264 Nitrogen compounds that would likely be reported (along with NO 2 ) as NO 2 with a conventi onal NOx monitor include peroxyacetyl nitrate (PAN), peroxypropionyl nitrate (PPN), peroxymethacryloyl nitrate (MPAN), and nitric acid (HNO 3 ), and as well as other nitrogen compounds not listed here. 265 Ryerson, et al, 2000 “An Efficient Photolysis System for Fast

- Response NO 2 Measurements, Journal of Geophysical Research, Volume 105, Issue D21.*** E.O. 12866 Review

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Page 494 of 668 requirement. The EPA believes c onventional NO x analyzers would not be appropriate for making PAMS measurements due to the uncertainty caused by interferences caused by NO z compounds. 5. Meteorology Measurements

. The curre nt PAMS requirements require m onitoring
M onitoring agencies are currently required to collect surface meteorology at all required PAMS sites. As noted in EPA’s TAD 266 (U.S. EPA, 1998) for the PAMS program, the PAMS requirements do not provide specific surface meteorological parameters to be monitored. As part of the implementation efforts for the original PAMS program, a list of r ecommend ed parameters

was developed and incorporated into the TAD which include s wind direction, wind speed, tempera ture, humidity, atmospheric pressure, precipitation, solar radiation, and ultraviolet (UV) radiation. Currently , NCore sites are required to measure the above parameters with the exceptions of atmospheric pressure, precipitation, solar radiation, and UV ra diation. In recognition of the importance of these ad ditional measurements for O 3 , the EPA is proposing to specify that required PAMS sites are required to collect wind direction, wind speed, temperature, humidity, atmospheric pressure, precipitation, sola r radiation, and UV radiation

. This proposed revision will provide clarity and consistency to the collection of surface meteorological parameters important to the understanding of O 3 formation. If PAMS measurements are moved to NCore sites in O 3 non - attain ment nonattainment areas, as is being proposed, the net impact of this proposed revision to the surface meteorological requirements for PAMS sites is to add the requirement for the monitoring of atmospheric pressure, precipitation, solar radiation, and UV

r adiation at affected NCore sites.

266 Technical Assistance Document (TAD) for Sampling and Analysis of Ozone Precursors, USEPA, 1998 Formatted: No underline*** E.O. 12866 Review

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Page 495 of 668 The existing PAMS requirements also require the collection of upper air meteorological measurements at one site in each PAMS area. The term “ upper air meteorological ” is not well defined in the existing PAMS requirements

. As part of the implementation efforts for the original PAMS program “ mixing height ” was added to the PAMS TAD as a recommended meteorological parameter to be monitored.
M ost monitoring agencies installed radar profile r s to me e t the requirement to collect upper air meteorology

. Radar profile r s provide data on wind and speed at multiple heights in the atmosphere. Radio acoustic sounding system ( RASS ) profilers are often included with radar profilers to obtain atmospheric temperature at multiple h eights in the atmosphere and to estimate mixing height. The EPA recognizes that the upper air data on wind speed and wind direction from radar profilers can be very useful in O 3 modeling. However, many of the current PAMS radar profilers are old and in nee d of replacement or expensive maintenance. In addition, the cost to install and operate radar profilers at all NCore sites would be prohibitive. Therefore , the EPA is not proposing to add require upper air wind speed and direction as required meteorological parameters to be monitored at required PAMS sites. Where monitoring agenc ies find the radar profiler data valuable, continued operation of existing radar profilers or the installation of new radar profilers would be appropriate to consider as part of the state’s Enhanced Monitoring Plan

. As discussed above, mixing height is one upper air meteorological measurement that has historically been measured at PAMS sites. A number of methods can be used to measure mixing height i n addition to radar profiler techno logy discussed above. Recent developments in ceilometer technology allow for the measurement of mixing height by changes in particulate*** E.O. 12866 Review

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Page 496 of 668 concentrations at the top of the bound a ry layer

. 267 (Eresmaa et al., 2006)

. Ceilometers provide the potential for continuo us mixing height data at a fraction of the cost of radar profilers. Due to the importance of mixing height measurements for O 3 modeling, the EPA is proposing to add the requirement for require monitoring agencies to measure mixing height at required PAMS sites

. The EPA is aware of a large network of ceilometers operated by the National Oceanic and Atmospheric Administration ( NOAA ) as part of the Automated Surface Observing System (ASOS). The EPA has been in discussions with NOAA regarding the potential for these systems to provide the needed mixing height data, however, the ASOS ceilometers are not currently equipped to provide mixing height data. Nonetheless, the EPA will continue to work with NOAA to determine if the ASOS ceilometers can be upgraded to me et the need for mixing height data, and is including proposed regulatory language that will allow states a waiver to use nearby mixing height data from ASOS or other sources to meet the requirement to collect mixing height data at required PAMS sites.
6. P AMS Season

. Currently, PAMS measurements are required to be taken during the months of June, July, and August. This three 3

- month period is referred to as the “PAMS Season”. As part of the
PAMS re

- evaluation, the EPA considered changes to the PAMS season . The three 3

- month
PAMS season was originally selected to represent the most active period for O 3 formation

. However, the EPA notes that in many areas the highest O 3 concentrations are observed outside of the PAMS season. 268 As an example, the highest O 3 co ncentrations in the mountain

-

267 Eresmaa, N, et al, (2006), “Mixing Height Determination by Ceilometer”, Atmospheric Chemistry and Physics, 6. 1485

- 1493. 268 The current O 3 monitoring season by state in 40 CFR part 58, appendix D, requires monitoring seasons from 4 to 12 months. As noted in section VI.B. of this rulemaking preamble , the EPA proposes to lengthen the seasons further for 33 states. Formatted: No underline*** E.O. 12866 Review

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Page 497 of 668 west Mountain

- West often occur during the winter months. Data collected during the current PAMS season would have limited value in understanding winter O 3 episodes. The CASAC AMMS (U.S. EPA, 2011c) noted in their report to the EPA that “it would be desirable to extend the PAMS monitoring season beyond the current June, July, August sampling period .” But , ” b ut that “the monitoring season should not be mandated and rigid; it should be flexible and adopted and coordinated on a regional airshed basis (i.e., within the same
O 3 region).” The EPA agrees with CASAC on the need for flexibility in determining when
PAMS measurements should be taken to meet local monitoring needs but also agrees with CASAC that the flexibility “should not conflict with national goals for the PAMS program.” A significant benefit of the standard PAMS season is that it ensures data availabili ty from all PAMS sites for national

- or regional

- scale modeling efforts. While the EPA agrees with the potential benefit of extending the availability of PAMS measurements outside of the current season, we also considered the burden of requiring monitoring agencies to operate additional PAMS measurements (e.g., hourly speciated VOC) for periods that in some cases, might be much longer than the current 3

- month season, for example, if the PAMS season was extended to match each state’s required O 3 monitoring s eason. Being mindful of the potential burden associated with a lengthening of the PAMS season as well as the potential benefits of the additional data, the EPA is proposing to maintain the current 3

- month PAMS monitoring season for required PAMS sites rath er than extending the PAMS season to other periods where elevated O 3 may be expected. The EPA believes that the 3

- month PAMS season will provide a consistent data set of O 3 and O 3 precursor measurements for addressing the national PAMS objectives. Monitori ng agencies are encouraged to consider collecting PAMS measurements in additional periods beyond the required PAMS season as part of the proposed*** E.O. 12866 Review

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Page 498 of 668 Enhanced Monitoring Plan . The monitoring agencies should consider factors such as the periods of expected O 3 e xceedances and regional consistency when determining potential expansion of the specific monitoring periods beyond the required PAMS season.
7. Timing and Other Implementation Issues

. The EPA recognizes that the proposed changes to the PAMS requirement requirement s will require resources and a reasonable implementation schedule if they are promulgated. The proposed network design changes would require monitoring agencies to start collection of PAMS measurements at many NCore sites that are not currently collecting PAMS measurements. These affected monitoring agencies would need to make capital investments (primarily for the installation of auto

- GCs, NO 2 monitors, and ceilometers). Monitoring agencies will also need time to develop the expertise, by traini ng existing staff or otherwise, to successfully collect PAMS measurements. The EPA believes that the current national funding level of the PAMS program is sufficient to support these proposed changes, especially in light of the staggered compliance deployme nt schedule described below. The current grant guidance includes the maintenance of a PAMS capital equipment reserve that could be used to assist monitoring agencies with the purchase of needed equipment. We also recognize that the proposed revisions would result in a potential shifting of PAMS resources, and we would work with the regional offices, affected states, and monitoring organizations such as the NACAA and the Association of Air Pollution Control Agencies (AAPCA) to facilitate any shifts in fundin g during the implementation phase of the program. For these reasons, the EPA is proposing a staggered compliance deployment schedule for the proposed changes to the PAMS requirements (including both the monitoring at required PAMS sites and the Enhanced Monitoring Plans). For areas currently designated as non Formatted: No underline*** E.O. 12866 Review

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Page 499 of 668 attainment nonattainment for O 3 based on the 2008 NAAQS, the EPA is p roposing to require monitoring agencies to incorporate the proposed PAMS requirements into their next annual monitoring network plan following promulgation of these proposed changes ( due July 1, 2016 , based on current schedules) and to comply with these pr oposed PAMS requirements by the following PAMS season (June 1, 2017 , based on current schedules). For new areas designated as
O 3 non - attainment nonattainment based on the initial round of designations following the promulgation of a revised O 3 standard, the EPA is proposing to require monitoring agencies to incorporate the proposed PAMS requirements into their next annual monitoring network plan following designations (due July 1, 2018 , based on current schedules) and to comply with new PAMS requirements by the following PAMS season (June 1, 201 9 , based on current schedules). Finally, the EPA is proposing that areas designated as O 3 non - attainment nonattainment following the initial round of designations be allowed 2 years after designation to comply with the proposed PAMS requirements. The EPA believes that the proposed compliance schedule will allow monitoring agencies adequate time to implement the proposed PAMS requirements. The EPA solicits comments on whether the proposed implementation schedule is practi cable, or whether additional time would be warranted for installation of new PAMS sites, the development of Enhanced Monitoring Plans, or other specific new PAMS requirements

. D. Revision

Addition of the a New Federal Reference Method (FRM) for Ozone O 3 To be used in a determination of compliance with the O 3 NAAQS, O 3 monitoring data must be obtained using either a Federal Reference Method ( FRM ) or a Federal Equivalent Method ( FEM ), , as defined in 40 CFR parts 50 and 53. Nearly all the monitoring methods for O 3 currently used by state and local monitoring agencies are FEM continuous analyzers utilizing a measurement principle based on quantitative measurement of the absorption of UV l ight by O 3 .*** E.O. 12866 Review

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Page 500 of 668 This type of O 3 analyzer was introduced into the monitoring networks in the 1980s and has since become the most predominant type of method used because of its all

- optoelectronic design and ease of installation and use. The existing O 3 FRM utili zes a measurement principle based on quantitative measurement of the chemiluminescence from the reaction of O 3 with ethylene. Ozone analyzers based on this FRM principle are no longer used for routine O 3 field monitoring and are no longer commercially avai lable. The current list of all approved FRMs and FEMs capable of providing ambient O 3 data for use in NAAQS attainment decisions may be found on the EPA’s website and in the docket for this action

. 269 (U.S. EPA, 2014g). The EPA proposes to revise the FRM to establish a new technique for measuring O 3 in the ambient air. This new technique would be a new type of analyzer based on Nitric Oxide

chemiluminescence (NO

- CL) methodology. Because of the similarity of this new chemiluminescence technique to the existing ethylene

- chemiluminescence (ET

- CL) methodology, the EPA proposes that it be incorporated into the existing O 3 FRM, using the same calibration procedure. Appendix D of 40 CFR part 50 would be revised to include both the original ET

- CL as well as the new NO

- CL methodology. A minor change is proposed to the existing O 3 FRM calibration procedure, which would be applicable to both chemiluminescence FRM methodologies. The proposed change in section 4.5.2.3 of the calibration procedure in part Part 50 provides for more flexibility in the range of the linearity test. FRMs, as set forth in several appendices to 40 CFR part 50, serve two primary purposes. The first is to provide a specified, definitive methodology for routinely measuring concentrations of various amb ient air pollutants for comparison to the NAAQS in part Part 50, for quality

269 List of Designated Reference and Equivalent Methods; US EPA, Office of Research and Development; National Exposure Research Laboratory; http://www.epa.gov/ttn/amtic/files/ambient/criteria/reference

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Page 501 of 668 assurance assessment of monitoring data, and for other air monitoring objectives. The second is to provide a standard of comparison for determining equivalence to the specified ref erence method of alternative and perhaps more practical pollutant measurement methods (equivalent methods, or FEMs) that can be used in lieu of the FRM for routine monitoring. Some of the FRMs contained in appendices to part Part 50 (such as the original SO 2 FRM and the lead FRM) are manual methods that are completely specified in a step

- by

- step manner. Others (such as the O 3 FRM) are in the form of a measurement principle along with an associated calibration procedure that must be implemented in a commercia lly

- produced FRM analyzer model. Such FRM

- type analyzers must be tested and shown to meet explicit performance and other qualification requirements that are set forth in 40 CFR part 53 (Ambient Air Monitoring Reference and Equivalent Methods) . Each analyze r model is then considered to be an FRM only upon specific designation as an FRM by the EPA under the provisions of 40 CFR 53.2 (General requirements for a reference method determination). As pollutant measurement technology advances and changes, the refe rence methods in part 50 are assessed by the EPA to determine if improved or more suitable measurement technology is available to better meet current FRM needs as well as potential future FRM requirements. New technology can either be presented to the EPA for evaluation by an FEM applicant under 40 CFR 53.16 (Supersession of reference methods), or (as in this case) the EPA can originate the process as provided in 40 CFR 53.7 (Testing of methods at the initiative of the Administrator). The current FRM for m easuring O 3 in the ambient air was promulgated on April 30, 1971 (36 FR 8186), in conjunction with the EPA’s establishment (originally as 42 CFR part 410) of the first national ambient air quality standards for six criteria pollutants (including O 3 ), as now*** E.O. 12866 Review

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Page 502 of 668 set forth in 40 CFR part 50. On February 8, 1979 (44 FR 8224), the original O 3 FRM calibration procedure was changed from a wet

- chemical standard to a UV photometric calibration procedure. Minor updates to technical references were made on July 18, 199 7 (62 FR 38895). This FRM is specified as a measurement principle and calibration procedure in Appendix D of part Part 50. The measurement principle of the FRM is based on the quantitative measurement of chemiluminescent light intensity emitted by the chemi cal reaction of O 3 in an air sample with ethylene gas mixed in a measurement cell. This ET

- CL measurement is calibrated by the specified calibration procedure, which is based on photometric assay of O 3 calibration concentrations in a dynamic flowing system , using measurement of the absorption of UV light by the O 3 calibration concentrations at a nominal wavelength of 254 nm. At the time of the FRM’s original promulgation, analyzers based on the ET

- CL FRM were widely used for field monitoring of O 3 . Laborato ry testing prior to, during, and following analyzer development indicated that interferences to which the method was susceptible were few and relatively minor in magnitude. Further, subsequent field experience with the FRM analyzers showed them to be stabl e, accurate, and reliable. Operation of these FRM analyzers requires a supply of ethylene gas, provided by an attendant high

- pressure compressed gas cylinder. Installation of this high

- pressure cylinder of flammable and potentially explosive gas proved
pro blematic at many field

- monitoring sites due to fire codes or other safety restrictions. Further, the ethylene gas cylinder required periodic replacement

– a considerable cost and operational inconvenience. Following the development of FEM O 3 analyzers base d on UV absorption, use of these newer UV FEM analyzers eventually supplanted the ET

- CL FRM analyzers because the UV analyzers required no gas supply or other reagents and were much easier to install and operate. Formatted: Line spacing: Double*** E.O. 12866 Review

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Page 503 of 668 Currently, nearly all compliance monitoring in the U.S. is carried out with UV absorption type FEM analyzers

. 270 (Long, 2014). This transition from ET

- CL FRM analyzers to UV absorption analyzers in U.S. (as well as world

- wide) monitoring networks has become so extensive that analyzer manufacturers no longer manufacture the ET

- CL FRM analyzers. The last new O 3 FRM analyzer was designated by EPA in 1979. As a result, no FRM O 3 analyzers are commercially available to serve as reference standards for testing and designation of new O 3 FEM analyzers, for O 3 compliance monitoring, and for quality assurance of field monitors. FRM units manufactured years ago are becoming increasingly difficult to maintain in operational condition due to aging of components and lack of replacement parts (several of the original FRM analyzer manufacturers no longer exist). Until the last few years, relatively few measurement techniques have been successfully implemented in a continuous ambient O 3 analyzer model that has achieved designation by the EPA as either an FRM or FEM

. 271 (U .S. EPA, 2014g). These include the ET

- CL technique, the UV absorption technique and differential optical absorption spectroscopy (DOAS, an open

- path method represented by two FEM instrument models from different manufacturers). A relatively new technology is nitric oxide (NO)

- O 3 chemiluminescence, which is represented by two FEM instrument models from a single manufacturer. An even newer technology is a “scrubberless” UV absorption technique that is represented by a single analyzer model for which FEM desig nation was recently achieved.

270 Draft

– Modern O 3 Instrument Deployment Data.xlsx 2013 to be placed in the Docket 271 List of Designated Reference and Equivalent Methods; US EPA, Office of Research and Development; National Exposure Research Laboratory; http://www.epa.g ov/ttn/amtic/files/ambient/criteria/reference

- equivalent

- methods

- list.pdf

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Page 504 of 668 As noted above, the ET

- CL technique is technically advantageous as an FRM, but its ethylene supply requirement and the lack of commercially available analyzers severely limit its ability to fulfill the needs for an O 3 FRM. Dif ferential optical absorption spectroscopy (DOAS) DOAS analyzers are not suitable for some FRM purposes because of their open

- path
nature. Commercial availability of conventional UV

- absorption O 3 analyzers is excellent, and their widespread use makes the mea surement technique desirable for consideration as an FRM. However, the technique is susceptible to potential measurement interference from mercury, some volatile aromatic hydrocarbons, water, and other compounds that sometimes occur in ambient air

. 272 (Spice r et al., 2010). These interferences are substantially reduced by the use of scrubbers (as discussed below) in UV FEM analyzers, such that the technique can be used extensively for compliance monitoring. Although the interferences are substantially reduced by the use of scrubbers, the potential for interferences prevents the technique from consideration as an FRM. It is important to make a distinction between use of the UV

- absorption measurement technique for assay of O 3 concentrations, as described in the FRM calibration procedure of part Part 50, Appendix D, and use of the UV absorption technique for measurement of O 3 in ambient air. For assay of calibration concentrations, the technique is used in a system with clean, zero air ( air that must be free of con taminants which would cause a detectable response from the
O 3 analyzer) such that potential ambient

- air

- borne interferences are not an issue. Under these clean

- air conditions, the UV assay technique is very accurate and highly reproducible

– , so much

272 Spicer et al., (2010). A re

- examination of ambient air ozone monitor interferences. J. Air and Waste Management Association, 60: 1353

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Page 505 of 668 so th at the National Institute of Standards and Technology (NIST) utilizes it for its O 3 Standard Reference Photometer. In contrast, use of the UV

- absorption technique to measure O 3 in ambient air is much more difficult because of the need to deal with UV

- absorbing (and hence potential interfering) species present in ambient air. Ambient UV O 3 monitors typically suppress interferences by using an “O 3 scrubber” that attempts to remove O 3 from ambient air without removing potentially interfering species, to create a zero

- O 3 reference air that still contains any potentially interfering species. In a differential measurement process that compares the UV absorption measurement of O 3 in th e ambient air sample with that in this zero

- O 3 reference air, the net effect of interferences is minimized by “ cancellation .”

. FEM analyzers using such O 3 scrubbers are able to meet the FEM interference test requirements of 40 CFR part 53 and provide adeq uate O 3 monitoring data at most typical O 3 monitoring sites. On October 7, 2011, the EPA designated two NO

- CL O 3 analyzers as FEMs (76 FR 62402). These analyzers use a variation of the current FRM measurement principle, based on measurement of the chemilu minescence produced by the chemical reaction of O 3 with NO rather than with ethylene. As explained below, the EPA believes that this variation has performance suitable for an O 3 FRM and offers a substantial implementation advantage over the existing
FRM.
T he NO

- CL measurement technique for O 3 is quite similar to the existing ET

- CL FRM technique, in that both are based on the measurement of the intensity of the chemiluminescence resulting from a chemical reaction of a reactant with the O 3 in the ambient air sample. The principle difference is that the reactant is NO rather than ethylene. As a potential variation of the*** E.O. 12866 Review

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Page 506 of 668 FRM measurement principle, the measurement would be calibrated with the same calibration procedure specified in the FRM. The performance of NO

- CL analyzers has been shown to be very similar to the performance of ET

- CL FRM analyzers

– , providing stable, accurate, highly reproducible measurements of ambient O 3 with minimal potential interferences

. 273 (U.S. EPA, 2014h). As with ET

- CL , some minor inte rference from variable humidity in ambient air can be minimized with a sample air dryer. The analyzers require a supply of NO gas, typically from a high

- pressure compressed gas cylinder. However, unlike ethylene, NO is neither flammable nor explosive, so

u se of the method in field applications is eased considerably relative to use of ET

- CL analyzers.
NO Nitric oxide gas is toxic, but it is possible to use a cylinder of much less toxic, non

combustible nitrous oxide (N 2 O) gas with a photolytic N 2 O

- to

- NO conve rter to supply NO gas for the instrument as needed. There will be no requirement for states to switch to NO

- CL analyzers; therefore, UV

- absorption FEM analyzers can still be used for routine O 3 monitoring. As noted previously, the EPA has designated two NO

- CL FEM analyzers (from the same manufacturer), both of which would qualify for re

- designation as FRMs if the NO

- CL technique is finalized as an FRM. NO

- CL analyzers would then be available for those applications where an FRM anal yzer is needed. Because of the similarity of the NO

- CL technique to the existing ET

- CL technique, the EPA is proposing to amend the ET

- CL FRM by adding the NO

- CL technique as a variation to the existing FRM measurement principle specified in Appendix D of Part 50. The specified

273 U.S.EPA, “Performance of the Propo sed New Federal Reference Method for Measuring Ozone Concentrations in Ambient Air. ” Report Number EPA #######; prepared by Office of Research and Development, National Exposure Research Laboratory, U.S. Environmental Protection Agency, Research Triangle Park, NC (2014)*** E.O. 12866 Review

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Page 507 of 668 calibration procedure would be applicable to both FRM ET

- CL and NO

- CL measurement techniques. Since the existing ET

- CL FRM measurement principle remains a technically adequate FRM, and the proposed new NO

- CL FRM is technically adequ ate, it is prudent to retain the existing FRM measurement principle. The designation of all currently designated O 3 FEMs is based on comparison to the ET

- CL FRM, so retention of the ET

- CL FRM allows those FEM designations to be retained. Adding the propos ed NO

- CL measurement technique to the current O 3 FRM would allow at least two commercially available FRM analyzer models (currently FEMs) to be re

- designated as FRMs to fulfill FRM analyzer needs. Some older FRM analyzers based on the existing ET

- CL

measur ement principle may still be in operable condition, and there is no technical reason to cancel their designation by withdrawing the original ET

- CL FRM technique. Additionally, retaining the existing ET

- CL FRM technique allows for the possibility of an inst rument manufacturer offering an ET

- CL FRM analyzer in the future. The second of the newly introduced O 3 measurement techniques is known as the

“ scrubberless ” UV absorption (UV

- SL) technique. It utilizes the UV

- absorption measurement technique that is widel y used in O 3 monitoring networks. The new UV

- SL technique specifies removal of O 3 from the sample air for the zero reference by a gas

- phase reaction with NO rather than via a conventional chemical scrubber. The NO reacts with the O 3 much faster than with

o ther potential interfering compounds and is very effective at removing the O 3 without affecting other compounds that may be present in the ambient air sample. The differential UV measurement can effectively eliminate interferences to an insignificant level . Other potential interference arising from changes in water vapor concentration can be minimized with a sample air dryer.*** E.O. 12866 Review

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Page 508 of 668 The UV

- SL technique appears to have characteristics that are advantageous for meeting the requirements of a new O 3 FRM. Analyzers imp lementing this technique require a supply of NO (such as a high

- pressure gas cylinder). As noted previously in connection with the NO

- CL technique, NO is neither flammable nor explosive, so use of the method in field applications is eased considerably rela tive to use of ET

- CL analyzers. Use of N 2 O gas, also supplied in compressed gas cylinders but less toxic than NO, is also possible with a photolytic N 2 O to NO converter. One commercially available UV

- SL analyzer was approved as an FEM on June 18, 2014 (79 FR 34734). The performance of the analyzer, as reported by the manufacturer 274 and some initial field and laboratory studies performed by the EPA 275 , (U.S. EPA, 2014h), suggests that the analyzer may meet existing, as well as the proposed, requirements for an O 3 FRM

. The CASAC AMMS provided a peer review of the proposed FRM and changes to the part Part 53 requirements on April 3, 2014. The CASAC AMMS recommended that the EPA consider the UV

- SL as a FRM. The EPA is independently conducting further laboratory and field tests of the UV

- SL analyzer to verify its performance. Although this new UV

- SL methodology shows substantial promise for future consideration as a new O 3 FRM, there is currently insufficient documented test and performance information available on the method to propose it as a new FRM at this time. The EPA is continuing to study the method and assess its potential suitability as a new O 3 FRM, and the EPA solicits comment on its potential and suitability as an FRM.

274 2B FEM test data via http://www.twobtech.com/model_211.htm 275 U.S.EPA, “Performance of the Proposed New Federal Reference Method for Measuring Ozone Concentrations in Ambient Air .” Report Number EPA #######; prepared by Office of Research and Development, National Exposure Rese arch Laboratory, U.S. Environmental Protection Agency, Research Triangle Park, NC (2014)*** E.O. 12866 Review

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Page 509 of 668 The EPA is not proposing to supersede (replace) the existing O 3 FRM measurement principle under the provisions of 40 CFR 53.16. Rather, for the reasons in the preamble and having conducted the necessary tests, the EPA is proposing, consistent with 40 CFR 53.7 , to revise the existing O 3 FRM to widen the scope of its ET

- CL measurement principle to include the NO

- CL measurement technique as well. Following promulgation of the proposed revised O 3 FRM measurement prin ciple, any new candidate O 3 FRM analyzers would be required to use either the ET

- CL or NO

- CL measurement principle, and would also be subject to the O 3 FRM performance requirements proposed in 40 CFR part 53. The FRM calibration procedure specified in Appe ndix D would apply to both O 3 FRM measurement techniques. A substantial number of laboratory tests have confirmed the excellent performance of the
NO

- CL analyzers as well as very close agreement with both ET

- CL and UV analyzers in collocated field tests. T herefore, the EPA believes the proposed FRM measurement principle that incorporates the NO

- CL methodology is the best approach to improve the availability of FRM analyzers for O 3 . No other currently known approach or alternative methodology appears to be

m ore appropriate for a new FRM. Adding the NO

- CL technology to the existing O 3 FRM is also endorsed by the EPA’s CASAC AMMS. The EPA solicits comment on the proposal to retain the existing O 3 FRM measurement principle and amend it to include the NO

- CL varia tion as well. Comments are also solicited on the nature and adequacy of the proposed revised FRM. The generic description of the FRM measurement principle for the existing ET

- CL FRM in Appendix D would be amended to include the NO

- CL variation (see the pro posed rule text for Appendix D). As noted previously, the new NO

- CL technique would also use the same calibration procedure in Appendix D and would be similarly coupled with the explicit O 3 FRM*** E.O. 12866 Review

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Page 510 of 668 analyzer performance requirements specified in subpart B of 40 CFR part 53. In addition to the incorporation of the NO

- CL methodology, numerous minor clarifications, wording changes, additional details, and a more refined numbering system are being proposed for Appendix D. Accordingly, the entire Appendix D is propos ed to be revised as identified in the proposed regulatory text. Because the new NO

- CL technique is proposed to be added to the existing FRM measurement principle, while the existing ET

- CL FRM principle would be retained and remain in effect, all existing d esignated FEM analyzer models will continue their designated status. Thus, this action would cause no negative consequences on monitoring agencies, and no disruption of, or required change to, their O 3 monitoring programs. Comparative testing has been

carr ied out at several field monitoring sites under a variety of ambient conditions, and the results confirm that the proposed new NO

- CL FRM measurement technique provides ambient O 3 measurements that compare and correlate excellently with measurements using t he existing ET

CL measurement principle, with no significant bias, offset, or discrepancy

. 276 (U.S. EPA, 2014h). E. Revisions to the Procedures for Testing Performance Characteristics and Determining Comparability Between Candidate Methods and Reference Met hods
The only substantial changes proposed to the requirements of Part 53 are in Tables B

- 1 and B

- 3 of Subpart B. Table B

- 1 has been updated in recent years with regard to FRM and FEM methods for SO 2 (74 FR 64877 , December 8, 2009 ) and CO (76 FR 54294 , Au gust 31, 2011 ). Similar update changes to Table B

- 1 are proposed here for O 3 . M odest changes proposed for

276 U.S.EPA, “Performance of the Proposed New Federal Reference Method for Measuring Ozone Concentrations in Ambient Air.” Report Number EPA #######; prepared by Office of Research and Development, National Exposure Research Laboratory, U.S. Environmental Protection Agency, Research Triangle Park, NC (2014) Formatted: Line spacing: Double*** E.O. 12866 Review

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Page 511 of 668 Table B

- 3 would add new interferent test concentrations specifically for NO

- CL analyzers, adding a test for NO 2 . T he table would also clarify that the existing test concentrations apply to
ET

- CL O 3 analyzers. Figure B

- 5 is revised to correct a minor inconsistency in the “Calculation s ” column for the two “ Precision ” rows to change “% URL” to “ % Standard Deviation. ” Several changes to the performance requirements given in Table B

- 1 are proposed for O 3 . The performance requirements for “standard range” instruments would be updated to be more consistent with current O 3 analyzer performance capabilities. The noise requirement limit would be re duced from 0.005 to 0.001 ppm for O 3 analyzers, the lower detectable limit would be reduced from 0.010 to 0.003 ppm, and the maximum interference equivalent limits would be reduced from 0.02 to 0.005 ppm for each potential interfering agent (interferent). T he performance limit requirement for the total of all interferents is proposed to be withdrawn for O 3 methods. This withdrawal is appropriate because O 3 analyzer test performance, as reported in recent FEM applications, has shown that the limits establish ed for individual interferents are sufficiently effective to define adequate analyzer performance, and the separate limit for the total of all interferences is unnecessary . Maximum zero drift for O 3 analyzers would be reduced from 0.02 to 0.004 ppm. The

e xisting limit for span drift at 20 per cent % of the upper range limit (URL) is proposed to be withdrawn. Analyzer performance test results have clearly shown that the existing 80% URL limits are fully adequate and better specify span drift performance and that the 20% URL span drift limits are ineffective and unnecessary. The span drift limit applicable to O 3 analyzers is proposed to be reduced from ±5.0% to ±3.0%. Lag time limits would be reduced from 20 to 2 minutes, and rise and fall time limits would be similarly reduced from 15 to 2 minutes.*** E.O. 12866 Review

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Page 512 of 668 For precision, the EPA proposes to change the form of the precision limit specifications (at both 20% and 80% of URL) for O 3 analyzers from ppm to percent (of the URL). This change would make the limits responsive to higher and lower measurement ranges, as appropriate, and is consistent with the same change previously made in the corresponding precision requirements for SO 2 and CO analyzers. Both limits would be set at 2 percent % for O 3 analyzers, which is equivalen t to, and , therefore effectively unchanged, from the existing limits of 0.01 ppm (for a URL of 0.5 ppm). Although the changes to Part 53 proposed here are generally restricted to methods for O 3 , this change in form for the precision limits is proposed to b e extended to methods for NO 2 , as well, to simplify Table B

- 1 and make it consistent for all pollutants covered by the Table. The precision limits that would be applicable to methods for NO 2 are proposed to be changed to 4% and 6% of the URL (for 20% and 8 0% of the URL, respectively). These values are exactly equivalent to the existing limits of 0.020 ppm and 0.030 ppm, respectively, for the specified URL of 0.5 ppm. Therefore, these precision limits for NO 2 remain effectively unchanged, but specified as a percent rather than an absolute concentration. A new footnote is proposed for Table B

- 1 to clarify that these revised precision limits are given as “standard deviation expressed as percent of the URL.” Therefore, Figure B

- 5 will be revised to correct a
min or inconsistency in the “Calculation” column for the two “Precision” rows to change the “% URL” to “% Standard Deviation ”. .” The EPA has reviewed the documented performance of currently designated FRM and FEM methods for O 3 (that are still in commercial pr oduction or in service in monitoring networks) and has verified that all would meet the proposed new performance requirements for*** E.O. 12866 Review

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Page 513 of 668 O 3 methods

. 277 (Long, 2014). Therefore, adoption of the proposed new performance requirements in Table B

- 1 would not require the withdrawal or cancelation of the FRM or FEM designation of any such O 3 analyzers. Finally, to meet a need for analyzers with more sensitive measurement ranges for monitoring in relatively clean areas, new, “lower range” performance limit requirements are proposed for O 3 analyzers. These lower range limits are set forth in a new “lower range” column
in Table B

- 1 and would be optional. But where a lower measurement range is included in the FRM or FEM designation, these proposed new requirements would provide more stringent performance for analyzers commensurate with greater accuracy for low

- level measurements in lower

- level concentration ranges. The EPA believes that these proposed changes in the performance requirements of Tables
B

- 1 and B

- 3 are appropriate, based on analyzer performance data available from analyzer manuals and recent FRM and FEM applications. The EPA solicits comment as to whether t he proposed changes are reasonable, appropriate, benefi cial , and achievable without undue burden

. The EPA is proposing minor change s to the general provisions in subpart A of Part 53 to ease the administrative burden associated with processing and reviewing modification requests to existing FRMs and FEMs. This change in 40 CFR 53.14(c) will extend the length of t ime for the Administrator to take action on a request for modification of a reference or equivalent method from 30 days to 90 days. Section 53.14(c) would read: "Within 90 calendar days after receiving a report under paragraph (a) of this section, the Admi nistrator will take one or more of the following actions:" The EPA is also propos ing to remove the obsolete provision that

277 Draft

- Modern O3 Instrument Deployment and Performance Data.xlsx, (2013) to be placed in the docket.*** E.O. 12866 Review

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Page 514 of 668 manufacture r s who offered PM 2.5 or PM 10

- 2.5 samplers or analyzers for sale as part of a FRM or FEM may continue to do so only so long as updates of the Product Manufacturing Checklist are submitted annually. This change is accomplished through the removal of section ( i ) from 40 CFR 53.9 and Figure E

- 2 from subpart E of part Part 53

. VII. Implementation of Proposed O 3 Standards The prop osed revisions to the primary and secondary O 3 NAAQS discussed in sections II.E and IV.G of this preamble , if finalized, would trigger a process under which states 278 make recommendations to the Administrator regarding area designations, and the EPA promulga tes the final area designations. States would also be required to review, modify, and supplement their existing state implementation plans (SIPs). SIPs. The proposed O 3 NAAQS revisions would also affect the transportation conformity and general conformity processes. The revised O 3 NAAQS and the subsequent designations process could affect which preconstruction permitting requirements apply to O 3 in some areas and the natu re of those requirements in others

. The EPA has regulations in place addressing the requirements for state implementation plans SIPs and several provisions in these existing rules cover O 3 . ( 40 CFR Part p art 51

. )

. States likewise have provisions in their SI Ps to address air quality for O 3 and to implement the existing
O 3 NAAQS. The EPA has also provided general guidance on the development of state implementation plans SIPs for all pollutants and administration of construction permitting programs, as well as specific guidance on implementing the O 3 NAAQS in some contexts under the Clean Air Act CAA and the EPA regulations.

278 This and a ll subsequent references to “state” are meant to include state, local, and tribal agencies responsible for the implementation of an O 3 control program.*** E.O. 12866 Review

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Page 515 of 668 When the EPA proposes to revise a NAAQS for a particu lar criteria pollutant, it considers the extent to which existing EPA regulations and guidance are sufficient to implement the standard and whether any revisions or updates to those regulation and guidance would be helpful or appropriate in facilitating th e implementation of the revised standard by states. The
C A A does not require that the EPA promulgate new implementing regulations every time that a NAAQS is revised. Likewise, the CA A does not require the issuance of additional implementing regulations or guidance by the EPA before a revised NAAQS becomes effective. Existing EPA regulations may be sufficient in many cases to enable the EPA and the states to begin the process of implementing a revised NAAQS. However, where the nature of revisions to a NAAQS indicate that additional EPA regulations or guidance (or revisions to existing regulations or guidance) may be helpful to implement unique aspects of the revised standard, the EPA endeavors to provide those regulations and guidance in a timely way to facil itate preparation of state implementation SIPs plans. It is important to note, however, that the existing EPA regulations in 40 CFR Part p art 51 applicable to SIPs generally and to particular pollutants continue to apply even without such updates. Accordingl y, the discussion below provides the EPA’s current thoughts about the extent to which revisions to existing regulations and additional guidance might be helpful or appropriate to aid in the implementation of a revised O 3 NAAQS, should one be finalized thro ugh this rulemaking. This section also provides background information for understanding the possible implications of the proposed NAAQS changes in some areas , and describes the EPA’s plans for providing revised rules or additional guidance on some subjec ts in a timely manner to assist states with their implementation efforts under the requirements of the CAA . This section also describes existing EPA interpretations of CAA requirements and other EPA guidance relevant to*** E.O. 12866 Review

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Page 516 of 6 68 implementation of revised O 3 NAAQS. Relevant CAA provisions that provide potential flexibility with regard to meeting implementation timelines are also discussed. This section also contains a discussion of how existing requirements to reduce the impact
on O 3 concentrations from the stationary source construction in permit programs under the CAA may be affected by the proposed revisions of the O 3 NAAQS. These are the Prevention of Significant Deterioration ( PSD ) and Nonattainment New Source Review (NNSR) programs. To facilitate th e timely implementation of the PSD requirements, the EPA proposes as part of this rulemaking to add a grandfathering provision to its regulations that would apply to certain PSD permit applications that are pending on the effective date of the revised O 3 N AAQS. If the proposed NAAQS revisions are finalized, this grandfathering provision could be finalized at the same time as the revised NAAQS (see section VII. D of this preamble ). The EPA intends to propose additional regulations and issue additional guidan ce, as necessary, related to the implementation requirements for any revised O 3 NAAQS resulting from this proposal. The EPA intends to take these actions on a schedule that provides timely assistance to air agencies. Accordingly, in this section, the EPA s olicits comment on several issues that the Agency a gency anticipates address ing in future guidance or regulatory actions to assist with implementation of the revised O 3 NAAQS . Because these issues are not relevant to the establishment of the NAAQS, and the CAA does not require that the EPA provide implementation rules or guidance for each revised NAAQS, the EPA does not expect to respond, nor is the Agency a gency required to respond, to these comments in the final action on this proposal. However the EPA expe cts these comments will be helpful as future guidance and regulations are developed. A. NAAQS Implementation Plans*** E.O. 12866 Review

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Page 517 of 668 1. Background As directed by the Clean Air Act the CAA , reducing pollution to meet national air quality standards always has been a shared task, one involving the federal government, states, tribes and local air quality management agencies. The EPA develops regulations and strategies to reduce pollution on a broad scale, while states and tribes are responsible for implementation planning and any additional emission reduction measures necessary to bring areas into attainment. The Agency a gency supports implementation planning with technical resources and guidanc e, while states and local agencies use their knowledge of local needs and opportunities in designing emission reduction strategies that will work best for their industries and communities. This partnership has proved effective since the EPA first issued O 3 standards more than three decades ago. For example, 101 areas were designated as nonattainment for the 1

- hour O 3 standards issued in 1979. As of the end of 2013, air quality in 98 of those areas meets the 1

- hour standards. The EPA strengthened the O 3 sta ndards in 1997, shifting to an 8

- hour standard to improve public health protection, particularly for children, the elderly, and other sensitive individuals, against effects such as reduced lung function and respiratory symptoms, hospital and
emergency room visits for asthma, and possible irreversible damage to the lungs. The 1997 standards drew significant public attention when they were proposed, with numerous parties voicing concerns about states’ ability to comply. However, after close collaboration betw een the
EPA , states, tribes and local governments to reduce O 3 - forming pollutants, significant progress has been made. Air quality in 90% of the original 113 areas designated as nonattainment for the 1997 O 3 NAAQS now meets the 1997 standards. The EPA desi gnated 46 areas as nonattainment for the 2008 O 3 NAAQS in 2012. We expect these areas to make similar progress in achieving clean air.*** E.O. 12866 Review

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Page 518 of 668 The majority of man

- made NO X and VOC emissions that contribute to O 3 formation in the United States U .S. come from the fo llowing sectors: on

- road and nonroad mobile sources, industrial processes (including solvents), consumer and commercial products, and the electric power industry. In 2011, the most recent year for which the National Emissions Inventory (NEI) is available, onroad and nonroad mobile sources accounted for about 60 % of annual NO X emissions; and the electric power industry accounted for about nearly 15% . With respect to VOC, industrial processes (including solvents) accounted for about 57 % of manmade VOC emissio ns; and mobile sources accounted for about 39 % . Emissions from natural sources, such as trees, also comprise around 70 % of total VOC emissions nationally, with a higher proportion during the O 3 season and in areas with more vegetative cover. See section VI I.F of this preamble for more detail on background O 3 . Since 2000, the EPA has issued numerous emissions and fuels standards for on

- road and nonroad mobile sources, as well as emissions standards for many types of stationary sources. Benefits from new eng ine standards increase each year as older, more

- polluting vehicles and engines are replaced with newer, cleaner models. Benefits from fuel programs generally begin as soon as a new fuel is available. The ongoing emission reductions from federal programs su ch as these will provide for substantial emissions reductions well into the future, and will complement state and local efforts to attain any revised O 3 NAAQS. Over the past fifteen 15 years, the EPA has established new emissions standards under title II o f the CAA, 42 U.S.C. 7521

– 7574 , for numerous classes of automobile, truck, bus, motorcycle, earth mover, aircraft, and locomotive engines, and for the fuels used to power these engines. The EPA also established new standards for the smaller engines used in small watercraft, and lawn and garden equipment. In March 2008, the EPA promulgated new standards*** E.O. 12866 Review

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Page 519 of 668 for locomotive and for marine diesel engines and in April 2010 the EPA promulgated new standards for Category 3 (C3) engines installed on U.S. ocean

- going ve ssels and to marine diesel fuels produced and distributed in the United States. U.S

. In September 2011, the EPA and the National Highway Transportation Safety Administration established greenhouse gas and fuel efficiency standards for new 2014

– 2018 model year medium and heavy

- duty engines and vehicles. In addition to improving fuel efficiency and reducing greenhouse gas emissions this rule reduces emissions of NO X from the subject vehicles. In March 2014, the EPA promulgated Tier 3 standards for tailpipe a nd evaporative emissions from passenger cars, light

- duty trucks, medium

- duty passenger vehicles, and some heavy

- duty vehicles. The associated gasoline sulfur standard will enable more stringent vehicle emissions standards and will make existing emissions

c ontrol systems more effective. Compared to current standards, the VOC and NO X tailpipe standards for light

- duty vehicles represent approximately an 80% reduction from today’s fleet average, and the heavy

- duty tailpipe standards represent about a 60% reduct ion in VOC and
NO X . The emission reductions from all of these mobile source programs are significant and will continue to be realized throughout the implementation period for any revised O 3 NAAQS. T he EPA projects that between 2011 and 2025, onroad and no nroad mobile NO X will decline by more than 60 % and onroad and nonroad mobile VOC will decline by more than 50 %

. 279 The reduction of VOC emissions from industrial processes has been achieved either directly or indirectly through implementation of control technology standards, including maximum achievable control technology (MACT), reasonably available control technology

279 [Placeholder for RIA citation ] “Regulatory Impact Analysis for the Proposed Revisions to the National Ambient Air Quality Standards for Ground

- Level Ozone,” (December 2014) at http://www.epa.gov/ttnecas1/ria.html

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Page 520 of 668 (RACT), and best available control technology (BACT) standards; or is anticipated due to proposed or upcoming proposals based on generally available control technology or best available controls under provisions related to consumer and commercial products . These standards have resulted in VOC emission reductions of almost a million tons per year accumulated starting in 1997 from a variety of sources including combustion sources, coating categories, and chemical manufacturing. The EPA also finalized emissio n standards and fuel requirements for new stationary engines. In the area of consumer and commercial products, the EPA finalized new national VOC emission standards for aerosol coatings in 2008 and will review and revise, as necessary, existing rules for h ousehold and institutional consumer products, architectural and industrial maintenance coatings, and automobile refinish coatings. Additionally, in O 3 nonattainment areas, we anticipate reductions of an additional 10,000 tons per year as states adopt rules implementing control techniques recommendations issued in 2008 for 4 four additional categories of consumer and commercial products, such as surface coatings and adhesives used in industrial manufacturing operations. These emission reductions primarily

res ult from solvent controls and typically occur where and when the solvent is used, such as during manufacturing processes. As noted above, the power industry is responsible for a nearly 15 % of NO X emissions

across the United States U.S . Power industry emis sion sources include large electric generating units (EGU) and some large industrial boilers and turbines. The EPA’s Clean Air Interstate Rule (CAIR), issued on March 10, 2005 , (70 FR 25612; May 12, 2005) , was designed to permanently reduce power industry emissions of NO X in the eastern United States U.S . The first phase of the cap was to begin in 2009, and a lower second phase cap was to begin in 2015. The EPA had projected that by 2015, the CAIR and other programs would reduce NO X emissions during the*** E.O. 12866 Review

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Page 521 of 668 O 3 s eason by about 50 % and annual NO X emissions by about 60 % from 2003 levels in the Eastern U.S. However, on July 11, 2008 , and December 23, 2008, the U.S. Court of Appeals for the D.C. Circuit (D.C. Circuit) issued decisions on petitions for review of the CA IR. In its July 11 opinion, the court found CAIR unlawful and decided to vacate CAIR and its associated Federal implementation plans (FIPs) in their entirety. State of North Carolina v. EPA, 531 F. 3d 896

. On December 23, 2008, however, the court granted E PA’s petition for rehearing to the extent that it remanded without vacatur for EPA to conduct further proceedings consistent with the Court’s prior opinion. Under this decision, CAIR will remain in place only until replaced by EPA with a rule that is consi stent with the Court’s July 11 opinion.
The EPA issued the final Cross State Air Pollution Rule ( CSAPR ) on July 6, 2011 , (76 FR 48208; August 8, 2011) , to replace CAIR. CSAPR requires states to significantly improve air quality by reducing power plant emissions that contribute to O 3 and/or fine particle pollution in other states. CSAPR requires a total of 28 states to reduce annual SO 2 emissions, annual NO X emissions and/or O 3 season NO X emissions to assist downwind states in attaining the 1997 O 3 and fine particle and 2006 PM 2.5 NAAQS. On December 30, 2 011, the D.C. Circuit issued an order staying CSAPR and ordering the EPA to continue implementing CAIR. Subsequently, on August 21, 2012, the D.C. Circuit issued an opinion vacating CSAPR. EME Homer City Generation LP v. EPA, 696 F. 3d 7

. In its decision t he Court again instructed the EPA to continue administering CAIR. The United States U.S. and other parties appealed the D.C. Circuit decision to the U.S. Supreme Court and on April 29, 201 4 , the U.S. Supreme Court issued an opinion reversing the judgment of the D.C. Circuit , upholding the EPA’s interpretation of the CAA “good neighbor” provision (CAA section 110 (a)(2)(d)(ii)), and remanding the case back to the D.C. Circuit for further proceedings consistent with the Supreme Court opinion. EME Homer*** E.O. 12866 Review

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Page 522 of 668 City Ge neration LP v. EPA , 134 S. Ct. 1584. On June 26, 2014, the U.S. Government filed a motion with the D.C. Circuit to lift the stay of the CSAPR. While the Court considers the motion, CAIR remains in place and no immediate action from states or affected sourc es is expected. The D.C. Circuit has since lifted the stay of the rule. Order, Document #1518738, EME Homer City Generation, L.P. v. EPA , Case #11

- 1302 (D.C. Cir. Oct. 23, 2014). The EPA proposed the Clean Power Plan for existing power plants on June 2, 2 014 (79 FR 34830; June 18, 2014). In this action the EPA proposed state

- specific rate

- based goals for carbon dioxide CO 2 emissions from the power sector, as well as guidelines for states to follow in developing plans to achieve the state

- specific goals. This rule, as proposed, would continue progress already underway to reduce carbon dioxide CO 2 emissions from existing fossi l fuel

- fired power plants in the United States U.S . Actions taken to comply with the proposed guidelines would reduce emissions of CO 2 and other air pollutants, including SO 2 , NOx and directly emitted
PM 2.5 , from the electric power industry. The EPA estimat es that the Clean Power Plan, as proposed, would reduce precursors for both ozone O 3 and particulate matter leading to decreases in the concentrations of those pollutants of approximately 25% in 2030. It should also be noted , in general, that new electric generating units ( EGUs ) are subject
to NO X limits under New Source Performance Standards (NSPS) under CAA section 111, as well as either PSD or NNSR requirements. The EPA’s regulations for commercial, industrial and solid waste incinerators set standards f or NO X and several air toxics for all commercial incinerators, as required under Section 129 of the Act. Air toxics rules for industrial boilers will yield co

- benefit NO X reductions as a result of tune

- ups and energy efficiency measures, especially from bo ilers that burn coal. And several new source performance standards and air toxics standards are expected to make further cuts to NO X and VOC emissions from new and Formatted: Subscript*** E.O. 12866 Review

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Page 523 of 668 existing sources of pollution. These include upcoming review and revisions for gas turbines and municipal waste combustors, along with proposed requirements for the petroleum refining industry. The new source performance standards The NSPS and air toxics standards that have recently taken effect for stationary engines w ill also make cuts to NO X an d VOC emissions. The EPA also anticipates reductions in O 3 precursors to result from implementation of the Mercury and Air Toxics Standard rule, as well as from measures to address Regional Haze best available retrofit technology (BART) determinations. While the EPA uses its regulatory opportunities to reduce NO X and VOCs, the Agency a gency also is pursuing non

- regulatory efforts as we strive toward cleaner air. Energy Star, a joint program of the EPA and the U.S. Department of Energy, protects the enviro nment and saves money through energy efficient products and practices. Improving energy efficiency in homes, buildings and industry helps reduce all emissions from the power sector

– including NO X

– while reducing compliance costs for electricity providers

. As part of its new Advance Program, the EPA is working collaboratively with state, local, and tribal governments that want to take steps to reduce air pollution in O 3 and particulate matter attainment areas. Although these areas are not currently subject to nonattainment planning requirements, Advance Program participants are interested in undertaking their own planning efforts with the goal of keeping their air healthy and creating an improved buffer against future air quality violations. Participating a reas are implementing a mix of voluntary and mandatory measures relating to mobile, area, and point sources as well as energy efficiency measures, and they are also pursuing education and awareness programs to improve their communities’ understanding of ai r quality issues. The EPA recognizes that a number of areas of the country have been working to reduce
O 3 precursors for many years and now may need to turn to newer, more innovative approaches*** E.O. 12866 Review

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Page 524 of 668 for reducing emissions as they develop their implementation plans. These approaches, such as smart growth policies and renewable energy portfolios, hold great promise for improved air quality and health, and the EPA is working with air quality agencies and stakeholders to identify ways to include these types of pro grams in implementation plans. For example, the EPA developed a roadmap for giving SIP credit to energy efficiency/renewable energy projects. 280 Recognition of innovative programs will allow states and tribes to pursue effective strategies that address some of the more challenging issues affecting air quality, such as land use planning, ever increasing motor vehicle use, and planning for long

- term energy needs. With respect to agricultural sources, the U.S. Department of Agriculture (USDA) has approved conse rvation systems and activities that reduce agricultural emissions of NO X and VOC. The EPA recognizes that USDA has been working with the agricultural community to develop site

- specific conservation systems and activities to control emissions of O 3 precurso rs. The EPA will continue to work with USDA on these activities with efforts to identify and/or improve the control efficiencies, prioritize the adoption of these conservation systems and activities, and ensure that appropriate criteria are used for identi fying the most effective application of conservation systems and activities. The EPA will work together with USDA and with states to identify appropriate measures to meet the primary and secondary standards, including site

- specific conservation systems an d activities. Based on prior experience identifying conservation measures and practices to meet the PM NAAQS requirements, the EPA will use a similar process to identify measures that could meet the O 3 requirements. The EPA anticipates that certain USDA ap proved conservation

280 “The Roadmap for Incorporating Energy Efficiency/Renewable Energy Pol icies and Programs into State and Tribal Implementation Plans,” (July 2012) at http://epa.gov/airquality/eere/

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Page 525 of 668 systems and activities that reduce agricultural emissions of NO X and VOC may be able to satisfy the requirements for applicable sources to implement reasonably available control measures for purposes of attaining the primary and seconda ry O 3 NAAQS. The Agency a gency also is active in work to reduce the international transport of O 3 and other pollutants that can contribute to “background” O 3 levels in the U.S. Under the Convention on Long

- Range Transboundary Air Pollution (LRTAP) of the United Nations Economic Commission for Europe, the United States U.S. has been a party to the Protocol to Abate Acidification, Eutrophication, and Ground

- level Ozone (known as the Gothenburg Protocol) since 2005. The U.S. is also active in the LRTAP Task Force for Hemispheric Transport of Air Pollution, which in 2010 produced a comprehensive assessment of the intercontinental transport of air pollution (including O 3 ) in the northern hemisphere. The United States U.S. has worked bilaterally with Canada under the US

- Canada Air Quality Agreement to adopt an Ozone Annex to address transboundary O 3 impacts. The EPA also continues to work with rapidly growing countries such as China on air quality management activities and the development of analytical tools to help these countries address significant air quality problems, including the emissions of O 3 - forming pollutants. This work includes supporting China’s efforts to rapidly deploy power plant pollution controls that can achieve NO X reductions of at least 80 to 90 %

. We know that developing the implementation plans that outline the steps a nonattainment area will take to meet an air quality standard requires a signific ant amount of work on the part of state, tribal or local air agencies. The EPA routinely looks for ways to reduce this workload, including assisting with air quality modeling by providing inputs such as emissions, meteorological and boundary conditions; an d sharing national

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Page 526 of 668 leverage in their development of their attainment demonstrations. At the same time, we work with air agencies to provide implementation flexibility to the extent allowed by law. 2. Timing of Rules and Guidance In public comment periods associated with several recent rulemakings, the EPA received comments from a variety of states and organizations asking for rules and guidance associated with a revised NAAQS to be issued in a timely manner. Although is suance of such rules and guidance is not a part of the NAAQS review process, National Ass’n of Manufacturers v

. EPA , 750 F. 3d 921, 926

- 27 (D.C. Cir. 2014), t oward that end the EPA intends to produce appropriate revisions to necessary implementation rules and provided additional guidance in time frames that would be more useful to states when developing their implementation plans than has been the case with some previous rules and guidance

. Certain requirements under the PSD preconstruction permit review program apply immediately to a revised NAAQS upon the effective date of that NAAQS, unless the EPA has established a grandfathering provision through rulemaking . To ensure a smooth transition to a revised O 3 NAAQS, the EPA is proposing a grandfathering provision similar to the one finalized in the 2012 PM 2.5 NAAQS Rule. See section VII. D of this proposal preamble for more details on the PSD program. Promulgation of the NAAQS starts a clock for the EPA to designate areas as either attainment or nonattainm ent. State recommendations for area designations are due to the EPA within 12 months of promulgation of the NAAQS. In an effort to allow states to make more informed recommendations, the EPA intends to issue guidance concerning the designations process wit hin 4 months of promulgation of the NAAQS, or approximately 8 months before state recommendations are due. The EPA has issued designation guidance for several NAAQS in*** E.O. 12866 Review

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Page 527 of 668 recent years. While generally the EPA considers information related to the same factors in making designation decisions, the guidance is tailored to the particular NAAQS. The EPA anticipates that the guidance for a revised NAAQS resulting from this proposal would be similar to the designation guidance for the 2008 O 3 NAAQS

. The EPA generally completes area designations 2 years after promulgation of a NAAQS. See section VII. C of this preamble for additional details on designations. Clean Air Act section 110 requires state implementation plans ( SIPs ) to be submitted within 3 years of promulgati on of a revised NAAQS. These SIPs are referred to as “infrastructure SIPs.” The EPA issued general guidance on submitting infrastructure SIPs on September 13, 2013. 281 It should be noted that this guidance did not address certain state planning and emissions control requirements related to interstate pollution transport. Should this guidance need to be modified for this prospective O 3 NAAQS, the EPA intends to issue that updated guidance no later than one 1 year after promulgation of a revised O 3 NAAQS. See section
VII.B.3 of this preamble for additional information on infrastructure SIPs. The EPA intends to propose any appropriate rules for assisting with implementing any revised O 3 NAAQS resulting from this proposal within 1 year after a revised NAAQS is established. The rules that EPA is considering , as with implementation of previous NAAQS, would address nonattainment area classification methodologies, SIP due dates, attainment dates, and required implementation programs such as NNSR and conformity. At that same time the EPA intends to address any modifications needed as a result of this revised NAAQS to guidance pertaining to developing nonattainment area emissions inventories and attainment

281 See memorandum from Stephen D. Page to Regional Air Directors, “Guidance on Infrastructure State Implementation Plan (SIP) Elements under Clea n Air Act Sections 110(a)(1) and 110(a)(2)” September 13, 2013.*** E.O. 12866 Review

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Page 528 of 668 demonstrations, and demonstrating conformity. The EPA anticipa tes finalizing these items by the time areas are designated nonattainment. Finalizing rules and guidance by this time would provide air agencies with the information to develop any CAA

- required SIPs associated with nonattainment designations. In an area de signated as nonattainment, new major sources and major modifications at existing sources are required to comply with NNSR requirements including the application of “lowest achievable emission rate” (LAER) and emissions offsets at ratios prescribed by the C AA. See section VII.B.4 of this preamble for additional information on nonattainment SIPs. 3. Section 110 State Implementation Plans The CAA section 110 specifies the general requirements for SIPs. Within 3 years after the promulgation of revised NAAQS (o r such shorter period as the Administrator may prescribe 282 ) each state must adopt and submit ‘‘infrastructure’’ SIPs to the EPA to address the requirements of section 110(a)(1) and (2), as applicable. These ‘‘infrastructure SIPs’’ establish
the basic state programs to implement, maintain, and enforce revised NAAQS and provide assurances of state resources and authorities. States are to develop and maintain an air quality management infrastructure that includes enforceable emission limitations, a permitting p rogram, an ambient monitoring program, an enforcement program, air quality modeling capabilities, and adequate personnel, resources, and legal authority. Section 110(b) of the CAA provides that the EPA may extend the deadline for the ‘‘infrastructure’’ SIP submission for a revised secondary standard by up to 18 months beyond the initial 3 years. If both the primary NAAQS and a distinct secondary NAAQS are finalized, the EPA currently believes it would be more efficient

282 While the CAA allows the EPA to set a shorter time for submission of these SIPs, the EPA does not currently intend to do so.*** E.O. 12866 Review

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Page 529 of 668 for states and the EPA if each affecte d state submits a single section 110 infrastructure SIP that addresses both standards at the same time (i.e., within 3 years of promulgation of the O 3 NAAQS), because the EPA does not at present discern any need for there to be any significant substantive difference in the infrastructure SIPs for the two standards. However, the EPA also recognizes that states may prefer the flexibility to submit the secondary NAAQS infrastructure SIP at a later date. The EPA solicits comment on these infrastructure SIP subm ittal timing considerations, and specifically on challenges that would justify needing 18 additional months to complete the submission of an infrastructure SIP for the secondary standard

. It is the responsibility of each state to review its air quality management program’s infrastructure SIP provisions in light of each revised NAAQS. Most states have revised and updated their infrastructure SIPs in recent years to address requirements associated with recently revised NAAQS. It may be the case that for a number of infrastructure elements, the state may believe it has adequate state regulations already adopted and approved into the SIP to address a particular requirement with respect to the revised O 3 NAAQS. For such portions of the state’s infrastructure S IP submittal, the state may provide a ‘‘certification’’ specifying that certain existing provisions in the SIP are adequate. Although the term ‘‘certification’’ does not appear in the CAA as a type of infrastructure SIP submittal, the EPA sometimes uses th e term in the context of infrastructure SIPs, by policy and convention, to refer to a state’s SIP submission. If a state determines that its existing EPA

- approved SIP provisions are adequate in light of the revised O 3 NAAQS with respect to a given infrastr ucture SIP element (or sub

- element), then the state may make a ”certification” that the existing SIP contains provisions that address those requirements of the specific CAA section 110(a)(2) infrastructure elements. In the case of a certification, the subm ittal does not have to include another copy of the relevant provision (e.g.,*** E.O. 12866 Review

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Page 530 of 668 rule or statute) itself. Rather, the submittal may provide citations to the already SIP

- approved state statutes, regulations, or non

- regulatory measures, as appropriate, which mee t the relevant CAA requirement. Like any other SIP submittal, such certification can be made only after the state has provided reasonable notice and opportunity for public hearing. This ‘‘reasonable notice and opportunity for public hearing’’ requirement f or infrastructure SIP submittals appears at section 110(a), and it comports with the more general SIP requirement at section 110(l) of the CAA. Under the EPA’s regulations at 40 CFR part 51, if a public hearing is held, an infrastructure SIP submittal must include documentation by the state that the public hearing was held in accordance with the EPA’s procedural requirements for public hearings. See 40 CFR part 51, appendix A ppendix V, paragraph 2.1(g), and 40 CFR 51.102. 4. Nonattainment Area Requirements Part D of the CAA describes the various program requirements that apply to states with nonattainment areas for different NAAQS. Section 182 (found in subpart 2 of part P art D) includes the SIP requirements that govern the O 3 program, and supplements the mo re general nonattainment area requirements in sections 172 and 173. Under CAA section 182, states generally are required to submit attainment demonstration SIPs within 3 or 4 years of the effective date of area designations by the EPA, depending on the cla ssification of the area. These plans need to show how the nonattainment area will attain the primary O 3 standard ‘‘as expeditiously as practicable,’’ but no later than within the relevant time frame from the effective date of designations associated with t he classification of the area. Section 181(a)(1) of the CAA establishes classification categories for areas designated nonattainment for the primary O 3 NAAQS. These categories range from “Marginal,” the lowest
O 3 classification with the fewest requiremen ts associated with it, to “Extreme,” the highest*** E.O. 12866 Review

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Page 531 of 668 classification with the most required programs. Areas with worse O 3 problems are given more time to attain the NAAQS and more associated emission control requirements. Pursuant to previous O 3 NAAQS reviews , the EPA set the secondary NAAQS equal to the primary NAAQS. Thus, previous implementation programs for O 3 standards did not include a separate classification threshold methodology for the secondary NAAQS. For this NAAQS review, which may result in a second ary standard different in form and level compared to the primary standard, the EPA is considering methodologies for establishing the air

- quality based thresholds for assigning the section 181 classifications to areas out of attainment with a secondary O 3 N AAQS. Any such methods would be proposed for comment if the EPA finalizes a distinct secondary NAAQS. The re are two main EPA rule making s relating to implementation of the 2008 O 3 NAAQS. In May 2012, the EPA issued the final Classification s Rule (77 FR 301 60; May 21, 2012). The Classifications Rule detailed the classifications approach, established attainment deadlines and revoked the 1997 O 3 NAAQS for purposes of transportation conformity. In June 2013, the EPA proposed a SIP Requirements Rule (78 FR 34178 ; June 6, 2013) to provide rules and guidance to states regarding development of SIPs to attain the 2008 O 3 NAAQS. The EPA believes that the overall framework and policy approach of the proposed SIP Requirements Rule for the 2008 O 3 NAAQS provides an effec tive and appropriate template for the general approach states would follow in planning for attainment of a revised primary O 3 standard. The EPA intends to develop and propose a new SIP Requirements Rule that will address, to the extent necessary, any new
i mplementation requirements that would result from any revised O 3 NAAQS. The EPA intends to propose this implementation rule within 1 year after the revised O 3 NAAQS are promulgated,*** E.O. 12866 Review

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Page 532 of 668 and finalize the implementation rule by no later than the time the area de signations process is finalized (approximately 2 years after promulgation of the O 3 NAAQS). In general, when developing an attainment plan , the state begins with the evaluation of the air quality improvements the nonattainment area can expect in the futur e due to ‘‘on the books’’ existing federal, state, and local emission reduction measures. The state then must conduct a further assessment of relevant NO X and VOC emission sources in the nonattainment area, and the additional reasonably available control m easures (RACM) and reasonably available control technology (RACT) that can be implemented by these sources, in determining how soon the area can attain the standard. Under section 172(c)(1) of the CAA as interpreted by the EPA, attainment demonstrations mu st include a RACM analysis showing that no additional reasonably available measures could be adopted and implemented such that the SIP could specify an attainment date that is 1 or more years earlier. The evaluation of these potential emissions reductions and associated air quality improvement is commonly performed with sophisticated air quality modeling tools. Given that
O 3 concentrations are affected both by regionally

- transported O 3 and O 3 precursor emissions and emissions of precursors from local sources in the nonattainment area (e.g., industrial sources, EGUs, and on

- road mobile sources), the EPA recommends the use of regional grid

- based models (such as CMAQ and CAMx) to develop O 3 attainment strategies. Although , as described above, the EPA proj ects significant improvements in O 3 concentrations regionally resulting from a number of ongoing emission reduction programs already in place (e.g., mobile source engine and fuel standards and regulations for power plants ) and from a number of recently pro mulgated rules such as the Cross State Air Pollution Rule (76 FR 48208 , ; August 8, 2011), the Mercury and Air Toxics Standards rule (77 FR 9304 , ; February 16, 2012) and the Tier 3 rule (79 FR*** E.O. 12866 Review

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Page 533 of 668 23414; April 28, 2014) that will result in VOC and NO X reduction s from many geographically dispersed sources, local reductions of direct O 3 precursors can also result in important health benefits. States must also ensure that a nonattainment area will make ‘‘reasonable further progress’’ (RFP) in accordance with subp art 2 of the CAA from the time of the nonattainment designation to its attainment date. The amount of RFP required is based on the classification of the nonattainment area. Under the approach outlined in the proposed SIP Requirements Rule for the 2008 O 3 N AAQS, areas designated nonattainment and classified as Moderate would generally be required to reduce emissions by 15 % over the first six years after the effective date of designations. Areas classified higher than Moderate would be required to produce ad ditional emission reductions after this 6

- year period for an area that average 3 % reductions per year. All RFP and attainment plans must also include contingency measures which would apply without significant delay in the event the area fails to attain by its attainment date or meet RFP milestones. The EPA expects that the same general approach for determining attainment of the previous 1997 and 2008 8

- hour O 3 primary standards by the attainment deadline would be followed for determining attainment with an y revised primary O 3 standard. Attainment would be evaluated based on the 3 most recent years of certified, complete, and quality

- assured air quality data in the nonattainment area. Areas are able to obtain up to two 1

- year attainment date extensions provi ded under CAA section 181 under certain circumstances. Under previous 8

- hour
O 3 NAAQS rules, an area whose design value based on the most recent 3 years of data exceeds the standard could receive a 1

- year attainment date extension if the air quality concen tration for the third year alone does not exceed the level of the standard. Similarly, an area that has received*** E.O. 12866 Review

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Page 534 of 668 a 1

- year extension could receive a second 1

- year extension if the average of the area’s air quality concentration in the ‘‘extension year’’ and the previous year does not exceed the level of the standard. B. Implementing a Distinct Secondary O 3 NAAQS, if One is Established In each of the previous O 3 NAAQS reviews the secondary standard was set equal to the primary standard. As discussed in sect ion IV above of this preamble , the EPA is proposing to
revise the level retain the current averaging time and form of the current secondary standard to a level within the range proposed for the primary standard and to revise the level

. The EPA is also soliciting comment on the alternative approach of revising the secondary standard to a cumulative, seasonal, concentration

- weighted form based on the W126 index. If the EPA were to establish a distinct secondary standard, there would be u nique implementation issues to consider . These could include issues related to, but not limited to, PSD implementation, nonattainment area classification thresholds, attainment planning, and conformity demonstrations. These issues would be addressed in fut ure implementation rules and guidance, as necessary. The EPA solicits comments on the specific kinds of implementation

related issues (with examples, where possible) that air agencies and affected sources would face if a separate and distinct secondary sta ndard is established.
C. Designation of Areas After the EPA establishes or revises a NAAQS, the CAA directs the EPA and the states to take steps to ensure that the new or revised NAAQS is met. One of the first steps, known as the initial area designations , involves identifying areas of the country that either do not meet the new or revised NAAQS along with the nearby areas that contribute to the violations. Formatted: Font: Times New Roman Formatted: Font: Times New Roman, Subscript Formatted: Font: Times New Roman Formatted: Font: Times New Roman Formatted: Font: Times New Roman Formatted: Font: Times New Roman Formatted: Font: Times New Roman*** E.O. 12866 Review

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Page 535 of 668 Section 107(d)(1) of the CAA provides that, "By such date as the Administrator may reasonably requ ire, but not later than 1 year after promulgation of a new or revised national ambient air quality standard for any pollutant under section 109, the Governor of each state shall
* * *

... submit to the Administrator a list of all areas (or portions thereof) in the state" that designates those areas as nonattainment, attainment, or unclassifiable. The EPA must then promulgate the area designations according to a specified process, including procedures to be followed if the EPA intends to modify a recommendati on. The CAA defines an area as nonattainment if it is violating the NAAQS or if it is contributing to a violation in a nearby area. Section 107(d)(1)(B)(i) further provides, "Upon promulgation or revision of a national ambient air quality standard, the A dministrator shall promulgate the designations of all areas (or portions thereof

) * * * )

... as expeditiously as practicable, but in no case later than 2 years from the date of promulgation of the new or revised national ambient air quality standard. Such p eriod may be extended for up to one year in the event the Administrator has insufficient information to promulgate the designations.” In certain contexts, w ith respect to the NAAQS, the term “promulgation” has been interpreted by the courts to be signature and widespread dissemination of a final NAAQS rule. 283 By no later than 120 days prior to promulgating area designations, the EPA is required to notify states of any intended modifications to their recommendations that the EPA may deem necessary. States the n have an opportunity to demonstrate why any proposed modification is inappropriate. Whether or not a state provides a recommendation, the EPA must timely promulgate the designation that the Agency a gency deems appropriate. While section 107 of the CAA specifically addresses states, the EPA intends to follow the same process for tribes to the extent practicable, pursuant to CAA section 301(d) regarding tribal

283 American Petroleum Institute v. Costle , 609 F.2d 20 (D.C. Cir. 1979 ) )

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Page 536 of 668 authority and the Tribal Authority Rule (63 FR 7254, February 12, 1998). To provide clarity and consistency in doing so, the EPA issued a 2011 guidance memorandum on working with tribes during the designation process. 284
As discussed in sections II and IV of this preamble , the EPA is proposing to revise both the primary and secondary O 3 NAAQS, which c urrently are identical 8

- hour standards that were set at 0.075 ppm in the 2008 NAAQS rule (73 FR 16436; March 27, 2008). If the EPA revises the primary and secondary O 3 NAAQS based on this proposal, the EPA intends to complete designations for both NAAQS f ollowing the standard 2

- year process discussed above. The EPA is required to sign the final rule for this O 3 NAAQS review no later than October 1, 2015 , under a
court

- ordered deadline . In accordance with section 107(d)(4) of the CAA, state Governors (and
t ribes, if they choose) should submit their initial designation recommendations for a revised primary and secondary NAAQS no later than 1 year after promulgation of any revised O 3 NAAQS (for example, by October 1, 2016 , if the EPA promulgates such NAAQS on October 1, 2015.) If the EPA intends to modify any state recommendation, the EPA would notify the appropriate state Governor (or tribal leader) no later than 120 days prior to making final designation decisions. A state or tribe that believes the modificat ion is inappropriate would then have the opportunity to demonstrate to EPA why it believes its original recommendation (or a revised recommendation) is more appropriate. The EPA would take any additional input into account in making the final designation d ecisions.

284 Memorandum titled, “ Page, S. (2011). Guidance to Regions for Working with Tribes during the National Ambient Air Quality Standards (NAAQS) Designations Process ,” , Memorandum from Stephen D. Page, Director, EPA Office of Air Quality Planning and Standards to Regional Air Directors, Regions I

- X, December 20, 2011. Available: http://www.epa.gov/ttn/oarpg/t1/memoranda/20120117naaqsguidance.pdf. xx*** E.O. 12866 Review

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Page 537 of 668 Consistent with previous designations, the EPA intends to use area

- specific multi

- factor analyses to support area boundary decisions for any revised primary or secondary O 3 standards. Historically, the EPA has evaluated information related to t he following factors for designations: air quality data, emissions

- related data, meteorology, geography/topography, and jurisdictional boundaries. The EPA solicits comment related to establishing area designation boundaries for the proposed revised primary and secondary NAAQS, including any relevant technical information that should be considered by the EPA and the extent to which different considerations may be relevant to establishing boundaries for a distinct secondary NAAQS. As noted earlier, t he EPA
in tends to issue designation guidance to the states shortly after the promulgation of any revised
O 3 NAAQS to provide information on the designation process and to assist states in developing their recommendations. The EPA invites preliminary comment on all aspects of the designation process at this time, which the EPA will consider in developing that guidance. D. Prevention of Significant Deterioration and Nonattainment New Source Review Programs for the Proposed Revised Primary O 3 NAAQS and the Proposed Secondary O 3 NAAQS The CAA, at parts C and D of title I, contains new source review ( NSR ) requirements that constitute preconstruction review and permitting programs applicable to new major stationary sources and major modifications of existing major so urces. The preconstruction review of each new major source and major modification generally applies on a pollutant

specific basis, and the requirements that apply for each pollutant generally depend on whether the area is designated as attainment (or uncla ssifiable) or nonattainment for that pollutant. For the O 3 NAAQS, in areas designated attainment and unclassifiable, the Prevention of Significant Deterioration ( PSD ) requirements under part C apply. In nonattainment areas for O 3 , the NNSR Formatted: Heading 4*** E.O. 12866 Review

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Page 538 of 668 requirements und er part D apply. Collectively, those two sets of permit requirements are commonly referred to as the “major NSR programs.” Until areas are designated for the proposed revised O 3 NAAQS, the NSR provisions applicable under an area’s designation for the 2008 NAAQS (including any applicable anti

backsliding requirements) would continue to apply. See 40 CFR 51.166(i)(2) and 52.21(i)(2). When the new designations for any revised O 3 NAAQS are effective , they generally will serve to determine whether the PSD or no nattainment NSR program applies. 1. Prevention of Significant Deterioration (PSD) The statutory requirements for a PSD permit program set forth under part C (sections 160 through 169 of the CAA) are addressed by the EPA’s PSD regulations found at 40 CFR 51.166 (minimum requirements for an approvable SIP) and 40 CFR 52.21 (federal PSD permit program for areas lacking an EPA

- approved PSD program in the applicable SIP and for lands owned by the federal government and tribal lands). Both sets of regulations a lready apply to O 3 . See 40 CFR 51.166(b)(23), (49); 40 CFR 52.21(b)(23), (50).

. Among other things, in attainment and unclassifiable areas, the PSD program requires a new major stationary source or a major modification to an existing major source to apply best available control technology (BACT) BACT for each applicable pollutant and to conduct an air quality impact analysis to demonstrate that the proposed source or project will not cause or contribute to a violation of any NAAQS or PSD increment ( see CAA section 165(a)(3)

- (4), 40 CFR 51.166(j)

- (k), 40 CFR 52.21(j)

- (k)). PSD requirements may also include, in appropriate cases, an analysis of potential*** E.O. 12866 Review

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Page 539 of 668 adverse impacts on Class I areas ( see CAA sections 162 and 165). 285 These existing requirements of the PSD program will remain applicable to O 3 and the demonstration required under 40 CFR 51.166(k) and 52.21(k) will apply to any revised O 3 NAQS NA A QS when such NAAQS become effective, except to the extent that a pending permit application is subject to the a g randfathering provision that the EPA is proposing in this rule. establishes through rulemaking

. To address ambient O 3 impacts of VOC and NO X precursor emissions from individual stationary sources, Appendix W to 40 CFR part 51 currently directs states to consult with the applicable EPA Regional Office to determine the appropriate techniques on a case

- by

- case basis, which may or may not involve the use of air quality models, for evaluating whether a PSD source causes or contributes to a violation of the O 3 NAAQS

. ( 40 CFR part 51, Appendix W, section 5.2.1.c

. )

. At present, the EPA is evaluating the models and techniques available to address atmospheric chemistry of O 3 formation in assessing such single source impacts, and as part of that evaluation has conducted discussions of such tools with the regulatory mode ling community. Consistent with its commitment to engage in a rulemaking process to determine whether updates to Appendix W in 40 CFR part 51 are warranted, 286 the EPA is planning to propose a rulemaking in the spring of 2015 to consider whether to update Ap pendix W. If the EPA concludes that it is technically and scientifically appropriate, it will propose appropriate

285 Congress established certain Class I areas in section 162(a) of t he CAA, including international parks, national wilderness areas, and national parks that meet certain criteria. Such Class I areas, known as mandatory federal Class I areas, are afforded special protection under the CAA. In addition, states and tribal gov ernments may establish Class I areas within their own political jurisdictions to provide similar special air quality protection. 286 See Letter from Gina McCarthy, Assistant Administrator, to Robert Ukeiley, at 1 (Jan. 4, 2012), available at http://www.epa.g ov/scram001/10thmodconf/review_material/Sierra _Club_Petition_OAR

- 11

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Page 540 of 668 regulatory updates to Appendix W as part of that rulemaking and may also make related updates to technical guidance, as appropriate. In the me antime, in order to demonstrate that a proposed source or modification does not cause or contribute to a violation of the applicable O 3 NAAQS, PSD permit applicants would follow the current provisions in Appendix W until any revisions to them are in effect

. For PSD, a “major stationary source” is one with the potential to emit 250 tons per year (TPY) or more of any regulated NSR pollutant, unless the new or modified source is classified under a list of 28 source categories contained in the statutory defini tion of “major emitting facility” in section 169(1) of the CAA. For those 28 source categories, a “major stationary source” is one with the potential to emit 100 TPY or more of any regulated NSR pollutant. A “major modification” is a physical change or a c hange in the method of operation of an existing major stationary source that results first, in a significant emissions increase of a regulated NSR pollutant at a project, and second, in a significant net emissions increase of that pollutant at the

source. 287 See 40 CFR 51.166(b)(2)(i), 40 CFR 52.21(b)(2)(i). The EPA’s regulations define the term “regulated NSR pollutant” to include “[a]ny pollutant for which a [NAAQS] has been promulgated and any pollutant identified [in EPA regulations] as a constituent or precursor to such pollutant .” ” ( 40 CFR 51.166(b)(49); 40 CFR 52.21(b)(50 ). ) )

. These regulations identify VOC and NO X as precursors to O 3 in all attainment and unclassifiable areas

. ( 40 CFR 51.166(b)(49)(i)(a); 40 CFR 52.21(b)(50)(i)(a ). ) )

. Thus, for

287 As explained in 40 CFR 52.21(a)(2)(iv)(a) and 51.166(a)(7)(iv)(a), “[t]he project is not a major modification if it does not cause a significant emissions increase. If the project causes a significant emissions increase, then the project is a major modific ation only if it also results in a significant net emissions increase.” The PSD regulations at 40 CFR 51.166(a)(7) and 52.21(a)(2) also explain in more detail the two

- pronged test for determining whether a proposed project at a facility i s a major modifica tion.*** E.O. 12866 Review

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Page 541 of 668 O 3 , the PSD program currently requires the review and control of emissions of VOC and NO X , as applicable, as precursors of O 3 . As noted above, section 165(a)(3) of the CAA and the implementing PSD regulations require the owner or operator of a proposed faci lity to, among other things, demonstrate that “emissions from construction or operation of such facility will not cause, or contribute to, air pollution in excess of any ... national ambient air quality standard in any air control region.” See also 40 CFR 51.166(k), 40 CFR 52.21(k). The EPA has interpreted this requirement to include any NAAQS that is in effect as of the date a permit is issued, unless it has grandfathered permit applications from the requirement to demonstrate that the proposed fac ility does not cause or contribute to a violation of the new or revised NAAQS. 288 S ee, e.g. , 73 FR 28321, 28324, 28340 (May 16, 2008); 78 FR 3253 (Jan. 15, 2013 ). ) ; Memorandum from Stephen D. Page, Director, Office of Air Quality Planning & Standards, “Appli cability of the Federal Prevention of Significant Deterioration Permit Requirements to New and Revised National Ambient Air Quality Standards” (April 1, 2010). Consistent with this interpretation, any revised O 3 NAAQS finalized through this rulemaking will need to be addressed by PSD permit applicants and

288 In the past the EPA has asserted the discretion to take such grandfathering action, under appropriate circumstances, either by rulemaking or through a case

- by

- case determination for a specific permit application . The United States Court of Appeals for the Ninth Circuit recently vacated a decision by the EPA to issue an individual PSD permit grandfathering a permit applicant from certain requirements. See Sierra Club v. EPA , 762 F.3d 971 (9th Cir. 2014). In light of that decision, the EPA is no longer asserting authority to grandfather permit applications on a case - by

- case basis. Sierra Club v. EPA , Case No. 11

- 73342 (9th Cir., Aug. 12, 2014). However, in the same opinion the court also stated that it did “not doubt, or express any opinion on, the EPA’s traditional authority to employ formal rulemaking to implement grandfathering” and distinguished that authority from the permit

- specific grandfathering at issue in the case before it. Id. , Slip. Op. at 23 982 , n.7 & 23

- 26 982

- 983 . Thus, the EPA does not interpret this opinion to limit its authority to grandfather through rulemaking, but rather believes that the decision offers support for such authority. Formatted: Keep lines together*** E.O. 12866 Review

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Page 542 of 668 permitting authorities, in permits issued on or after the date when the revised NAAQS become effective, unless the permit application has been grandfathered through rulemaking, as described below in this p roposal. Because the complex chemistry of ozone O 3 formation poses significant challenges for the assessing the impacts of individual stationary sources on ozone O 3 formation, the EPA’s judgment has been that it was not technically sound to designate a spe cific air quality model that must be used in the PSD permitting process to make this demonstration for ozone O 3 . 289 The EPA has explained that sources must make the demonstration required under CAA section 165(a)(3) and the implementing regulations, that this demonstration necessarily involves an analysis, and has established a process to determine on a case

- by

- case basis, in consultation with the appropriate EPA Regional Office, what analytical techniques should be used to assess the impact of an individual s ource . 290 ( 40 CFR Part 51, Appendix W, Section 5.2.1.c

. )

. The EPA has, however, granted a petition from Sierra Club requesting, among other things, that it initiate rulemaking to designate air quality models for ozone O 3 , and consistent with that petition gra nt, has been going through a process to evaluate potential updates to Appendix W. 291 While that process is underway, individual sources should continue to follow the existing procedures to determine what method is appropriate to use to evaluate their impacts on ozone O 3 formation. The PSD rules in 40 CFR 51.166(i)(2) and 52.21(i)(2) contai n an exemption for particular pollutants from the PSD requirements if the owner or operator of the source demonstrates that the area in which the facility is located is designated as nonattainment for that

289 Letter from Gina McCarthy, Assistant Administrator, to Robert Ukeiley, at 2 (Jan. 4, 2012), available at http://www. epa.gov/ scram001/10thmodconf/review_material/Sierra _Club_Petition_OAR

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Page 543 of 668 pollutant under CAA section 107. Thus, new major s ources and modifications will generally be subject to the PSD program requirements for O 3 if they are locating in an area that does not have a current nonattainment designation under CAA section 107 for O 3 . As explained in the recent proposal for the imple mentation rule for the 2008 O 3 NAAQS, references to historical nonattainment designations for a revoked standard should not be viewed as current “nonattainment designation[s] under CAA § section 107” within the meaning of 40 CFR 51.166(i)(2) and 52.21(i)(2) and, therefore, do not trigger the exemption from PSD requirements that would otherwise result from those provisions

. ( 78 FR 34216 ( , June 6, 2013). a. PSD Grandfathering Provision Recognizing that some PSD applications may have already been submitted and could be in the review process when a revised O 3 NAAQS becomes effective, the EPA is proposing a transition plan that would enable certain PSD applications to make the demonstration that the proposed project will not cause or contribute to a violation of any NAAQS with respect to the O 3 NAAQS that were in effect when on the date the reviewing authority determines the permit application was submitted, complete or the date the public notice on the draft permit or preliminary determination is first published (depending on which grandfathering provision applies), rather than the revised O 3 NAAQS , if any is finalized

. 292

292 The proposed grandfathering provision is intended to apply to pending PSD permit applications that meet one or both of the specified criteria and that are for sources locating in areas where PSD continues to apply with respect to O 3 at the time the permit is issued

. The proposed grandfathering provision is not intended to apply to sources locating i n areas where NNSR applies at the time of permit issuance (for example, if the area had been designated as attainment for ozone O 3 when the permit application wa s submitted but was subsequently designated as nonattainment for ozone O 3 and that nonattainment designation would be in effect when the permit would be issued). For such sources, the permit application must be resubmitted in accordance with the applicable NNSR requirements. Formatted: Not Superscript/ Subscript*** E.O. 12866 Review

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Page 544 of 668 The EPA is proposing and taking comment on adding a grandfathering provision to EPA’s regulations at 40 CFR 51.166 and 52.21 that would apply s pecifically to two categories of PSD permit applications that are pending when the EPA issues the revised O 3 NAAQS: (1) applications for which the reviewing authority has formally determined that the application is complete on or before the signature date of the revised NAAQS; and (2) applications for which the reviewing authority has first published a public notice that of a draft permit or preliminary determination has been prepared before the effective date of the revised NAAQS. These two categories are p roposed because some states do not do completeness determinations as part of their permit process

. As explained above, the EPA interprets the CAA and implementing PSD regulations at 40 CFR 52.21(k)(1) and 51.166(k)(1) to require that PSD permit applicati ons must include a demonstration that new major sources and major modifications will not cause or contribute to a violation of any NAAQS that is in effect as of the date the PSD permit is issued. Thus, if the EPA revises the O 3 NAAQS, any proposed new sour ce or modification with a PSD permit application pending at the time the revised O 3 NAAQS takes effect would be expected to conduct an analysis to demonstrate that it does not cause or contribute to a violation of that NAAQS, absent some type of transition provision exempting the application from that requirement. This demonstration, as noted above, should be completed in consultation with the applicable EPA Regional Office. Nevertheless, the Agency a gency has previously recognized that the CAA provides dis cretion for the EPA to grandfather PSD permit applications from requirements that become applicable while the applications are pending (45 FR 52683, August 7, 1980; 52 FR 24672, July 1, 1987; 78 FR 3086, January 15, 2013). As discussed in more detail in th ese referenced actions,*** E.O. 12866 Review

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Page 545 of 668 section 165(a)(3) of the CAA requires that a permit applicant demonstrate that its proposed project will not cause or contribute to a violation of any NAAQS. At the same time, section 165(c) of the CAA requires that a PSD permit be granted or denied within 1 year after the permitting authority determines the application for such permit to be complete. In addition, section 301 of the CAA authorizes the Administrator “to prescribe such regulations as are necessary to carry out his func tions under this chapter.” When read in combination, these three provisions of the CAA provide the EPA with the discretion to issue regulations to grandfather pending permit applications from having to address a revised NAAQS where necessary to achieve bot h CAA objectives to protect the NAAQS and to avoid delays in processing PSD permit applications. Moreover, in a recent opinion the U.S. Court of Appeals for the Ninth Circuit recognized the EPA’s traditional exercise of grandfathering authority through rul emaking and indicated that this approach was consistent with statutory requirement to “enforce whatever regulations are in effect at the time the agency makes a final decision” because it involved identifying “an operative date, incident to setting the new substantive standard, and the grandfathering of pending permit applications was explicitly built into the new regulations.” Sierra Club v. EPA , Case No. 11

- 73342, Slip. Op. at 26 (Aug. 12, 762 F.3d 971, 983 ( 9 th Cir. 2014). In the EPA’s most recent adopti on of a grandfathering provision for PSD, it adopted a provision for PM 2.5 that provides a reasonable transition for implementing certain new PSD requirements related to the 2012 PM 2.5 NAAQS for pending permit applications that have met certain criteria. A s finalized, the PM 2.5 grandfathering provision included the same two categories of permit applications that today are being proposed for O 3 . See 40 CFR 51.166(i)(10) and 52.21(i)(11). In the rulemaking , adding the grandfathering provision for the PM 2.5 NA AQS,*** E.O. 12866 Review

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Page 546 of 668 the EPA also provided a detailed rationale and legal basis for including the grandfathering provision in the PSD program. See 78 FR 3087 at 3253

- 59 (January 15, 2013); see also 77 FR 39023

- 24 (June 29, 2012). When the PM 2.5 NAAQS grandfathering prov ision was originally proposed, the EPA provided for only one category of pending PSD applications

— applications for which the reviewing authority has published a public notice on the draft permit prior to the effective date of the revised PM 2.5 NAAQS. A maj ority of the commenters supported the adoption of a grandfathering provision but some responded that a grandfathering milestone based on the submittal of a complete application would be more appropriate in order to avoid significant burdens associated with having to withdraw an application. These commenters pointed out the significant level of effort, resources and time involved in preparing all of the information necessary for a complete permit application. They claimed that it would be unfair to establish grandfathering milestones beyond the complete application date because the processes and timeframe involved in generating the draft permit or preliminary determination materials and publishing the public notice are largely out of the control of the permit applicant and vary from agency to agency. Based on this and other pertinent information provided by the commenters, the EPA concluded in that rulemaking that it should add an additional grandfathering milestone to avoid substantial additional burden and delay for permit applications that have reached a stage in the review process by which significant resources have been expended to complete PSD analyses and demonstrations that would have to be redone to address the revised NAAQS. Accordingly, the EPA adop ted a grandfathering provision for the PM 2.5 NAAQS in the final rule that included two milestones for establishing grandfathering eligibility. The EPA believes that these*** E.O. 12866 Review

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Page 547 of 668 considerations and this rationale also apply to pending PSD permit applications that would be affected by a revised O 3 NAAQS. Accordingly, the EPA is proposing to apply these same two milestones in this proposed rulemaking for the revised O 3 NAAQS. The proposed grandfathering provision does not apply to any applicable PSD requirements related to O 3 other than the requirement to demonstrate that the proposed source does not cause or contribute to a violation of any revised O 3 NAAQS. Sources with proje cts qualifying under the grandfathering provision will be required to apply BACT to all applicable pollutants, demonstrate that the project emissions will not cause or contribute to a violation of the existing O 3 NAAQS, and address any Class I area and add itional O 3 - related impacts in accordance with the PSD regulatory requirements. For the reasons provided both herein and in the prior EPA actions referenced above, the EPA proposes to amend the federal PSD permitting regulations at 40 CFR 52.21 to add th e described grandfathering provision for the proposed O 3 NAAQS revision. Specifically, the proposed provision provides that qualifying new sources and modifications seeking PSD permits under 40 CFR 52.21 shall not be required to demonstrate that their prop osed emissions will not cause or contribute to a violation of the revised O 3 NAAQS, but instead must demonstrate that their proposed emissions will not cause or contribute to a violation of the O 3 NAAQS in effect on the date the reviewing authority determi nes the permit application complete or the date the public notice on the draft permit or preliminary determination is first published, depending on which prong of the grandfathering provision is applicable for that source. See proposed 40 CFR 52.21(i)(12). For sources subject to the PSD program under section 52.21, it should be noted that the EPA intends for a source that satisfies either milestone in the proposed revisions to section*** E.O. 12866 Review

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Page 548 of 668 52.21(i) to be grandfathered from this requirement if those revisions are finalized. Accordingly, if a particular source does not qualify under the first milestone based on a complete application, it may qualify under the second milestone based on the issuance of a public notice. Conversely, a source may qualify for grandfather ing under the first milestone, even if it does not satisfy the second. As explained below, states with EPA

- approved PSD programs in their SIPs would have additional flexibility for implementing the proposed grandfathering provision to the extent that
any a lternative approach is at least as stringent as the federal provision. The EPA also proposes that states that issue PSD permits under a SIP

- approved PSD permit program should have discretion to “grandfather” pending PSD permits in the same
manner under the se same circumstances. Therefore, the EPA is proposing to revise its rules at 40 CFR 51.166 to provide a comparable exemption applicable to SIP

- approved PSD programs, although such states are under no obligation to grandfather. See proposed 40 CFR 51.166(i )(11). The EPA recognizes that such states interested in grandfathering PSD sources for ozone O 3 will not have time to revise their rules and submit them to the EPA for approval into the SIP, since the need to grandfather sources will occur immediately upon the effective date of the revised O 3 NAAQS. As explained in an earlier rulemaking, the EPA believes that states implementing a
SIP

- approved PSD program have the discretion to allow grandfathering consistent with the grandfathering provision contained in t he federal rule provisions, even in the absence of an express grandfathering provision in their state rules, if the particular state’s laws and regulations may be interpreted to provide such discretion. See 78 FR 3086 at 3258. Because state SIPs cannot be less stringent than federal requirements, the states’ discretion must be limited to applying grandfathering consistent with the federal rule provisions for ozone O 3 . However, we believe that such consistent application affords states with ample*** E.O. 12866 Review

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Page 549 of 668 flexibility for implementing the provision. Accordingly, a state may elect to apply both milestones or it may elect to rely solely upon one of the milestones for grandfatherin g PSD permits for ozone O 3 . For example, in states that do not issue a formal completeness determination, the complete application milestone would not serve any practical purpose for grandfathering a PSD source, so the state may choose not to use this miles tone. These states may elect to rely solely upon the public notice milestone, regardless of whether it issues formal completeness determinations. However, the EPA anticipates that once a decision is made concerning either the use of both milestones or only one, states will apply the provision consistently to all PSD permit applications that would qualify under the elected milestone(s). The EPA seeks comments on all aspects of the proposed grandfathering provisions under either 40 CFR 52.21 or 51.166 as they would apply to exempt certain pending PSD permit applications from having to address the revised O 3 NAAQS. b. PSD Screening Tools The EPA has historically allowed the use of screening tools to help facilitate the implementation of the NSR program by red ucing the source’s burden and streamlining the permitting process for circumstances where pollutant emissions or ambient impacts could be considered de minimis . For example, the EPA has established significant emission rates or SERs that are used to determ ine when the NSR requirements should be applied to a particular new or modified source with regard to each regulated NSR pollutant. See 40 CFR 51.166(b)(23) and 52.21(b)(23). For O 3 , the EPA established a separate SER in these regulations of 40 tpy for emi ssions of each O 3 precursor -- VOC and NO X . For PSD, these SER values for VOC and NO X are used to determine when the proposed major source or major modification must complete PSD review for that precursor, including complying with BACT for that precursor and*** E.O. 12866 Review

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Page 550 of 668 completing the appropriate air quality analyses associated with the proposed emissions increase of that precursor. Another key screening tool commonly used for PSD is the significant impact level (SIL). This particular tool is used to determine the exte nt to which an ambient impact analysis must be completed for the applicable pollutant. The EPA has not established a SIL for O 3 . T he PSD regulations currently state that “[n]o de minimis air quality level is provided for ozone. However,
any net emissions i ncrease of 100 tons per year or more of [ VOC ] or [ NO X ] subject to PSD would be required to perform an ambient impact analysis , includ ing the gathering of ambient air quality data. ” 293 The EPA intends to consider whether it is appropriate to make any revisions to the PSD regulations related to the screening tools for O 3 in a separate rulemaking that will specifically address various implementation issues for O 3 . However, there are no su ch revisions being proposed in today’s rulemaking. Until any rulemaking to amend existing regulations is completed, permitting decisions should continue to be based on the existing 40 TPY SER for O 3 precursors ( NO X and VOC) in existing regulations. Further decisions regarding the need for an analysis to assess the impact of an individual source on the O 3 NAAQS and the method of analysis depend on the nature of the source and its emissions, and, as noted above, should be

293 Th is language is contained in a footnote in the PSD regulations at 40 CFR 51.166(i)(5)(i) and 52.21(i)(5)(i ) ) , and it ha s not been revisited by the EPA since the issuance of the 8

- hour ozone O 3 NAAQS. These values do not reflect a categorical conclusion by the EPA that sources emitting less than 100 tpy of VOCs or NO X will not cause or contribute to a violation of the current (or any revised) ozone O 3 NAAQS, nor does it reflect a conclusion that such sources should be categorically excluded from the requirement for an ambient impact analysis. Instead, the EPA recommends consultation with the appropriate EPA Regional Office in accordance with section 5.2.1.c of Appendix W when a review of an applic ation for a new source or modification involves emissions less than 100 tpy of either ozone O 3 precursor. See Letter from Gina McCarthy, Assistant Administrator, to Robert Ukeiley, at 4 (Jan. 4, 2012), available at http://www. epa.gov/ scram001/10thmodconf/re view_material/Sierra _Club_Petition_OAR

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Page 551 of 668 determined in consultation with the E PA Regional Office on a case

- by

- case basis in accordance with section 5.2.1.c. of Appendix W to 40 CFR part 51. c. Other PSD Transition Issues As explained earlier in this section, the EPA anticipates that the existing O 3 air quality in some areas will n o longer be in attainment of the primary O 3 standard when it is revised, and that these areas will be designated as “nonattainment” at a later date consistent with the designation process set forth for O 3 under the CAA. However, until such nonattainment de signation occurs, proposed new major sources or major modifications located in any area designated attainment or unclassifiable for the 2008 O 3 NAAQS will continue to be required to obtain a PSD permit. 294 This raises the question as to how a source can be i ssued a PSD permit in light of known existing ambient violations of the revised NAAQS. Section 165(a)(3)(B) of the CAA requires that a proposed source may not construct unless it demonstrates that it will not cause or contribute to a violation of any NAA QS. This statutory requirement is implemented through a provision contained in the PSD regulations at 40 CFR 51.166(k) and 52.21(k). If a source cannot make this demonstration or if its initial air quality impact analysis shows that the source’s impact doe s cause or contribute to a violation, a PSD permit may not be issued until that adverse impact is mitigated. 295 The PSD regulations, however, do not explicitly specify remedial actions that a prospective source can take to address

294 Any proposed major stationary source or major modification for O 3 that does not receive its PSD permit by the effective date of a new nonattainment designation for the area where the source would locate would then be required to satisfy all of the applicable NNSR preconstruction permit requirements for O 3 . 295 See, e.g ., Stephen D. Page, Director, Office of Air Quality Planning and Standards, to Regional Air Division Directors, “Guidance Concerning Implementation of the 1

- hour SO 2 NAAQS for the Prevention of Significant Deterioration Program,” (August 23, 2010); 44 FR 3278 (January 16, 1979). Formatted: Font: Not Italic Formatted: Subscript*** E.O. 12866 Review

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Page 552 of 668 such a situation. Neverthel ess, the EPA has historically recognized in regulations and through other actions that sources applying for PSD permits may utilize offsets as part of the required PSD demonstration under the CAA section 165(a)(3)(B), even though the PSD provisions of the Clean Air Act do not expressly reference offsets, in contrast to the NNSR provisions of the
Act. 296 The EPA has looked to the procedures contained in a separate set of regulations at 40 CFR 51.165(b) to guide the process by which a source that is located in an area designated as attainment or unclassifiable for a NAAQS, but that is determined to cause or contribute to a violation of that NAAQS in any area, can use offsets to mitigate its adverse impact on the NAAQS and ultimately meet the PSD demonstration r equirement under the CAA section 165(a)(3)(B) and the implementing regulations. 297 Section 51.165(b) states that plans shall include a preconstruction review permit program (or its equivalent) to satisfy the requirements of CAA section 110(a)(2)(D)(i) for major sources and major modifications, and that the program shall apply to any major stationary source or major modification locating in an area designated attainment or unclassifiable for any NAAQS, when that source would cause or contribute to a NAAQS vi olation. 298 Paragraph (b)(3) of that

296 See , e.g., In re Interpower of New York, Inc ., 5 E.A.D. 130, 141 (EAB 1994) (describing an EPA Region 2 PSD permit that relied in part on offsets to demonstrate the source would not cause or contribute to a violation of the NAAQS). 52 FR 24698 (July 1, 1987) ; 78 FR 3261

- 62 (Jan. 15, 2013)

. 297 78 FR 3261 (January 15, 2013); Stephen D. Page, Director, Office of Ai r Quality Planning and Standards, to Regional Air Division Directors, “Guidance Concerning Implementation of the 1

- hour SO 2 NAAQS for the Prevention of Significant Deterioration Program,” (August 23, 2010). 298 The definition of “major stationary source” and “major modification” in this regulation is based on the respective definitions in the NNSR regulations at 40 CFR 51.165(a), which are more inclusive than the respective PSD definitions, but clearly include major sources covered by the PSD requirements. Formatted: Font: Not Italic

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Page 553 of 668 regulation provides that the required permit program may include a provision allowing a proposed major source or major modification to reduce the impact of its emissions on air quality by obtaining sufficient emissions re ductions to, at a minimum, compensate for its adverse ambient impact where the source or modification would otherwise cause or contribute to a violation of any NAAQS. Although section 51.165(b) refers explicitly to CAA section 110(a)(2)(D)(i), which now ad dresses transport issues, but not CAA section 165(a)(3)(B), the EPA has previously explained that 51.165(b) may also be interpreted to apply to the section 165(a)(3)(B) demonstration based on the regulatory history

. ( 78 FR 3262, n. 256

. )

. 299 Generally, the offset needed to compensate for a proposed source’s adverse impact would be determined by the ability of any particular emissions reduction to mitigate the source’s adverse impact at the location of the violation. As long as the emissions re duction or offset can be shown to compensate for the source’s adverse impact, there is no implied requirement that the amount of the emissions reduction be equal to or greater than the proposed emissions increase.
See 44 FR 3278 (January 16, 1979 ) )

. (“Alth ough full emissions offsets are not required, such a

299 Briefly, in 1980, the EPA had determined that the statutory requirements under CAA section 165(a)(3)(B), taken together with the requirements of CAA section 110(a)(2)(D) required all major sources locating outside a nonattainment area , but causing or contr ibuting to a NAAQS violation to reduce the impact on air quality so as to assure attainment and maintenance of the NAAQS. 45 FR 31310 (May 13, 1980). In a footnote, the EPA further indicated that this offset requirement must apply to sources causing or con tributing to a newly discovered NAAQS violation until the area is designated nonattainment. See 45 FR 31310 (May 13, 1980). In the 1980 rule, the EPA adopted section 51.18(k), which was later renumbered section 51.165(b). The EPA revised 51.165(b) to expressly authorize an offset program to meet the requirements of CAA section 110(a)(2)(D)(i), but t his provision may also be interpreted to apply to section 165(a)(3)(B), consistent with the EPA’s reading of section 51.18(k) in 1980. It is also worth noting that at the time of these rules, before the 1990 CAA amendments, section 110(a)(2)(D) required ea ch state to have “a permit or equivalent program for any major emitting facility...to assure (i) that national air quality standards are achieved and maintained....” Formatted: Keep lines together*** E.O. 12866 Review

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Page 554 of 668 source must obtain emissions offsets sufficient to compensate for it air quality impact where the violation occurs.”) In previous discussions of the use of emissions offsets to help make the demonstrat ion required under CAA section 165(a)(3)(B), the EPA has explained that any emissions used for PSD purposes must meet applicability criteria that are at least as stringent as the offset criteria set forth in the NNSR requirements for offsets under 40 CFR 5 1.165(a)(3). See 78 FR 3262. The EPA continues to believe that these criteria provide the most appropriate criteria for determining the creditability of PSD offsets. d. PSD for a Distinct Secondary Standard , if One is Established As noted above, the CAA r equires that proposed new major stationary sources and major modifications demonstrate that their emissions increases will not cause or contribute to a violation of any NAAQS, which includes the primary and secondary NAAQS. For O 3 , the existing primary and secondary NAAQS are defined in the same form and at the same level. As described earlier in this preamble, the Administrator is proposing to retain the current averaging time and form and revise the level of the current secondary standard to within the ra nge proposed for the primary standard of 70 to 65 ppb . In addition, among other things, the Agency a gency is seeking comment on the alternative approach of revising the secondary standard to establish a distinct O 3 secondary standard . If the Agency a gency we re to finalize a secondary standard that differs from the primary standard, PSD permit applicants would be required to provide an analysis that specifically addresses the revised secondary standard and make the necessary showing of compliance with that sta ndard, as well as any revised primary standard. Moreover, if such a secondary standard is expressed in a distinctly different form than the primary standard,*** E.O. 12866 Review

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Page 555 of 668 the required analysis for making the compliance demonstration would need to be consistent with tha t form. Should the Administrator decide to establish a distinct secondary NAAQS for O 3 , the
EPA would consider whether the approaches put forth in any regulatory updates to Appendix W and associated guidance, as noted in this preamble above, are sufficient for making the necessary compliance demonstration for that standard for purposes of PSD. If appropriate, the EPA may consider establishing a surrogacy policy that would allow a source to make the PSD

- required demonstration of compliance with a distinct secondary O 3 NAAQS solely through a demonstration of compliance with the primary NAAQS .[ INSERT CITE ].

. Therefore, the EP A expects that projects subject to the revised ozone O 3 NAAQS could generally move forward consistent with the PSD program requirements and NNSR program requirements as subject to the revised primary and secondary ozone O 3 NAAQS. The EPA seeks comment on th is potential approach as well as any other options that should be considered for showing compliance with any revised primary and secondary O 3 NAAQS. 2. Nonattainment New Source Review
P art D of title I of the CAA includes preconstruction review and permit ting requirements for new major stationary sources and major modifications when they locate in areas designated nonattainment for a particular pollutant. As explained in section VII.D.1 of this preamble, the relevant part D requirements are typically refer red to as the NNSR program. The EPA’s regulations for the N NSR programs are contained in 40 CFR 51.165, 52.24 and part P art 51, Appendix S

. For example, the EPA has developed minimum program requirements for an NNSR program that is approvable in a SIP, and those requirements, which include requirements for O 3 , are contained in 40 CFR 51.165. In addition, 40 CFR part 51, Appendix S contains requirements*** E.O. 12866 Review

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Page 556 of 668 constituting an interim NNSR program. This program governs NNSR permitting in nonattainment areas that lack a SIP

- approved NNSR permitting program, and applies during the time between the date of the relevant designation and the date that the EPA approves into the SIP a NNSR program. 300 This program is commonly known as the Emissions Offset Interpretative Rule, and is applicable to O 3 as well. 301 As with PSD, the NNSR requirements apply on a pollutant

- specific basis. However, in nonattainment areas , NNSR applies only to nonattainment pollutants, that is, pollutants for which an area is designated nonattainment on the date when the permit is issued. As explained in section VII.D.1 in of this preamble, prior to the designation of areas for any revised O 3 NAAQS, applicability of either PSD or NNSR for O 3 to a proposed major new or modified source will depend on an are a’s current designations with regard to the O 3 NAAQS. Accordingly, a major stationary source or major modification proposing to locate in an area currently designated nonattainment for the 2008 O 3 NAAQS must satisfy the NNSR permit requirements for O 3 . The EPA is not proposing any new or revised NNSR requirements in this proposal. As explained in section VII.A.2 of this preamble, the CAA requires that area designations for new or revised NAAQS be addressed subsequent to the effective date of such new or rev ised NAAQS. The EPA anticipates that the area designation process for any revised O 3 NAAQS will be completed within 2 years after the revised NAAQS become effective. Accordingly, any revisions to the existing NNSR requirements for O 3 will be proposed at a later date consistent with the designation process for any revised O 3 NAAQS. The EPA will also at the same time propose any necessary

300 See Appendix S, Part I; 40 CFR 52.24(k). 301 As appropriate, certain NNSR requirements under 40 CFR 51.165 or Appendix S can also apply to sources and modifications located in areas that are designated attainment or unclassifiable in the Ozone Transport Region. See, e.g., CAA 184(b)(2), 40 C.F.R. 52.24(k). Formatted: Normal*** E.O. 12866 Review

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Page 557 of 668 revisions to the NNSR requirements under Appendix S so that states will be able to issue NNSR permits for the revised O 3 N AAQS on and after the effective date of designations of new nonattainment areas for O 3 until such time that their own NNSR program is approved as part of their SIP, where the state does not already have an approved NNSR program applicable to O 3 . This section provides an explanation of some of the key requirements of the NNSR program as it currently applies to O 3 . For NNSR, “major stationary source” is generally defined as a source with the potential to emit at least 100 tpy of the pollutant for which t he area is designated nonattainment. In some cases, however, the CAA and the NNSR regulations define “major stationary source” for NNSR in terms of a lower rate dependent on the pollutant. For

ozone O 3 , in addition to the general threshold level of 100 tpy, lower major source thresholds have been defined for O 3 nonattainment areas based on the stringency of the area’s classification. The NNSR program requires the review and control of emissions of both VOC and NOx as precursors of ozone O 3 , and both are revie wed separately in accordance with the applicable major source threshold. For example, the threshold for O 3 nonattainment areas classified as Serious is 50 tpy for both VOC and NOx. See 40 CFR 51.165(a)(1)(iv)(A)( 1 )( i ) and (a)(1)(iv)(A)( 2 )( iv ), respectively

. As explained earlier in section VII.D.1 of this preamble, a major modification is a physical change or change in the method of operation of an existing major stationary source that results in both a significant emissions increase, and a significant net emissions increase. To determine whether an emissions increase is significant, the NNSR rules define significant emissions rates or SERs for each applicable pollutant. The SER for VOC is 40 tpy, as is the SER for NOx. See 40 CFR 51.165(a)(1)(x)(A). It sho uld be noted that there are additional more stringent criteria that must be considered in determining a major modification in nonattainment*** E.O. 12866 Review

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Page 558 of 668 areas classified as Serious, Severe or Extreme for O 3 . See 40 CFR 51.165(a)(1)(x)(B), (C) and (E). New major statio nary sources and major modifications for O 3 must comply with the lowest achievable emissions rate (LAER) LAER as defined in the CAA and NNSR rules, as well

as perform ing other analyses as required under section 173 of the CAA . In addition, appropriate emissions reductions, known as emissions offsets, must be secured to offset the proposed emissions increase of the precursors that trigger NNSR for O 3 . The appropriate emissions offset needed for a particular source will depend upon the classification for the O 3 nonattainment area in which the source or modification will locate. Generally, the ratio of the total emissions reduction to the emissions increase is at least 1:1; however, more stringent ratios apply to O 3 nonattainment areas according to the area classification. See , e.g., 40 CFR 51.165(a)(9) and 40
CFR Part part 51, App. Appendix S, IV.G.2.
E. Transportation and General Conformity Programs 1. What are T ransportation and G eneral C onformity? Conformity is required under CAA section 176(c) to ensure that federal actions are consistent with (“conform to”) the purpose of the SIP. Conformity to the purpose of the SIP means that federal activities will not cause new air quality violations, worsen existing violations, or delay timely attainment of the rel evant NAAQS or interim reductions and milestones. Conformity applies to areas that are designated nonattainment, and those nonattainment areas redesignated to attainment with a CAA section 175A maintenance plan after 1990 (“maintenance areas”). The EPA’s Transportation Conformity Rule (40 CFR 51.390 and Part 93, subpart A) establishes the criteria and procedures for determining whether transportation activities conform*** E.O. 12866 Review

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Page 55 9 of 668 to the SIP. These activities include adopting, funding or approving transportation plan s, transportation improvement programs (TIPs) and federally supported highway and transit projects. For further information on conformity rulemakings, policy guidance and outreach materials, see the EPA’s website W ebsite at http://www.epa.gov/otaq/statereso urces/transconf/index.htm . The EPA may issue future transportation conformity guidance as needed to implement a revised O 3 NAAQS. With regard to general conformity, the EPA first promulgated general conformity regulations in November 1993. (40 CFR part 51, subpart W, 40 CRF CFR part 93, subpart B) Subsequently the EPA finalized revisions to the general conformity regulations on April 5, 2010. (75 FR 17254

- 17279 ) )

. Besides ensuring that federal actions not covered by the transportation conformity rule will not interfere with the SIP, the general conformity program also fosters communications between federal agencies and state/local air quality agencies, provides for public notification of and access to federal agency conformity determinations and allows for air quality review of individual federal actions. More information on the general conformity program is available at http://www.epa. gov/air/genconform/

. 2. Why I s the EPA D iscussing T ransportation and G eneral C onformity in this P roposed
R ulemaking? The EPA is discussing transportation and general conformity in this proposed O 3 NAAQS rulemaking in order to provide affected parties with information on when and how conformity must be implemented after nonattainment areas are designated for a revised O 3 NAAQS. The information presented here is consistent with existing conformity regulations and statutory provisions that are not addressed b y this O 3 NAAQS rulemaking. Affected parties would include state and local transportation and air quality agencies, metropolitan planning organizations*** E.O. 12866 Review

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Page 560 of 668 (MPOs), and federal agencies including the U.S. Department of Transportation (DOT), the U.S. Department of Defense, the U.S. Department of Interior , and the U.S. Department of Agriculture. 3. When W ould T ransportation and G eneral C onformity A pply to A reas D esignated
N onattainment for a R evised O 3 NAAQS , if One is Established ? Transportation and general con formity apply one year after the effective date of nonattainment designations for a revised O 3 NAAQS. This is because CAA section 176(c)(6) provides a 1

- year grace period from the effective date of initial designations for any revised NAAQS before transpor tation and general conformity apply in areas newly designated nonattainment for a specific pollutant and NAAQS. 4. Will T ransportation and G eneral C onformity A pply to a D istinct S econdary O 3 NAAQS, if
O ne is E stablished? CAA section S ection 176(c)(1)(A) of the CAA states that conformity to a SIP means “conformity to an implementation plan’s purpose of eliminating or reducing the severity and number of violations of the national ambient air quality standards and achieving expeditious attainment of such st andards...” In other words, because the CAA refers to the NAAQS without distinguishing between them, conformity applies to both the primary and secondary NAAQS for all criteria pollutants. Therefore, if a distinct secondary O 3 NAAQS is established, both
tr ansportation and general conformity will apply in any areas designated nonattainment for such a NAAQS. Current transportation and general conformity regulations already apply to such a secondary NAAQS, and nothing in this proposal affects those transporta tion and general conformity requirements. The EPA will consider the need to issue additional guidance*** E.O. 12866 Review

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Page 561 of 668 concerning the implementation of transportation and general conformity in areas designated nonattainment for a distinct secondary O 3 NAAQS, if one is esta blished

. 5. What I mpact W ould the I mplementation of a R evised O 3 NAAQS H ave on a S tate’s
T ransportation and/or G eneral C onformity SIP? If the EPA revises the O 3 NAAQS, but does not make specific changes to its transportation or general conformity regula tions , then states should not need to revise their transportation and/or general conformity SIPs. The EPA is not proposing any changes to its transportation or general conformity regulations. While we are not proposing any revisions to the general conformi ty regulations at this time, we recommend, when areas develop SIPs for a revised O 3 NAAQS, that state and local air quality agencies work with federal agencies with large facilities that are subject to the general conformity regulations to establish an emi ssions budget for those facilities in order to facilitate future conformity determinations under the conformity regulations. Such a budget could be used by federal agencies in determining conformity or identifying mitigation measures if the budget level is included and identified in the
SIP. However, because some federal agencies may not have an established facility

- wide emissions budget in the SIP for the purpose of meeting general conformity requirements, state, local and tribal agencies are encouraged to maintain ozone SIP emissions inventories on an annual basis, at a minimum, to facilitate compliance of federal agencies with CAA section 176(c). Finally, states with new nonattainment areas may also need to revise conformity SIPs in order to ensure the st ate regulations apply in any newly designated areas if the existing SIP does include current conformity provisions. If this is the first time that transportation conformity will apply in a state, such a state is required by the statute and EPA regulations to submit a SIP revision that addresses three specific*** E.O. 12866 Review

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Page 562 of 668 transportation conformity requirements that address consultat ion procedures and written commitments to control or mitigation measures associated with conformity determinations for transportation plans, TIPs or projects. (40 CFR 51.390) Additional information and guidance can be found in the EPA’s “Guidance for Devel oping Transportation Conformity State Implementation Plans” ( http://www.epa.gov/otaq/stateresources/transconf/policy/420b09001.pdf ). ( http://www.epa.gov/o taq/stateresources/transconf/policy/420b09001.pdf )

. F. How Background O 3 Is Addressed in C AA Implementation Provisions 1. Introduction
T he EPA and state, local and tribal air agencies, need to determine how to most effectively and eff

iciently use the CAA’s various provisions to provide required public health and welfare protection from the harmful effects of O 3 . In most cases, reducing man

- made emissions of NO X and VOCs will reduce O 3 formation and provide additional health and welfare protection. The EPA recognizes, however, that “background” O 3 levels, which can be significant in some areas on some days, may present a challenge to air agencies in preparing clean air plans.
T hat is, O 3 and O 3 - forming pollution from natural and international sources could prevent ambient levels from reaching attainment levels in locations where the impacts of such sources are large relative to the impact of controllable man

- made sources of NO X and VOC emissions within the U.S., especially in loca tions with few remaining untapped opportunities for local emission reductions. Climate change may also influence future O 3 concentrations. Modeling studies in EPA’s Interim Assessment (U.S. EPA, 2009b) and cited in support of the 2009 Endangerment Finding (74 FR 66,496; Dec. 15, 2009) show that, while the impact is not uniform, simulated climate*** E.O. 12866 Review

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Page 563 of 668 change causes increases in summertime O 3 concentrations over substantial regions of the country, with increases tending to occur during higher peak pollution episod es in the summer

. Increases in temperature are expected to be the principal factor in driving any O 3 increases, although increases in stagnation frequency may also contribute (Jacob and Winner, 2009). These temperature increases could lead to more prevalen t wildfires, the impacts of which may lessened by various mitigation measures including taking steps to minimize fuel loading in areas vulnerable to fire. The term “background” O 3 is often used to refer to O 3 that originates from natural sources of O 3 (e.g., wildfires and stratospheric O 3 intrusions) and O 3 precursors, as well as from manmade international emissions of O 3 precursors. Using the term generically and the lack of specificity , however, can lead to confusion as to what sources of O 3 are bein g considered. The PA provides three specific definitions of background O 3 : natural background, North American background, and United States background. Natural background (NB) is defined as the O 3 that would exist in the absence of any manmade O 3 precursor emissions. North American background (NAB) is defined as that O 3 that would exist in the absence of any manmade O 3 precursor emissions from North America. U.S. background (USB) is defined as that O 3 that would exist in the absence of any manmade emissions inside the United States U .S . Because background O 3 is difficult to measure, air quality modeling is conducted to estimate NA, NAB, and USB. The PA identifies several key findings related to background O 3 . First, background O 3 can comprise a considerable fraction of total seasonal mean O 3 across the U.S. Studies have estimated that seasonal mean USB 8

- hour ozone O 3 values across U.S. locations varied between 25 to 50 ppb in 2007 ( USEPA U.S. EPA , 2014c, Figure 211) . The largest seasonal average values of background are modeled to occur at locations in the intermountain western U.S. and the*** E.O. 12866 Review

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Page 564 of 668 highest daily USB levels are highest in the spring and early summer seasons . Second, the modeling indicates that U.S. anthropogenic emission sources are the do minant contributor to the majority of modeled O 3 exceedances of the NAAQS across the U.S. This conclusion is based on results that indicate background contributions are generally similar on high O 3 days as on all other O 3 days. As a result, the proportiona l influence of background sources tends to be lower on high ozone O 3 days. Third, while the majority of modeled O 3 exceedances have local and regional emissions as their primary cause, there can be events where O 3 levels approach or exceed the concentration levels being proposed in this notice (i.e., 60

- 70 ppb) in large part due to background sources. These cases of high USB levels on high O 3 days typically result from stratospheric intrusions of O 3 , wildfire O 3 pl umes, or long

- range transport of O 3 from sources outside the U.S. In most locations , in the U.S. , these events are relatively infrequent and the CAA contains provisions that can be used to help deal with certain events, including providing varying degrees of regulatory relief for air agencies and potential regulated entities. Regulatory relief associated with U.S. background O 3 may include: 302

 Relief from designation as a nonattainment area (through exclusion of data affected by exceptional events)

 Relief from the more stringent requirements of higher nonattainment area classifications (through treatment as a rural transport area; through exclusion of data affected by exceptional events; or through international transport provisions)

302 Note that the relief mechanisms discu ssed here do not include the CAA’s interstate transport provisions found in sections 110(a)(2)(D) and 126. The interstate transport provisions are intended to address the cross

- state transport of O 3 and O 3 precursor emissions from man

- made sources within t he continental U.S. rather than background O 3 as it is defined in this section.*** E.O. 12866 Review

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Page 565 of 668  Relief from adopting m ore than reasonable controls to demonstrate attainment (through international transport provisions) None of these relief mechanisms are completely burden

- free, meaning they all require some level of assessment or demonstration by a state and/or EPA to leg ally invoke. In no case does the CAA authorize a blanket exclusion from the basic application of an air quality management regime because an area is significantly impacted by background O 3 . While any prediction of the exact nature of future implementation challenges associated with alternative prospective standards is inherently uncertain, there is no question that, as the levels of alternative prospective standards are lowered, background will represent increasingly larger fractions of total O 3 levels and may subsequently complicate efforts to attain these standards. For a prospective standard of 70 ppb, the EPA does not believe that background O 3 would create significant implementation

- related challenges at locations throughout the U.S. and prevent attainm ent of the NAAQS. However, as the levels of prospective standards are lowered, the areas that would most likely need to use the relief mechanisms discussed in this section as part of attaining the lower prospective levels are rural locations in the western U.S., consistent with the previously mentioned locations where we have estimated the largest seasonal average values of background occur. The remainder of this section discusses these relief mechanisms and the methods associated with legally invoking them . These relief mechanisms depend on distinguishing background O 3 by the following types of drivers: routine natural emissions, non

routine natural events and international emissions. The EPA welcomes comment on any of these issues related to O 3 background and implementation. 2. Exceptional Events Exclusions*** E.O. 12866 Review

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Page 566 of 668 A state can request and the EPA can agree to exclude data associated with event

influenced exceedances or violations of a NAAQS, including the proposed O 3 NAAQS, provided the event meets the statutory requirements in section 319 of the CAA:

 The event “affects air quality.”

 The event “is not reasonably controllable or preventable.”

 The event is “caused by human activity that is unlikely to recur at a particular location or [is] a natural even t.” 303 The EPA’s implementing regulations , the 2007 Exceptional Events Rule, further specify that states must provide evidence that: 304

 “There is a clear causal relationship between the measurement under consideration and the event that is claimed to have affected the air quality in the area;”

 “The event is associated with a measured concentration in excess of normal historical fluctuations, including background;” and

 “There would have been no exceedance or violation but for the event.” The ISA contains di scussions of natural events that may contribute to O 3 or O 3 precursors. These include stratospheric O 3 intrusion and wildfire events

. 305 As indicated above, to satisfy the exceptional event requirements and to qualify for data exclusion under the Exceptional Events

303 A natural event is further described in 40 CFR 50.1(k) as “an event in which human activity plays little or no direct causal role.” 304 See 72 Federal Register 13560 (March 22, ( 2007 ), ). Treatment of Data Influenced by Exceptional Events; Final Rule. 40 CFR Part 50 .1, 40 CFR Part 50.14 and 40 CFR Part 51 .930 ; Federal Register 72:13560

. 305 The preamble to the Exceptional Events Rule (72 FR 13560, March 22, 2007) id entifies both stratospheric O 3 intrusions and wildfires as natural events that could also qualify as exceptional events under the CAA and Exceptional Event Rule criteria. Note that O 3 resulting from routine natural emissions from vegetation, microbes, anim als and lightning are not exceptional events authorized for exclusion under the section 319 of the CAA. Formatted: Font: 12 pt*** E.O. 12866 Review

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Page 567 of 668 Rule, a state must develop and submit evidence addressing each of the identified criteria. The extent to which a stratospheric O 3 intrusion event or a wildfire event contribute to O 3 levels can be uncertain, and in most cases requires detailed inve stigation and analysis to adequately determine

. Strong stratospheric O 3 intrusion events, most prevalent at high elevation sites during winter or spring, can be identified based on measurements of low relative humidity, evidence of deep atmospheric mixing , and a low ratio of carbon monoxide CO to O 3 based on ambient
measurements. Accurately d etermin ing the extent of weaker intrusion events remains challenging

. 306 (U.S. EPA 2013a, p.3

- 34). Although states have submitted only a few exceptional event demonstrations for stratospheric O 3 intrusion, the EPA recently approved a demonstration from Wyoming for a June 2012 stratospheric O 3 event. 307 While stratospheric O 3 intrusions can increase mon itored ground

- level ambient O 3 concentrations, w ildfire plumes can either suppress or enhance O 3 depending upon a variety of factors including fuel type, combustion stage , plume chemistry, aerosol effects, meteorological conditions and distance from the fi re (Jaffe and Widger Wig d er , 2012). As such, determining the impact of wildfire emissions on specific O 3 observations is challenging. The EPA has, however, recently approved two an exceptional event demonstrations demonstration for wildfires affecting
1

- hour O 3 levels in Sacramento, California in 2008 that successfully used a variety of analytical tools (e.g ., regression modeling, back trajectories, satellite imagery, etc.) to support the exclusion

306 See ISA page 3

- 34 307 See www.epa.gov/ttn/analysis/exevents.htm U.S. EPA (2014) Treatment of Data Influenced by Exceptional Events: Examples of Reviewed Exceptional Event Submissions. U.S. Environmental Protection Agency, Research Triangle Park, NC. A vailable at http://www.epa.gov/ttn/analysis/exevents.htm

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Page 568 of 668 of O 3 data affected by large fires

. 308 The first example involve d wildfires affecting 1

- hour O 3 levels in Sacramento, California in 2008. The second example involved large scale prescribed fires in the Flint Hills area of Kansas in 2011

. While the EPA does not include the O 3 effects of prescribed fires with in the defin ition of U.S. background because they are not natural, the physical conditions of these prescribed fires may resemble large natural wildfires on the same type of landscape. Because of previously expressed stakeholder feedback regarding implementation of t he Exceptional Events Rule and specific stakeholder concerns regarding the analyses that can be used to support O 3 - related exceptional event demonstrations, the EPA intends to propose revisions to the Exceptional Events Rule in a future notice and comment rulemaking effort and will solicit public comment at that time. Additionally, t he EPA intends to develop guidance to address implementing the Exceptional Events Rule criteria for fires that could affect ambient O 3 concentrations. Additionally, t he EPA intends to develop guidance to address implementing the Exceptional Events Rule criteria for wildfires that could affect ambient O 3 concentrations. Wildfire emissions are a component of background O 3 (Jaffe and Wigder, 2012) and can significantly contribut e to periodic high O 3 levels (Emery , 2012). Besides their effect on air quality, w ildfires pose a direct threat to public safety

– a threat that can be mitigated through management of wildland vegetation. Attempts to suppress wildfires have resulted in uni ntended consequences, including increased risks to both humans and ecosystems. Indeed, “Fire policy

308 See exam

ples U.S. EPA (2014) Treatment of Data Influenced by Exceptional Events: Examples of Reviewed Exceptional Event Submissions. U.S. Environmental Protection Agency, Research Triangle Park, NC . Examples of O 3 - related exceptional event submissions at www.epa.gov/ttn/analysis/exevents.htm a vailable at http://www.epa.gov/ttn/analysis/exevents.htm

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Page 569 of 668 that focuses on [wildfire] suppression only, delays the inevitable, promising more dangerous and destructive future...fires” (Stephens, S. et al., 2013 ). The use of wildland prescribed fire can influence the occurrence of catastrophic wildfires which may help manage the contribution of wildfires to background O 3 levels and periodic peak O 3 events

. Additionally prescribed fires can have benefits to those plant a nd animal species that depend upon natural fires for propagation, habitat restoration, and reproduction, as well as myriad ecosystem functions (e.g., carbon sequestration). As previously indicated, the CAA and the EPA ’s implementing regulations allow for t he exclusion of air quality monitoring data from design value calculations when they are substantially affected by certain background influ ences. Additionally, the CAA requires the EPA to set the NAAQS at levels requisite to protect public health and welfare without regard to the source of the pollutant. However, EPA understands the importance of prescribed fire which mimics a natural process necessary to manage and maintain fire

- adapted ecosystems and climate change adaptation, while reducing risk of uncontrolled emissions from catastrophic wildfires. The EPA is committed to working with f ederal land managers, t ribes, and s tates to effectivel y manage prescribed fire use to reduce the impact of wildland

- fire related emissions on ozone through policies and regulations implementing these standards. 3. Rural Transport Areas
CAA C lean A ir A ct section 182(h) authorizes the EPA Administrator to dete rmine that an area designated nonattainment can be treated as a rural transport area. In accordance with the statute, a nonattainment area may qualify for this determination if it meets the following criteria:

 The area does not contain emissions sources th at make a significant contribution to monitored O 3 concentrations in the area, or in other areas; and*** E.O. 12866 Review

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Page 570 of 668  The area does not include and is not adjacent to a Metropolitan Statistical Area

. 309
H istorically , the EPA has recognized few nonattainment areas under this statutory provision. 310 The EPA has not finalized issued separate written guidance to further elaborate on the interpretation of these CAA qualification criteria. However, the EPA developed draft guidance in 2005 that explains the kinds of technical analyses that states could use to establish that transport of O 3 and/or O 3 precursors into the area is so overwhelming that the contribution of local emissions to an observed 8

- hour O 3 concentration above the level of the NAAQS is relatively minor and determine th at emissions within the area do not make a significant contribution to the O 3 concentrations measured in the area or in other areas

. 311 While this guidance was not prepared specifically for rural transport areas, it could be useful to states for developing t echnical information to support a request that the EPA treat a specific O 3 nonattainment area as a rural transport area. An area that qualifies for treatment as a rural transport area is deemed to have fulfilled all
O 3 - related planning and control requirements if it meets the CAA’s requirements for areas classified Marginal, which is the lowest classification specified in the CAA. Therefore, a state

309 Note that the EPA interprets the rural transport provisions of section 182(h) would not apply to an O 3 monitor that is located in a relatively rural location, but is heavily influenced by short

range upwind contributions from a nearby urbanized area. The EPA will work closely with states to determine whether a particular monitor violating the NAAQS i s considered to be affiliated with a nearby urban area, or is an isolated rural area monitor. 310 For the 1979 1

- hour O 3 standard , Essex County, New York, and Smyth County, Virginia (White Top Mountain) were recognized by the EPA as rural transport areas. 311 The draft EPA guidance document titled “ U.S. Environmental Protection Agency (2005). Criteria For Assessing Whether an Ozone Nonattainment Area is Affected by Overwhelming Transport ” (draft 6

- 29

- 05) was not finalized and did not specifically address the provisions of CAA section 182(h). The draft [Draft EPA Guidance]. U.S. Environmental Protection Agency, Research Triangle Park, NC. June 2005. Available at http://www.epa.gov/scram00 1/guidance/guide/owt_ guidance can be viewed at www.epa.gov/scram001/guidance/guide/owt_guidance_07

- 13

- 05.pdf _07

- 13

- 05.pdf

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Page 571 of 668 would not need to develop an attainment plan or an attainment demonstra tion for such an area or adopt the various mandatory measures required in nonattainment areas classified as Moderate or above . The only requirements that would apply, regardless of the level of O 3 air quality, would be NNSR (at the Marginal major source th reshold and offset ratio), conformity requirements associated with a nonattainment designation, and the emission inventory and source emission statement requirements. 4. International Transport
CAA C lean A ir A ct section 179B recognizes the possibility th at certain nonattainment areas may be heavily impacted by O 3 or O 3 precursor emissions from international sources beyond the regulatory jurisdiction of the state

. The EPA’s science review suggests that the influence of international sources on U.S. O 3 leve ls will be largest in locations that are in the immediate vicinity of an international border with Canada or Mexico, but other locations can also potentially be affected when conditions are favorable for long

- range transport

. 312 (U.S. EPA 2013a, p.3

- 140)

. Se c tion 179B allows states to consider in their attainment demonstrations whether an area might have met the O 3 NAAQS by the attainment date “but for” emissions contributing to the area originating outside the United States U .S

. If a state is unable to demonstrate attainment in such an area after adopting all reasonably available control measures (RACM, including RACT, as required by CAA section 182(b)), the EPA can nonetheless approve the CAA

- required state attainment plan and de monstration using the authority in section 179B. When the EPA approves this type of attainment plan, states avoid potential sanctions and federal implementation plans (FIPs), FIPs, and there would be no adverse consequence for a

312 ISA (U.S. EPA , 2013 , p. 3

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Page 572 of 668 finding that the area fail ed to attain the NAAQS by the relevant attainment date. For example, the area would not be reclassified to the next highest classification or required to implement a section 185 penalty fee program. Section 179B authority does not allow the EPA to avoid designating an area as nonattainment or for the area to be classified with a lower classification than is indicated by actual air quality. Generally, monitoring data influenced by international transport may not be excluded from regulatory determinations, unless the data are influenced by an excludable exceptional event. Section 179B also does not provide for any relaxation of mandatory emissions control measures (including contingency measures) or the prescribed emissions reductions necessary to achieve re asonable further progress (RFP). RFP. The EPA’s guidance on ‘but for’ demonstrations involving international emissions indicates that states may want to consider conducting air quality modeling using O 3 episodes that do not involve international transport of emissions ( see guidance document entitled “Criteria for Assessing the Role of Transported O 3 /Precursors in O 3 Nonattainment Areas” U.S. EPA 1991) 313 ), running the model with boundary conditions that reflect general U.S. background concentrations, and analy zing monitoring data if a dense network has been established. Additional information that may be helpful at nonattainment areas abutting international borders could include evaluating changes in O 3 with changes in wind direction at monitors near the border , and comparing emissions on both sides of the border. States are encouraged to consult

313 EPA

- 450/4

- 91

- 015, May 1991. U.S. Environmental Protection Agency (1991). Criteria for Assessing the Role of Transported Ozone/Precursors in Ozone Nonattainment Areas. EPA

450/4

- 91

- 015. U.S. Environmental Protection Agency, Office of Air Quality Planning and S tandards, Research Triangle Park, NC. May 1991. Formatted: Font: 12 pt*** E.O. 12866 Review

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Page 573 of 668 with their EPA Regional Office to establish appropriate technical requirements for these analyses. The EPA has used section 179B authority previously to approve attain ment plans for Mexican border areas in El Paso, TX (O 3 , PM 10 , and CO plans); Nogales, AZ (PM 10 plan); and Imperial Valley, CA (PM 10 plan). The 1

- hour O 3 attainment plan for El Paso, TX was approved by EPA as sufficient to demonstrate attainment of the NAAQ S by the Moderate classification deadline of November 15, 1996, taking into account “but for” international emissions sources in Ciudad Juárez, Mexico (69 FR 32450, June 10, 2004). The state’s demonstration included airshed modeling using only the U.S. emi ssions data because emissions data from Ciudad Juárez were not available.
VIII. Statutory and Executive Order Reviews Additional information about these statutes and Executive Orders can be found at http://www2.epa.gov/laws

- regulations/laws

- and

- executive

- orders.

A

. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review This action is an economically significant regulatory action tha t was submitted to the Office of Management and Budget (OMB) for review . Any changes made in response to OMB recommendations have been documented in the docket . The EPA prepared an analysis of the potential costs and benefits associat ed with this action. This analysis is contained in the document, Regulatory Impact Analysis for the O 3 NA AQS , November, 2014

. A copy of the analysis is available in the RIA docket (EPA

- HQ

- OAR

- 2013

- 0169 ) and the analysis is briefly summarized here. The RIA estimates the costs and monetized human health and welfare benefits Formatted: Subscript Formatted: Subscript Formatted: Subscript*** E.O. 12866 Review

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Page 574 of 668 of attaining four alternative O 3 NAAQS nationwide. Specifically, the RIA examines the alternatives of 60 ppb, 65 ppb, 70 ppb, and 75 ppb. The RIA contains illustrative analys es that consider a limited number of emissions control scenarios that states and Regional Planning Organizations might implement to achieve these alternative O 3 NAAQS. However, the CAA and judicial decisions make clear that the economic and technical feasi bility of attaining ambient standards are not to be considered in setting or revising NAAQS, although such factors may be considered in the development of s tate plans to implement the standards. Accordingly, although an RIA has been prepared, the results o f the RIA have not been considered in issuing this proposed rule.
A . National Technology Transfer and Advancement Act Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law No. 104

- 113, §12(d) (15 U.S.C. 272 note) directs the EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. V oluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs the EPA to provide Con gress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards. This proposed rulemaking involves environmental monitoring and measurement

c onsistent with the Agency’s Performance Based Measuremen t System (PBMS) . The EPA
propose s not to require the use of specific, prescribed analytical methods. Rather, the Agency plans to allow the use of any method that meets the pr escribed performance criteria. Ambient air concentrations of ozone are currently m easured by the Federal reference method (FRM) in 40 CFR part 50, Appendix D (Measurement Principle and Calibration Procedure for the*** E.O. 12866 Review

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Page 575 of 668 Measurement of Ozone in the Atmosphere) or by Federal equivalent methods (FEM) that meet the requirements of 40 CFR part 53

. Procedures are available in part 53 that allow for the approval of an FEM for O 3 that is similar to the FRM. Any method that meets the performance criteria for a candidate equivalent method may be approved for use as an FEM. This approach is consistent w ith EPA’s PBMS. The PBMS approach is intended to be more flexible and cost

effective for the regulated community; it is also intended to encourage innovation in analytical technol ogy and improved data quality. The EPA is not precluding the use of any metho d, whether it constitutes a voluntary consensus standard or not, as long as it meets the specified performance criteria.
B

. Paperwork Reduction Act The information collection requirements in this proposed rule have been submitted for approval to the Offic e of Management and Budget (OMB) under the Paperwork Reduction Act , 44 U.S.C. 3501 et seq. ( PRA )

. The Information Collection Request (ICR) document prepared by EPA has been assigned EPA ICR No. XXXX

. # 2313.03 . You can find a copy of the ICR in the docket for this rule, and it is briefly summarized here. The information collected and reported under 40 CFR part 58 is needed to determine compliance with the NAAQS, to characterize air quality and associated healt h and ecosystems impacts, to develop emission control strategies, and to measure progress for the ai r pollution
program. We are proposing to extend the length of the required O 3 monitoring season in 33 states and propose that the revised O 3 monitoring seas ons become effective on January 1 , 2017. We are also proposing revisions to the PAMS monitoring requirements that reduce the number of required PAMS sites while improving spatial coverage, and proposing to require states with O 3

non - attainment areas to dev elop an enhanced monitoring plan as part of the PAMS requirements.*** E.O. 12866 Review

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Page 576 of 668 For areas currently designated as nonattainment for O 3 based on the 2008 NAAQS, we propose that these areas comply with the PAMS requirements by June 1, 2017. For new areas designated based on a revised NAAQS, if finalized, we propose that those areas comply with the PAMS requirements by January 1, 2019. In addition, we are proposing to revise the O 3 FRM to establish a new, additional technique for measuring O 3 in the ambient air. We propose that it be incorporated into the existing O 3 FRM, using the same calibration procedure in Appendix D of 40 CFR part 50. We also propose to make changes to the procedures for testing performance characteristics and determining comparability between candidate FEMs and reference methods.
T he annual average reporting burden for the collection under 40 CFR part 58 (averaged over the first 3 years of this ICR) for XXX respondents is estimated to increase by a total of XX l abor hours per year with an incre ase of $XX per year For the purposes of ICR # 2313.03 , the burden figures represent the burden estimate based on the requirements contained in the proposed rule. The burden estimates are for the 3

- year period from 2015 through 2017. The implementation of the PAMS changes, if finalized, will occur beyond the time frame of this ICR with likely implementation dates between 2017 and 2019. The cost estimates for the PAMS network (including proposed revisions) will be captured in future routine updates to the Ambie nt Air Quality Surveillance ICR that are required every 3 years by OMB.

. Burden is defined at 5 CFR 1320.3(b ). State, local, and tribal entities are eligible for state assistance grants provided by the Federal government under the CAA which can be used fo r related activities. The proposal for a new FRM in 40 CFR part 50 and revisions to the O 3 FEM procedures for testing performance characteristics in 40 CFR part 53 does not add any additional information collection requirements.*** E.O. 12866 Review

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Page 577 of 668 The ICR burden estimates are associated with the proposed changes to the O 3 seasons. This information collection is estimated to involve 158 respondents for a total cost of approximately $24,115,182 (total capital, labor, and operation and maintenance) plus a total burden of 339,9 30 hours for the support of all operational aspects of the entire O 3 monitoring network. The labor costs associated with these hours are $19,813,692. Also included in the total are other costs of operations and maintenance of $2,210,132 and equipment and c ontract costs of $2,091,358. The actual labor cost increase to expand the O 3 monitoring seasons is $1,668,433. In addition to the costs at the state, local, and tribal air quality management agencies, there is a burden to EPA of 41,418 hours and $2,617,591

. Burden is defined at 5 CFR 1320.3(b ). State, local, and tribal entities are eligible for state assistance grants provided by the Federal government under the CAA which can be used for related activities. An agency may not conduct or sponsor, and a perso n is not required to respond to, a collection of information unless it displays a curre ntly valid OMB control number. The OMB control numbers for EPA’s regulations in 40 CFR are listed in 40 CFR part 9

. To comment on the Agency’s need for this informati on, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, EPA has established a public docket for this rule, which includes this ICR, under Docket ID number EPA

HQ

- OAR

- 2008

- 0699. Subm it any comments rela ted to the ICR to EPA and OMB . Send comments to the EPA at the air and Radiation Docket and Information Center Docket in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Ave. NW., Washington DC. The Docket Center Public Reading Room i s open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is (202) 566

- 1744, and the telephone number for the Air and Radiation Docket and Information Center*** E.O. 12866 Review

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Page 578 of 668 Docket is (202) 56

- 1742. An e lectronic version of the public docket is available at www.regulations.gov

. Send comments to OMB at the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washingto n, DC 20503, Attention: Desk Office for EPA. Since OMB is required to make a decision concerning the ICR between 30 and 60 days after [ Insert date of publication in the Federal Register.], I NSERT DATE OF PUBLICATION IN THE FEDERAL REGISTER ] , a comment to OMB is best assured of having its full effect if OMB receives it by [ Insert date I NSERT DATE 30 days after publ ication in the Federal Register DAYS AFTER PUBLICATION IN THE FEDERAL REGISTER ] . The final rule will respond to any OMB or public com ments on the information collection requirements contained in this proposal.
C

. Regulatory Flexibility Act The Regulatory Flexibility Act (RFA) generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small busine sses, small organizations, and small governmental jurisdictions. For purposes of assessing the impacts of today’s proposed rule on small entities, small entity is defined as: (1) a small business that is a small industrial entity as defined by the Small
Bu siness Administration’s (SBA) regulations at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that i s any not

- for

- profit enterprise which is independently owned and operated and is not dominant in its field. Formatted: Font: Bold

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Page 579 of 668 After considering the economic impacts of today's proposed rule on small entities, I certify that this action will not have a significant economic i mpact on a substantial number of small entities

. under the Regulatory Flexibility Act ( RFA )

. The reason is that this proposed rule will not impose any requirements on small entities. Rather, this rule establishes national standards for allowable concentrations of O 3 in ambient air as required by section 109 of the
CAA

. See also American Trucking Associations v. EPA , 175 F. 3d at 1044

- 45 (NAAQS do not have significant impacts upon small entities because NAAQS themselves impose no regulations upon small entities). Similarly, the proposed revisions to 40 CFR part 58 address the requirements for states to collect information and report compliance with the NAAQS and will not impose any requirements on small entities. Similarly, the addition of a new FRM in 40 CFR part 50 and revisions to the FEM procedures for testing in 40 CFR part 53 will not impose any requirements on small entities.
D

. Unfunded Mandates Reform Act Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104

- 4 , establishes requirements for f ederal agencies to assess the effects of their regulatory actions on

s tate, local, and t ribal governme nts and the private sector. Under section 202 of the UMRA, the EPA generally must prepare a written statement, including a cost

- benefit analysis, for proposed and final rules with “f

ederal mandates” that may result in exp enditures to state, local, and t rib al governments, in the aggregate, or to the private sector, of $100 million or more in any 1 year. Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires the EPA to identify and consider a reaso nable number of regulatory alternatives and to adopt the least costly, most cost

- effective or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are Formatted: Font: Italic, No underline Formatted: No underline

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Page 580 of 668 inc onsistent with applicable law. Moreover, section 205 allows the EPA to adopt an alternative other than the least costly, most cost

- effective or least burdensome alternative if the Administrator publishes with the final rule an explanation why that alternative was not adopted. Before the EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, incl uding t ribal governments, it must have developed under section 203 of the UMRA a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of the EPA regulat ory proposals with significant f ederal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements. Today’s proposed rule contains no f ederal mandates (under the regulatory provision s of Title II of the UMRA) for state, local, or t ribal gov ernments or the private sector. The proposed rule imposes no new expendit ure or enforceable duty on any state, local or t ribal governments or the private sector, and the EPA has determined that this proposed rule contains no regulatory requirements that might significantly or uniquely a ffect small governments. This action does not contain any unfunded mandate as described in the Unfunded Mandates Reform Act ( UMRA ) , 2 U. S. C. 1531

– 1538, and does not significantly or uniquely affect small governments. Furthermore, as indicated previously , in setting a NAAQS the EPA cannot consider the economic or technological feasibility of attaining ambient air quality standards, although such factors may be considered to a degree in the development of s tate plans to implement the standards. See also Am erican Trucking Associations v. EPA , 175 F. 3d at 1043 (noting that because the EPA is precluded from considering costs of implementation in establishing NAAQS, preparation of a Regulatory Impact Analysis (RIA) pursuant to the Unfunded Mandates Reform Formatted: Font: Italic, No underline*** E.O. 12866 Review

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Page 581 of 668 Act would not furnish any information which the court could consider in reviewing the NAAQS).
Th e proposed revisions to 40 CFR part 58 do not contain a Federal mandate that may result in expenditures of $100 million or more for state, local, and tribal govern ments, in the aggregate, or the private sector in any o ne year. The addition of a new FRM in 40 CFR part 50 and revisions to the FEM procedures for testing performance in 40 CFR part 53 will not result in associated cost because it does not add any new req uirements or require state, local, tribal governments to change or add monitoring methods. Accordingly, the EPA has determined that the provisions of sections 202, 203, and 205 of the UMRA do not apply to this propos al

. The EPA acknowledges, however, that any corresponding revisions to associated SIP requirements, 40 CFR part 51, might result in such effects. Accordingly, EPA will address, as appropriate, unfunded mandates if and when it proposes any revisions to 40 CFR parts 51.
E

. Executive Order 12866: Regulatory Planning and Review 13132: Federalism This action does not have federalism implications. It will not have sub stantial direct effects on the s tates, on the relationship between the national government and the s tates, or on the distributio n of power and responsibilities among the various levels of government.
F

. Executive Order 13175: Consultation and Coordination with Indian Tribal Governments This action does not have tribal implications, as specified in Executive Order 13175. It does no t have a substantial direct effect on one or more Indian Tribes as tribes are not obligated to adopt or implement any NAAQS. In addition, tribes are not obligated to conduct ambient monitoring for O 3 or to adopt the ambient monitoring requirements of 40 CFR part 58. Thus, Executive Order 13175 does not apply to this rule. Formatted: Font: Not Bold, Italic Formatted: Font: Not Italic*** E.O. 12866 Review

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Page 582 of 668 The EPA specifically solicits comment on this rule from tribal officials. Prior to finalization of this proposal, the EPA intends to conduct outreach consistent with the EPA Policy on Consultation and Coordination with Indian Tribes. Outreach to tribal environmental professionals will be conducted through participation in the Tribal Air call, which is sponsored by the National Tribal Air Association. In addition, the EPA intends to offer formal consultation to the tribes during the public comment period. If consultation is requested, a summary of the result of that consultation will be presented in the notice of final rulemaking and w ill be available in the docket.
G

. Executive Order 13045: Protection of Children from Environmental Health & Safety Risks Under section 3(f)(1) of Executive Order (EO) 12866 (58 FR 51735, October 4, 1993), the O 3 NAAQS action is an “economically significan t regulatory action” because it is likely to have an annual effect on the economy of $100 million or more. Accordingly, the EPA submitted this action to the Office of Management and Budget (OMB) for review under EO 12866 and any changes made in response to OMB recommendations have been documented in the docket for this action. In addition, the EPA prepared this RIA of the potential costs and benefits associated with this action. This analysis is contained in the document, Regulatory Impact Analysis for the
O 3 NA AQS , Month, 2014

. A copy of the analysis is available in the RIA docket (EPA

- HQ

OAR

- 2013

- 0169 ) and the analysis is briefly summarized here. The RIA estimates the costs and monetized human health and welfare benefits of attaining four alternative O 3 NA AQS nationwide. Specifically, the RIA examines the alternatives of 60 ppb, 65 ppb, 70 ppb, and 75 ppb. The RIA contains illustrative analyses that consider a limited number of emissions control scenarios that states and Regional Planning Organizations migh t implement to achieve these alternative O 3 NAAQS. However, the CAA and judicial decisions make clear that the economic*** E.O. 12866 Review

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Page 583 of 668 and technical feasibility of attaining ambient standards are not to be considered in setting or revising NAAQS, although such factors ma y be considered in the development of s tate plans to implement the standards. Accordingly, although an RIA has been prepared, the results of the RIA have not been considered in issuing this proposed rule.
F

. Executive Order 12898: Federal Actions to Address Environmental Justice in Minority Populations and Low

- Income Populations Executive Order 12898 (59 FR 7629 (Feb. 16, 1994)) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of th eir mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low

income populations in the United States. The EPA has determined that this proposed rule will not have disproportionately high and adverse human health or environmental effects on minority or low

- income populations because it increases the level of environmental protection for all affected populations without having any disproportionately high and adverse human health or environmental effects on any population, including any minority or low

- income population. The proposed rule , if finalized, will establish uniform national standards for O 3 air polluti on. G

. Executive Order 13045: Protection of Children from Environmental Health & Safety Risks Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997) applies to any rule that: (1) is d etermined to be “economically significant” as defined under Executive Order 12866, and (2) concerns an environmental health or safety risk that the EPA has reason to believe may have a*** E.O. 12866 Review

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Page 584 of 668 disproportionate effect on children. If the regulatory action meets bot h criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agen cy. This proposed rule This action is subject to Executi ve Order 13045 because it is an economically significant regulatory action as defined by Executive Order 12866, and we believe the EPA believe s that the environmental health risk addressed by this actio n may have a disproportionate effect on children. The proposed rule will establish uniform national ambient air quality standards for O 3 ; these standards are designed to protect public health with an adequate margin of safety, as required by CAA section 109. However, the protection offered by these standards may be especially important for children because children, especially children wit h asthma, along with other at

- risk population s 314 such as all people with lung disease and people active outdoors, are potentially susceptible to health effects resulting from O 3 exposure. Because children are considered a n at

- risk lifestage , we have careful ly evaluated the environmental health effects of exposure to O 3 pollution among children. Discussions of the results of the evaluation of the scientific evidence, policy considerations, and the exposure and risk assessments pertaining to children are conta ined in sections II.B and II.C of this preamble

. H. Executive Order 13132: Federalism Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure “meaningful and timely input by s tate and local officials in the development of regulatory policies that have federalism implications.” “Policies

314 As used here and similarly throughout this document, the term population refers to p eople having a quality or characteristic in common, including a specific pre

- existing illness or a specific age or life s tage.*** E.O. 12866 Review

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Page 585 of 668 that have f

ederalism implications” are defined in the Executive Order to include regulations that have “sub stantial direct effects on the s tat es, on the relationship between the national government and the s tates, or on the distribution of power and responsibilities among the various levels of government.” This proposed rule does not have federalism implications. It will not have sub stantial d irect effects on the s tates, on the relationship between the national government and the s tates, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. The rule does not alter the relationship between the f ederal government and the s tates regarding the establishment and implementation of air quality improvement programs as codified in the CAA. Under section 109 of the CAA, the EPA is mandated to establish NAAQS; however, CAA section 116 preserves the rights of s tates to establish more stringent requirements if deemed necessary by a s tate. Furthermore, this proposed rule does not impact CAA section 107 which establishes that the s tates have primary responsibility for implementation of the NAAQS. Finally, as noted in section E (above) on UMRA, this rule does n ot impose significant costs on s tate, local, or t ribal governments or the private sector. Thus, Executive Order 13132 does n ot apply to this rule. However, as also noted in section D (above) on UMRA, EPA recognizes that s tates will have a substantial interest in this rule and any corresponding revisions to associated SIP requirements and air quality surveillance requirements, 4 0 CFR part 51 and 40 CFR part 58, respectively. Therefore, in the spirit of Executive Order 13132, and consistent with the EPA policy to promote communications between the EPA and s tate and local governments, the EPA specifically solicits comment on this p roposed rule from s tate and local officials.
I

. Executive Order 13175: Consultation and Coordination with Indian Tribal Governments*** E.O. 12866 Review

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Page 586 of 668 Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 200 0), requires the EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” This rule concerns the establishment of O 3 NAAQS , establishes an add itional FRM, revises FEM procedures for testing, and revises air quality surveillance requirements . T he Tribal Authority Rule gives t ribes the opportunity to develop and implement CAA programs such as the O 3 NAAQS, but it leaves to the discretion of the t r ibe whether to develop these programs and which programs, or appropriate elements of a program, they will adopt. This proposed rule does not have t ribal implications, as specified in Executive Order 13175. It does not have a substantial direct effect on on e or more Indian Tribes, since t ribes are not obligated to adopt or implement any NAAQS. In addition, tribes are not obligated to conduct ambient monitoring for O 3 or to adopt the ambient monitoring requirements of 40 CFR part 58. Thus, Executive Order 13175 does not apply to this rule. Although Executive Order 13175 does not apply to this rule, the EPA contacted tribal environmental professionals during the develop ment of the this proposal. The EPA staff participated in the regularly scheduled Tribal Air call sponsored by the National Tribal Air Association during the [ season ] of 2014 as the proposal was under development. The EPA specifically solicits additional co mm ent on this proposed rule from t ribal officials.
J H

. Executive Order 13211: Actions that Significantly Affect Energy Supply, Distribution , or Use This proposed rule action is not a “significant energy action” as defined in Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or U se” (66 FR 28355 (May 22, 2001)) because in the Agency’s judgment it is not Formatted: Indent: First line: 0.5"*** E.O. 12866 Review

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Page 587 of 668 likely to have a significant adverse effect on the supply, distribution, or use of energy. The
pur pose of this rule is to establish revised NAAQS for O 3 , establish an additional FRM, revise FEM procedures for testing, and revises air quality surveillance requirements . The rule does not prescribe specific pollution control strategies by which these ambi ent standards and monitoring revisions will be met. Such strategies will be developed by s tates on a case

- by

- case basis, and the EPA cannot predict whether the control options selected by s tates will include regulations on energy suppliers, distributors, o r users. Thus, the EPA concludes that this rule is not likely to have any adverse energy effects and does not constitute a significant energy action as defined in Executive Order 13211.
I. National Technology Transfer and Advancement Act This rulemaking i nvolves environmental monitoring and measurement . Consistent with the Agency’s Performance Based Measurement System (PBMS) , the EPA propose s not to require the use of specific, prescribed analytical methods. Rather, the Agency plans to allow the use of any method that meets the pr escribed performance criteria. Ambient air concentrations of ozone are currently measured by the Federal reference method (FRM) in 40 CFR part 50, Appendix D (Measurement Principle and Calibration Procedure for the Measurement of Ozone in the Atmosphere) or by Federal equivalent methods (FEM) that meet the requirements of 40 CFR part 53. Procedures are available in part 53 that allow for the approval of an FEM for O 3 that is similar to the FRM. Any method that meets the performance criteria for a candidate equivalent method may be approv ed for use as an FEM. This approach is consistent with EPA’s PBMS. The PBMS approach is intended to be more flexible and cost

- effective for the regulated community; it is also intended to encourage innovation in analytical technol ogy and improved*** E.O. 12866 Review

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Page 588 of 668 data qual ity. The EPA is not precluding the use of any method, whether it constitutes a voluntary consensus standard or not, as long as it meets the specified performance criteria.
J

. Executive Order 12898: Federal Actions to Address Environmental Justice in Minori ty Populations and Low

- Income Populations The EPA believes the human health or environmental risk addressed by this action will not have potential disproportionately high and adverse human health or environmental effects on minority, low

- income or indigenous populations because it does not affect the level of protection provided to human health or the environment. This action proposes the strengthening of the O 3 NAAQS

. If the proposed revisions are finalized, the revised O 3 NAAQS will increase publi c health protection. Analyses evaluating the potential implications of a revised O 3 NAAQS for environmental justice populations are discussed in appendix 9A of the Regulatory Impact Analysis (RIA) that accompanies this notice of proposed rulemaking. The RI A is available on the Web, through the EPA’s Technology Transfer Network website at http://www.epa.gov/ttn/naaqs/standards/ozone/s_o3_index.html

. References Abt Associates, Inc. (1995). Ozone NAAQS benefits analysis: California crops. Report to U.S. EPA, July

. Adams, W. C. (2006 ) )

. Comparison of chamber 6.6 hour exposures to 0.04

- 0.08 ppm ozone via square - wave and triangular profiles on pulmonary responses. Inhalation Toxicol. 18: 127

- 136. http://dx.doi.org/10.1080/08958370500306107

. Adams, WC. (2003). Comparison of chamber and face mask 6.6

- hour exposure to 0.08 ppm ozone via square

- wave and triangular profiles on pulmonary responses. Inhal Toxicol 15: 265

- 281. Adams, WC. (2002). Comparison of chamber and face

- mask 6.6

- hour exposures to ozone on pulmonary function and symptoms responses. Inhal Toxicol 14: 745

- 764. http://dx.doi.org/10.1080/08958370290084610

. Adams, P. F.; Hendershot, G. E.; Marano, M. A. (1999 ) )

. Current estimates from the National Health Interview Survey, 1996. Hyat tsville, MD: U.S. Department of Health and Human*** E.O. 12866 Review

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Page 589 of 668 Services, Public Health Service, National Center for Health Statistics; DHHS publication no. (PHS) 99

- 1528. (Vital and health statistics: v. 10, data from the National Health Survey, no. 200). Available: htt p://www.cdc.gov/nchs/products/pubs/pubd/series/sr10/pre

- 200/pre

- 200.htm [12 March, 2001]. Adamson, I; Prieditis, H. (1995). Response of mouse lung to carbon deposition during injury and repair. Environmental Health Perspectives. 103: 1: 72

- 76

. Akbari, H. (2002 ) )

. Shade trees reduce building energy use and CO 2 emissions from power plants. Environmental Pollution 116 (2002) S119

– S126 Alexeeff, SE; Litonjua, AA; Suh, H; Sparrow, D; Vokonas, PS; Schwartz, J. (2007). Ozone exposure and lung function: Effect modified by obesity and airways hyperresponsiveness in the VA Normative Aging Study. Chest 132: 1890

- 1897. http://dx.doi.org/10.1378/chest.07

- 1126 Alexis, NE; Lay, JC; Hazucha, M; Harris, B; Hernandez, ML; Bromberg, PA; Kehrl, H; Diaz

Sanchez, D; Kim, C; D evlin, RB; Peden, DB. (2010). Low

- level ozone exposure induces airways inflammation and modifies cell surface phenotypes in healthy humans. Inhal Toxicol 22: 593

- 600. Alexis, N; Urch, B; Tarlo, S; Corey, P; Pengelly, D; O'Byrne, P; Silverman, F. (2000). Cy clooxygenase metabolites play a different role in ozone

- induced pulmonary function decline in asthmatics compared to normals. Inhal Toxicol 12: 1205

- 1224. Andersen, CP; Wilson, R; Plocher, M; Hogsett, WE. (1997). Carry

- over effects of ozone on root growth and carbohydrate concentrations of ponderosa pine seedlings. Tree Physiol 17: 805

- 811. ATS (American Thoracic Society). (2000). What constitutes an adverse health effect of air pollution? Am. J. Respir. Crit. Care Med. 161: 665

- 673. ATS (American Thoracic Society). (1991). Lung function testing: selection of reference values and interpretive strategies. Am. Rev. Respir. Dis. 144: 1202

- 1218. ATS (American Thoracic Society). (1985 ) )

. Guidelines as to what constitutes an adverse respiratory health effect, with special reference to epidemiological studies of air pollution. Am. Rev. Respir. Dis. 131: 666

- 668. Avol, EL; Trim, SC; Little, DE; Spier, CE; Smith, MN; Peng, RC; Linn, WS; Hackn ey, JD; Gross, KB; D'Arcy, JB; Gibbons, D; Higgins, ITT. (1990). Ozone exposure and lung function in children attending a southern California summer camp. In Proceedings of the 83rd A&WMA Annual Meeting. Pittsburgh, PA: Air & Waste Management Association. Balmes, JR; Chen, LL; Scannell, C; Tager, I; Christian, D; Hearne, PQ; Kelly, T; Aris, RM. (1996). Ozoneinduced decrements in FEV1 and FVC do not correlate with measures of inflammation. Am J Respir Crit Care Med 153: 904

- 909. Formatted: Subscript*** E.O. 12866 Review

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Page 590 of 668 Barraza

- Villarreal, A; Sunyer , J; Hernandez

- Cadena, L; Escamilla

- Nunez, MC; Sienra

- Monge, JJ; Ramirez

- Aguilar, M; Cortez

- Lugo, M; Holguin, F; Diaz

- Sanchez, D; Olin, AC; Romieu, I. (2008). Air pollution, airway inflammation, and lung function in a cohort study of Mexico City schoolchil dren. Environ Health Perspect 116: 832

- 838. http://dx.doi.org/10.1289/ehp.10926

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. Wong, CM; Yang, L; Thach, TQ; Chau, PY; Chan , KP; Thomas, GN; Lam, TH; Wong, TW; Hedley, AJ; Peiris, JS. (2009). Modification by influenza on health effects of air pollution in Hong Kong. Environ Health Perspect 117: 248

- 253. http://dx.doi.org/10.1289/ehp.11605

. Woodwell, D. A.; Cherry, D. K. (2004 ) )

. National Ambulatory Medical Care Survey: 2002 summary. Hyattsville, MD: National Center for Health Statistics; DHHS publication no. (PHS) 2004

- 1250. (Advance data from vital and health statistics; no. 346). Available: http://www.cdc.gov/nchs/data/ad/ad3 46.pdf [3 August, 2005 ] ]

. Xia, Y; Tong, H. (2006). Cumulative effects of air pollution on public health. Stat Med 25: 3548

- 3559. http://dx.doi.org/10.1002/sim.2446

. Zanobetti, A; Schwartz, J. (2011). Ozone and survival in four cohorts with potentially predisposing diseases. Am J Respir Crit Care Med 184: 836

- 841. http://dx.doi.org/10.1164/rccm.201102

- 0227OC

. Zanobetti, A; Schwartz, J. (2008a). Is there adaptation in the ozone mortality relationship: A multi

- city case

- crossover analysis. Environ Health 7: 22. http://dx.doi.org/10.1186/1476

- 069X

- 7

- 22

. Zanobetti, A; Schwartz, J. (2008b). Mortality displacement in the association of ozone with mortality: An analysis of 48 cities in the United States. Am J Respir Crit Care Med 177: 184

- 189. http://dx.doi.o rg/10.1164/rccm.200706

- 823OC

. Zanobetti, A; Schwartz, J. (2006). Air pollution and emergency admissions in Boston, MA. J Epidemiol Community Health 60: 890

- 895. http://dx.doi.org/10.1136/jech.2005.039 834 http://dx.doi.org/10.1136/jech.2005.039834

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Page 617 of 668*** E.O. 12866 Review

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Page 618 of 668 Page X 5 81 of Y 6 25

– O 3 NAAQS Proposed Rule List of Subjects 40 CFR Part 50 Environmental protection, Air pollution control, Carbon monoxide, Lead, Nitrogen dioxide, Ozone, Particulate matter, Sulfur oxides. 40 CFR Part 51 Environmental protecti on, Administrative practices and procedures, Air pollution control, Intergovernmental relations. 40 CFR Part 52 Environmental Protection, Administrative practices and procedures, Air pollution control, Incorporation by reference, Intergovernmental relations. 40 CFR Part 53 [to be filled in] 40 CFR Part 58 Environmental protection, Administrative practice and proced ure, Air pollution control, Intergovernmental relations, Reporting and recordkeeping requirements

________________________________ Dated:

_________________________________ Gina McCarthy , Administrator

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Page 619 of 668 For the reasons set forth in the preamble, chapter I of title 40 of the Code of Federal Regulations is proposed to be amended as follows:

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Page 620 of 668 PART 50

– NATIONAL PRIMARY AND SECONDARY AMBIENT AIR QUALITY STANDARDS 1. The authority citation for part 50 continues to read as follows: Authority: 42 U.S.C. 7401 et seq

. 2. The language in Amend §50.14 by: a. Revising paragraphs (c)(2)( iii ) and (c)(2)(vi ) is ); b. Removing and reserving paragraphs (c)(2)(iv) and (c)(2)(v); c. Revising paragraph (c)(2)(vi), Table 1 heading and its entries; d. Revising paragraph (c)(3)(i); and e. Removing and reserving paragraphs (c)(3)(ii) and (c)(3)(iii);
2. 3

. The revised to read text reads as follows and Table 2 is inserted. : § 50. 14 Treatment of air quality monitoring data influenced by exceptional events.
* * * * * (c) *** (2) *** (iii) Flags placed on data as being due to an exceptional event together with an initial description of the event shall be submitted to EPA not later th an July 1 st of the calendar year following the year in which the flagged measurement occurred, except as allowed under paragraph (c)(2)( vi) of this section. (iv) [Reserved] (v) [Reserved]
* * * * * (vi) Table 1 identifies the data submission process for new or revised NAAQS , beginning with the 2015 Ozone NAAQS

. Th is process shall apply to those data that will or may influence the Formatted: Underline

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Page 621 of 668 initial designation of areas for any new or revised NAAQS. W hen EPA sets a NAAQS for a new pollutant or revises the NAAQS for an existing pollutant, it may revise or set a new schedule for flagging exceptional event data, providing initial data descriptions and providing detailed data documentation in AQS for the initial designations of areas for those NAAQS.

Table 1 . Schedu le for Exceptional Event Flagging and Documentation Submission for Data to be Used in Initial Area Designations Exceptional Event / Regulatory

Action Exceptional Event Deadline Schedule d

Exceptional event data flagging and initial description deadline for data years 1, 2 and 3 a 3. a If state and tribal recommendations for the new/revised NAAQS are due August through January, then the flagging and initial description deadline will be the Jul y 1 prior to the recommendation deadline. If state and tribal recommendations for the new/revised NAAQS are due February through July, then the flagging and initial description deadline will be the January 1 prior to the recommendation deadline

. Excepti onal event demonstration submittal deadline for data years 1, 2 and 3 a 3. a No later than the date that state and tribal recommendations are due to EPA

.

Exceptional event data flagging, initial description, and exceptional event demonstration submittal deadline for data year 4 b and potential data year 5 c 5. c By the last day of the month that is 1 year and 7 months after promulgation of a new or revised NAAQS, unless either option a or b applies. a. If the EPA follows a 3

- year designation schedule, the deadline is 2 years and 7 months after promulgation of a new or revised NAAQS. b. I f the EPA notifies the state/tribe via Federal Register notice, letter or guidance that it intends to complete the initial area designations process according to a schedule oth er than a 2

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Page 622 of 668

of specified for final designations decisions in such EPA notification

.

a Where data years 1, 2, and 3 are those years expected to be considered in state and tribal recommendations

. b Where b Where data year 4 is the additional year of data that the EPA may consider when it makes final area designations for the new/revised NAAQS under a 2

- year designations schedule

. c Where c Where data year 5 is the additional year of data that the EPA may consider when it makes final area designations for the new/revised NAAQS under an extended designations schedule. d The d The date by which air agencies must certify their ambient air quality moni toring data in AQS is annually on May 1 of the year following the year of data collection. The EPA cannot require air agencies to certify data prior to this date. In some cases, however, air agencies may choose to certify a prior year's data in advance of May 1 of the following year, particularly if the EPA has indicated its intent to promulgate final designations in the months of May, June, July or August. Exceptional event flagging, initial description, and demonstration deadlines for "early certified" da ta will follow the deadlines for "year 4" and “year 5” data.
(3 ) Submission of demonstrations

. (i) Except as allowed under paragraph (c)(2)(vi) of this section, a State that has flagged data as being due to an exceptional event and is requesting exclusion of the affected measurement data shall, after notice and opportunity for public comment, submit a demonstration to justify data exclusion to EPA not later than th e lesser of, 3 years following the end of the calendar quarter in which the flagged concentration was recorded or, 12 months prior to the date that a regulatory decision must be made by EPA. A State must submit the public comments it received along with it s demonstration to
EPA

. (ii) [Reserved] (iii) [Reserved]

***** 3 . Section 50. 19 is added to read as follows: Formatted: Normal, Indent: Left: 0", Hanging: 0.5", No widow/orphan control, Tab stops: 0", Left + 0.5", Left + 1", Left + 1.5", Left + 2", Left + 2.5", Left + 3", Left + 3.5", Left + 4", Left + 4.5", Left + 5", Left + 5.5", Left + 6", Left*** E.O. 12866 Review

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Page 623 of 668 § 50. 19 National primary and secondary ambient air quality standards for ozone. (a) The level of the national 8

- hour primary ambient air quality standard for ozone (O 3 ) is (0.065

- 0.070 ) parts per million (ppm), daily maximum 8

- hour average, measured by a reference method based on appendix D to this part and designated in accordance with part 53 of this chapter or an equivalent method designated in accordance with part 53 of this chapter. (b) The 8

- hour primary O 3 ambient air quality standard is met at an ambient air quality monitoring site when the 3

- year average of the annual fourth

- highest daily maximum 8

- hour average O 3 concentration is less tha n or equal to (0.065

- 0.070 ) ppm, as determined in accordance with appendix U to this part. (c) The level of the national secondary ambient air quality standard for O 3 is (0.065

- 0.070 ) ppm , daily maximum 8

- hour average, measured by a reference method based on appendix D to this part and designated in accordance with part 53 of this chapter or an equivalent method designated in accordance with part 53 of this chapter. (d) The 8

- hour secondary O 3 ambient air quality standard is met at an ambient air quality

mo nitoring site when the 3

- year average of the annual fourth

- highest daily maximum 8

- hour average O 3 concentration is less than or equal to (0.065

- 0.070 ) ppm, as determined in accordance with appendix U to this part.

***** The EPA proposes to revise 4

. Revise Appendix D to part 50 of this chapter under Subchapter C to read as follows:
A PPENDIX D TO P ART 50

— R EFERENCE M EASUREMENT P RINCIPLE AND C ALIBRATION P ROCEDURE FOR THE M EASUREMENT OF O ZONE IN THE A TMOSPHERE (C HEMILUMINESCENCE M ETHOD ) Formatted: Small caps Formatted: Centered*** E.O. 12866 Review

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Page 624 of 668 1.0 Applicability

. 1.1 This chemiluminescence method provides reference measurements of the concentration of ozone (O 3 ) in ambient air for determining compliance with the national primary and secondary ambient air quality standards for O 3 as specified in 40 CFR part 50. This
aut omated method is applicable to the measurement of ambient O 3 concentrations using continuous (real

- time) sampling and analysis. Additional quality assurance procedures and guidance are provided in 40 CFR part 58, appendix A, and in Reference 14.
2.0 Measur ement Principle

. 2.1 This reference method is based on continuous automated measurement of the
i ntensity of the characteristic chemiluminescence released by the gas phase reaction of O 3 in sampled air with either ethylene (C 2 H 4 ) or nitric oxide (NO) gas. A n ambient air sample stream and a specific flowing concentration of either C 2 H 4 (ET

- CL method) or NO (NO

- CL method) are mixed in a measurement cell, where the resulting chemiluminescence is quantitatively measured by a sensitive photo

- detector. References 8

- 11 describe the chemiluminescence measurement principle.
2.2 The measurement system is calibrated by referencing the instrumental chemiluminescence measurements to certified O 3 standard concentrations generated in a dynamic flow system and assayed by pho tometry to be traceable to a National Institute of Standards and Technology (NIST) standard reference photometer for O 3 (see Section 4, Calibration Procedure, below).
2.3 An analyzer implementing this measurement principle is shown schematically in Figure 1. Designs implementing this measurement principle must include : an appropriately designed mixing and measurement cell; a suitable quantitative photometric measurement system Formatted: Underline

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Page 625 of 668 with adequate sensitivity and wave length specificity for O 3 ; a pump, flow contro l, and sample conditioning system for sampling and drying the ambient air and moving it into and through the measurement cell; a means to supply, meter, and mix a constant, flowing stream of either C 2 H 4 or NO gas of fixed concentration with the sample air flow in the measurement cell; suitable electronic control and measurement processing capability; and other associated apparatus as may be necessary. The analyzer must be designed and constructed to provide accurate, repeatable, and continuous measurements of O 3 concentrations in ambient air, with measurement performance that meets the requirements specified in subpart B of part 53 of this chapter.
2.4 An analyzer implementing this measurement principle and calibration procedure will be considered a federal reference method (FRM) only if it has been designated as a reference method in accordance with part 53 of this chapter

. 2.5 Sampling considerations

. The use of a particle filter on the sample inlet line of a chemiluminescence O 3 FRM analyzer is required to prevent buildup of particulate matter in the measurement cell and inlet components. This filter must be changed weekly (or at least often as specified in the manufacturer’s operation/instruction manual) , and the sample inlet system used with the analyzer must be kept clean, to avoid loss of O 3 in the O 3 sample air prior to the concentration measurement.
3.0 Interferences

. 3.1 Except as described in 3.2 below , the chemiluminescence measurement system is inherently free of significant interferences from other pollutant substances that may be present in ambient air.
3.2 A small sensitivity to variations in the humidity of the sample air is minimized by a sample air dryer. Potential loss of O 3 in the inlet air filter and in the air sample handling Formatted: Underline

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Page 626 of 668 component s of the analyzer and associated exterior air sampling components due to buildup of airborne particulate matter is minimized by filter replacement and cleaning of the other inlet components. 4.0 Calibration Procedure

. 4.1 Principle. The calibration procedu re is based on the photometric assay of O 3 concentrations in a dynamic flow system. The concentration of O 3 in an absorption cell is determined from a measurement of the amount of 254 nm light absorbed by the sample. This determination requires knowledge o f (1) the absorption coefficient (α) of O 3 at 254 nm, (2) the optical path length ( l ) through the sample, (3) the transmittance of the sample at a nominal wavelength of 254 nm, and (4) the temperature (T) and pressure (P) of the sample. The transmittance i s defined as the ratio I/I 0 , where I is the intensity of light which passes through the cell and is sensed by the detector when the cell contains an O 3 sample, and I 0 is the intensity of light which passes through the cell and is sensed by the detector whe n 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 0 . The quantities defined above are related by the Beer

Lambert absorption law,
Transm itance = I I 0 = e − α cl (1)
where: α = absorption coefficient of O 3 at 254 nm = 308 ±4 atm−1 cm−1 at 0 °C and 760
torr, 1, 2, 3, 4, 5, 6, 7

c = O 3 concentration in atmospheres, and
l = optical path length in cm. Formatted: Underline

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Page 627 of 668 A stable O 3 generator is used to produc e O 3 concentrations over the required calibration concentration range

. Each O 3 concentration is determined from the measurement of the transmittance (I/I 0 ) of the sample at 254 nm with a photometer of path length l and calculated from the equation,

c ( atm ) = − 1

α l ( ln I I 0 ) (2a)

or

c ( ppm ) = − 10 6

α l ( ln I I 0 )

. (2b)
The calculated O 3 concentrations must be corrected for O 3 losses, which may occur in the photometer, and for the temperature and pressure of the sample.
4.2 Applicability

. This procedure is applicable to the calibration of ambient air
O 3 analyzers, either directly or by means of a transfer standard certified by this procedure

. Transfer standards must meet the requirements and specifications set forth in Reference 12.
4.3 Apparatus. A complete UV calibration system consists of an O 3 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 O 3 concentration at the system output and allow the photometer to a ccurately assay the output concentration to the precision specified for the photometer (4.3.1). Figure 2 shows a commonly used configuration and serves to illustrate the calibration procedure, which follows. Other configurations may require appropriate

var iations in the procedural steps. All connections between components in the calibration system downstream of the O 3 generator must be of glass, Teflon, or other relatively inert materials. Additional information regarding the assembly of a UV photometric ca libration apparatus is given in Reference 13. For certification of transfer standards which provide their own source of Formatted: Underline

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Page 628 of 668 O 3 , the transfer standard may replace the O 3 generator and possibly other components shown in Figure 2; see Reference 12 for guidance.
4 .3.1 UV photometer. The photometer consists of a low

- pressure mercury discharge lamp, (optional) collimation optics, an absorption cell, a detector, and signal

- processing electronics, as illustrated in Figure 2. It must be capable of measuring the transmit tance, I/I 0 , at a wavelength of 254 nm with sufficient precision such that the standard deviation of the concentration measurements does not exceed the greater of 0.005 ppm or 3% of the concentration. Because the low

- pressure mercury lamp radiates at sever al wavelengths, the photometer must incorporate suitable means to assure that no O 3 is generated in the cell by the lamp, and that at least 99.5% of the radiation sensed by the detector is 254 nm radiation. (This can be readily achieved by prudent selectio n of optical filter and detector response 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 3 from contact with cell walls and gas handling components. See Reference 13 for additional information.
4.3.2 Air flow controllers

. Air flow controllers are dev ices capable of regulating air flows as necessary to meet the output stability and photometer pr ecision requirements.
4.3.3 Ozone generator

. The ozone generator used must be capable of generating stable levels of O 3 over the required concentration range.
4.3.4 Output manifold

. The output manifold must be constructed of glass, Teflon, or other relativ ely inert material, and should be of sufficient diameter to insure a negligible pressure drop at the photometer connection and other output ports. The system must have a vent designed to Formatted: Underline

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Page 629 of 668 insure atmospheric pressure in the manifold and to prevent ambient ai r from entering the manifold. 4.3.5 Two

- way valve

. A m anual or automatic two

- way valve, or other means is used to switch the photometer flow between zero air and the O 3 concentration.
4.3.6 Temperature indicator

. A device to indicate temperature must be us ed that is

a ccurate to ±1 °C. 4.3.7 Barometer or pressure indicator

. A device to indicate barometric pressure must be used that is a ccurate to ±2 torr.
4.4 Reagents

. 4.4.1 Zero air

. The zero air must be free of contaminants which would cause a detectable

r esponse from the O 3 analyzer, and it must be free of NO, C 2 H 4 , and other species which react with O 3 . A procedure for generating suitable zero air is given in Reference 13. As shown in Figure 2, the zero air supplied to the photometer cell for the I 0 refer ence measurement must be derived from the same source as the zero air used for generation of the O 3 concentration to be assayed (I measurement). When using the photometer to certify a transfer standard having its own source of O 3 , see Reference 12 for guid ance on meeting this requirement. 4.5 Procedure

. 4.5.1 General operation

. The calibration photometer must be dedicated exclusively to use as a calibration standard. It must always be used with clean, filtered calibration gases, and never used for ambient a ir sampling. A number of advantages are realized by locating the calibration photometer in a clean laboratory where it can be stationary, protected from the physical shock of transportation , operated by a responsible analyst, and used as a common standard for all field calibrations via transfer standards. Formatted: Underline

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Page 630 of 668 4.5.2 Preparation

. Proper operation of the photometer is of critical importance to the accuracy of this procedure. Upon initial operation of the photometer, the following steps must be carried out 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 to be consistent with the documented stability of the photometer and the guidance provided in Reference 12

. 4.5.2.1 Instruction manual . C arry out all set up and adjustment procedures or checks as described in the operation or instruction man ual associated with the photometer. 4.5.2.2 System check . C heck the photometer system for integrity, leaks, cleanliness, proper flow rates, etc. Service or replace filters and zero air scrubbers or other consumable materials, as necessary. 4.5.2.3 Linearit y . 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 and assay an O 3 concentration near the upper range limit of the system or appropriate calibration scale for the instrument , then accurately dilute that concentration with zero air and re

assay it. Repeat at several different dilution ratios. Compare the assay of the original concentration with the assay of the diluted concent ration divided by the dilution ratio, as follows
E = A 1 − A 2 / R

A 1 × 100% (3)
where: E = linearity error, percent
A 1 = assay of the original concentration
A 2 = assay of the diluted concentration R = dilution ratio = flow of original concentration divided by the total flow Formatted: Underline

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Page 631 of 668 The linearity error must be less than 5%. Since the accuracy of the measured flow

- rates will affect the linearity error as measured this way, the test is not necessarily conclusive. Additional information on verifying linearity is contained in Reference 13. 4.5.2.4 Inter

- comparison . T he photometer must be inter

- compared annually , either directly or via transfer standards, with a NIST standard reference photometer (SRP) or calibration photometers used by other agencies or laboratories. 4.5.2. 5 Ozone losses

. Some portion of the O 3 may be lost upon contact with the photometer cell walls and gas handling components. The magnitude of this loss must be determined and used to correct the calculated O 3 concentration. This loss must not exceed 5%.
Som e guidelines for quantitatively determining this loss are discussed in Reference 13. 4.5.3 Assay of O 3 concentrations

. The operator must carry out the following steps to properly assay O 3 concentrations. 4.5.3.1 Allow the photometer system to warm up and s tabilize. 4.5.3.2 Verify that the flow rate through the photometer absorption cell, F, allows the cell to be flushed in a reasonably short period of time (2 liter/min is a typical flow). The precision of the measurements is inversely related to the time re quired for flushing, since the photometer drift error increases with time. 4.5.3.3 E nsure that the flow rate into the output manifold is at least 1 liter/min greater than the total flow rate required by the photometer and any other flow demand connected to the manifold. 4.5.3.4 E nsure that the flow rate of zero air, Fz, is at least 1 liter/min greater than the flow rate required by the photometer. Formatted: Underline

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Page 632 of 668 4.5.3.5 With zero air flowing in the output manifold, actuate the two

- way valve to allow the photometer to samp le first the manifold zero air, then Fz. The two photometer readings must be equal (I = I 0 ).
N OTE : In some commercially available photometers, the operation of the two

- way valve and various other operations in section 4.5.3 may be carried out automatically by the photometer. 4.5.3.6 Adjust the O 3 generator to produce an O 3 concentration as needed. 4.5.3.7 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 Io. 4.5.3.8 Actuate the two

- way valve to allow the photometer to sample the O 3 concentration until the absorption cell is thoroughly flushed and record the stable measured value of I. 4.5.3.9 Record the temperature and pressure of the sample in the phot ometer absorption cell. (See Reference 13 for guidance.) 4.5.3.10 Calculate the O 3 concentration from equation 4. An average of several determinations will provide better precision. [ O 3 ] OUT = (

− 1

α l ln I I 0 ) ( T 273 ) ( 760 P ) × 10 6

L (4)
where: [O 3 ] OUT = O 3 concentration, ppm α = absorption coefficient of O 3 at 254 nm = 308 atm−1 cm−1 at 0° C and 760 torr
l = optical path length, cm T = sample temperature, K P = sample pressure, torr L = correction factor for O 3 losses from 4.5.2.5 = (1−fraction of O 3 lost). Formatted: Small caps*** E.O. 12866 Review

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Page 633 of 668 N OTE : Some commercial photometers may automatically evaluate all or part of equation
4. It is the operator's responsibility to verify that all of the information required for equation 4 is obtained, either automatically by the photometer or manually. For “automatic” photometers which evaluate the first term of equation 4 based on a linear approximation, a manual correction may be required, particularly at higher O 3 levels. See the photometer instruction manual and Reference 13 for guidance. 4.5.3.11 Obtain additional O 3 concentration standards as necessary by repeating steps 4.5.3.6 to 4.5.3.10 or by Option 1. 4.5.4 Certification of transfer standards

. A transfer standard is certified by relating the output of the transfer standard to one or more O 3 calibration standar ds as determined according to section 4.5.3. The exact procedure varies depending on the nature and design of the transfer standard. Consult Reference 12 for guidance. 4.5.5 Calibration of ozone analyzers

. Ozone analyzers must be calibrated as follows, usi ng O 3 standards obtained directly according to section 4.5.3 or by means of a certified transfer standard. 4.5.5.1 Allow sufficient time for the O 3 analyzer and the photometer or transfer standard
to warm

- up and stabilize. 4.5.5.2 Allow the O 3 analyzer to sample zero air until a stable response is obtained and then adjust the O 3 analyzer's zero control. Offsetting the analyzer's zero adjustment to +5% of scale is recommended to facilitate observing negative zero drift (if any). Record the stable zero air re sponse as “Z”. Formatted: Small caps

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Page 634 of 668 4.5.5.3 Generate an O 3 concentration standard of approximately 80% of the desired upper range limit (URL) of the O 3 analyzer. Allow the O 3 analyzer to sample this O 3 concentration standard until a stable response is obtained. 4.5.5.4 Adjust the O 3 analyzer's span control to obtain the desired response equivalent to the calculated standard concentration. Record the O 3 concentration and the corresponding analyzer response. If substantial adjustment of the span control is necessary, recheck the zero and span adjustments by repeating steps 4.5.5.2 to 4.5.5.4. 4.5.5.5 Generate additional O 3 concentration standards (a minimum of 5 are recommended) over the calibration scale of the O 3 analyzer by adjusting the O 3 source or by Option 1. For each O 3 co ncentration standard, record the O 3 concentration and the corresponding analyzer response. 4.5.5.6 Plot the O 3 analyzer responses (vertical or Y

- axis) versus the corresponding
O 3 standard concentrations (horizontal or X

- axis). Compute the linear regression slope and intercept and plot the regression line to verify that no point deviates from this line by more than 2 percent of the maximum concentration tested. 4.5.5.7 Option 1 : The various O 3 concentrations required in steps 4.5.3.11 and 4.5.5.5 may be obta ined by dilution of the O 3 concentration generated in steps 4.5.3.6 and 4.5.5.3. With this option, accurate flow measurements are required. The dynamic calibration system may be modified as shown in Figure 3 to allow for dilution air to be metered in downs tream of the
O 3 generator. A mixing chamber between the O 3 generator and the output manifold is also required. The flow rate through the O 3 generator (Fo) and the dilution air flow rate (FD) are measured with a flow or volume standard that is traceable to a NIST flow or volume calibration standard

. Each O 3 concentration generated by dilution is calculated from: Formatted: Underline*** E.O. 12866 Review

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Page 635 of 668 [ O 3 ] ′ OUT = [ O 3 ] OUT ( F O F O + F D ) (5)
where: [O 3 ]′ OUT = diluted O 3 concentration, ppm
FO = flow rate through the O 3 generator, liter/min
FD = diluent air flow rate, liter/min
Note: Additional information on calibration and pollutant standards is provided in Section 12 of Reference 14. 5.0 Frequency of Calibration

. 5.1 The frequency of calibration, as well as the number of points necessary to establish the calibration curve, and the frequency of other performance checking will vary by analyzer; however, the minimum frequency, acceptance criteria, and subsequent actions are specified in Appendix D of Reference 14: Measurement Quality Objectives and Validation Templates. The user's quality control program shall provide guidelines for initial establishment of these variables and for subsequent alteration as operational experience is accumulated. Manufacturers of analyzers should include in their instruction/oper ation manuals information and guidance as to these variables and on other matters of operation, calibration, routine maintenance, and quality control.
6.0 References

. 1. E.C.Y. Inn and Y. Tanaka, “Absorption coefficient of Ozone in the Ultraviolet and
Vis ible Regions”, J. Opt. Soc. Am., 43, 870 (1953). 2. A. G. Hearn, “Absorption of Ozone in the Ultraviolet and Visible Regions of the Spectrum”, Proc. Phys. Soc. (London), 78, 932 (1961). Formatted: Underline

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Page 636 of 668 3. W. B. DeMore and O. Raper, “Hartley Band Extinction Coefficients of Ozone in the Gas Phase and in Liquid Nitrogen, Carbon Monoxide, and Argon”, J. Phys. Chem., 68, 412 (1964). 4. M. Griggs, “Absorption Coefficients of Ozone in the Ultraviolet and Visible Regions”, J. Chem. Phys., 49, 857 (1968). 5. K. H. Becker, U. Schura th, and H. Seitz, “Ozone Olefin Reactions in the Gas Phase. 1. Rate Constants and Activation Energies”, Int'l Jour. of Chem. Kinetics, VI, 725 (1974). 6. M. A. A. Clyne and J. A. Coxom, “Kinetic Studies of Oxy

- halogen Radical Systems”, Proc. Roy. Soc., A30 3, 207 (1968). 7. J. W. Simons, R. J. Paur, H. A. Webster, and E. J. Bair, “Ozone Ultraviolet Photolysis. VI. The Ultraviolet Spectrum”, J. Chem. Phys., 59, 1203 (1973). 8. Ollison, W.M.; Crow, W.; Spicer, C.W. “Field testing of new

- technology ambient air ozone monitors.” J. Air Waste Manage. Assoc., 63 (7), 855

- 863 (2013). 9. Parrish, D.D.; Fehsenfeld, F.C. “Methods for gas

- phase measurements of ozone, ozone precursors and aerosol precursors.” Atmos. Environ., 34 (12

- 14), 1921

- 1957(2000). 10. Ridley, B.A.; Grahek, F.E.; Walega, J.G. “A small, high

- sensitivity, medium

response ozone detector suitable for measurements from light aircraft.” J. Atmos. Oceanic Technol., 9 (2), 142

- 148(1992). 11. Boylan, P., Helmig, D., and Park, J.H. “Characterization and mitiga tion of water vapor effects in the measurement of ozone by chemiluminescence with nitric oxide.” Atmos. Meas. Tech. 7, 1231

- 1244 (2014). 12. Transfer Standards for Calibration of Ambient Air Monitoring Analyzers for Ozone, EPA publication number EPA

- 454/B

- 13

- 004, October 2013. EPA, Office of Air Quality*** E.O. 12866 Review

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Page 637 of 668 Planning and Standards, Research Triangle Park, NC 27711. [Available at www.epa.gov/ttnamti1/files/ambient/qaq c/OzoneTransferStandardGuidance.pdf .] 13. Technical Assistance Document for the Calibration of Ambient Ozone Monitors, EPA publication number EPA

- 600/4

- 79

- 057, September, 1979

. [ A vailable at www.epa.gov/ttnamti1/files/ambient/criteria/4

- 79

- 057.pdf .] 14. QA Handbook for Air Pollution Measurement Systems

— Volume II. Ambient Air Quality Monitoring Program. EPA

- 454/B

- 13

- 003, May 2013. [Available at http://www.epa.gov/ttnamti1/files/ambient/pm25/qa/QA

- Handbook

- Vol

- II.pdf .]*** E.O. 12866 Review

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Page 638 of 668 Figure 1. Gas

- phase chemiluminescence analyzer schematic diagram , where PMT means photomultiplier tube.*** E.O. 12866 Review

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Page 639 of 668 Formatted: Font: (Default) Arial, Font color: Black*** E.O. 12866 Review

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Page 640 of 668 Figure 2. Schematic diagram of a typical UV photometric calibration system. Formatted: Font color: Black*** E.O. 12866 Review

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Page 641 of 668*** E.O. 12866 Review

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Page 642 of 668 Figure 3. Schematic diagram of a typical UV photometric calibration system (Option 1). Appendix U to Part 50 is added to read as follows: Appendix U to Part 50
-- Interpretation of the P rimary and Secondary National Ambient Air Quality Standards for Ozone
1. General (a) This appendix explains the data handling conventions and computations necessary for determining whether the primary and secondary national ambient air quality standards (NAAQS) for ozone (O 3 ) specified in §50.19 are met at an ambient O 3 air quality monitoring site. Data reporting, data handling, and computation procedures to be used in making comparisons between Formatted: Font color: Black*** E.O. 12866 Review

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Page 643 of 668 reported O 3 concentrations and the levels of the O 3 NAAQS ar e specified in the following sections. (b) Whether to exclude , or retain , or make adjustments to the data affected by exceptional events , including wildfires, stratospheric O 3 intrusions, or other natural events, is determined by the requirements under §§5 0.1, 50.14 and 51.930. (c) The terms used in this appendix are defined as follows:
8

- hour average refers to the moving average of eight consecutive hourly O 3 concentrations measured at a site, as explained in section 3 of this appendix. Annual fourth

- highe st daily maximum refers to the fourth highest value measured at a site during a particular year. Collocated monitors refers to the instance of two or more O 3 monitors operating at the same site. Daily maximum 8

- hour average O 3 concentration refers to the m aximum calculated 8

- hour average value measured at a site on a particular day, as explained in section 3 of this appendix. Design value refers to the metric ( i.e. , statistic) that is used to compare ambient O 3 concentration data measured at a site to the N AAQS in order to determine compliance, as explained in section 4 of this appendix. Minimum data completeness requirements refer to the amount of data that a site is required to collect in order to make a valid determination that the site is meeting the NAA QS.
Monitor refers to a physical instrument used to measure ambient O 3 concentrations.
O 3 monitoring season refers to the span of time within a year when individual s tates are required to measure ambient O 3 concentrations, as listed in Appendix D to part 58 of this chapter.
Site refers to an ambient O 3 air quality monitoring site.*** E.O. 12866 Review

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Page 644 of 6 68 Site data record refers to the set of hourly O 3 concentration data collected at a site for use in comparisons with the NAAQS.
Yea r refers to calendar year.
2. Selection of Data for use in Comparisons with the Primary and Secondary Ozone NAAQS (a) All valid hourly O 3 concentration data collected using a federal reference method specified in Appendix D to this part, or an equivalent m ethod designated in accordance with part 53 of this chapter, meeting all applicable requirements in part 58 of this chapter, and submitted to EPA’s Air Quality System (AQS) database, or otherwise available to EPA, shall be used in design value calculations . Data not meeting these requirements shall not be used in design value calculations. (b ) All design value calculations shall be implemented on a site

- level basis. If data are reported to EPA from collocated monitors, those data shall be combined into a s ingle site data record as follows: (i) The monitoring agency may designate one monitor as the primary monitor for the site. If a primary monitor has not been designated by the monitoring agency, the monitor with the largest number of hourly O 3 concentratio ns reported for the year shall be designated as the primary monitor. (ii) Hourly O 3 concentration data from a collocated monitor shall be substituted into the site data record whenever a valid hourly O 3 concentration is not obtained from the primary monito r. In the event that hourly O 3 concentration data are available for two or more collocated monitors, the hourly concentration data for those monitors shall be averaged and substituted into the site data record. (c ) In certain circumstances, including but n ot limited to site closures or relocations, data from two nearby sites may be combined into a single site data record for the purpose of calculating a*** E.O. 12866 Review

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Page 645 of 668 valid design value. The appropriate Regional Administrator may approve such combinations after taking int o consideration factors such as distance between sites, spatial and temporal patterns in air quality, local emissions and meteorology, jurisdictional boundaries, and terrain features.
3. Data Reporting and Data Handling Conventions (a) Hourly average O 3 co ncentrations shall be reported in parts per million (ppm) to the third decimal place, with additional digits to the right of the third decimal place truncated. Each hour shall be identified using local standard time (LST). (b) Moving 8

- hour averages shall be computed from the hourly O 3 concentration data for each hour of the year and shall be stored in the first, or start, hour of the 8

- hour period. An 8

- hour average shall be considered valid if at least 6 of the hourly concentrations for the 8

- hour period are available. In the event that only 6 or 7 hourly concentrations are available, the 8

- hour average shall be computed on the basis of the hours available, using 6 or 7 as the divisor. In addition, in the event that 5 or fewer hourly concentrations are ava ilable, the 8

- hour average shall be considered valid if, after substituting zero for the missing hourly concentrations, the resulting 8

- hour average is greater than the level of the NAAQS. The 8

- hour averages shall be reported to three decimal places, with additional digits to the right of the third decimal place truncated. Hourly O 3 concentrations that have been approved under §50.14 as having been affected by exceptional events shall be counted as missing or unavailable in the calculation of 8

- hour
averag es. (c) The daily maximum 8

- hour average O 3 concentration for a given day is the highest of the 17 consecutive 8

- hour averages beginning with the 8

- hour period from 7:00 AM to 3:00 PM and ending with the 8

- hour period from 11:00 PM to 7:00 AM (i.e., the 8

- hour averages for 7:00 AM*** E.O. 12866 Review

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Page 646 of 668 to 11:00 PM). Daily maximum 8

- hour average O 3 concentrations shall be determined for each day with ambient O 3 monitoring data, including days outside the O 3 monitoring season if those data are available. (d) A daily maximum 8

- hour average O 3 concentration shall be considered valid if valid 8

- hour averages are available for at least 13 of the 17 consecutive 8

- hour periods starting from 7:00 AM to 11:00 PM. In addition, in the event that fewer than 13 valid 8

- hour averages are availa ble, a daily maximum 8

- hour average O 3 concentration shall also be considered valid if it is greater than the level of the NAAQS. Hourly O 3 concentrations that have been approved under §50.14 as having been affected by exceptional events shall be included when determining whether these criteria have been met. (e) The primary and secondary O 3 design value statistic is the annual fourth

- highest daily maximum 8

- hour O 3 concentration, averaged over three years, expressed in parts per million. The fourth

- highest daily maximum 8

- hour O 3 concentration for each year shall be determined based only on days meeting the validity criteria in 3(d). The 3

- year average shall be computed using the three most recent, consecutive years of ambient O 3 monitoring data. Design val ues shall be reported to three decimal places, with additional digits to the right of the third decimal place truncated.
4. Comparisons with the Primary and Secondary Ozone NAAQS (a) The primary and secondary national ambient air quality standards for O 3 a re met at an ambient air quality monitoring site when the 3

- year average of the annual fourth

- highest daily maximum 8

- hour average O 3 concentration (i.e., the design value) is less than or equal to (0.065

– 0.070) ppm.*** E.O. 12866 Review

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Page 647 of 668 (b) A design value greater than the l evel of the NAAQS is always considered to be valid. A design value less than or equal to the level of the NAAQS must meet minimum data completeness requirements in order to be considered valid. These requirements are met for a 3

- year period at a site if va lid daily maximum 8

- hour average O 3 concentrations are available for at least 90% of the days within the O 3 monitoring season, on average, for the 3

- year period, with a minimum of at least 75% of the days within the O 3 monitoring season in any one year. (c ) When computing whether the minimum data completeness requirements have been met, meteorological or ambient data may be sufficient to demonstrate that meteorological conditions on missing days were not conducive to concentrations above the level of the NA AQS. Missing days assumed less than the level of the NAAQS are counted for the purpose of meeting the minimum data completeness requirements, subject to the approval of the appropriate Regional Administrator. (d) Comparisons with the primary and secondary O 3 NAAQS are demonstrated by examples 1 and 2 as follows: Example 1: Site Meeting the Primary and Secondary O 3 NAAQS

Year Percent valid days within O 3 monitoring

season 1st highest

daily max 8

- hour O 3 (ppm) 2nd highest

daily max 8

- hour O 3 (ppm) 3rd highest

daily max 8

- hour O 3 (ppm) 4th highest

daily max 8

- hour O 3 (ppm) 5th highest

daily max 8

- hour O 3 (ppm)
2014 100 0.082 0.080 0.075 0.069 0.068
2015 96 0.074 0.073 0.065 0.062 0.060
2016 98 0.070 0.069 0.067 0.066 0.060 Average 98 0.065*** E.O. 12866 Review

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Page 648 of 668 As shown in Example 1, this site meets the primary and secondary O 3 NAAQS because the 3

- year average of the annual fourth

- highest daily maximum 8

- hour average O 3 concentrations ( i.e. , 0.065666 ppm, truncated to 0.065 ppm) is less than or equal to (0.065

– 0.070) ppm. The minimum data completeness requirements are also met because the average percent of days within the O 3 monitoring season with valid ambient monitoring data is greater than 90%, and no single year has less than 75% data completeness. Example 2: Site Fail ing to Meet the Primary and Secondary O 3 O 3 NAAQS

Year Percent valid days within O 3 monitoring

season 1st highest

daily max 8

- hour O 3 (ppm) 2nd highest

daily max 8

- hour O 3 (ppm) 3rd highest

daily max 8

- hour O 3 (ppm) 4th highest

daily max 8

- hour O 3 (ppm) 5th highest

daily max 8

- hour O 3 (ppm)
2014 96 0.085 0.080 0.079 0.074 0.072
2015 74 0.084 0.083 0.072 0.071 0.068
2016 98 0.083 0.081 0.081 0.075 0.074 Average 89 0.073 As shown in Example 2, this site fails to meet the primary and secondary O 3 NAAQS because the 3

- year average of the annual fourth

- highest daily maximum 8

- hour average O 3 concentrations ( i.e. , 0.073333 ppm, truncated to 0.073 ppm) is greater than (0.065

– 0.070) ppm, even though the annual data completeness is less than 75% in one year and the 3

- year average data completeness is less than 90%. PART 51

— REQUIREMENTS FOR PREPARATION, ADOPTION, AND SUBMITTAL OF IMPLEMENATION PLANS [XX]. 6

. The authority citation for part 51 continues to read as follows: Formatted: Not Superscript/ Subscript*** E.O. 12866 Review

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Page 649 of 668 Authority : 23 U.S.C. 101; 42 U.S.C. 7401

- 7671q. Subpart I

– [Amended]

– — Review of New Sources and Modifications [XX]. Section 7 Amend § 51.166 is amended by adding paragraph (i)(11) to read as follows: § 51.166 Prevention of significant deterioration of air quality . * * * * * (i) * * * (11) The plan may provide that the requirements of paragraph (k)(1) of this section shall not apply to a stationary source or modification with respect to the national ambient air quality standards for ozone in effect on [ INSERT EFFECTIVE DATE OF FI NAL RULE ] if: (i) The reviewing authority has determined a permit application subject to this section to be complete on or before [ INSERT SIGNATURE DATE OF FINAL RULE ]. Instead, the requirements in paragraph (k)(1) of this section shall apply with respect to t he national ambient air quality standards for ozone in effect at the time the reviewing authority determined the permit application to be complete; or (ii) The reviewing authority has first published before [ INSERT EFFECTIVE DATE OF
FINAL RULE ] a public no tice of a preliminary determination or draft permit for the permit application subject to this section. Instead, the requirements in paragraph (k)(1) of this section shall apply with respect to the national ambient air quality standards for ozone in effect at the time of first publication of a public notice on of the preliminary determination or draft permit

. * * * * * PART 52

—

APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS [XX]. 8

. The authority citation for part 52 continues to read as follows: Formatted: Font: Bold*** E.O. 12866 Review

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Page 650 of 668 Authority: 42 U.S.C. 7401 et seq
. [XX]. Section 9

. Amend § 52.21 is amended by adding paragraph (i)(12) to read as follows: § 52.21 Prevention of significant deterioration of air quality.
* * * * * (i) * * * (12) The requirements of paragraph (k)(1) of th is section shall not apply to a stationary source or modification with respect to the national ambient air quality standards for ozone in effect on [ INSERT EFFECTIVE DATE OF FI NAL RULE ] if: (i) The Administrator has determined a permit application subject to this section to be complete on or before [ INSERT SIGNATURE DATE OF FI NAL RULE ]. Instead, the requirements in paragraph (k)(1) of this section shall apply with respect to the national ambient air quality standards for ozone in effect at the time the Admi nistrator determined the permit application to be complete; or (ii) The Administrator has first published before [ INSERT EFFECTIVE E FFECTIVE DATE OF FINAL RULE ] a public notice that of a preliminary determination or draft permit subject to this section has been prepared . Instead, the requirements in paragraph (k)(1) of this section shall apply with respect to the national ambient air quality standards for ozone in effect on the date the Administrator first published a public notice that of a preliminary determination or draft permit has been prepared

.

* * * * *

* * * * **** E.O. 12866 Review

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Page 651 of 668 PART 53

—

AMBIENT AIR MONITORING REFERENCE AND EQUIVALENT METHODS 10

. The EPA proposes to revise authority citation for part 5 3 continues to read as follows:
In s ubpart A,
1. Revise § Authority: Sec. 301(a) of the Clean Air Act (42 U.S.C. sec. 1857g(a)), as amended by sec. 15(c)(2) of Pub. L. 91

- 604, 84 Stat. 1713, unless otherwise noted. Subpart A

— General Provisions § 53.9 [Amended]
11

. Amend § 53.9 by removing paragraph (i).
12

. Amend § 53.14 (c) by revising paragraph (c) introductory text to read as follows : § 53.14 Modification of a reference or equivalent method.

* * * * * (c) Within 90 calendar days after receiving a report under paragraph (a) of this section, the Administrator w ill take one or more of the following actions: 2. Remove section (i) from § 53.9.
In s ubpart B, 1. Revise * * * * * Subpart B

— Procedures for Testing Performance Characteristics of Automated Methods for SO 2 , CO, O 3 , and NO 2 13. Amend § 53.23 by revising paragraph §53.23 (e) ( 1) ( vi) to read as follows:

* * * * * (e) * * * (1) * * * Formatted: Indent: First line: 0.5"

Formatted: Indent: Left: 0", First line: 0.5"*** E.O. 12866 Review

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Page 652 of 668 (vi) Precision : Variation about the mean of repeated measurements of the same pollutant concentration, denoted as the standard deviation expressed as a percentage of the upper range limit s

. 315
2 * * * * *
14 . Revise and Tables Table B

- 1 and to Subpart B

- 3 of Part 53 to read as follows:

315 NO 2 precision in Table B

- 1 is also changed to percent to agree with the calculation specified in 53.23(e)(10)(vi). Formatted: Underline

Formatted: Subscript

Formatted: Font: 12 pt

### *** E.O. 12866 Review

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Page 653 of 668 Table B
- 1 to Subpart B of Part 53

— Performance Limit Specifications for Automated Methods

Performance parameter Units 1 

### SO 2 

### O 3 

### CO NO 2 

### (Std. range) Definitions and

test procedures Std. range 3 

### Lower

r ange 2,3 

### Std.

range 3 

### Lower

range 2,3 

### Std.

range 3 

### Lower range 2,3 

### 1. Range ppm 0

- 0.5 <0.5 0

- 0.5 <0.5 0

- 50 <50 0

- 0.5 Sec. 53.23(a). 2. Noise ppm 0.001 0.0005 0.001 0.0005 0.2 0.1 0.005 Sec. 53.23(b). 3. Lower detectable limit ppm 0.002 0.001 0.003 0.001 0.4 0.2 0.010 Sec. 53.23(c). 4. I nterference equivalent Each interferent Total, all interferents ppm ppm ±0.005

--- 4±0.005

--- ±0.005

--- ±0.005

--- ±1.0

--- ±0.5

--- ±0.02

0.04 Sec. 53.23(d).

Sec. 53.23(d). 5. Zero drift, 12 and 24 hour ppm ±0.004 ±0.002 ±0.004 ±0.002 ±0.5 ±0.3 ±0.02 Sec. 53.23(e). 6. Span drift, 24 hour 20% of upper range limit 80% of upper range limit Percent Percent ---

±3.0 ---

±3.0 ---

±3.0 ---

±3.0 ---

±2.0 --- ±2.0 ±20.0

±5.0 Sec. 53.23(e)

Sec. 53.23(e). 7. Lag time Minutes 2 2 2 2 2.0 2.0 20 Sec. 53.23(e). 8. Rise time Minutes 2 2 2 2 2.0 2.0 15 Sec. 53.23(e). 9. Fall time Minutes 2 2 2 2 2.0 2.0 15 Sec. 53.23(e). 10. Precision 20 % of upper range limit 80 % of upper range limit Percent 5


### Percent 5 

### ---

2

--- 2 ---

2

--- 2 ---

2

--- 2 ---

2

--- 2 --

1.0

--- 1.0 --- 1.0

--- 1.0 4

6 Sec. 53.23(e).

Sec. 53.23(e). Sec. 53.23(e). Sec. 53.23(e). 1. 

### To convert from parts per million (ppm) to μg/m 3 

### at 25 °C and 760 mm Hg, multiply by M/0.02447, where M is th e molecular weight of the gas. Percent means percent of the upper measurement range limit. 2

. 

### Tests for interference equivalent and lag time do not need to be repeated for any lower range provide d the test for the standard range shows that the lower range specification (if applicable) is met for each of these test parameters. 3

. 

### For candidate analyzers having automatic or adaptive time constants or smoothing filters, describe their functional natu re, and describe and conduct suitable tests to demonstrate their function aspects and verify that performances for calibration, noise , lag, rise, fall times, and precision are within specifications under all applicable conditions. For candidate analyzers w ith operator

- selectable Formatted: Font: Bold

### *** E.O. 12866 Review

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Page 654 of 668 time constants or smoothing filters, conduct calibration, noise, lag, rise, fall times, and precision tests at the highest an d lowest settings that are to be included in the FRM or FEM designation. 4

. 

### For nitric oxide interference f or the SO 2 

### UVF method, interference equivalent is ±0.0003 ppm for the lower range. 5

. 

### Standard deviation expressed as percent of the URL.

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Page 655 of 668

### *** E.O. 12866 Review

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Page 656 of 668 15. Revise Table B

- 3 to Subpart B of Part 53 to read as follows:

Table B
- 3 to Subpart B of Part 53

— Interferent Test Concentration, 1 

### Parts per Million Pollutant Analyzer type Hydro chloric acid Ammo nia Hydrogen sulfide Sulfur dioxide Nitrogen dioxide Nitric oxide Carbon dioxide
E th ylene

O zone m - Xy lene Water vapor Carbon mon

oxide Methane Ethane Naphthalene



### SO 2 

### Ultraviolet fluorescence 5 

### 0.1 4 

### 0.14 0 .5 0 .5 0 .5 0 .2 20,000 6 0.05 SO 2 

### Flame photometric 0.01 4 

### 0.14 750 3 

### 20,000 50 SO 2 

### Gas chromatography 0.1 4 

### 0.14 750 3 

### 20,000 50

SO 2 

### Spectrophotometric

- wet chemical (pararosanaline) 0.2 0.1 0.1 4 

### 0.14 0 .5 750 0 .5

SO 2 

### Electrochemical 0.2 0.1 0.1 4 

### 0.14 0 .5 0 .5 0 .2 0 .5 3 

### 20,000 SO 2 

### Conductivity 0.2 0.1 4 

### 0.14 0 .5 750 SO 2 

### Spectrophotometric

- gas phase, including DOAS 4 

### 0.14 0 .5 0 .5 0. 2

O 3 

### Ethylene chemiluminescene 3 

### 0.1 750 4 0.08 3 

### 20,000

O 3 

### NO

chemiluminescene 3 

### 0.1 0.5 750 0.08 20,000

O 3 

### Electrochemical 3 

### 0.1 0 .5 0.5 0.08 Formatted: Font: Bold

### *** E.O. 12866 Review

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Page 657 of 668 O 3 

### Spectrophotometric

- wet chemical (potassium iodide) 3 

### 0.1 0 .5 0.5 0.5 0.08

O 3 

### Spectrophotometric

- gas phase, including ultraviolet absorption and DOAS 0 .5 0.5 0 .5 0.08 0 .02 20,000

CO Non

- dispersive Infrared 750 20,000 4 

### 10

CO Gas chromatography with flame ionization detector 20,000 4 

### 10 0.5

CO Electrochemical 0 .5 0 .2 20,000 4 

### 10 CO Catalytic combustion

- thermal detection 0.1 750 0 .2 20,000 4 

### 10 5.0 0.5

CO IR fluorescence 750 20,000 4 

### 10 0.5 CO Mercury replacement

- UV photometric 0 .2 4 

### 10 0.5

NO 2 

### Chemiluminescent 3 

### 0.1 0 .5 4 

### 0.1 0 .5 20,000 NO 2 

### Spectrophotometric

- wet chemical (azo

- dye reaction) 0 .5 4 

### 0.1 0 .5 750 0 .5

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Page 658 of 668 1

. Concentrations of interferents listed must be prepared and controlled to ±10 percent of the stated value. 2

. Analyzer types not listed will be considered by the Administrator as special cases. 3

. Do not mix with the pollutant. 4

. Concentration of pollutant used for test. These pollutant concentrations must be prepared to ±10 percent of the stated value. 5

. If candidate method utilizes an elevated

- temperature scrubber for removal of aromatic hydrocarbons, perform this interference test. 6

. If naphthalene test concentration cannot be accurately quantified, remove the scrubber, use a test concentration that causes a full scale response, reattach the scrubber, and evaluate response for interference.

3. Revise f

igure B

- 5 i s revised 16 . Amend Appendix A to correct a minor inconsistency in the “Calculation s ” column for the
two “ Precision ” rows to change “% URL” to % Standard Deviation. Subpart B of Part 53 by revising “ F igure B

- 5 is revised ” to read as follows: Appendix A to Subpart B of Part 53

— Optional Forms for Reporting Test Results

* * * * * CALCULATION OF ZERO DRIFT, SPAN DRIFT, AND PRECISION Applicant____________________________________________________________ Date_________________________ Analyzer___________________

_________________________________________ Pollutant_____________________

TEST PARAMETERS CALCULATIONS TEST DAY (n) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 

### NO 2 

### Electrochemical 0.2 3 

### 0.1 0.5 4 

### 0.1 0 .5 750 0 .5 20,000 50 NO 2 

### Spectrophotometric

- gas phase 3 

### 0.1 0.5 4 

### 0.1 0 .5 0 .5 20,000 50

Formatted: Indent: Left: 0"

### *** E.O. 12866 Review

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Page 659 of 668 SPAN ZE RO DRIFT 12

HOUR 12 ZD = C max − C

min

24 HOUR Z = ( L 1 + L 2 ) / 2

24 ZD = Z n − Z n − 1 24 ZD = Z n

′

− Z n − 1 ′

SPAN DRIFT 24

HOUR S

n = 1 6 ∑ P i 12

i = 7 SD n = S

n − S n − 1 S n − 1 × 100%

SD n = S

n − S n − 1 ′ S n − 1 ′ × 100%

PREC

ISION 20%

URL ( P 20 ) P 20 = % STANDARD

DEVIATION OF (P 1 ...P 6 ) 80% URL ( P 80 ) P 8 0 = % STANDARD

DEVIATION OF (P 7 ...P 12 )



### Figure B

- 5. Form for calculating zero drift, span drift, and precision (§ 53.23(e)).

### *** E.O. 12866 Review

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Page 660 of 668 In subpart C,
1. Revise

* * * * **** E.O. 12866 Review

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Page 661 of 668 Subpart C

— Procedures for Determining Comparability Between Candidate Methods and Reference Methods
17

. Ame nd §53.32 by revising paragraph §53.32 (g)(1)(iii) is to read as follows: §53.32 Test procedures for methods for SO 2 , CO, O 3 , and NO 2 .

* * * * * (g) * * * (1) * * * (iii) The measurements shall be made in the sequence specified in table C

- 2 of this subpart. The EPA proposes to amend part 58 as follows: In subpart * * * * * Subpart E , [Amend] 1. Remove figure E

- 2 18. Amend Subpart E by removing “ Figure E

- 2 to Subpart E of Part 53 ”. PART 58

-- [ Amended ]

— AMBIENT AIR QUALITY SURVEILLANCE
1 1 9

. The authority citation for part 5 8 continues to read as follows:
A UTHORITY : 42 U.S.C. 7403, 7405, 7410, 7414, 7601 (a), , 7611, 7614, and 7619.
In s ubpart B

– [Amended] 2. Section Subpart B

— Monitoring Network
2 0

. Amend §58.10 is amended by adding paragraph paragraph s (a)(10) and ( a)( 11) to read as follows: §58.10 Annual monitoring network plan and periodic network assessment

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Page 662 of 668 * * * * * (a )( ) * * * ( 10 ) The annual monitoring network plan shall provide for the required O 3 sites to be operating on the first day of the applicable required O 3 monitoring season in effect on January 1, 2017 as listed in Table D

- 3 of appendix D of this part. ( a)( 1 1) The annual monitoring network plan shall include the E nhanced Monitoring Plan (EMP) for areas designated as O 3 nonattainment , as required under 40 CFR part 58 Appendix D, section 5(f) beginning with the annual monitoring pl ans due on July 1, 2016.
* * * * * 3. Section 21

. Amend §58.13 is amended by adding paragraph paragraph s (g) and (h) to read as follows: §58.13 Monitoring network completion.
* * * * * (g) The O 3 monitors required under appendix D, section 4.1 of this part must operate on the first day of the applicable required O 3 monitoring season in effect January 1, 2017. (h) The Photochemical Assessment Monitoring sites required under 40 CFR part 58 Appendix D, section 5(a) must be physically established and operating under all of the requirements of this part, including the requirements of appendix A, C, D, an d E of this part, no later than June 1, 2017, or two years fo llowing designation as O 3 nonattainment

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4

. Subpart F

—

Air Quality Index Reporting Amend § 58.50 by revising paragraph (c) to read as follows: § 58.50 Index reporting. Formatted: Font: Bold*** E.O. 12866 Review

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Page 663 of 668 * * * * * (c) The population of a metropolitan statistical area for purposes of index reporting is the latest available U.S. census population.
* * * * * Subpart G

— Federal Monitoring
22

. Amend Appendix D to part 58 is amended by:

a. Under section 4

—

by revising section 4.1(i) as follows: and “ Table D

- 3 to Appendix D of part 58 ; and b. Revising section 5 and its heading. The revised text reads as follows: Appendix D to part 58

— Network Design Criteria for Ambient Air Quality Monitoring : * * * * *
4. P OLLUTANT

- S PECIFIC D ESIGN C RITERIA FOR SLAMS S ITES * * * * *
4.1 * * * ( i ) Since O 3 levels decrease sign ificantly in the colder parts of the year in many areas, O 3 is required to be monitored at SLAMS monitoring sites only during the “ozone season” as described below in Table D

– 3 of this appendix . These ozone seasons are also identified in the AQS fil es on a state

- by

- state basis. Deviations from the O 3 monitoring season must be approved by the EPA Regional Administrator. These requests will be reviewed by Regional Administrators taking into consideration , at a minimum, the frequency of out

of

- season O 3 NAAQS exceedances , as well as occurrences of the Moderate air quality Formatted: List Paragraph, Numbered + Level: 2 + Numbering Style: a, b, c,
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Page 664 of 668 index level and regional consistency

. Any deviations based on the Regional Administrator’s waiver of requirements must be described in the annual monitoring network plan and updated in AQS. Changes to the O 3 monitoring season requirements in Table D

- 3 revoke any previously approved Regional Administrator waivers for affected
states. Requests for monitoring season waivers must be accompanied by relevant supporting information. Information on h ow to analyze O 3 data to support a change to the
O 3 season in support of the 8

- hour standard for a specific state can be found in footnote reference 8 to this appendix. O 3 monitors at NCore stations are required to be operated on

a year - round basis ( Januar y to December )

. T ABLE D

- 3 3 1 TO A PPENDIX D OF PART 58. O ZONE M ONITORING S EASON BY STATE
. 316

State Begin M onth End Month Alabama March October Alaska April October Arizona January December Arkansas March November California January December Colorado January December Connecticut March September Delaware March October District of Columbia March October Florida January December Georgia March October

316 The required O 3 monitoring season for NCore stations is January through December. Formatted: Small caps Formatted: Small caps Formatted: Small caps*** E.O. 12866 Review

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Page 665 of 668 Hawaii January December Idaho April September Illinois March October Indiana March October
Iowa March October
Kansas March October Kentucky March October Louisiana (Northern) AQCR 019,022 March October

Louisiana (Southern) AQCR 106 January December Maine April September Maryland March October Massachusetts March September Michigan March October Minnesota March October Mississippi March October Missouri March October
Montana April September Nebraska March October Nevada January December New Hampshire March September New Jersey March October New Mexico January December New York March October*** E.O. 12866 Review

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Page 666 of 668 North Carolina March October North Dakota March September Ohio March October Oklahoma March November Oregon May September Pennsylvania March October Puerto Rico January December Rhode Island March September South Carolina March October South Dakota March October
Tennessee March October
Texas (Northern) AQCR 022, 210, 211, 212, 215, 217, 218 March November

Texas (Southern) AQCR 106, 153, 213, 214, 216 January December

Utah January December
Vermont April September Virginia March October Washington May September West Virginia March October Wisconsin March October 15 Wyoming January September American Samoa January December Guam January December*** E.O. 12866 Review

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Page 667 of 668 Virgin Islands January December

* * * * *

5

. Appendix D to part 58 is amended by revising section 5, 1 The required O 3 monitoring season for NCore stations is January through December.

* * * * * 5. N ETWORK D ESIGN FOR P HOTOCHEMICAL A SSESSMENT M ONITORING S TATIONS (PAMS)

AND E NHANCED O ZONE M ONITORING , as follows: (a) State and local monitoring agencies are required to collect and report the following PAMS measurements at each NCore site required under paragraph 3(a) of this appendix located in an area designated as nonattainment for O 3 . (b) PAMS measurements inclu de: (1) Hourly averaged speciated volatile organic compounds (VOCs), (2) 8 3

- hour averaged carbonyls daily, (3) Hourly averaged O 3 , (4) Hourly averaged nitrogen oxide (NO), nitrogen dioxide (NO 2 ), and total reactive nitrogen (NO y ),

(5) Hourly averaged 3 meter ambient temperature, (6) Hourly vector

- averaged 10 meter wind direction, (7) Hourly averaged 10 meter wind speed, (8) Hourly average atmospheric pressure, (9) Hourly averaged relative humidity, and (10) Hourly averaged mixing

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Page 668 of 668 (c) The EPA Regional Administrator may grant a waiver to allow the collection of required PAMS measurements at an alternative location where the monitoring agency can demonstrate that the alternative location will provide representative data useful for reg ional or national scale modeling and the tracking of trends in O 3 precursors. (d) The EPA Regional Administrator may also grant a waiver to allow representative meteorological data from nearby monitoring stations to be used to meet the requirements to col lect temperature, wind direction, wind speed, atmospheric pressure, relative humidity, or hourly averaged mixing height where the monitoring agency can demonstrate the data is collected in a manner consistent with EPA quality requirements for these measure ments. (e) At a minimum, the monitoring agency shall collect the required PAMS measurements during the months of June, July, and August. (f) States with O 3 nonattainment areas are required to develop and implement an Enhanced Monitoring Plan (EMP) detailing enhanced O 3 and O 3 precursor monitoring activities to be performed which is subject to review and approval by the EPA Regional Administrator. The EMP wil l include monitoring activities deemed important to understanding the O 3 problems in the state. Such activities may include, but are not limited to, the following: (1) Additional O 3 monitors beyond the minimally required under paragraph 4.1 of this appendi x, (2) Additional NO X or NO y monitors beyond those required under 4.3 of this appendix, (3) Additional speciated VOC measurements including data gathered during different periods other than required under paragraph 5(e) of this appendix, or locations othe r than those required under paragraph 5(a) of this appendix, and (4) Enhanced upper air measurements of meteorology or pollution concentrations.