## Beverly Eaves Perdue

Governor

Gwendolyn Keyes Fleming Regional Administrator

USEPA

, Region 4

Sam Nunn Federal Center

61 Forsyth Street

, SW
Atlanta, Georgia 30303-8960 

### Director

August 13 ,2 012 

### Dee Freeman Secretary

Subject: State Implementation Plan Revisions incorporating Nitrogen Dioxide and Sulfur Dioxide National

Ambient Air Quality Standards (NAAQS)

Dear Ms. Fleming :

Recent review of records indicates that US EPA Region 4 does not have North Carolina's submittal of

its final rules 15A NCAC 02D .0407

, Nitrogen Oxides

, and

. 0402

, Sulfur Dioxide, adopting the nitrogen dioxide
(NOx) and sulfur dioxide (S02) NAAQS, respectively. Please find enclosed North Carolina 's submitta l of its

final rules adopted by the Environmental Management Commission (EMC) July 14, 2011

. The rules were the subject of a public hearing held on May 4

, 2011 and were approved by the State Rules Review Commission at its August 18, 2011 meeting

. The rules became effective September 1

, 2011.

Enclosed is the he a ring record for this public he a ring and a copy of the rules for which approval is requested. The hard copy of the rules and hearing record is identical to the .pdf file recorded on the CD

. Please proceed to approve the aforementioned rules as part of the federally-approved State Implementation Plan

.

If 

### you need additional information or have any questions regarding this submittal, please contact Ms

. J oelle Burleson of my staff at (919) 707-8720 or joelle

. burleson @ncdenr

. gov.

Enclos ur es

SCH/jb

c: Nacosta Ward Lynorae Benjamin

Sushma Ma se more Hearing Record Fi l e

1641 Mail Service Center, Raleigh

, North Carolina 27699-1641

217 West Jones Street

, Raleigh

, NC 27603 

### Sincere l y,

# ~Cr~

Sheila C. Holman

Phone : 919

- 707

- 8401 / FAX 919-715-0718 / lnternet: www

. ncair

. org

An Equal Opportuniiy / Affirmative Action Employer

# N~¥th Carolina 

# JVaturalllf

# STATE OF NORTH CAROLINA

DEPARTMENT OF ENVIRONMEN T AND NATURAL RESOURCES DIVISION OF AIR QUALITY

REPORT OF PROCEEDINGS OF PUBLIC HEARINGS

ON PROPOSED AMENDM ENTS TO RULES

15A NCAC 02D .0402 (SULFUR OXIDES), 15A NCAC 02D .0407 (NITROGEN DIOXIDE)

MAY 4, 2011
RALEIGH, NC 27604



# ENVIRONMENTAL MANAGEMENT COMMISSION

## This page was intentionally left blank.

## CONTENTS

CHAPTER I Summaries and Recommendations I-1

Background and Summary I-1

Comments and Responses Thereto I-2

Hearing Officer’s Recommendation I-2

CHAPTER II Regulations Proposed for Adoption II-1

CHAPTER III Report of Proceedings III-1

Introduction III-1

Designation of Hearing Officer III-2

Public Notice III-3

Transcript III-5

CHAPTER IV Exhibits IV- 1

Proposed Regulations With Amendments as Presented at the Hearing IV-2 Hearing Officer Comments at Hearing IV-4

CHAPTER V Written Comments Du ring Comment Period V-1

Index of Commenters V-1

Comments V-2

CHAPTER VI Attachments VI-1

CHAPTER VII Documentation VII-1

## This page was intentionally left blank.

### CHAPTER I

BACKGROUND AND SUMMARY

The Division of Air Quality (DAQ), under section 110 of the Clean Air Act (CAA), 42 U.S.C.

7410, is required to submit a State Implementation Plan (SIP) for EPA approval that provides for

the attainment and maintenance of sulfur dioxide (SO 2 

### ) and nitrogen dioxide (NO 2 

### ) National

Ambient Air Quality Standards (NAAQS) throug h control programs directed at sources of SO 2



### and NO 2 

### emissions. If DAQ fails to adopt and implement the required SIP by the time periods

provided in the CAA, the EPA has respons ibility under the CAA to adopt a Federal

Implementation Plan (FIP) to assure that areas attain the NAAQS in an expeditious manner.

Proposed amendment to Rule 15A NCAC 02D .0402, Sulfur Oxides.

The purpose of the amendment is to adjust the ambient air quality standard to incorporate the

United States Environmental Protection Agency (USEPA) standard for SO 2



### .

The proposed amendment updates the am bient air quality standard for SO 2 

### by incorporating the

strengthened primary National Ambient Air Quality Standard (NAAQS) for SO 2 

### by replacing the

current 24-hour and annual standard with a new 1-hour SO 2 

### standard at a level of 75 (ppb), based

on the 3-year average of the annual 99th percentile of 1-hour daily maximu m concentrations. Two

existing primary standards of 140 ppb that is ev aluated over 24-hours, and 30 ppb annual standard

that is evaluated over an entire year will be revoked one year after the effective date of initial

designations under Section 107(d) of the Clean Air Act. The standard is attained at an ambient air

quality monitoring site when the three-year average of the annual (99th percentile) of the daily

maximum one-hour average concentrations is less than or equal to 75 ppb, as determined in

accordance with Appendix T of 40 CFR Part 50.

Proposed amendment to Rule 15A NCAC 02D .0407, Nitrogen Dioxide.

The purpose of the amendment is to adjust the am bient air quality standard to reflect the United

States Environmental Protection Agency (USEPA) standard for NO 2 

### . The USEPA revised the

standard January 22, 2010 in 40 CFR 50 and 58.

The proposed amendment updates the am bient air quality standard for NO 2 

### by supplementing the

existing annual standard for NO2 of 53 parts per billion (ppb) for a new short-term standard based

### on the 3-year average of the 98th percentile of the yearly distribution of 1-hour daily maximum

concentrations. The level of this new standard is set at 100 ppb.

PUBLIC COMMENTS AND RESPONSES THERETO

Comment: Mr. Richard A. Schutt, Chief, Air Planning Branch, offered no comments during the

comment period in his letter dated May 26, 2011.

CONCLUSION

Only one person submitted a letter offering no comments for the hearing record during the

comment period.

HEARING OFFICER'S RECOMMENDATION

The Hearing Officer recommends that the proposed amendments as presented in Chapter II of this

hearing report be adopted by the Environmental Management Commission.

### 15A NCAC 02D .0402 SULFUR OXIDES 1

(a) The ambient air quality standards for sulf ur oxides measured as sulfur dioxide are: 2

(1) 80 micrograms per cubic meter (0.03 p.p.m. ppm ) annual arithmetic mean, 3

(2) 365 micrograms per cubic meter (0.14 p.p.m. ppm ) maximum 24-hour concentration not to be exceeded 4

more than once per year, 5

(3) 1300 micrograms per cubic meter (0.5 p.p.m. ppm ) maximum three-hour concentration not to be exceeded 6

more than once per year. 7

(b) Sampling and analysis shall be in accordance with procedures in Appendix A or A-1 40 CFR Part 50 or equivalent 8

methods established under by a Federal Equivalent Method (FEM) designated in accordance with 40 CFR Part 53. 9

(c) Applicability of the standards listed in Paragraph (a)(1) and (2) of this rule is in effect until one year after the effec tive 10

date of initial designations under Section 107(d) of the Clean Air Act for the sulfur dioxide standard in Paragraph (d) of this 11

Rule. 12

(d) The primary one-hour annual ambient air quality standard fo r oxides of sulfur is 75 parts per billion (ppb, which is 1 pa rt 13

in 1,000,000,000), measured in the ambient air as sulfur dioxide. 14

(e) The one-hour primary standard is met at an ambient air qua lity monitoring site when the three-year average of the annual 15

(99th percentile) of the daily maximum one-hour average concentr ations is less than or equal to 75 ppb, as determined in 16

accordance with Appendix T of 40 CFR Part 50. 17

18

History Note: Authority G.S. 143-215.3(a)(1); 143-215.107(a)(3); 19

Eff. February 1, 1976; 20

Amended Eff. July 1, 1984; December 1, 1976. 21

22

23

24

### 15A NCAC 02D .0407 NITROGEN DIOXIDE 1

(a) The primary annual ambient air quality standard for nitrogen dioxide oxides of nitrogen is 0.053 parts per million 53 parts 2

per billion (100 micrograms per cubic meter) annual arithmetic mean. average concentration measured in the ambient air as 3

nitrogen dioxide. 4

(b) Sampling and analysis shall be in accordance with pro cedures in Appendix F 40 CFR Part 50 or equivalent methods 5

established under 40 CFR Part 53. 6

(b) The primary one hour ambient air quality standard for oxide s of nitrogen is 100 parts per billion one hour annual average 7

concentration measured in the ambient air as nitrogen dioxide. 8

(c) The standards are attained when the annual arithmetic mean concentration in a calendar year is less than or equal to 0.053 9

parts per million, rounded to three decimal places (fractional parts equal to or greater than 0.0005 parts per million are 10

rounded up). To demonstrate attainment, an annual mean must be based on hourly data that are at least 75 percent complete 11

or on data derived from manual methods that are at least 75 pe rcent complete for the scheduled sampling days in each 12

calendar quarter. 13

(c) The secondary ambient air quality standard for nitroge n dioxide is 0.053 parts per million (100 micrograms per cubic 14

meter) annual arithmetic mean concentration. 15

(d) Sampling and analysis shall be in accordance with: 16

(1) procedures in Appendix F 40 CFR Part 50; or 17

(2) by a Federal Equivalent Method (FEM) de signated in accordance with 40 CFR, Part 53. 18

(e) The annual primary standard is attained when the annual aver age concentration in a calendar year is less than or equal to 19

53 parts per billion, as determined in accordance with Appendix S of 40 CFR , Part 50 for the annual standard. 20

(f) The one hour primary standard is attain ed when the three-year average of the annual 98th percentile of the daily maximum 21

one-hour average concentration is less than or equal to 100 ppb, as determined in accordance with Appendix S of 40 CFR, 22

Part 50 for one hour standard. 23

(g) The secondary standard is attained when the annual arithmetic mean concentration in a calendar year is less than or equal 24

to 0.053 parts per million, rounded to three decimal places (frac tional parts equal to or greater than 0.0005 parts per million 25

are rounded up). To demonstrate attainment, an annual mean must be based on hourly data that are at least 75 percent 26

complete or on data derived from manual methods that are at least 75 percent complete for the scheduled sampling days in 27

each calendar quarter. 28

History Note: Authority G.S. 143-215.3(a)(1); 143-215.107(a)(3); 29

Eff. February 1, 1976; 30

Amended Eff. October 1, 1989; July 1, 1984; December 1, 1976. 31

32

33

34

## CHAPTER III

REPORT OF PROCEEDINGS

Introduction

The Department of Environment and Natural Re sources, Division of Air Quality, held a public hearing on May 4, 2011, at 6:30 P.M. at DENR – Division of Air Quality Annex Training Room (AQ 526) 2728 Capital Blvd., Raleigh, NC 27604.

The hearing considered the proposed amendm ents to Rules 15A NCAC 02D .0402, Sulfur Oxides, and 15A NCAC 02D .0407, Nitrogen Dioxide . The proposed effective date for these amendments is projected to be September 1, 2011.

A public notice announcing this hear ing was mailed to each person on the official mailing list for rule-making hearings. The public notice was also published in the North Carolina Register at least 15 days before the public hearing and in the Charlotte Observer , the Wilmington Star News

, the Asheville Citizen Times , the Winston Salem Journal , and the Raleigh News and Observer at least 30 days prior to the public hearing.

## ENVIRONMENTAL MANAGEMENT COMMISSION

NORTH CAROLINA

DEPARTMENT OF ENVIRONMENT AND NATURAL RESOURCES

Beverly Eaves Perdue, Governor

Dee Freeman, Secretary



# MEMORANDUM

TO: Mayor Darryl 

### D. Moss March 24, 2011 Donnie Brewer

Yvonne C

. Bailey

Thomas F. Cecich

Stan L. Crowe

John S

. Curry

Marion Deerhake

Tom Ellis

William L. Hall, Jr.

Ernest W. Larkin



### From: Stephen T

. Smith

# ~~**~ ~** 

Subject: Hearing Officer Appointment Stephen T

. Smith

Chairman

Charles Peterson

Vice Chairman

Kevin Martin

David H. Moreau Jeffrey V

. Morse Darryl D

. Moss

David B. Peden

Thomas H. Percival

Dickson Phillips Ill

Forrest R

. Westall, Sr.



### A 

### public hearing has been scheduled for May 4, 2011 at 6:30p.m

. at the Division of Air Quality central

office in Raleigh to receive public comments on amendments to the Nitrogen Dioxide and Sulfur Oxides

rules to incorporate the revised National Ambient Air Quality Standards (NAAQS) for these pollutants

into the state rules. The attached public notice describes the hearing's purpose.

I am hereby appointing you to serve as hearing officer for this hearing

. Please receive all relevant public

comment and report your findings and recommendations to the Environmental Management Commission.

Ms

. Joe lie Burleson will provide staff support for you.

If you have any questions, please feel free to contact Joelle Burleson at (919) 733-14 74, or me.

SCH/jb

Attachment

cc : Sheila Holman

Lois Thomas
Hearing Record File

An Equal Opportunity Affirmative Action Employer

## NORTH CAROLINA ENVIRONMENTAL MANAGEMENT COMMISSION

PUBLIC NOTICE

Notice is hereby given for a public hearing to be heard by the North Carolina Department of Environment and Natural Resources, Quality

the proposed amendments of air quality

DATES AND LOCATION:

COMMENT PROCEDURES:

INFORMATION: To receive comments on amendments

15A NCAC 02D .0402, Sulfur Oxides, and

020 Nitrogen incorporate

the revised primary National Ambient Quality

Standards (NAAQS) for sulfur

...... '-"

.......**~** 

## ....... nitrogen dioxide (N02), promulgated by United

"-JLLAILLI...:J 

## Environmental Protection Agency (USEPA), into the

state air quality rules.

NOTE: The proposed amendments considered in this hearing, if adopted, will be effective statewide; if they

are later adopted by a local air pollution control

agency, then that agency will enforce them in its area of jurisdiction.

May 4, 2011, 6:30P.M.

DENR- Division of Air Quality, Central Office

Air Quality Annex Training Room (AQ 526)

2728 Capital Blvd., Raleigh, NC 27604

All persons interested in these matters are invited to

attend the public hearings. Any person desiring to

comment is requested to submit a written

statement for inclusion in the record of proceedings at the public hearing. The hearing

officer may limit oral presentation lengths if many people want to speak. The hearing record will remain

open until May 31, 2011 to receive additional written

statements. To be included, the statement must be received_qy the Divj_§_ion by**May_~1,** 

## 4_Q11.

Copies of the proposed rule changes may be

downloaded at http://daq.state.nc.us/Rules/Hearing/ Copies of the proposals may also be reviewed at the regional offices of the North Carolina Department of

Environment and Natural Resources, Division of Air Quality, located at the following cities:

Asheville 828/296-4500

## Fayetteville

Mooresville Raleigh Washington Wilmington

Winston-Salem 910/433-3300

704/663-1699

919/791-4200

252/946-6481

910/796-7215

336/771-5000

Comments should be sent to and additional

information concerning the or the

may be obtained by contacting:

Ms. Joelle Burleson

Division of Air Quality

1641 Mail Service Raleigh, North Carolina 27699-1641 (919) 733-14 7 4Phone (919) 715-7 4 76 Fax joelle.burleson@ncdenr.gov

Director

## Transcript

Transcripts of the May 4, 2011 hearings have not been prepared; however, an audio recording of each proceeding will be kept on f ile with the Division of Air Quality for one year from the date of the final actions by the Environmental Management Commission.

A list of those attending the hearing as follows:

Hearing Officer: Mr. Darryl D. Moss 

## , member of the Environmental Management

Commission

Staff Members at both hearings: Ms. Joelle Burleson, DAQ, DENR Mr. Glenn Sappie, DAQ, DENR Mr. Steve Schliesser, DAQ, DENR Mr. Patrick Knowlson, DAQ, DENR

Members of the General Public didn’t attend the hearing

### This page is intentionally blank

## CHAPTER IV

EXHIBITS

EXHIBIT PAGE

Proposed Regulations as Publishe d in the Public Notice and Presented at the Hearing IV-2

Hearing Officer Comments at the Public Hearing IV-4

### PROPOSED RULES

25:19 NORTH CAROLINA REGISTER APRIL 1, 2011

2224 Quality maintains a Geographic Information Systems data layer

of the UWL. (t) The Schedule of Classifications and Water Quality Standards

for the French Broad River Basin was amended effective September 1, 2009 with the r eclassification of the entire watershed of Big Laurel Creek (Index No. 6-112) from source to

the French Broad River from Class C Tr to Class C ORW Tr. (u) The Schedule of Classifications and Water Quality

Standards for the French Broad River Basin was amended effective September 1, 2009 with the reclassification of the entire watershed of Spring Creek [Index No. 6-118-(1) and 6- 118-(27)] from source to the French Broad River from Class C

Tr and Class C to Class C ORW Tr and Class C ORW. (v) The Schedule of Classifications and Water Quality

Standards for the French Broad River Basin was amended July 1, 2011 with the reclassi fication of Boylston Creek [Index No. 6-52-(0.5)], from source to a point 0.3 mile upstream of Murray Branch and all tributaries to this portion of the Creek, from Class C to Class C Tr. (w) The Schedule of Classifications and Water Quality

Standards for the French Broad River Basin was amended December 1, 2011 with the recla ssification of a portion of the French Broad River [Index No. 6-(54.5)] from the confluence of the Mills River to a point 0.2 miles downstream of the

confluence of the Mills River from Class B to Class WS-IV&B

CA.

Authority G.S. 143-214.1; 143-215.1; 143-215.3(a)(1).

* * * * * * * * * * * * * * * * * *

Notice is hereby given in accordance with G.S. 150B-21.2 that the Environmental Management Commission intends to amend

the rules cited as 15A NCAC 02D .0402 and .0407.

Proposed Effective Date: September 1, 2011

Public Hearing :
Date: May 4, 2011

Time: 6:30 p.m.

Location: 2728 Capital Blvd, Air Quality Annex Training Room AQ-526, Raleigh , NC 27604

Reason for Proposed Action: Rules 15A NCAC 02D .0402 and .0407 are proposed for amendment to incorporate the revised primary National Ambient Air Quality Standard (NAAQS) for sulfur dioxide (SO2) and nitrogen dioxide (NO2) promulgated by the United States Environmen tal Protection Agency into the state ambient air quality standards rules.

Procedure by which a person can object to the agency on a proposed rule: If you have any objections to the proposed rule, please mail a letter including your specific reasons to: Ms. Joelle Burleson, Division of Air Quality, 1641 Mail Service Center, Raleigh, NC 27699-1641.

Comments may be submitted to: Joelle Burleson, Division of Air Quality, 1641 Mail Service Center, Raleigh, NC 27699- 1641; phone (919) 733-1474; fax (919) 715-7476; email joelle.burleson@ncdenr.gov

Comment period ends: May 31, 2011

Procedure for Subjecting a Proposed Rule to Legislative

Review: If an objection is not resolved prior to the adoption of the rule, a person may also submit written objections to the Rules Review Commission after the adoption of the Rule. If the Rules Review Commission receives written and signed objections after the adoption of the Rule in accordance with G.S. 150B-21.3(b2) from 10 or more persons clearly requesting review by the legislature and the Rules Review Commission approves the rule, the rule will become effective as provided in G.S. 150B-21.3(b1). The Commission will receive written objections until 5:00 p.m. on the day following the day the Commission approves the rule. The Commission will receive those objections by mail, delivery service, hand delivery, or facsimile transmission. If you have any further questions concerning the submission of objections to the Commission, please call a Commission staff a ttorney at 919-431-3000.

Fiscal Impact: A copy of the fiscal note can be obtained from the agency.

State

Local Substantial Economic Impact ( > $3,000,000 

### )

None

CHAPTER 02 - ENVIRONMENTAL MANAGEMENT

SUBCHAPTER 02D - AI R POLLUTION CONTROL REQUIREMENTS

SECTION .0400 - AMBIENT AIR QUALITY STANDARDS

15A NCAC 02D .0402 SULFUR OXIDES (a) The ambient air quality standards for sulfur oxides measured

as sulfur dioxide are: (1) 80 micrograms per cubic meter (0.03 p.p.m.

ppm ) annual arithmetic mean, (2) 365 micrograms per cubic meter (0.14 p.p.m.

ppm ) maximum 24-hour concentration not to be exceeded more than once per year, (3) 1300 micrograms per cubic meter (0.5 p.p.m.

ppm ) maximum three-hour concentration not to be exceeded more than once per year. (b) Sampling and analysis shall be in accordance with procedures in Appendix A or A-1 40 CFR Part 50 or equivale nt
methods established under by a Federal Equivalent Method (FEM) designated in accordance with 40 CFR Part 53. (c) Applicability of the standards listed in Subparagraph (a)(1) and (2) of this Rule is in effect until one year after the effective date of initial designations under Section 107(d) of the Clean Air Act for the sulfur dioxide standard in Paragraph (d) of this Rule. (d) The primary one-hour annual ambient air quality standard for oxides of sulfur is 75 parts per billion (ppb, which is 1 part in 1,000,000,000), measured in the ambient air as sulfur dioxide.

### PROPOSED RULES

25:19 NORTH CAROLINA REGISTER APRIL 1, 2011

2225 (e) The one-hour primary standa rd is met at an ambient air quality monitoring site when the three-year average of the annual (99th percentile) of the daily maximum one-hour average concentrations is less than or equal to 75 ppb, as determined in accordance with Appendix T of 40 CFR Part 50.

Authority G.S. 143-215.3(a)(1); 143-215.107(a)(3).

15A NCAC 02D .0407 NITROGEN DIOXIDE (a) The primary annual ambient air quality standard for nitrogen

dioxide oxides of nitrogen is 0.053 parts per million 53 parts per

billion ( 100 micrograms per cubic meter ) annual arithmetic

mean. average concentration measur ed in the ambient air as nitrogen dioxide. (b) Sampling and analysis shall be in accordance wi th procedures in Appendix F 40 CFR Part 50 or equivalent methods

established under 40 CFR Part 53. (b) The primary one-hour ambient air quality standard for oxides of nitrogen is 100 parts per billion one hour annual average concentration measured in the ambient air as nitrogen

dioxide. (c) The standards are attained when the annual arithmetic mean concentration in a calendar year is less than or equal to 0.053 parts per million, rounded to three decimal places (fractional parts equal to or greater than 0. 0005 parts per million are rounded up). To demonstrate attainment, an annual mean must be based on hourly data that are at least 75 percent complete or on data derived from manual methods that are at least 75 percent complete for the scheduled sampling da ys in each calendar

quarter. (c) The secondary ambient air quality standard for nitrogen dioxide is 0.053 parts per million (100 micrograms per cubic meter) annual arithmetic mean concentration. (d) Sampling and analysis shall be in accordance with: (1) procedures in Appendix F 40 CFR Part 50; or (2) by a Federal Equivalent Method (FEM) designated in accordance with 40 CFR, Part

53. (e) The annual primary standard is attained when the annual average concentration in a calendar year is less than or equal to 53 parts per billion, as determined in accordance with Appendix S of 40 CFR , Part 50 for the annual standard. (f) The one hour primary standard is attained when the threeyear average of the annual 98th percentile of the daily maximum one-hour average concentration is less than or equal to 100 ppb, as determined in accordance with Appendix S of 40 CFR, Part

50 for one hour standard. (g) The secondary standard is attained when the annual

arithmetic mean concentration in a calendar year is less than or equal to 0.053 parts per million, rounded to three decimal places (fractional parts equal to or greater than 0.0005 parts per million are rounded up). To demonstrat e attainment, an annual mean must be based on hourly data that are at least 75 percent complete or on data derived from manual methods that are at least 75 percent complete for the scheduled sampling days in each calendar quarter.

Authority G.S. 143-215.3(a)(1); 143-215.107(a)(3).

## Hearing Officer's Suggested Hearing Comments

INTRODUCTION

[Hearing officer]:

Good evening ladies and gentlemen. My name is Darryl Moss. I am a member of

the North Carolina Environmental Manage ment Commission. My role as hearing

officer is to listen to all relevant comment on these proc eedings and report them to

the full commission. Sitting with me is Ms. Joelle Burleson. She is with the North

Carolina Division of Air Qu ality, Planning Section.

Some of the staff from the Division of Ai r Quality are here to assist. Ms. Burleson,

please introduce the staff present.

[Ms. Burleson] (Introduces staff)

[Hearing officer]:

This evening we are conducting a hearin g on amendments to the state ambient air

quality standards rules to incorporate th e revised National Ambient Air Quality

Standards (NAAQS) for nitrogen dioxid e (NO2) and sulfur dioxide (SO2).

Incorporation of the NAAQS into the state standards is one of the first steps in

implementation of the revised NAAQS. Separa te from tonight’s hearing, the Division

of Air Quality has been taking comment on another early step in the implementation

process for SO2 which is development of the State recommendations for attainment

and nonattainment boundary options. That comment period on the draft

recommendations closed on April 30, 2011.

## This hearing will be held according to the North Carolina Administrative

Procedures Act. The public notice for the hearing has been advertised in the North

Carolina Register and five newspapers in the state. Notice has been sent to those on

the official DAQ mailing list. I will en ter the public notice and the proposed

amendments and adoptions in to the hearing record with out reading them at this

time.

Any person desiring to comment is requ ested to submit a written statement for

inclusion into the hearing record. Once ca lled to speak, please come to the podium

and state your name clearly, identify the rule or rules you are commenting on, and

whom you represent.

[HEARING]:

I will now open the hearing and take relevant comments on amendments to

incorporate the revised National Ambient Ai r Quality Standards for nitrogen dioxide

into 15A NCAC 02D .0407, Ni trogen Dioxide, and for sulfur dioxide into 15A

NCAC 02D .0402, Sulfur Oxid es. Staff will now provide a brief overview of the

revised standards.

[Staff:] Overview Presentation

[hearing officer:] Additional background in formation on these proposed rule changes

is available on the Division of Air Quality website. The focus of tonight’s hearing is

on incorporation of the revised NAAQS them selves into the stat e ambient air quality

standards rules.

--------------------------------------- ------------------------------------ -----------------------------

## 3 [Hearing officer]: Optional Time Limit

Many people have requested to speak at this hearing. Due to time constraints,

speakers’ presentations will be limited to ___ minutes. Speakers are requested to

submit a written statement by the close of the comment period for inclusion into the

hearing record.

--------------------------------------- ------------------------------------ -----------------------------

[Hearing officer]:

I will now take any comments that you may have.

[SPEAKERS]

[Hearing officer]:

Is there anyone else who would like to comment? If there ar e no more comments,

then this hearing is closed. The hearing record will remain op en until May 31, 2011,

for additional written comments.

Thank you for participating in tonight’s hearing.

## V-1



# CHAPTER V

COMMENTS RECEIVED AT THE PUBLIC HEARING

AND DURING THE COMMENT PERIOD

INDEX OF COMMENTORS

NAME REPRESENTING PAGE

Mr. Richard A. Schutt USEPA, Region 4 V-2

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

REGION 4



## Ms. Sheila C. Holman, Director

Division of Air Quality ATLANTA FEDERAL CENTER

61 FORSYTH STREET
ATLANTA, GEORGIA 30303-8960



## May 26,2011

North Carolina Department of Environment

and Natural Resources

1641 Mail Service Center Raleigh, North Carolina 27699-1641

Dear Ms. Holman:

Thank you for your letter dated March 29, 2011, transmitting a prehearing package regarding the

revisions to the North Carolina State Implementation Plan (SIP) revising 15A NCAC 02D.0402- Sulfur

Oxides (S02) and 15A NCAC 02D.0407- Nitrogen Dioxide (N02). Specifically, the SIP revision incorporates the revised primary National Ambient Air Quality Standards for S02 and N0 2 promulgated by the U.S. Environmental Protection Agency on June 22, 2010, and February 9, 2010, respectively.

These proposed revisions will be the subject of a public hearing, if requested, with written comments

due by the close of business on May 31, 2011. We have completed our review of the submittal and offer

no comments at this time.

We look forward to continuing to work with you and your staff. If you have any questions, please

contact Jane Spann, Acting Chief, Regulatory Development Section at (404) 562-9029, or have your
staff contact Nacosta C. Ward at (404) 562-9140.

Air Planning Branch

Internet Address (URL) • http://www.epa.gov

Recycled/Recyclable • Printed wHh Vegetable Oil Based Inks on Recycled Paper (Minimum 30% Postconsumer)

## VI-1

CHAPTER VI

INDEX OF ATTACHMENTS

ATTACHMENTS PAGE

Sulfur Dioxide Amendments Economic Analysis VI-2

Nitrogen Dioxide Amendments Economic Analysis VI-4

Summary Presentation on Nitrogen Dioxi de and Sulfur Dioxide Ambient Air Quality Standards Amendments VI-7

Federal Register - Final National Ambient Air Quality Standard for Sulfur Dioxide

Rule VI-18

Federal Register - Final National Ambient Air Quality Standard for Nitrogen

Dioxide Rule VI-103

## 1 ECONOMIC ASSESSMENT Revision of Ambient Standards for Sulfur Dioxide (SO 2 

## )

I. Basic Information

Contact Information 1. Division of Air Quality File Number ( 495 )

2. Analyst: Vladimir Zaytsev vladimir.zaytsev@ncmail.net

3. Office DENR, Air Quality Planning, Rule Development Branch

4. Phone 919/733

- 1468

5. Comments to Agency Contact Joelle Burleson, 919/733

- 1474 Joelle.Burleson@ncdenr.gov 6. Title of the Proposed Rule Sulfur dioxide ambient air quality standards

7. Rule Citations 15A NCAC 02D .0402

8. Brief Description of the Proposed Rule Changes Updates to sulfur dioxide ambient air quality standards to match changes made by the

United States Environmental Protection Agency 9. Rule Category Division 1

– Regulatory Behavior
10. Authorizing Statute G.S. 143

- 215.3(a)(1); 143

- 215.107(a)(3)



## Screening Analysis

Rule Actions General Statute Yes

or
No

1 1 . Federal Law Certification Required

- Does the proposed rule purport to implement a federal law requiring a certification statement by the rulemaking coordinator? NCGS 150B

- 21(f)(1) Yes

1 2 . Temporary Rules

- Does this rule meet the criteria listed relating to temporary rules? NCGS 150B

- 21.1 No

1 3 . Emergency Rules

- Does this rule meet the criteria relating to emergency rules? NCGS 150B

- 21.1(a) No

1 4

. Establishes or Increases Fees

- Is the agency required to compl y with the requirements of G.S. 12

- 3.1? NCGS 150B

- 12

- 3.1

NCGS 150B

- 21.3(c1) No

1 5 . State Funds

- Does the proposed rule require the expenditure or distribution of funds subject to the Executive Budget Act, Article 1 of Chapter 143? NCGS 150B

- 21.4(a) Yes

1 6 . NC DOT Analysis

- Does the proposed rule affect NC DOT environmental permitting that will result in an increased cost? NCGS 150B

- 21.4(a1) No

1 7 . Local Government Unit Funds

- Does the proposed rule affect the expenditures or revenues of a unit of local government? NCGS 150B

- 21.4(b) Yes

1 8 . Substantial Economic Impact Analysis

- Federal Rule Exemption

- Does this rule meet the criterion of Federal Exemption? NCGS 150B

21.4(b1) Yes

1 9 . Technical Change

- Are only technical changes being incorporated such that public notice and rulemaking hearings are not required? NCGS 150B

- 21.5 No

20 . Repeal of Regulatory Deadwood

- Is the rule obsolete? NCGS 150B

- 2(1b)

NCGS 150B

- 21.5(b) No

## 2

II. Certification Statement On June 2, 2010, EPA strengthened the primary National Ambient Air Quality Standard (NAAQS) for sulfur dioxide (SO 2 

## ) by replacing the current 24-hour and annual standard with a new 1-hour SO2 standard at a level of 75 (ppb), based on the 3-year average of the annual

99 th 

## percentile of 1-hour daily maximum concentrations. EPA is revoking the two existing primary standards of 140 ppb that is evaluated over 24-hours, and 30 ppb annual standard that is evaluated over an entire year because there is little health evidence to suggest an association between long-term exposure to SO 2 

## and health effects. The new 1-hour standard applies only to the primary standard set to protect public health, especially for children, the elderly, and people with asthma. More details found on EPA ’s regulatory action websites : Final Rule (PDF) (85pp, 624k) - Federal Register, June 22, 2010 Fact Sheet (PDF) (6pp, 43k) Regulatory Impact Analysis

Under section 110 of the CAA, 42 U.S.C. 7410, North Carolina is required to submit, for EPA approval, State Implementation Plan (SIP) that provide for the attainment and

maintenance of SO 2 

## standards through control programs directed at sources of SO 2 

## emissions. If North Carolina fails to adopt and implement the required SIP by the tim e periods provided in the CAA, the EPA has responsibility under the CAA to adopt a Federal Implementation Plan (FIP) to assure that areas attain the NAAQS in an expeditious manner.

The Division of Air Quality (DAQ), Ambient Monitoring section estimates that new sulfur dioxide monitoring requirements may result in eight required sulfur dioxide population weighted emission index (PWEI) monitors in the state of North Carolina. These eight PWEI monitors will be located in seven Metropolitan Statistical Areas (MSAs): Asheville, Charlotte-Concord-Gastonia, Durham-Chapel Hill, Greensboro-High Point, Hickory, Wilmington, and Winston-Salem. The North Carolina Division of Air Quality (NC DAQ) expects three existing monitors to meet the requirements for PWEI monitoring. These monitors are located in Forsyth, Mecklenburg, and New Hanover Counties. Thus, five new PWEI monitoring sites will be required. The NC DAQ plans to use existing sites to house as many of these PWEI monitors as possible to reduce the cost of implementation of the rule. These five new monitors will be located in the Asheville, Charlotte-Concord-Gastonia, Durham-Chapel Hill, Greensboro-High Point, and Hickory MSAs.

The DAQ has enough equipment to set up five additional sulfur dioxide monitoring sites in buildings at existing sites and estimates it will cost $63,450 to set up five PWEI monitoring sites. In addition, the NCDAQ estimates it will cost $107,000 a year for supplies and labor to operate the five new sites. Sometime within the next five years, DAQ anticipates the monitoring equipment will need to be replaced at an estimated cost of $135,000.

Although it is uncertain whether State or units of local government funds are affected, the amendment to the Rule 15A NCAC 02D .0402 does purport to implement a federal regulation, and therefore an impact statement is not required (G.S. 150B-21.4(b1). The agency submits a certification statement by the rule-making coordinator, accordingly.

## 1

ECONOMIC ASSESSMENT Revision of Ambient Standards for Nitrogen Dioxide (NO 2 

## )

I. Basic Information

Contact Information
1. Division of Air Quality File Number (494)

2. Analyst: Vladimir Zaytsev vladimir.zaytsev@ncmail.net

3. Office DENR, Division of Air Quality, Planning Section, Rules Development Branch

4. Phone 919/ 715

- 4398

5. Comments to Agency Contact Joelle Burleson, 919/733

- 1474 Joelle.burleson@ncdenr.gov 6. Title of the Proposed Rule NITROGEN DIOXIDE

7. Rule Citations 15A NCAC 02D .0407

8. Brief Description of the Proposed Rules Updates to nitrogen dioxide ambient air quality standards to match changes made by the

United States Environmental Protection Agency 9. Rule Category Division 1

– Regulatory Behavior
10. Authorizing Statute G.S. 143

- 215.3(a)(1); 143

- 215.107(a)(3)



## Screening Analysis

Rule Actions General Statute Yes

or
No 10. Federal Law Certification Required

- Does the proposed rule purport to implement a federal law requiring a certification statement by the rulemaking coordinator? NCGS 150B

- 21(f)(1) Yes

11. Temporary Rules

- Does this rule meet the criteria listed relating to temporary rules? NCGS 150B

- 21.1 No

12. Emergency Rules

- Does this rule meet the criteria relating to emergency rules? NCGS 150B

- 21.1(a) No

13. Establishes or Increases Fees

- Is the agency required to compl y with the requirements of G.S. 12

- 3.1? NCGS 150B

- 12

- 3.1

NCGS 150B

- 21.3(c1) No

14. State Funds

- Does the proposed rule require the expenditure or distribution of funds subject to the Executive Budget Act, Article 1 of Chapter 143? NCGS 150B

- 21.4(a) Yes

15. NC DOT Analysis

- Does the proposed rule affect NC DOT

e nvironmental permitting that will result in an increased cost? NCGS 150B

- 21.4(a1) No

16. Local Government Unit Funds

- Does the proposed rule affect the expenditures or revenues of a unit of local government? NCGS 150B

- 21.4(b) Yes

17. Substantial Economic Impact Analysis

- Federal Rule Exemption

- Does this rule meet the criterion of Federal Exemption? NCGS 150B

21.4(b1) Yes 18. Technical Change

- Are only technical changes being incorporated such that public notice and rulemaking hearings are not required? NCGS 150B

- 21.5 No

19. Repeal of Regulatory Deadwood

- Is the rule obsolete? NCGS 150B

- 2(1b)

NCGS 150B

- 21.5(b) No

## 2

II. Certification Statement On January 22, 2010, Environmental Protection Agency (EPA) strengthened the health-based National Ambient Air Quality Standard (NAAQS) for nitrogen dioxide (NO 2 

## ). EPA is supplementing the existing annual standard for NO 2 

## of 53 parts per billion (ppb) by

es tablishing a new short-term standard based on the 3-year average of the 98th percentile of the yearly distribution of 1-hour daily maximum concentrations. EPA is setting the level of this new standard at 100 ppb. EPA is making changes in data handling conventions for NO 2 

## by adding provisions for this new 1-hour primary standard that new standard will protect public health, including the health of sensitive populations - people with asthma, children, and the elderly. EPA is also retaining, with no change, the current annual average NO 2 

## standard of 53 ppb.

For additional information on development of its national ambient air quality standards (NAAQS) for nitrogen dioxide see the following EPA website s: Final Rule (PDF) (65pp, 418k) - Federal Register - Feb 9, 2010 Fact Sheet (PDF) (5pp, 35k) Regulatory Impact Analysis (RIA) (PDF) (155pp, 2.6 MB)

Under section 110 of the CAA, 42 U.S.C. 7410, North Carolina is required to submit, for EPA approval, State Implementation Plan (SIP) that provide for the attainment and

maintenance of NO 2 

## standards through control programs directed at sources of NO 2 

## emissions. If North Carolina fails to adopt and implement the required SIP by the time periods provided in the CAA, the EPA has responsibility under the CAA to adopt a Federal Implementation Plan (FIP) to assure that areas attain the NAAQS in an expeditious manner.

The Division of Air Quality (DAQ), Ambient Monitoring section estimates that new nitrogen dioxide monitoring requirements may result in six required nitrogen dioxide monitors in the state of North Carolina. Four of these will be near-road monitors in metropolitan statistical areas with over 500,000 people. These four monitors will go in Durham, Guilford, Mecklenburg, and Wake Counties. The Durham, Guilford and Wake County near-road monitors will be located along the I-40 corridor. The Mecklenburg County near-road monitor will be located along one of the interstate highways in or near downtown Charlotte. The other two required monitors will be area-wide monitors located in metropolitan statistical areas with over one million people. There is already a nitrogen dioxide monitor operating in Charlotte that should meet the area-wide monitoring requirements so only one additional area-wide monitor will be required in Raleigh. This monitor may go at an existing site in Raleigh if the existing site meets the area-wide siting requirements.

The DAQ estimates it may cost $370,000 for new equipment and buildings to set up four near-road monitoring sites and to add a nitrogen dioxide monitor to the existing site in Raleigh. The United States Environmental Protection Agency (USEPA) is considering providing the State and local air program agencies with funds via the 103 Grant process for purchasing equipment to establish the network. The 103 Grant does not require matching funds and restricts the use of the funds to monitoring activities and expenses. At this time it is not clear if the 103 Grant funds will also cover the $28,000 estimated labor costs for ordering the equipment and setting up the sites. There may also be additional costs incurred by the North Carolina Department of Transportation to make the monitoring sites safe for

## 3

nearby high-speed traffic. In addition, DAQ estimates it may cost $100,000 a year for supplies and labor to operate the five new sites. Even if the USEPA increases the 105 Grant to provide additional funds to help with these ongoing costs DAQ would need to provide matching funds.

Although it is uncertain whether State or units of local government funds are affected, the amendment to the Rule 15A NCAC 02D .0407 does purport to implement a federal regulation, and therefore an impact statement is not required (G.S. 150B-21.4(b1). Instead, the agency submits a certification statement under NCGS 150B-21(f1) by the rule-making

coordinator.

## 1 

# Revision of Sulfur Dioxide and

Nitrogen Dioxide Ambient Air Nitrogen Dioxide Ambient Air Nitrogen Dioxide Ambient Quality Standards

1 

## Public Hearing

May 4, 2011



# Background

• Under Clean Air Act (CAA) Nitrogen Dioxide (NO2) and Under Clean Air Act (CAA)

, Nitrogen Dioxide (NO2) and Sulfur Dioxide (SO2) are “criteria pollutants”

• US EPA sets National Ambien t Air Quality Standards (NAAQS)

– Primary - protect public health

– Secondary – protect public welfare



## St t i d t d l St t I l t ti Pl

2 

## • St a t es requ i re d t o d eve l op St a t e I mp l emen t a ti on Pl an (SIP) to attain the standards

• US EPA required periodica lly review/revise NAAQS as

necessary

## 2 

# Early Steps in Implementing NAAQS

States must:

• Adopt Ambient Air Quality Standards

• Recommend Nonattainment Boundaries

• Establish Monitoring Network

3 

## Establish Monitoring Network



# Sulfur Dioxide (SO 2 

# )

June 2010 - New scientific studies provide stronger

evidence for link between short

- term SO 2 

## exposures evidence for link between short term SO exposures , ranging from 5 minutes to 24 hours, and adverse respiratory outcomes.

USEPA Revoked (effective 1 year after designations)

• Annual standard = 30 parts per billion (ppb)

• 24

- hr standard = 140 ppb

4 

## 24 hr standard 140 ppb

USEPA Set New 1-hr standard = 75 ppb

• 3-year average of the annual 99 th percentile of 1-hour daily max concentrations

## 3 

# Current SO 2 

# Design Values

ALLEGHANY

A SHE CAMDEN

CASWELL GATES NORTHAMPTON

PASQUOTANK PERSON ROCKINGHAM STOKES SURRY VANCE

ALAMANCE

ALEXANDER

ANSON AVERY

BEAUFORT BERTIE

BLADEN BUNCOMBE BURKE

CABARRUS CALDWELL

CARTERET CATAWBA CHATHAM

CHEROKEE CHOWAN

CLAY CLEVELAND

COLUMBUS CRAVEN

CUMBERLAND CURRITUCK

DARE DAVIDSON DAVIE

DUPLIN DURHAM

EDGECOMBE FORSYTH

FRANKLIN

GASTON GRAHAM GRANVILLE

GREENE GUILFORD HALIFAX

HARNETT HAYWOOD

HENDERSON HERTFORD

HOKE HYDE IREDELL

JACKSON JOHNSTON

JONES LEE

LENOIR LINCOLN MC DOWELL

MACON MADISON MARTIN

MECKLENBURG MITCHELL

MONTGOMERY MOORE NASH

NEW HANOVER ONSLOW ORANGE

PAMLICO PASQUOTANK

PENDER PERQUIMANS PERSON

PITT

POLK RANDOLPH

RICHMOND

ROBESON ROCKINGHAM

ROWAN

RUTHERFORD

SAMPSON

SCOTLAND STANLY STOKES SURRY

SWAIN

TRANSYLVANIA TYRRELL

UNION WAKE WARREN

WASHINGTON WATAUGA

WAYNE WILKES

WILSON YADKIN

YANCEY

31 20

40

110 14

County 2008-2010 Design

Values

5 BRUNSWICK New Hanover 110 ppb

Mecklenburg 40 ppb

Forsyth 20 ppb

Beaufort 31 ppb

Wake 14 ppb 

## Standard = 75 ppb



# 2009 SO2 Emissions Inventory New Hanover, Brunswick, Pender Counties

6

## 4 

# Sulfur Dioxide (SO 2 

# ) Nonattainment Boundary Recommendations

• NC DAQ developing boundary recommendations considering: recommendations considering:

Air Quality Data, Emissions-Related Data, Meteorology, Geography/Topography, Jurisdictional Boundaries



# • Focus on southeastern area of state (New Hanover, Brunswick, Pender County area)



# • Made 7 options available for comment

7 

# • Held public meetings

• Comment period closed April 30, 2011

• Boundary recommendations due to USEPA June 3, 2011



# Sulfur Dioxide (SO 2 

# ) Monitoring

Network

C Q • N DA developing proposed monitoring network plan based on USEPA population weighted emissions index (PWEI) criteria

• Will be incorporated in annual network monitoring plan - 30 day public comment period in ne t fe months

8 

# period in ne x t fe w months

• EPA reviews and approves plan

• Network operational by January 1, 2013

## 5 

# Sulfur Dioxide (SO 2 

# )

Deadline Milestone June 2010 EPA sets new primary SO2 standard June 2011 State boundary recommendations to EPA February 2012 EPA feedback on State recommendations April 2012 State deadline to respond to EPA feedback June 2012 EPA makes final designations January 2013 New SO2 monitoring operational

9 

## June 2013 State Plan for Attainment areas due February 2014 State Plan for Nonattainment areas due

August 2017 All areas attain the standard



# Sulfur Dioxide (SO 2 

# )

Challenges:

• V iolations in Wilmington

• Permitting

• Monitoring $$$

– NC needs 5 additional SO2 monitors (3 currently running)



### • ~$64,000 initial cost... ~$107,000 recurring annual costs 

# USEPA e pectations for Maintenance

10 

# • USEPA e x pectations for Maintenance

Plan due June 2013

– Modeling demonstrations necessary to show all sources contributing to (or have the potential to cause or contribute to)

monitored and modeled violations of the new standard.

– Awaiting USEPA guidance

## 6 

# Nitrogen Dioxide (NO 2 

# )

NO 2 

# is the indicator for entire NOx Group of Gases

NO i f f hi hl ti k

– 2 

## i s one o f a group o f hi g hl y reac ti ve gases k nown as oxides of nitrogen (NOx)

– Other oxides of nitrogen include nitrous acid and

nitric acid

– NO 2 

## is the component of NOx of greatest interest and

serves as the indicator for the entire NOx family

11



# Nitrogen Dioxide (NO 2 

# )

January 2010 – USEPA determined the existing primary annual average NO2 standard alone is primary annual average NO2 standard alone is
not sufficient to protect public health.

USEPA Retained

• Annual standard = 53 parts per billion (ppb)

12 

# USEPA Set New 1-hr standard = 100 ppb

• 3-year average of the annual 98 th 

### percentile of 1-hour daily max

concentrations

## 7 1-hr

.

13



# Nitrogen Dioxide (NO 2 

# )

December 2010 - NCDAQ submitted boundary

recommendations to USEPA recommendations to USEPA

• Attainment for Mecklenburg and Forsyth Counties

• Attainment / Unclassifiable for counties where

monitors will be needed

– Wake, Durham, Guilford

14

## 8 

# Nitrogen Dioxide (NO 2 

# ) Monitoring

Network

C Q • N DA developing proposed monitoring network plan based on USEPA criteria

• Near-road or roadside monitors (4)

• Community wide monitors (2)



# • Will be incorporated in annual network

it i l 30 d bli t

15 

# mon it or i ng p l an - 30 d ay pu bli c commen t period in next few months

• EPA reviews and approves plan

• Network operational by January 1, 2013



# Nitrogen Dioxide (NO 2 

# )

Challenges:

• Permitting

• Monitoring $$$

– NC needs 5 additional NO2 monitors (2 currently)



### • ~$400,000 initial cost... ~$100,000 recurring annual costs



# – Road-side monitors

16 

### • Safety?

• Access?

• Purpose... and future use of data?



# • USEPA expectations for Maintenance Plan

## 9 

# Nitrogen Dioxide (NO 2 

# )

Deadline Milestone January 2010 EPA sets new primary NO2 standard January 2011 State boundary recommendations to EPA January 2012 EPA makes final designations January 2013 New NO2 monitoring operational January 2015 Next EPA review of NO2 standard January 2016/17 Nonattainment re-des ignations based on new monitoring January 2021/22 All areas attain the standard

17



# Secondary Standards for SO 2 

# and NO 2



## • Public welfare standards

• Proposal by USEPA is scheduled for July 2011 Proposal by USEPA is scheduled for July 2011

18

## 10 

# Status of NAAQS

-Both revised primary NO2 and SO2
NAAQS tl i ff t NAAQS curren tl y i n e ff ec t
-Litigation

– SO2 Petition for Reconsideration and Motion for Stay denied

– Petition for Review of Denial filed

19 

# Petition for Review of Denial filed

– Court expected to consolidate

– NO2 Petition for Review filed

– Motion filed for extension of Briefing Schedule and Granted by Court



# Hearing Focus

-Incorporation of NAAQS into state ambient air

qua li ty r u l es ty u es

-15A NCAC 02D .0402, Sulfur Oxides

– Revokes Annual standard = 30 parts per billion (ppb) and 24-hr standard = 140 ppb 1 year after designations

– Adds New 1

- hr standard = 75 ppb

20 

# Adds New 1

- hr standard = 75 ppb



# -15A NCAC 02D .0407, Nitrogen Dioxide

– Adds New 1-hr standard = 100 ppb

## 11 

# Contact Information

Comment Period Closes May 31, 2011

Joelle Burleson, EIT
Rules Development Branch Supervisor
NC Division of Air Quality

(919) 733-1474

– Visit our web site:

htt // i /

21 • htt p: // www.nca i r.org /

• Joelle.Burleson@ncdenr.gov

## Tuesday,

June 22, 2010



# Part II



# Environmental Protection Agency

40 CFR Parts 50, 53, and 58
Primary National Ambient Air Quality Standard for Sulfur Dioxide; Final Rule


### 35520 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

**ENVIRONMENTAL PROTECTION**
**AGENCY**

**40 CFR Parts 50, 53, and 58**

**[EPA–HQ–OAR–2007–0352; 9160–4]**

**RIN 2060–A048**

**Primary National Ambient Air Quality**
**Standard for Sulfur Dioxide**

**AGENCY :**  Environmental Protection Agency (EPA).

**ACTION :**  Final rule.

**SUMMARY :**  Based on its review of the air quality criteria for oxides of sulfur and the primary national ambient air quality standard (NAAQS) for oxides of sulfur as measured by sulfur dioxide (SO 2 ), EPA is revising the primary SO 2 NAAQS to provide requisite protection of public health with an adequate margin of safety. Specifically, EPA is establishing a new 1-hour SO 2 standard at a level of 75 parts per billion (ppb), based on the 3-year average of the annual 99th percentile of 1-hour daily
maximum concentrations. The EPA is also revoking both the existing 24-hour and annual primary SO 2 standards.

**DATES :**  This final rule is effective on August 23, 2010.

**ADDRESSES :**  EPA has established a
docket for this action under Docket ID No. EPA–HQ–OAR–2007–0352. All
documents in the docket are listed on
the http://www.regulations.gov Web site. Although listed in the index, some information is not publicly available,

e.g., confidential business information
or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy form. Publicly available docket
materials are available either electronically through http:// www.regulations.gov or in hard copy at
the Air and Radiation Docket and Information Center, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave., 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 FURTHER INFORMATION CONTACT :**  Dr. Michael J. Stewart, Health and Environmental Impacts Division, Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Mail code C504–06, Research Triangle Park, NC 27711; telephone: 919–541– 7524; fax: 919–541–0237; e-mail: stewart.michael@epa.gov

.

**SUPPLEMENTARY INFORMATION :** 

Table of Contents

The following topics are discussed in this preamble:

I. Background

A. Summary of Revisions to the SO 2

Primary NAAQS B. Statutory Requirements
C. Related SO 2 Control Programs D. History of Reviews of the Primary

NAAQS for Sulfur Oxides E. Summary of Proposed Revisions to the

SO 2 Primary NAAQS F. Organization and Approach to Final SO 2

Primary NAAQS Decisions II. Rationale for Decisions on the Primary
Standards
A. Characterization of SO 2 Air Quality 1. Anthropogenic Sources and Current

Patterns of SO 2 Air Quality

2. SO 2 Monitoring
B. Health Effects Information 1. Short-Term (5-Minute to 24-Hour) SO 2

Exposure and Respiratory Morbidity
Effects a. Adversity of Short-Term Respiratory

Morbidity Effects 2. Health Effects and Long-Term Exposures

to SO 2 3. SO 2 -Related Impacts on Public Health C. Human Exposure and Health Risk

Characterization D. Approach for Determining Whether To

Retain or Revise the Current Standards E. Adequacy of the Current Standards 1. Rationale for Proposed Decision 2. Comments on the Adequacy of the

Current Standards a. Comments on EPA’s Interpretation of the

Epidemiologic Evidence b. Comments on EPA’s Interpretation of the

Controlled Human Exposure Evidence
c. Comments on EPA’s Characterization of

SO 2 -Associated Exposures and Health
Risks 3. Conclusions Regarding the Adequacy of

the Current 24-Hour and Annual
Standards
F. Conclusions on the Elements of a New

Short-Term Standard
1. Indicator a. Rationale for Proposed Decision
b. Comments on Indicator
c. Conclusions on Indicator 2. Averaging Time a. Rationale for Proposed Decision b. Comments on Averaging Time c. Conclusions on Averaging Time

3. Form a. Rationale for Proposed Decision
b. Comments on Form
c. Conclusions on Form
4. Level a. Rationale for Proposed Decision
b. Comments on Level
c. Conclusions on Level 5. Retaining or Revoking the Current 24-

Hour and Annual Standards a. Rationale for Proposed Decision b. Comments on Retaining or Revoking the

Current 24-Hour and Annual Standards c. Conclusions on Retaining or Revoking
the Current 24-Hour and Annual
Standards G. Summary of Decisions on Primary

Standards III. Overview of the Approach for Monitoring and Implementation IV. Amendments to Ambient Monitoring and Reporting Requirements A. Monitoring Methods 1. Requirements for SO 2 Federal Reference

Method (FRM) a. Proposed Ultraviolet Fluorescence SO 2

FRM and Implementation
b. Public Comments
c. Conclusions on Ultraviolet Fluorescence

SO 2 FRM and Implementation 2. Requirements for Automated SO 2

Methods a. Proposed Performance Specifications for

Automated Methods
b. Public Comments
c. Conclusions for Performance

Specifications for SO 2 Automated
Methods B. Network Design 1. Approach for Network Design a. Proposed Approach for Network Design b. Alternative Network Design
c. Public Comments 2. Modeling Ambient SO 2 Concentrations 3. Monitoring Objectives a. Proposed Monitoring Objectives
b. Public Comments c. Conclusions on Monitoring Objectives 4. Final Monitoring Network Design 5. Population Weighted Emissions Index a. Proposed Use of the Population

Weighted Emissions Index
b. Public Comments
c. Conclusions on the Use of the

Population Weighted Emissions Index 6. Regional Administrator Authority a. Proposed Regional Administrator

Authority
b. Public Comments c. Conclusions on Regional Administrator

Authority 7. Monitoring Network Implementation a. Proposed Monitoring Network

Implementation
b. Public Comments c. Conclusions on Monitoring Network

Implementation C. Data Reporting 1. Proposed Data Reporting
2. Public Comments 3. Conclusions on Data Reporting V. Initial Designation of Areas for the 1-Hour

SO 2 NAAQS A. Clean Air Act Requirements 1. Approach Described in Proposal
2. Public Comments B. Expected Designations Process VI. Clean Air Act Implementation Requirements A. How This Rule Applies to Tribes

B. Nonattainment Area Attainment Dates 1. Attaining the NAAQS 2. Consequences of a Nonattainment Area

Failing To Attain by the Statutory

Attainment Date C. Section 110(a)(1) and (2) NAAQS

Maintenance/Infrastructure Requirements 1. Section 110(a)(1)–(2) Submission


### 35521 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

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 comprising the sensitive group rather than to a single person in such a group. ’’ S. Rep. No. 91–1196, 91st Cong., 2d Sess. 10 (1970). See also American Lung Ass’n v. EPA, 134 F. 3d 388, 389 (DC Cir. 1998) ( ‘‘ NAAQS must protect not only average healthy individuals, but also ‘sensitive citizens’—children, for example, or people with asthma, emphysema, or other conditions rendering them particularly vulnerable to air pollution. If a pollutant adversely affects the health of these sensitive individuals, EPA must strengthen the
entire national standard. ’’ ); Coalition of Battery Recyclers Ass’n v. EPA, No. 09–1011 (DC Cir. May 14, 2010) slip op. at 7 (same). 2 EPA is currently conducting a separate review of the secondary SO 2 NAAQS jointly with a review of the secondary NO 2 NAAQS ( see http:// www.epa.gov/ttn/naaqs/standards/no2so2sec/
index.html for more information). D. Attainment Planning Requirements

1. SO 2 Nonattainment Area SIP

Requirements
2. New Source Review and Prevention of

Significant Deterioration Requirements 3. General Conformity E. Transition From the Existing SO 2

NAAQS to a Revised SO 2 NAAQS VII. Appendix T—Interpretation of the Primary NAAQS for Oxides of Sulfur and Revisions to the Exceptional Events
Rule A. Interpretation of the NAAQS for Oxides

of Sulfur 1. Proposed Interpretation of the Standard 2. Comments on Interpretation of the

Standard 3. Conclusions on Interpretation of the

Standard B. Exceptional Events Information

Submission Schedule
VIII. Communication of Public Health
Information IX. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory

Planning and Review B. Paperwork Reduction Act C. Regulatory Flexibility Act
D. Unfunded Mandates Reform Act
E. Executive Order 13132: Federalism
F. Executive Order 13175: Consultation

and Coordination With Indian Tribal

Governments
G. Executive Order 13045: Protection of

Children From Environmental Health & Safety Risks
H. Executive Order 13211: Actions That

Significantly Affect Energy Supply,
Distribution or Use I. National Technology Transfer and

Advancement Act J. Executive Order 12898: Federal Actions

To Address Environmental Justice in Minority Populations and Low-Income Populations
References

I. Background

A. Summary of Revisions to the SO 2 Primary NAAQS

Based on its review of the air quality
criteria for oxides of sulfur and the primary national ambient air quality standard (NAAQS) for oxides of sulfur as measured by sulfur dioxide (SO 2 ), EPA is making revisions to the primary

SO 2 NAAQS so the standards are requisite to protect public health with an adequate margin of safety, as appropriate under section 109 of the Clean Air Act (Act or CAA). Specifically, EPA is replacing the
current 24-hour and annual standards
with a new short-term standard based on the 3-year average of the 99th percentile of the yearly distribution of 1-hour daily maximum SO 2 concentrations. EPA is setting the level of this new standard at 75 ppb. EPA is adding data handling conventions for

SO 2 by adding provisions for this new 1-hour primary standard. EPA is also establishing requirements for an SO 2 monitoring network. These new provisions require monitors in areas
where there is an increased coincidence of population and SO 2 emissions. EPA is also making conforming changes to the Air Quality Index (AQI).

B. Statutory Requirements

Two sections of the Clean Air Act (Act or CAA) govern the establishment
and revision of National Ambient Air Quality Standards NAAQS. Section 108
of the Act directs the Administrator to identify and list air pollutants that meet certain criteria, including that the air pollutant ‘‘ in his judgment, cause[s] or contribute[s] to air pollution which may reasonably be anticipated to endanger public health and welfare ’’ and ‘‘ the presence of which in the ambient air
results from numerous or diverse mobile or stationary sources. ’’ CAA section 108(a)(1)(A) and (B). For those air pollutants listed, section 108 requires the Administrator to issue air quality
criteria that ‘‘ accurately reflect the latest scientific knowledge useful 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 ambient air

*** ’’ Section 108(a)(2).

Section 109(a) of the Act directs the Administrator to promulgate ‘‘ primary ’’
and ‘‘ secondary ’’ NAAQS for pollutants for which air quality criteria have been 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 [the air quality] criteria and allowing an adequate margin of safety, are requisite to protect the public health. ’’ 1 Section 109(b)(1). A secondary standard, in turn,

must ‘‘ specify a level of air quality the attainment and maintenance of which, in the judgment of the Administrator, based on [the air quality] criteria, is requisite to protect the public welfare from any known or anticipated adverse effects associated with the presence of such pollutant in the ambient air. ’’ 2 Section 109(b)(2) This rule concerns exclusively the primary NAAQS for
oxides of sulfur.

The requirement that primary standards include an adequate margin of safety is intended to address
uncertainties associated with
inconclusive scientific and technical
information available at the time of standard setting. It is also intended to provide a reasonable degree of protection against hazards that research has not yet identified. Lead Industries

Association v. EPA, 647 F.2d 1130, 1154 (DC Cir 1980), cert. denied, 449 U.S. 1042 (1980); American Petroleum

Institute v. Costle, 665 F.2d 1176, 1186 (DC Cir. 1981), cert. denied, 455 U.S. 1034 (1982). 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 scientific certainty. Thus, in selecting primary standards that include an adequate margin of safety, the Administrator is seeking not only to prevent pollution
levels that have been demonstrated to be harmful but also to prevent lower pollutant levels that may pose 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 levels, see Lead Industries Association v. EPA, 647 F.2d at 1156 n. 51, 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 a margin of safety, EPA considers such factors as the nature and severity of the health effects involved, the size of the at-risk population(s), and the kind and degree of the uncertainties that must be addressed. The selection of any particular approach to providing an adequate margin of safety is a policy choice left specifically to the Administrator’s judgment. Lead
Industries Association v. EPA, 647 F.2d

at 1161–62.

In setting standards that are

‘‘ requisite ’’ to protect public health and welfare, as provided in section 109(b),
EPA’s task is to establish standards that are neither more nor less stringent than necessary for these purposes. In so doing, EPA may not consider the costs of implementing the standards.
Whitman v. American Trucking


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Associations, 531 U.S. 457, 471, 475–76 (2001).

Section 109(d)(1) of the Act requires the Administrator to periodically undertake a thorough review of the air quality criteria published under section 108 and the NAAQS and to revise the criteria and standards as may be appropriate. The Act also requires the Administrator to appoint an independent scientific review committee composed of seven members, including at least one member of the National Academy of Sciences, one physician, and one person representing State air pollution control agencies, to review the air quality criteria and NAAQS and to ‘‘ recommend to the Administrator any new * * * standards and revisions of existing criteria and standards as may be appropriate under section 108 and subsection (b) of this

section. ’’ CAA section 109(d)(2). This independent review function is performed by the Clean Air Scientific Advisory Committee (CASAC) of EPA’s Science Advisory Board.

C. Related SO 2 Control Programs

States are primarily responsible for ensuring attainment and maintenance of ambient air quality standards once EPA
has established them. Under section 110 of the Act, and related provisions, States are to submit, for EPA approval, State implementation 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 EPA, also administer the prevention of significant deterioration program that covers these pollutants. See CAA sections 160–169. In addition, Federal programs provide
for nationwide reductions in emissions of these and other air pollutants through
the Federal motor vehicle and motor vehicle fuel control program under title II of the Act (CAA sections 202–250)
which involves controls for emissions from all moving sources and controls for the fuels used by these sources; new source performance standards under section 111; and title IV of the Act (CAA sections 402–416), which specifically provides for major reductions in SO 2 emissions. EPA has also promulgated the Clean Air Interstate Rule (CAIR) to require additional SO 2 emission
reductions needed in the eastern half of
the United States to address emissions which contribute significantly to nonattainment with, or interfere with maintenance of, the PM NAAQS by downwind States in the CAIR region. This rule was remanded by the DC Circuit, and although it remains in effect, EPA is reevaluating it pursuant to
the court remand.

Currently, there are several areas designated as being in nonattainment of the primary SO 2 NAAQS ( see section VI). Moreover, as a result of this final rule, additional areas could be classified
as non-attainment. Certain States would then be required to develop SIPs that identify and implement specific air pollution control measures to reduce
ambient SO 2 concentrations to attain
and maintain the revised SO 2 NAAQS, most likely by requiring air pollution
controls on sources that emit oxides of sulfur (SO

x ).

D. History of Reviews of the Primary NAAQS for Sulfur Oxides

On April 30, 1971, the EPA promulgated primary SO 2 NAAQS (36 FR 8187). These primary standards, which were based on the findings outlined in the original 1969 Air Quality Criteria for Sulfur Oxides, were set at 0.14 parts per million (ppm) averaged over a 24-hour period, not to be exceeded more than once per year, and 0.030 ppm annual arithmetic mean. In 1982, EPA published the Air Quality
Criteria for Particulate Matter and Sulfur Oxides (EPA, 1982) along with an addendum of newly published controlled human exposure studies, which updated the scientific criteria upon which the initial standards were based (EPA, 1982). In 1986, EPA published a second addendum presenting newly available evidence from epidemiologic and controlled human exposure studies (EPA, 1986). In 1988, EPA published a proposed decision not to revise the existing standards (53 FR 14926) (April 26, 1988). However, EPA specifically requested public comment on the alternative of revising the current standards and adding a new 1-hour primary standard of 0.4 ppm (400 ppb) to protect asthmatics against 5–10 minute peak SO 2 concentrations.

As a result of public comments on the 1988 proposal and other post-proposal developments, EPA published a second proposal on November 15, 1994 (59 FR 58958). The 1994 re-proposal was based in part on a supplement to the second addendum of the criteria document, which evaluated new findings on 5–10

minute SO 2 exposures in asthmatics (EPA, 1994a; EPA, 1994b). As in the 1988 proposal, EPA proposed to retain the existing 24-hour and annual
standards. EPA also solicited comment on three regulatory alternatives to further reduce the health risk posed by exposure to high 5-minute peaks of SO 2 if additional protection were judged to be necessary. The three alternatives were: (1) Revising the existing primary

SO 2 NAAQS by adding a new 5-minute standard of 0.6 ppm (600 ppb) SO 2 ; (2) establishing a new regulatory program
under section 303 of the Act to supplement protection provided by the existing NAAQS, with a trigger level of 0.6 ppm (600 ppb) SO 2 , one expected exceedance; and (3) augmenting implementation of existing standards by focusing on those sources or source types likely to produce high 5-minute peak concentrations of SO 2

.

On May 22, 1996, EPA announced its final decision not to revise the NAAQS
for SO

x (61 FR 25566). EPA found that asthmatics—a susceptible population group—could be exposed to short-term

SO 2 bursts resulting in repeated ‘exposure events’ such that tens or
hundreds of thousands of asthmatics could be exposed annually to lung
function effects ‘‘ distinctly exceeding * * * [the] typical daily variation in lung function ’’ that asthmatics routinely experience, and found further that repeated occurrences should be regarded as significant from a public health standpoint. 61 FR at 25572, 25573. Nonetheless, the agency
concluded that ‘‘ the likelihood that asthmatic individuals will be exposed * * * is very low when viewed from a national perspective ’’ , that ‘‘ 5-minute peak SO[ 2 ] levels do not pose a broad public health problem when viewed from a national perspective ’’ , and that

‘‘ short-term peak concentrations of SO[ 2 ] do not constitute the type of ubiquitous public health problem for which establishing a NAAQS would be appropriate. ’’ Id. at 25575. EPA concluded, therefore, that it would not revise the existing standards or add a standard to specifically address 5- minute exposures. EPA also announced an intention to propose guidance, under section 303 of the Act, to assist States in responding to short-term peaks of

SO 2 and later initiated a rulemaking to do so (62 FR 210 (Jan. 2, 1997).

The American Lung Association and
the Environmental Defense Fund challenged EPA’s decision not to
establish a 5-minute standard. On January 30, 1998, the Court of Appeals
for the District of Columbia Circuit found that EPA had failed to adequately explain its determination that no
revision to the SO 2 NAAQS was appropriate and remanded the
determination back to EPA for further explanation. American Lung Ass’n v. EPA, 134 F. 3d 388 (DC Cir. 1998). Specifically, the court held that EPA had failed to adequately explain the
basis for its conclusion that short-term

SO 2 exposures to asthmatics do not constitute a public health problem,


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noting that the agency had failed to explain the link between its finding that repeated short-term exposures were significant, and that there would be tens
to hundreds of thousands of such exposures annually to a susceptible subpopulation. 134 F. 3d at 392. The court also rejected the explanation that
short-term SO 2 bursts were ‘‘ localized, infrequent, and site-specific ’’ as a rational basis for the conclusion that no public health problem existed for purposes of section 109: ‘‘ [N]othing in the Final Decision explains why ‘localized’, ‘site-specific’, or even ‘infrequent’ events might nevertheless create a public health problem, particularly since, in some sense, all pollution is local and site-specific

*** ’’

. Id. The court accordingly remanded the case to EPA to adequately explain its determination or otherwise
take action in accordance with the opinion. In response, EPA has collected and analyzed additional air quality data
focused on 5-minute concentrations of

SO 2. These air quality analyses conducted since the last review helped inform the current review, which (among other things) address the issues
raised in the court’s remand of the Agency’s last decision.

EPA formally initiated the current review of the air quality criteria for
oxides of sulfur and the SO 2 primary NAAQS on May 15, 2006 (71 FR 28023) with a general call for information. EPA’s draft Integrated Review Plan for the Primary National Ambient Air Quality Standards for Sulfur Dioxide (EPA, 2007a) was made available in April 2007 for public comment and was discussed by the CASAC via a publicly accessible teleconference on May 11, 2007. As noted in that plan, SO X includes multiple gaseous ( e.g., SO 3 ) and particulate ( e.g., sulfate) species.
Because the health effects associated with particulate species of SO X have
been considered within the context of the health effects of ambient particles in the Agency’s review of the NAAQS for particulate matter (PM), the current review of the primary SO 2 NAAQS is focused on the gaseous species of SO X and does not consider health effects directly associated with particulate species.

The first draft of the Integrated
Science Assessment for Oxides of Sulfur-Health Criteria (ISA) and the
Sulfur Dioxide Health Assessment Plan: Scope and Methods for Exposure and Risk Assessment (EPA, 2007b) were reviewed by CASAC at a public meeting held on December 5–6, 2007. Based on
comments received from CASAC and from the public, EPA developed the
second draft of the ISA and the first draft of the Risk and Exposure Assessment to Support the Review of
the SO 2 Primary National Ambient Air Quality Standard (Risk and Exposure Assessment (REA)). These documents were reviewed by CASAC at a public meeting held on July 30–31, 2008. Based
on comments received from CASAC and the public at this meeting, EPA released the final ISA in September of 2008 (EPA, 2008a; henceforth referred to as ISA). In addition, comments received were considered in developing the second draft of the REA. Importantly,
the second draft of the REA contained a draft staff policy assessment that considered the evidence presented in the final ISA and the air quality, exposure, and risk characterization results presented in the second draft REA, as they related to the adequacy of
the current SO 2 NAAQS and potential alternative primary SO 2 standards. This document was reviewed by CASAC at a public meeting held on April 16–17, 2009. In preparing the final REA report, which included the final staff policy assessment, EPA considered comments received from CASAC and the public at and subsequent to that meeting. The final REA containing the final staff policy assessment was completed in August 2009 (EPA 2009a; henceforth referred to as REA)).

On December 8, 2009 EPA published its proposed revisions to the primary

SO 2 NAAQS. 74 FR 64810 presented a number of conclusions, findings, and determinations proposed by the Administrator. EPA invited general, specific, and/or technical comments on all issues involved with this proposal, including all such proposed judgments, conclusions, findings, and determinations. EPA invited specific comment on the level, or range of levels, appropriate for such a standard, as well as on the rationale that would support that level or range of levels. These comments were carefully considered by
the Administrator as she made her final decisions, as described in this notice, on the primary SO 2 NAAQS

The schedule for completion of this review is governed by a judicial order resolving a lawsuit filed in September 2005, concerning the timing of the

current review. Center for Biologic Diversity v. Johnson (Civ. No. 05–1814) (D.D.C. 2007). The order that now governs this review, entered by the court in August 2007 and amended in December 2008, provides that the Administrator will sign, for publication, a final rulemaking concerning the review of the primary SO 2 NAAQS no later than June 2, 2010. E. Summary of Proposed Revisions to
the SO 2 Primary NAAQS

For the reasons discussed in the preamble of the proposal for the SO 2 primary NAAQS, EPA proposed to make revisions to the primary SO 2 NAAQS (and to add SO 2 data handling conventions) so the standards provide requisite protection of public health with an adequate margin of safety. Specifically, EPA proposed to replace
the current 24-hour and annual
standards with a new short-term SO 2 standard. EPA proposed that this new
short-term standard would be based on the 3-year average of the 99th percentile (or 4th highest) of the yearly distribution of 1-hour daily maximum

SO 2 concentrations. EPA proposed to set
the level of this new 1-hour standard within the range of 50 to 100 ppb and
solicited comment on standard levels as high as 150 ppb. EPA also proposed to establish requirements for an SO 2 monitoring network at locations where

maximum SO 2 concentrations are expected to occur and to add a new Federal Reference Method (FRM) for measuring SO 2 in the ambient air. Finally, EPA proposed to make corresponding changes to the Air Quality Index for SO 2

. F. Organization and Approach to Final

SO 2 Primary NAAQS Decisions
This action presents the
Administrator’s final decisions regarding the need to revise the current

SO 2 primary NAAQS, and what those
revisions should be. Revisions to the primary NAAQS for SO 2 , and the rationale supporting those revisions, are
described below in section II.

An overview of the approach for monitoring and implementation is presented in section III. Requirements
for the SO 2 ambient monitoring network and for a new, additional FRM for measuring SO 2 in the ambient air are
described in section IV. EPA’s current plans for designations and for implementing the revised SO 2 primary NAAQS are discussed in sections V and VI respectively. Related requirements for data completeness, data handling, data reporting, rounding conventions, and exceptional events are described in section VII. Communication of public health information through the AQI is
discussed in section VIII. A recitation of statutory authority and a discussion of
those executive order reviews which are relevant are provided in section IX.

Today’s final decisions are based on a thorough review in the ISA of
scientific information on known and potential human health effects associated with exposure to SO 2 in the


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3 A small number of sites, 98 total from 1997 to 2007 of the approximately 500 SO 2 monitors, and not the same sites in all years, voluntarily reported 5-minute block average data to AQS (ISA, section 2.5.2). Of these, 16 reported all twelve 5-minute averages in each hour for at least part of the time between 1997 and 2007. The remainder reported only the maximum 5-minute average in each hour. air. These final decisions also take into account: (1) Assessments in the REA of the most policy-relevant information in the ISA as well as quantitative exposure and risk analyses based on that information; (2) CASAC Panel advice and recommendations, as reflected in its
letters to the Administrator and its public discussions of the ISA and REA; (3) public comments received during the development of the ISA and REA; and (4) public comments received on EPA’s notice of proposed rulemaking.

II. Rationale for Decisions on the Primary Standards

This section presents the rationale for
the Administrator’s decision to revise the existing SO 2 primary standards by replacing the current 24-hour and
annual standards with a new 1-hour SO 2 standard at a level of 75 ppb, based on the 3-year average of the annual 99th percentile of 1-hour daily maximum concentrations. As discussed more fully below, this rationale takes into account: (1) Judgments and conclusions presented in the ISA and the REA; (2)
CASAC advice and recommendations as reflected in the CASAC panel’s
discussions of drafts of the ISA and REA at public meetings, in separate written comments, and in letters to the Administrator (Henderson 2008a; Henderson 2008b; Samet, 2009); (3) public comments received at CASAC meetings during the development of the ISA and the REA; and (4) public
comments received on the notice of proposed rulemaking.

In reaching this decision, EPA has drawn upon an integrative synthesis of the entire body of evidence on human
health effects associated with the presence of SO 2 in the ambient air, and upon the results of the quantitative exposure and risk assessments reflecting this evidence. As discussed below, this body of evidence addresses a broad range of health endpoints associated with exposure to SO 2 in the ambient air. In considering this entire body of evidence, EPA chose to focus most on those health endpoints for which the ISA found the strongest evidence of an
association with SO 2 ( see section II.B below). Thus, the rationale for this final
decision on the SO 2 NAAQS focused primarily on respiratory morbidity following short-term (5-minutes to 24- hours) exposure to SO 2, for which the ISA found a causal relationship.

As discussed below, a substantial
amount of new research has been
conducted since EPA’s last review of the

SO 2 NAAQS, with important new information coming from epidemiologic studies in particular. In addition to the
substantial amount of new epidemiologic research, the ISA
considered a limited number of new controlled human exposure studies and re-evaluated key older controlled human exposure studies. In evaluating both the new and key older controlled human exposure studies, the ISA utilized updated guidelines published by the American Thoracic Society (ATS)
on what constitutes an adverse effect of air pollution ( see ISA, section 3.1.3; p. 3–4). Importantly, all controlled human exposure and epidemiologic studies evaluated in the ISA have undergone intensive scrutiny through multiple layers of peer review and opportunities for public review and comment. Thus,
the review of this information has been
extensive and deliberate.

After a background discussion of the principal emitting sources and current patterns of SO 2 air quality and a description of the current SO 2 monitoring network from which those air quality patterns are obtained (section II.A), the remainder of this section
discusses the Administrator’s rationale for her final decisions on the primary
standards. Section II.B includes an
overview of the scientific evidence related to the respiratory effects
associated with ambient SO 2 exposure. This overview includes a discussion of the at-risk populations considered in the ISA. Section II.C summarizes the key approaches taken by EPA to assess exposures and health risks associated with exposure to ambient SO 2 . Section II.D summarizes the approach that was
used in the current review of the SO 2 NAAQS with regard to consideration of
the scientific evidence and the air quality, exposure, and risk-based results related to the adequacy of the current standards and potential alternative standards. Sections II.E and II.F discuss, respectively, the Administrator’s decisions regarding the adequacy of the
current standards and the elements of a new short-term standard, taking into consideration public comments on the proposed decisions. Section II.G
summarizes the Administrator’s decisions with regard to the SO 2 primary NAAQS.

A. Characterization of SO 2 Air Quality

1. Anthropogenic Sources and Current
Patterns of SO 2 Air Quality

Anthropogenic SO 2 emissions originate chiefly from point sources,
with fossil fuel combustion at electric utilities (

∼ 66%) and other industrial facilities (

∼ 29%) accounting for the majority of total emissions (ISA, section 2.1). Other anthropogenic sources of

SO 2 include both the extraction of metal from ore as well as the burning of high sulfur-containing fuels by locomotives, large ships, and equipment utilizing diesel engines. SO 2 emissions and ambient concentrations follow a strong east to west gradient due to the large numbers of coal-fired electric generating units in the Ohio River Valley and upper Southeast regions. In the 12 Consolidated Metropolitan Statistical Areas (CMSAs) that had at least four

SO 2 regulatory monitors from 2003– 2005, 24-hour average concentrations in the continental U.S. ranged from a reported low of

∼ 1 ppb in Riverside, CA and San Francisco, CA to a high of

∼ 12 ppb in Pittsburgh, PA and Steubenville, OH (ISA, section 2.5.1). In addition,
outside or inside all CMSAs from 2003– 2005, the annual average SO 2 concentration was 4 ppb (ISA, Table 2– 8). However, spikes in hourly
concentrations occurred. The mean 1-
hour maximum concentration outside or inside CMSAs was 13 ppb, with a maximum value of greater than 600 ppb outside CMSAs and greater than 700 ppb inside CMSAs (ISA, Table 2–8).

Temporal and spatial patterns of 5- minute peaks of SO 2 are also important given that controlled human exposure
studies have demonstrated that exposure to these peaks can result in adverse respiratory effects in exercising asthmatics ( see section II.B below). For those monitors which voluntarily reported 5-minute block average data, 3
when maximum 5-minute concentrations were reported, the absolute highest concentration over the ten-year period exceeded 4000 ppb, but for all individual monitors, the 99th percentile was below 200 ppb (ISA, section 2.5.2 Table 2–10). Median
concentrations from these monitors reporting 5-minute data ranged from 1 ppb to 8 ppb, and the average for each maximum 5-minute level ranged from 3 ppb to 17 ppb. Delaware, Pennsylvania, Louisiana, and West Virginia had mean values for maximum 5-minute data exceeding 10 ppb. Among aggregated within-State data for the 16
monitors from which all 5-minute average intervals were reported, the median values ranged from 1 ppb to 5 ppb, and the means ranged from 3 ppb to 11 ppb (ISA, section 2.5.2 at 2–43). The highest reported concentration was 921 ppb, but the 99th percentile values


### 35525 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

4 A causal relationship is based on ‘‘ [e]vidence [that] is sufficient to conclude that there is a causal relationship between relevant pollutant exposures and the health outcome. That is, a positive
association has been observed between the pollutant and the outcome in studies in which chance, bias, and confounding could be ruled out with reasonable confidence. Evidence includes, for example, controlled human exposure studies; or observational studies that cannot be explain by plausible alternatives or are supported by other lines of evidence ( e.g. animal studies or mechanism of action information). Evidence includes replicated and consistent high-quality studies by multiple investigators. ’’ ISA Table 1–2, at 1–11. for aggregated within-State data were all below 90 ppb ( id ).

2. SO 2 Monitoring

Although EPA established the SO 2 standards in 1971, uniform minimum monitoring network requirements for

SO 2 monitoring were only adopted in May 1979. From the time of the implementation of the 1979 monitoring rule through 2008, the SO 2 monitoring network has steadily decreased in size from approximately 1496 sites in 1980 to the approximately 488 sites operating in 2008. At present, except for SO 2 monitoring required at National Core Monitoring Stations (NCore stations), there are no minimum monitoring requirements for SO 2 in 40 CFR part 58 Appendix D, other than a requirement for EPA Regional Administrator approval before removing any existing monitors and a requirement that any ongoing SO 2 monitoring must have at
least one monitor sited to measure the
maximum concentration of SO 2 in that area. EPA removed the specific minimum monitoring requirements for

SO 2 in the 2006 monitoring rule revisions, except for monitoring at NCore stations, based on the fact that
there were no SO 2 nonattainment areas at that time, coupled with trends showing an increasing gap between national average SO 2 concentrations and
the current 24-hour and annual
standards. The rule was also intended to provide State, local, and Tribal air monitoring agencies flexibility in meeting perceived higher priority monitoring needs for other pollutants, or to implement the new multi-pollutant sites (NCore network) required by the 2006 rule revisions (71 FR 61236, (October 6, 2006)). More information on

SO 2 monitoring can be found in section

IV.

B. Health Effects Information

The ISA concluded that there was
sufficient evidence to infer a ‘‘ causal relationship ’’ between respiratory morbidity and short-term (5-minutes to 24-hours) exposure to SO 2 (ISA, section 5.2). Importantly, we note that a ‘‘ causal relationship ’’ is the strongest finding the
ISA can make. 4 This conclusion was based on the consistency, coherence, and plausibility of findings observed in controlled human exposure studies of 5–10 minutes, epidemiologic studies mostly using 1-hour daily maximum and 24-hour average SO 2 concentrations, and animal toxicological studies using exposures of minutes to hours (ISA, section 5.2). This evidence is briefly summarized below and discussed in more detail in the proposal ( see sections II.B.1 to II.B.5, see 74 FR at 64815–821). We also note that the ISA judged evidence of an association
between SO 2 exposure and other health categories to be less convincing; other associations were judged to be suggestive but not sufficient to infer a causal relationship ( i.e., short-term exposure to SO 2 and mortality) or inadequate to infer the presence or absence of a causal relationship ( i.e., short-term exposure to

SO 2 and cardiovascular morbidity, and long-term exposure to SO 2 and respiratory morbidity, other morbidity, and mortality). Key conclusions from the ISA are described in greater detail in
Table 5–3 of the ISA.

1. Short-Term (5-minute to 24-hour) SO 2 Exposure and Respiratory Morbidity
Effects

The ISA examined numerous controlled human exposure studies and found that moderate or greater decrements in lung function ( i.e., ≥ 15% decline in Forced Expiratory Volume (FEV 1 ) and/or ≥ 100% increase in specific airway resistance (sRaw)) occur in some exercising asthmatics exposed

to SO 2 concentrations as low as 200–300 ppb for 5–10 minutes. The ISA also found that among asthmatics, both the percentage of individuals affected, and the severity of the response increased with increasing SO 2 concentrations. That is, at 5–10 minute concentrations ranging from 200–300 ppb, the lowest levels tested in free breathing chamber studies, approximately 5–30% percent of exercising asthmatics experienced moderate or greater decrements in lung function (ISA, Table 3–1). At concentrations of 400–600 ppb, moderate or greater decrements in lung function occurred in approximately 20– 60% of exercising asthmatics, and compared to exposures at 200–300 ppb, a larger percentage of asthmatics experienced severe decrements in lung function ( i.e., ≥ 20% decrease in FEV 1 and/or ≥ 200% increase in sRaw; ISA, Table 3–1). Moreover, at SO 2 concentrations ≥ 400 ppb (5–10 minute exposures), moderate or greater decrements in lung function were often statistically significant at the group mean level and frequently accompanied by respiratory symptoms. Id.

The ISA also found that in locations meeting the current SO 2 NAAQS, numerous epidemiologic studies reported positive associations between
ambient SO 2 concentrations and respiratory symptoms in children, as well as emergency department visits and hospitalizations for all respiratory causes and asthma across multiple age groups. Moreover, the ISA concluded that these epidemiologic studies were
consistent and coherent. This evidence
was consistent in that associations were reported in studies conducted in numerous locations and with a variety of methodological approaches (ISA, section 5.2; p. 5–5). It was coherent in that respiratory symptom results from epidemiologic studies of short-term (predominantly 1-hour daily maximum or 24-hour average) SO 2 concentrations were generally in agreement with respiratory symptom results from controlled human exposure studies of
5–10 minutes. These results were also coherent in that the respiratory effects observed in controlled human exposure
studies of 5–10 minutes further provided a basis for a progression of respiratory morbidity that could lead to the increased emergency department visits and hospital admissions observed in epidemiologic studies (ISA, section 5.2; p. 5–5). In addition, the ISA found that when evaluated as a whole, SO 2 effect estimates in multi-pollutant models generally remained positive andrelatively unchanged when copollutants were included. Therefore, although recognizing the uncertainties associated with separating the effects of

SO 2 from those of co-occurring pollutants, the ISA concluded that ‘‘ the
limited available evidence indicates that
the effect of SO 2 on respiratory health outcomes appears to be generally robust and independent of the effects of gaseous co-pollutants, including NO 2 and O 3 , as well as particulate copollutants, particularly PM 2.5 ’’ (ISA, section 5.3; p. 5–9).

The ISA also found that the respiratory effects of SO 2 were consistent with the mode of action as it is currently understood from animal toxicological and controlled human exposure studies (ISA, section 5.2; p. 5– 2). The immediate effect of SO 2 on the respiratory system is bronchoconstriction. This response is mediated by chemosensitive receptors
in the tracheobronchial tree. Activation of these receptors triggers central nervous system reflexes that result in


### 35526 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

5 We also note that very young children were not included in the controlled human exposure studies and this absence of data on what is likely to be a sensitive life stage is a source of uncertainty for children’s susceptibility to SO 2

. bronchoconstriction and respiratory symptoms that are often followed by rapid shallow breathing ( id ). The ISA noted that asthmatics are likely more sensitive to the respiratory effects of SO 2 due to pre-existing inflammation
associated with the disease. For example, pre-existing inflammation may
lead to enhanced release of inflammatory mediators, and/or
enhanced sensitization of the chemosensitive receptors ( id ).

Taken together, the ISA concluded that the controlled human exposure, epidemiologic, and toxicological evidence supported its determination of a causal relationship between respiratory morbidity and short-term (5- minutes to 24-hours) exposure to SO 2

. a. Adversity of Short-Term Respiratory Morbidity Effects

As discussed more fully in the proposal (section II.B.1.c, 74 FR at 64817) and in section II.E.2.b below, based on: (1) American Thoracic Society (ATS) guidelines; (2) advice and recommendations from CASAC ( see specific consensus CASAC comments in sections II.E.2.b and II.F.4.b below); and (3) conclusions from previous NAAQS reviews, EPA found that 5–10 minute exposures to SO 2 concentrations at least as low as 200 ppb can result in adverse health effects in some asthmatics ( i.e., 5–30% of the tested individuals in controlled human exposure studies of 200–300 ppb). As just mentioned, at SO 2 concentrations ≥ 400 ppb, controlled human exposure studies have reported decrements in lung function that are often statistically significant at the group mean level, and that are frequently accompanied by respiratory symptoms. Being mindful that the ATS guidelines specifically indicate decrements in lung function with accompanying respiratory symptoms as being adverse ( see proposal section II.B.1.c, 74 FR at 64817 and section II.E.2.b below), exposure to 5–10 minute

SO 2 concentrations ≥ 400 ppb can result in health effects that are clearly adverse.

The ATS also indicated that exposure to air pollution that increases the risk of an adverse effect to a population is adverse, even though it may not increase the risk of any individual to an unacceptable level (ATS 2000; see proposal section II.B.1.c, 74 FR at 64817). As an example, ATS states:

A population of children with asthma could have a distribution of lung function
such that no individual child has a level associated with significant impairment. Exposure to air pollution could shift the
distribution toward lower levels without bringing any individual child to a level that is associated with clinically relevant consequences. Individuals within the population would, however, have
diminished reserve function and are at potentially increased risk if affected by another agent, e.g., a viral infection. Assuming that the relationship between the risk factor and the disease is causal, the
committee considered that such a shift in the risk factor distribution, and hence the risk profile of the exposed population, should be considered adverse, even in the absence of
the immediate occurrence of frank illness (ATS 2000, p. 668).

As mentioned above, the ISA reported that exposure to SO 2 concentrations as low as 200–300 ppb for 5–10 minutes results in approximately 5–30% of exercising asthmatics experiencing moderate or greater decrements in lung function (defined in terms of a ≥ 15%
decline in FEV 1 or 100% increase in sRaw; ISA, Table 3–1). Even though these results were not statistically significant at the group mean level, in light of EPA’s interpretation of how to apply the ATS guidelines for defining an adverse effect, as described above,
the REA found that these results could reasonably indicate an SO 2 -induced shift in these lung function
measurements for this subset of the population. As a result, an appreciable percentage of exercising asthmatics exposed to SO 2 concentrations as low as 200 ppb would be expected to have diminished reserve lung function and would be expected to be at greater risk if affected by another respiratory agent, for example, viral infection. Importantly, as explained immediately above, diminished reserve lung function in a population that is attributable to air pollution is considered an adverse effect under ATS guidance. In addition to the 2000 ATS guidelines, the REA was also mindful of previous CASAC recommendations (Henderson 2006) and NAAQS review conclusions (EPA 2006, EPA 2007d) indicating that moderate decrements in lung function can be clinically significant in some asthmatics (discussed in detail below, see section II.E.2.b). The REA further considered that subjects participating in these controlled human exposure studies do
not include severe asthmatics and that it was reasonable to presume that persons with more severe asthma than the study participants would have a
more serious health effect from shortterm exposure to 200 ppb SO 2. 5 Taken together, the REA concluded that exposure to SO 2 concentrations at least as low as 200 ppb can result in adverse health effects in asthmatics and that this conclusion was in agreement with
consensus CASAC comments and recommendations expressed during the

current SO 2 NAAQS review ( see sections II.E.2.b and II.F.4.b below).

In addition to the controlled human exposure evidence, epidemiologic
studies also indicate that adverse respiratory morbidity effects are
associated with SO 2 (REA, section 4.3). As mentioned above, in reaching the conclusion of a causal relationship between respiratory morbidity and
short-term SO 2 exposure, the ISA generally found positive associations
between ambient SO 2 concentrations and emergency department visits and hospitalizations for all respiratory causes and asthma. Notably, emergency department visits, hospitalizations, episodic respiratory illness, and aggravation of respiratory diseases ( e.g. asthma) attributable to air pollution are
considered adverse health effects under ATS guidelines.

2. Health Effects and Long-Term Exposures to SO 2

There were numerous studies published since the last review examining possible associations between long-term SO 2 exposure and mortality and morbidity (respiratory morbidity, carcinogenesis, adverse prenatal and neonatal outcomes) endpoints. However, the ISA concluded that the evidence relating long-term (weeks to years) SO 2 exposure to adverse health effects was ‘‘ inadequate to infer the presence or absence of a causal relationship ’’ (ISA, Table 5–3). That is, the ISA found the long-term
health evidence to be of insufficient quantity, quality, consistency, or statistical power to make a
determination as to whether SO 2 was truly associated with these health outcomes (ISA, Table 1–2).

3. SO 2 -Related Impacts on Public Health

Interindividual variation in human responses to air pollutants indicates that some populations are at increased risk
for the detrimental effects of ambient exposure to SO 2 . The NAAQS are intended to provide an adequate margin of safety for both the general population and susceptible populations that are potentially at increased risk for health effects in response to exposure to ambient air pollution ( see footnote 1 above). To facilitate the identification of populations at increased risk for SO 2 - related health effects, studies have
identified factors that contribute to the susceptibility of individuals to SO 2. Susceptible individuals are broadly defined as those with a greater


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6 This aspect of susceptibility is referred to as vulnerability in the proposal and in the ISA. 7 The ISA cites one chamber study with intermittent exercise where healthy and asthmatic

Continued likelihood of an adverse outcome given a specific exposure in comparison with the general population (American Lung Association, 2001). The susceptibility of
an individual to SO 2 can encompass a multitude of factors which represent normal developmental phases or life stages ( e.g., age) or biologic attributes ( e.g., gender); however, other factors ( e.g., socioeconomic status (SES)) may
influence the manifestation of disease
and also increase an individual’s susceptibility (American Lung Association, 2001). In addition, populations may be at increased risk to

SO 2 due to an increase in their exposure during certain life stages ( e.g., childhood or old age) or as a result of external factors ( e.g., SES) that contribute to an individual being disproportionately exposed to higher concentrations than the general population. 6 It should be noted that in some cases specific populations may be affected by multiple susceptibility factors. For example, a population that is characterized as having low SES may have less access to healthcare resulting in the manifestation of a disease, which increases their susceptibility to SO 2 , while they may also reside in a location that results in disproportionately high exposure to SO 2

.

To examine whether SO 2 differentially affects certain populations, stratified analyses are often conducted in epidemiologic investigations to identify the presence
or absence of effect modification. A thorough evaluation of potential effect modifiers may help identify susceptible populations that are at increased risk to

SO 2 exposure. These analyses are based on the proper identification of confounders and subsequent adjustment for them in statistical models, which helps separate a spurious from a true causal association. Although the design of toxicological and human clinical
studies does not allow for an extensive examination of effect modifiers, the use
of animal models of disease and the study of individuals with underlying disease or genetic polymorphisms do allow for comparisons between subgroups. Therefore, the results from these studies, combined with those results obtained through stratified analyses in epidemiologic studies, contribute to the overall weight of evidence for the increased susceptibility of specific populations to SO 2 . Those populations identified in the ISA to be potentially at greater risk of experiencing an adverse health effect
from SO 2 were described in detail in the proposal (section II.B.5) and include: (1) Those with pre-existing respiratory disease; (2) children and older adults; (3) persons who spend increased time outdoors or at elevated ventilation rates; (4) persons with lower SES; and (5) persons with certain genetic factors.

As discussed in the proposal (section II.B.5.g, 74 FR at 64821), large proportions of the U.S. population are likely to be at increased risk of experiencing SO 2 -related health effects. In the United States, approximately 7% of adults and 9% of children have been diagnosed with asthma. Notably, the prevalence and severity of asthma is higher among certain ethnic or racial groups such as Puerto Ricans, American Indians, Alaskan Natives, and African Americans (EPA 2008b). Furthermore, a higher prevalence of asthma among persons of lower SES and an excess burden of asthma hospitalizations and mortality in minority and inner-city communities have been observed (EPA, 2008b). In addition, population groups based on age comprise substantial segments of individuals that may be potentially at risk for SO 2 -related health impacts. Based on U.S. census data from 2000, about 72.3 million (26%) of the U.S. population are under 18 years of age, 18.3 million (7.4%) are under 5 years of age, and 35 million (12%) are 65 years of age or older. There is also concern for the large segment of the population that is potentially at risk to

SO 2 -related health effects because of increased time spent outdoors at elevated ventilation rates (those who work or play outdoors). Overall, the considerable size of the population groups at risk indicates that exposure to
ambient SO 2 could have a significant impact on public health in the United

States.

C. Human Exposure and Health Risk
Characterization

To put judgments about SO 2 - associated health effects into a broader public health context, EPA has drawn upon the results of the quantitative exposure and risk assessments. Judgments reflecting the nature of the evidence and the overall weight of the
evidence are taken into consideration in these quantitative exposure and risk
assessments. These assessments include
estimates of the likelihood that
asthmatic children at moderate or greater exertion ( e.g. while exercising) in St. Louis or Greene County, Missouri would experience SO 2 exposures of potential concern. In addition, these analyses include an estimate of the number and percent of exposed
asthmatic children in these locations likely to experience SO 2 -induced lung function responses ( i.e., moderate or greater decrements in lung function
defined in terms of sRaw or FEV 1 ) under varying air quality scenarios ( i.e., current air quality and air quality simulated to just meet the current or potential alternative standards). These
assessments also characterize the kind and degree of uncertainties inherent in
such estimates.

As previously mentioned, the ISA
concluded that the evidence for an association between respiratory morbidity and short-term SO 2 exposure

was ‘‘ sufficient to infer a causal relationship ’’ (ISA, section 5.2) and that
the ‘‘ definitive evidence ’’ for this
conclusion was from the results of 5–10 minute controlled human exposure studies demonstrating decrements in lung function and/or respiratory symptoms in exercising asthmatics (ISA, section 5.2). Accordingly, the air quality and exposure analyses and their
associated risk characterizations focused
on 5-minute concentrations of SO 2 in excess of potential health effect
benchmark values derived from the controlled human exposure literature ( see proposal section II.C.1, 74 FR at 64821, and REA, section 6.2). These benchmark levels are not potential standards, but rather are SO 2 exposure concentrations which represent

‘‘ exposures of potential concern ’’ which are used in these analyses to estimate potential exposures and risks associated
with 5-minute concentrations of SO 2

. The REA considered 5-minute benchmark levels of 100, 200, 300, and 400 ppb in these analyses, but especially noted exceedances or exposures with respect to the 200 and 400 ppb 5-minute benchmark levels.
These benchmark levels were highlighted because (1) 400 ppb represents the lowest concentration in free-breathing controlled human exposure studies where moderate or greater lung function decrements occurred which were often statistically significant at the group mean level and were frequently accompanied by respiratory symptoms; and (2) 200 ppb
is the lowest level at which moderate or greater decrements in lung function in free-breathing controlled human exposure studies were found in some individuals, although these lung function changes were not statistically significant at the group mean level. Notably, 200 ppb is also the lowest level that has been tested in free-breathing controlled human exposure studies (REA, section 4.2.2). 7


### 35528 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

children were exposed to 100 ppb SO 2 in a mixture
with ozone and sulfuric acid. The ISA notes that compared to exposure to filtered air, exposure to the pollutant mix did not result in statistically significant changes in lung function or respiratory symptoms (ISA, section 3.1.3.4).

8 Benchmark values derived from the controlled human exposure literature were associated with a 5-minute averaging time. However, as noted in footnote 3 above, only 98 ambient monitors located in 13 States from 1997–2007 reported measured 5-

minute SO 2 concentrations since such monitoring is not required ( see section II.A.2 and section IV). In contrast, 809 monitors in 48 States, DC, Puerto Rico, and the Virgin Islands reported 1-hour SO 2 concentrations over a similar time period. Therefore, to broaden analyses to areas where
measured 5-minute SO 2 concentrations were not available, the REA utilized a statistical relationship to estimate the highest 5-minute level in an hour, given a reported 1-hour average SO 2 concentration (REA, section 6.4). Then, similar to measured 5-

minute SO 2 concentrations, statistically estimated

5-minute SO 2 concentrations were compared to 5- minute potential health effect benchmark values (REA, chapters 7 and 8, respectively). 9 EPA recently conducted a complete quality assurance review of all individual subject data. The results of this review did not substantively change any of the entries in ISA, Table 3–1, and did not in any way affect the conclusions of the ISA ( see Johns and Simmons, 2009). The REA utilized three approaches to
characterize health risks. In the first approach, for each air quality scenario, statistically estimated 5-minute SO 2 concentrations 8 and measured ambient

5-minute SO 2 concentrations were compared to the 5-minute potential
health effect benchmark levels discussed above (REA, chapter 7). This air quality analysis included all available ambient monitoring data as well as a more detailed analysis in 40 counties. The air quality analysis was
considered a broad characterization of national air quality and human exposures that might be associated with
these 5-minute SO 2 concentrations. An advantage of the air quality analysis is its relative simplicity; however, there is uncertainty associated with the assumption that SO 2 air quality can serve as an adequate surrogate for total exposure to ambient SO 2 . Actual exposures might be influenced by factors not considered by this approach, including small-scale spatial variability
in ambient SO 2 concentrations (which might not be represented by the current fixed-site ambient monitoring network) and spatial/temporal variability in human activity patterns. A more detailed overview of the air quality analysis and its associated limitations and uncertainties is provided in the proposal ( see sections II.C.2, 74 FR at 64822 and II.C.3, 74 FR at 64823, respectively) and the air quality analysis is thoroughly described in the REA (chapter 7).

In the second approach, an inhalation exposure model was used to generate more realistic estimates of personal exposures in asthmatics (REA, chapter 8). This analysis estimated temporally and spatially variable
microenvironmental 5-minute SO 2 concentrations and simulated asthmatics’ contact with these pollutant
concentrations while at moderate or greater exertion ( i.e., while at elevated ventilation rates). The approach was designed to estimate exposures that are not necessarily represented by the existing ambient monitoring data and to better represent the physiological conditions corresponding with the respiratory effects reported in controlled human exposure studies. AERMOD, an EPA dispersion model, was used to
estimate 1-hour ambient SO 2 concentrations using emissions estimates from stationary, non-point, and where applicable, port sources. The Air Pollutants Exposure (APEX) model, an EPA human exposure model, was then used to estimate population exposures using the estimated hourly
census block level SO 2 concentrations.
From the 1-hour census block concentrations, 5-minute maximum SO 2 concentrations within each hour were estimated by APEX (REA, section 8.7.1) using the statistical relationship
mentioned above in footnote 8. Estimated exposures to 5-minute SO 2 levels were then compared to the 5- minute potential health effect
benchmark levels discussed above. This approach to assessing exposures was more resource intensive than using
ambient levels as an indicator of exposure; therefore, the final REA included the analysis of two locations: St. Louis and Greene County, MO. Although the geographic scope of this analysis was limited, the approach provided estimates of SO 2 exposures in
asthmatics and asthmatic children in St. Louis and Greene Counties, and thus served to complement the broader air quality characterization. A more detailed overview of this exposure analysis and its associated limitations and uncertainties is provided in the proposal ( see sections II.C.2, 74 FR at 64822 and II.C.3, 74 FR at 64823, respectively) and the exposure analysis is thoroughly described in the REA (chapter 8).

The third approach was a quantitative risk assessment. This approach combined results from the exposure analysis ( i.e., the number of exposed
total asthmatics or asthmatic children while at moderate or greater exertion) with exposure-response functions
derived from individual level data from controlled human exposure studies ( see ISA, Table 3–1 and Johns (2009) 9 ) to estimate the percentage and number of exposed asthmatics and asthmatic children in St. Louis and Greene County likely to experience a moderate or greater lung function response ( i.e., decrements in lung function defined in
terms of FEV 1 and sRaw) under the air quality scenarios mentioned above (REA, chapter 9). A more detailed overview of this analysis and its
associated limitations and uncertainties is provided in the proposal ( see sections II.C.2, 74 FR at 64822 and II.C.3, 74 FR at 64823, respectively) and the quantitative risk analysis is thoroughly described in the REA (chapter 9).

Notably, for the reasons described in the REA (REA, section 10.3.3) and the proposal ( see section II.E.1.b, 74 FR at 64827), when considering the St. Louis and Greene County exposure and risk results as they relate to the adequacy of the current standards, the REA
concluded that the St. Louis results
were more informative in terms of ascertaining the extent to which the current standards protect against health
effects linked to the various benchmarks (linked in turn to 5-minute SO 2 exposures). The results in fact suggested that the current standards may not adequately protect public health (REA, section 10.3.3, p. 364). Moreover, the REA judged that the exposure and risk estimates for the St. Louis study area provided useful insights into exposures
and risks for other urban areas in the U.S. with similar population and SO 2 emissions densities ( id. ). For similar reasons, the St. Louis results were more informative for ascertaining the adequacy of the potential alternative
standards under consideration.

Key results of the air quality, exposure, and risk analyses were presented in the policy assessment chapter of the REA (chapter 10) and summarized in the proposal ( see Tables 2–4 in the preamble to the proposed rule). In considering these results, the proposal noted that these analyses support that 5-minute SO 2 exposures, reasonably judged important from a public health perspective, were associated with air quality adjusted upward to simulate just meeting the current standards ( see proposal, section II.E.1.c, 74 FR at 64828). Moreover,
these results indicated that 99th percentile 1-hour daily maximum standard levels in the range of 50–100 ppb could substantially limit exposures
of asthmatic children at moderate or greater exertion from 5-minute SO 2 concentrations ≥ 400 ppb, and appreciably limit exposures of these
children from 5-minute SO 2 concentrations ≥ 200 ppb (REA, p. 392– 393). Results of these analyses also
indicated that a 1-hour standard at 150


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ppb could still substantially limit exposures of asthmatic children at moderate or greater exertion from 5-

minute SO 2 concentrations ≥ 400 ppb, but would provide these children appreciably less protection from exposure to 5-minute SO 2 concentrations ≥ 200 ppb (REA, p. 395– 396).

D. Approach for Determining Whether
To Retain or Revise the Current
Standards

EPA notes that the final decision on retaining or revising the current primary

SO 2 standards is a public health policy judgment to be made by the Administrator. This judgment has been informed by a recognition that the
available health effects evidence reflects a continuum consisting of ambient
levels of SO 2 at which scientists generally agree that health effects are likely to occur, through lower levels at which the likelihood and magnitude of the response become increasingly
uncertain. The Administrator’s final decisions draw upon scientific information and analyses related to health effects, population exposures and risks; judgments about the appropriate response to the range of uncertainties
that are inherent in the scientific evidence and analyses; and comments received from CASAC and the public.

To evaluate whether the current primary SO 2 standards are adequate or whether revisions are appropriate, EPA has used an approach in this review described in chapter 10 of the REA which builds upon the approaches used in reviews of other criteria pollutants, including the most recent reviews of the

NO 2 , Pb, O 3 , and PM NAAQS (EPA, 2008c; EPA, 2007c; EPA, 2007d; EPA, 2005), and reflects the latest body of
evidence and information that is currently available, as reflected by the ISA. As in other recent reviews, EPA considered the implications of placing more or less weight or emphasis on different aspects of the scientific evidence and the exposure-/risk-based information, recognizing that the weight to be given to various elements of the evidence and exposure/risk information is part of the public health policy judgments that the Administrator will make in reaching decisions on the
standard.

A series of general questions framed this approach to considering thescientific evidence and exposure-/riskbased information. First, EPA’s
consideration of the scientific evidence and exposure/risk information with regard to the adequacy of the current standards has been framed by the following questions: • To what extent does evidence that has
become available since the last review reinforce or call into question evidence for

SO 2 -associated effects that were identified in
the last review?

• To what extent has evidence for different health effects and/or susceptible populations
become available since the last review?

• To what extent have uncertainties
identified in the last review been reduced and/or have new uncertainties emerged?

• To what extent does evidence and exposure-/risk-based information that has
become available since the last review reinforce or call into question any of the basic elements (indicator, averaging time, form, and level) of the current standard?

To the extent that the available evidence and exposure-/risk-based information suggests it may be appropriate to consider revision of the current standards, EPA considers that evidence and information with regard to its support for consideration of a
standard that is either more or less stringent than the current standards. This evaluation is framed by the following questions:

• Is there evidence that associations, especially causal or likely causal associations, extend to ambient SO 2 concentrations as low as, or lower than, the concentrations that have previously been associated with health effects? If so, what are the important uncertainties associated with
that evidence?

• Are exposures above benchmark levels
and/or health risks estimated to occur in areas that meet the current standard? If so, are the estimated exposures and health risks important from a public health perspective? What are the important uncertainties
associated with the estimated risks?

To the extent that there is support for consideration of a revised standard, EPA then considers the specific elements of the standard (indicator, averaging time, form, and level) within the context of the currently available information. In so doing, the Agency addresses the following questions regarding the
elements of the standard:

• Does the evidence provide support for considering a different indicator for gaseous

SO X ?

• Does the evidence provide support for considering different, or additional averaging

times?

• What ranges of levels and forms of alternative standards are supported by the evidence, and what are the associated
uncertainties and limitations?

• To what extent do specific averaging times, levels, and forms of alternative standards reduce the estimated exposures
above benchmark levels and risks attributable to exposure to ambient SO 2 , and what are the
uncertainties associated with the estimated exposure and risk reductions?

The questions outlined above have
been addressed in the REA. The following sections present considerations regarding the adequacy
of the current standards and
conclusions on the elements of a new
short-term standard in terms of indicator, averaging time, form, and
level.

E. Adequacy of the Current Standards

This section discusses considerations
related to the decision as to whether the
current 24-hour and annual SO 2 primary NAAQS are requisite to protect public health with an adequate margin of safety. Specifically, section II.E.1 provides an overview of the rationale supporting the Administrator’s proposal
that the current standards do not provide adequate public health protection; section II.E.2 discusses public comments received on the adequacy of the current standards; and
section II.E.3 discusses the
Administrator’s final decision on
whether the current SO 2 primary NAAQS is requisite to protect public health with an adequate margin of safety, as required by sections 109(d) and (b) of the Act.

1. Rationale for Proposed Decision

In the proposal, the Administrator initially concluded that the current 24-
hour and annual SO 2 NAAQS were not adequate to protect public health with an adequate margin of safety ( see section II.E.4, 74 FR at 64829). In reaching this conclusion, she considered the: (1) Scientific evidence and conclusions in the ISA; (2) exposure and risk information presented in the REA; (3) conclusions of the policy assessment chapter of the REA; and (4) views expressed by CASAC. These
considerations are discussed in detail in the proposal ( see section II.E., 74 FR at 64826) and are summarized in this

section.

In the proposal the Administrator noted the following in considering the adequacy of the current 24-hour and annual primary SO 2 standards:

• The conclusion of the ISA that the results of controlled human exposure and epidemiologic studies form a plausible and coherent data set that supports a causal relationship between short-term (5-minutes to 24-hours) SO 2 exposures and adverse respiratory effects, and that the epidemiologic evidence (buttressed by the clinical evidence) indicates that the effects seen in the epidemiologic studies are attributable to exposure to SO 2 (ISA, section 5.2).

• The conclusion of the ISA that ‘‘ [i]n the epidemiologic studies, respiratory
effects were observed in areas where the maximum ambient 24-h avg SO 2 concentration was below the current 24-


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h avg NAAQS level * * *. ’’ (ISA, section 5.2, p. 5–2.) and so would occur
at ambient SO 2 concentrations that are present in locations meeting the current 24-hour NAAQS.

• These respiratory effects also
occurred in areas with annual air quality levels considerably lower than those allowed by the current annual standard, indicating that the current annual standard is also not providing protection against short-term health effects reported in epidemiologic studies (ISA, section 5.2).

• Analyses in the REA supporting that 5-minute exposures, reasonably judged important from a public health perspective ( i.e., respiratory effects judged to be adverse to the health of asthmatics, see sections II.B.1.c above, and II.E.2.b below), were associated with air quality adjusted upward to simulate just meeting the current 24-
hour and annual standards.

• CASAC advice ‘‘ that the current
24-hour and annual standards are not adequate to protect public health, especially in relation to short term exposures to SO 2 (5–10 minutes) by exercising asthmatics ’’ (Samet, 2009, p. 15).

Based on these considerations (discussed in more detail in the proposal, see sections II.E.1 and II.E.2), the Administrator proposed that the
current 24-hour and annual SO 2 standards are not requisite to protect public health with an adequate margin of safety against adverse respiratory
effects associated with short-term (5-minute to 24-hour) SO 2 exposures. In considering approaches to revising the current standards, the Administrator initially concluded it appropriate to consider setting a new 1-hour standard.
The Administrator noted that a 1-hour standard would likely provide increased public health protection, especially for members of at-risk groups, from the respiratory effects described in both epidemiologic and controlled human exposure studies.

2. Comments on the Adequacy of the
Current Standards

This section discusses public comments on the proposal that either supported or opposed the Administrator’s proposed decision to
revise the current SO 2 primary NAAQS. Comments on the adequacy of the
current standards that focused on the scientific and/or the exposure/risk basis for the Administrator’s proposed
conclusions are discussed in sections
II.E.2.a–II.E.2.c. Comments on the epidemiologic evidence are considered
in section II.E.2.a. Comments on the controlled human exposure evidence are considered in section II.E.2.b. Comments on human exposure and
health risk assessments are considered
in section II.E.2.c. To the extent these
comments on the evidence and information are also used to justify
commenters’ conclusions on decisions related to indicator, averaging time, form, or level, they are noted as well in the appropriate sections below (II.F.1– II.F.4, respectively). The summaries of comments, and responses thereto, presented below are not exclusive: other comments and responses are being included in the Response to Comment (RTC) Document which is part of the record for this rulemaking (EPA, 2010).

Many public commenters agreed with the proposal that based on the available information, the current SO 2 standards are not requisite to protect public health with an adequate margin of safety and
that revisions to the standards are therefore appropriate. Among those calling for revisions to the standards were environmental groups ( e.g., Sierra Club, WEACT for Environmental Justice, Center for Biological Diversity, (CBD) Environmental Defense Fund (EDF), Natural Resources Defense Council (NRDC)); medical/public health organizations ( e.g., American Lung Association (ALA), American Thoracic Society (ATS)); State environmental organizations ( e.g., National Association of Clean Air Agencies (NACAA),
Northeast States for Coordinated Air Use Management (NESCAUM); State environmental agencies ( e.g., such agencies in DE, IA, IL, MI, NY, NM, OH, PA, TX, VT); the Fond du Lac Band of Lake Superior Chippewa (Fond du Lac) Tribe, local groups ( e.g., HoustonGalveston Area Council, Alexandria Department of Transportation and Environmental Services) and most individual commenters (

∼ 13,000). These commenters generally concluded that
the current SO 2 standards need to be revised and that a more stringent standard is needed to protect the health of susceptible population groups. In supporting the need to adopt a more stringent NAAQS for SO 2 , these
commenters often referenced the conclusions of CASAC, as well as evidence and information presented in the proposal. As such, the rationale offered by these commenters was consistent with that presented in the proposal to support the Administrator’s proposed decision to revise the current

SO 2 NAAQS.

Most industry commenters ( e.g., Utility Air Regulatory Group (UARG), American Petroleum Institute (API), Arizona Public Service, National
Petrochemical & Refiners Association (NPRA), Montana-Dakota Utilities Co., Dominion Resources, Council of Industrial Boiler Owners (CIBO), Edison Electric Institute (EEI), Duke Energy, National Mining Association (NMA)); and some organizations ( e.g., Texas Association of Business, The Annapolis Center for Science-Based Public Policy (ACSBPP), South Carolina Chamber of Commerce) opposed the proposed
revisions to the SO 2 primary NAAQS. In supporting their views, industry commenters generally concluded that EPA did not appropriately consider
uncertainties associated with the epidemiologic and controlled human exposure evidence.

More specifically, with respect to the epidemiologic studies, many of these
commenters concluded that results ofthese studies are confounded by copollutants and thus too uncertain to
determine whether SO 2 is truly
associated with the health outcomes being measured ( e.g., hospital admissions; Federal Register see below). With respect to the controlled human exposure studies, many
commenters were critical of the 5-
minute benchmark levels that were
derived from these studies and subsequently used by EPA in the air quality, exposure, and risk analyses. These groups were particularly
concerned about the Administrator’s reliance on the 200 ppb 5-minute benchmark level in assessing the adequacy of the current and potential alternative standards. In general, many industry groups maintained that adverse respiratory effects did not occur following 5–10 minute SO 2 exposures < 400 ppb ( e.g., API, EEI, CIBO) and some groups stated that even at SO 2 concentrations ≥ 400 ppb, reported effects may not be of clinical concern, and thus are likely not adverse ( e.g., UARG). Many industry groups ( e.g., API, UARG) also disagreed with EPA’s (and CASAC’s) conclusions that severe
asthmatics were not included in these controlled human exposure studies, and that severe asthmatics would likely have a more pronounced response to SO 2 exposures at a given level, or would respond to even lower levels of SO 2

.

In responding to these specific comments, we note that the Administrator relied in the proposal on the evidence, information, and judgments contained in the ISA and the REA (including the policy assessment chapter), as well as on the advice of CASAC. In considering the evidence, information, and judgments of the ISA and the REA, the Agency notes that
these documents have been reviewed and discussed extensively by CASAC at multiple public meetings ( see above, section I.D) and in their letters to the


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10 As noted in the proposal ( see sections II.D.1, 74 FR at 64824–64825 and II.F.4.a, 74 FR at 64835), there is special sensitivity in this review in disentangling SO 2 -related effects from PM-related effects (especially sulfate PM). EPA Administrator. Thus, it is important to note that CASAC generally accepted the key findings and conclusions presented in both the ISA and REA ( see Henderson 2008a, Henderson 2008b, and Samet, 2009).

a. Comments on EPA’s Interpretation of the Epidemiologic Evidence

Many industry groups ( e.g., API, UARG, American Chemistry Council (ACC), Dominion Resources, ExxonMobil, Progress Energy, CIBO, The Fertilizer Institute, EEI, Dow Chemical Company (Dow), MeadWestvaco Corporation (MWV), (NMA) and some organizations ( e.g., ACSBPP) commented that, given the presence of numerous co-pollutants in the air, the epidemiologic studies do not support the contention that SO 2 itself is causing health effects. For example,
UARG stated: ‘‘ The epidemiological
evidence cannot determine that SO 2 is a cause of or a contributor to hospital admissions ( ‘‘ HA ’’ ), emergency department ( ‘‘ ED ’’ ) visits or respiratory symptoms, the effects cited in the Proposed Rule. ’’

Although EPA has recognized that multiple factors can contribute to the etiology of respiratory disease and that more than one air pollutant could independently impact respiratory health, we continue to judge, as discussed in the ISA, that the available evidence supports the conclusion that there is an independent effect of SO 2 on respiratory morbidity. In reaching this judgment, we recognize that a major methodological issue affecting SO 2 epidemiologic studies concerns the
evaluation of the extent to which other air pollutants, particular PM 2.5 , 10 may confound or modify SO 2 -related effect estimates. The use of multi-pollutant regression models is a common approach for evaluating potential confounding by co-pollutants in epidemiologic studies. It is therefore important to note that when the ISA
evaluated U.S. and internationalepidemiologic studies employing multipollutant models, SO 2 effect estimates generally remained positive andrelatively unchanged when copollutants, including PM, were included ( see ISA, p. 5–5). Therefore, although recognizing the uncertainties associated with separating the effects of SO 2 from those of co-occurring pollutants, the ISA
concluded that the limited available
evidence indicates that the effect of SO 2 on respiratory health outcomes appears to be generally robust and independent of the effects of gaseous co-pollutants, including NO 2 and O 3, as well as particulate co-pollutants, particularly

PM 2.5 (ISA, section 5.2; p. 5–9).

In considering questions of confounding and causation, the epidemiologic studies should not be considered in a vacuum. As emphasized by the ISA, and endorsed by CASAC, controlled human exposure studies provide support for the plausibility of the associations reported in epidemiologic studies (ISA, section 5–5; Henderson 2008a; Henderson 2008b). These controlled human exposure studies exposed exercising asthmatics to 5–10 minute peaks of SO 2 and reported decrements in lung function and/or respiratory symptoms in up to 60% of these individuals (depending on exposure concentration; see ISA, Table 5–3; p. 5–11). Thus, these experimental study results provide strong support for an independent contribution of SO 2 to the respiratory health effects reported in epidemiologic studies: ‘‘ The effects of

SO 2 on respiratory symptoms, lung function, and airway inflammation
observed in the human clinical studies using peak exposures further provides a basis for a progression of respiratory morbidity resulting in increased emergency department visits and hospital admissions. Collectively, these findings provide biological plausibility
for the observed association between
ambient SO 2 levels and emergency department visits and hospitalizations for all respiratory diseases and asthma, notably in children and older adults.

*** ’’ (ISA, section 5.2 at p. 5–5). Thus, EPA is not relying solely on the epidemiologic studies to evaluate whether associations reported in these studies ( e.g., associations with emergency department visits) are likely
the result of ambient SO 2 exposure. b. Comments on EPA’s Interpretation of the Controlled Human Exposure
Evidence

Many industry groups ( e.g., API, ACC, Progress Energy, EEI, CIBO) commented
that adverse health effects do not occur following 5–10 minute SO 2 exposures < 400 ppb. In addition, some groups ( e.g., UARG) commented that adverse respiratory effects do not occur in exercising asthmatics following SO 2 exposures below 600 ppb. The disagreement is not whether effects occur in exercising asthmatics at these exposure levels and exposure durations. Rather, the issue is whether the effects experienced can properly be regarded as adverse. In general, these groups conclude that EPA’s judgment of
adverse health effects at SO 2 exposure levels below 600 or 400 ppb is inappropriately based on an unsound interpretation of ATS guidelines. More specifically, these groups generally contend that decrements in lung function without accompanying respiratory symptoms are not adverse
effects of SO 2 exposure, and that decrements in lung function in a percentage of exercising asthmatics does not represent a shift in lung function at the population level. Some of these groups also contend that EPA followed
the advice of individual CASAC members, rather than consensus CASAC
written comments on the ISA and REA when concluding respiratory effects
associated with SO 2 exposures below 600 or 400 ppb are adverse. Furthermore, some groups contend that effects below 400 ppb should not be considered adverse because compared
to the number of asthmatics experiencing decrements in lung function, there were similar numbers of asthmatics experiencing increases in lung function. EPA disagrees with these comments, and believes that the clinical evidence also supports the conclusion
that the current standards are not requisite to protect public health with and adequate margin of safety.

The Agency disagrees that adverse respiratory effects do not occur in exercising asthmatics following 5–10

minute SO 2 exposures ranging from 400–600 ppb. As previously mentioned,

at SO 2 concentrations ranging from 400– 600 ppb, moderate or greater decrements in lung function occur in approximately 20–60% of exercising asthmatics (again, defined in terms of a

≥ 15% decline in FEV 1 or 100% increase in sRaw; ISA, Table 3–1). Moreover, at

concentrations ≥ 400 ppb, decrements in lung function are often statistically significant at the group mean level, and are frequently accompanied by respiratory symptoms (ISA, Table 5–1). ATS guidelines on what constitutes an adverse health effect of air pollution clearly state that reversible loss of lung
function in combination with the presence of symptoms should be considered adverse (ATS 1985, 2000). Moderate or greater decrements in lung function accompanied by respiratory symptoms fit this description. Thus, the Agency’s conclusion of adverse health
effects associated with SO 2 concentrations ≥ 400 ppb is consistent with ATS guidelines.

The Agency also disagrees with industry commenters regarding the adversity of the respiratory effects seen in exercising asthmatics following 5–10

minute SO 2 exposures ranging from 200–300 ppb. As mentioned above (section II.B.1), and discussed more


### 35532 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

11 See hearing transcripts from EPA Clean Air Scientific Advisory Committee (CASAC), July 30– 31 2008, Sulfur Oxides-Health Criteria (part 3 of 4) pages 211–213). These transcripts can be found in Docket ID No. EPA–HQ–ORD–2006–0260. Available

at http://www.regulations.gov. fully in the proposal ( see section II.B.3, 74 FR at 64819), the ISA reported that exposure to SO 2 concentrations as low as 200–300 ppb for 5–10 minutes results in approximately 5–30% of exercising asthmatics experiencing moderate or greater decrements in lung function. In 2000, the ATS updated its guidelines on

‘‘ what constitutes an adverse health effect of air pollution. ’’ These guidelines indicated that 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 (ATS 2000). For example, ATS notes that a population of
asthmatics could have a distribution of lung function such that no individual has a level associated with significant impairment. Exposure to air pollution
could shift the distribution to lower levels that still do not bring any
individual to a level that is associated with clinically relevant effects. However, this would be considered
adverse because individuals within the population would have diminished reserve function, and therefore would be at increased risk if affected by another agent (ATS 2000).

Considering the 2000 ATS guidelines,
the results of the clinical studies conducted at 200–300 ppb were reasonably interpreted by EPA to
indicate an SO 2 -induced shift in these lung function measurements for a subset of this population. That is, an appreciable percentage of this population of exercising asthmatics would be expected to experience moderate or greater decrements in lung function in response to SO 2 concentrations as low as 200 ppb, and thus would be expected to have diminished reserve lung function. As a result, this sub-population would be at greater risk of a more severe response if affected by another respiratory agent ( e.g., viral infection, or O 3 ).

EPA is also mindful of CASAC comments on this issue following the
second draft ISA. The second draft ISA placed relatively little weight on health
effects associated with SO 2 exposures at 200–300 ppb. CASAC strongly disagreed
with this characterization of the health
evidence. Their consensus letter following the second draft ISA states:

Our major concern is the conclusions in the ISA regarding the weight of the evidence for health effects for short-term exposure to
low levels of SO 2 . Although the ISA presents
evidence from both clinical and epidemiological studies that indicate health effects occur at 0.2 ppm or lower, the final chapter emphasizes health effects at 0.4 ppm
and above * * * CASAC believes the clinical and epidemiological evidence warrants stronger conclusions in the ISA regarding the
available evidence of health effects at 0.2 ppm or lower concentrations of SO 2 . The
selection of a lower bound concentration for health effects is very important because the ISA sets the stage for EPA’s risk assessment decisions. In its draft Risk and Exposure Assessment (REA) to Support the Review of the SO2 Primary National Ambient Air Quality Standards (July 2008), EPA chose a range of 0.4 ppm–0.6 ppm SO 2 concentrations for its benchmark analysis. As CASAC will emphasize in a forthcoming letter on the REA, we recommend that a lower bound be set at least as low as 0.2 ppm. (Henderson 2008a)

EPA also notes the similar CASAC
comments on the first draft of the REA. The consensus CASAC letter following
the 1st draft REA states:

The CASAC believes strongly that the weight of clinical and epidemiology evidence indicates there are detectable clinically
relevant health effects in sensitive subpopulations down to a level at least as low as 0.2 ppm SO 2 . These sensitive subpopulations represent a substantial segment of the at-risk population. (Henderson 2008b; p. 1) See Coalition of Battery Recyclers

Association v. EPA, No. 09–1011 (DC Cir., May 14, 2010), slip opinion at 9, holding that it was reasonable for EPA to conclude that a two IQ point mean population loss is an adverse effect based in part on CASAC advice that such a decrement is significant. CASAC’s strong advice regarding the adversity of effects at the 200 ppb level similarly supports EPA’s conclusion that the observed lung decrements are
adverse.

In addition to the considerations described above, we also note the following key points:

• In the current SO 2 NAAQS review,
clinicians on the CASAC Panel advised that moderate or greater decrements in lung function can be clinically significant in some individuals with respiratory disease. 11

• In the last O 3 NAAQS review,
CASAC indicated that moderate decrements in lung function can be clinically significant in some asthmatics (Henderson 2006), and that in the context of standard setting, a focus on the lower end of the range of moderate functional responses is most appropriate for estimating potentially adverse lung function decrements in people with lung disease ( e.g., asthma; see 73 FR at 16463).

• In the last O 3 NAAQS review, the Criteria Document and the Staff Paper indicated that for many people with lung disease ( e.g., asthma), even moderate decrements in lung function or respiratory symptoms would likely
interfere with normal activities and result in additional and more frequent use of medication (EPA 2006, EPA 2007d).

• Subjects participating controlled human exposure studies do not include severe asthmatics, and it is reasonable to presume that persons with more severe asthma than the study participants
would have a more serious health effect from short-term exposure to 200 ppb

SO 2

.

Considering these key points along with the ATS guidelines and consensus
CASAC comments on the draft ISA and REA described above, we reasonably conclude that 5–10 minute exposures to

SO 2 concentrations at least as low as 200 ppb can result in adverse health effects in exercising asthmatics.

In addition, as noted above some groups ( e.g., API) contend that effects below 400 ppb should not be considered adverse because compared to the number of asthmatics experiencing decrements in lung function, there were
similar numbers of asthmatics experiencing increases in lung function.

The commenters correctly point out
that at the lowest concentration tested in free-breathing chamber studies (200 ppb), there are a similar number of asthmatics experiencing a moderate or greater decrease in lung function ( i.e., ≥
100 increase in sRaw or ≥ 15 decrease

in FEV 1 ) and experiencing what might be called a moderate improvement in lung function ( i.e., ≥ 100 decrease in

sRaw or ≥ 15 increase in FEV 1 ). This
observation is consistent with data presented in Figures 4–2 and 4–3 of the ISA showing essentially no SO 2 -induced change in lung function at 200 ppb when averaged across asthmatics participating in the three Lin et al., controlled human exposure studies. However, these figures also demonstrate
that asthmatics who are sensitive to SO 2 at a higher concentration (600 ppb) experience, on average, a greater decrement in lung function at lower concentrations, including 200 ppb, when compared with all subjects combined. Therefore, while some asthmatics are relatively insensitive to

SO 2 -induced respiratory effects even at

concentrations ≥ 600 ppb, there is clear empirical evidence that others experience significant bronchoconstriction following exposures to both relatively high (600 ppb) and low (200 ppb) SO 2 concentrations. Among these SO 2 - sensitive asthmatics, Figures 4–2 and 4–
3 of the ISA show a clear increase in


### 35533 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

bronchoconstriction with increasing

SO 2 concentrations from 200–400 ppb. Given this clear relationship of exposure
and effect at all levels in the sensitive asthmatics ( i.e. those who experienced significant decrements in lung function at the highest exposure concentration used (600 ppb)), EPA does not accept the commenter’s premise that controlled human exposure studies do not
demonstrate adverse effects in some
asthmatics at 5–10 minute levels below 400 ppb.

In addition to disagreeing with EPA’s proposed finding of adverse health effects following 5– 10 minute SO 2 exposures as low as 200 ppb, many industry groups ( e.g., API, UARG, ACC, ExxonMobil) also disagreed with EPA
that severe asthmatics were not included in controlled human exposure studies. That is, these groups contend that EPA is incorrect in assuming that severe asthmatics would likely have a more pronounced response to SO 2 exposures at a given level, or would respond to even lower levels of SO 2 and
that this should be taken into account when judging the adequacy of the current standards. As support for their assertion, multiple industry groups cite controlled human exposure studies in the ISA stating that they included

‘‘ severe asthmatics ’’ and also cite a study by Linn et al. (1987) which concluded that among asthmatics, responses to SO 2 exposure are not dependent on the clinical severity of asthma and that ‘‘ the subjects with the highest risk [of temporary respiratory disturbances from
ambient SO 2 ] can be identified only by actually measuring their responses to

SO 2 ’’

.

We disagree with the assertion that
severe asthmatics have been evaluated
in 5–10 minute controlled human exposure studies. Although studies cited in the ISA referred to a group of subjects as ‘‘ moderate/severe ’’asthmatics, these individuals had wellcontrolled asthma, were able to withhold medication, were not dependent on corticosteroids, and were able to engage in moderate to heavy levels of exercise. By today’s standards, these individuals would clearly be
classified as moderate asthmatics. EPA therefore concludes that persons with
asthma that is more severe than moderate asthma, as that term is currently understood, were not included in the controlled human exposure studies (and understandably so, for ethical reasons).

In addition, EPA agrees with the
commenters that there is little evidence from controlled human exposure studies to suggest that the respiratory effects of

SO 2 differ between mild and moderate asthmatics ( see Linn et al., 1987). However, this may very well be due, at least in part, to persistence of medication among the moderate asthmatic subjects. More importantly, the moderate asthmatics began the exposure with compromised lung
function relative to the mild asthmatics. Therefore, similar functional declines
from different baselines between mild and moderate asthmatics would clearly not have the same physiological importance. CASAC specifically addressed the issue of asthma severity
in a letter to the Administrator: ‘‘ For ethical reasons severe asthmatics were not part of these clinical studies, but it is not unreasonable to presume that they would have responded to even a greater degree (Henderson 2008a; p. v). ’’ It is also important to note that in addition to the strict health-specific inclusion and exclusion criteria for a given controlled human exposure study, many asthmatics who might otherwise be able to participate choose not to participate because of anxiety related to what they viewed as potential adverse health risks. EPA concludes that it is appropriate to assume, as CASAC suggested, that persons with more severe asthma would respond to an even greater degree than
the moderate asthmatics in the clinical
studies.

c. Comments on EPA’s Characterization
of SO 2 -Associated Exposures and Health
Risks

Several commenters discussed the analyses of SO 2 -associated exposures and health risks presented in the REA. As in past reviews (EPA 2005, 2007c, 2007d), EPA has estimated risks
associated with the current standards to inform judgments on the public health
risks that could exist under different standard options. Some industry commenters ( e.g., API, UARG, Lignite Energy Council (LEC), Jackson Walker, ASARCO, the National Rural Electric Cooperative Association) concluded that when considering the adequacy of the current standards, the Administrator should consider exposures and risks
associated with actual SO 2 air quality rather than air quality allowed by the current NAAQS. They consequently challenged the relevance and appropriateness of EPA’s use of SO 2 concentrations that have been simulated to just meet the current standards in assessing the adequacy of the current
standards.

In addition to the objections noted above, we note that UARG generally
concluded that the results of EPA’s quantitative risk assessment are fundamentally flawed in that they substantially overestimate risks associated with the various air quality
scenarios. UARG contends that this is because EPA did not use proper exposure-response functions in estimating risks associated with SO 2 exposure. Moreover, UARG contends
EPA further overestimates risk because of the use of 50 ppb exposure bins in estimating the number of occurrences of an adverse lung function response ( see below).

With respect to comments that when considering the adequacy of the current standards, the Administrator should consider exposures and risks associated
with actual SO 2 air quality rather than that simulated to just meet the current standards, these commenters generally concluded: (1) It is more relevant to assess exposures and risks associated
with actual SO 2 air quality since adjusting air quality to just meet the current standards require large adjustments to air quality that are highly uncertain; and (2) NAAQS are intended to address actual, rather than highly improbable, risks to human health. In addition, these groups generally concluded that exposure and risk estimates presented in the REA suggest relatively little health risk associated
with current levels of SO 2 , and thus,
there is no need to revise the current

SO 2 standards.

We disagree with these commenters that exposure- and risk-related considerations in the NAAQS reviews should rely only on actual air quality, and that EPA therefore improperly adjusted air quality in its risk and exposure analyses to simulate air quality allowed by the current primary

SO 2 NAAQS. EPA is required to review whether the present standards—not present air quality—are requisite to protect public health with an adequate margin of safety. Section 109(b)(1). In making this determination it is relevant to consider exposures and risks which could be permissible under the current
standards. See American Trucking

Associations v. EPA, 283 F.3d 355, 370 (DC Cir. 2002) (existence of evidence showing adverse effects occurring at levels allowed by the current standards justifies finding that it is appropriate to revise the existing NAAQS). Consequently, it is at the very least reasonable for EPA, in its REA, to make air quality adjustments to estimate SO 2 - related exposures and health risks that could exist in areas that just meet the present standards. Thus, although we acknowledge that exposure and health
risk estimates associated with current ambient concentrations are substantially
smaller than those associated with air quality adjusted to just meet the current standards, we also note that this is


### 35534 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

12 In conducting these analyses, EPA is not trying
to evaluate whether areas would or would not be in attainment of the current standards. Again, those issues are addressed during the implementation of the NAAQS. irrelevant to the question of whether the current standards are requisite to protect public health with an margin of safety.

In both of these cases, EPA is not trying to evaluate whether areas would
or would not be in attainment of the
current standards. Those are issues that are addressed during the implementation of the NAAQS. Instead, in this rulemaking EPA is evaluating what NAAQS would be appropriate under section 109(b)(1), by evaluating the impact on or risks to public health from air quality that is at the level of the current standards, as well as evaluating air quality that is at the level of various
alternative standards. EPA uses this
information to inform the decision on what NAAQS would be requisite to protect public health with an adequate margin of safety.

If EPA determines that the current standards require revision, EPA is further required to determine what revisions are appropriate in light of the requirement that primary NAAQS be requisite to protect public health with an adequate margin of safety. Section 109(d)(1). It is thus similarly reasonable for EPA to make air quality adjustments to simulate different potential alternative standards to provide information on exposures and risks under these potential alternative
standards. 12

We agree that there are uncertainties inherent in making air quality adjustments. These uncertainties are discussed thoroughly in the REA (REA, sections 6.5 and 7.4.2.5). For example, the REA noted the following regarding adjustment of SO 2 concentrations:

This procedure for adjusting either the ambient concentrations ( i.e., in the air quality characterization) or health effect benchmark levels ( i.e., in the exposure assessment) was necessary to provide insight into the degree of exposure and risk which would be
associated with an increase in ambient SO 2 levels such that the levels were just at the current standards in the areas analyzed. Staff recognizes that it is extremely unlikely that

SO 2 concentrations in any of the selected
areas where concentrations have been adjusted would rise to meet the current NAAQS and that there is considerable uncertainty associated with the simulation of conditions that would just meet the current standards. Nevertheless, this procedure was necessary to assess the ability of the current standards, not current ambient SO 2 concentrations, to protect public health (REA, section 6.5; p. 64)

These air quality adjustments are not meant to imply an expectation that SO 2 concentrations will increase broadly across the United States or in any given area. Rather, as just noted above, they

are meant to estimate SO 2 -related exposures and health risks if air quality
were at the level of the current and potential alternative standards. Such
estimates can inform decisions on whether the current standards, or particular potential alternative standards, provide the requisite protection of public health.

As mentioned above, UARG generally concluded that under all air quality scenarios, the results of EPA’s quantitative risk assessment (the third of the analyses conducted in the REA (chapter 9), see section II.C above) are substantially overestimated because EPA did not use proper methods toestimate the parameters of the exposureresponse functions used in its analyses. UARG contends this is because many of the subjects in the controlled human exposure studies from which EPA’s exposure-response functions were derived ( see REA, Table 9–3) were exposed to more than one SO 2 concentration, yet EPA treated each exposure event as being independent ( e.g., if the same subject was exposed to 200 and 300 ppb SO 2 , EPA considered these as representing two independent exposure events). UARG contends that observations from the same subject exposed to different SO 2 concentrations are not independent observations and should not be treated as such. Notably,
when UARG derived their own exposure-response functions taking into
account that observations from the same subject exposed to different SO 2 concentrations are not independent of each other, they estimated appreciably less risk than that estimated by EPA.

There are a variety of techniques and/ or assumptions that can be used to fit individual subject data from the controlled human exposure studies ( see REA, Table 9–3) to exposure-response curves. Moreover, any technique or assumption utilized will have inherent
uncertainties. EPA discussed the
uncertainties associated with our quantitative risk assessment in detail in the REA (REA, section 9.4); we also gave an overview of key uncertainties in the proposal ( see section II.C.3, 74 FR at 64824). The approach used to estimate the exposure-response functions was
not first introduced in the SO 2 risk assessment, it was previously recommended to EPA by an applied statistician serving on the O 3 CASAC
Panel and used in the O 3 risk assessment (which had individual controlled human exposure data similar
to that in the current SO 2 NAAQS review; see EPA 2007d and EPA 2007e). Importantly, this approach allowed EPA
to use all the available individual subject data. Moreover, an inspection of the estimated exposure-response curve and the underlying data suggest that any biases in the parameter estimates are likely to be slight ( see EPA 2010, section II.C). Consequently, EPA does not accept UARG’s view that the methodology used in EPA’s quantitative risk assessment was inappropriate.

We further note that UARG’s exposure-response functions do not fit the underlying controlled human exposure data (the proportions of subjects who responded at each exposure level) nearly as well as the exposure-response functions estimated using EPA’s approach. We believe this could be due to the methodology usedin UARG’s reanalysis of the individuallevel data from the controlled human exposure studies used in the quantitative risk assessment. UARG attempted to estimate subject-specific exposure-response functions, and to use
the results of these estimates to obtain estimates of the two parameters in the population-level exposure-response
functions. As described in more detail
in section II.C of the RTC document (EPA 2010), EPA does not believe there are sufficient data to properly estimate the parameters of subject-specific exposure-response functions. Morespecifically, UARG chose a threeparameter quadratic function for the subject-specific exposure-response functions. However, none of the subjects had more than three exposures, and many had only one or two. EPA believes that this information is particularlylimited for estimating these subjectspecific exposure-response functions, especially given that a large percentage of the total number of subjects had fewer exposures than the number of parameters UARG was attempting to estimate ( i.e., UARG estimated three parameters in its exposure-response functions, but over fifty percent of subjects only had one or two exposures). It appears that UARG’s population-level exposure-response function estimates depended on these subject-specific exposure-response function estimates and thus could explain why UARG’sestimated population-level exposureresponse functions do not fit the underlying controlled human exposure data nearly as well as the approach used by EPA. A more detailed response to
this comment can be found in section II.C of the RTC document (EPA 2010).

As mentioned above, UARG also
concluded that EPA further
overestimates the total number of occurrences of an adverse lung function response ( i.e., total number of


### 35535 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

13 Although in St. Louis, the percent of exposed asthmatic children at moderate or greater exertion estimated to have at least one defined lung function response per year was not appreciably affected, it was found that for this same metric, the already very low risk estimates in Greene County became appreciably lower when the binning issue discussed above was considered. However, as noted
above in section II.C and discussed in more detail in the REA (REA, section 10.3.3) and the proposal ( see section II.E.b, 74 FR at 64827), the St. Louis exposure and risk results were found to be more informative in addressing the adequacy of the current and potential alternative standards. Moreover, while the Administrator’s rationale in the proposal relied minimally on the St. Louis quantitative risk results ( see above), she importantly placed no weight on any metric from the Greene County quantitative risk assessment. occurrences of increases in sRaw ≥ 100 or 200% and/or declines in FEV 1 ≥ 15 or 20%) in its quantitative risk assessment. More specifically, UARG concluded that the use of 50 ppb bins, combined with assigning all exposures within a bin the probability of an adverse lung function response at the midpoint of that bin ( e.g., all exposures from 0–50 ppb were assigned the probability of an adverse lung function response occurring at 25 ppb), resulted
in a substantial overestimate of the total number of occurrences of lung function responses in asthmatics at moderate or greater exertion. UARG generally
concludes that this is because the vast majority of exposures of asthmatics at moderate or greater exertion are occurring below the midpoint of the 0– 50 ppb exposure bin ( i.e., most exposures are occurring below 25 ppb), yet EPA is assigning these very low SO 2 exposures the higher probability of a lung function response associated with the midpoint of the 0–50 ppb exposure
bin. UARG contends that this results in
a substantial overestimation of the total number of occurrences of lung function response in asthmatics and asthmatic children at moderate or greater exertion.
UARG further notes that this methodological concern was raised in its comments on the second draft REA,
but EPA failed to address this issue and relied heavily on this metric in the proposal with respect to the adequacy of the current and potential alternative standards. EPA’s response to this
comment is discussed below and in
more detail in section II.C of the RTC document (EPA 2010).

EPA generally agrees with UARG’s
technical comments that there is a
substantial overestimation of the total occurrences of lung function responses because of the binning issues described above. However, we strongly disagree that: (1) This issue was not acknowledged in the final REA; and (2)
the metric of total occurrences was relied on heavily in the policy assessment chapter of the REA (REA, chapter 10) and in the Administrator’s rationale with respect to the adequacy of the current and potential alternative standards. First, EPA did respond to this
concern in the final REA. More specifically, page 344 of the final REA

states:

As noted in public comments on the 2nd
draft SO 2 REA, the assignment of response probability to the midpoint of the exposure bin combined with the lack of more finely divided intervals in this range can lead to significant overestimation of risks based on total occurrences of a defined lung function response. This is because the distribution of population exposures for occurrences is not evenly distributed across the bin, but rather is more heavily weighted toward the lower range of the bin. Thus, combining all exposures estimated to occur in the lowest bin with a response probability assigned to the midpoint of the bin results in a significant overestimate of the risk. Therefore, staff places less weight on the estimated number of occurrences of lung function responses.

Thus, as noted in the final REA, less weight was placed on this metric in the quantitative risk assessment chapter (REA, chapter 9), and importantly, no weight was placed on this metric in either the policy assessment chapter of the REA (REA, chapter 10) or in the
Administrator’s rationale sections of the proposal preamble. Rather, the policy assessment chapter of the REA and the Administrator’s rationale at the proposal considered the percent of exposed
asthmatic children at moderate or greater exertion estimated to have at least one defined lung function response per year in St. Louis. Importantly, this metric is not appreciably affected by the binning issue raised in UARG’s comments. As stated on page 344–345 of
the final REA:

This overestimation of total occurrences does not impact the risk metric expressed as incidence or percent incidence of a defined lung function response 1 or more times per year because the bulk of the exposures contributing to these risk metrics are not skewed toward the lower range of the reported exposure bins. 13

Finally, it is important to note that the
Administrator’s rationale in the proposal regarding the adequacy of the current and potential alternative standards in general placed only limited
reliance on the results of the quantitative risk assessment in St. Louis, with no reliance on the estimates of total occurrences. Rather, in addition to the substantial weight that she placed
on the scientific evidence as described in the ISA, the Administrator placed relatively more weight on the results of the St. Louis exposure analysis. For example, in discussing the adequacy of the current standards, the proposal

states: ‘‘ The Administrator especially
notes the results of the St. Louis exposure analysis which, as summarized above, indicates that substantial percentages of asthmatic children at moderate or greater exertion would be exposed, at least once annually, to air quality exceeding the 400 and 200 ppb benchmarks ’’ ( see 74 FR at 64829). We note that results of the quantitative risk assessment in St. Louis, with respect to the percent of
asthmatic children estimated to have at least one lung function response per year (using EPA’s exposure-response functions), supports the Administrator’s overall conclusions in the proposal regarding the adequacy of the current and potential alternative standards.

3. Conclusions Regarding the Adequacy
of the Current 24-Hour and Annual
Standards

In reviewing the adequacy of the current standards, the Administrator has
considered the scientific evidence assessed in the ISA, the exposure and risk results presented in the REA, the conclusions of the policy assessment chapter of the REA, and comments from CASAC and the public. These
considerations are described below.

As in the proposal, the Administrator accepts and agrees with the ISA’s
conclusion that the results of controlled human exposure and epidemiologic studies form a plausible and coherent data set that supports a causal relationship between short-term (5 minutes to 24 hours) SO 2 exposures and adverse respiratory effects. The Administrator acknowledges that there
are uncertainties associated with the epidemiologic evidence ( e.g., potential confounding by co-pollutants). However, she agrees that the epidemiologic evidence, supported by the controlled human exposure evidence, generally indicates that the
effects seen in these studies are attributable to exposure to SO 2 , rather than co-pollutants, most notably PM 2.5

. She also accepts and agrees with the
conclusion of the ISA that ‘‘ [i]n the epidemiologic studies, respiratory
effects were observed in areas where the maximum ambient 24-h avg SO 2 concentration was below the current 24- h avg NAAQS level .*** ’’ (ISA, section 5.2, p. 5–2) and so would occur
at ambient SO 2 concentrations that are present in locations meeting the current 24-hour NAAQS. The Administrator
also notes that these effects occurred in areas with annual air quality levels considerably lower than those allowed by the current annual standard, indicating that the annual standard also


### 35536 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

14 We also note that such a standard would, among other things, address the deficiency in the current NAAQS which occasioned the remand of that standard for failing to adequately explain the absence of protection from short-term SO 2 bursts
which could cause adverse health effects in hundreds of thousands of heavily breathing
asthmatics. American Lung Ass’n v. EPA, 134 F. 3d

at 392–93. is not providing protection against such effects. Existence of epidemiologic studies showing adverse effects occurring at levels allowed by the current standards is an accepted justification for finding that it is appropriate to revise the existing
standards. See, e.g. American Trucking

Associations v. EPA, 283 F. 3d at 370 ; see also American Farm Bureau v. EPA, 559 F. 3d.512, 521–23 (DC Cir. 2009) (effects associated with short-term exposure seen in areas with ambient concentrations lower than long-term standard, so that without further explanation, standard does not adequately protect against short-term exposures).

With respect to the controlled human exposure studies, the Administrator judges that effects following 5–10

minute SO 2 exposures ≥ 400 ppb and

≥ 200 ppb can result in adverse health effects to asthmatics. This judgment is based on ATS guidelines, explicit
CASAC consensus written advice and recommendations, and judgments made by EPA in previous NAAQS reviews. Thus, similar to the proposal, she notes analyses in the REA supporting that 5- minute exposures ≥ 400 ppb and ≥ 200 ppb were associated with air quality adjusted upward to simulate just meeting the current standards. The Administrator especially notes the results of the St. Louis exposure analysis which, as summarized in the proposal ( see section II.E.1.b and Table

3, see 74 FR at 64841), indicates that substantial percentages of asthmatic children at moderate or greater exertion would be exposed, at least once annually, to air quality exceeding the 400 and 200 ppb 5-minute benchmarks given air quality simulated to just meet
the current standards. The Administrator judged these 5-minute exposures to be significant from a public health perspective due to their estimated frequency: Approximately 24% of child asthmatics at moderate or greater exertion in St. Louis are estimated to be exposed at least once per year to air quality exceeding the 5- minute 400 ppb benchmark, a level associated with lung function decrements in the presence of respiratory symptoms. Additionally, approximately 73% of child asthmatics in St. Louis at moderate or greater exertion would be expected to be exposed at least once per year to air quality exceeding the 5-minute 200 ppb
benchmark. This health evidence and
risk-based information underlie
CASAC’s conclusion that the current

SO 2 standards do not adequately protect public health. As discussed in the proposal, CASAC stated: ‘‘ the current
24-hour and annual standards are not adequate to protect public health, especially in relation to short-term exposures to SO 2 (5–10 minutes) by exercising asthmatics ’’ (Samet, 2009, p. 15). The Administrator agrees with this
conclusion.

In considering approaches to revising the current standards, the Administrator concludes that it is appropriate to set a new standard, that such standard must provide requisite protection with an adequate margin of safety to a susceptible population ( i.e., asthmatics at elevated ventilation), and that the standard must afford protection from short-term exposures to SO 2 in order to prevent the adverse health effects reported in both the controlled human exposure and epidemiologic studies.
The Administrator notes that a 1-hour standard could provide increased public health protection, especially for members of at-risk groups, from health
effects described in both controlled human exposure and epidemiologic studies, and hence, health effects
associated with 5-minute to 24-hour exposures to SO 2

. 14 As discussed in section II.F.5 below, given the degree of protection afforded by such a standard, it may be appropriate to replace, and not retain, the current 24-hour and annual standards in conjunction with setting a
new short-term standard.

F. Conclusions on the Elements of a
New Short-Term Standard

In considering a revised SO 2 primary NAAQS, the Administrator notes the need to protect at-risk populations from: (1) 1-hour daily maximum and 24-hour average exposures to SO 2 that could cause the types of respiratory morbidity effects reported in epidemiologic studies; and (2) 5–10 minute SO 2 exposure concentrations reported in controlled human exposure studies to result in moderate or greater decrements in lung function and/or respiratory symptoms. Considerations with regard to potential alternative standards and the specific conclusions of the
Administrator are discussed in the following sections in terms of indicator, averaging time, form, and level (sections II.F.1 to II.F.4 below). 1. Indicator

a. Rationale for Proposed Decision

In the last review, EPA focused on

SO 2 as the most appropriate indicator
for ambient SO X . In making a decision
in the current review on the most appropriate indicator, the Administrator
has considered the conclusions of the
ISA and REA as well as the views expressed by CASAC and the public. The REA noted that, although the presence of gaseous SO X species other
than SO 2 has been recognized, no
alternative to SO 2 has been advanced as being a more appropriate surrogate for ambient gaseous SO X . Controlled human exposure studies and animal toxicology studies provide specific evidence for health effects following exposure to SO 2 . Epidemiologic studies also typically report levels of SO 2 , as opposed to other gaseous SO X . Because emissions that lead to the formation of

SO 2 generally also lead to the formation
of other SO X oxidation products, measures leading to reductions in population exposures to SO 2 can generally be expected to lead to reductions in population exposures to other gaseous SO X . Therefore, as noted in the proposal, meeting an SO 2 standard that protects the public health can also be expected to provide protection against potential health effects that may be independently associated with other gaseous SO X even though such effects are not discernable from currently available studies indexed by SO 2 alone. See American Petroleum

Institute v. EPA, 665 F, 2d 1176, 1186 (DC Cir. 1981) (reasonable for EPA to
use ozone as the indicator for all photochemical oxidants even though
health information on the other photochemical oxidants is unknown; regulating ozone alone is reasonable since it presents a ‘‘ predictable danger ’’ and in doing so EPA did not abandon its responsibility to regulate other photochemical oxidants encompassed by the determination that photochemical oxidants as a class may be reasonably anticipated to endanger public health or welfare). Given these key points, the REA concluded that the available evidence supports the
retention of SO 2 as the indicator in the current review (REA, section 10.5.1). Consistent with this conclusion, CASAC
stated in a letter to the EPA
Administrator that: ‘‘ for indicator, SO 2 is clearly the preferred choice ’’ (Samet 2009, p. 14).

b. Comments on Indicator

A small number of commenters directly addressed the issue of the
indicator for the standard. These


### 35537 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

commenters generally endorsed the proposal to continue to use SO 2 as the
indicator for ambient SO X.

c. Conclusions on Indicator

Based on the available information discussed above, and consistent with
the views of CASAC and other commenters, the Administrator concludes that it is appropriate to

continue to use SO 2 as the indicator for
a standard that is intended to address effects associated with exposure to SO 2 , alone or in combination with other gaseous SO X . In so doing, the Administrator recognizes that measures leading to reductions in population exposures to SO 2 will also reduce population exposures to other oxides of
sulfur.

2. Averaging Time

This section discusses considerations related to the averaging time of the SO 2 primary NAAQS. Specifically, this
section summarizes the rationale for the Administrator’s proposed decision regarding averaging time (II.F.2.a below;

see section II.F.2 of the proposal for more detail at 74 FR 64832–64833), discusses public comments and EPA responses related to averaging time (II.F.2.b), and presents the
Administrator’s final conclusions regarding averaging time (II.F.2.c). Notably, public comments and the
Administrator’s conclusions on whether
to retain or revoke the current 24-hour and/or annual standards given a new 1-
hour standard are discussed in section

II.F.5.

a. Rationale for Proposed Decision

In considering the most appropriate averaging time for the SO 2 primary NAAQS, the Administrator noted in the proposal the conclusions and judgments
made in the ISA about the available scientific evidence, air quality correlations discussed in the REA, conclusions of the policy assessment chapter of the REA, and CASAC recommendations (section II.F.2 in the proposal). Specifically, she noted the following:

• The REA conclusion that an appropriate averaging time should focus protection on SO 2 exposures from 5- minutes to 24-hours (REA, section, 10.5.2).

• Air quality, exposure, and risk analyses from the REA indicating it is likely a 1-hour standard—with the appropriate form and level—can substantially reduce 5–10 minute peaks
of SO 2 shown in controlled human exposure studies to result in respiratory symptoms and/or decrements in lung function in exercising asthmatics ( i.e. 5- minute SO 2 concentrations ≥ 200 and 400 ppb).

• Air quality analyses indicating that a 1-hour standard—with the appropriate form and level—can substantially reduce the upper end of the distribution
of SO 2 levels more likely to be associated with adverse respiratory effects ( see section II.F.3 below); that is: (1) 99th percentile 1-hour daily maximum air quality concentrations in U.S. cities where positive effect estimates in epidemiologic studies of hospital admissions and emergency department visits for all respiratory causes and asthma were observed; and (2) 99th percentile 24-hour average air quality concentrations found in U.S. cities where emergency department visit and hospitalization studies (for all respiratory causes and asthma) reported statistically significant associations in multi-pollutant models with PM.

• The REA conclusion that a 5- minute averaging time is undesirable because it would result in significant and unnecessary instability due to the
likelihood that locations would frequently shift in and out of attainment—thereby reducing public health protection by disrupting an area’s ongoing implementation plans and associated control programs.

• CASAC statement addressing whether a 1-hour averaging time can adequately control 5–10 minute peak exposures and whether there should be a 5-minute averaging time. CASAC
stated that the REA’s rationale for a onehour standard was ‘‘ convincing ’’ (Samet 2009, p. 16), and that ‘‘ a one-hour standard is the preferred averaging time ’’ (Samet 2009, p. 15).

• CASAC’s statement that they were

‘‘ in agreement with having a short-term
standard and finds that the REA supports a 1-hour standard as protective of public health ’’ (Samet 2009, p. 1).

b. Comments on Averaging Time

A large number of public commenters
also endorsed the establishment of a new standard with a 1-hour averaging time (although some groups’ support hinged on the accompanying level).
These included a number of State organizations ( e.g., NACAA, NESCAUM); State environmental agencies ( e.g., such agencies in IA, IL, NY, MI, NM, OH, PA, TX, VT); public health and environmental organizations ( e.g., ALA, ATS, New York Department of Health (NYDOH), Sierra Club, EDF); the Fond du Lac Tribe; local groups ( e.g., Houston-Galveston Area Council, New York City); and almost all of the individual commenters (13,000). The supporting rationales offered by these commenters often acknowledged the recommendations of CASAC and the
Administrator’s rationale as discussed in the proposal.

Though many industry commenters did not support the proposed revisions
to the SO 2 primary NAAQS (as discussed above in section II.E.2), a few of these groups did express that if a short-term standard were to be set, a 1- hour averaging time could be appropriate, depending on the level and form selected ( e.g., ExxonMobil, Kean Miller). Other industry commenters ( e.g., ASARCO, RIO Tinto Alcan, Association of Battery Recyclers (ABR)) and the South Dakota Department of Environment and Natural Resources (SD DENR) expressed that EPA should have considered longer averaging times ( e.g., 3 hours). In addition, although health and environmental groups were supportive of setting a new 1-hour standard to protect against short-term exposures to SO 2 (again, depending on
the level of the 1-hour standard selected), these groups also commented that a 5-minute standard to protect susceptible populations from health effects associated with 5-minute peaks
of SO 2 would be optimal ( e.g., ALA, ATS, Sierra Club, EDF). These comments, and EPA’s responses, are
discussed in more detail below.

As discussed above, industry commenters who disagreed with setting a new 1-hour standard generally based this conclusion on their interpretation
of the scientific evidence and their
conclusion that this evidence does not support the proposed revisions to the

current SO 2 NAAQS. EPA’s responses to these commenters were presented above
in section II.E.2.a and II.E.2.b.

Also noted above, some industry commenters ( e.g., ASARCO, RIO Tinto Alcan, ABR) and the SD DENR expressed that EPA should have considered longer averaging times ( e.g., 3-hour, 8-hour, 24-hour). In general, these groups concluded that a standard with a longer averaging time could potentially provide the same public health protection as a 1-hour standard, while also providing a more stable regulatory target. For example, in its comments, the SD DENR states: ‘‘ DENR recommends EPA evaluate a 3-hour or
8-hour standard to determine if these averaging periods are also protective of the public health. If they are, EPA should propose a 3-hour or 8-hour
sulfur dioxide standard instead of a 1- hour standard. A longer averaging period would smooth out the variability of the upper range measurements and provide a more stable standard. ’’ Similarly, Rio Tinto Alcan stated in its

comments: ‘‘ the short-term averaging period defined by EPA ( i.e., 5 minutes


### 35538 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

to 24 hours) is not limited to only 5- minute, 1-hour and 24-hour averaging periods. EPA could explain in more detail why these three averaging periods were examined when considering appropriate averaging periods to limit short-term peaks of SO 2 * * * a longer term average could provide additional stability to the standard while at the same time effectively protecting public
health. ’’

Although we agree that alternative averaging times could potentially provide similar public health protection (assuming an appropriate form and level), we believe that a 1-hour averaging time is reasonably justified by the scientific evidence presented in the ISA and by the air quality information presented in the REA. As described in detail in the proposal ( see section II.F.2), the controlled human exposure evidence presented in the ISA provided support for an averaging time that protects against 5–10 minute peak SO 2 exposures (REA, section 10.5.2, pp. 371–372), and results from epidemiologic studies most directly provided support for both 1-hour and 24-hour averaging times (REA, section 10.5.2, p. 372). Thus, we found it most reasonable to consider these averaging
times for a revised SO 2 NAAQS given that there is very little basis in the health evidence presented in the ISA to consider other averaging times ( e.g., 3- hour or 8-hour). In so doing, we first noted the likelihood that averaging times of 1 and 24 hours could provide protection against 5-minute peak SO 2 exposures. As described in detail in the proposal ( see section II.F.2, 74 FR at 64830–64833), it was initially concluded that a 1-hour averaging time, rather than a 24-hour averaging time, would be more appropriate for limiting 5-minute peaks of SO 2. Similarly, we concluded that a 1-hour standard, given the appropriate form and level, could likely limit 99th percentile 24-hour average air quality concentrations found in U.S. locations where emergency department visit and hospitalization studies (for all respiratory causes and asthma) observed statistically significant associations in multi-pollutant models with PM ( i.e., 99th percentile 24-hour average SO 2 concentration ≥ 36 ppb). Taken together, we reasonably concluded that a 1-hour standard, with an appropriate form and level, can provide adequate protection against the range of health outcomes associated with averaging times from 5 minutes to 24 hours (proposal section II.F.2 and REA, section 10.5.2.3). We also note that our conclusion is in agreement with
CASAC comments on the second draft REA. CASAC stated that they were ‘‘ in agreement with having a short-term
standard and finds that the REA supports a one-hour standard as protective of public health ’’ (Samet 2009, p. 1). In addition, as discussed in more detail below in section II.F.3, we
found that a 1-hour standard in combination with the selected form, will provide a stable regulatory target.

As noted above, although health and environmental groups were supportive of setting a new 1-hour standard to protect against short-term exposures to

SO 2 (again, depending on the level of the 1-hour standard selected), these groups generally commented that a 5- minute standard to protect against
health effects associated with 5-minute peaks would be optimal ( e.g., ALA, Sierra Club, EDF). For example, in their combined comments ALA, EDF, NRDC, and Sierra Club (ALA et al., ) stated: ‘‘ We need a short-term SO 2 standard, optimally a 5-minute standard, to protect against bursts of pollution that can result from start-up, shutdown, upset, malfunction, downwash, complex terrain, atmospheric inversion conditions, and other situations ’’ and
that ‘‘ EPA has over emphasized a concern about the stability of a 5-minute
standard * * * The record does not show that any alleged instability of a 5- minute standard has any relevance to whether such a standard is requisite to protect public health. ’’

We agree that there needs to be a short-term standard to protect against 5- minute peaks of SO 2 . However, we do not believe setting a 5-minute standard to be the best way of accomplishing that objective. As in past NAAQS reviews, EPA properly considered the stability of the design of pollution control programs
in its review of the elements of a NAAQS, since more stable programs are more effective, and hence result in enhanced public safety. American Trucking Associations v. EPA, 283 F. 3d at 375 (choice of 98th percentile form for 24-hour PM NAAQS, which allows a number of high exposure days per year to escape regulation under the NAAQS, justifiable as ‘‘ promot[ing] development of more ‘effective [pollution] control programs’ ’’ , since such programs would
otherwise be ‘‘ less ‘stable’—and hence * * * less effective—than programs designed to address longer-term average
conditions ’’ , and there are other means (viz. emergency episode plans) to control those high exposure days). In this review, there were legitimate concerns about the stability of a standard using a 5-minute averaging time. Specifically, there was concern that compared to longer averaging times ( e.g., 1-hour, 24-hour), year-to-year variation in 5-minute SO 2 concentrations were likely to be substantially more temporally and spatially diverse. Thus, it is more likely that locations would frequently shift in and out of attainment thereby reducing public health protection by disrupting an area’s ongoing implementation plans and associated control programs. Consequently, the REA concluded that a 5-minute averaging time would not provide a stable regulatory target and therefore would not be the preferred approach to provide adequate public health protection. A 1-hour averaging
time does not have these drawbacks. As noted in the REA and the proposal ( see proposal sections II.F.2.a and II.F.2.c), air quality, exposure, and risk analyses support that a 1-hour averaging time, given an appropriate form and level can adequately limit 5-minute SO 2 exposures and provide a more stable regulatory target than setting a 5-minute standard. More specifically, based on the air quality and exposure analyses presented in chapters 7 and 8 of the REA, there is also a strong likelihood that a 99th percentile 1-hour daily
maximum standard will limit 5–10 minute peaks of SO 2 shown in controlled human exposure studies to result in decrements in lung function and/or respiratory symptoms in exercising asthmatics ( see especially REA Tables 7–11 to 7–14 and Figure 8– 19).

We also note that a 1-hour standard to protect against 5-minute exposures is in agreement with CASAC advice and recommendations. That is, CASAC stated that they were ‘‘ in agreement with having a short-term standard and finds that the REA supports a 1-hour standard as protective of public health ’’ (Samet 2009, p. 1). Similarly, in a CASAC statement addressing whether a 1-hour averaging time can adequately control 5–10 minute peak exposures and
whether there should be a 5-minute averaging time, CASAC stated that the REA had presented a ‘‘ convincing
rationale ’’ (Samet 2009, p. 16) for a 1- hour standard, and that ‘‘ a one-hour standard is the preferred averaging time ’’ (Samet 2009, p. 15).

c. Conclusions on Averaging Time

In considering the most appropriate averaging time(s) for the SO 2 primary NAAQS, the Administrator notes the conclusions and judgments made in the
ISA about the available scientific evidence, air quality considerations from the REA, CASAC advice and recommendations, and public
comments received. Based on these considerations, the Administrator
concludes that a new standard based on


### 35539 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

15 As noted above, such a standard also satisfactorily addresses the issue raised by the reviewing court in the litigation that followed the
last review of the SO 2 NAAQS: Why was no protection afforded in the standard for a susceptible subpopulation known to experience repeated adverse effects from exposure to 5–10 minute SO 2 bursts. American Lung Ass’n, 134 F. 3d at 392–93. 1-hour daily maximum SO 2 concentrations will provide increased protection against effects associated with short-term (5 minutes to 24 hours) exposures. The rationale for this
decision is described below.

Similar to the proposal ( see section II.F.2.c), the Administrator first agrees
with the REA’s conclusion that the standard should focus protection on
short-term SO 2 exposures from 5 minutes to 24 hours. As noted above, CASAC’s strong recommendation supports this approach as well. 15 The Administrator further agrees that the standard must provide requisite protection from 5–10 minute exposure events, but believes that this can be provided without having a standard with a 5-minute averaging time. The Administrator agrees with the REA conclusion that it is likely a 1-hour standard—with the appropriate form and level—can substantially reduce 5– 10 minute peaks of SO 2 shown in controlled human exposure studies to result in respiratory symptoms and/or decrements in lung function in exercising asthmatics. The
Administrator further believes that a 5- minute averaging time would result in significant and unnecessary instability
and is undesirable for that reason. The
Administrator also notes the statements
from CASAC mentioned above addressing whether a 1-hour averaging time can adequately control 5–10 minute peak exposures and whether there should be a 5-minute averaging time. As noted above, addressing this question, CASAC stated that the REA had presented a ‘‘ convincing rationale ’’ (Samet 2009, p. 16) for a 1-hour standard, and that ‘‘ a one-hour standard is the preferred averaging time ’’ (Samet 2009, p. 15).

Second, as in the proposal the Administrator agrees that a 1-hour averaging time (again, with the appropriate form and level) would provide protection against the range of
health outcomes associated with averaging times of 1 hour to 24 hours. Specifically, the Administrator finds that a 1-hour standard can substantially reduce the upper end of the distribution
of SO 2 levels more likely to be associated with adverse respiratory effects ( see discussion on Form, section II.F.3); that is: (1) 99th percentile 1-hour daily maximum SO 2 air quality concentrations in U.S. locations where positive SO 2 effect estimates were reported in epidemiologic studies of emergency department visits and hospital admissions for all respiratory causes and asthma; and (2) 99th percentile 24-hour average SO 2 air quality concentrations found in U.S. locations where emergency department visit and hospital admission studies using multi-pollutant models with PM reported statistically significant associations (for all respiratory causes or asthma) with ambient SO 2 ( see REA, section 10.5.2.2 and proposal section II.F.2, 74 FR at 64831). Finally, the Administrator again notes that establishing a new 1-hour averaging time is in agreement with CASAC recommendations. As noted above, CASAC stated that they were ‘‘ in agreement with having a short-term
standard and finds that the REA supports a one-hour standard as protective of public health ’’ (Samet 2009, p. 1). Moreover, CASAC agreed
with the REA that a ‘‘ one-hour standard is the preferred averaging time ’’ (Samet 2009, p.15).

3. Form

This section discusses considerations
related to the form of the 1-hour SO 2 primary NAAQS. Specifically, this
section summarizes the rationale for the Administrator’s proposed decision regarding form (II.F.3.a; see proposal section II.F.3, 74 FR at 64833–64834 of the proposal for more detail), discusses comments related to form (II.F.3.b), and presents the Administrator’s final conclusions regarding form (II.F.3.c).

a. Rationale for Proposed Decision

In considering the most appropriate
form for the SO 2 primary NAAQS, the Administrator noted in the proposal the conclusions and judgments made in the ISA about available scientific evidence, air quality information discussed in the REA, conclusions of the policy assessment chapter of the REA, and CASAC recommendations ( see section II.F.3, 74 FR at 64833–64834 in the proposal). Specifically, the proposal referenced the following:

• Information in the ISA that suggested that adverse respiratory effects are more likely to occur at the upper end of the distribution of ambient

SO 2 concentrations. That is, the ISA describes a few studies that reported an

increase in SO 2 -related respiratory health effects at the upper end of the
distribution of SO 2 concentrations (ISA, section 5.3, p. 5–9).

• The REA conclusion that a concentration-based form averaged over three years would better reflect the continuum of health risks posed by increasing SO 2 concentrations ( i.e. the percentage of asthmatics affected and the severity of the response increases with increasing SO 2 concentrations; REA, section 10.5.3) by giving proportionally greater weight to years when 1-hour daily maximum SO 2 concentrations are well above the level of the standard, than just above the level
of the standard.

• Analyses in the REA that suggested for a given SO 2 standard level, a 99th percentile form is appreciably more effective at limiting 5-minute peak SO 2 concentrations than a 98th percentile form (REA, section 10.5.3 and REA, Figures 7–27 and 7–28).

• Analyses in the REA indicating that over the last 10 years and for the vast majority of the sites examined, there appears to be little difference in 98th and 99th percentile design value stability (REA, section 10.5.3).

• The REA conclusion that taken together, the evidence and air quality
information indicate that consideration should be given primarily to a 1-hour daily maximum standard with a 99th percentile or 4th highest daily maximum form (REA, section 10.5.3.3).

• CASAC indications that: ‘‘ there is adequate information to justify the use of a concentration-based form averaged over 3 years ’’ (Samet 2009, p. 16).

• CASAC recommendations that when evaluating 98th vs. 99th percentile forms, EPA should consider the number of days per year 98th vs. 99th percentile forms would allow SO 2 concentrations to exceed the selected standard level. Similarly, CASAC
recommendations to consider the
number of exceedences of 5-minute benchmarks given 98th vs. 99th percentile forms at a given standard level (Samet 2009).

b. Comments on Form

Most all State organizations and agencies ( e.g., NAACA, NESCAUM and agencies in FL, NM, PA, SC, TX, VT) supported a 99th percentile or 4th highest form. Similarly, public health ( e.g., ALA, ATS) and environmental organizations ( e.g., CBD, WEACT for Environmental Justice) and the Alexandria Department of Transportation and Environmental Services preferred either a 99th percentile or a more stringent form ( e.g., no exceedence) to further limit the
occurrence of SO 2 concentrations that
exceed the standard level in locations that attain the standard. In contrast, many industry groups ( e.g., UARG, NAM, LEC, RRI Energy, AirQuality Research & Logistics (AQRL)), and the SD DENR conditionally supported a


### 35540 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

16 EPA did not propose or seek comment on a 98th percentile form or a more restrictive form ( e.g., an exceedence based form). EPA also considered a 4th highest form, which is generally equivalent to the 99th percentile. However, a percentile based form is preferred since it results in a sampling from the same part of the annual distribution of 1-hour daily maximum SO 2 concentrations regardless of the number of 1-hour daily maximum concentrations reported in a given year for a particular location. 98th percentile form if EPA were to set
a 1-hour standard. 16 EPA responses to specific comments on the form of the
standard can be found below and in the RTC document (EPA 2010).

As mentioned above, a number of industry groups and the SD DENR preferred a 98th percentile form. In general, their preference for a 98th percentile form was based on their
conclusion that a form based on the 98th percentile would be more stable
than a form based on the 99th percentile, and that a 98th percentile
form is consistent with the forms selected in recent NAAQS reviews ( i.e.

PM 2.5 and NO 2 ). For example AQRL
stated: ‘‘ The Administrator should reconsider her proposal and choose instead the 98th percentile (or equivalent nth highest value) form of the standard for the added reliability and stability it offers in determining compliance or progress towards attainment. This approach has been promulgated for recent revisions of the

PM 2.5 and NO 2 standards and this consistency should be maintained with

SO 2. ’’

We agree with the commenters that it is important that a 1-hour standard have a form that is reasonably stable, but we disagree that a 98th percentile form is significantly more stable than a 99th percentile form. We note that the REA discussed analyses (also briefly described in the proposal; see section II.F.3, 74 FR at 64834) comparing trends in 98th and 99th percentile design
values from 54 sites located in the 40
counties selected for the detailed air quality analysis (REA section 10.5.3 and Thompson, 2009). These results suggested that at the vast majority of sites, there would have been similar changes in 98th and 99th percentile design values over the last ten years ( i.e. based on evaluating overlapping three year intervals over the last ten years; see REA, Figure 10–1 and Thompson, 2009). As part of this analysis, all of the design values over this ten year period for all 54 sites were aggregated and the standard deviation calculated (REA, Figure 10–2 and Thompson, 2009).
Results demonstrated similar standard
deviations— i.e. similar stability—based on aggregated 98th or aggregated 99th percentile design values over the ten year period ( see REA, Figure 10–2 and Thompson 2009). Thus, we believe that in most locations, there will not be a substantial difference in stability between 98th and 99th percentile forms.

We also disagree with the commenters that the forms of NAAQS standards
should be consistent across different NAAQS pollutants. This is almost like advocating consistent levels or averaging times for different NAAQS pollutants. Each pollutant is manifestly different from another, and the decision as to an appropriate standard for each, and appropriate elements (including form) of each standard and the interaction of these elements, necessarily is fact-specific. Cf. Sierra
Club v. EPA, 353 F. 3d 976, 986 (DC Cir. 2004) ( ‘‘ This court has adopted an ‘every tub on its own bottom’ approach to EPA’s setting of standards pursuant to the CAA, under which the adequacy of the underlying justification offered by the agency is the pertinent factor—not what the agency did on a different record concerning a different industry ’’ ) (Roberts J.). There is thus no basis to say a priori that any element of one NAAQS should be consistent with another, although if all other things are equal, selecting stable forms for each NAAQS is a legitimate objective.

A 99th percentile form, rather than a 98th percentile form, is also needed for the standard to provide requisite public health protection. In this review of the primary SO 2 NAAQS, we considered information in the ISA suggesting that adverse respiratory effects are more likely to occur at the upper end of the
distribution of ambient SO 2 concentrations. That is, the ISA described a few studies that reported an

increase in SO 2 -related respiratory health effects at the upper end of the
distribution of SO 2 concentrations ( i.e., above 90th percentile SO 2 concentrations; ISA, section 5.3, p. 5–9). Moreover, we considered the extent to which different percentile forms, given the same standard level, limit 5-minute
concentrations of SO 2 above benchmark
levels. As noted above in section II.F.3.a, and in more detail in the proposal ( see section II.F.3.a, 74 FR at 64834), air quality analyses presented in the REA suggested that at a given SO 2 standard level, a 99th percentile form is appreciably more effective at limiting 5- minute peak SO 2 concentrations than a 98th percentile form (REA, section 10.5.3, and REA, Figures 7–27 and 7– 28). Taken together with the analyses suggesting that 98th and 99th percentile forms have similar stabilities, we reasonably concluded that a 99th percentile form was most appropriate
for a 1-hour SO 2 standard. As mentioned above, a number of health and environmental groups supported a 99th percentile form, but expressed that they would prefer a morerestrictive form, such as a noexceedence based form. In addition, the Alexandria Department of Transportation and Environmental Services only recommended a no, or one exceedence based form. In general, these groups concluded that a more restrictive form would further limit the: (1) Number of days an area could exceed
the standard level and still attain the standard; and (2) the occurrence of 5- minute peaks of SO 2 above benchmark
levels.

It is important that the particular form selected for a 1-hour daily maximum
standard reflect the nature of the health risks posed by increasing SO 2 concentrations. The REA and proposal ( see section II.F.3, 74 FR at 64833) noted
that the form of the standard should
reflect results from controlled human exposure studies demonstrating that the percentage of asthmatics affected, and the severity of the respiratory response ( i.e. decrements in lung function, respiratory symptoms) increases as SO 2 concentrations increase. Taking this into consideration, EPA staff concluded that a concentration-based form, averaged over three years, is more appropriate than an exceedance-based form (REA, section 10.5.3). This is because a concentration-based form averaged over three years gives proportionally greater weight to years when 1-hour daily maximum SO 2 concentrations are well above the level of the standard, as it gives to years when 1-hour daily maximum SO 2 concentrations are just above the level of the standard. In contrast, an expected exceedance form gives the same weight to years when 1-hour daily maximum

SO 2 concentrations are just above the level of the standard as it gives to years when 1-hour daily maximum SO 2 concentrations are well above the level of the standard. Therefore, we
concluded that a concentration-based form, averaged over three years (which also increases the stability of the standard) better reflects the continuum of health risks posed by increasing SO 2 concentrations ( i.e. the percentage of asthmatics affected and the severity of the response increases with increasing

SO 2 concentrations; REA, section 10.5.3). Moreover, we note that analyses
in the REA indicate that in most locations analyzed, a 99th percentile form would correspond to the 4th highest daily maximum concentration in a year, and that the 99th percentile,
combined with the standard level


### 35541 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

selected, will substantially limit 5- minute peaks of SO 2 above the 200 ppb and higher benchmark levels ( see below, section II.F.4). Finally, we note that a
concentration based form is in agreement with CASAC advice that:

‘‘ there is adequate information to justify
the use of a concentration-based form averaged over 3 years ’’ (Samet 2009, p. 16).

c. Conclusions on Form

The Administrator agrees that the
form of the standard should reflect the health evidence presented in the ISA indicating that the percentage of asthmatics affected and the severity of the response increases with increasing

SO 2 concentrations. The Administrator also agrees that it is reasonable to consider the standard’s stability as part
of consideration of the form of the standard. Thus, the Administrator agrees that the standard should use a concentration-based form averaged over three years in order to give due weight to years when 1-hour SO 2 concentrations are well above the level of the standard, than to years when 1-
hour SO 2 concentrations are just above
the level of the standard. She also notes
that a concentration-based form averaged over 3 years would likely beappreciably more stable than a noexceedence based form.

In selecting a specific concentration based form, the Administrator first notes that a few epidemiologic studies described in the ISA reported an

increase in SO 2 -related respiratory health effects at the upper end of the
distribution of ambient SO 2 concentrations ( i.e., above 90th percentile SO 2 concentrations; see ISA, section 5.3, p. 5–9). The Administrator
notes further that numerous controlled human exposure studies have reported decrements in lung function and/or respiratory symptoms in exercising asthmatics exposed to peak 5–10 minute

SO 2 concentrations. The Administrator
therefore concludes that the form of a
new 1-hour standard should be especially focused on limiting the upper
end of the distribution of ambient SO 2 concentrations ( i.e., above 90th percentile SO 2 concentrations) in order to provide protection with an adequate margin of safety against effects reported in both epidemiologic and controlled human exposure studies.

In further considering specific concentration based forms, the
Administrator notes as outlined above in section II.F.3.b, and discussed in more detail in the REA (REA, section 10.5.3) and proposal ( see section II.F.3, 74 FR at 64834), that a 99th percentile form is likely to be appreciably more effective at limiting 5-minute benchmark exposures of concern compared to a 98th percentile form. Taken together with the considerations just discussed above, the Administrator has selected a 99th percentile form, averaged over 3 years. The
Administrator concludes that a 99th percentile form, given the level selected ( see section II.F.4 immediately below), will limit both the upper end of the
distribution of ambient SO 2 concentrations reported in some epidemiologic studies to be associated
with increased risk of SO 2 -related respiratory morbidity effects ( e.g., emergency department visits), as well as 5-minute peak SO 2 concentrations resulting in decrements in lung function and/or respiratory symptoms in exercising asthmatics participating in controlled human exposure studies.

4. Level

As discussed below and in more detail in the proposal (section II.F.4, 74 FR at 64834), the Administrator proposed to set a 1-hour standard with a 99th percentile form (averaged over three years), with a level in the range of 50 to 100 ppb. The Administrator also
solicited comment on standard levels greater than 100 ppb up to 150 ppb.
This section summarizes the rationale for the Administrator’s proposed range of standard levels (II.F.3.a), discusses comments related to the range of standard levels (II.F.3.b), and presents
the Administrator’s final conclusions regarding the level of a new 1-hour SO 2 standard (II.F.3.c).

a. Rationale for Proposed Decision

In assessing the level of a 1-hour standard with a 99th percentile form (averaged over three years), the
Administrator considered the broad range of scientific evidence assessed in the ISA, including the epidemiologic studies and controlled human exposure studies, as well as the results of air quality, exposure, and risk analyses presented in the REA. In light of this body of evidence and analyses, the Administrator found it is necessary to provide increased public health protection for at-risk populations against an array of adverse respiratory health effects related to short-term ( i.e., 5 minutes to 24 hours) exposures to
ambient SO 2 . In considering the most appropriate way to provide this protection, the Administrator was
mindful of the extent to which the available evidence and analyses could
inform a decision on the level of a standard. The Administrator’s proposed decisions on level, as discussed in detail in the proposal ( see section II.F.4.e), are
outlined below.

Given the above considerations, the Administrator proposed to set a level for a new 99th percentile 1-hour daily maximum primary SO 2 standard within the range from 50 to 100 ppb and took comment on levels above 100 ppb, up to 150 ppb. In reaching this proposed decision, the Administrator considered: (1) The evidence-based considerations from the final ISA and the final REA; (2) the results of the air quality, exposure, and risk assessments discussed above and in the final REA; (3) CASAC advice and
recommendations on both the ISA and REA discussed above and provided in CASAC’s letters to the Administrator; and (4) public comments received on
the first and second drafts of the ISA and REA. In considering what level of
a 1-hour SO 2 standard is requisite to protect public health with an adequate margin of safety, the Administrator was mindful that this choice requires judgments based on an interpretation of
the evidence and other information that
neither overstates nor understates the strength and limitations of that evidence
and information.

As noted above, the Administrator selected an upper end of a range of levels to propose at 100 ppb. The
selection of this level focused on the
results of the controlled human exposure studies and is primarily based on the results of the air quality and exposure analyses which suggest that a
1-hour standard should be at or below 100 ppb to appreciably limit 5-minute

SO 2 benchmark concentrations

≥ 200 ppb ( see proposal Tables 2–4, and proposal sections II.F.4.a and II.F.4.b). That is, as described in the proposal ( see section II.F.4.e), the 40-county air quality analysis estimates that a 100 ppb
1-hour standard would allow at most 2 days per year on average when estimated 5-minute daily maximum SO 2 concentrations exceed the 400 ppb benchmark, and at most 13 days per year on average when 5-minute daily

maximum SO 2 concentrations exceed the 200 ppb benchmark ( see proposal Table 2). Furthermore, given a simulated 1-hour 100 ppb standard level, most counties in the air quality analysis were estimated to experience 0 days per year on average when 5-minute daily maximum SO 2 concentrations exceed the 400 ppb benchmark and ≤ 3 days per year on average when 5-minute daily maximum SO 2 concentrations were estimated to exceed the 200 ppb benchmark ( see REA, Tables 7–14 and 7–12). The Administrator also noted that the St. Louis exposure analysis
indicated that a 1-hour standard at


### 35542 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

100 ppb would still be estimated to protect > 99% of asthmatic children at moderate or greater exertion from experiencing at least one 5-minute SO 2 exposure ≥ 400 ppb per year, and about 97% of these children from exposures ≥ 200 ppb. In contrast, as described in the proposal ( see section II.F.4.b), the St. Louis exposure analysis estimated that a 1-hour standard at 150 ppb would likely only protect about 88% of asthmatic children at moderate or greater exertion from experiencing at least one 5-minute

SO 2 exposure ≥ 200 ppb per year.

As noted above and described in detail in the proposal ( see section II.F.4.e), the Administrator selected 50 ppb as the lower end of a range of levels to propose, which is consistent with
CASAC’s advice. The selection of this level focused in part on the U.S. epidemiologic evidence described in detail in the proposal ( see sections II.B.2, II.F.4.a, and II.F.4.e). With respect to these epidemiologic studies, seven of ten U.S. emergency department visit and hospital admission studies reporting generally positive associations
with ambient SO 2 were conducted in locations where 99th percentile 1-hour daily maximum SO 2 levels were about 75–150 ppb, and three of these studies observed statistically significant positive associations between ambient

SO 2 and respiratory-related emergency department visits and hospitalizations in multi-pollutant models with PM (NYDOH (2006), Ito et al., (2007), and Schwartz et. al, (1995)). Thus, the
Administrator noted that a 99th percentile 1-hour daily maximum standard set at a level of 50 ppb is well below the 99th percentile 1-hour daily

maximum SO 2 concentrations reported
in locations where these three studies were conducted ( i.e. well below 99th percentile 1-hour daily maximum SO 2 levels of 78–150 ppb seen in NYDOH (2006), Ito et al., (2007), and Schwartz et. al, (1995)). Finally, the Administrator noted that two epidemiologic studies reported generally positive associations
between ambient SO 2 and emergency department visits in cities when 99th percentile 1-hour daily maximum SO 2 concentrations were approximately 50 ppb, but did not consider that evidence strong enough to propose setting a standard level lower than 50 ppb.

In considering the results of the air quality and exposure analyses, the
Administrator also noted that the 40- county air quality analysis estimates that a 99th percentile 1-hour daily
maximum standard set at a level of 50 ppb would result in zero days per year when estimated 5-minute SO 2 concentrations exceed the 400 ppb 5- minute benchmark level and at most 2 days per year when modeled 5-minute

SO 2 concentrations exceed the 200 ppb 5-minute benchmark level ( see proposal section II.F.4.b and proposal Table 2). In addition, the St. Louis exposure analysis estimates that a 99th percentile 1-hour daily maximum standard set at a level of 50 ppb would likely protect > 99%
of asthmatic children at moderate or greater exertion from experiencing at least one 5-minute exposure both ≥ 400 and > 200 ppb per year ( see proposal section II.F.4.b and Table 3). In addition, although not directly analyzed in the REA, the proposal (section II.F.4.b) noted that a 1-hour daily maximum standard at a level of 75 ppb would be bound by the exposure estimates from air quality adjusted to just meet 99th percentile 1-hour daily maximum standards at 50 and 100 ppb. Thus, a 1-hour daily maximum standard at a level of 75 ppb would be estimated to protect > 99% of asthmatic children at moderate or greater exertion in St. Louis from experiencing at least one

exposure ≥ 400 ppb per year, and about 97% to > 99% of these children from experiencing at least one exposure ≥ 200 ppb per year.

The Administrator thus proposed to
set the level of a new 1-hour standard that would protect public health with an adequate margin of safety between 50 ppb and 100 ppb. In so doing, the Administrator relied on reported findings from both epidemiologic and controlled human exposure studies, as well as the results of air quality and exposure analyses. The Administrator
noted that the lower end of the proposed range was consistent with CASAC advice that there is clearly
sufficient evidence for consideration of standard levels starting at 50 ppb (Samet 2009, p. 16). With respect to the upper end of the proposed range, the
Administrator noted that CASAC concluded that standards up to 150 ppb

‘‘ could be justified under some interpretations of weight of evidence, uncertainties, and policy choices regarding margin of safety ’’ ( id. ), although the letter did not provide any indication of what interpretations, uncertainties, or policy choices might support selection of a level as high as 150 ppb.

In light of the range of levels included in CASAC’s advice, the Administrator also solicited comment on setting a standard level above 100 ppb and up to 150 ppb. In so doing, the Administrator recognized that there are uncertainties with the scientific evidence, such as attributing effects reported in epidemiologic studies specifically to

SO 2 given the presence of co-occurring pollutants, especially PM, and the uncertainties associated with using
ambient SO 2 concentrations as a surrogate for exposure. However, the Administrator noted that compared to the proposed range of 50–100 ppb, a standard level as high as 150 ppb would not comparably limit 5-minute SO 2 exposures ≥ 200 ppb. That is, she noted that the St. Louis exposure analysis estimated that a 150 ppb standard would protect approximately 88% of
asthmatic children at moderate or greater exertion from experiencing at
least one SO 2 exposure ≥ 200 ppb per year (compared to > 99% and approximately 97% given standards at 50 and 100 ppb respectively; see proposal Table 3 at 74FR at 64841).

b. Comments on Level

Most State and local agencies and organizations that commented on this issue expressed support for setting the
level of a 1-hour SO 2 standard somewhere within the proposed range of 50 to 100 ppb. More specifically, State environmental organizations ( i.e., NACAA and NESCAUM); State environmental agencies ( e.g., such agencies in DE, IL, MI, NY, NM, PA, VT), the Fond du Lac Tribe, and local groups ( e.g., NYDOH, City of Houston, New York City, Houston-Galveston Area Council) supported a level of a 1-hour

SO 2 standard in the range of 50 to 100 ppb. In addition, State environmental agencies in IA and TX specifically supported a standard level of 100 ppb. In general, these groups cited the
conclusions of CASAC and the
Administrator’s rationale as stated in the proposal as a basis for their recommendations, though State environmental agencies in IA and TX generally recommended placing more weight on the controlled human exposure evidence rather than on the epidemiology.

A number of environmental and medical/public health organizations ( e.g., ALA, ATS, EDF, Sierra Club, WEACT for Environmental Justice, NRDC, CBD) and some local organizations ( e.g., Alexandria Department of Transportation and Environmental Services, and Harris County (TX) Public Health & Environmental Services) supported setting a standard level at or near 50 ppb. This recommendation was typically based on the commenters’ interpretation of the controlled human exposure and epidemiologic evidence,
as described below.

With regard to the controlled human exposure evidence, health and environmental groups generally
concluded that a 1-hour SO 2 standard


### 35543 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

no higher than 50 ppb is needed to protect against 5-minute SO 2 benchmark exposures as low as 100 ppb identified from mouthpiece exposure studies, rather than the 200 ppb 5-minute SO 2 benchmark identified from ‘‘ free breathing ’’ controlled human exposure studies. More specifically, ALA et al.,
stated:

In its analysis of data from chamber studies in the ISA and in the REA, EPA focuses on
studies of ‘‘ free breathing ’’ exposure. In doing so, EPA improperly and arbitrarily downplays important evidence that reported increased airway resistance, a measure of bronchoconstriction, in subjects with mild asthma at concentrations of 100 ppb. Regrettably, EPA does not rely on the mouthpiece studies in formulating its proposed standards * * * In downplaying the mouthpiece studies, EPA ignores the large segment of people who rely on oral or oronasal breathing some or all of the time.

The Administrator disagrees with the assertion that results from mouthpiece studies were improperly downplayed. These studies are discussed in the ISA, REA, and proposed rule as demonstrating respiratory effects of SO 2 at concentrations of 100 ppb, the lowest concentration tested using a mouthpiece exposure system. Nonetheless, these mouthpiece studies are not a reasonable proxy for actual exposure. In these studies, SO 2 is delivered directly through the mouth, typically in conjunction with nasal occlusion. This allows a greater fraction of the inhaled

SO 2 to reach the tracheobronchial airways. Although we agree with
commenters that some individuals do breathe oronasally both while at rest and during exercise, nasal ventilation still constitutes a significant percentage of total ventilation. The consequence is that individuals exposed to SO 2 through a mouthpiece are likely to experience greater respiratory effects from a given

SO 2 exposure than they would in real life. Thus, as noted in the REA (REA, section 6.2) and in the proposal preamble ( see section II.B.1.b), these mouthpiece studies only provide very limited evidence of decrements in lung function following exposure to 100 ppb

SO 2. Therefore, the Administrator did not place great weight on these mouthpiece studies when considering the appropriate level of a 1-hour SO 2 standard.

In addition to their interpretation of the controlled human exposure evidence, health and environmental groups ( e.g., ALA, ATS, EDF, NRDC, Sierra Club, CBD) and the Alexandria Department of Transportation and Environmental Services generally concluded that the epidemiologic
evidence indicates that a standard no higher than 50 ppb is required to protect public health. For example, it its
comments the CBD stated:

Epidemiologic studies referenced in the Proposed Rule showed positive, and in many cases statistically significant, relationships
between ambient SO 2 concentrations and hospital admissions where 99th percentile 1- hour concentrations ranged from 50–460 ppb. Of these studies, two showed positive and sometimes statistically significant relationships in single-pollutant models at 50 ppb, and three studies showed statistically significant correlations at 78–150 ppb in multi-pollutant models. These three multipollutant studies, moreover, ‘‘ lend[] strong support * * * to the conclusion that

SO 2 effects are generally independent ’’ of those of co-pollutants like particulate matter. Giving these studies their proper weight, and allowing for an adequate margin of safety, EPA should set a one-hour NAAQS at a level no higher than the lowest concentration at which positive, adverse relationships have been demonstrated: 50 ppb (note that footnotes were omitted).

The Administrator agrees that the epidemiologic studies referenced in the proposal need to be considered in judging the appropriate level for a new 99th percentile 1-hour SO 2 standard. However, she disagrees that when considered in total, these studies strongly support an SO 2 standard no higher than 50 ppb. The Administrator notes that selecting a standard level of 50 ppb would place considerable weight on the two U.S. emergency department
visit studies conducted in locations where 99th percentile 1-hour SO 2 concentrations were approximately 50 ppb ( i.e., Wilson et al., (2005) in Portland, ME and Jaffe et al., (2003) in Columbus, OH). However, the
Administrator does not find this appropriate given that, importantly,
neither of these studies evaluated thepotential for confounding by copollutants through the use of multipollutant models and thus, left
unaddressed the issue of whether the effects seen in the studies were partially or totally attributable to exposure to sulfate PM. In addition, the
Administrator notes that the overall results reported in these studies are mixed. It is important to note that mixed results do not automatically disqualify studies from being used as part of the evidence base for setting levels in NAAQS reviews. However, in this review the Administrator judges that the lack of mutipollutant model evaluation for potential confounding by PM in two
locations with the lowest SO 2 levels combined with the presence of mixed emergency department visit results renders these two studies inappropriate to serve as the primary basis for the
selection of the level of the SO 2 NAAQS. As an additional matter, the suggestion in some of the comments that EPA should necessarily base the level of a NAAQS on the lowest level seen in epidemiologic studies has been rejected repeatedly. See, e.g. American
Petroleum Inst. v. EPA, 665 F. 2d at 1187 ( ‘‘ In so arguing NRDC essentially ignores the mixed results of the medical studies evident in the record, choosing instead to rely only on the studies that favor its position. The Administrator, however, was required to take into
account all the relevant studies revealed
in the record. Because he did so in a rational manner, we will not overrule his judgment as to the margin of safety. ’’ ) Thus, although the
Administrator finds that these two studies provide limited evidence of emergency department visits in cities where 99th percentile 1-hour daily

maximum SO 2 concentrations are approximately 50 ppb, she also
concludes that these studies do not provide enough evidence to warrant a
standard at this level.

As discussed above in section, II.E.2, a number of industry groups ( e.g., ACC, UARG) did not support setting a new 1-
hour SO 2 standard. However, several of these groups ( e.g., UARG, API) and the
SC Chamber of Commerce concluded that, if EPA does choose to set a new 1- hour standard, the level of that standard
should be ≥ 150 ppb. In addition, State environmental agencies in SD (SD DENR) and OH recommended standard levels at 150 ppb. As a basis for this recommendation, these groups generally emphasized uncertainties in the scientific evidence. Specifically, as discussed in more detail above (section II.E.2.a), these commenters typically
concluded that the available epidemiologic studies do not support
the conclusion that SO 2 causes the reported health effects. This was based on their assertion that the presence of co-pollutants in the ambient air precludes the identification of a specific

SO 2 contribution to reported effects. Thus, these groups generally concluded that weight should not be placed on the cluster of three epidemiologic studies reporting statistically significant effects in multipollutant models with PM ( i.e., NYDOH 2006; Ito 2007; and Schwartz 1995). That is, these groups contend that
these studies do not demonstrate an independent effect of SO 2 . In addition, as noted in section II.E.2.b, many of these groups also disagreed with the Agency’s judgment that adverse respiratory effects occur following 5- minute exposures to SO 2 concentrations as low as 200 ppb. These comments and EPA’s responses are discussed below


### 35544 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

and in section II of the RTC document (EPA 2010).

As described in more detail in section II.E.2.a, we agree that the interpretation
of SO 2 epidemiologic studies is complicated by the fact that SO 2 is but one component of a complex mixture of pollutants present in the ambient air. However, the ISA concluded that when U.S. and international epidemiologic literature is evaluated as a whole, SO 2 effect estimates generally remained positive and relatively unchanged in multi-pollutant models with gaseous or particulate co-pollutants. Thus, although recognizing the uncertainties associated with separating the effects of

SO 2 from those of co-occurring pollutants, the ISA concluded that the
limited available evidence from studies employing multi-pollutant models
indicates that the effect of SO 2 on respiratory health outcomes appears to be generally robust and independent of the effects of gaseous co-pollutants, including NO 2 and O 3 , as well as particulate co-pollutants, particularly

PM 2.5 (ISA, section 5.2; p. 5–9).

In addition, as described in detail above in section II.E.2.a, the ISA emphasized that controlled human exposure studies provide support for the plausibility of the associations reported in epidemiologic studies. The ISA noted
that the results of controlled human exposure and epidemiologic studies form a plausible and coherent data set that supports a causal relationship between short-term (5-minutes to 24- hours) SO 2 exposures and adverse respiratory effects, and that the epidemiologic evidence (buttressed by the clinical evidence) indicates that the effects seen in the epidemiologic studies are attributable to exposure to SO 2 (ISA, section 5.2). The ISA in fact made the strongest finding possible regarding causality: ‘‘ [e]valuation of the health evidence, with consideration of issues related to atmospheric sciences, exposure assessment, and dosimetry,
led to the conclusion that there is a causal relationship between respiratory morbidity and short-term exposure to

SO 2. This conclusion is supported by the consistency, coherence, and plausibility of findings observed in the human clinical, epidemiologic, and animal toxicological studies. ’’ ISA p. 5–2 (emphasis original).

As mentioned above, many groups dispute the ISA conclusion that taken together, results from U.S. and international epidemiologic studies employing multipollutant models
indicate that SO 2 has an independent effect on the respiratory health outcomes reported in these studies. Thus, these groups contend that the Administrator should not place weight on epidemiologic studies and their associated air quality information in general, and more specifically, the Administrator should not place weight on air quality information from the three U.S. epidemiologic studies reporting statistically significant effects in multipollutant models with PM ( i.e., NYDOH 2006; Ito 2007; and Schwartz 1995). Specific comments on these three epidemiologic studies reportingstatistically significant effects in multipollutant models with PM, and EPA responses are presented below and in the RTC document (EPA 2010).

Industry groups ( e.g., API) had several comments with respect to the study conducted by the NYDOH (NYDOH, 2006). First, these groups generally concluded that the results of this study are mixed. That is, while SO 2 effect estimates were positive and statistically significant even in multipollutant
models with PM 2.5 or NO 2 in the Bronx,

SO 2 effect estimates were actually negative in Manhattan in both single and multipollutant models. These groups also contend that this report was not peer-reviewed and that the authors of this study indicated that high correlations among pollutants in the Bronx made it difficult to confidently identify which pollutants are actually increasing risks. For these reasons, industry groups generally concluded that this study should not be relied upon by the Administrator.

We acknowledge that the results of the NYDOH analysis are mixed when comparing the Bronx and Manhattan study areas. However, we disagree that the presence of mixed results renders this study unreliable. We note that the mixed results reported in this study are likely to reflect greater statistical power for identifying effects in the Bronx, where the average daily emergency department visits differed substantially from those in Manhattan. Specifically, daily asthma emergency department visits were six times higher in the Bronx study area (43 per day) than in the Manhattan study area (7.2 per day). Thus, the more prominent effects in the Bronx likely at least partially reflect greater statistical power for identifying effects there. To put these numbers in perspective, the crude daily rates of asthma emergency department visits can be estimated by dividing the daily asthma counts by the population. The mean daily crude rates of asthma emergency department visits were over eight-fold higher in the Bronx study area (16.9 per 100,000 persons) than in the Manhattan area (2.02 per 100,000 persons). Population age structures were quite different in the two communities, with larger proportions of younger persons in the Bronx versus Manhattan. There are likely additional differences in population structures of the two communities, including differences in SES, race/ethnicity, and access to primary asthma care. These differences in the two communities may explain the differences in the results, and do not prevent EPA from legitimately relying on this study.

As mentioned above, these groups
also contend that the NYDOH epidemiologic study should not berelied upon because it was not peerreviewed. We disagree with this assertion. The NYDOH study was subject to multiple peer-review processes. This included reviews by the Agency for Toxic Substances and Disease Registry (ATSDR), EPA, and

CASAC.

Finally, as also mentioned above, these groups contend that the NYDOH epidemiologic study is unreliable because the study authors indicated that high correlations among pollutants in
the Bronx make it difficult to confidently identify which pollutants are actually increasing risks. In response, we note that high correlations among ambient air pollutant concentrations are not specific to the NYDOH study, and may contribute to uncertainty in the interpretation of many epidemiologic studies of air pollution. The approach most commonly utilized to disentangle the effects of correlated pollutants in air pollution epidemiology is the copollutant model. The NYDOH uses copollutant models and finds that the
results for SO 2 remain significant in models considering the simultaneous
effects of NO 2 , O 3 , and PM 2.5 . This indicates an independent effect of SO 2 on the asthma emergency department visits reported in this study.

With respect to Ito et al., (2007), industry groups generally commented
that since the SO 2 effect estimate did not remain statistically significant in multipollutant models with NO 2 , this study does not indicate an independent
effect of SO 2 on emergency department visits in the NYC study area. API specifically commented:

The RR for an increase of 6 ppb SO 2 was statistically significant (1.20; 95% CI: 1.13, 1.28) and remained so when PM 2.5 , O 3 , or CO was included in the model, but became nonsignificant when NO 2 was included in the model (RR not provided, 95% CI: 0.9, 1.1). Because associations with SO 2 could be
attributable to NO 2 , this study cannot be used
to assess the effects of SO 2 on health effects
with small incremental increases in

exposure.


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17 See Coalition of Battery Recyclers Association

v. EPA, No. 09–1011 (DC Cir., May 14, 2010), slip opinion at 9, holding that it was reasonable for EPA to conclude that a two IQ point mean population loss is an adverse effect based in part on
consideration of comments from the American Academy of Pediatrics that such a loss should be prevented. We disagree with the commenters. We believe that this study does demonstrate an independent effect of SO 2 on emergency department visits in NYC.
We note that evidence from controlled human exposure studies has
demonstrated effects of NO 2 (EPA, 2008b) and SO 2 independently on respiratory morbidity. Since each of these criteria pollutants has an independent effect on the respiratory system, it is logical that each may be responsible for an increase in emergency department visits for asthma in epidemiologic studies. In addition,
the authors note that the attenuation of
the SO 2 effect estimate when NO 2 is
included in the model is ‘‘ consistent
with the result of monitor-to-monitor correlations, suggesting that NO 2 has less exposure error than CO or SO 2 in
this data set. ’’ Thus, it appears as though the high spatial heterogeneity of SO 2 compared to NO 2 , leading to increased exposure error, may be causing the
attenuation of the SO 2 effect estimate
when NO 2 is included in the model in this study—not that the effects seen in the study are attributable to NO 2

. Overall, the results from this study are
consistent with the SO 2 effect on respiratory emergency department visits and hospital admissions across studies and are coherent with the respiratory
effects observed in controlled human exposure studies. This study thus provides persuasive evidence of an independent effect of short-term SO 2 exposure on respiratory morbidity.

With respect to Schwartz et al., (1995), industry groups generally commented that the results of this study are mixed, and therefore should not be considered by the Administrator. More specifically, these commenters noted that although the results in New Haven remained statistically significant in the presence of PM 10 , the SO 2 effect
estimate in Tacoma was reduced and no longer statistically significant in the presence of PM 10 . Commenters also noted that in both cities, the SO 2 effect estimate was reduced and no longer statistically significant in the presence
of O 3

.

We disagree that the results of this study of hospital admissions should not be considered by the Administrator. As noted by the commenters, this study was conducted in two cities, New Haven, CT and Tacoma, WA. These cities were chosen because they differ in several important aspects and the author expected the results from the two cities
to be different due to the inherent nature of the study design and study
locations. ‘‘ New Haven has almost twice
the mean SO 2 concentration of Tacoma,
almost two and a half times the SO 2 concentration in the peak winter season, and a much larger summer ozone peak than Tacoma (Schwartz 1995). ’’ Since the study was designed to examine the differences in these two cities, the fact
that the results differed in the two cities
does not invalidate those results. In addition, EPA considers the SO 2 effect
to be robust to inclusion of O 3 in New
Haven. The central effect estimate for

SO 2 changed from 1.03 to 1.02 after the
addition of O 3 as a copollutant and likely lost statistical significance due to a greater than 40% reduction in the number of days included because O 3 was only measured during the warm months. This reduction likely led to model instability and a loss of statistical significance. To be consistent with how results of other studies were interpreted in the ISA, and as supported by the CASAC, the effect of SO 2 is considered
robust to the inclusion of O 3 in New

Haven.

In addition to generally concluding that the epidemiology is too uncertain to
demonstrate that SO 2 has an independent effect on the respiratory effects reported in those studies, many industry groups ( e.g., API, ACC, Progress Energy, EEI, CIBO) also
commented that adverse health effects do not occur following 5–10 minute SO 2 exposures < 400 ppb in controlled human exposure studies (an issue also discussed above in section II.E.2.b). Thus, these groups generally maintained
that the level of a 1-hour standard should not take into account limiting 5- minute peaks as low as 200 ppb. From this argument, many of these groups
further maintained that 1-hour standard
levels ≥ 150 ppb are requisite to protect public health with an adequate margin of safety.

As first discussed in section II.E.2.b above, we disagree with the commenters that adverse respiratory effects do not occur following 5-minute SO 2 exposures as low as 200 ppb. The ISA reported that exposure to SO 2 concentrations as low as 200–300 ppb for 5–10 minutes results in approximately 5–30% of exercising asthmatics experiencing moderate or greater decrements in lung function (defined in terms of a ≥ 15%
decline in FEV 1 or 100% increase in sRaw; ISA, Table 3–1). Considering the 2000 ATS guidelines described in section II.E.2.b, we determined that these results could reasonably indicate

an SO 2 -induced shift in these lung
function measurements for this subpopulation. Under this scenario, an appreciable percentage of exercising asthmatics exposed to SO 2 concentrations as low as 200 ppb would likely have diminished reserve lung function and thus would likely be at greater risk if affected by another respiratory agent ( e.g., viral infection). Importantly, diminished reserve lung function in a population that is attributable to air pollution is
considered an adverse effect under ATS guidance. 17 Also noted in section II.E.2.b, we were mindful of CASAC’s pointed comments. The second draft ISA placed relatively little weight on
health effects associated with SO 2 exposures at 200–300 ppb. CASAC strongly disagreed with this
characterization of the health evidence. Their consensus letter following the
second draft ISA states:

Our major concern is the conclusions in the ISA regarding the weight of the evidence for health effects for short-term exposure to
low levels of SO 2 . Although the ISA presents
evidence from both clinical and epidemiological studies that indicate health effects occur at 0.2 ppm or lower, the final chapter emphasizes health effects at 0.4 ppm
and above * * * CASAC believes the clinical and epidemiological evidence warrants stronger conclusions in the ISA regarding the
available evidence of health effects at 0.2 ppm or lower concentrations of SO 2 . The
selection of a lower bound concentration for health effects is very important because the ISA sets the stage for EPA’s risk assessment decisions. In its draft Risk and Exposure Assessment (REA) to Support the Review of
the SO 2 Primary National Ambient Air Quality Standards (July 2008), EPA chose a range of 0.4 ppm—0.6 ppm SO 2 concentrations for its benchmark analysis. As CASAC will emphasize in a forthcoming letter on the REA, we recommend that a lower bound be set at least as low as 0.2 ppm (Henderson 2008a).

Similarly, we were also mindful of
CASAC comments on the first draft of
the REA. The consensus CASAC letter following the 1st draft REA states:

The CASAC believes strongly that the weight of clinical and epidemiology evidence indicates there are detectable clinically
relevant health effects in sensitive subpopulations down to a level at least as low as 0.2 ppm SO 2 . These sensitive subpopulations represent a substantial segment of the at-risk population (Henderson 2008b).

As noted in section II.E.2.b, we were also mindful of: (1) Previous CASAC recommendations (Henderson 2006) and NAAQS review conclusions (EPA 2006, EPA 2007d) indicating that moderate decrements in lung function can be clinically significant in some asthmatics ( see section II.E.2.b for more detail) and


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18 The ISA concluded that collective evidence from key controlled human exposure studies considered in the previous review, along with a limited number of new controlled human exposure studies, consistently indicates that with elevated ventilation rates a large percentage of asthmatic individuals tested in a given chamber study (up to 60%, depending on the study) experience moderate or greater decrements in lung function, frequently accompanied by respiratory symptoms, following peak exposures to SO 2 at concentrations of 0.4–0.6 ppm. (ISA, p. 3–9). (2) controlled human exposure studies not including severe asthmatics and thus, that it is reasonable to assume that persons with more severe asthma than the study participants would have a
more serious health effect from shortterm exposure to 200 ppb SO 2. CASAC
echoed this concern in its comments on the policy assessment chapter of the

REA:

Chapter 10 should better address uncertainty in identifying alternative NAAQS
for SO 2 . In particular, the uncertainties
discussed in the health risk characterization should be considered in specifying a NAAQS that provides adequate margin of safety. One particular source of uncertainty needing acknowledgment is the characteristics of persons included in the clinical studies. The draft REA acknowledges that clinical studies are unlikely to have included severe asthmatics that are likely to be potentially at greater risk than those persons included in the clinical studies (Samet 2009; p. 15).

Taken together, the Administrator concluded that exposure to SO 2 concentrations as low as 200 ppb can
result in adverse health effects in asthmatics. Consequently the
Administrator also concluded that a 1-hour standard of 150 ppb is not requisite to protect public health with an adequate margin of safety, even with a 99th percentile form. This conclusion
takes into account the St. Louis exposure analysis estimating that only 88% of asthmatic children at moderate or greater exertion would be protected
from at least one 5-minute SO 2 exposure
≥ 200 ppb per year at a 1-hour standard level of 150 ppb, and appropriate weight placed on the epidemiologic evidence ( see section II.F.4.c for a discussion of the epidemiologic evidence with respect to level).

c. Conclusions on Standard Level

Having carefully considered the public comments on the appropriate
level for a 1-hour SO 2 standard, as discussed above, the Administrator
believes the fundamental conclusions
reached in the ISA and REA remain valid. In considering the level at which the 1-hour primary SO 2 standard should be set, the Administrator continues to place primary emphasis on the body of controlled human exposure and epidemiologic evidence assessed in the ISA, as summarized above in section II.B. In addition, the Administrator
continues to view the results of exposure and risk analyses, discussed above in section II.C, as providing supporting information for her decision.

In considering the level of a 1-hour

SO 2 standard, the Administrator notes that there is no bright line clearly mandating the choice of level within the reasonable range proposed. Rather, the choice of what is appropriate within this reasonable range is a public health policy judgment entrusted to the Administrator. This judgment must include consideration of the strengths
and limitations of the evidence and the appropriate inferences to be drawn from the evidence and the exposure and risk
assessments. These considerations and
the Administrator’s final decision with regard to the level of a new 1-hour SO 2 standard are discussed below.

In considering the controlled human exposure studies, the Administrator notes that these studies provide the most direct evidence of respiratory effects from exposure to SO 2 . These studies exposed groups of exercising
asthmatics to defined concentrations of

SO 2 for 5–10 minutes and found adverse respiratory effects. As noted above ( see section II.C), SO 2 exposure levels which resulted in respiratory effects in these
studies were considered 5-minute benchmark exposures of potential concern in the analyses found in the REA. With respect to this evidence, the Administrator notes the following key points:

• Exposure of exercising asthmatics

to 5–10 minute SO 2 concentrations ≥ 400 ppb results in moderate or greater decrements in lung function (in terms of

FEV 1 or sRaw) in 20–60% of tested individuals in these studies. Moreover, these decrements in lung function are often statistically significant at the group mean level and are frequently accompanied by respiratory symptoms. 18 Based on ATS guidelines, exposure to SO 2 concentrations ≥ 400 ppb clearly result in adverse respiratory effects ( i.e., decrements in lung function in the presence of respiratory symptoms). Therefore, the
Administrator has concluded it appropriate to place weight on the 400 ppb 5-minute SO 2 benchmark
concentration of concern.

• Exposure of exercising asthmatics

to 5–10 minute SO 2 concentrations at 200–300 ppb results in moderate or greater decrements in lung function in 5–30% of the tested individuals in these
studies. The Administrator notes that although these decrements in lung
function have not been shown to be statistically significant at the group mean level, or to be frequently accompanied by respiratory symptoms,
she considers effects associated with exposures as low as 200 ppb to be adverse in light of CASAC advice, similar conclusions in prior NAAQS reviews, and the ATS guidelines described in detail above ( see section II.E.2.b and II.F.4.b). Therefore, she has concluded it appropriate to place weight on the 200 ppb 5-minute benchmark

concentration.

• There is very limited evidence from two mouthpiece exposure studies suggesting respiratory effects in exercising asthmatics following SO 2 exposures at 100 ppb. However, given the uncertainties and potential unrepresentativeness associated with mouthpiece studies ( see section II.F.4.b above), the Administrator found it appropriate not to place weight on this

5-minute SO 2 benchmark concentration.

The Administrator also considered the results of the air quality, exposure, and risk analyses, as they serve to estimate the extent to which a given
1-hour standard limits the 5-minute
benchmark concentrations of concern
identified from controlled human exposure studies ( see REA chapters 7–9, proposal section II.F.4.b, and proposal Tables 2–4). In considering these results as they relate to limiting

5-minute SO 2 benchmark concentrations

≥ 200 and 400 ppb, the Administrator notes the following key points:

• The 40-county air quality analysis estimates that a 100 ppb 1-hour daily
maximum standard would allow at most 2 days per year on average in any county when estimated 5-minute daily

maximum SO 2 concentrations exceed the 400 ppb benchmark, and at most 13 days per year on average when 5-minute daily maximum SO 2 concentrations exceed the 200 ppb benchmark ( see proposal, Table 2, 74 FR at 64840). Furthermore, given a simulated 1-hour 100 ppb standard level, most of the counties in that air quality analysis were estimated to experience 0 days per year on average when 5-minute daily

maximum SO 2 concentrations exceed the 400 ppb benchmark and ≤ 3 days per year on average when 5-minute daily

maximum SO 2 concentrations were estimated to exceed the 200 ppb benchmark ( see REA, Tables 7–14 and 7–12).

• The St. Louis exposure analysis estimates that a 99th percentile 1-hour daily maximum standard at a level of 100 ppb would likely protect > 99% of asthmatic children in that city at moderate or greater exertion from experiencing at least one 5-minute

exposure ≥ 400 ppb per year, and


### 35547 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

19 For example, as noted in the proposal (proposal, section II.F.4, 74 FR at 64835) evidence of a pattern of results from a group of studies that
find effect estimates similar in direction and magnitude would warrant consideration of and
reliance on such studies even if the studies did not all report statistically significant associations in single- or multi-pollutant models. The SO 2 epidemiologic studies fit this pattern, and are buttressed further by the results of the clinical studies. ISA, section 5.2. approximately 97% of those asthmatic children at moderate or greater exertion from experiencing at least one exposure

≥ 200 ppb per year ( see proposal, section II.F.4.b).

• The St. Louis risk assessment estimates that a 99th percentile 1-hour standard level at 100 ppb would likely protect about 97–98% of exposed asthmatic children in that city at moderate or greater exertion from experiencing at least one moderate or greater lung function response (defined

as a ≥ 100% increase in sRaw; see proposal, section II.F.4.b).

Given the above considerations, the
Administrator concludes that a 1-hour standard at a level of 100 ppb would appropriately limit 5-minute SO 2 benchmark concentrations ≥ 200 or 400 ppb. Moreover, although the Administrator acknowledges that the air quality and exposure analyses mentioned above suggest that a 50 ppb standard may somewhat further limit 5-

minute SO 2 concentrations/exposures in excess of the 200 ppb benchmark ( see proposal section II.F.4.b), she does not
believe this information alone warrants a standard level lower than 100 ppb. More specifically, although she considers the health effects resulting
from 5-minute SO 2 exposures as low as 200 ppb to be adverse, she also recognizes that such effects are appreciably less severe than those at

SO 2 concentrations ≥ 400 ppb. Thus, she
concludes that there is little difference in limiting 5-minute concentrations/

exposures ≥ 400 ppb given 1-hour standard levels in the range of 50 to 100 ppb.

In considering the epidemiologic evidence with regard to level, the
Administrator notes that there have been more than 50 peer reviewed epidemiologic studies published worldwide evaluating SO 2 (ISA, Tables 5–4 and 5–5). These studies have generally reported positive, although not always statistically significant
associations between more serious health outcomes ( i.e. respiratory-related emergency department visits and hospitalizations) and ambient SO 2 concentrations and have generally included populations potentially at
increased risk for SO 2 -related respiratory effects (e.g, children, older adults, and those with pre-existing respiratory disease). The Administrator finds that in assessing the extent to
which these studies and their associated air quality information can inform the level of a new 99th percentile 1-hour daily maximum standard for the U.S., air quality information from the U.S.
and Canada is most relevant since these
areas have similar monitor network designs and patterns of air quality. However, as described in proposal section II.F.4.a, SO 2 concentrations reported for Canadian studies were not directly comparable to those reported
for U.S. studies due to use of different monitoring protocols in those studies. Thus, the Administrator focused on 99th percentile air quality information from U.S. studies for informing potential 1-hour standard levels. She
concludes that this information provides evidence of associations
between ambient SO 2 and emergency department visits and hospital admissions in U.S. cities with particular 99th percentile 1-hour SO 2 levels, and thus provides information that is particularly relevant for setting the level
of a 1-hour SO 2 standard. With regard to these studies she notes the following key points:

• Ten studies (some conducted in multiple locations) reported mostly positive, and sometimes statistically significant, associations between
ambient SO 2 concentrations and emergency department visit and hospital admissions in locations where 99th percentile 1-hour daily maximum

SO 2 levels ranged from approximately 50–460 ppb.

• Within this broader range of SO 2 concentrations, there is a cluster of three epidemiologic studies between 78–150 ppb (for the 99th percentile of the 1-
hour SO 2 concentrations) where the SO 2 effect estimate remained positive andstatistically significant in multipollutant models with PM (NYDOH (2006), Ito et al., (2007), and Schwartz et al., (1995)). Notably, althoughstatistical significance in multipollutant models is an important consideration, it is not the only consideration when relying on such epidemiologic evidence. 19 However, as noted earlier, there is special sensitivityin this review in disentangling PMrelated effects (especially sulfate PM)
from SO 2 -related effects in interpreting the epidemiologic studies; thus, these studies are of particular relevance here, lending strong support both to the
conclusion that SO 2 effects are generally independent of PM (ISA, section 5.2) and that these independent adverse
effects of SO 2 have occurred in cities with 1-hour daily maximum, 99th percentile concentrations in the range of 78–150 ppb. Nor did EPA find the comments criticizing these studies persuasive, as explained above in
section II.F.4.b and in the RTC document (EPA 2010). The Administrator therefore judges it appropriate to place substantial weight
on this cluster of three U.S. epidemiologic studies in selecting a standard level, as they are a group of studies that reported positive and statistically significant associations
between ambient SO 2 and emergency department visits or hospital admissions even when potential confounding by
PM was considered.

• The Administrator agrees with the finding in the ISA that the controlled human exposure evidence lends biological plausibility to the effects reported in epidemiologic studies (ISA, p. 5–9).

• There is limited evidence from two epidemiologic studies employing single pollutant models that found generally positive associations between ambient

SO 2 and emergency department visits in locations where 99th percentile 1-hour

SO 2 concentrations were approximately 50 ppb ( see proposal, Figures 1 and 2). However, considering that the results of these studies were mixed, and importantly, that neither of these two studies evaluated the potential for confounding by co-pollutants through the use of multipollutant models (particularly with PM), the Administrator judges it appropriate to place limited weight on these studies.

• With regard to the cluster of three
studies conducted in the Bronx (NYDOH 2006), NYC (Ito et al., 2007), and New Haven (Scwartz et al., 1995), there is a degree of uncertainty as to whether the 99th percentile 1-hour daily

maximum SO 2 concentrations reported from monitors in these three study areas reflect the highest 99th percentile 1-hour daily maximum SO 2 concentration. Our limited qualitative analysis suggests that 99th percentile 1- hour daily maximum SO 2 concentrations reported by monitors in these study areas are reasonable approximations for the absolute highest 99th percentile 1-hour daily maximum

SO 2 concentration that can occur across
the entire area in these studies (including the areas where monitors were not located) ( see Brode, 2010). However, although a reasonable approximation, it is still likely that
these monitored concentrations are
somewhat lower than the absolute highest 99th percentile 1-hour daily

maximum SO 2 concentrations occurring across these epidemiologic study areas.


### 35548 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

Weighing all of this evidence, the
Administrator concludes that the epidemiologic studies provide strong support for setting a standard that limits the 99th percentile of the distribution of 1-hour daily maximum SO 2 concentrations to 75 ppb. This judgment takes into account the strong determinations in the ISA (and endorsed by CASAC), based on a much broader body of evidence, that there is a causal association between exposure

to SO 2 and the types of respiratory morbidity effects reported in these
studies. The Administrator further judges that it is not necessary based on existing epidemiologic evidence, to set a standard below 75 ppb. That is, the
Administrator concludes that a standard level of 75 ppb is sufficiently below the

SO 2 levels in three cities where epidemiologic studies found statistically significant effects in multipollutant models with PM ( i.e., 78, 82, and 150 ppb) to provide an adequate margin of safety given the uncertainty as to whether monitors in these study locations reflected the highest 1-hour daily maximum SO 2 concentration across the entire study area. Thus, a standard set at a level of 75 ppb is likely further below the 99th percentile 1-hour daily maximum concentrations in these three study areas than the bare comparison of levels would otherwise indicate. Finally, the Administrator again notes that epidemiologic evidence below 75 ppb is more uncertain because studies below 75 ppb did not evaluate potential confounding of results in multipollutant models, and because these studies reported mixed results.

Given the above considerations and the comments received on the proposal,
the Administrator determines that the appropriate judgment, based on the entire body of evidence and information available in this review, and the related uncertainties, is a standard level of 75 ppb. She concludes that such a standard, with a 1-hour averaging time and 99th percentile form, will provide a significant increase in public health protection compared to the current standards and would be expected to protect against the respiratory effects
that have been linked with SO 2 exposures in both controlled human exposure and epidemiologic studies. Specifically, she concludes that such a standard will limit 1-hour exposures at and above 75 ppb for those in susceptible populations that are at-risk of experiencing adverse health effects from short-term exposure to SO 2 . Such
a standard will also maintain SO 2 concentrations below those in locations where key U.S. epidemiologic studies have reported that ambient SO 2 is associated with clearly adverse respiratory health effects, as indicated by increased hospital admissions and emergency department visits. She also
notes that a 1-hour standard at a level of 75 ppb is expected to substantially limit asthmatics’ exposure to 5–10

minute SO 2 concentrations ≥ 200 ppb, thereby substantially limiting the
adverse health effects associated with such exposures. Finally, the
Administrator notes that a standard level of 75 ppb is consistent with the
consensus recommendation of CASAC.

In setting the standard level at 75 ppb rather than at a lower level, the
Administrator notes that a 1-hour standard with a level lower than 75 ppb would only result in significant further public health protection if, in fact, there is a continuum of serious, adverse health risks caused by exposure to SO 2 concentrations below 75 ppb. Based on the available evidence, the
Administrator does not believe that such assumptions are warranted. Taking
into account the uncertainties that remain in interpreting the evidence
from available controlled human exposure and epidemiologic studies, the
Administrator notes that the likelihood of obtaining benefits to public health with a standard set below 75 ppb decreases, while the likelihood of requiring reductions in ambient concentrations that go beyond those that are needed to protect public health

increases.

Therefore, the Administrator judges
that a 1-hour SO 2 standard at 75 ppb is sufficient to protect public health with an adequate margin of safety. This includes protection with an adequate margin of safety for susceptible populations at increased risk for adverse respiratory effects from short-term exposures to SO 2 for which the evidence supports a causal relationship with SO 2 exposures. The Administrator does not
believe that a lower standard level is needed to provide this degree of protection. These conclusions by the Administrator appropriately consider the requirement for a standard that is neither more nor less stringent than necessary for this purpose and recognizes that the CAA does not require that primary NAAQS be set at a zero-risk level or to protect the most susceptible individual, but rather at a level that reduces risk sufficiently so as to protect the public health with an adequate margin of safety.

5. Retaining or Revoking the Current
24-Hour and Annual Standards

This section discusses considerations related to retaining or revoking the current 24-hour and annual SO 2 primary NAAQS. Specifically, this section
summarizes the rationale for the Administrator’s proposed decision regarding whether to retain or revoke the current standards (section II.F.5.a), discusses public comments related to
whether to retain or revoke the current standards (II.F.5.b), and presents the
Administrator’s final conclusions regarding whether to retain or revoke the current standards (II.F.5.c).

a. Rationale for Proposed Decision

As noted in the proposal ( see section II.F.5), the REA recognized that the particular level selected for a new 99th percentile 1-hour daily maximum standard would have implications for deciding whether to retain or revoke the
current 24-hour and annual standards. That is, with respect to SO 2 -induced respiratory morbidity, the lower the level selected for a 99th percentile 1-hour daily maximum standard, the less additional public health protection
the current standards would be expected to provide. CASAC expressed a similar view following their review of
the 2nd draft REA: ‘‘ Assuming that EPA adopts a one hour standard in the range suggested, and if there is evidence showing that the short-term standard provides equivalent protection of public health in the long-term as the annual standard, the panel is supportive of the REA discussion of discontinuing the
annual standard ’’ (Samet 2009, p. 15). With regard to the current 24-hour standard, CASAC was generally supportive of using the air quality analyses in the REA as a means of determining whether the current
24-hour standard was needed in
addition to a new 1-hour standard to protect public health. CASAC stated:

‘‘ The evidence presented [in REA Table 10–3] was convincing that some of the
alternative one-hour standards could also adequately protect against
exceedances of the current 24-hour
standard ’’ (Samet 2009, p. 15).

In accordance with the REA findings
and CASAC recommendations mentioned above, the Administrator noted that 1-hour standards in the range of 50–100 ppb would have the effect of maintaining 24-hour and annual SO 2 concentrations generally well below the
levels of the current 24-hour and annual NAAQS ( see REA Tables 10–3 and 10– 4 and REA Appendix Tables D–3 to D– 6). Thus, if a new 99th percentile 1-hour daily maximum standard was set in the proposed range of 50–100 ppb, then the Administrator proposed to revoke the
current 24-hour and annual standards. However, as noted in the proposal, if a standard was set at a level >100 ppb and


### 35549 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

up to 150 ppb, then the Administrator
indicated that she would retain the existing 24-hour standard, recognizing that a 99th percentile 1-hour daily maximum standard at 150 ppb would not have the effect of maintaining 24- hour average SO 2 concentrations below
the level of the current 24-hour standard in all locations analyzed ( see REA Appendix Table D–4). Under this scenario, the Administrator would still
revoke the current annual standard recognizing: (1) 99th percentile 1-hour daily maximum standards in the range of 50–150 ppb would maintain annual average SO 2 concentrations below the level of the current annual standard ( see REA Table 10–4 and REA Appendix tables D–5 and D–6); and (2) the lack of sufficient evidence linking long-term

SO 2 exposure to adverse health effects.

b. Comments on Retaining or Revoking
the Current 24-Hour and Annual
Standards

As noted above, most industry groups were opposed to the proposed revisions
to the SO 2 NAAQS. However, some of these groups noted that if a 1-hour standard was adopted, then they would support revoking the current 24-hour and annual standards. State agencies generally supported revoking the
current standards if a 1-hour standard was set in the proposed range, although NAACA, NESCAUM, and VT, while supportive of revoking the existing standards, also suggested that EPA explore setting a new 24-hour standard to minimize the potential that multiple hours within a day would exceed a 1-hour standard ( see RTC document (EPA 2010), section IV). Groups which supported revoking the current 24-hour and annual standards (if a 1-hour standard was set in the proposed ranged) generally referenced the
Administrator’s rationale and CASAC advice described in the proposal ( see section II.F.5).

Public health ( e.g., ALA, ATS) and environmental organizations ( e.g., CBD, WEACT for Environmental Justice) were generally opposed to revoking the
current 24-hour and annual standards. These groups generally concluded that
the 24-hour standard should be revised
while the annual standard should be retained. In support of this position,

ALA et al., cited air quality information from the REA indicating that if air quality was simulated to just meet a 99th percentile 1-hour daily maximum standard in the proposed range of 50– 100 ppb, then in some locations analyzed, 99th percentile 24-hour average SO 2 concentrations would be above concentrations ( i.e., above 99th percentile 24-hour average concentrations) in cities where U.S. emergency department visit and hospital admission studies reported positive associations with SO 2 . In addition, many of these groups were opposed to revoking the current annual standard. In general, these groups concluded that given the uncertainties
associated with SO 2 exposure and longterm health effects, EPA should err on the side of being health protective and retain the existing annual standard. EPA responses to comments on whether the
current standards should be retained or revoked are presented below as well as in section IV of the RTC document (EPA 2010).

As stated in the REA and proposal, 99th percentile 24-hour average SO 2 concentrations in cities where U.S. emergency department visit and hospital admission studies (for all respiratory causes and asthma; identified from Table 5–5 of the ISA) were conducted ranged from 16 ppb to 115 ppb (Thompson and Stewart, 2009). Moreover, as stated in the REA and proposal ( see section II.F.2), effect estimates that remained statistically significant in multi-pollutant models
with PM were found in cities with 99th percentile 24-hour average SO 2 concentrations ranging from approximately 36 ppb to 64 ppb. In its comments, ALA et al., stated (based on the air quality information in REA Appendix Table D–2) ‘‘ with a 1-hour 50 ppb 99th percentile standard, 7 counties would experience a 99th percentile 24-hour concentration of 16 ppb or greater, the range found to be harmful in epidemiological studies. With an hourly standard of 100 ppb, 24
of 30 counties would have 99th percentile 24-hour concentrations above 16 ppb, with 1 county exceeding 36 ppb. ’’ Thus, these commenters generally
maintained that a lowered 24-hour standard is needed to protect against
these 24-hour SO 2 concentrations.

We disagree that a lowered 24-hour standard is needed to protect against 24-hour average SO 2 concentrations of
concern identified from cities where U.S. emergency department visit and hospital admission studies were
conducted. As noted in detail in the REA, there is uncertainty as to whether the health effects reported in epidemiologic studies using 24-hour average SO 2 concentrations are in fact due to 24-hour average SO 2 exposures (REA, section 10.5.2). That is, when describing epidemiologic studies observing positive associations between
ambient SO 2 and respiratory symptoms,
the ISA stated ‘‘ that it is possible that
these associations are determined in large part by peak exposures within a 24-hour period ’’ (ISA, section 5.2 at p. 5–5). Similarly, the ISA stated that:

‘‘ The effects of SO 2 on respiratory symptoms, lung function, and airway
inflammation observed in the human clinical studies using peak exposures further provides a basis for a progression of respiratory morbidity resulting in increased emergency department visits and hospital
admissions ’’ and makes the associations observed in the epidemiologic studies

‘‘ biologica[lly] plausib[le] ’’ ( id. ). In contrast, evidence from controlled human exposure studies of 5–10 minutes and epidemiologic studies using 1-hour daily maximum SO 2 concentrations provided appreciably stronger evidence of respiratory morbidity effects following SO 2 exposures ≤ 1-hour.

Given that respiratory morbidity effects following SO 2 exposure may be most related to averaging times ≤ 1-hour,
EPA found it most reasonable to
consider the extent to which a 1-hour averaging time, given an appropriate form and level (which as discussed above, also substantially limits 5-minute benchmark exposures of concern; see sections II.F.2 and II.F.4), limited 99th percentile 24-hour average
concentrations of SO 2 in locations where emergency department visit/ hospitalization studies reported that the

SO 2 effect estimate remainedstatistically significant in multipollutant models with PM ( i.e., locations with 99th percentile 24-hour average SO 2 concentrations ≥ 36 ppb). Considering this, we note that ALA et al., identified only one county with 99th percentile 24-hour average SO 2 concentrations ≥ 36 ppb given a 99th percentile 1-hour daily maximum standard at 100 ppb, and no counties

≥ 36 ppb given a 99th percentile 1-hour daily maximum standard at 50 ppb. Thus, given a 99th percentile 1-hour daily maximum standard level at 75 ppb ( i.e., the form and level selected for a
new 1-hour SO 2 standard), it is possible that no county in the ALA et al., analysis would have had a 99th percentile 24-hour average SO 2 concentration ≥ 36 ppb.

With regard to the annual standard, we also disagree that this standard needs to be retained. First, the ISA
found that ‘‘ [t]he evidence linking shortterm SO 2 exposure and cardiovascular effects, and morbidity and mortality with long-term exposures to SO 2 is inadequate to infer a causal relationship. ’’ ISA, p. 5–10. Thus, an annual standard is unnecessary to prevent long-term health effects. The remaining issue is whether such a standard provides further protection


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against short-term effects, given the new
one hour standard. We conclude that it does not. As noted in the proposal, our air quality information indicates that 1- hour standard levels in the range of 50– 100 ppb are estimated to generally keep
annual SO 2 concentrations well below
the level of the current annual standard. CASAC agreed. The panel stated:

‘‘ Assuming that EPA adopts a one hour standard in the range suggested, and ifthere is evidence showing that the shortterm standard provides equivalentprotection of public health in the longterm as the annual standard, the panel is supportive of the REA discussion of discontinuing the annual standard ’’ (Samet 2009, p. 15). Taken together, this information indicates that retaining the
annual standard would add no additional public health protection.

c. Administrator’s Conclusions on Retaining or Revoking the Current 24-
Hour and Annual Standards

In accordance with the REA findings
and CASAC recommendations mentioned above, the Administrator
concludes that a 1-hour standard at level of 75 ppb would have the effect of maintaining 24-hour and annual SO 2 concentrations generally well below the
levels of the current 24-hour and annual NAAQS ( see REA Tables 10–3 and 10– 4 and REA Appendix Tables D–3 to D– 6). She also concludes that, as noted above in section II.F.2, a 1-hour standard at 75 ppb will likely limit 99th percentile 24-hour SO 2 concentrations in U.S. locations where emergency department visit and hospital admission studies reported statistically significant associations in multi-pollutant models with PM. Finally, she notes the lack of sufficient health evidence to support an annual standard to protect against health effects associated with long-term

SO 2 exposure. Taken together, the Administrator concludes it appropriate
to revoke the current 24-hour and
annual standards.

G. Summary of Decisions on the Primary Standards

For the reasons discussed above, and taking into account information and assessments presented in the ISA and
REA as well as the advice and recommendations of CASAC, the
Administrator concludes that the current 24-hour and annual primary standards are not requisite to protect public health with an adequate margin of safety. The Administrator also concludes that establishing a new 1- hour standard will appropriately protect public health with an adequate margin of safety, and specifically will afford requisite increased protection for asthmatics and other at-risk populations against an array of adverse respiratory health effects related to short-term (5 minutes to 24 hours) SO 2 exposure. These effects include decrements in lung function (defined in terms of sRaw
and FEV 1 ), increases in respiratory symptoms, and related serious indicators of respiratory morbidity including emergency department visits and hospital admissions for respiratory

causes.

Specifically, the Administrator is establishing a new short-term primary

SO 2 standard with a 1-hour (daily maximum) averaging time and a form defined as the 3-year average of the 99th percentile of the yearly distribution of 1- hour daily maximum SO 2 concentrations, and a level of 75 ppb. In addition to setting a new 1-hour standard at 75 ppb, the Administrator is revoking the current 24-hour and annual standards recognizing that a 1-hour standard set at 75 ppb will have the effect of generally maintaining 24-hour
and annual SO 2 concentrations well
below the levels of the current 24-hour
and annual standards.

III. Overview of the Approach for Monitoring and Implementation

We received several comments regarding the approaches discussed in the proposal for monitoring and modeling for comparison to the proposed new 1-hour SO 2 NAAQS, designations of areas as either attaining or not attaining the NAAQS, and implementation of the new NAAQS in State implementation plans (SIPs) that
would ensure ultimate attainment of the new NAAQS in transitioning from the annual and 24-hour NAAQS in a timely
manner. These comments raised fundamental questions regarding our contemplated approaches in all three areas, and caused us to re-examine them and review their consistency with past practice under the SO 2 NAAQS implementation program. After conducting that review, and in response to the public comments we are revising our general anticipated approach toward implementation of the new 1-hour NAAQS. This revised approach wouldbetter address: (1) The unique sourcespecific impacts of SO 2 emissions; (2) the special challenges SO 2 emissionspresent in terms of monitoring shortterm SO 2 levels for comparison with the NAAQS in many situations; (3) the superior utility that modeling offers for assessing SO 2 concentrations; and (4) the most appropriate method for ensuring that areas attain and maintain
the new 1-hour SO 2 NAAQS in a manner that is as expeditious as practicable, taking into account the potential for substantial SO 2 emissions reductions from forthcoming national and regional rules that are currently underway.

Below, we provide an overview of our revised approach to monitoring, and of our expected approaches to designations of areas, and implementation of the NAAQS. Due to the unique challenges presented by SO 2 , we do not expect that the anticipated approaches discussed below would be necessarily transferable to other NAAQS pollutant situations. For NAAQS pollutants other than SO 2 , air quality monitoring is more appropriate for determining whether all areas are attaining the NAAQS, and there is comparatively less dependence upon conducting refined modeling. Each of these subjects ( i.e., our revised approach to monitoring, and our expected approaches to designations of areas, and implementation of the NAAQS) is further addressed later in the preamble, in sections IV, V and VI, respectively. Where specific public comments on the proposal are addressed and responded to, further details of the specific revised approaches are explained. In many respects, both the overview discussion below and the subsequent more detailed discussions explain our expected and intended future action in implementing the new 1-hour NAAQS—in other words, they constitute guidance, rather than final agency action—and it is possible that our approaches may continue to evolve as we, States, and other stakeholders proceed with actual implementation. In other respects, such as in the final regulatory provisions regarding the promulgated monitoring network, we are explaining EPA’s final conclusions regarding what is required by this rule. We expect to issue further guidance regarding implementation, particularly concerning issues that may arise regarding the application of refined dispersion modeling under this revised approach for monitoring and implementation, and issues that States and other stakeholders may also ask us to address as we proceed toward various stages of ensuring attainment. EPA intends to solicit public comment prior to finalizing this guidance.

The main necessary elements of implementing the new 1-hour NAAQS are: (1) An approach for assessing
ambient concentrations to determine compliance with the NAAQS; (2) a process for using these assessments to designate areas relative to the new standard; and (3) the development of State plans that include control measures sufficient for ensuring the NAAQS is attained everywhere as expeditiously as possible, which we


### 35551 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

believe should be no later than 2017. EPA’s revised anticipated approach to determining compliance with the new

SO 2 NAAQS is consistent with our historical approach to SO 2 designations and implementation through permits and emissions limitations, which
involves the combined use of monitoring and modeling. The emphasis we would place on monitoring and modeling, compared with each other, under the revised expected approach is therefore significantly different than that in the approach discussed in the proposal, which was less in line with our historical practice for SO 2 , as the public comments highlighted.

In the SO 2 NAAQS proposal, we recommended a monitoring-focused approach for comparison to the new NAAQS, featuring a two-pronged monitoring network design. This
included monitors in certain CBSAs based on a combination of population
and SO 2 emissions coupled with
additional monitors within a State based
on that State’s contribution to national

SO 2 emissions. The resulting proposed network would have required approximately 348 monitors nationwide
to be sited at the locations of maximum
concentration. Numerous State and local government commenters expressed concerns regarding the burdens of implementing the proposed monitoring network and the sufficiency of its scope for purposes of identifying violations.
These commenters contended that our proposed monitoring network was too small and insufficient to cover the range
of SO 2 sources, and yet too burdensome and expensive to expand to an adequate scale. Some of these commenters (the City of Alexandria, and the States of Delaware, North Carolina and Pennsylvania) suggested using modeling to determine the scope of monitoring requirements, or favored modeling over monitoring to determine compliance with the NAAQS.

Partly in response to these comments, and after reconsidering the proposal’s monitoring-focused approach in light of EPA’s historical approach to SO 2 NAAQS implementation and area designations decisions, we intend to use a hybrid analytic approach that would combine the use of monitoring and modeling to assess compliance with the
new 1-hour SO 2 NAAQS. We believe that some type of hybrid approach is
more consistent with our historical approach and longstanding guidance
toward SO 2 than what we originally proposed. In addition, we believe that
for a short-term 1-hour standard it is more technically appropriate, efficient, and effective to use modeling as the principle means of assessing compliance for medium to larger sources, and to rely more on monitoring for groups of smaller sources and sources not as conducive to modeling.
We discuss the details of the final revised monitoring network requirements in section IV later in the preamble, but note here the relationship that the revised approach toward monitoring and modeling—taken partly in response to the public comments
mentioned above—has to the other two general subject areas in implementation for which we are providing guidance, namely initial area designations and development of substantive implementation plans that ensure timely attainment and maintenance of the NAAQS. Our ultimate intention is to place greater emphasis on modeling than did the proposed rule as the most technically appropriate, efficient, and readily available method for assessing
short-term ambient SO 2 concentrations in areas with large point sources. This projected change in approach would necessarily result in a lesser emphasis on the less appropriate, more expensive, and slower to establish monitoring tool than did the proposed rule. Therefore, the minimum requirements for the SO 2 monitoring network in this final rule are of a smaller scale than proposed, and we do not expect monitoring to become the primary method by which ambient concentrations are compared to the new
1-hour SO 2 NAAQS.

Instead, in areas without currently operating monitors but with sources that might have the potential to cause or contribute to violations of the NAAQS, we anticipate that the identification of NAAQS violations and compliance with
the 1-hour SO 2 NAAQS would primarilybe done through refined, sourceoriented air quality dispersion modeling analyses, supplemented with a new, limited network of ambient air quality monitors. Historically, we have favored dispersion modeling to support SO 2 NAAQS compliance determinations for
areas with sources that have the potential to cause an SO 2 NAAQS violation, and we have explained that for an area to be designated as

‘‘ attainment, ’’ dispersion modeling regarding such sources needs to show
the absence of violations even if monitoring does not show a violation. This has been our general position throughout the history of implementation of the SO 2 NAAQS

program. See, e.g., ‘‘ Air Quality Control Regions, Criteria, and Control techniques; Attainment Status Designations, ’’ 43 FR 40412, 40415–16 (Sept. 11, 1978); ‘‘ Air Quality Control Regions, Criteria, and Control Techniques, ’’ 43 FR 45993, 46000–02 (Oct. 5, 1978); ‘‘ Air Quality Implementation Plans: State Implementation Plans; General Preamble, ’’ 57 FR 13498, 13545, 13547– 48 (Apr. 16, 1992); ‘‘ Approval and Promulgation of State Implementation Plans; Call for Sulfur Dioxide SIP Revisions for Billings/Laurel, MT, ’’ 58 FR 41430 (Aug. 4, 1993); ‘‘ Designation of Areas for Air Quality Planning Purposes; Ohio, ’’ 59 FR 12886, 12887 (Mar. 18, 1994); ‘‘ Ambient Air Quality Standards, National and Implementation Plans for Sulfur Oxides (Sulfur Dioxide), ’’ 60 FR 12492, 12494– 95 (Mar. 7, 1995); ‘‘ Air Quality Implementation Plans; Approval and Promulgation: Various States: Montana, ’’ 67 FR 22167, 22170–71, 22183–887 (May 2, 2002).

Compared to other NAAQS pollutants, we would not consider ambient air quality monitoring alone to be the most appropriate means of determining whether all areas are attaining a short-term SO 2 NAAQS. Due to the generally localized impacts of

SO 2 , we have not historically considered monitoring alone to be an adequate, nor the most appropriate, tool to identify all maximum concentrations
of SO 2 . In the case of SO 2 , we further believe that monitoring is not the most cost-efficient method for identifying all
areas of maximum concentrations. However, for some situations monitoring is well suited, and we therefore will require it to some extent, as further explained in section IV of the preamble. For example, monitoring may appropriately be relied upon to assess compliance with the NAAQS by groups of smaller sources and sources that may not be as conducive to modeling as are larger SO 2 sources.

States will need to make any adjustments to the existing monitoring network to ensure that monitors meeting today’s network design regulations for the new 1-hour NAAQS are sited and operational by January 1, 2013. We also expect to provide additional guidance regarding the application of refined dispersion modeling under this revised expected approach for implementation
of the new SO 2 standard. Appendix A
to the Guideline on Air Quality Models (Appendix W of 40 CFR part 51), Summaries of Preferred Air Quality Models, provides ‘‘ key features of refined air quality models preferred for specific regulatory applications ’’ ( see Appendix A to Appendix W of Part 51 at A.0(1)). Refined dispersion modeling, following our current Guideline on Air Quality Models with appropriate flexibility for use in implementation, is anticipated to better reflect and account


### 35552 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

20 EPA is authorized by the Clean Air Act to take up to 3 years to complete the initial area designations in the event that insufficient information is available to complete the designations within 2 years.

21 Since three complete years of data from any newly sited monitors meeting the new monitoring network design criteria are not expected to be obtained until the end of 2015, any newly sited monitors will not play a role in EPA’s initial area designations.

22 EPA anticipates making the determination of when monitoring alone is ‘‘ appropriate ’’ for a specific area on a case-by-case basis, informed by that area’s factual record, as part of the designations process. EPA would expect to address this issue for such areas by examining the historic treatment of the area with respect to prior SO 2 designations as well as whether the area is one in which monitoring would be the more technically appropriate tool for determining compliance with the new SO 2 NAAQS. An example of a situation in which monitoring may be the more preferred approach is a shipping port (non-point source or ‘‘ area ’’ source) that is not in close proximity to other significant stationary SO 2

sources. for source-specific SO 2 impacts than the more limited monitoring-focused proposal. As noted above, EPA intends to solicit public comment prior to finalizing this guidance.

Based on a revised, hybrid approach, we expect to implement the new SO 2 standard in the following manner. In accordance with CAA section 107(d), EPA must designate areas as

‘‘ attainment, ’’ ‘‘ nonattainment ’’ or

‘‘ unclassifiable ’’ for the new 1-hour SO 2 NAAQS by June 2012 ( i.e., two years following promulgation of the new NAAQS). 20 State Governors are required to submit their initial area designation
recommendations to EPA no later than June 2011. We expect that EPA’s final area designation decisions in 2012 would be based principally on data reported from SO 2 monitors currently in place today, and any refined modeling the State chooses to conduct specifically for initial area designations. 21 For these initial designations, we would expect to designate an area ‘‘ nonattainment ’’ if either monitoring data or appropriate refined modeling results show a violation. Any area that has monitoring and appropriate modeling data showing no violations we would expect to designate as ‘‘ attainment. ’’ 22 All other areas, absent monitoring data and air quality modeling results showing no violations, we would expect to initially designate as ‘‘ unclassifiable, ’’ as required by the Clean Air Act. The expected presumptive boundary for any area designated ‘‘ nonattainment ’’ would be the county boundary associated with the
violation unless additional information provided to EPA demonstrates otherwise, as has been our general approach for other NAAQS pollutants. Any area initially designated

‘‘ nonattainment ’’ or ‘‘ unclassifiable ’’ could request redesignation to ‘‘ attainment ’’ after an assessment based on air quality modeling, conducted in accordance with the new guidance, and available monitoring data indicates that the standard has been met, as well as meeting all other requirements of the CAA for redesignation to attainment.

This anticipated approach toward initial area designations is a change from the approach discussed in the proposal, and logically follows from our general change in approach to the use and utility of monitoring versus modeling for determining short-term

SO 2 ambient concentrations. As public commenters pointed out, establishment and implementation of the proposed monitoring network would have been
both too limited and too late to inform initial area designations, and the expense and burden of accelerating it and expanding it would have been severe for State implementing agencies.
Given the time needed to establish monitors, it is not realistic to expect either such an expanded monitoring
network or even the more reasonable
limited network of the final rule to be the chief tool for informing initial designations.

That means that some other approach is needed to inform initial designations of areas and other implementation
decisions under the new SO 2 NAAQS. In addition to using any valid data generated by existing monitors, refined dispersion modeling may inform designation and implementation decisions regarding sources that may have the potential to cause or contribute to a NAAQS violation. In order for modeling to be done on the scale sufficient to identify all areas that might violate the new 1-hour standard, EPA anticipates issuing guidance that addresses a variety of issues, such as how to identify and appropriately assess the air quality impacts of small SO 2 sources ( e.g., those emitting less than
100 tons of SO 2 per year) that may potentially cause or contribute to a
violation of the new SO 2 NAAQS. EPA expects that it will take more time for EPA to issue that guidance than is
available in order to use it for the initial round of attainment designations. In addition to any smaller sources that might cause or contribute to NAAQS violations, States would need to model approximately 2000 larger sources across the country ( i.e., sources that emit greater than 100 tons per year and are collectively responsible for about 99% of all SO 2 emissions from point sources in the U.S.) to determine whether areas are attaining or not attaining the 1-hour standard. While these sources emitting 100 or more tons
of SO 2 per year represent the significant fraction of the total emissions from point sources in the U.S., smaller sources also have the potential to violate
the new SO 2 NAAQS.

After receiving EPA’s forthcoming modeling guidance, States might initially focus modeling assessments on these larger sources that have been subject to permitting requirements and are generally better characterized than
smaller sources. But even this effort
would entail a substantial burden on States, under a compressed timeline following EPA’s issuance of further modeling guidance. Consequently, EPA
does not believe that for this new 1-hour

SO 2 NAAQS it would be realistic or appropriate to expect States to complete such modeling and incorporate the results in initial designation recommendations, which under CAA section 107(d)(1)(A) must be submitted to EPA within 1 year of the promulgation of the 1-hour standard.

The remaining issue, then, is how to most appropriately use a modified hybrid approach, and its constituent modeling and monitoring tools, in the implementation plan development process in order to ensure expeditious
attainment and maintenance of the NAAQS. Under the CAA, all States must develop and submit to EPA State implementation plans (SIPs) to attain
and maintain the new 1-hour SO 2 NAAQS. CAA section 110(a)(1) requires States, regardless of designation status, to adopt SIPs that provide for implementation, maintenance and enforcement of each primary NAAQS. Traditionally, for areas that were designated ‘‘ attainment ’’ or

‘‘ unclassifiable ’’ , we accepted State submissions of prevention of significant deterioration (PSD) permitting programs
and other ‘‘ infrastructure ’’ SIP elements contained in CAA section 110(a)(2) as being sufficient to satisfy the section 110(a)(1) SIP submission requirement. However, due to our recognition here that monitoring is not generally the most appropriate or effective tool for assessing compliance with the new 1-
hour SO 2 NAAQS, that additional guidance from EPA on conducting refined modeling for the new 1-hour NAAQS is anticipated to support our expected implementation approach, and
that considerable time and resources may be needed to fully identify and properly characterize all SO 2 sources (including those emitting less than 100
tons of SO 2 per year) that may potentially cause or contribute to a
violation of the new SO 2 NAAQS, we
also had to assess how and when to best use modeling as the primary method in implementation.


### 35553 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

23 The schedule for State plans addressing areas designated ‘‘ nonattainment ’’ is governed by CAA section 191. The schedule for State plans for all other areas, including areas designated

‘‘ unclassifiable ’’ and ‘‘ attainment, ’’ is governed by CAA section 110(a)(1).

The approach that EPA expects to take, which is described in sections V and VI of the preamble, is consistent with the language of the Clean Air Act
and would accommodate the time
needed for an accurate assessment of ambient air quality levels for the 1-hour

SO 2 standard. Section 107(d)(1) requires areas to be designated ‘‘ attainment ’’ if they meet the standard, ‘‘ nonattainment ’’ if they do not meet the standard or contribute to a nearby violation, or

‘‘ unclassifiable ’’ if they cannot be designated on the basis of available information. EPA’s expected approach
would enable us to make the appropriate designation decision required by the CAA, based on the
record of information that will be before EPA regarding each area. Areas would be designated ‘‘ nonattainment ’’ if either available monitoring data or modeling shows that a violation exists, or

‘‘ attainment ’’ if both available monitoring data and modeling indicate the area is attaining. All other areas would be designated ‘‘ unclassifiable, ’’ as required by section 107(d)(1)(A).

We currently anticipate that our projected post-designation implementation approach would look to robust CAA section 110(a)(1) SIPs, which have sometimes been previously
referred to as ‘‘ maintenance ’’ or

‘‘ infrastructure ’’ SIPs but for the new

SO 2 NAAQS would serve as substantive

‘‘ attainment ’’ SIPs. Our current thinking is that, to be approved by EPA, such plans would need to provide for
attainment and maintenance of the new
1-hour SO 2 NAAQS as expeditiously as practicable, which we expect to be no later than five years after initial designation (or approximately August 2017) in all areas of the State, including any area initially designated

‘‘ nonattainment, ’’ and also including any area designated ‘‘ unclassifiable ’’ that has

SO 2 sources with the potential to cause
or contribute to a violation of the NAAQS. The CAA establishes deadlines for States to submit these plans to

EPA. 23 State plans that address areas designated as ‘‘ nonattainment ’’ ( i.e.,

‘‘ nonattainment area SIPs ’’ ) are due
within 18 months from the effective date of the designation, under CAA section 192. EPA anticipates that this deadline would be February 2014. State plans addressing all other areas ( i.e.,

‘‘ maintenance SIPs ’’ ) are due within 3 years following the promulgation of the new NAAQS, or June 2013, under CAA section 110(a)(1).

Section 110(a)(1), unlike section 192, does not specify a maximum deadline by which States are required to show they have met the requirements to implement, maintain, and enforce a NAAQS. EPA believes, however, that August 2017 is the latest date by which areas should show they have achieved
attainment and maintenance of the
standard because this deadline is the same as would be required for areas designated nonattainment in June 2012. It is therefore presumptively reasonable as it is identical to the period Congress provided for nonattainment areas to reach attainment. Moreover, EPA notes
that the maintenance SIPs will be due in June 2013, rather than in February 2014, giving States and sources at least as much time between SIP development and submission and the date by which attainment should be achieved as they
would have had the area been designated nonattainment in 2012. These section 110(a)(1) SIPs would be able to rely on modeling reflecting any

SO 2 reductions that we expect to result
before the attainment date from compliance with the rules EPA expects to promulgate before 2013, (including technology-based standards under CAA section 112(d) for certain source categories emitting large amounts of SO 2 such as Electric Generating Units and industrial boilers, and revised rules establishing further limits on SO 2 emitted by sources in upwind States which contribute significantly to downstream States’ inability to attain or
maintain the PM 2.5 NAAS (the so-called Clean Air Interstate Replacement rule)). Thus, we intend that a State’s section 110(a)(1) SIP may account for projected emissions reductions, including any from national and regional rules that are promulgated before these SIP submissions, provided that those
reductions occur under a schedule that ensures attainment as expeditiously as practicable. We expect that date to be no later than 5 years from the date of initial designation or August 2017.

Under this anticipated approach,
attainment SIPs for nonattainment areas
would have to include enforceable emissions limitations, timetables for compliance, and appropriate testing/ reporting to assure compliance, and demonstrate attainment through air quality modeling for all sources contributing to monitored and modeled violations, or that have the potential to
cause or contribute to a violation of the NAAQS. The SIPs under section 110(a)(1) would need to demonstrate through refined air quality modeling that any source or group of sources that have the potential to cause or contribute to a violation of the NAAQS are, or will be, sufficiently controlled to ensure timely attainment and maintenance of the NAAQS. We would expect this to include any individual sources with the potential to emit 100 or more tons per year of SO 2 , and other sources that may
also cause or contribute to violations of
the new SO 2 NAAQS. We expect to develop guidance for the States’ use on how best to identify and assess the impact of sources that may have this potential. As mentioned previously, we intend to provide an opportunity for notice and comment on this guidance before finalizing it.

EPA again notes that it anticipates several forthcoming national and regional rules, such as the pending
Industrial Boilers MACT standard under CAA section 112(d), that are likely to require significant reductions in SO 2 emissions over the next several years. A limited qualitative assessment based on the results of preliminary modeling of some sample facilities indicates that
well controlled sources should meet the

new SO 2 NAAQS ( see Brode 2010b). Exceptions could include unique sources with specific characteristics that contribute to higher ambient impacts (short stack heights, complex terrain,

etc. ). These national and regional rules are expected to lead to SO 2 reductions that will help achieve compliance with
the new SO 2 NAAQS prior to 2017. If, upon EPA review of submitted SIPs that rely upon those reductions or other local controls, it appears that States will nevertheless fail to attain the NAAQS as expeditiously as practicable (and no later than August 2017), the Clean Air Act provides authorities for EPA to solve such failure, including, as appropriate, disapproving submitted SIPs, re-designating unclassifiable areas to nonattainment, issuing SIP calls, and promulgating FIPs.

For the reasons discussed above, EPA has determined that it is appropriate and efficient to principally use modeling to assess compliance for medium to larger sources, and to rely more on monitoring for groups of
smaller sources and sources not as conducive to modeling. EPA’s revised monitoring network requirements have been developed to be consistent with this approach. However, EPA is still considering how monitoring and modeling data would be used together in specific situations to define
attainment and nonattainment
boundaries and under what circumstances it may be appropriate to rely on monitoring data alone to make
attainment determinations. EPA intends


### 35554 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

to address these issues as it develops implementation guidance.

In light of the new approach that EPA intends to take with respect to implementation of the SO 2 NAAQS, EPA intends to solicit public comment on guidance regarding modeling, and also solicit public comment on additional implementation planning guidance, including the content of the maintenance plans required under section 110(a)(1) of the Clean Air Act. EPA also notes that State monitoring plans and the SIP submissions that States will make will also be subject to public notice and comment.

IV. Amendments to Ambient Monitoring and Reporting Requirements

In this section of the preamble, we describe the proposal, the public
comments that we received on the proposed monitoring and reporting requirements, and the final requirements for the SO 2 monitoring network. We are modifying our proposed approach to the amount of monitoring to require following consideration of public comments and a review of our historic practice in assessing compliance with the SO 2 NAAQS. As we explain above in section III, we will use a hybrid approach that combines monitoring and modeling, using each of these analytic tools where they are most appropriate and effective. This approach and its requirements are intended to support the revised SO 2 NAAQS, described in section II above. For a short-term 1-hour standard, dispersion modeling of stationary sources will generally be more technically appropriate, efficient, and
effective because it takes into account fairly infrequent combinations of meteorological and source operating conditions that can contribute to peak ground-level concentrations of SO 2

. Even an expansive monitoring network could fail to identify all such locations. Consequently, we have revised the scope of the monitoring network, reflecting a modified and expanded set of objectives. This section also describes and explains the final requirements for
the new SO 2 Federal Reference Method (FRM), and the SO 2 network design, monitoring objectives, data reporting, and data quality objectives that support the revised primary SO 2 NAAQS.

A. Monitoring Methods

1. Requirements for SO 2 Federal Reference Method (FRM)

The proposal to promulgate an
automated SO 2 FRM was based on a need to update the cumbersome existing manual wet-chemistry (pararosaniline) method to a continuous-type automated method that can readily provide 1-hour

SO 2 measurement capability. See 74 FR at 64846–849. The following paragraphs provide background, rationale, and the final changes to the automated SO 2 Federal Reference Method (FRM) and to the associated performance specifications for automated SO 2 analyzers.

a. Proposed Ultraviolet Fluorescence

SO 2 FRM and Its Implementation

FRMs, set forth in several appendices to 40 CFR Part 50, serve (1) To provide a specified methodology for definitively measuring concentrations of ambient air pollutants for comparison to the NAAQS in Part 50, and (2) to provide a standard of comparison for determining equivalency of alternative pollutant measurement methods that
can be used in lieu of the FRM for such monitoring.

The FRM for measuring SO 2 in the ambient air was promulgated on April 30, 1971 in conjunction with the first primary SO 2 NAAQS (36 FR 8196). This

SO 2 FRM is specified in Appendix A of
Part 50 and identified as the pararosaniline manual method. See generally 74 FR at 64846. In the interim, EPA has designated many SO 2 methods as equivalent methods (FEMs), most of
which are based on the ultraviolet fluorescence (UVF) measuring technique. Id. In fact, virtually all SO 2 monitoring data are now obtained with FEMs that use the UVF technique.

In light of this, EPA proposed to
establish a new automated SO 2 FRM
based on UVF—the same measurement technique employed by FEM analyzers now in widespread use by most State and local monitoring agencies and having the measurement capability needed to implement the proposed 1-
hour SO 2 NAAQS. FRM analyzers using this UVF technique can provide the needed detection limits, precision, and accuracy and fulfill other purposes of an FRM, including use as an appropriate standard of reference for testing and designation of new FEM analyzers. At proposal, EPA specified the new method in performance-based form, describing a generic reference measurement principle and associated calibration procedure in a new Appendix A–1 to 40 CFR Part 50. Associated performance requirements applicable to candidate automated SO 2 analyzers (both FRMs and FEMs) were proposed in 40 CFR Part 53.

EPA also proposed retaining the existing manual pararosaniline FRM for

SO 2 . Although EPA recognized that theexisting method is cumbersome for onehour measurements, it is capable of making measurements of 1 hour or even 30 minute periods. 74 FR at 64846; see also Part 50 Appendix A at 1.1 ( ‘‘ [t]he method is applicable to the
measurement of ambient SO 2 concentrations using sampling periods ranging from 30 minutes to 24 hours ’’ ). Supersession of the existing manual FRM, as defined in § 53.16, would require not only withdrawal of that existing FRM but also the cancellation of the designations of all existing SO 2 FEMs. Loss of the use of these FEM analyzers would leave State and local monitoring agencies with no approved

SO 2 monitors until new FRM and FEM analyzers could be designated under the new FRM. The resulting costs and disruptions to monitoring agencies is unnecessary because the current SO 2 FEMs readily and accurately measure (and report) one-hour ambient

measurements. See 74 FR at 64847. Accordingly, EPA concluded that supersession of the existing FRM was not warranted, given the costs and disruptions which would occur to State monitoring programs and the limited benefits from such an action given the suitability of the in-use FEMs. Id. at
68646; see also section 53.16(b)(1) stating that in exercising its discretion as to whether to proceed with supersession of an FRM, EPA will consider the benefits (in terms of requirements and purposes of the Act) from specifying a new reference method, potential economic consequences of such supersession for State and local monitoring agencies, and disruption to State and local air quality monitoring programs. Instead, EPA proposed to add the new UVF FRM while retaining the existing FRM for some period of time to support the continued approval of existing SO 2 FEM analyzers.

b. Public Comments on the Proposed FRM and Implementation

EPA received comments from State and local groups ( e.g., City of Houston, Houston-Galveston Area Council, KY, NC, NY, PA, SC, SD, and WI) and industry ( e.g., AirQuality Research and Logistics (AQRL), Consumers Energy, ExxonMobil, Montana Sulfur and Chemical Company, Inc. (MSCC), and the Utility Air Regulatory Group (UARG)), all generally supporting EPA’s proposal to adopt the proposed
automated UVF as an FRM. For example, South Dakota supported adding the UVF SO 2 method as an
additional FRM and stated that this method is currently being used in the
network and will reduce the cost of implementing the new monitoring


### 35555 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

requirements for this rule. The UARG stated that the proposal to specify a different FRM to judge compliance is entirely reasonable, and UARG generally supported the proposed specifications for a new FRM but
maintained that the current FRM could not be used along with a new FRM. ExxonMobil stated that it supports

‘‘ * * * EPA allowing monitoring agencies to choose mobile monitoring that meets monitoring quality requirements. ’’ AQRL stated that ‘‘ EPA is correct in choosing to designate [promulgate] a new (automated) FRM
for measurement of SO 2

. ’’

EPA did not receive any public comments opposing the proposed
automated UVF SO 2 FRM but did
receive a few technical comments on specific provisions of the method. EPA proposed use of an inlet line particle filter as a requirement for new UVF SO 2 FRM analyzers, believing that use of a particle filter is advantageous to prevent interference, malfunction, or damage to the analyzer from particles in the sampled air. The State of Missouri questioned this requirement, noting that
such a filter can sometimes cause problems and that filter requirements for other FRM and FEM analyzers have been analyzer-specific depending on the manufacturer’s stipulation. EPA believes, however, that for new SO 2 FRM analyzers, the benefits and uniformity provided by a mandatory filter requirement outweigh possible disadvantages of such a filter.

Missouri also suggested that the language of proposed Sections 4.1.1 and 4.1.2 regarding calibration system flow rate requirements were somewhat confusing, and that the high (50–100 ppm) concentration requirement for the calibration standard specified in Section 4.1.6.1 is sometimes a problem. In response to these comments, the language of Sections 4.1.1 and 4.1.2 has been clarified, and the concentration of the standard specified in Section 4.1.6.1 has been reduced to 10 ppm.

EPA received a number of comments from States ( e.g., NC, NYSDEC, PA, SC, and SD) that supported the EPA proposed plan of temporary retention of the existing wet-chemistry pararosaniline FRM and for FEMs approved based on that method. For example, Pennsylvania stated ‘‘ [t]his methodology should enable State and local agencies to continue using their existing monitoring equipment and [thereby] avoid large capital fund outlays for samplers and ultimately avoid any delays in collecting data that would be comparable to the proposed new primary sulfur dioxide NAAQS. ’’ North Carolina requested ‘‘ * * * that the EPA maintain the current reference
method for at least an additional 10

years. ’’ Wisconsin and the Center for Biological Diversity (CBD) suggested expeditiously phasing out the existing
manual SO 2 FRM.

In contrast, however, EPA also received comments from industry that opposed the retention of the existing pararosaniline FRM while promulgating
a new automated UVF FRM. In particular, UARG stated ‘‘ * * * having two FRMs specified for a given NAAQS—is not viable, ’’ pointing out that there is only one FRM for each NAAQS under the present standards, a result UARG appears to believe is legally mandated.

EPA disagrees with this comment. First, there is nothing in the Act that mandates a single FRM for each NAAQS. Section 109 of the Act, in fact,
does not address this issue at all. Second, as noted previously, there are sound policy reasons for not withdrawing the existing FRM at this time. Therefore, EPA sees no legal or other obstacle in adding a new automated UVF FRM while retaining the existing manual FRM.

UARG further maintained that EPA provided no support for its statement that the existing FEMs, which constitute the bulk of the existing SO 2 monitoring network, are adequate for the current and proposed new SO 2 NAAQS. UARG
also stated that ‘‘ although the FEMs may be adequate for many other purposes, they may only be used to judge compliance with the 1-hour NAAQS if they are shown to qualify as FRMs or
FEMs under the new FRM definition. ’’

EPA disagrees with this comment also. In answer to UARG’s second point, it is not necessary that these existing FEMs be re-designated as FRMs pursuant to the new automated FRM to continue their approved use. There is no legal impediment to such continued use, since they are (and will continue to be) FEMs approved based on an FRM that adequately measures one-hour
ambient SO 2 concentrations. Nor is there any technical impediment to the continued use of these FEMs, given that they are automated continuous monitoring methods capable of measuring SO 2 concentrations ranging from a few minutes to a 1-hour period. The existing FEMs in the network use the same UVF technology as the proposed (and now final) automated FRM and have been reporting 1-hour monitoring data for decades. These FRMs have been tested against the test and performance requirements of Part 53, which are designed specifically to test such continuous methods. Further, the proposed SO 2 method performance specifications for the standard measurement range were derived from data submitted in FEM applications for analyzers that were subsequently designated as FEMs. Therefore, these FEMs are technically and legally sound to judge compliance with the one-hour NAAQS.

EPA has clarified the regulatory text so that the rules state unambiguously
that both SO 2 FRMs apply to the new one-hour standard (as well as to the 24- hour and annual standards so long asthey are retained), as do all presentlydesignated FEMs.

c. Conclusions on Ultraviolet
Fluorescence SO 2 FRM and Implementation

We are finalizing the proposed new
automated SO 2 FRM, which is based on UVF technology, with the following minor technical changes: The language
of Sections 4.1.1 and 4.1.2 has been clarified, and the minimum
concentration of the calibration standard specified in Section 4.1.6.1 has been reduced to 10 ppm. The new FRM is codified as Appendix A–1 to 40 CFR
Part 50 and titled ‘‘ Reference Measurement Principle and Calibration
Procedure for the Measurement of Sulfur Dioxide in the Atmosphere (Ultraviolet Fluorescence Method). ’’ EPA is retaining the previously existing manual pararosaniline SO 2 FRM for the time being and re-codifying it as Appendix A–2 to 40 CFR Part 50. However, EPA plans to rescind this
manual FRM at a future time when new

SO 2 FRM analyzers have adequately permeated State monitoring networks.

2. Requirements for Automated SO 2 Methods

a. Performance Specifications for
Automated Methods

In association with the proposal to adopt a new automated FRM, EPAproposed to update the performancebased designation requirements for FEM

SO 2 analyzers currently specified in 40 CFR Part 53. As noted in the proposal preamble (74 at 64846), these requirements were established in the1970’s, based primarily on the wetchemical measurement technology
available at that time. Those initial requirements have become significantly
outdated and need to be modified to match current technology, particularly because they would apply to new SO 2 FRM analyzers under the proposed new
FRM. The better instrumental performance available with the proposed new UVF FRM technique allows the performance requirements in Part 53 to be made more stringent for


### 35556 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

both FRM and FEM SO 2 analyzers. Updating these performance requirements is needed to ensure that, going forward, all new SO 2 monitors will have improved performance.

EPA solicited comments on the proposed new performance requirements for automated SO 2 methods that were included in Table B–1 (Performance Specifications for Automated Methods) of Part 53. We proposed revised performance specifications for noise, lower detectable limit, interference equivalent, zero drift, span drift, lag time, rise time, fall time, and precision. EPA proposed
to reduce the allowable noise limit from 5 to 1 ppb, the lower detectable limit from 10 to 2 ppb, the interference equivalent limits from ± 20 ppb to ± 5 ppb for each interferent, and from 60 ppb to 20 ppb for the total of all interferents, the zero drift limit from ± 20

to ± 4 ppb, the lag time limit from 20 to 2 minutes, both rise and fall time limits from 15 to 2 minutes, and the precision limits from 15 ppb to 2 percent of the upper range limit. EPA further proposed to eliminate the requirements for span drift at 20% of the upper range limit. In addition, to address the need for more sensitive, lower measurement ranges for

SO 2 analyzers, EPA proposed a separate set of performance requirements that would apply specifically to narrower measurement ranges, i.e. ranges extending from zero to concentrations less than 0.5 ppm. Other minor changes were proposed in the wording of a few sections of Part 53 Subparts A and B, including provision for alternate data recording devices in § 53.21 to supplement the older language relating specifically to strip chart recorders.

b. Public Comments

EPA received a number of comments from industry (AQRL and UARG) and from the multi-State organization NESCAUM regarding the proposed interferent limit requirements listed in
Table B–1. UARG submitted comments supportive of all the proposed requirements for the new UVF SO 2 FRM, except for the proposed total interferent limits of 20 ppb. UARG acknowledged that EPA proposed to
reduce the total interferent level substantially from 60 ppb to 20 ppb, but maintained that the proposed level of 20 ppb is still too high because it amounts to 20%–40% of the levels being considered for the NAAQS (50–150 ppb). AQRL recommended limiting

‘‘ * * * each interferent to no more than

± 3 ppb and total interference to no more than 12 ppb. ’’ NESCAUM recommended tightening the nitric oxide (NO)
interference limit from 100:1 to 300:1 ( i.e., one third of the proposed value of

± 5 ppb). NESCAUM states that the proposed interferent value of ± 5 ppb
results in substantial NO interference at
sites with low SO 2 levels in urban areas.

EPA revisited the issue of the interferent equivalent limit for SO 2 analyzers in context of the above
comments and reconsidered what is reasonably feasible with current technology. We reviewed the current instrument specifications and test data
submitted for numerous SO 2 FEM applications. We also took into account
that the test concentrations of most of these interferents are substantially higher than the concentrations normally
observed in ambient air. EPA considered lowering the testing concentrations of these interferents, which would have correspondingly lowered the interferent equivalent for each analyte. However, EPA took a more conservative approach and retained the existing test concentrations for H 2 S,

NO 2 , NO, O 3 , m-xylene, and water vapor. Based on this review, we found
that it is not feasible to further lower the limit requirement for these interferents
below ± 5 ppb. However, in response to the NESCAUM comment, EPA
determined that the interferent equivalent limit requirement for NO
interference could be reduced to ± 3 ppb (166:1) for the new, lower measurement range to reduce possible NO
interference at sites with low SO 2 levels
in urban area.

In regard to the total limit for all interferent equivalents for SO 2 analyzers, EPA notes that many of the interferents for which testing is required (specified in Table B–3 of Part 53) would likely react with each other and
would thus not co-exist in ambient air at the specified test concentrations. Therefore, EPA determined that the limit requirement for total interference equivalent can be eliminated, and Table B–1 now reflects this change.

EPA received comment from AQRL on the existing span drift requirement
for SO 2 analyzers specified in Table B1. AQRL recommended lowering the span drift requirement at 80% URL to 2.5%, stating that ‘‘ ambient air monitors in the 21st century should be able to hold span drift to no more than ± 2.5% under the conditions specified in EPA testing * * *. ’’ Based on information from FEM testing laboratories and manufacturers’ data (EPA, 2009c), EPA largely agrees with this comment and concludes that the span drift requirement at 80% can be lowered to

± 3%. Table B–1 has been changed to
include this revised limit.

EPA received comment from the State of Wisconsin suggesting that the proposed revised provisions of section 53.21 (Test conditions) be further changed to more specifically recognize use of digital recorders for obtaining test results rather than maintaining the tie to analog strip chart recorder technology. EPA acknowledges that industry has moved away from strip chart recording technology to digital data recording. However, the proposed language of § 53.21 calls for a graphic representation of analyzer responses to test
concentrations to facilitate visual
examination of test results and allows

any ‘‘ alternative measurement data recording device ’’ as long as it can provide such a graphic representation. Describing the analog strip chart recorder in this section provides an appropriate model to help define the type of graphic representation needed
for the Part 53 tests. EPA believes that the proposed language of § 53.21 is adequately broad to permit digital or other types of data recording devices.

c. Conclusions for Performance Specifications for SO 2 Automated
Methods

Based on typical performance capabilities of current UVF analyzers and manufacturers’ actual testing data, we are keeping the limit for each interference equivalent for SO 2 analyzers at ± 5 ppb. However, we are lowering the interference equivalent requirement for NO to ± 3 ppb for the lower measurement range. A footnote denoting this specific requirement is being added to Table B–1. We are eliminating the total interference equivalent requirement for SO 2 analyzers, and Table B–1 is being revised to incorporate this change.

The 24-hour span drift at 80% of the upper range limit for SO 2 analyzers is being lowered to ± 3% in Table B–1 to be in line with current technology. Also,
unrelated to SO 2 , a typographical error for the noise requirement for CO analyzers is being corrected to 0.5 ppm
in Table B–1.

Finally, information on generation
and verification of test concentrations for naphthalene was inadvertently omitted from Table B–2, Test Atmospheres, even though it was added as a required interferent test in our proposal. Therefore, we are adding that information for naphthalene. Also in Table B–2, we are correcting the
verification information for nitric oxide.

B. Network Design

Ambient SO 2 monitoring data are collected by State, local, and Tribal monitoring agencies ( ‘‘ monitoring agencies ’’ ) in accordance with the monitoring requirements contained in


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24 Prior to this rulemaking there were no minimum monitoring requirements, except for those required at the multi-pollutant National Core (NCore) monitoring sites. The monitoring rule promulgated in 2006 (71 FR 61236) removed minimum monitoring requirements (except for those NCore stations). This change was largely driven by the fact that there was no longer an SO 2 nonattainment problem under the then-existing standards. However, this logic does not apply to the revised primary SO 2 NAAQS.

25 Required monitor estimates were based on 2008
Census estimates and the 2005 National Emissions Inventory.

26 CBSAs are defined by the U.S. Census Bureau, and are comprised of both Metropolitan Statistical Areas and Micropolitan Statistical Areas ( http://

www.census.gov ). 40 CFR parts 50, 53, and 58. A monitoring network is generally designed to measure, report, and provide related information on air quality data as described in 40 CFR Part
58. To ensure that the data from the network is accurate and reliable, the
monitors in the network must meet a number of requirements including the use of monitoring methods that EPA has approved as Federal Reference Methods (FRMs) or Federal Equivalent Methods (FEMs) (discussed in some detail above in section IV.A), focusing on particular monitoring objectives, and following specific siting criteria, data reporting, quality assurance and data handling rules or procedures.

With the revision to the SO 2 NAAQS,
which establishes a new 1-houraveraging period intended to limit shortterm exposures that may occur anywhere in an area, EPA evaluated the existing network to determine if it was adequate to support the revised SO 2 NAAQS. A significant fact for ambient

SO 2 concentrations is that stationary sources are the predominant emission
sources of SO 2 and the peak, maximum

SO 2 concentrations that may occur are most likely to occur nearer the parent stationary source, as noted in the ISA (ISA, 2–1), section II.A.1 above, and in section IV.B.1 below. According to the 2005 National Emissions Inventory, there are 32,288 sources (facilities) emitting SO 2 , of which 1,928 are emitting 100 tons per year (tpy) or more. In the proposal (74 FR 64851), EPA hadanticipated requiring 348 sourceoriented monitors in the network design based on a population and emissions
metric and a State’s emissions
contribution to the National Emissions Inventory (NEI). In response to this proposal, EPA received numerous comments arguing that the required
number of monitors in the network
would be too small. Other commenters argued that expanding the monitoring to an adequate scale would impose a large burden and expense on the States. Some
commenters referred to SO 2 modeling in
their submissions as an addition or alternative to monitoring. Consequently, as part of developing a balanced response to these comments, we revisited how we had historically dealt
with SO 2 for various purposes including designations and implementation through permitting and emissions limitations. As explained in section III, this has been realized through a combined monitoring and modeling approach. As set out below, and in sections III, VI, and VII, our ultimate
intention is to utilize a combined monitoring and modeling approach, a hybrid analytic approach, to assess compliance with the revised SO 2 NAAQS.

As a result of this contemplated hybrid analytic approach, the minimum number of monitors required in the network through this rulemaking is reduced to approximately 163 monitors from the approximated 348 monitors that were proposed. This section of the preamble includes a discussion of the proposal, the comments received, and
the details of and the rationale for the final changes to the SO 2 network design requirements.

1. Approach for Network Design

a. Proposed Approach for Network Design

To fully support the proposed
revision to the SO 2 NAAQS, EPA indicated the need to identify where short-term, peak ground-level

concentrations— i.e. , concentrations from 5 minutes to one hour (or potentially up to 24 hours)—may occur. Given that large stationary sources are the predominant source of emissions,monitoring short-term, peak groundlevel concentrations would require monitors to be sited to assess impacts of individual or groups of sources and
therefore be source-oriented in nature. As a result, under a monitoring-focused approach, EPA proposed a two-prongedmonitoring network of all sourceoriented monitors. However, due to the multiple variables that affect ground
level SO 2 concentrations from individual or groups of sources, including stack heights, emission velocities, stack diameters, terrain, and meteorology, EPA could not specify a source specific threshold, algorithm, or metric by which to require monitoring. The design of the proposed networkrepresented a primarily monitoringfocused approach to assess compliance with the primary SO 2 NAAQS.

In preparation for the SO 2 NAAQS proposal, EPA conducted an analysis of the approximately 488 SO 2 monitoring sites operating during calendar year 2008 (Watkins and Thompson, 2009). This analysis indicated that approximately ∼ 35% of the monitoring network was addressing locations of maximum (highest) concentrations, likely linked to a specific source or group of sources. Meanwhile, just under half ( ∼ 46%) of the sites were reported
to be for the assessment of concentrations for general population exposure. These data allowed EPA to
conclude that the network 24 was not properly focused to support the revised NAAQS (under the assumption that source-oriented monitoring data would be the primary tool for assessing compliance with the NAAQS). As a result, EPA proposed a two-pronged monitoring network (74 FR 64850),based on the premise of a monitoringfocused approach, with minimum requirements for: (1) Monitors in urban areas where there is a higher coincidence of population and emissions, utilizing a Population Weighted Emissions Index (PWEI), and (2) monitors in States based on each
State’s contributions to the national SO 2 emissions inventory. In addition, all the
monitors in the network would be sited at locations of expected maximum hourly concentrations and thereforelikely be source-oriented. This twopronged network would have resulted in a minimum of approximately 348
monitors nationwide 25 providing data for comparison with the 1-hour standard and supporting its implementation.

Under the first prong of the network design, EPA proposed that the ambient

SO 2 monitoring network account for

SO 2 exposure by requiring monitors in locations where population and emissions may lead to higher potential for population exposure to peak hourly

SO 2 concentrations. In order to do this, EPA developed a Population Weighted Emissions Index (PWEI) that uses population and emissions inventory
data at the CBSA 26 level to assign required monitoring for a given CBSA (with population and emissions being obvious relevant factors in prioritizing numbers of required monitors). The PWEI for a particular CBSA was proposed to be calculated by multiplying the population (using the latest Census Bureau estimates) of a CBSA by the total amount of SO 2 emissions in that CBSA. The CBSA SO 2 emission value would be in tons per year, and calculated by aggregating the county level emissions for each county
in a CBSA. We would then divide the resulting product of CBSA population
and CBSA SO 2 emissions by 1,000,000 to provide a PWEI value, the units of


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which would be millions of people-tons

per year.

We proposed that the first prong of
the SO 2 network design require monitors in CBSAs, according to the following criteria. For any CBSA with a calculated PWEI value equal to or greater than 1,000,000, a minimum of
three SO 2 monitors would be required within that CBSA. For any CBSA with a calculated PWEI value equal to or greater than 10,000, but less than 1,000,000, a minimum of two SO 2 monitors would be required within that CBSA. For any CBSA with a calculated PWEI value equal to or greater than 5,000, but less than 10,000, a minimum
of one SO 2 monitor would be required
within that CBSA. EPA estimated that the proposed criteria would have resulted in 231 required sites in 131

CBSAs.

Under the second prong of the network design, EPA proposed to require a monitor or monitors in each State, allocated by State-level SO 2 emissions. This prong of the network design was intended to allow a portion of the overall required monitors to be placed where needed, independent of the first prong of the network design,
inside or outside of CBSAs. EPA proposed to require monitors, using State boundaries as the geographic unit for allocation purposes, in proportion to

a State’s SO 2 emissions, i.e., a State with higher emissions would have been required to have a proportionally higher number of monitors. The proposed percent contribution of individual
States would have been based on the most recent NEI, with SO 2 emissions being aggregated by State. The number of required monitors per State would correspond to every one percent (after rounding) of each State’s contribution to
the national SO 2 inventory. EPA also proposed that each State have at least one monitor required as part of this second prong, even if a particular State contributes less than 0.5% of the total anthropogenic national emissions inventory. As a result, the proposed second prong would have required approximately 117 monitoring sites
based on State-level SO 2 emissions in the most recent NEI, which at the time of the proposal, was the 2005 NEI.

EPA also stated in the proposal that the multi-pollutant National Core (NCore) monitoring sites would not have counted towards meeting the proposed monitoring requirements. However, data from the NCore would be compared to the NAAQS even though NAAQS comparisons are not the sole objective of NCore monitors. The monitoring rule promulgated in 2006 (71 FR 61236) and codified at 40 CFR Part 58 and its Appendices established the NCore multi-pollutant network requirement to support integrated air quality management data needs. In particular, NCore sites are intended to provide long-term data for air quality trends analysis, model evaluation, and, for urban sites, tracking metropolitan air quality statistics. To do this, NCore sites are required to measure various pollutants, including SO 2 , but they are not source oriented monitoring sites, and therefore are not likely to be the location of maximum expected

concentration in an area. NCore sites are intended to provide data representing
concentrations at the broader neighborhood and urban spatial scales.
These reasons were the rationale justifying why SO 2 monitors at NCore stations would not have been part of the minimum monitors required under the proposed network.

b. Alternative Network Design

EPA also solicited comment on an alternative network design, including
alternative methods to determine the minimum number of monitors per State (74 FR 64854). EPA requested comment on whether a screening approach for assessing the likelihood of a NAAQS exceedance could be developed and serve as a basis for determining the number and location of required monitors. In particular, EPA requested
comment on whether it should utilize existing screening tools such as AERSCREEN or SCREEN3, which use parameters such as effective stack height and emissions levels to identify facilities with the potential to cause an exceedance of the proposed standard. For that set of sources, EPA could then require States to conduct more refined modeling (using the American Meteorological Society (AMS)/EPA Regulatory Model (AERMOD)) to determine locations where monitoring should be conducted. Any screening or refined modeling would likely be carried out by States by using EPA recommended models and techniques referenced by 40 CFR Part 51, Appendix W, which provides guidance on air quality modeling. Such screening or refined modeling uses facility emission tonnage, stack heights, stack diameters, emission temperatures, emission velocities, and accounts for local terrain and meteorology in determining where expected maximum hourly concentrations may occur. In using this approach, EPA would then require States to locate monitors at the point of
maximum concentration around sources identified as likely causing NAAQS
exceedances. EPA also noted that this alternative approach would not distinctly use population as a factor for where monitors should be placed.

c. Public Comments

EPA received many comments on the proposed network design and the alternative network design approaches.
Based on comments that were clear enough on the issue, EPA believes the commenters’ positions on the network design approach generally fell into one of three categories: (1) Those who supported the two-prong approach, but suggested some modification to it, (2) those who supported the alternative network design, and (3) those who suggested other concepts for the network instead of the two approaches EPA presented in the proposal.

The commenters who generally supported the two-prong network design, but suggested some modification
included some State and local air agencies ( e.g. NACAA and nine other State groups or agency commenters) and industry groups ( e.g. AQRL, ACC, and eight other commenters). Of this group, some of the State and local air agencies specifically commented on how EPA should modify one or both of the prongs of the proposed network design. Some particular individual suggestions will be
addressed here and those comments not
addressed here will be addressed in the response to comment document. However, one recurring suggestion from the State and local agency commenters in this group was that the network design leads to some duplicative and/or unneeded monitoring, and therefore they requested that EPA include a provision to ‘‘ waive ’’ the monitoring network design requirements in situations where minimum monitoring requirements appear duplicative or unnecessary. In particular, NACAA
stated that it ‘‘ * * * is concerned that the two pronged approach in the proposed regulation will lead to duplicative monitoring in some areas and require monitors in areas where
monitors are not needed. EPA recognizes the potential for duplicative monitoring, but the proposal does not permit the removal of duplicative

monitors. ’’ This NACAA comment was echoed by some of the other States who commented on the proposed approach ( e.g. AK, FL, IL, NC, SC, and WI). The industry commenters were also generally supportive of the two-prong approach, with some making general suggestions to modify the network design. For example, AQRL stated that
the ‘‘ * * * network design proposal seems to provide the flexibility for States and the EPA regions to work together to arrive at the adequate monitoring network. ’’ AQRL also


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suggests that ‘‘ a State/local area should have the option to shutdown or relocate any site mandated [by monitoring requirements] if measured design values at the site are less than 75% of the
selected standard level. ’’ Multiple industry commenters ( e.g. API, LEC, and RRI Energy) expressed concern that the proposed network design had no monitoring required specifically to measure background concentrations of

SO 2. Dow Chemical suggested that EPA maintain some of the existing monitors that characterize population exposure
and other non-source oriented sites for trends analysis.

Those commenters who did not support the proposed network design, and instead generally supported the concepts of the alternative network design, include public health and environmental groups ( e.g. ALA, CBD, EDF, EJ, NRDC, and SC) and the States of Delaware and Iowa. In particular, ALA, EDF, NRDC, and SC stated ‘‘ * * * the proposed 348 monitors are a grossly inadequate number to detect peak concentrations from the nearly 2,000 major sources that emit more than 100 tons per year of sulfur dioxide * * * ’’
and that ‘‘ it is most appropriate to use screening tools to site all the monitors in the areas of highest expected

concentration * * * ’’ The Center for Biological Diversity, with regard to the proposed network design, stated that

‘‘ * * * a number of communities with very significant SO 2 emissions will not have any monitoring stations at all

*** ’’ Further, the State of Iowa
claimed that ‘‘ the proposed design of the

SO 2 ambient monitoring network provides insufficient assurances that the public is protected from the health
effects of SO 2 exposure, ’’ and suggested
that ‘‘ * * * the final rule contain provisions that require monitors to be sited only at locations where dispersion modeling indicates that the NAAQS is
violated. ’’

Commenters also suggested other concepts for the monitoring network design in lieu of the approaches discussed in the proposal. NESCAUM, NYSDEC, and PADEP, all suggested using an emissions-only approach to trigger required monitoring instead of using the PWEI to require monitors in an area. For example, NYSDEC suggests that the proposed approach, using the PWEI, is ‘‘ * * * not more predictive than using emissions data alone. ’’
NYSDEC went on to recommend that monitors be required in CBSAs with aggregated emissions of 50,000 tons per year or more and that ambient monitoring be considered for point sources with 20,000 tons per year. PADEP made several suggestions on network design, including monitoring in any CBSA ‘‘ where there is a sulfur
dioxide source or combination of sources within 50 miles emitting a total of at least 20,000 tons of SO 2 per year

*** ’’

Among all three groups of commenters discussed above, there was a subset of commenters who specifically mentioned using modeling in some form. Modeling was a component of the alternative network design, where monitors would be required based on screening models and possibly refined modeling of individual sources. EPA also expected that under the proposed approach, many States would use modeling as a quantitative analysis tool to site required monitors. Finally, source modeling is a critical element for PSD and facility permitting. In their comments, NESCAUM recommended that EPA allow modeling to be used in conjunction with monitoring data to
better determine nonattainment areas.
North Carolina advocated that EPA require SO 2 sources, without specifying a threshold size for sources, to perform modeling to demonstrate that fence-line (ambient) air does not exceed the NAAQS due to that particular source’s
emissions. North Carolina went on to suggest that if a source’s modeling showed an exceedance of the NAAQS,
the source could ‘‘ then be required to reduce emissions from the stack, install continuous emissions monitoring (CEM) in the stack itself, or require a fence-line monitor at the target facility. ’’ North Carolina also stated, in the context of discussing its own PSD program, that

‘‘ the costs for modeling are small compared to the costs for monitoring. ’’
Sierra Club stated that EPA should

‘‘ * * * employ modern computer
models to determine whether areas should be designated nonattainment because they do not meet the NAAQS in
areas where there is no monitor. ’’ From these comments, EPA gathers that some public commenters find modeling a useful tool and support the use of modeling to ascertain ambient
concentrations of SO 2

. 2. Modeling Ambient SO 2 Concentrations

EPA considered the various and sometimes competing concerns raised by the commenters including duplicative monitoring, lack of adequate number of monitors, insufficient flexibility, the monitoring burden, and the modeling suggestions. EPA considered its historic practice and the analytic tools available to arrive at a balanced approach that took into account these concerns. In the past, EPA used a combination of modeling and monitoring for SO 2 during permitting, designations, and re-designations in recognition of the fact that a single monitoring site is generally not adequate to fully characterize ambient concentrations, including the maximum ground level concentrations, which exist around stationary SO 2 sources. With representative and appropriate meteorological and other input data, refined dispersion models are able to characterize air quality impacts from the
modeled sources across the domain of interest on an hourly basis with a high degree of spatial resolution, overcoming the limitations of an approach based solely on monitoring. By simulating plume dispersion on an hourly basis across a grid of receptor locations, dispersion models are able to estimate the detailed spatial gradients of ambient concentrations resulting from SO 2 emission sources across a full range of meteorological and source operating conditions. The 1-hour NAAQS is intended to provide protection against short-term (5 minute to 24 hour) peak exposures, whether they result from typical meteorological conditions or not.
Because ambient monitors are in fixed locations and a single monitor can only represent impacts which occur at the location of the monitor, a single monitor cannot identify all instances of peak ground-level concentrations if, for example, different wind directions on various days cause peak ground-level
concentrations in different areas that do not overlap. The uncertainty associated with this limitation is much higher for an hourly standard than a long-term standard due to the higher degree of spatial and temporal variability associated with peak hourly impacts (discussed in ISA chapters 2.4 and 2.5). This limitation of ambient monitoring may be true even if the source-oriented
ambient monitor was sited with the aid of modeling data, since the model is less reliable at predicting the precise location of maximum impacts than at predicting the distribution of impacts across the full modeling domain, and no single monitor can be sited in a way to always measure the peak ground-level

SO 2 concentrations that may be occurring in the area around a source.

EPA’s Guideline on Air Quality Models, Appendix W to 40 CFR Part 51, provides recommendations on modeling techniques and guidance for estimating pollutant concentrations in order to assess control strategies and determine
emission limits. These recommendations were originally published in April 1978 and were incorporated by reference in the PSD regulations, 40 CFR sections 51.166 and


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27 Background monitoring can be considered to be representative of ambient concentrations upwind of (and therefore not typically influenced by) a geographic area such as an urban area, or of an individual or group of emission sources. 52.21 in June 1978 (43 FR 26382). The purpose of Appendix is to promote consistency in the use of modeling within the air quality management process. Appendix W is periodically
revised to ensure that new model developments or expanded regulatory requirements are incorporated. The most recent revision to Appendix W was published on November 9, 2005 (70 FR 68218), wherein EPA adopted AERMOD as the preferred dispersion model for a wide range of regulatory applications in all types of terrain. AERMOD is a steady-state plume dispersion model that employs hourly sequential preprocessed meteorological data to simulate transport and dispersion from multiple point, area, or volume sources for averaging times from one hour to multiple years, based on an
advanced characterization of the atmospheric boundary layer. AERMOD also accounts for building wake effects ( i.e., downwash) on plume dispersion. To support the promulgation of AERMOD as the preferred model for near-field dispersion (50 km or less), EPA evaluated the performance of the model across a total of 17 field study data bases (Perry, et al., 2005; EPA, 2003), including several field studies based on model-to-monitor comparisons
of SO 2 concentrations from operating power plants.

EPA anticipates that additional guidance for States may be needed to clarify how to conduct dispersion modeling under Appendix W to support the implementation of the new 1-hour

SO 2 NAAQS. Although AERMOD is identified as the preferred model under Appendix W for a wide range of applications and will be appropriate for most modeling applications to support
the new SO 2 NAAQS, Appendix W allows flexibility to consider the use of alternative models on a case-by-case basis when an adequate demonstration
can be made that the alternative model performs better than, or is more appropriate than, the preferred model for a particular application.

In conclusion, EPA believes that a hybrid analytic approach that uses a combination of modeling and monitoring information addresses the varying and competing concerns expressed by the commenters. Modeling large emission sources, along with smaller sources with the potential to violate the NAAQS, deals effectively with the concern that the monitoring network is not large enough to account for all sources that could have high
ambient SO 2 concentrations. EPA
believes that more SO 2 sources will ultimately be directly addressed through modeling alone versus the number of sources which would have been monitored under the proposed network design (which proposed a minimum of 348 monitors). Because modeling provides a technically appropriate and efficient method to identify locations of
maximum concentrations attributable to the major stationary SO 2 sources, in the final network design (discussed below in section IV.B.4), EPA is not requiring
that monitors must be in locations of expected maximum concentration, and thus, typically source-oriented. Instead, monitors required under the final network design now can address multiple monitoring objectives (discussed in IV.B.3 below), with fewer number of monitors required overall
than the number estimated in the proposal. The flexibility that States now have, where relatively fewer required monitors may be sited to meet multiple objectives, effectively addresses concerns about duplicative monitoring and the need for waivers, the need for measuring background concentrations,
and that emissions data rather than the PWEI could be more predictive of high
ambient SO 2 concentrations as a basis on which to require monitoring. The comments that suggested the use of modeling, along with an examination of past practice, resulted in the change to a hybrid approach where we use both modeling and monitoring to assess
ambient SO 2 concentrations.

3. Monitoring Objectives

Because EPA contemplates an ultimate approach that combines both monitoring and modeling, the monitor objectives of the final network design
are now broadened to include assessment of source impacts, highest concentration, population exposure, general background concentrations, SO 2 transport, and long-term trends. The following paragraphs provide background, rationale, and details for the final changes to monitoring objectives.

a. Proposed Monitoring Objectives

EPA proposed that all minimally required monitoring sites in the proposed two-prong network design be sited at locations of expected maximum 1-hour concentrations, which would also likely discern 5-minute peaks. EPA noted that in general, such locations would be close to larger emitting sources (in tons per year) and/or areas of relatively high emissions densities where multiple sources may be contributing to peak ground-level concentrations. As a result, the proposed monitoring network would have been comprised primarily of
source-oriented monitors. EPA also proposed that when selecting monitoring sites from among a pool of candidate locations (which would be source-oriented under the proposed network design), States prioritize these
sites based on where the maximum expected hourly concentrations would occur in greater proximity to populations. EPA solicited general comments on the role of population exposure in the site selection process.

b. Public Comments

Commenters discussed a variety of issues on the subject of monitoring objectives including the importance of considering population exposure, the need for flexibility in monitor placement, monitoring for background concentrations, monitoring for long term trends analysis, and characterizing potential long-range transport of SO 2

.

EPA received many comments from States ( e.g., NACAA, DE, IL, IN, MO, SD, WI), the public health group ATS, and industry ( e.g., AQRL, Consumers Energy, Dominion, Dow, EPRI, ExxonMobil, Montana Sulfur and Chemical, NPRA, Portland Cement, Rio Tinto, and UARG) suggesting that required monitors account for, or be focused on, population exposure. EPA also received many comments from States ( e.g., NACAA, NESCAUM, FL, IL, IN, IA, MI, OH, SC, and WI) and industry ( e.g., API, Dow, and TxOGA)asking for more flexibility in (sourceoriented) monitor placement with regard to both the target source and the physical location of a monitor relative to that source. For example NACAA stated
that ‘‘ for source oriented monitors, placement at the point of 1-hour
maximum concentration must be
realistic and flexible. EPA must allow agencies to determine the most scientifically defensible location, while taking into account potential exposures and access to locations with adequate siting. ’’ Wisconsin stated that ‘‘ * * * monitor siting should be balanced toward population-based monitors with a preference toward maximum

exposure. ’’ Wisconsin added that ‘‘ * * * placing monitors at the maximum downwind location does not necessarily result in effective protection of public
health. ’’

EPA received a number of comments on background monitoring 27 from industry (API, LEC, and RRI Energy) and
from the State of South Carolina. API
stated that ‘‘ because the monitors provide background concentrations


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28 Spatial scales are defined in 40 CFR Part 58 Appendix D, section 1. Each scale is a description of the physical dimensions of an air parcel nearest a monitoring site throughout which pollutant concentrations are reasonably similar. needed to model impacts of new sources or sources undergoing major modification in addition to providing data for judging compliance with the NAAQS, it is important that some
monitors be sited in a manner suitable for assessing this background. ’’ API went on to state that ‘‘ * * * EPA should encourage States to site an appropriate
number of area-wide monitors for use in establishing ambient background levels
of SO 2

. ’’ South Carolina states that ‘‘ to better support the monitoring objectives, in particular those improving our understanding and context for the source oriented monitoring data, the monitoring requirements must include the ability for States to address the needs for area and regional background

concentration measurements. ’’

A number of commenters, including States ( e.g., Missouri, NESCAUM, Ohio, and South Carolina), citizens (Valley Watch at the Atlanta public hearing), the CBD, and Dow, commented on SO 2 transport and related cross-boundary monitoring. Dow stated that ‘‘ SO 2 distribution has long been known as an interstate issue with the vast majority of

SO 2 sources being power plants and
other fossil fuel combustion facilities. These facilities are more likely to impact distant areas than local areas and the resultant ground-level
concentrations are often minimal. ’’ Ohio stated that, under the proposed approach, ‘‘ * * * it is likely that OH, WV, KY, and IN will find sources along
the Ohio River which could result in monitors being located across the river
from each other. ’’ In such situations,
Ohio asserts that ‘‘ States are capable of working with our neighbors to
determine which State would be in the best position to site and operate a

monitor. ’’

c. Conclusions on Monitoring Objectives

A hybrid analytical approach, as
noted above in section III and IV.B.1 would ultimately make the most appropriate use of available tools such as modeling and monitoring. Thus, unlike under the proposal, the monitoring network will not have to be focused solely at locations of expected
maximum concentration relative to an

SO 2 source given the anticipated adoption of a hybrid analytical approach. The final network design is intended to be flexible to meet multiple monitoring objectives, most of which were identified in the public comments. Ambient monitoring networks are generally designed to meet three primary monitoring objectives, as listed in 40 CFR Part 58 Appendix D, Section 1, including: (1) Providing air pollution data to the general public in a timely manner, (2) support compliance with ambient air quality standards and emissions strategy development, and (3) support air pollution research studies (which includes health studies and research). In order to support these air quality management objectives, monitoring networks can have a variety of monitoring sites that can be sited, as necessary, to characterize (a) emission sources ( i.e., source-oriented monitoring), (b) the highest concentration in an area, (c) population exposure, (d) general background concentrations, (e) regional transport, and (f) welfare-based impact.

In light of the approach described in section III and further in IV.B.1 above, EPA is finalizing an SO 2 network design, with broadened objectives,
which EPA believes will address the concerns noted in the public comments above, particularly those regarding siting flexibility, population exposure, cross-boundary impacts, and the need for the network to address multiple monitoring objectives. The final network design requires that any SO 2 monitors required in a particular CBSA as determined based on PWEI values, discussed below in section IV.B.4, shall satisfy the minimum monitoring requirements if they are sited at locations where they can meet any one or more of the following objectives ( see Part 58 Appendix D section 4.4.2 as added by today’s final rule):

(1) Source-Oriented Monitoring: This is accomplished with a monitor sited to determine the impact of significant sources or source categories on air quality. In some situations, such monitoring sites may also be classified as high concentration sites (discussed below). Examples of source-oriented monitors include those sited to capture or assess peak ground-level concentrations from one or more major

SO 2 sources, or those sited in an area with multiple smaller sources with overlapping plumes.

(2) Highest Concentration: This is assessed by a monitor sited to measure the highest concentrations expected to occur in the area covered by the network. Such a location may, or maynot, also be considered a sourceoriented location (discussed above). Depending on the case, this location is representative of the highest concentration occurring across a relatively homogeneous area with spatial scales typically ranging from tens of meters up to four kilometers. 28 (3) Population Exposure: This is assessed by a monitor sited to measure typical concentrations in areas of (relatively) high population density. Some examples are a monitor placed in an area of elevated or high SO 2 concentrations that also has a high population density, an area that might be included in public health studies, or in areas with vulnerable and susceptible populations.

(4) General Background: This is assessed by placing a monitor in an area to determine general background concentrations. Such locations might be considered to be representative of ambient concentrations upwind of (and therefore not typically influenced by) a geographic area such as an urban area, or of an individual or group of emission sources. EPA notes that although a required monitor is allowed to be sited to assess background concentrations, the required monitor is not allowed to be sited outside of the parent CBSA (whose PWEI value triggered required monitoring, discussed in section IV.B.4 and IV.B.5). If a State believes that there is a need to conduct background monitoring outside of CBSAs with required monitoring, EPA notes that States always have the prerogative to conduct monitoring above the minimum requirements in any location the State believes is appropriate.

(5) Regional Transport: This is assessed by placing a monitor in a
location to determine the extent of regional pollutant transport. Such locations could be either upwind or downwind of urban areas, characterizing the entry or exit of the pollutant in a region, respectively. EPA notes that although a required monitor is allowed to be sited to assess regional transport, the required monitor is not allowed to be sited outside of the parent CBSA (whose PWEI value triggered required monitoring, discussed in section IV.B.4 and IV.B.5). If a State
believes that there is a need to conduct background monitoring outside of CBSAs with required monitoring, EPA notes that States always have the prerogative to conduct monitoring above the minimum requirements in any
location the State believes is appropriate.

In regard to the public comments expressing concerns on the issue of cross-boundary transport, i.e., a source on one side of a political boundary contributes to peak ground-level
concentrations on the other side of that boundary, EPA will allow a required monitor to be placed outside of the parent CBSA (whose PWEI value triggered monitoring, discussed in section IV.B.4 and IV.B.5) under one


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29 The rationale for finalizing the use of the PWEI and the number of monitors required through its application are discussed in section III.B.4.

30 CBSAs are defined by the U.S. Census Bureau, and are comprised of both Metropolitan Statistical Areas and Micropolitan Statistical Areas ( http://

www.census.gov ). particular condition. A source-oriented monitor may be sited outside of the parent CBSA, whose PWEI value triggered required monitoring, if that monitor is characterizing the location of expected maximum concentration of a source inside that parent CBSA. If a State chooses to exercise this flexibility in source-oriented monitor siting, the State must provide clear rationale for their choice in their annual monitoring plan, which is subject to EPA regional approval. If the source-oriented monitor is to be placed in another State, such as the example provided by the State of Ohio in the public comments above, the two States are responsible for
collaboration on the location and operation of that monitoring site.

Further, due to the broadened objectives of the final network design, EPA also is finalizing the provision that

an NCore SO 2 monitor within a CBSA (where a CBSAs PWEI value triggered required monitoring) can be counted towards meeting the minimum monitoring requirements in this rulemaking (discussed in section IV.B.4) because they can meet some of the expanded objectives of the network. NCore sites are intended to provide long-term data for air quality trends analysis, model evaluation, and, for urban sites, tracking metropolitan air quality statistics, and therefore are appropriate to allow to count towards minimum monitoring requirements under the revised monitoring scheme.

Finally, EPA strongly encourages State and local air agencies to consider using required monitoring, as appropriate, to characterize those
sources which are not as conducive to dispersion modeling and to assess population exposure. Sources that are not conducive to dispersion modelinginclude (1) sources classified as nonpoint sources (a.k.a. ‘‘ area-sources ’’ ) such as shipping ports, (2) a source situated in an area of complex terrain and/or situated in a complex meteorological regime, and (3) locations that have multiple, relatively small sources with overlapping plumes.

4. Final Monitoring Network Design

The use of a hybrid analytic approach (discussed above in section III and IV.B.1) makes it unnecessary for the final monitoring network design to be distinctly focused on monitoring locations of expected maximum concentration (and thus be primarily source-oriented), as discussed in section IV.B.3 above. Instead, with the dual use of modeling and monitoring for designations, the final monitoring network is designed to provide flexibility for required monitors to address the multiple monitoring objectives just discussed in the preceding section. This flexibility in monitoring objectives is in response, in part, to the many public comments received from States ( e.g., NACAA and six other States), industry (API, EPRI, UARG, and eight other groups), and from the American Thoracic Society (ATS), urging EPA to ensure that some or all of the required monitors be sited and suited to characterize population exposure and, from many of these same commenters, to allow flexibility in implementing the siting requirements for the monitors. Under a hybrid approach, and the different monitoring objectives resulting thereof, the final monitoring network design also does not need to be a two-prong approach like the one proposed. Therefore, EPA is adopting a modified version of the first prong of the proposed network design, which will use PWEI values to require
monitors in certain CBSAs where there is increased coincidence of population
and SO 2 emissions. There is no second prong in the final network design by which monitors are required based on a
State’s individual contribution to the national anthropogenic SO 2 inventory, as was proposed.

The final monitoring network design requires monitoring in CBSAs based on calculated PWEI values, where a PWEI shall be calculated (as discussed in section IV.B.5 below) for each CBSA. For any CBSA with a calculated PWEI value equal to or greater than 1,000,000,
a minimum of three SO 2 monitors are required within that CBSA. This requirement remains the same as proposed. For any CBSA with a calculated PWEI value equal to or greater than 100,000, but less than 1,000,000, a minimum of two SO 2 monitors are required within that CBSA. For any CBSA with a calculated PWEI value equal to or greater than 5,000, but less than 100,000, a minimum of one

SO 2 monitor is required within that CBSA. EPA has adjusted the thresholds for requiring one or two monitors in a
CBSA and the rationale for this adjustment is explained more fully below in section IV.B.5. As just explained in section III.B.3, these
monitors shall be sited to meet one or more of a number of monitoring site objectives, including the assessment of source impacts, highest concentrations, population exposure, general background, and regional transport. EPA believes that the monitors required within these PWEI breakpoints provide
a reasonable minimum number of monitors in a CBSA, where there is a relatively increased coincidence of population and SO 2 emissions and therefore increased potential for exposures, because we are directly accounting for both population and
emissions that exist in individual

CBSAs. 29 EPA estimates that these minimum monitoring criteria (based on 2008 population and 2005 NEI data) require 163 monitors within 131 CBSAs.
EPA also intends for SO 2 monitors at NCore stations to satisfy these minimum monitoring requirements. Based on analysis of proposed and approved NCore sites (as of April 2010), all of which are scheduled to be operational no later than January 1, 2011, EPA
estimates that 52 of the total 80 SO 2 monitors at NCore stations are within the 131 CBSAs that have required
monitors based on their PWEI values. As a result, EPA estimates that between these minimum monitoring requirements and the NCore network,
there will be at least 191 SO 2 monitors operating across the country.

5. Population Weighted Emissions Index

In the proposal, EPA had introduced a metric based on population and emissions as a basis for locating
monitors in the network. EPA anticipated that this metric would characterize the potential for exposure based on the proximity of source emissions to populations. The following paragraphs provide background, rationale, and details for the final changes of the calculation and use of the Population Weighted Emissions Index in determining minimum monitoring requirements.

a. Proposed Use of the Population Weighted Emissions Index

In the proposed network design approach, which utilized a two-prong network design, EPA created the Population Weighted Emissions Index (PWEI) in an attempt to focus monitoring resource where there was a higher proximity of population and SO 2 emissions. In effect, areas with higher PWEI values have higher potential for population exposure to short-term SO 2 emissions. EPA proposed that the PWEI be calculated using population and emissions inventory data at the Core Based Statistical Area (CBSA) 30 level to assign required monitoring for a given CBSA, with population and emissions being the relevant factors. To calculate the PWEI for a particular CBSA, using


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the latest Census Bureau estimates, the population of a CBSA must be multiplied by the total amount of SO 2 emissions in that CBSA. The CBSA emission value is in tons per year (using
the latest available National Emissions Inventory [NEI] data), and is calculated by aggregating the county level emissions for each county in a CBSA. We then divide the resulting product of CBSA population and CBSA SO 2 emissions by 1,000,000 to provide a PWEI value in more manageable units of millions of people-tons per year.

With the change in the approach
discussed in section III and section IV.B.1 above, and considering the final monitoring network design discussed in IV.B.4 above, the use of the PWEI from that which was proposed also changes. The following paragraphs discuss some of the public comments received on the general use and calculation of the PWEI;
other comments that focused on the detailed application of the PWEI as proposed will be addressed in the response to comments document since our approach in applying the PWEI has changed.

b. Public Comments

EPA received a number of comments from State and local groups ( e.g., NACAA and eight others) and industry ( e.g., AQRL, ACC, and eight others) who generally agreed with the two-pronged network design concept which had the PWEI as a component. More specifically, some State commenters ( e.g. NACAA, AK, FL, IL, NC, SC, and WI) expressed concern that the PWEI (along with the second prong of the proposed network design) created monitoring requirements that were

‘‘ duplicative ’’ and also called for monitors in areas where they were not needed. Even amongst some of the commenters who generally agreed with the PWEI concept, some provided examples of where the PWEI appeared to be duplicative in its proposed application. One example was provided by the State of Florida, ‘‘ in the case of Homosassa Springs, the [proposed network design] requires two monitors [in that CBSA as a result of the proposed use of the PWEI]. The driving source is the Crystal River Power Plant, with emissions in 2008 of over 85,000 tons per year of SO 2 . The next largest source in the CBSA has emissions of roughly two tons per year. ’’ EPA believes that Florida is asserting that the one large source disproportionately drove the PWEI too high for that particular CBSA and only one monitor was actually needed. EPA notes that these particular comments on duplicative monitoring were made under the premise that all proposed required monitors would be sited in locations of expected maximum concentration, and therefore would be source-oriented in nature. As a result,
these commenters believed it was necessary that a waiver provision be included if they could show that the required number of monitors was too many, as in Florida’s example.

As discussed in section IV.B.4 above, a hybrid approach results in a final network design with a reduced number of required monitors from the number proposed, a different application of the PWEI, and provides flexibility in meeting additional monitoring objectives for the required monitors, making the need for a waiver from the minimally required monitors unnecessary. If a CBSA is required to have multiple monitors now, those monitors are not specifically required to
be located near sources where
maximum concentrations of SO 2 are expected to occur. Instead, they can be
sited at different locations to fulfill a variety of objectives, although, as noted in secion IV.B.3 above, EPA is strongly encouraging States to consider monitoring near sources not conducive to dispersion modeling and for characterization of population

exposures.

EPA received comments from Michigan, South Carolina, and CBD requesting clarification on the logic behind the proposed PWEI thresholds, or breakpoints, by which three, two, one, or no monitors would be required in a given CBSA. In addition, some States ( e.g., MI, MO, SC, and WI) and industry ( e.g., LCA, LMOGA, and LPPA) suggested specific adjustments to the proposed application of the PWEI. For example, Michigan suggested that the required monitor breakpoint values be adjusted to the ‘‘ natural breakpoints in
the overall distribution ’’ . South Carolina suggested EPA identify a way to normalize the PWEI stating the PWEI would be more appropriate ‘‘ * * * if it
used a value that better addressed difference in area, population distribution, land use, number, types of

sources, etc. ’’

In the proposed network design, EPA selected the PWEI values, or breakpoints, to require one or more
monitors based on the overall
distribution of PWEI values across all
CBSAs. Based on U.S. Census Bureau data ( http://www.census.gov ), there are approximately 939 CBSAs in the country. EPA proposed and now requires that a PWEI value be calculated
for each of these CBSAs to determine if monitoring is required in that CBSA.
Based on 2008 census estimates and the 2005 NEI, the average CBSA PWEI value is 21,900 while the median value is only 121. This indicates that a relatively small number of CBSAs with high PWEI values are driving the very upper end of the PWEI distribution. The proposed breakpoint where one monitor was required in a CBSA was a PWEI value of 5,000. EPA estimated that 131 out of 939 CBSAs (

∼ 14%) have a PWEI value of 5,000 or more. Further, these 131 CBSAs occupy

∼ 98% of the sum of PWEI values across all 939 CBSAs, where high PWEI values indicate increased coincidence in population
and SO 2 emissions. Within this group of CBSAs with PWEI values of 5,000 or more, EPA considered the relative amounts of population, emissions, and general frequency of occurrence of relatively larger SO 2 sources (such as those that emit 100 tons per year or more) in selecting the breakpoints to require two and three monitors in a CBSA for the proposed network design.
These considerations were made in an effort to apply a nationally applicable process by which to require a minimum number of monitors for an area, which
all were to be sited in locations of expected maximum concentration, and therefore likely source-oriented monitors. In regard to the comments suggesting modification to the calculation or to normalize the PWEI, EPA believes that the proposed calculation, under a hybrid analytical approach, is still most appropriate. Under a hybrid analytical approach, States have the flexibility to move monitoring resources where needed within CBSAs that have a high coincidence of population and emissions instead of only being able to
site monitors to characterize sources. States have the option to consider
additional factors such as those listed in
South Carolina’s comments above in further identifying where required monitoring may be most appropriate in their areas with required monitoring.

Several States ( e.g. NESCAUM, NYSDEC, and PADEP) suggested abandoning the PWEI concept altogether and instead using some form of emissions-only approach to require monitors. For example, NESCAUM, who generally supported a ‘‘ hot-spot ’’ monitoring approach, suggested that the
PWEI be abandoned and EPA instead

‘‘ * * * adopt an emissions-only approach, resulting in fewer CBSA monitors. We [NESCAUM] suggest a threshold of 50,000 tpy CBSA SO 2 emissions to trigger the first CBSA
monitor and a second CBSA monitor required when emissions exceed 200,000 tpy. ’’ NESCAUM states that the proposed use of the PWEI ‘‘ * * * can


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31 In simulating NYSDEC’s suggested network design, EPA assumed that no CBSA would have more than one monitor. According to the 2005 NEI, there are 162 sources emitting 20,000 tpy or more a year. 93 of those sources are estimated to be inside CBSAs that have emissions of 50,000 tpy, leaving approximately 62 sources that would need a monitor to satisfy NYSDEC’s suggested network design. result in multiple monitors in large cities that have relatively small CBSA

SO 2 emissions, or no monitor in a CBSA with large emissions. ’’ NYSDEC suggests that the proposed approach, using the PWEI, is ‘‘ * * * not more predictive than using emissions data alone. ’’ NYSDEC went on to suggest that monitors be required in CBSAs with aggregated emissions of 50,000 tons per year or more and that ambient monitoring be considered for point sources with 20,000 tons per year. PADEP made several suggestions on network design, with one that suggested monitoring in any CBSA ‘‘ where there is
a sulfur dioxide source or combination of sources within 50 miles emitting a total of at least 20,000 tons of SO 2 per year * * * ’’

EPA reviewed emissions and 2005 NEI data and compared the suggestions provided by NESCAUM and NYSDEC to the requirement of the final network design. Under NESCAUM’s suggested design, EPA estimates there would be 75 required monitors in 65 CBSAs. Of these 65 CBSAs, 6 CBSAs that are not covered by the final network design would be included; however, 72 CBSAs that will
have monitors under the final network design would otherwise not have monitors under NESCAUM’s design.
EPA believes that the exclusion of those 72 CBSAs would lead to too sparse a network to adequately meet the monitoring objectives of the network. Under NYSDEC’s suggested network design, EPA estimates that there would
be a minimum of 65 monitors in the
same 65 CBSAs of the NESCAUM suggested design. Further, if States ensured that monitors were placed near all sources emitting 20,000 tons per year (as NYSDEC suggested should be

‘‘ considered ’’ for monitoring), there
could be an additional 69 monitors. 31 EPA believes that the final network design as discussed above in section IV.B.4, with the increased flexibility for monitors to meet multiple monitoring objectives (discussed in IV.B.3 above) including, among others, characterization of source impacts or population exposure, is better served using PWEI values to require monitors because it explicitly accounts for population to require and distributemonitors as compared to an emissionsonly approach. If there is reason for concern that other CBSAs or areas not included in the final network design,
such as the six CBSAs that were
included in the NESCAUM and NYSDEC suggested network designs noted above, warrant monitoring resources, States or the EPA Regional Administrator may take action to require monitoring in such areas. The authority of an EPA Regional Administrator to require additional monitoring above the minimum requirements is discussed in section
IV.B.6 below.

EPA received a number of comments from States ( e.g., IA, NESCAUM, NC, NYSDEC, SC, and WI) and industry ( e.g., CE, Dominion, EEI, LCA, LMOGA, LPPA, and UARG) raising concern over the way the PWEI is calculated. Specifically, many commenters in this group indicated that they believed that
the 2005 NEI would be used in an exclusive or permanent fashion to calculate the PWEI, and that updated
NEI data would not be used. For example, NESCAUM states that ‘‘ EPA should not require States to rely solely on EPA’s inventories [for calculating the PWEI], such as the National Emissions Inventory (NEI), as they do not always have the updated information that is necessary for such regulatory decisions. ’’

Wisconsin ‘‘ * * * believes that States
should be allowed to use their own annual point source inventories instead of EPA’s National Emissions Inventory (NEI) for evaluating emission sources. Wisconsin’s point inventory is updated annually and has a reporting threshold of five tons per year for SO 2 , making it more sensitive to changes in facility operations than the NEI, which is updated triennially. ’’ UARG stated that
their ‘‘ primary concern with this network design is its reliance on old
emissions data. For electric utilities which report their SO 2 emissions to EPA annually, the use of more recent data would be appropriate. ’’

EPA does not intend for relatively old emissions data to be used in calculating
the PWEI values for individual CBSAs. As was detailed in the proposed regulatory text for 40 CFR Part 58 Appendix D (74 FR 64880), EPA stated
that ‘‘ The PWEI shall be calculated by multiplying the population of each CBSA, using the most current census data, by the total amount of SO 2 in tons per year emitted within the CBSA area, using an aggregate of the most recent county level emissions data available in the National Emissions Inventory for each county in each CBSA. ’’ Although commenters suggested that there may be
other resources from which emissions data may be obtained, particularly at the individual State level, the NEI is comprised of emissions data which is collected by EPA from the States
themselves. The Air Emissions Reporting Requirements (40 CFR Part 51), by which EPA sets out how States are to report their emission inventories, was recently revised in December of 2008. That rulemaking was intended to provide enhanced options to States for emissions data collection and exchange and unify reporting dates for various categories of inventories. EPA notes that the NEI is updated in full every three years and the 2008 NEI is scheduled to be available by January 2011. States will have submitted their data by May 31, 2010, before this rule is promulgated and published, and EPA will provide comment on these submittals during the
summer of 2010. States will have an opportunity to revise their 2008 data
submissions in the fall of 2010. In the triennial update, both point and nonpoint data are required to be submitted by States and are included in the inventory. Further, States are required to submit emissions data annually for all sources emitting 2,500 tons per year or more of SO 2 as well as for sources emitting other pollutants in
excess of thresholds set for those pollutants. In all point source submittals to the NEI, States are also allowed to submit emissions data for sources of any emissions level, but are not required to do so. Starting with the 2009 NEI, the
annual and triennial State NEI submittals will be due one year after the end of the emissions year. States have an additional opportunity to revise their
submittals based on EPA comment in the spring of the following year, with EPA publishing the inventory no later than 6 months after the inventory submittal dates (18 months after the end of the emissions year). This approach and schedule is accelerated over past NEI schedules and has been designed as part of the development of the new Emission Inventory System (EIS). Rather than representing old emissions data, the NEI available through EIS represents a timely and appropriate source of
emissions data.

EPA believes that the process by which the NEI will be updated (through use of the EIS) will be adjusted in a
manner that will allow for more frequent insertion of State suppliedemissions data, allowing for a more upto-date inventory. EPA takes this opportunity to encourage States to supply all of their available emissions
information to the NEI as soon as practicable. Therefore, EPA believes that the NEI is an appropriate and nationally representative source of emissions data by which PWEI calculations may be


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made. PWEI calculations for all CBSAs will use the same year of data at any given time, and States, local agencies,
and Tribes will have uniform opportunity for revising their emissions data for this purpose. EPA again encourages States to view the NEI submittals as their opportunity to
submit their best available SO 2 and other inventory data with the knowledge that it will be used for the purpose of PWEI values.

c. Conclusions on the Use of the Population Weighted Emissions Index

In the final network design, EPA has determined that it is appropriate to use PWEI values as the mechanism by which to require monitors in certain CBSAs, similar to its use in the first prong of the proposed two-prong network design. EPA believes that using
the PWEI metric to inform where monitoring is required is more appropriate for the SO 2 network design than utilizing a population-only or emissions-only type of approach, because it takes into account not just one factor, i.e., only population or only emissions, but instead takes into account the exposure from SO 2 emissions to groups of people who are in greater proximity to such emissions.

In the final rule, EPA is retaining the requirement to calculate the PWEI by multiplying the population of each CBSA, using the most current census
data/estimates from the U.S. Census bureau, by the total amount of SO 2 in tons per year emitted within the CBSA area, using an aggregate of county level
emissions data available in the most recent published version of the National Emissions Inventory for each county in each CBSA. The resulting product shall be divided by one million, providing a PWEI value, the units of which are million persons-tons per year. For any
CBSA with a calculated PWEI value equal to or greater than 1,000,000, a
minimum of three SO 2 monitors are required within that CBSA. For any
CBSA with a calculated PWEI value equal to or greater than 100,000, but less than 1,000,000, a minimum of two SO 2 monitors are required within that CBSA. For any CBSA with a calculated PWEI value equal to or greater than 5,000, but less than 100,000, a minimum of one

SO 2 monitor is required within that
CBSA. EPA believes that the monitors required within these breakpoints provide a reasonable minimum number
of monitors in a CBSA that considers the combination of population and
emissions that exist in a CBSA. These criteria (based on 2008 population and 2005 NEI data) are estimated to require
163 monitors within 131 CBSAs. EPA has changed the PWEI breakpoint in the final rule at which two monitors are required in a CBSA to 100,000 from the breakpoint of 10,000 in the proposed network design based on multiple considerations. First, EPA changed the breakpoint because of a hybrid analytic approach and attendant changes in monitoring objectives ( see section IV.B.3), with the result being that the monitoring network is no longer intended to be comprised primarily of
source-oriented monitors that are sited at locations of expected maximum concentration. This change in objective of the network design allows fewer monitors to provide the necessary amount of ambient monitoring data EPA to meet the multiple monitoring objectives. Second, the breakpoint of

100,000 occurs near a ‘‘ natural ’’ breakpoint in the PWEI distribution, a consideration that Michigan suggested,
where the estimated 28 CBSAs with PWEI values of 100,000 or more occupy

∼ 87% of the sum of PWEI values across all 939 CBSAs. Finally, EPA considered
commenters’ assertion that the first prong of the proposed network design created duplicative monitoring in certain CBSAs. This duplicative monitoring is especially recognized in some CBSAs with relatively small populations and somewhat large emissions which are dominated by a single source (such as the Homosassa Springs, FL example discussed above). Raising the second breakpoint helps to alleviate some of the duplicative monitoring that many of the State
commenters noted.

EPA therefore is keeping the first and third breakpoints, which require one monitor in a CBSA having a PWEI value of 5,000 and three monitors in a CBSA having a PWEI value of 1,000,000. EPA believes maintaining these breakpoints along with the revised 100,000 PWEI breakpoint, will (1) ensure that highly populated areas will be monitored for
ambient SO 2 concentrations even if the emissions in that area are moderate, which is appropriate given the fact that the greater population creates increased potential for exposure to those moderate emissions, and (2) that those areas with higher emissions or emission densities, with moderate or modest populations
will be monitored because those increased emissions are likely to have a significant impact on nearby populations.

6. Regional Administrator Authority

The following paragraphs provide background, rationale, and details for the final changes to Regional Administrator authority to use discretion in requiring additional SO 2 monitors beyond the minimum network requirements.

a. Proposed Regional Administrator Authority

EPA proposed that the Regional

Administrators will have discretion to require monitoring above the minimum requirements, as necessary, to address

situations where the minimum monitoring requirements are not sufficient to meet monitoring objectives. EPA recognized that the minimumrequired monitors in the proposed twopronged network design were based on indicators that may not have always provided spatial coverage for all the

areas that have SO 2 sources. Although the network design and the objectives of the network design have changed from those that were proposed because of our contemplated use of a hybrid analytical approach, EPA believes it is still important for Regional Administrators to have the discretion, and authority, to require monitoring above the minimum requirements. Providing the RAs with

this discretion will allow them to fill any identified gaps in meeting the monitoring objectives of the network.

b. Public Comments

Some commenters ( e.g., LCA, LMOGA, LPPA, and South Carolina) expressed concerns with the proposed provision authorizing the Regional Administrator to require additional monitoring above the minimum requirements. The LCA, LMOGA, and

LPPA stated that ‘‘ the EPA’s proposal to allow the Regional Administrator discretion to require a State to add

additional monitors is flawed in that it provides unfettered discretion. Criteria

should be added * * * that limit such discretion and require the Regional

Administrator to consider certain objective factors when determining whether to require any additional

ambient SO 2 monitors to the network. ’’
South Carolina stated that ‘‘ the Regional

Administrators should not have the discretion to require monitoring above the requirements described in [the proposal for] Part 58 and its Appendices. State monitoring organizations must be given discretion to decide the appropriate use of resources to meet uniform monitoring requirements. Additional monitoring requirements should not be imposed without concurrence of the monitoring organization and additional funding that completely supports the additional

costs. ’’


### 35566 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

32 Moreover, as explained in section IV.A, the existing FEM monitors in operation may continue to be used to monitor compliance with the NAAQS. c. Conclusions on Regional Administrator Authority

The authority of Regional Administrators to require additional monitoring above the minimum required is not unique to the SO 2 NAAQS. For example, Regional Administrators have the authority to use their discretion to require additional

NO 2 or Pb monitors (40 CFR Part 58 Appendix D section 4.3.4 and 4.5, respectively) and to work with State and local air agencies in designing and/or maintaining an appropriate ozone monitoring network (40 CFR Part 58 Appendix D section 4.1). EPA believes that the nationally applicable final network design, although somewhat dictated by local factors (population and emissions), may not account for all
locations where monitors should be sited, including where potentially high
concentrations of SO 2 may be occurring. Examples include locations that have the potential to violate or contribute to violations of the NAAQS, areas that might have high concentrations of SO 2 that are not characterized by modeling
or have sources that are not conducive to modeling, and locations with susceptible and vulnerable populations. As a result, EPA believes it is important for Regional Administrators to have the authority to address possible gaps in the minimally required monitoring network, especially near sources or areas that are not conducive to modeling by granting them authority to require monitoring above the minimum requirements. However, in response to public comments, EPA notes that Regional Administrators would use this authority in collaboration with State agencies to design and/or maintain the most appropriate SO 2 monitoring network to meet the needs of a given area. For all the situations where the Regional Administrators may require additional monitoring, it is expected that the Regional Administrators will work on a case-by-case basis with State or local air agencies. Further, any monitor required through the Regional Administrator and selected by the State agency, or any new monitor proposed by the State itself, is not done so with unfettered discretion, since any such action would be included in the Annual Monitoring Network Plan per § 58.10, which must be made available for public inspection or comment, and approval by the EPA Regional Administrator.

Therefore, EPA is finalizing the proposal that Regional Administrators may use their authority to require monitoring above the minimum requirements, as necessary, in any area,
to address situations where the minimally required monitoring network is not sufficient to meet monitoring objectives. In all cases in which a Regional Administrator may consider the need for additional monitoring, it is expected that the Regional
Administrators will work with the State or local air agencies to evaluate
evidence or needs to determine if a particular area may warrant additional monitoring.

7. Monitoring Network Implementation

The following paragraphs provide background, rationale, and details for the final approach for the monitoring network implementation.

a. Proposed Monitoring Network Implementation

EPA proposed that State and, where appropriate, local air monitoring agencies submit a plan for deploying

SO 2 monitors in accordance with the proposed requirements discussed above by July 1, 2011. EPA also proposed that
the SO 2 network be physically established no later than January 1, 2013. EPA also proposed that the number of sites required to operate as a result of the Population Weighted Emissions Index (PWEI) values
calculated for each CBSA be reviewed and revised for each CBSA through the 5-year network assessment cycle required in § 58.10.

b. Public Comments

EPA received comments from the ALA, EDF, NRDC, and SC that supported ‘‘ * * * a more accelerated deployment of new monitoring than the 2013 target date proposed by EPA. The sooner monitors are in place, the sooner the public will experience the health
benefits of the new standard. ’’ However, EPA received comment from States ( e.g., IA, MI, NC, SC and WI), industry ( e.g., LCA, LMOGA, and LPPA) and public health and environmental groups ( e.g., ALA, EDF, NRDC, and SC) expressing concern with the proposed deployment schedule of the proposed SO 2 network
in that it was too fast or needed to be phased in. The States of Iowa, South Carolina, and Wisconsin suggested that EPA allow the proposed network to deploy on a phased schedule. For example, South Carolina recommended

a ‘‘ phased implementation with largest source/highest probability population exposure areas designated for implementation in 2013 (some proportion of the highest PWEI monitors) and establishment of the remaining PWEI and the State level emissions triggered monitoring required the following year. ’’ Meanwhile, the States of Michigan and North Carolina, along with the industry commenters LCA, LMOGA, and LPPA, suggested EPA reconsider implementation dates in light of the multiple rulemakings that impose mandates on States that have and will be occurring in the future. For example, North Carolina stated that

‘‘ EPA must keep in mind that it is simultaneously revising numerous
ambient standards and associated monitoring requirements. EPA seems to view each of these proposals as independent actions; but the State and local agencies must consider the cumulative impact of EPA’s various regulatory actions on their ability to comply. ’’ North Carolina goes on to say
that ‘‘ EPA must allow States the flexibility to prioritize among the new requirements to get community based monitors in place first and to establish the others as funding and personnel
resources allow. ’’

EPA believes that with the use of a hybrid analytical approach, the concerns raised by States and industry commenters suggesting a phased or delayed implementation are addressed
because the final network minimum design requirements result in fewer monitors being required than in the proposed network design. EPA’s analysis of the existing network had
indicated that a substantial number of
monitors were not sited at locations of
maximum concentrations. These
monitors would have had to be relocated to count towards minimum monitoring requirements under the proposed monitoring-focused approach. Under a combined modeling and monitoring approach, the required monitors can be used to satisfy multiple monitoring objectives and therefore, many of the monitors in the existing network will satisfy the requirements in the final network design, eliminating any need for a phased or delayed network implementation. In regard to the suggestion by public health and environmental groups to speed up implementation, EPA notes that under a hybrid analytical approach much of the existing network will fulfill minimum monitoring requirements, and an accelerated schedule is not necessary; the network implementation date provides a balance between ensuring the minimally required network is fully in place in a reasonable amount of time and providing States adequate time to fulfill all the requirements in this rulemaking. 32

EPA received comment on the frequency by which the minimally


### 35567 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

33 Note that some commenters supported more than one form of reported 5-minute data. required network will be reviewed and possibly adjusted based on updated population and emissions inventories. The State commenters listed above, and some others including NACAA, indicated that they believed that the proposal for reviewing the SO 2 network every five years was intended to be a separate review from the required 5-year network assessments required in § 58.10(d). NACAA stated ‘‘ EPA proposes that the SO 2 monitoring network be evaluated every five years. This is an unnecessary duplication of effort in light of the current requirements for the annual network plan and five year network review. ’’ NACAA went on to say that ‘‘ the current requirements [in § 58.10] should be regarded as the primary source of monitoring network information for all NAAQS pollutant monitoring, regardless of the pollutant. ’’

EPA concurs with NACAA’s statements that the existing requirements for network assessment are an appropriate primary source of monitoring network information. In the proposal, EPA did not intend for a required 5-year review of the SO 2 network to be an additional effort on top of the existing required network

assessments but instead to be included as part of the 5-year assessment in § 58.10(d). EPA notes that CBSA populations and emissions inventories change over time, suggesting a need for periodic review of the monitoring network. At the same time, EPA recognizes the advantages of a stable monitoring network. However, after considering comments, EPA is not finalizing the proposed language for 40 CFR Part 58 Appendix D, section 4.4.3(2) which simply referenced back to § 58.10. This proposed text it is not needed and appears to simply cause confusion. EPA asserts that the existing requirements in § 58.10 provide a sufficient and appropriate mechanism for network updates and assessment.

c. Conclusions on Monitoring Network Implementation

Based on the public comments, and due to the contemplated use of a hybrid analytical approach, EPA is finalizing, as was proposed, that State and, where appropriate, local air monitoring agencies submit a plan for deploying

SO 2 monitors in accordance with the proposed requirements presented below by July 1, 2011. Minimally required SO 2 monitors shall be physically established no later than January 1, 2013. C. Data Reporting
The following paragraphs provide background, rationale, and details for monitor data reporting requirements.

a. Proposed Data Reporting

Controlled human exposure studies indicate that exposures to peaks of SO 2 on the order of 5 to 10 minutes result in moderate or greater decrements in lung function and/or respiratory symptoms in exercising asthmatics (section II.B.1 above, ISA section 5.2, REA section 7.2.3, and REA section 10.3.3.2). As a result, the 1-hour standard is intended to protect against short term exposures, including exposures on the order of 5 minutes up to 24 hours, as is discussed in section II.F.2 above. Therefore, in support of the revised NAAQS and its intent, EPA proposed that State and local agencies shall report to AQS the maximum 5- minute block average of the twelve 5- minute block averages of SO 2 for each hour. This 5-minute block reporting requirement is in addition to the existing requirement to report the 1- hour average. In addition, EPA solicited comment on the advantages and disadvantages (including associated resource burdens) of alternatively requiring State and local agencies to report all twelve 5-minute SO 2 values
for each hour or the maximum 5-minute
concentration in an hour based on a moving 5-minute averaging period rather than time block averaging.

EPA also proposed Data Quality Objectives (DQOs) for the SO 2 network. DQOs generally specify the tolerable levels for potential decision error used as a basis for establishing the quality and quantity of data needed to support the objectives of the monitors. EPA proposed the goal for acceptable measurement uncertainty for SO 2 methods to be defined as an upper 90 percent confidence limit for the coefficient of variation (CV) of 15 percent for precision and as an upper 95 percent confidence limit for the absolute bias of 15 percent for bias.

b. Public Comments

EPA received many comments on the reporting of 5-minute data values. The comments generally fell into one of the following categories: 33 (1) Those State, public health, and environmental groups who supported the proposed requirement to report the maximum 5- minute block average of the twelve 5- minute block averages of SO 2 for each hour ( e.g., Missouri, NESCAUM, North Carolina, ALA, EJ, EDF, NRDC, and SC), (2) those State, public health, and environmental groups who supported the reporting of all twelve 5-minute averages of each hour ( e.g., Kentucky, NYSDEC, AQRL, ALA, ATS, CBD, EJ, EDF, NRDC, and SC), (3) those State, public health, and environmental groups who supported reporting the

maximum 5-minute concentration in an hour based on a moving 5-minute average ( e.g., South Dakota, ALA, CBD, EJ, EDF, NRDC, and SC), and (4) those State and industry groups who did not support the reporting of any 5-minute data ( e.g., Iowa, South Carolina, LEC, and RRI Energy).

Public health and environmental groups ( e.g. ALA, CBD, EJ, EDF, NRDC, and SC) supported an approach where 5-minute data must be reported. However, these commenters were flexible in their position and supported multiple forms or types of 5-minute data reporting. The ALA, EJ, EDF, NRDC, and
SC stated that ‘‘ we support the proposed requirement for State and local monitoring agencies to report both hourly average and maximum 5-minute averages out of the twelve 5-minute block averages of SO 2 for each hour. ’’ They also expressed a preference for alternative 5-minute data reporting stating that they ‘‘ strongly prefer that States be required to report the peak 5-
minute concentrations of SO 2 based on a rolling average. ’’ Similarly, CBD stated
that ‘‘ * * * EPA should require that State and local agencies report all 12
five-minute SO 2 values for each hour in addition to 1-hour averages. Where possible, EPA also should require reporting of rolling five-minute averages
rather than block data * * * ’’

Missouri generally supported the proposed requirement to report the maximum 5-minute average in the hour, saying ‘‘ it is not a problem to report both the hourly average and the maximum 5- minute block average. ’’ Nevertheless, Missouri went on to note constraints, stating that ‘‘ * * * [their] data logger
and associated software do not have the capability to report all twelve 5-minute

SO 2 values for each hour ’’ and that they

‘‘ * * * could not do this without software being developed for this purpose and it could be time intensive
to validate this data. ’’

Kentucky did not support the proposal to report the maximum 5-
minute data block in the hour because
of the limitations in their data acquisition systems. They explained
that ‘‘ the data acquisition system used by the [State] does not have the capability to automatically report the
maximum 5-minute block of data from an hour concentration. [State] personnel would have to manually determine that


### 35568 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

34 The REA assessed exposure and risks
associated with 5-minute SO 2 concentrations above 5-minute health effect benchmark levels derived from controlled human exposure studies. In the analyses, the REA noted that very few State and local agencies report ambient 5-minute SO 2 data (REA, section 10.3.3.2) and that the lack of 5-minute data necessitated the use of statistically estimated

5-minute SO 2 data in order to expand the geographic scope of the exposure and risk analyses (REA, section 7.2.3). value and then manually enter that data into AQS. ’’ Kentucky goes on to suggest
that ‘‘ the only feasible option for the [State] to submit 5-minute data to AQS
would be to submit all twelve 5-minute blocks of data for each hour to AQS. ’’

South Dakota stated that its ‘‘ * * * preference would be to report the maximum 5-minute average for each hour calculated using a 5-minute rolling

average. ’’ South Dakota goes on to state
that ‘‘ * * * while doubling the work required to validate data and load the data into AQS, the additional data should help determine if the selected
standard concentration level has achieved the necessary reduction in high concentration 5-minute levels and provide the necessary data for further study of health impacts * * * ’’

South Carolina stated that it ‘‘ * * * does not support mandatory reporting of 5-minute averages in addition to the 1- hour average required for comparison to
the standard. The validation and reporting of 5-minute averages imposes a significant additional burden on the reporting organization and its Quality System. ’’ Iowa, who also did not support any form of 5-minute data reporting
stated that ‘‘ the five-minute data is not used to determine compliance with the NAAQS, and represents ancillary data, ’’
and that ‘‘ validating and uploading the
five-minute data will take at least as much staff time as generating the hourly data used for compliance. ’’ As a result,
Iowa states that ‘‘ if EPA determines that five-minute data is needed, we recommend that EPA require the maximum five-minute average in each hour, rather than all twelve five-minute averages, in order to reduce the burden associated with generation of the ancillary data set. ’’

With regard to the proposed DQOs,
EPA received comments from some States ( e.g., Kentucky, North Carolina, NYSDEC, and South Carolina) providing general support for the goals for acceptable measurement uncertainty for precision and bias. North Carolina
stated that the ‘‘ * * * precision and bias measurement uncertainty criteria
should emulate those that have been established for other recent NAAQS and NCore pollutants. ’’ NYSDEC stated that

‘‘ the proposal does not seem unreasonable, however these statistics are now expressed in terms of confidence limits: Precision—90% confidence of a CV of 15% and Bias— 95% confidence of a CV of 15%. ’’
NYSDEC raises concern that ‘‘ * * * the results are now dependent on the number of audits performed. This is highly variable because some agencies run automatic audits every night, [while] others use the old standard of once every 2 weeks. ’’

In regard to comments on the proposed DQOs, EPA notes that the precision and bias estimation technique
on which NYSDEC comments were focused were proposed and adopted in the monitoring rule promulgated on October 6, 2006 and EPA did not intend to reopen those requirements for comment. Moreover, SO 2 precision and bias estimates have been performed in this manner for the past four years and
there have been no adverse effects on data quality at the minimum required level of performance checks every two weeks. The statistics for the precision and bias estimates and the DQO goals
are based on the accumulation of the one-point precision checks aggregated at the frequencies required in CFR which is every two weeks. Any organization performing more frequent checks (such as every night) would accumulate more data for the precision and bias estimates, have higher confidence in the data, and would have less potential for outliers or higher than normal values effecting the precision and bias estimate. In addition, monitoring organizations running precision checks every 24 hours would be more able to control data quality to meet the DQO goals than organizations running the check every two weeks.

c. Conclusions on Data Reporting

EPA received a fairly diverse set of comments on the appropriateness of reporting 5-minute data and in what particular format it may be provided in. EPA has considered the comments by the States regarding validation of potentially 13 data values per hour (instead of 1 or 2) and some States’ lack of data acquisition capacity or processing capability to report any particular type of 5-minute value. EPA believes that in light of these comments, adopting a requirement for continuous

SO 2 analyzers to report all twelve 5- minute values or a rolling 5-minute value does not appear to provide enough added value for the potential increased burden on States, such as
increased staff time dedicated to data processing and QA, or in improving or adjusting data acquisition capabilities. However, EPA also believes that obtaining some form of 5-minute data is appropriate because such data have been critical to this NAAQS review, and are anticipated to be of high value to inform future health studies and, subsequently, future SO 2 NAAQS

reviews. 34 Indeed, as noted earlier, it was EPA’s failure to adequately explain the absence of protection from elevated short-term (5- to 10-minute exposure)

SO 2 concentrations for heavily breathing
asthmatics that occasioned the remand
of the 1996 SO 2 primary NAAQS (American Lung Association, 134 F.3d at 392). This belief is supported further by the expectation that a significant portion of the monitors operating to satisfy the final monitoring network design will likely be sited for population exposures, which have traditionally provided ambient data that is often utilized by epidemiologic health studies. Therefore, EPA is finalizing the requirement that State and local air agencies operating continuous SO 2 analyzers shall report the maximum 5- minute block average out of the twelve 5-minute block averages in each hour, for each hour of the day, and that State and local air agencies operating any type of SO 2 analyzer shall report the integrated 1-hour average value, as was proposed. EPA encourages States capable of reporting all twelve 5-minute data blocks in an hour to report such data to AQS. AQS is currently set-up to
take the 5-minute maximum value in an hour under parameter code 42406 and
can take all twelve 5-minute values under parameter code 42401 (with a duration code of H). EPA notes that if
a State were to choose to submit all twelve 5-minute blocks in the hour, by default, they would be submitting the
maximum 5-minute data block within that hour, although they have not singled out that particular value. Since the 5-minute data is not directly being used for comparison to the NAAQS, EPA believes that any State electing to
submit all twelve 5-minute values is still satisfying the intent of having the maximum 5-minute value reported. Therefore, if a State chooses to submit all twelve 5-minute values in an hour, they will be considered to be satisfying the data reporting requirement of submitting the maximum 5-minute value in an hour, and they do not have to separately report the maximum 5-
minute value from within that set of data values to AQS under parameter
code 42406.

EPA proposed new regulation text for 40 CFR Part 58 Appendix C, which
would have added section 2.1.2 that would have required any SO 2 FRM or


### 35569 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

FEM used for making NAAQS decisions to be capable of providing both 1-hour and 5-minute averaged concentration data. EPA is not finalizing this proposed language, as the manual wet-chemistry pararosaniline reference method cannot provide 5-minute data. Therefore, the proposed language is inappropriate. However, both the UVF FEM and the
new UVF FRM continuous methods are capable of providing 5-minute averaged data. As a result, the language in 58.12(g) and 58.16(g) requiring 5-minute

SO 2 data has been adjusted to appropriately specify that only those States operating continuous FRM or FEMs are required to report the
maximum 5-minute data value for each
hour.

With regard to acceptable measurement uncertainties, EPA reviewed summary data for each Primary Quality Assurance Organization (PQAO) in the 2008 Data Quality Indicator Report on SO 2 data within the 2008 Criteria Pollutant Quality Indicator Summary Report for AQS Data ( http:// www.epa.gov/ttn/amtic/qareport.html ). Of the 100 PQAOs in the report, none of those organizations had summary CV or bias values exceeding 10 percent. Thus, EPA believes that the SO 2 network can and does easily attain measurement uncertainty criteria more stringent than the finalized goal values and the monitoring required under the final network design should be able to maintain this level of performance. Therefore, in consideration of comments and existing quality assurance data, EPA is changing the final goals from those which were proposed for acceptable measurement uncertainty for SO 2 methods to be defined for precision as an upper 90 percent confidence limit for the coefficient of variation (CV) of 10 percent and for bias as an upper 95 percent confidence limit for the absolute bias of 10 percent.

V. Initial Designation of Areas for the

1-Hour SO 2 NAAQS

This section of the preamble further addresses the process under which EPA intends to identify whether areas of the country attain or do not attain or are

‘‘ unclassifiable ’’ regarding the new 1-
hour SO 2 NAAQS. After EPA establishes a new NAAQS, the CAA directs States and EPA to take this first step, known
as the ‘‘ initial area designations, ’’ in ensuring that the NAAQS is ultimately
attained.

We are revising our discussion of an expected approach toward issuing initial area designations in response to comments we received on the proposed rule’s treatment of monitoring and modeling (both generally and in the specific context of designations), and to make the expected process more consistent with our historical approach to implementing the SO 2 NAAQS. A revised anticipated approach for issuing designations logically follows from our revised hybrid approach to monitoring and modeling as discussed above in
sections III and IV. It would also affect a revised expected implementation approach that we later discuss in section VI. 1. Designations.

a. Clean Air Act Requirements

The CAA requires EPA and the States to take steps to ensure that the new NAAQS are met following promulgation. The first step is for EPA to identify whether areas of the country meet, do not meet, or cannot yet be classified as either meeting or not meeting the new NAAQS. Section 107(d)(1)(A) provides that, ‘‘ By such date as the Administrator may reasonably require, but not later than 1 year after promulgation of a new or revised NAAQS 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 should be designated as nonattainment, attainment, or unclassifiable for the new NAAQS. 42 U.S.C. 7407(d)(1)(A)(i)–(iii). 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 up to one year in the event the Administrator
has insufficient information to promulgate the designations within 2

years. ’’ 42 U.S.C. 7407(d)(1)(B)(i).

Under CAA section 107(d)(1)(B)(ii), no later than 120 days prior to promulgating designations, EPA is required to notify States of any intended
modifications to their boundaries as EPA may deem necessary, and States will have an opportunity to comment on
EPA’s tentative decision. Whether or not a State provides a recommendation, the EPA must promulgate the designation that it deems appropriate. 42 U.S.C. 7407(d)(1)(B)(ii).

Accordingly, since the new 1-hour

SO 2 NAAQS is being promulgated today, Governors should submit their
initial SO 2 designation
recommendations to EPA no later than June 2, 2011. If the Administrator intends to modify any State’s boundary recommendation, the EPA will notify the Governor no later than 120 days prior to designations or, February 2012.
States that believe the Administrator’s modification is inappropriate will have an opportunity to demonstrate why they
believe their recommendation is more appropriate before designations are finalized in June 2012.

For initial designations that will be finalized in June 2012, States should use monitoring data from the existing SO 2 network for the years 2008–2010, as well as any refined SO 2 dispersion modeling ( see Appendix W to 40 CFR Part 51) for sources that may have the potential to cause or contribute to a NAAQS violation, provided that it is
recent and available. EPA will then issue designations based on the record
of information for that area. Under our anticipated approach, an area that has monitoring data or refined modeling results showing a violation of the NAAQS would be designated as

‘‘ nonattainment. ’’ An area that has both monitoring data and appropriate modeling results showing no violations would be designated as ‘‘ attainment. ’’ All other areas, including those with

SO 2 monitors showing no violations but without modeling showing no violations, would be designated as

‘‘ unclassifiable. ’’ Areas with no SO 2 monitors at all i.e., ‘‘ rest of State, ’’ would be designated as ‘‘ unclassifiable ’’ as well.

b. Approach Described in Proposal

In the proposed rule’s preamble, we explained that we had proposed a new

SO 2 ambient monitoring network, with new monitors expected to be deployed no later than January 2013. We also explained that we expected compliance with the new NAAQS to be determined based on 3 years of complete, quality assured, certified monitoring data. We further explained that we did not expect newly-cited monitors for the proposed network to generate sufficient monitoring data for us to use in determining whether areas complied with the new NAAQS by the statutory deadline to complete initial designations. Therefore, we explained, we intended to complete designations by June 2012 based on 3 years of complete, quality assured, certified air quality monitoring data as generated from the current monitoring network.

Consequently, we discussed our expectations to base initial designations on air quality data from the years 2008– 2010 or 2009–2011, from SO 2 monitors operating at current locations, which we expected to continue through 2011. While those monitors are generally sited to measure 24-hour and annual average

SO 2 concentrations, we noted that they all report hourly data, and we estimated
that at least one third of those monitors might meet the proposed network


### 35570 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

design requirements and not need to be moved. We explained that if any
monitor in the current network
indicated a violation of the new 1-hour NAAQS, we would intend to designate
the area as ‘‘ nonattainment. ’’ We further explained that if a monitor did not indicate a violation, our designation
decision for the area would be made on a case-by-case basis, with one possibility being a designation of

‘‘ unclassifiable. ’’

We also explained that while the CAA section 107 designation provisions specifically address States, we intended to follow the same process for Tribes to the extent practicable, pursuant to CAA section 301(d), 42 U.S.C. 7601(d), and the Tribal Authority Rule, 40 CFR part

49.

c. Comments

Several commenters stated that the EPA did not provide nonattainment boundary guidance in the proposed rule and argued that guidance should be developed. Commenters also stated that
EPA should consider boundaries that
are less than the Core Based Statistical Area (CBSA), and perhaps even smaller than the county boundary (State of Michigan, Sierra Club).

In response, we note that the CAA requires that the EPA designate as

‘‘ nonattainment ’’ any area that does not meet (or contributes to an area that does not meet) the NAAQS. 42 U.S.C. 7407(d)(1)(A)(i). States with monitored
or modeled SO 2 violations will need to recommend an appropriate nonattainment boundary that both includes sources contributing to that violation, as well as informs the public
of the extent of the violation. For purposes of determining nonattainment boundaries, the EPA expects to consider the county line as the presumptive boundary for SO 2 . This would be consistent with our approach under other NAAQS. States recommending less-than-countywide nonattainment boundaries should provide additional information along with their recommendation, demonstrating why a smaller area is more appropriate, as we have advised for other NAAQS. If States request it, EPA may develop additional guidance on the factors that States should consider when determining
nonattainment boundaries.

In addition, as further discussed in section IV.B above, in the SO 2 NAAQSproposal, we proposed a monitoringfocused approach for comparison to the new NAAQS. The proposed network would have required approximately 348
monitors nationwide to be sited at the
locations of maximum concentration. Numerous State and local government commenters expressed concerns regarding the perceived burdens of implementing the proposed monitoring network and the sufficiency of its scope for purposes of identifying violations. Some of these commenters (the City of Alexandria, and the States of Delaware, North Carolina and Pennsylvania) suggested using modeling to determine the scope of monitoring requirements, or favored modeling over monitoring to determine compliance with the NAAQS. Partly in response to these comments, and after reconsidering the proposal’s monitoring-focused approach, specifically regarding how we have historically implemented SO 2 designations, we now anticipate taking a revised approach toward designations, using a hybrid analytic approach that combines the use of monitoring and available modeling to assess compliance
with the new 1-hour SO 2 NAAQS. We discuss a revised expected approach toward designations below, and further discuss in section VI how we expect a hybrid approach to affect other implementation activities.

d. Expected Designations Process

As discussed in sections III and IV of this preamble, in response to the comments and after reviewing our
historical SO 2 implementation practice, we intend to use a hybrid analytic approach for assessing compliance with
the new 1-hour SO 2 NAAQS for initial designations. We also believe that a hybrid approach is more consistent with our historical approach and longstanding guidance toward SO 2 NAAQS designations and implementation than what we originally proposed. Technically, for a short-term 1-hour standard, it is more appropriate and efficient to principally use modeling to assess compliance for medium to larger sources, and to rely more on monitoring for groups of
smaller sources and sources not as conducive to modeling.

In cases where there is complete air quality data from FRM and FEM SO 2 monitors, that data would be considered by EPA in designating areas as either

‘‘ attainment ’’ or ‘‘ nonattainment ’’ for the

new SO 2 NAAQS. See Appendix T to Part 50 section 3b. In addition, in cases where a State submits air quality modeling data that are consistent with our current guidance or our expected revisions thereto, and which indicates that an area is attaining the standard or violating the standard, these data may support recommendations of

‘‘ attainment ’’ or ‘‘ nonattainment. ’’ As explained in section IV above, we would not consider monitoring alone to be an adequate, nor the most accurate, tool to identify all areas of maximum
concentrations of SO 2. In the case of

SO 2, we further believe that monitoring
is not the most cost-efficient method for identifying all areas of maximum

concentrations.

Due to the necessarily limited spatial coverage provided by any monitoring regime, and the strong source-oriented
nature of SO 2 ambient impacts, we recognize that using this more traditional approach in designations, would be more likely to identify a greater number of potential instances of nonattainment, if areas were to immediately conduct modeling of current source emissions, as compared to the approach we discussed in the proposed rule. As discussed in section III, forthcoming national and regional rules, such as the pending Industrial
Boilers ‘‘ Maximum Achievable Control Technology ’’ (MACT) standard under CAA section 112(d), are likely to result in significant SO 2 emissions reductions in the next three to four years. A limited qualitative assessment of preliminary modeling of some sample facilities that would be covered by those rules
indicates that well-controlled facilities
should meet the new SO 2 NAAQS. However, there are some exceptions. These exceptions include unique sources with specific source characteristics that contribute to higher ambient impacts (short stack heights, complex terrain, etc. ).

Again as described in section III, in order for States to conduct modeling on a large scale for the new 1-hour NAAQS, EPA expects additional guidance would be needed to clarify how to conduct dispersion modeling under Appendix W to support the implementation of the
new 1-hour SO 2 NAAQS, and how to identify and appropriately assess the air quality impacts of sources that potentially may cause or contribute to violations of the NAAQS. Our anticipated modeling guidance will provide for refined modeling that will
better reflect and account for sourcespecific impacts by following our

current Guideline on Air Quality Models, Appendix W to 40 CFR Part 51, with appropriate flexibility for use in implementation. EPA intends to solicit public comment on this modeling guidance. We expect it will take some time for EPA to issue this guidance, and believe that given the timing and substantial burden of having to model several hundred sources, it would not be realistic or appropriate to expect States to complete such modeling and incorporate the results in designation
recommendations for the new 1-hour

SO 2 NAAQS that, under CAA section


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35 See SO 2 Guideline Document, Office of Air Quality Planning and Standards, Research Triangle Park, NC 27711, EPA–452/R–94–008, February

1994. 107(d), are due to EPA within 1 year of the promulgation of the NAAQS.

Consequently, we expect that in most instances, Governors will submit designation recommendations of

‘‘ unclassifiable ’’ rather than conduct large-scale refined modeling of sources in advance of receiving our anticipated guidance. The absence of monitoring data showing violations for most areas, combined with the paucity of refined modeling of sources that have the potential to cause or contribute to violations of the NAAQS, will likely
result in informational records that are insufficient to support initial designations of either ‘‘ attainment ’’ or

‘‘ nonattainment. ’’ Under the Clean Air Act, in such a situation EPA is required to issue a designation for the area as

‘‘ unclassifiable. ’’ However, we do not expect this result to delay expeditious
attainment and maintenance of the new NAAQS, or to cause inappropriate, indefinite uncertainty regarding
whether or not sources cause or contribute to NAAQS violations.

As described more fully in section III above and in section VI below, EPA’s expected implementation approach would rely on the CAA section 110(a)(1) SIP obligation to ensure that all areas of the country attain and maintain the NAAQS on a timely basis even if they are designated ‘‘ unclassifiable ’’ initially.
This SIP is due under CAA section 110(a)(1) within 3 years after promulgation of the new NAAQS, and does not depend upon EPA designating

an area ‘‘ nonattainment ’’ based on recently monitored or modeled SO 2 levels. This period of time would allow States to use EPA’s anticipated guidance on modeling for the new 1-hour SO 2 NAAQS, as well as account for SO 2 reduction levels at individual sources that are anticipated to result from promulgated national and regional rules
to show attainment.

Once areas have both appropriate monitoring data (if required) and modeling data as appropriate, consistent with the new guidance, showing no
violations of the SO 2 NAAQS, and have met other applicable requirements of CAA section 107(d)(3), the Agency would consider re-designating them
from ‘‘ unclassifiable ’’ or ‘‘ nonattainment ’’

to ‘‘ attainment ’’ under CAA section 107(d)(3).

VI. Clean Air Act Implementation Requirements

This section of the preamble discusses the CAA requirements that States and
emissions sources would need to address when implementing the new 1-
hour SO 2 NAAQS based on the structure outlined in the CAA and existing rules. The EPA believes that existing guidance documents and regulations will be useful in helping States and sources to implement the new SO 2 NAAQS, but we also expect to develop additionalguidance on modeling for the new onehour standard and on developing SIPs under Section 110(a)(1) of the CAA. 35 In light of the new approach that EPA intends to take with respect to implementation of the SO 2 NAAQS, EPA intends to solicit public comment on guidance regarding modeling, and also solicit public comment on additional implementation planning guidance, including the content of the maintenance plans required under section 110(a)(1) of the Clean Air Act. EPA also notes that State monitoring plans and the SIP submissions that States will make will also be subject to public notice and comment. ’’

In this section, we also further discuss how EPA’s modified expected approaches toward monitoring and modeling and toward initial designations under the new SO 2 NAAQS (compared to how the proposed rule discussed addressing these issues) are anticipated to affect the types of SIP submissions States will need to provide to EPA and the timing of EPA’s actions on those submissions leading up to
attainment and maintenance of the new

SO 2 NAAQS. In section IV above, we
discuss the final amendments to the ambient monitoring and reporting requirements, and explain how in response to comments received on the proposal and after revisiting our historical practice in assessing compliance with prior SO 2 NAAQS, we have revised both the scope of the revised monitoring network and our expectations on how monitoring will be used in conjunction with modeling in assessing compliance and designating areas. In section V above, we discuss how we have revised our expected approach for issuing designations for
the new 1-hour SO 2 NAAQS, and similarly explain how, in response to comments and after reviewing our historical approach, we have modified our expectations as discussed in the proposal for how and when monitoring and modeling will be used for designations. In this section VI, we
describe in more detail how and when we expect States to demonstrate attainment, implementation,
maintenance and enforcement of the
new one-hour SO 2 NAAQS. The CAA assigns important roles to EPA, States and Tribal governments to achieve the NAAQS. States have the primary responsibility for developing and implementing State implementation plans (SIPs) that contain State measures necessary to achieve the air quality
standards in each area once EPA has established the NAAQS. EPA provides assistance to States and Tribes by providing technical tools, assistance, and guidance, including information on the potential control measures that may assist in helping areas attain the
standards.

Under section 110 of the CAA, 42 U.S.C. 7410, and related provisions, States are directed to submit, for EPA approval, SIPs that provide for the attainment, implementation, maintenance, and enforcement of such standards through control programs
directed at sources of SO 2 emissions.

See CAA sections 110(a), and 191–192, 42 U.S.C. 7410(a) and 7514–7514a. If a State fails to adopt and implement the required SIPs by the time periods provided in the CAA, EPA has the responsibility under the CAA to adopt a Federal implementation plan (FIP) to ensure that areas attain the NAAQS in an expeditious manner. The States, in conjunction with EPA, also administer the prevention of significant deterioration (PSD) program for SO 2

. See sections 160–169 of the CAA, 42 U.S.C. 7470–7479. In addition, Federal programs provide for nationwide
reductions in emissions of SO 2 and other air pollutants under Title II of the Act, 42 U.S.C. 7521–7574. These programs involve limits on the sulfur content of the fuel used by automobiles, trucks, buses, motorcycles, non-road engines and equipment, marine vessels
and locomotives. Emissions reductions
for SO 2 are also obtained from implementation of the new source performance standards (NSPS) for stationary sources under sections 111 and 129 of the CAA, 42 U.S.C. 7411 and 7429; and the national emission standards for hazardous air pollutants (NESHAP) for stationary sources under section 112 of the CAA, 42 U.S.C. 7412 (such reductions resulting due to control of hazardous air pollutants (HAP) such as hydrogen chloride (HCl) under those rules). Title IV of the CAA, sections 402–416, 42 U.S.C. 7651a– 7651o, specifically provides for major
reductions in SO 2 emissions. EPA has also promulgated the Clean Air Interstate Rule (CAIR) to define
additional SO 2 emission reductions
needed in the Eastern United States to eliminate significant contribution of upwind States to downwind States’


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nonattainment, or inability to maintain,
the PM 2.5 NAAQS pursuant to CAA section 110(a)(2)(D), 42 U.S.C. 7410(a)(2)(D), a rule which EPA is reevaluating pursuant to court remand.

A. How This Rule Applies to Tribes

CAA section 301(d) authorizes EPA to treat eligible Indian Tribes in the same
manner as States under the CAA and requires EPA to promulgate regulations specifying the provisions of the statute for which such treatment is appropriate. EPA has promulgated these regulations—known as the Tribal Authority Rule or TAR—at 40 CFR Part

49. See 63 FR 7254 (February 12, 1998). The TAR establishes the process for
Indian Tribes to seek treatment-as-aState eligibility and sets forth the CAA
functions for which such treatment will be available. Under the TAR, eligible Tribes may seek approval for all CAA and regulatory purposes other than a
small number of functions enumerated at section 49.4. Implementation plans
under section 110 are included within the scope of CAA functions for which eligible Tribes may obtain approval. Section 110(o) also specifically describes Tribal roles in submitting implementation plans. Eligible Indian Tribes may thus submit implementation plans covering their reservations and other areas under their jurisdiction.

The CAA and TAR do not, however, direct Tribes to apply for treatment as a State or implement any CAA program. In promulgating the TAR EPA explicitly determined that it was not appropriate to treat Tribes similarly to States for purposes of, among other things, specific plan submittal andimplementation deadlines for NAAQSrelated requirements. 40 CFR 49.4(a). In addition, where Tribes do seek approval of CAA programs, including section 110 implementation plans, the TAR provides flexibility and allows them to submit partial program elements, so long as such elements are reasonably
severable— i.e., ‘‘ not integrally related to program elements that are not included in the plan submittal, and are consistent with applicable statutory and regulatory requirements. ’’ 40 CFR 49.7.

To date, very few Tribes have sought treatment as a State for purposes of section 110 implementation plans. However, some Tribes may be interested in pursuing such plans to implement today’s proposed standard, once it is promulgated.

1. Approach Described in the Proposal

In the proposed rule preamble, EPA
described the various roles and requirements States would address in implementing the proposed NAAQS. Such references to States generally included eligible Indian Tribes to the extent consistent with the flexibility provided to Tribes under the TAR.
Where Tribes do not seek treatment as a State for section 110 implementation plans, we explained that EPA under its discretionary authority will promulgate

FIPs as ‘‘ necessary or appropriate to protect air quality. ’’ 40 CFR 49.11(a). EPA also noted that some Tribes operate air quality monitoring networks in their areas. We explained that for such
monitors to be used to measure attainment with the proposed revised primary NAAQS for SO 2 , the criteria and procedures identified in the proposed rule would apply.

2. Current Approach

EPA did not receive any comments on this issue. However, as discussed elsewhere in this preamble, the final rule reflects in several respects modified expected approaches regarding the use of monitoring and modeling, the manner in which we expect to issue designations under the new SO 2 NAAQS, and the types of SIP submissions we expect would be needed to show attainment, implementation, maintenance and enforcement of the new NAAQS. Those changes in expected approach would, as appropriate, also apply to how we address data and any other submissions from Tribes for purposes of the new SO 2 NAAQS.

B. Nonattainment Area Attainment

Dates

The latest date by which an area designated as nonattainment is required
to attain the SO 2 NAAQS is determined
from the effective date of the nonattainment designation for the affected area. For areas designated
nonattainment for the revised SO 2 NAAQS, SIPs must provide for attainment of the NAAQS as expeditiously as practicable, but no later than 5 years from the effective date of the nonattainment designation for the

area. See section 192(a) of the CAA, 42 U.S.C. 7651a(a). The EPA expects to
determine whether an area has
demonstrated attainment of the new SO 2 NAAQS by evaluating air quality monitoring and modeling data consistent with 40 CFR part 50, Appendix T and 40 CFR part 51, Appendix W. ( Note that this differs from how we explained we would expect to
make such determinations in the proposed rule, where we only mentioned monitoring as supplying the data we would evaluate. This expanded and changed discussion reflects the contemplated changes in our overall approaches to using monitoring and modeling, expectations for issuing designations, and expectations for reviewing SIP submissions showing attainment, implementation, maintenance, and enforcement of the

new SO 2 NAAQS.)

1. Attaining the NAAQS

a. Approach Described in the Proposal

In the proposal preamble, we set forth the basic five conditions provided under section 107(d)(3)(E) of the CAA, 42 U.S.C. 7407(d)(3)(E) that a
nonattainment area must meet in order to be redesignated as attainment:

• EPA must have determined that the
area has met the SO 2 NAAQS;

• EPA has fully approved the State’s implementation plan;

• The improvement in air quality in the affected area is due to permanent
and enforceable reductions in emissions;

• EPA has fully approved a maintenance plan for the area; and

• The State(s) containing the area have met all applicable requirements under section 110 and part D.

b. Current Approach

EPA did not receive any comments on this aspect of the preamble of the proposal. However, in light of the fact that in the final rule, in response to
other comments and consistent with historic practice, we are revising our proposed anticipated approaches to the overall use of monitoring and modeling and our expected approaches to issuing initial designations and reviewing SIP submissions, it follows that the way in
which a nonattainment area seeks redesignation as an attainment area would also be affected by the final rule’s overall changed approaches. For example, for EPA to determine that a
nonattainment area has met the SO 2 NAAQS, we anticipate that the area would need to not only provide any monitoring data showing such compliance (and there would need to be an absence of monitoring data showing otherwise), but modeling where appropriate, consistent with modeling guidance that we plan to issue, would
also need to show that the area is attaining and maintaining the NAAQS.

2. Consequences of a Nonattainment Area Failing To Attain by the Statutory

Attainment Date
a. Approach Described in the Proposal

We explained in the proposal that any

SO 2 nonattainment area that fails to attain by its statutory attainment date would be subject to the requirements of sections 179(c) and (d) of the CAA, 42


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U.S.C. 7509(c) and (d). EPA is required to make a finding of failure to attain no later than 6 months after the specified attainment date and publish a notice in
the Federal Register . The State would then need to submit an implementation plan revision no later than one year following the effective date of the Federal Register notice making the
determination of the area’s failure to
attain. This submission must
demonstrate that the standard will be attained as expeditiously as practicable, but no later than 5 years from the effective date of EPA’s finding that the area failed to attain. In addition, section 179(d)(2) provides that the SIP revision must include any specific additional measures as may be reasonably prescribed by EPA, including ‘‘ all measures that can be feasibly implemented in the area in light of technological achievability, costs, andany nonair quality and other air qualityrelated health and environmental impacts. ’’

b. Current Approach

EPA did not receive any comments on this aspect of the discussion in the preamble to the proposal. However, due to the changes in the final rule’s discussion of the overall expected approaches to monitoring and modeling, designations and EPA review of SIP submissions, it follows that the implementation of CAA sections 179(c) and (d) would also be affected by those changes. For example, under the anticipated approach, a nonattainment
area’s initial demonstration of attainment would need to show through modeling consistent with modeling guidance that we plan to issue, that the
area attains and maintains the new SO 2 NAAQS. If the area fails to attain on time, any remedial implementation plan submission would also need to show, where appropriate, through modeling consistent with modeling guidance that we plan to issue, that the area attains
and maintains the new SO 2 NAAQS.

C. Section 110(a)(1) and (2) NAAQS Maintenance/Infrastructure Requirements

We are significantly revising our expected approaches to the use of monitoring and modeling, expected issuance of initial designations, and
EPA review of SIP submissions. This change in anticipated approach has particular relevance for how States would meet their statutory obligations under CAA section 110(a) to implement,
maintain and enforce the new SO 2 NAAQS. In short, under such an approach, all areas, whether designated as attainment, nonattainment, or unclassifiable, would need to submit SIPs under CAA section 110(a) that show that they are attaining and maintaining the 1-hour SO 2 NAAQS as expeditiously as practicable through permanent and enforceable measures. In other words, the duty to show
maintenance of the SO 2 NAAQS would not be limited to areas that are initially designated as nonattainment, but instead would apply regardless of designation. As has been expected historically, areas initially designated
attainment for SO 2 are expected to
submit to EPA the infrastructure elements of the 110(a) SIP, including the PSD program. Historically, EPA has
determined this to be sufficient to
demonstrate maintenance absent other available information to suggest the area would have difficulty maintaining the NAAQS.

As required by CAA section 192,
nonattainment areas must demonstrate attainment as expeditiously as practicable, and no later than 5 years after designation (which would be August 2017). Under a hybrid approach
as we have discussed earlier in sections III, IV, and V of this preamble, EPA believes that August 2017 would be the latest point that could be as expeditiously as practicable for
attainment and unclassifiable areas as well, and EPA anticipates establishing this date through future rulemaking
actions on individual SIPs.

As noted in earlier sections of this preamble, in the SO 2 NAAQS proposal, we recommended a monitoring-focused approach for comparison to the NAAQS. We received public comments that contended our proposed monitoring
network was too small and insufficient
to assess the hundreds of areas that might violate the new SO 2 NAAQS and yet too burdensome and expensive to expand to an adequate scale. Some commenters, especially State air agencies, recommended the use of modeling either to determine potential nonattainment areas or to identify areas subject to monitoring requirements.

Because SO 2 is primarily a localized pollutant, modeling is the the most appropriate tool to accurately predict

SO 2 impacts from large sources, EPA has used it in the past to determine SO 2 attainment status, and it can be performed more quickly and less costly than monitoring. Consequently, as part of developing a balanced response to the
numerous comments we received on modeling and monitoring, we expect to use a hybrid analytic approach that combines the use of monitoring and modeling to assess compliance with respect to the new SO 2 NAAQS. A hybrid analytic approach for assessing compliance with the new SO 2 NAAQS would make the most appropriate use of available tools and be
more consistent with our historical approach than was what we originally proposed. For a short-term 1-hour standard, it is more accurate and efficient to use modeling to assess medium to larger sources and to rely on monitoring for groups of smaller sources
and sources not as conducive to modeling.

We expect that States would initially focus performance of attainment demonstration modeling on larger sources ( e.g., those ≥ 100 tons per year (tpy) of SO 2 ), and that States would also identify and eventually conduct refined modeling of any other sources that may be anticipated to cause or contribute to a violation to determine compliance
with the new SO 2 NAAQS. As discussed in Section III, EPA anticipates providing additional guidance to States to clarify how to conduct dispersion modeling under Appendix W to support the implementation of the new 1-hour SO 2 NAAQS. Prior to issuing this guidance, EPA intends to solicit public comment.

Since determining compliance with
the SO 2 NAAQS will likely be a uniquely source-driven analysis, EPA explored options to ensure that the SO 2 designations process realistically accounts for anticipated SO 2 reductions at those sources that we expect will be achieved by current and pending national and regional rules. To ensure that all areas of the country attain the NAAQS on a timely basis, while accommodating modeling that is both informed by anticipated modeling guidance and accounts for those anticipated SO 2 reductions, EPA’s intention is to emphasize the CAA section 110(a)(1) requirement that all
States submit a SIP that shows implementation, maintenance and enforcement of the NAAQS. This SIP
would be due under CAA section 110(a)(1) within 3 years after promulgation of the new NAAQS, and would not depend upon EPA designating an area nonattainment based on recently monitored or modeled

SO 2 levels. In addition, like an attainment SIP required for a designated
nonattainment area under CAA section 192, to show attainment this SIP can
account for controlled SO 2 levels at
individual sources that will be achieved
after submission of the SIP but before
the demonstrated attainment date. EPA intends to implement this approach in a way that ensures expeditious attainment of the NAAQS, under a schedule that we explain more fully
below.


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36 In the proposed rule preamble, we explained that two elements identified in section 110(a)(2) were not listed in our summary because, as EPA interprets the CAA, SIPs incorporating any necessary local nonattainment area controls would not be due within 3 years, but rather are generally due at the time the nonattainment area planning requirements are due. See 74 FR 64860 at n. 39. These elements are: (1) Emission limits and other control measures, section 110(a)(2)(A), and (2) Provisions for meeting part D, section 110(a)(2)(I), which requires areas designated as nonattainment to meet the applicable nonattainment planning requirements of part D, title I of the CAA. To implement our revised intended approach in the final rule, however, it would be necessary for States to include, if relied upon to show attainment and
maintenance of the new SO 2 NAAQS, any necessary
emission limits and other control measures under section 110(a)(2)(A). 1. Section 110(a)(1)–(2) Submission

a. Approach Described in the Proposal

In the preamble to the proposal, we explained that section 110(a)(2) of the CAA directs all States to develop and maintain a solid air quality management infrastructure, including enforceable emission limitations, an ambient monitoring program, an enforcement program, air quality modeling capabilities, and adequate personnel, resources, and legal authority. Section 110(a)(2)(D) also requires State plans to prohibit emissions from within the State which contribute significantly to

nonattainment or maintenance areas in any other State, or which interfere with programs under part C of the CAA to prevent significant deterioration of air quality or to achieve reasonable progress toward the national visibility goal for Federal class I areas (national parks and wilderness areas).

Under sections 110(a)(1) and (2) of the CAA, all States are directed to submit
SIPs to EPA which demonstrate that basic program elements have been addressed within 3 years of the promulgation of any new or revised NAAQS. Subsections (A) through (M) of section 110(a)(2) set forth the elements that a State’s program must contain in
the SIP. 36 The proposed rule listed section 110(a)(2) NAAQS implementation requirements as the following:

• Ambient air quality monitoring/ data system: Section 110(a)(2)(B) requires SIPs to provide for setting up and operating ambient air quality monitors, collecting and analyzing data and making these data available to EPA upon request.

• Program for enforcement of control

measures: Section 110(a)(2)(C) requires SIPs to include a program providing for
enforcement of SIP measures and the regulation and permitting of new/
modified sources.

• Interstate transport: Section 110(a)(2)(D) requires SIPs to include provisions prohibiting any source or other type of emissions activity in the State from contributing significantly to nonattainment or interfering with maintenance of the NAAQS in another State, or from interfering with measures required to prevent significant deterioration of air quality or to protect visibility.

• Adequate resources: Section 110(a)(2)(E) directs States to provide assurances of adequate funding, personnel and legal authority to implement their SIPs.

• Stationary source monitoring system: Section 110(a)(2)(F) directs States to establish a system to monitor emissions from stationary sources and to submit periodic emissions reports to

EPA.

• Emergency power: Section 110(a)(2)(G) directs States to include contingency plans, and adequate authority to implement them, for emergency episodes in their SIPs.

• Provisions for SIP revision due to NAAQS changes or findings of inadequacies: Section 110(a)(2)(H) directs States to provide for revisions of their SIPs in response to changes in the NAAQS, availability of improved methods for attaining the NAAQS, or in response to an EPA finding that the SIP is inadequate.

• Consultation with local and Federal government officials: Section 110(a)(2)(J) directs States to meet applicable local and Federal government consultation requirements when developing SIPs and reviewing preconstruction permits.

• Public notification of NAAQS
exceedances: Section 110(a)(2)(J) directs States to adopt measures to notify the public of instances or areas in which a NAAQS is exceeded.

• PSD and visibility protection: Section 110(a)(2)(J) also directs States to adopt emissions imitations, and such other measures, as may be necessary to prevent significant deterioration of air quality in attainment areas and protect visibility in Federal Class I areas in accordance with the requirements of CAA Title I, part C.

• Air quality modeling/data: Section 110(a)(2)(K) requires that SIPs provide for performing air quality modeling for predicting effects on air quality of emissions of any NAAQS pollutant and submission of data to EPA upon request.

• Permitting fees: Section 110(a)(2)(L) requires the SIP to include requirements for each major stationary source to pay permitting fees to cover the cost of reviewing, approving, implementing and enforcing a permit.

• Consultation/participation by affected local government: Section 110(a)(2)(M) directs States to provide for consultation and participation by local political subdivisions affected by the

SIP.

b. Final

EPA did not receive any comments on this aspect of the approached explained in the proposal preamble. However, in light of the modified approach discussed above, EPA is providing additional guidance concerning the CAA section 110(a)(1) maintenance plan requirement as a part of this discussion
so that States will have sufficient information to meet this requirement with a SIP submittal three years after promulgation of the NAAQS. Section 110(a)(1) of the CAA states that each State, after reasonable notice and public hearing, is required to adopt and to submit to EPA, within 3 years after promulgation of any new or revised NAAQS for any pollutant, a SIP which provides for the implementation, maintenance, and enforcement of any new or revised NAAQS in each area of the State. As stated previously, in light of the new approach that EPA intends to take with respect to implementation
of the SO 2 NAAQS, EPA intends to solicit public comment on guidance regarding modeling, and also solicit public comment on additional implementation planning guidance, including the content of the maintenance plans required under section 110(a)(1) of the Clean Air Act.

EPA expects that most areas of the country would be designated as unclassifiable for the 1-hour NAAQS for

SO 2 , due to a lack of both monitoring and modeling information concerning the attainment status of areas, in advance of States conducting further refined modeling according to our anticipated guidance. For areas that are designated unclassifiable, States are required to submit section 110(a)(1) plans to demonstrate implementation,
maintenance and enforcement of the

new SO 2 NAAQS. As previously explained in section III of the preamble, in order to meet the requirements of section 110(a)(1) and to ensure timely attainment of the NAAQS on a schedule that is as expeditious as would be required if an area had been designated nonattainment, EPA’s current expectation is that States would submit SIPs which provide for attainment, implementation, maintenance, and
enforcement of the 1-hour SO 2 NAAQS in all areas as expeditiously as practicable, which EPA believes in these cases would be no later than 5 years
from the effective date of the area’s designation. The section 110(a)(1) maintenance plan would also need to contain the following elements: (1) An


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attainment emissions inventory, (2) a control strategy, as appropriate, (3) a maintenance demonstration, using an EPA approved air quality model as appropriate, (4) a contingency plan, and (5) a plan for verification of continued
attainment of the standard. Attainment areas that appear to have difficulty maintaining attainment may also have
to submit some of these elements. These elements are now explained in detail.

(1) Attainment Emissions Inventory

The State should develop an accurate attainment emissions inventory to identify the level of emissions in the
area which is sufficient to attain the 1-
hour SO 2 NAAQS. This inventory
should be consistent with EPA’s most recent guidance on emissions inventories currently available, and
should include the emissions for the time period associated with the modeling and monitoring data showing attainment. Major source size thresholds
for SO 2 are currently listed as 100 ton/yr, however, in cases where sources, individually, or collectively, that are below this level may potentially cause
or contribute to a violation of the standard, these sources should also be included in the emissions inventory for the affected area. EPA notes that, unlike any monitoring or modeling data used in the initial designations context,
which would be limited to current emissions levels, this estimate under a hybrid approach we expect to use for
the new SO 2 NAAQS would be able to rely on modeled controlled emissions levels at sources achieved by enforceable national, regional or local rules that will be in place within the timeframe for demonstrating attainment.
This is because demonstrations of
attainment and maintenance of a NAAQS, unlike designations, are necessarily projections regarding future and continuing levels of ambient air pollution concentrations given that the statutory deadlines for their submission are in advance of the required
achievement of attainment and

maintenance. See, e.g., CAA sections 191(a) and 192(a).

(2) Maintenance Demonstration

The key element of a section 110(a)(1) maintenance plan is a demonstration using, as appropriate, refined SO 2 dispersion modeling ( see Appendix W to 40 CFR Part 51) which provides an
indication of how the area will attain
and maintain the 1-hour SO 2 NAAQS as expeditiously as practicable, which EPA believes would be within the 5 year period following the designation of the

area. For SO 2 the State may generally
demonstrate maintenance of the NAAQS by using refined dispersion modeling to show that the future mix of
sources and emission rates in an area
will not cause a violation of the 1-hour

SO 2 NAAQS. As a result of applying the control strategy, EPA anticipates that additional guidance for States may be needed to clarify how to conduct dispersion modeling under Appendix W to support the implementation of the
new 1-hour SO 2 NAAQS.

As explained above in IV.B, EPA
believes that for SO 2 attainment and maintenance demonstrations, monitoring data alone is generally not adequate to characterize fully short-term ambient concentrations around major stationary sources of SO 2, and as a result may not capture the maximum SO 2 impacts. With representative and appropriate meteorological and other input data, refined dispersion models are able to characterize air quality impacts from the modeled sources
across the domain of interest on an hourly basis with a high degree of spatial resolution, overcoming the limitations of an approach based solely on monitoring. By simulating plume dispersion on an hourly basis across a grid of receptor locations, dispersion
models are able to estimate the detailed spatial gradients of ambient concentrations resulting from SO 2 emission sources across a full range of meteorological and source operating conditions. To capture such results on a monitor would normally require a prohibitively expansive air quality monitoring network. Further, as we have observed in prior actions ( see., e.g., 43 FR 45993, 45997, 46000–03 (Oct. 5, 1978)), monitoring data would not be adequate to demonstrate attainment if sources are using stacks with heights that are greater than good engineering practice (GEP), or other prohibited dispersion techniques, as section 123 prohibits credit in an attainment demonstration for any such practices.

Refined dispersion modeling for the section 110(a)(1) maintenance plan is expected to follow EPA’s Guideline on Air Quality Models, Appendix W to 40 CFR Part 51, which provides recommendations on modeling techniques and guidance for estimating pollutant concentrations in order to assess control strategies and determine
emission limits. These recommendations were originally published in April 1978 and were incorporated by reference in the PSD regulations, 40 CFR sections 51.166 and 52.21 in June 1978 (43 FR 26382– 26388). The purpose of Appendix W is to promote consistency in the use of modeling within the air quality management process. Appendix W is periodically revised to ensure that new model developments or expanded regulatory requirements are incorporated. The most recent revision to Appendix W was published on November 9, 2005 (70 FR 68218), wherein EPA adopted AERMOD as the preferred dispersion model for a wide range of regulatory applications in all types of terrain. To support the promulgation of AERMOD as the preferred model, EPA evaluated the performance of the model across a total of 17 field study data bases (Perry, et al., 2005; EPA, 2003), including several
field studies based on model-to-monitor comparisons of SO 2 concentrations from operating power plants. AERMOD is a steady-state plume dispersion model that employs hourly sequential preprocessed meteorological data to simulate transport and dispersion from multiple point, area, or volume sources for averaging times from one hour to multiple years, based on an advanced characterization of the atmospheric boundary layer. AERMOD also accounts for building wake effects ( i.e., downwash) on plume dispersion.

As stated previously, EPA anticipates that additional guidance for States, Tribal, and local governments is needed to clarify how to conduct refined dispersion modeling under Appendix W to support the implementation of the
new 1-hour SO 2 NAAQS. EPA intends to solicit public comment on guidance regarding modeling. Although AERMOD is identified as the preferred model under Appendix W for a wide range of applications and will be appropriate for most modeling applications to support
the new SO 2 NAAQS, Appendix W allows flexibility to consider the use of alternative models on a case-by-case basis when an adequate demonstration
can be made that the alternative model performs better than, or is more appropriate than, the preferred model for a particular application.

(3) Control Strategy

The EPA believes that in order to meet the implementation, maintenance and enforcement plan requirements of section 110(a)(1) for the new SO 2 NAAQS, States should consider all
control measures that are reasonable to implement in light of the attainment
and maintenance needs for the affected area(s). The EPA believes that where additional controls are necessary it would be appropriate for the level of
controls in these areas to be similar to that required in areas that are designated as nonattainment for SO 2

. These controls would provide for the
attainment and maintenance of the SO 2 1-hour standard as expeditiously as


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practicable. EPA believes that expeditious attainment in these areas will be within 5 years of the effective date of designation of an area. This approach would allow States to take
into consideration emission reductions that we expect to be achieved from the implementation of future controls from
national control measures as well as regional and local control measures that will be in place by the anticipated attainment date and are projected to help achieve attainment and
maintenance of the standard. It would also reduce the risk of such areas failing to meet the NAAQS as expeditiously as

nonattainment areas must meet it.

(4) Contingency Plan

The contingency plan is considered to be an enforceable part of the section 110(a)(1) plan and should ensure that there are appropriate contingency measures which can be implemented as expeditiously as practicable once they are triggered. The contingency plan should clearly identify the measures to be adopted, provide a schedule and procedures for adoption and implementation, and provide a specific time limit for actions by the State.

The EPA believes that in this case the contingency measures implemented under the contingency plan requirement for the section 110(a)(1) plan in
unclassifiable areas under a revised approach for SO 2 should closely resemble the contingency measures required under section 172(c)(9) of the CAA. Section 172(c)(9) of the CAA defines contingency measures as
measures in the SIP which are to be implemented in the event that an area fails to attain the NAAQS, or fails to meet the reasonable further progress (RFP) requirement, by the applicable
attainment date for the area. Contingency measures become effective without further action by the State or EPA, upon determination by EPA that the area (1) failed to attain the NAAQS by the applicable attainment date, or (2) fail to meet RFP. These contingency
measures should consist of other
available control measures that are not included in the control strategy for the

SIP.

The EPA interprets the contingency measure provision as primarily directed at general control programs which can
be undertaken on an area-wide basis.

Since SO 2 control measures are based on what is directly and quantifiably necessary to attain the SO 2 NAAQS, it would be unlikely for an area to implement the necessary emissions control yet fail to attain the NAAQS. Therefore, for SO 2 programs, EPA believes that State agencies should have a comprehensive program to identify
sources of violations of the SO 2 NAAQS and undertake an aggressive follow-up for compliance and enforcement, including expedited procedures for establishing enforceable consent agreements pending the adoption of
revised SIPs.

Such an approach toward minimum contingency measures for SO 2 would not preclude a State from requiring additional contingency measures that are enforceable and appropriate for a particular source or source category. A contingency measure for an SO 2 SIP might be a consent agreement between
the State and EPA to reduce emissions
from a source further in the event that the contingency measures are triggered. Alternatively, a source might adopt a contingency measure such as switching to low sulfur coal or reducing load until more permanent measures can be put into place to correct the problem. In either case, the contingency measure should be a fully adopted provision in
the SIP in order for it to become
effective at the time that EPA
determines that the area either fails to attain the NAAQS or fails to meet RFP.

As a necessary part of the section 110(a)(1) plan, the State should also identify specific indicators, or triggers,
which will be used to determine when the contingency measures need to be implemented. The identification of triggers would allow a State an opportunity to take early action to address potential violations of the NAAQS before they occur. By taking early action, States may be able to prevent any actual violations of the NAAQS, and therefore, reduce the need on the part of EPA to start the process to re-designate the areas as nonattainment. An example of a trigger
would be monitored or modeled violations of the NAAQS. The EPA will review what constitutes an approvable contingency plan on a case-by-case
basis.

(5) Verification of Continued

Attainment

The submittal should provide an
indication of how the State will track the progress of the section 110(a)(1) plan. This is necessary due to the fact that the emissions projections made for
the attainment and maintenance demonstrations depend on assumptions of point, area, and mobile source growth. One option for tracking the progress of the attainment and maintenance demonstrations, provided here as an example, would be for the State to update periodically the emissions inventory. The attainment
and maintenance demonstration should project maintenance during the five year period following the designations for
the 1-hour SO 2 NAAQS, not simply that
the area will be in attainment in the fifth

year.

States should develop interim emission projection years to show a trend analysis for attainment and
maintenance of the standard. These emission projections can also be used as triggers for implementing contingency measures. The EPA recognizes that it would be difficult and time consuming to develop projections for each year of the 5 year period. Therefore, the number of interim projection years should
reflect whatever information exists regarding the potential for increases in emissions in the intervening years. For instance, if there is a high probability
that emissions will increase to such an extent as to jeopardize continued
maintenance of the standard even temporarily over the intervening years, the number of interim projection periods should be sufficient to
document that such increases will not
interfere with maintenance of the 1-hour

SO 2 NAAQS.

When modeling for the attainment and maintenance demonstrations, one option for tracking progress would also
be for the State to reevaluate periodically the modeling assumptions and data input. Such reevaluation, for example, could address any delays in source compliance with national, regional or local rules for which the State had previously modeled timely

SO 2 reductions. In any event, the State
should monitor the indicators for triggering the contingency measures on a regular basis.

EPA recognizes that the approach
discussed above for SO 2 SIPs submitted under CAA section 110(a)(1)–(2) is significantly different from the one outlined in the proposal, and from what we have applied in the context of other criteria pollutants. However, EPA anticipates using a revised approach under section 110(a)(1)–(2) as part of an overall revised hybrid monitoring and modeling approach in response tocomments on the proposed monitoringfocused approach to implementation of
the new SO 2 NAAQS. We believe that such an approach would best account for the unique source-specific and localized impacts inherent to SO 2 , and would be the most reasonable way to
ensure that all areas of the United States timely attain and maintain the new NAAQS, while at the same time avoiding inappropriately requiring immediate refined modeling of all sources without appropriate EPA guidance. This would also allow
attainment demonstrations to account


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for expected substantial SO 2 reductions
that will occur well in advance of the attainment deadline. Of course, for such a unique SO 2 approach to work, it would be imperative for all areas to timely submit, and for EPA to able to approve, adequate attainment, implementation, maintenance and
enforcement SIPs that show attainment as expeditiously as practicable, and no later than 5 years following initial designations. Only by applying such a timeframe to the section 110(a)(1) SIP approach we are adopting for SO 2 could the approach be a reasonable one. To that end, EPA would not intend to approve SIPs that do not meet this schedule, and would take necessary and appropriate actions in response to any
submission that would result in unacceptable delay of attainment. Such actions may include, but are not limited to, any combination of SIP disapproval, redesignation to nonattainment, and promulgation of a Federal implementation plan (FIP). Any future action establishing an attainment deadline will be completed through notice-and-comment rulemaking on
individual SIP submissions.

The timeline below shows how we expect the several steps from promulgation of the new NAAQS through attainment should proceed, whether areas are designated nonattainment or unclassifiable, assuming timely action at each step:

• June 2010: EPA issues new SO 2 NAAQS, which starts periods within
which CAA section 107 initial area designations must occur and CAA section 110(a)(1)–(2) SIPs must be
submitted.

• June 2011: States submit initial area designations recommendations, based on available monitoring data, and on any refined modeling performed in advance of submitting CAA section 110(a)(1)–(2) SIPs.

• June 2012: EPA issues initial area designations. Any monitored or modeled violations would trigger nonattainment designations. (Per below, States designated nonattainment would submit nonattainment SIPs by February 2014, relying on refined modeling that demonstrates attainment by no later than August 2017.) States would be designated attainment if they submit both monitoring and modeling showing adequate evidence of no violations. All other cases would be initially designated as unclassifiable.

• June 2013: States submit CAA section 110(a)(1)–(2) SIPs. SIPs would rely on refined modeling and any required monitoring that demonstrates
attainment and maintenance of the new

SO 2 NAAQS as expeditiously as practicable, and no later than August
2017. For areas within the State designated attainment and unclassifiable, the section 110(a) SIP must contain any additional Federally enforceable control measures necessary
to ensure attainment and maintenance of the NAAQS. (Control measures to be implemented in designated nonattainment areas are due later as part of the nonattainment SIP in February 2014.)

• February 2014: Any initially designated nonattainment areas submit CAA section 191–192 SIPs showing attainment no later than August 2017.

• June 2014: EPA approves or disapproves submitted CAA section 110(a)(1)–(2) SIPs. For attainment and unclassifiable areas, EPA’s action would be based on adequacy of States’ modeling (and any required monitoring) showing attainment as expeditiously as practicable, and no later than August 2017, in partial reliance on SO 2 reductions from national and regional standards that are achieved by the
attainment date. EPA would also have discretion to re-designate areas based on these SIPs, including to nonattainment if SIPs are inadequate, as well as promulgate FIPs.

• February 2015: EPA approves or disapproves CAA section 191–192 attainment SIPs submitted by areas initially designated as nonattainment,
with similar remedies as discussed
above if SIPs are deficient.

• June 2016: CAA section 110(c) deadline by which EPA must issue a FIP for any area whose section 110(a)(1) SIP is disapproved in June 2014.

• February 2017: CAA section 110(c) deadline by which EPA must issue a FIP
for a nonattainment area whose section 192 SIP is disapproved in February

2015.

August 2017: Expected date by which all areas, regardless of classification, achieve attainment, implementation,
maintenance and enforcement of the

new SO 2 NAAQS.

D. Attainment Planning Requirements

1. SO 2 Nonattainment Area SIP Requirements
a. Approach Described in the Proposal

We explained in the preamble to the proposal that any State containing an area designated as nonattainment with respect to the SO 2 NAAQS would need to develop for submission to EPA a SIP meeting the requirements of part D, Title I, of the CAA, providing for attainment by the applicable statutory
attainment date. See sections 191(a) and 192(a) of the CAA. As indicated in section 191(a), all components of the SO 2 part D SIP must be submitted
within 18 months of the effective date of an area’s designation as

nonattainment.

Section 172 of the CAA addresses the general requirements for areas designated as nonattainment. Section 172(c) directs States with nonattainment
areas to submit a SIP which contains an attainment demonstration showing that
the affected area will attain the standard by the applicable statutory attainment
date. The SIP must show that the area will attain the standard as expeditiously as practicable, and must ‘‘ provide for the implementation of all Reasonably Available Control Measures (RACM) as expeditiously as practicable (including
such reductions in emissions from existing sources in the area as may be obtained through the adoption, at a minimum, of Reasonably Available Control Technology (RACT)). ’’

SIPs required under Part D of the CAA must also provide for reasonable further progress (RFP). See section 172(c)(2) of
the CAA. The CAA defines RFP as ‘‘ such
annual incremental reductions in emissions of the relevant air pollution as are required by part D, or may reasonably be required by the Administrator for the purpose of ensuring attainment of the applicable NAAQS by the applicable attainment
date. ’’ See section 171 of the CAA. Historically, for some pollutants, RFP has been met by showing annual
incremental emission reductions sufficient to maintain generally linear progress toward attainment by the applicable attainment date.

All SO 2 nonattainment area SIPs must include contingency measures which must be implemented in the event that
an area fails to meet RFP or fails to attain the standards by its attainment
date. See section 172(c)(9) of the CAA. These contingency measures must be fully adopted rules or control measures that take effect without further action by
the State or the Administrator. The EPA interprets this requirement to mean that the contingency measures must be implemented with only minimal further action by the State or the affected sources with no additional rulemaking actions such as public hearings or legislative review.

Emission inventories are also critical for the efforts of State, local, and Federal agencies to attain and maintain the NAAQS that EPA has established for criteria pollutants including SO 2

. Section 191(a) in conjunction with section 172(c) requires that areas designated as nonattainment for SO 2 submit an emission inventory to EPA no later than 18 months after designation as
nonattainment. In the case of SO 2 ,


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37 The terms ‘‘ major ’’ and ‘‘ minor ’’ define the size of a stationary source, for applicability purposes, in terms of an annual emissions rate (tons per year, tpy) for a pollutant. Generally, a minor source is any source that is not ‘‘ major. ’’ ‘‘ Major ’’ is defined by the applicable regulations—PSD or

nonattainment NSR.

38 In addition, the PSD program applies to noncriteria pollutants subject to regulation under the Act, except those pollutants regulated under section 112 and pollutants subject to regulation only under section 211(o). sections 191(a) and 172(c) also direct States to submit periodic emission
inventories for nonattainment areas. The periodic inventory must include
emissions of SO 2 for point, nonpoint, mobile, and area sources.

b. Current Approach

EPA did not receive any comments on this issue. Thus, EPA has no changes to
make to this discussion.

2. New Source Review and Prevention of Significant Deterioration Requirements
a. Approach Described in the Proposal

We provided a discussion of the new source review and prevention of significant deterioration programs in the preamble to the proposed rule. The Prevention of Significant Deterioration (PSD) and nonattainment New Source Review (NSR) programs contained in parts C and D of Title I of the CAA govern preconstruction review of any new or modified major stationary sources of air pollutants regulated under the CAA as well as any precursors to the formation of that pollutant when identified for regulation by the
Administrator. 37 The EPA rules addressing these programs can be found at 40 CFR 51.165, 51.166, 52.21, 52.24, and Part 51, appendix S.

The PSD program applies when a major source located in an area that is designated as attainment or unclassifiable for any criteria pollutant is constructed or undergoes a major
modification. 38 The nonattainment NSR program applies on a pollutant-specific basis when a major source constructs or modifies in an area that is designated as nonattainment for that pollutant. The minor NSR program addresses major and minor sources that undergo
construction or modification activities that do not qualify as major, and it applies, as necessary to assure attainment, regardless of the designation
of the area in which a source is located.

The PSD requirements include but are not limited to the following:

• Installation of Best Available Control Technology (BACT);

• Air quality monitoring and modeling analyses to ensure that a project’s emissions will not cause or contribute to a violation of any NAAQS or maximum allowable pollutant increase (PSD increment);

• Notification of Federal Land Manager of nearby Class I areas; and public comment on the permit.

To the extent necessary to address these PSD requirements for the new
1-hour SO 2 NAAQS, SIPs are due no later than 3 years after the promulgation date. Generally, however, the owner or operator of any major stationary source or major modification obtaining a final PSD permit on or after the effective date
of the new 1-hour SO 2 NAAQS will be required, as a prerequisite for the PSD permit, to demonstrate that the
emissions increases from the new or
modified source will not cause or
contribute to a violation of that new NAAQS. The EPA anticipates that
individual sources will be able to complete this demonstration under the PSD regulations based on current guidance in EPA’s Guideline on Air Quality Models, Appendix W of 40 CFR

Part 51.

The owner or operator of a new or modified source will still be required to demonstrate compliance with the
annual and 24-hour SO 2 increments, even when their counterpart NAAQS
are revoked. The annual and 24-hour
increments are established in the CAA
and will need to remain in the PSD regulations because EPA does not interpret the CAA to authorize EPA to remove them. It appears necessary for Congress to amend the CAA to make appropriate changes to the statutory SO 2 increments. In 1990, the CAA was
amended to accommodate PM 10 increments in lieu of the statutory TSP

increments.

In association with the requirement to demonstrate compliance with the NAAQS and increments, the owner or operator of a new or modified source must submit for review and approval a source impact analysis and an air quality analysis. The source impact analysis, primarily a modeling analysis,
must demonstrate that allowable emissions increases from the proposed source or modification, in conjunction with emissions from other existing
sources will not cause or contribute to either a NAAQS or increment violation. The air quality analysis must assess the ambient air quality in the area that the proposed source or modification would
affect.

For the air quality analysis, the owner or operator must submit in its permit application air quality monitoring data that shall have been gathered over a period of one year and is representative of air quality in the area of the proposed project. If existing data representative of the area of the proposed project is not available, new data may need to be collected by the owner or operator of the
source or modification. Where data is already available, it might be necessary
to evaluate the location of the monitoring sites from which the SO 2 data were collected in comparison to any new siting requirements associated
with the 1-hour SO 2 NAAQS. If existing sites are inappropriate for providing the necessary representative data, then new monitoring data will need to be collected by the owner or operator of the proposed project.

Historically, EPA has allowed the use of several screening tools to help facilitate the implementation of the new source review program by reducing the permit applicant’s burden, and streamlining the permitting process for
de minimis circumstances. These screening tools include a significant emissions rate (SER), significant impact levels (SILs), and a significant monitoring concentration (SMC). The SER, as defined in tons per year for each regulated pollutant, is used to determine whether any proposed source or
modification will emit sufficient amounts of a particular pollutant to require the review of that pollutant under the NSR permit program. EPA
will consider whether to evaluate the existing SER for SO 2 to see if it would change substantially based on the NAAQS levels for the 1-hour averaging period. Historically, for purposes of defining the SER, we have defined a de minimis pollutant impact as one that results in a modeled ambient impact ofless than approximately 4% of the shortterm NAAQS. The current SER for SO 2 (40 tpy) is based on the impact on the
24-hour SO 2 NAAQS. See 45 FR 52676, 52707 (August 7, 1980). We have typically used the most sensitive averaging period to calculate the SER, and we may want to evaluate the new 1-hour period for SO 2 because it is likely to represent the most sensitive averaging period for SO 2

.

The SIL, expressed as an ambient pollutant concentration (ug/m3), is used to determine whether the impact of a particular pollutant is significant enough to warrant a complete air quality impact analysis for any applicable NAAQS and increments. EPA has promulgated regulations under 40 CFR 51.165(b) which include SILs for SO 2 to determine whether a source’s impact
would be considered to cause or contribute to a NAAQS violation for the 3-hour (the secondary NAAQS), 24-hour or annual averaging periods. These SILs were originally developed in 1978 to limit the application of air quality dispersion models to a downwind


### 35579 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

distance of no more than 50 kilometers

or to ‘‘ insignificant levels. ’’ See 43 FR 26398, June 19, 1978. Through guidance, EPA has also allowed the use
of SILs to determine whether or not it is necessary for a source to carry out a comprehensive source impact analysis
and to determine the extent of the impact area in which the analysis will be carried out. The existing SILs for SO 2 were not developed on the basis of specific SO 2 NAAQS levels, so there may be no need to revise the existing SILs. Even upon revocation of the annual and 24-hour NAAQS, the corresponding SIL should still be useful
for increment assessment. A SIL for the 1-hour averaging period does not exist, and would need to be developed for use with modeling for 1-hour SO 2 NAAQS and any 1-hour increments.

Finally, the SMC, also measured as an ambient pollutant concentration ( μ g/m 3 ), is used to determine whether it may be appropriate to exempt a proposed project from the requirement to collect ambient monitoring data for a particular pollutant as part of a complete permit application. EPA first defined SMCs for regulated pollutants under the PSD program in 1980. See 45 FR 52676, 52709–10 (August 7, 1980). The existing SMC for SO 2 , based on a 24-hour averaging period, may need to
be re-evaluated to consider the effect of basing the SMC on the 1-hour averaging period, especially in light of revocation of the NAAQS for the 24-hour averaging period. Third, even if the 1-hour averaging period does not indicate the
need for a revised SMC for SO 2 , the fact that the original SMC for SO 2 is based on 1980 monitoring data (Lowest Detectable Level, correction factor of

‘‘ 5 ’’ ), could be a basis for revising the existing value. More up-to-date monitoring data and statistical analyses of monitoring accuracy may yield a different—possibly lower—correction factor today. The new 1-hour NAAQS will not necessarily cause this result, but may provide a ‘‘ window of opportunity ’’ to re-evaluate the SMC for

SO 2

.

States which have areas designated as
nonattainment for the SO 2 NAAQS are directed to submit, as a part of the SIP
due 18 months after an area is designated as nonattainment, provisions requiring permits for the construction and operation of new or modified stationary sources anywhere in the nonattainment area. Prior to adoption of the SIP revision addressing major source
nonattainment NSR for SO 2 nonattainment areas, the requirements of 40 CFR part 51, appendix S will apply. Nonattainment NSR requirements include but are not limited

to:

• Installation of Lowest Achievable Emissions Rate (LAER) control technology;

• Offsetting new emissions with creditable emissions reductions;

• A certification that all major sources owned and operated in the State by the same owner are in compliance with all applicable requirements under the CAA;

• An alternatives and siting analysis demonstrating that the benefits of a proposed source significantly outweigh
the environmental and social costs imposed as a result of its location, construction, or modification; and

• Public comment on the permit. Minor NSR programs must meet the statutory requirements in section 110(a)(2)(C) of the CAA which requires

‘‘ * * * regulation of the modification and construction of any stationary source * * * as necessary to assure that the [NAAQS] are achieved. ’’ These programs must be established in each State within 3 years of the promulgation of a new or revised NAAQS.

b. Comments and Responses

Several commenters stated that in order to avoid confusion and lag time as it relates to PSD/NSR and permitting activities, which must be taken by States following the promulgation of the revised NAAQS, EPA must provide guidance as soon as possible related to
these issues. Commenters also stated that EPA must develop guidance as soon as possible to address the screening tools for PSD/NSR such as SILs, SERs, SMCs, and the development of
increments. Several commenters also stated that guidance should be provided
as it relates to the use of AERMOD to
address PSD issues.

The EPA acknowledges that a decision to promulgate a new short-term

SO 2 NAAQS will have implications for the air permitting process. The full
extent of how a new short-term SO 2 NAAQS will affect the NSR process will need to be carefully evaluated. First, major new and modified sources applying for NSR/PSD permits will initially be required to demonstrate that their proposed emissions increases of

SO 2 will not cause or contribute to a violation of any NAAQS or PSD
increments for SO 2 , including the new
1-hour SO 2 NAAQS. In addition, we believe that section 166(c) of the CAA
authorizes EPA to consider the need to promulgate a new 1-hour increment. Historically, EPA has developed increments for each applicable averaging period for which a NAAQS has been promulgated. However, increments for a particular pollutant do not necessarily need to match the averaging periods that have been established for NAAQS for the same pollutant. Environmental Defense Fund,

Inc. v. EPA, 898 F.2d 183, 189–190 (DC Cir. 1990) ( ‘‘ * * * the ‘goals and purposes’ of the PSD program, set forth in § 160, are not identical to the criteria
on which the ambient standards are
based. ’’ ) Thus, we would need to
evaluate the need for a new 1-hour SO 2 increment in association with the goals and purposes of the statutory PSD program requirements.

We agree with the commenters that there may be a need for EPA to provide additional screening tools or to revise existing screening tools that are frequently used under the NSR/PSD program for reducing the burden of completing SO 2 ambient air impact analyses. These screening tools include the SILs, as mentioned by the commenter, but also include the SER for
emissions of SO 2 and the SMC for SO 2

. The existing sceening tools apply to the averaging periods used to define the existing NAAQS for SO 2 , including the annual, 24-hour, and 3-hour averaging periods. EPA intends to evaluate the need for possible changes or additions to each of these useful screening tools
for SO 2 due to the revision of the SO 2 NAAQS to provide for a 1-hour standard. We believe it is highly likely
that in order to be most useful for implementing the new 1-hour averaging period for NSR purposes, new 1-hour screening values will be appropriate.

Finally, in response to the comment concerning the need for additional guidance as it relates to the use of AERMOD to address PSD issues, EPA anticipates providing additional technical guidance on modeling and analysis as a part of the SIP demonstration process. As stated previously, EPA intends to solicit public comment on guidance regarding modeling, and also solicit public comment on additional implementation planning guidance. However, EPA believes that the air quality models currently required for NSR/PSD permitting as provided in the EPA’s Guideline on Air Quality Models, Appendix W of CFR 40 Part 51 would be appropriate for demonstrating compliance with the revised SO 2 NAAQS under these programs. At this time, EPA is not considering modifying the AERMOD dispersion model and its underlying science for predicting SO 2 concentrations to accommodate the revised NAAQS for SO 2.


### 35580 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

39 Criteria pollutants are those pollutants for which EPA has established a NAAQS under section
109 of the CAA.

40 Transportation conformity is required under CAA section 176(c) (42 U.S.C. 7506(c) to ensure that Federally supported highway and transit project activities are consistent with ( ‘‘ conform to ’’ ) the purpose of the SIP. Transportation conformity applies to areas that are designated nonattainment, and those areas redesignated to attainment after 1990 ( ‘‘ maintenance areas ’’ with plans developed under CAA section 175A) for transportation-related criteria pollutants. Due to the relatively small amounts of sulfur in gasoline and on-road diesel fuel, transportation conformity does not apply to
the SO 2 NAAQS. 40 CFR 93.102(b)(1). c. Current Approach

In the preamble to the proposed regulation, EPA noted that ‘‘ PSD permit requirements are effective on the promulgation date of a new or revised
standard. ’’ However, this statement did not reflect an important distinction that
needs to be clarified here. Under section 51.166(b)(49)(i) and 52.21(b)(50)(i) of EPA’s regulations, a pollutant that has not been regulated previously would
become a ‘‘ regulated NSR pollutant ’’ upon promulgation of a NAAQS. See, 75 FR 17004, 17018–19. However, in the case of pollutants that are already

‘‘ regulated NSR pollutants, ’’ at the time a new NAAQS is promulgated or an existing NAAQS is revised, EPA interprets the CAA and EPA regulations to require implementation of the new or
revised standard in the Federal PSD permitting process upon the effective date of any new or revised standards. Section 165(a)(3) of the CAA and section 52.21(k) of EPA’s regulations require that a permit applicant
demonstrate that it will not cause or
contribute to a violation of ‘‘ any ’’ NAAQS. See, Memorandum from Stephen D. Page, Director of EPA Office of Air Quality Planning and Standards,

‘‘ Applicability of the Federal Prevention of Significant Deterioration Permit Requirements to New and Revised National Ambient Air Quality
Standards ’’ (April 1, 2010).

Amendments to the existing PSD requirements set forth in EPA regulations concerning SILs, SERs and SMCs may involve notice and comment rulemaking which could take at least one year to complete. For PM 2.5 , EPA developed SERs under the initial NSR implementation requirements for PM 2.5

. See 73 FR 28321, May 16, 2008. The
SILs and SMC for PM 2.5 are being developed under a subsequent rulemaking simultaneously with the promulgation of PM 2.5 increments, pursuant to a CAA schedule that allows EPA 2 years from the promulgation of new and revised NAAQS to promulgate increments. Under such an approach,
SILs and SMC are not available until the increments are promulgated. States and industry have criticized that approach because it has left State permitting authorities without an EPA-approved de
minimis value that could be used in determining the level of analysis that individual PSD sources must undergo,
and could result in more detailed analyses for sources that will have only have de miminis impacts on the NAAQS.

To address this concern, we believe it is appropriate to proceed with development of the PSD screening tools in advance of an increment rulemaking to hasten their availability. In addition, we are assessing the possibility of developing interim screening tools that can be used by States prior to the completion of the SIP-development process if the States establish an appropriate record for individual permitting actions based on the supporting technical information provided by EPA. It is our expectation, that if such interim screening tools are appropriate, we would make the interim SIL and the supporting record for EPA’s
assessment available before the effective
date of the new 1-hour SO 2 NAAQS to facilitate more efficient PSD permit
reviews once the new standard becomes
effective.

3. General Conformity

a. Approach Described in the Proposal

Section 176(c) of the CAA requires
that all Federal actions conform to an applicable implementation plan developed pursuant to section 110 and part D of the CAA. The EPA rules developed under section 176(c) prescribe the criteria and procedures for demonstrating and assuring conformity
of Federal actions to a SIP. Each Federal agency must determine that any actions covered by the general conformity rule conform to the applicable SIP before the
action is taken. The criteria and procedures for conformity apply only in
nonattainment areas and those nonattainment areas redesignated to attainment since 1990 ( ‘‘ maintenance

areas ’’ ) with respect to the criteria pollutants under the CAA: 39 carbon monoxide (CO), lead (Pb), nitrogen dioxide (NO 2 ), ozone (O3), particulate matter (PM 2.5 and PM 10 ), and sulfur dioxide (SO 2 ). The general conformity rules apply one year following the effective date of designations for any new or revised NAAQS. 40

The general conformity determination examines the impacts of direct and
indirect emissions related to Federal actions. The general conformity rule provides several options to satisfy air quality criteria, such as modeling or offsets, and requires the Federal action to also meet any applicable SIP requirements and emissions milestones. The general conformity rule also requires that notices of draft and final general conformity determinations be provided directly to air quality regulatory agencies and to the public by publication in a local newspaper.

b. Current Approach

EPA did not receive any comments on this aspect of the discussion in the proposal and expects to follow that approach.

E. Transition From the Existing SO 2 NAAQS to a Revised SO 2 NAAQS

a. Proposal

In addition to proposing a short-term
1-hour SO 2 NAAQS, EPA proposed to
revoke the annual and 24-hour standards (annual 0.03 ppm and 24- hour 0.14 ppm). Specifically, EPA proposed that the level for the 1-hour
standard for SO 2 be a range between 50– 100 ppb, and took comment on setting the level of the standard up to 150 ppb. We explained that if the Administrator sets the 1-hour standard at 100 ppb or lower, EPA proposed to revoke the 24-
hour standard. If the Administrator set
the level of the 1-hour standard between a range of 100–150 ppb, then EPA proposed to retain the 24-hour standard.

We explained that if EPA revised the

SO 2 NAAQS and revoked either the annual or 24-hour standard, EPA wouldneed to promulgate adequate antibacksliding provisions. The CAA establishes anti-backsliding requirements where EPA relaxes a NAAQS. Here, in EPA replacing the
annual and 24-hour standards with a short term 1-hour standard, EPA mustaddress the section 172(e) antibacksliding provision of the CAA and determine whether it applies on its face or by analogy, and what provisions are appropriate to provide for transition to
the new standard. States will need to insure that the health protection provided under the prior SO 2 NAAQS
continues to be achieved as well as maintained as States begin to implement the new NAAQS. This means that States are directed to continue implementing
attainment and maintenance SIPs associated with the prior SO 2 NAAQS until such time as they are subsumed by any new planning and control requirements associated with the new NAAQS.

Whether or not section 172(e) directly applies to EPA’s final action on the SO 2 NAAQS, EPA has previously looked to other provisions of the CAA to
determine how to address antiVerDate Mar<15>2010 16:20 Jun 21, 2010 Jkt 220001 PO 00000 Frm 00062 Fmt 4701 Sfmt 4700 E:\FR\FM\22JNR2.SGM 22JNR2srobinson on DSKHWCL6B1PROD with RULES2

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41 The areas that are currently designated as nonattainment for the pre-existing SO 2 primary NAAQS are Hayden, AZ; Armstrong, PA; Laurel, MT; Piti, GU; and Tanguisson, GU. The areas that are designated nonattainment for both the primary and the secondary standards are East Helena, MT, Salt Lake Co, MT, Toole Co, UT, and Warren Co, NJ. ( See http://www.epa.gov/oar/oaqps/greenbk/
lnc.html ). The Billings/Laurel, MT, area is the only area currently subject to a SIP call. backsliding. The CAA contains a number of provisions that indicate Congress’s intent to not allow provisions from implementation plans to be altered or removed if the plan revision would jeopardize the air quality protection being provided by the existing plan when EPA revises a NAAQS to make it more stringent. For example, section 110(l) provides that EPA may not approve a SIP revision if it interferes with any applicable requirement concerning attainment and RFP, or any other applicable requirement under the CAA. In addition, section 193 of the CAA prohibits the modification of a control, or a control requirement, in effect or required to be adopted as of November 15, 1990 ( i.e., prior to the promulgation
of the Clean Air Act Amendments of 1990), unless such a modification would ensure equivalent or greater emissions reductions. Further, section 172(e) of the CAA specifies that if EPA revises a NAAQS to make it less stringent than a previous NAAQS, control obligations no less stringent than those that apply in nonattainment area SIPs may not be relaxed, and adopting those controls that have not yet been adopted as needed may not be avoided. The intent of Congress, concerning the aforementioned sections of the CAA,
was confirmed in a recent DC Circuit Court opinion on the Phase I ozone implementation rule. See South Coast Air Quality Management Dist. v. EPA, 472 F.3d 882 (DC Cir. 2006).

To ensure that the anti-backsliding provisions and principles of section 172(e) are met and applied upon EPA
revocation of the annual and 24-hour standards, EPA is providing that those

SO 2 NAAQS will remain in effect for one year following the effective date of the initial designations under section 107(d)(1) for the new SO 2 NAAQS before the current NAAQS are revoked in most attainment areas. However, any existing SIP provisions under CAA sections 110, 191 and 192 associated
with the annual and 24-hour SO 2 NAAQS will remain in effect, including all currently implemented planning and emissions control obligations, including
both those in the State’s SIP and that have been promulgated by EPA in FIPs.
This will ensure that both the new nonattainment NSR requirements and the general conformity requirements for a revised standard are in place so that there will be no gap in the public health protections provided by these two programs. It will also ensure that all
nonattainment areas under the annual and/or 24-hour NAAQS and all areas for
which SIP calls have been issued will continue to be protected by currently required control measures.

EPA is also providing that the annual and 24-hour NAAQS remain in place for any current nonattainment area, or any
area for which a State has not fulfilled the requirements of a SIP call, until the affected area submits, and EPA approves, a SIP with an attainment, implementation, maintenance and enforcement SIP which fully addresses
the attainment and maintenance requirements of the new SO 2 NAAQS. This, in combination with the CAA mechanisms provided in sections 110(l), 193, and 172(e) will help to ensure that continued progress is made toward timely attainment of the SO 2 NAAQS. Also, in light of the nature of the new

SO 2 NAAQS, the lack of classifications (and mandatory controls associated with such classifications pursuant to the CAA), and the small number of current nonattainment areas, and areas subject to SIP calls, EPA believes that retaining the current standard for a limited period
of time until attainment and maintenance SIPs are approved for the
new standard in current nonattainment areas and SIP call areas, and one year after designations in other areas, will adequately serve the anti-backsliding requirements and goals of the CAA. 41

b. Comments and Responses

Several commenters stated that they support EPA’s proposal stating that the
annual and 24-hour SO 2 NAAQS EPA would remain in effect for one year following the effective date of the initial designations under section 107(d)(1) for
the revised SO 2 NAAQS before the current NAAQS are revoked in most
attainment areas. The commenters also support EPA’s proposal that any existing SIP provisions under CAA sections 110, 191 and 192 associated
with the annual and 24-hour SO 2 NAAQS would remain in effect, including all currently implemented planning and emissions control obligations, including both those in the
State’s SIP and that have been promulgated by EPA in FIPs. Several commenters also stated that they support EPA’s proposal that an area’s nonattainment designation and the subsequent CAA requirements under
the current SO 2 NAAQS will remain in effect until the affected State submits, and EPA approves a SIP which meets all of the relevant CAA requirements for
the affected nonattainment area. EPA appreciates the support of the commenters on its strategy for addressing the anti-backsliding requirements related to the current and
revised SO 2 standard, pursuant to section 172(e) of the CAA.

One commenter, however, stated that while they support EPA’s proposal to address the anti-backsliding provisions of section 172(e) of the CAA, they believe that EPA’s proposal is deficient in several respects. The commenter stated that EPA’s proposal to not
terminate the annual and 24-hour
standards for SO 2 in any nonattainment area, or any area for which a State has not fulfilled the requirements of a SIP call, until after the affected area submits and EPA approves a SIP with an attainment demonstration which fully

‘‘ addresses ’’ the attainment requirements
of the revised SO 2 NAAQS is flawed.
The commenter states that EPA’s use of
the term ‘‘ addresses ’’ is impermissibly and arbitrarily ambiguous and that the agency needs to clarify that ‘‘ fully addressing ’’ the attainment requirements of the revised NAAQS actually means providing for timely attainment of the NAAQS, and the submittal of a SIP that fully meets all of the requirements of section 110 and part D of Title I of the CAA, including sections 172, 173, and
191–193 of the CAA.

Another commenter stated that the
24-hour SO 2 standard should not be
revoked in attainment areas until EPA approves section 110(a)(2)

‘‘ infrastructure ’’ SIPs under the new 1- hour standard for such areas, in order to avoid delays in between attainment designation and such SIP approvals resulting in leaving the public unprotected or creating inter-state conflict that triggers section 126 petitions. This commenter further stated
that the annual SO 2 standard should not be revoked until EPA approves SIPs in
attainment areas under the future SO 2 secondary standard, which may also be based on an annual averaging time.

EPA agrees with the comment made by the commenter regarding the need to approve SIPs in nonattainment areas (and in SIP call areas) before revoking the 24-hour and annual NAAQS for
such areas. EPA clarifies that for those areas designated as nonattainment for the current NAAQS, or areas which have not met the requirements of a SIP call, that the State must submit a SIP that meets all of the applicable CAA requirements as they relate to section 110 and part D of Title I of the CAA, including sections 110(a), 172, 173, and
191–193 of the CAA. In addition to the


### 35582 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

submittal of the SIP related to these requirements, EPA must approve the
submittal for the area before the current
standard can be revoked for the affected

area.

EPA disagrees with the comment. This rulemaking concerns only the primary standards for SO 2 . 74 FR at
64812 n. 2. The annual SO 2 standard is a primary standard, not a secondary
standard. See 40 CFR section 50.4 (a). The exclusive secondary standard for

SO 2 is the 3-hour standard codified in

40 CFR section 50.5. EPA is not determining the adequacy of this secondary standard in this review or this rulemaking, as just noted. The commenter’s request to retain the annual primary standard until SIPs reflecting a new secondary standard are approved is effectively a request to amend the present secondary standard, and is therefore inappropriate given the scope of this review. In any case, in the event that any substantive responsive to this comment is required, air quality
information indicates that a 1-hour standard of 75 ppb is estimated to generally keep annual SO 2 concentrations well below the level of
the current annual standard. 74 FR at 64845. Thus, there would be no loss of protection to public welfare due to revocation of the annual primary
standard.

EPA further disagrees with the commenter’s request that we not revoke
the 24-hour standard in attainment areas before section 110(a)(2) ‘‘ infrastructure ’’ SIPs are approved under the new 1-hour

SO 2 standard. An area that has shown
it has attained the 24-hour standard and that is not the subject of a SIP call, even after revocation of the 24-hour standard, will still have in its SIP its prior

‘‘ infrastucture ’’ SIP elements. There is no need to delay revocation when that will not cause the area to become subject to
a new SIP under the new 1-hour NAAQS any faster than the statute already requires ( i.e., three years from the date of promulgation of the new NAAQS). Furthermore, as we have explained in sections III, IV, V and VI of this preamble, all areas are required by section 110(a)(1) of the Clean Air Act to submit such SIPs by June 2013, and we expect that to be approved they will all need to show attainment, implementation, maintenance and enforcement of the new NAAQS as expeditiously as practicable, which we believe is no later than August 2017. EPA believes this anticipated approach would more than sufficiently address the backsliding concerns raised by the

commenter. c. Final

EPA is making no changes to the proposed rule’s discussion of the transition strategy discussion for SO 2 with the exception of the clarifications
noted above.

VII. Appendix T—Interpretation of the Primary NAAQS for Oxides of Sulfur and Revisions to the Exceptional Events
Rule

EPA proposed to add Appendix T, Interpretation of the Primary National Ambient Air Quality Standards for Oxides of Sulfur, to 40 CFR Part 50 in order to provide monitoring data handling procedures for the proposed

SO 2 1-hour primary standard. The proposed section 50.17 which sets the averaging period, level, indicator, and form of the NAAQS referred to this Appendix T. The proposed Appendix T detailed the computations necessary for determining when the proposed 1-hour primary SO 2 NAAQS is met based on data from ambient monitoring and also addressed monitoring data reporting, data completeness considerations, and rounding conventions.

EPA proposed two versions of Appendix T. The first applied to a 1- hour primary standard based on the annual 4th high value form, while the second applied to a 1-hour primary standard based on the 99th percentile daily value form. The final version of the Appendix reflects our choice to adopt the 99th percentile daily form ( see section II. E.3 above).

For the 1-hour primary standard, EPA proposed monitoring data handling procedures, a cross-reference to the Exceptional Events Rule, a grant of
discretion for the Administrator to consider otherwise incomplete monitoring data to be complete, and a provision addressing the possibility of there being multiple SO 2 monitors at one site. EPA is finalizing these proposals, with one change from the proposal with regard to the multiple monitor provision.

EPA is also making certain drafting changes to the proposed regulatory text to clarify certain points and to assure that the regulatory text conforms with
EPA’s intentions as stated in the preamble. Specifically, EPA has slightly
edited the text of the rule from that proposed by adding the phrase ‘‘ at an ambient air monitoring site ’’ to section 50.17 (b) and to section 1.1 of Appendix T to part 50, and also by adding a section 50.17 (c) stating that the level of the standard is to be measured by an FRM found in Appendix A or A–1 to Part 50, or by a properly designated FEM. Both of these provisions are being added to conform the text of the new 1- hour standard to the language of other NAAQS. See. e.g. the text of the 8-hour primary standard for ozone in section 50.10 (a) and (b). The reference to ‘‘ at an ambient monitoring site ’’ makes clear that the regulatory text refers to situations where compliance with a NAAQS is measured by means of monitoring. This text does not restrict or otherwise address approaches which EPA or States may use to implement the new 1-hour NAAQS, which may include, for example, use of modeling ( see sections III—VI above). See CAA sections 107 (d) (3) (A) (any ‘‘ air quality
data ’’ may be used for redesignations); 110 (a) (1) (which does not address the issue of the types of data States may use in devising plans for implementation, maintenance, and enforcement of a primary NAAQS); 192 (a) (which does not specify the types of data that maysupport a demonstration that a nonattainment area has attained a NAAQS). Similarly, EPA notes that Appendix T applies when ambient monitoring data is gathered and utilized in support of
the new 1-hour SO 2 NAAQS. As noted in sections III, IV, V, and VI above, there
are circumstances when EPA is considering use of modeling in the SO 2 NAAQS implementation effort, and other considerations would apply if and to the extent modeling is utilized.

The EPA is also making SO 2 -specific changes to the deadlines in 40 CFR 50.14, by which States must flag ambient air data that they believe have been affected by exceptional events and submit initial descriptions of those events, and to the deadlines by which
States must submit detailed justifications to support the exclusion of those data from EPA monitoring-based
determinations of attainment or nonattainment with the NAAQS.

A. Interpretation of the Primary NAAQS for Oxides of Sulfur
The purpose of a monitoring data interpretation rule for the SO 2 NAAQS is to give effect to the form, level, averaging time, and indicator specified in the regulatory text at 40 CFR 50.17, anticipating and resolving in advance various future ambiguities that could otherwise occur regarding use of ambient monitoring data. The new Appendix T provides definitions and requirements that apply to the new 1- hour primary standard for SO 2 . The requirements concern how ambient monitoring data are to be reported, what ambient monitoring data are to be considered (including the issue of which of multiple monitors’ data sets
will be used when more than one monitor has operated at a site), and the


### 35583 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

applicability of the Exceptional Events Rule to the primary SO 2 NAAQS.

1. Proposed Interpretation of the
Standard Based on Data From Ambient Monitoring

With regard to monitoring data completeness for the proposed 1-hour primary standard, the proposed Appendix T followed past EPA practice for other NAAQS pollutants by requiring that in general at least 75% of the monitoring data that should have resulted from following the planned monitoring schedule in a period must be available for the key air quality statistic from that period to be considered valid. For the 1-hour primary SO 2 NAAQS, the key air quality statistics are the daily
maximum 1-hour concentrations in three successive years. It is important that sampling within a day encompass the period when concentrations are likely to be highest and that all seasons of the year are well represented. Hence, the 75% requirement was proposed to be applied at the daily and quarterly
levels.

Recognizing that there may be years with incomplete data, the proposed Appendix T for the 99th percentile form provided that a design value derived from incomplete monitoring data will
nevertheless be considered valid if the relevant one of two diagnostic
substitution tests validated such a design value as being either above the NAAQS level or equal to or below the NAAQS level.

The first proposed diagnostic data substitution test, relevant when the design value derived from incomplete data was equal to or below the NAAQS level, was intended to identify those cases with incomplete monitoring data in which it nevertheless is very likely, if not virtually certain, that the daily 1- hour design value would have been observed to be less than or equal to the level of the NAAQS if monitoring data had been minimally complete. This test involved the substitution of a high historical concentration for any missing data. The second proposed diagnostic data substitution test, relevant when the design value derived from incomplete data was above the NAAQS level, was intended to identify those cases with incomplete monitoring data in which it nevertheless is very likely, if not virtually certain, that the daily 1-hour design value would have been observed to be above the level of the NAAQS if monitoring data had been minimally complete. This test involved the
substitution of a low historical concentration for any missing data.

It should be noted that one possible outcome of applying the relevant proposed substitution test is that a 3- year period with incomplete monitoring data may nevertheless be determined to not have a valid design value and thus to be unusable in making 1-hour primary NAAQS compliance determinations based on monitoring for that 3-year period.

Also, we proposed that the Administrator have general discretion to use incomplete monitoring data based on case specific factors, either at the request of a State or at her own initiative. Similar provisions existed already for some other NAAQS.

The 99th percentile version of the proposed Appendix T provided a table for determining which day’s maximum
1-hour concentration will be used as the 99th percentile concentration for the year. The proposed table is similar to
one used now for the 24-hour PM 2.5 NAAQS and the new 1-hour NO 2 NAAQS, which are both based on a 98th percentile form, but adjusted to reflect a 99th percentile form for the 1-hour primary SO 2 standard. The proposed Appendix T also provided instructions for rounding (not truncating) the average of three annual 99th percentile hourly concentrations before comparison to the level of the primary NAAQS.

2. Comments on Interpretation of the
Standard

Several commenters expressed support for EPA’s proposed 75% completeness requirement for daily and quarterly monitoring data. A comment
was received that the substitution test
should not be used to make attainment or non-attainment designations. This
commenter also said that the same completeness requirement as used for
nonattainment should be used for attainment. Another commenter agreed that there should be completeness criteria, but thought that monitoring
data should be substituted to make the set only 75% complete. We received one comment that the computation of design values where multiple monitors are present at a site should be averaged and not taken from a designated primary
monitor. We received no comment on the provision which would afford the Administrator (or her delegee) discretion to use incomplete monitoring data based on specified factors and accordingly are adopting that provision as proposed.

3. Conclusions on Interpretation of the
Standard

Consistent with the Administrator’s decision to adopt a 99th percentile form for the 1-hour NAAQS, the final version of Appendix T is based on that form. We agree with the three comments expressing the view that the requirement for 75% monitoring data completeness per quarter should apply with respect to the 1-hour standard. The final rule includes this requirement.

We agree that nonattainment based on data from ambient monitoring should not be declared without a very high confidence that actual air quality did not meet the NAAQS, but we believe the proposed (and final) substitution test provides this irrefutable proof. In the relevant substitution test (Appendix T section 3.c.iii), the lowest daily
maximum concentration observed in the same calendar quarter within the 3-year period is the value used in the substitution. Moreover, to guard against the possibility that even this lowest observed value is unrepresentative because only a small number of days that happened to have had poor air quality have valid monitoring data, substitution is permitted only if there are at least 200 days across the three matching quarters of the three years
under consideration for which 75 percent of the hours in the day have reported concentrations. (If less than 200 days are available, the outcome is
that no conclusion can be reached based on data from monitoring as to whether the NAAQS is met, an outcome which satisfies the concern expressed by the commenter.) While it is conceivable that the actual daily maximum concentration on the day(s) without sufficiently complete data could have been even
lower than the value selected as the substitute value, the value that is selected for substitution will be quite low, and therefore it is extremely unlikely to be a candidate for selection as the annual 99th percentile daily
maximum concentration. The actual effect of the data substitution, if any, is to change which of the actually observed and ranked daily maximum concentrations during the year is identified as the 99th percentile; the direction of the change, if any, will always be towards a lower design value. For example, if the substitution test of
section 3.c.iii is used because there is one quarter of 92 days is missing 70 of its 92 daily maximum concentration values; causing there to be only 295 days with valid daily values for the whole year, it would be necessary to substitute 47 values to make that quarter 75 percent complete. This would result in 343 days of actual or substituted monitoring data for the year. The increase from 292 days to 342 days would cause the annual 99th percentile value to shift from the 3rd highest value to the 4th highest. Since a low


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42 Selecting the maximum or minimum observed concentration for an hour, the maximum or minimum annual 99th percentile, or the maximum or minimum three-year design value would introduce such a bias. Averaging multiple 1-hour measurements when available, designating one monitor as primary and using a second monitor’s measurement only when the primary monitor fails to give a valid measurement, or simply choosing to use the data record from only one of the monitors (on some basis that is independent of the concentration values obtained) would not introduce
such a bias. concentration is being used for the substitution, it is impossible for the 4th highest value to itself be a substituted value. If this shift results in the 3-year design value remaining above the NAAQS, the failure to meet the NAAQS
is confirmed. If this shift results in the 3-year design value changing to be equal to or below the NAAQS, under the
terms of the substitution test the
outcome is that no conclusion could be
reached based on this ambient monitoring data as to whether the NAAQS is met. Since either the same or a lower ranking actually measured concentration will always be identified, it is impossible for the outcome of the
substitution test of section 3.c.iii to be that an area truly meeting the NAAQS based on ambient monitoring data is
determined to not meet it based on ambient monitoring data.

The commenter who said that the same completeness requirement should
be used for nonattainment as for attainment appears to have been referring to a particular feature of the proposed diagnostic substitution test rather than to the basic completeness requirement of 75%, which in both the proposal and the final rule applies equally to both attainment and
nonattainment situations. This particular feature is discussed in the next paragraph.

The commenter who said that it is appropriate to substitute data to make the set only 75% complete appears to have taken note that in the proposed
substitution test relevant in the case of an incomplete design value equal to or below the NAAQS (section 3.c.ii), data are substituted until 100% completeness is reached for the affected quarter, while in the test relevant in the case of an incomplete design value above the NAAQS (section 3.c.iii) data are substituted only until 75% completeness is reached. EPA believes this distinction is appropriate, and we have retained the 100% substitution
limit in the final rule. In the case of an incomplete design value that is equal to or below the NAAQS, the concern is
that the actual concentrations on the days without a valid daily maximum 1- hour concentration may have been quite high such that the concentration on one of those days would have been selected as the annual 99th percentile value. To be selected as the annual 99th percentile value, a daily maximum must be ranked no lower than the 4th highest daily value for the year. If substitution stopped when 75% of the days in a quarter had an actual or substituted value, there could be a situation in which only one, two, or three historical high values would need to be substituted to reach the 75% limit. It would therefore be possible for one of the actually measured concentrations (for the same or another quarter) to be identified as the annual 99th percentile
value even if the substitution value is higher than any value actually measured, defeating the very purpose of the diagnostic test for an incomplete design value below the NAAQS, which is to essentially rule out the possibility of not meeting the NAAQS (when making monitoring-based determinations). The simplest way to
ensure that at least four values are substituted (when there are at least four missing daily values) is to require substitution up to the 100% limit.

With regard to situations with multiple monitors operating at one site,
we note that there are few cases of this
situation for SO 2 monitoring. Of over

500 SO 2 monitoring sites in operation any time during 2007–2009, for example, only seven stations reported 1- hour data to the Air Quality System
under two or more distinct Pollutant Occurrence Codes (POC). In the same period, collocated monitors reported data to AQS under distinct POCs for only one of over 400 nitrogen dioxide sites, for only two of almost 400 carbon monoxide sites, and for only eight of almost 1300 ozone sites. Even so, we believe is it important to have a well defined monitor data handling procedure for such situations. Also, there is a practical advantage in implementation if the same or similar procedure is used across NAAQS pollutants especially for these four gaseous pollutants that are measured on a 1-hour basis. A procedure that is simple to implement also has advantages in implementation. Finally, the procedure should not introduce any upward or downward bias in the determination of the design value for the monitoring site. 42

The proposed procedure for multiple

SO 2 monitors was the same as EPA recently proposed and finalized for the new 1-hour NAAQS for nitrogen dioxide, where there were no adverse comments received on the proposal (75 FR 6474, February 9, 2010). It is also the same as recently proposed in the reconsideration of the 8-hour ozone NAAQS (75 FR 2938, January 19, 2010). In the proposed procedure, in general,
data from two monitors would never be mixed within a year but data from different monitors in different years could be used to calculate the 3-year design value. As noted above, one
commenter on the SO 2 proposal suggested that instead of designating a primary monitor when there are two monitors at a site, the measurements for an hour from multiple monitors should be averaged instead. EPA has also
received at least one comment disagreeing with the recent proposal regarding multiple ozone monitors. The comment in the ozone rulemaking favored hour-by-hour substitution of data from a secondary monitor when the designated primary monitor has not given a value measurement, as opposed to the proposed restriction against mixing data within a year. These
comments have caused us to rethink the
direction set in the final NO 2 rule and in the proposals for SO 2 and ozone. We
now believe that substitution of monitoring data hour-by-hour is an acceptable and in some ways superior approach to the other possibleapproaches, while averaging hour-byhour would be unduly complex. Also, averaging hour-by-hour might not be transparent depending on whether the averaging is done at the monitoring agency before submission to EPA or by EPA as part of calculating a design value. However, in light of the rarity of collocated monitors, it would be an
unwarranted demand on limited EPA resources to develop and maintain software for hour-by-hour data substitution. Also, an hour-by-hour data substitution approach depends on the advance designation of a primary monitor, which itself could introduce confusion and would require software changes to EPA’s data system. Therefore, EPA believes that the most practical, and still a technically valid approach, is to allow monitoring agencies the option of hour-by-hour substitution between secondary and primary monitors before submission of data to EPA, and for EPA to select for use in calculating design values the one monitoring data record which has the highest degree of completeness for a given year. The final rule is based on this approach. EPA will also consider this approach when finalizing the ozone NAAQS reconsideration rule, and when proposing data interpretation provisions for a planned rulemaking to review the carbon monoxide NAAQS. The already finalized procedures for nitrogen dioxide data interpretation will be


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implemented as promulgated, but will affect only an extremely small number
of collocated SO 2 monitoring situations.

Finally, as proposed, the final version of Appendix T has a cross reference to the Exceptional Events Rule (40 CFR 50.14) with regard to the exclusion of monitoring data affected by exceptional events. In addition, the specific steps for including such data in completeness calculations while excluding such data from actual design value calculations is clarified in Appendix T.

B. Exceptional Events Information
Submission Schedule

The Exceptional Events Rule at 40 CFR 50.14 contains generic deadlines for a State to submit to EPA specified information about exceptional events and associated air pollutant
concentration data. A State must initially notify 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. The State must also, after notice and opportunity for public comment, submit a demonstration to justify any claim within 3 years after the quarter in which the data were collected. However, if a regulatory decision based on the data (for example, a designation action) is anticipated, the schedule to flag data in AQS and submit complete
documentation to EPA for review is shortened, and all information must be submitted to EPA no later than one year
before the decision is to be made.

These generic deadlines are suitable for the period after initial designations have been made under a NAAQS, when the decision that may depend on data exclusion is a redesignation from
attainment to nonattainment or from nonattainment to attainment. However, these deadlines present problems with respect to initial designations under a newly revised NAAQS. One problem is that some of the deadlines, especially the deadlines for flagging some relevant data, may have already passed by the time the revised NAAQS is promulgated. Until the level and form of the NAAQS have been promulgated a
State does not know whether the criteria for excluding data (which are tied to the level and form of the NAAQS) were met on a given day. Another problem is that it may not be feasible for information on some exceptional events that may affect final designations to be collected and submitted to EPA at least one year in advance of the final designation
decision. This could have the unintended consequence of EPA designating an area nonattainment
because of uncontrollable natural or other qualified exceptional events.

The Exceptional Events Rule at section 50.14(c)(2)(v) 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 data for initial designation of areas for those NAAQS. ’’

For the specific case of SO 2 , the signature date for the revised SO 2 NAAQS is June 2, 2010. State/Tribal area designations recommendations will be due by June 2, 2011, and EPA will make initial area designations under the revised NAAQS by June 1, 2012 (since June 2, 2012 would be on a Saturday) and will be informed by air quality data from the years 2008–2010 or 2009–2011
if there is sufficient data for these data years and by any refined modeling that is conducted. ( See Sections III, V and VI
above for more detailed discussions of the designation schedule and what data EPA expects to use.) Because final designations would be made by June 1, 2012, all events to be considered during the designations process would have to be flagged and fully documented by States one year prior to designations, by June 1, 2011. A State would not be able to flag and submit documentation regarding events that occurred between June to December 2011 by one year before designations are made in June

2012.

EPA is adopting revisions to 40 CFR 50.14 only to change submission dates for information supporting claimed exceptional events affecting SO 2 data.
The rule text at the end of this notice shows the changes that will apply to the
new 1-hour SO 2 NAAQS. For air quality data collected in 2008, we are extending the generic July 1, 2009 deadline for flagging data (and providing a brief initial description of the event) to October 1, 2010. EPA believes this extension will provide adequate time for States to review the impact of exceptional events from 2008 on the revised standard and notify EPA by flagging the relevant data in AQS. EPA is not changing the foreshortened deadline of June 1, 2011 for submitting documentation to justify an SO 2 -related exceptional event from 2008. We believe the generic deadline provides adequate time for States to develop and submit proper documentation.

For data collected in 2009, EPA is extending the generic deadline of July 1, 2010 for flagging data and providing initial event descriptions to October 1, 2010. EPA is retaining the deadline of June 1, 2011 for States to submit documentation to justify an SO 2 -related exceptional event from 2009. For data collected in 2010, EPA is promulgating a deadline of June 1, 2011 for flagging data and providing initial event descriptions and for submitting documentation to justify exclusion of the flagged data. EPA believes that this deadline provides States with adequate time to review and identify potential exceptional events that occur in calendar year 2010, even for those events that might occur late in the year.
EPA believes these deadlines will be feasible because experience suggests that exceptional events affecting SO 2 data are few in number and easily assessed, so no State is likely to have a large workload.

If a State intends 2011 data to be
considered in SO 2 designations, 2011 data must be flagged and detailed event documentation submitted 60 days after the end of the calendar quarter in which the event occurred or by March 31, 2012, whichever date occurs first. Again, EPA believes these deadlines will be feasible because experience suggest that exceptional events affecting

SO 2 data are few in number and easily assessed, so no State is likely to have a large workload.

Table 1 summarizes the designation
deadlines discussed in this section and provides designation schedule information from recent, pending or prior NAAQS revisions for other pollutants. EPA is revising the final SO 2 exceptional event flagging and
documentation submission deadlines accordingly to provide States with reasonably adequate opportunity to review, identify, and document exceptional events that may affect an area designation under a revised NAAQS.


### 35586 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

T ABLE 

### 1—S CHEDULE FOR 

### E XCEPTIONAL 

### E VENT 

### F LAGGING AND 

### D OCUMENTATION 

### S UBMISSION FOR 

### D ATA 

### T O 

### B E 

### U SED IN 

### D ESIGNATIONS 

### D ECISIONS FOR 

### N EW OR 

### R EVISED 

### NAAQS

NAAQS pollutant/standard/(level)/promulgation date Air quality data collected for calendar year Event flagging & initial description deadline Detailed documentation submission deadline

PM 2.5 /24-Hr Standard (35 μ g/m 3 ) Promulgated October 17, 2006. 2004–2006 October 1, 2007 a .................................... April 15, 2008 a

.

Ozone/8-Hr Standard (0.075 ppm) Promulgated March 12, 2008. 2005–2007

2008 June 18, 2009 a

....................................... June 18, 2009 a

....................................... June 18, 2009 a

. June 18, 2009 a

. 2009 60 Days after the end of the calendar quarter in which the event occurred orFebruary 5, 2010, whichever date occurs first b

. 60 Days after the end of the calendar quarter in which the event occurred orFebruary 5, 2010, whichever date occurs first b

. NO 2 /1-Hour Standard (80–100 PPB, final

level TBD). 2008

2009 July 1, 2010 a

.......................................... July 1, 2010 a

.......................................... January 22, 2011 a

. January 22, 2011 a

. 2010 April 1, 2011 a ......................................... July 1, 2011 a

. SO 2 /1-Hour Standard (50–100 PPB, final

level TBD). 2008

2009 October 1, 2010 b

.................................... October 1, 2010 b

.................................... June 1, 2011 b

. June 1, 2011 b

. 2010 June 1, 2011 b ......................................... June 1, 2011 b

. 2011 60 Days after the end of the calendar quarter in which the event occurred orMarch 31, 2012, whichever date occurs first b

. 60 Days after the end of the calendar quarter in which the event occurred orMarch 31, 2012, whichever date occurs first b

.

a These dates are unchanged from those published in the original rulemaking, and are shown in this table for informational purpos es—the Agency is not opening these dates for comment under this rulemaking.

b Indicates change from general schedule in 40 CFR 50.14. Note: EPA notes that the table of revised deadlines only applies to data EPA will use to establish the final initial designations for new or revised NAAQS. The general schedule applies for all other purposes, most notably, for data used by EPA for redesignations to atta inment.

Note further that EPA is reprinting portions of this Table in section 5014 but, with respect to the pollutants other
than SO 2 , is doing so only for readers’ convenience and is not reopening or otherwise reconsidering any aspect of
the rules related to these other pollutants.

VIII. Communication of Public Health
Information

Information on the public health implications of ambient concentrations of criteria pollutants is currently made available primarily through EPA’s Air Quality Index (AQI) program. The current 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 pollution (40 CFR 58.50). The AQI establishes a nationally uniform system of indexing pollution levels for nitrogen dioxide, carbon monoxide, ozone, particulate matter and SO 2 . 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 levels in a particular location are characterized as good (0–50), moderate (51–100), unhealthy for sensitive groups (101– 150), unhealthy (151–200), very unhealthy (201–300), or hazardous (300–500). The AQI index value of 100 typically corresponds to the level of the short-term primary NAAQS for each pollutant. 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 unhealthy, 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). 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 supports the review of the primary NAAQS.

The Agency recognizes the importance of revising the AQI in a timely manner to be consistent with any revisions to the primary NAAQS. Therefore, EPA proposed to finalize conforming changes to the AQI in connection with the Agency’s final
decision on the SO 2 NAAQS. Conforming changes that were proposed include setting the 100 level of the AQI at the same level as the revised primary

SO 2 standard if a short-term primary standard was promulgated, and revising the other AQI breakpoints at the lower end of the AQI scale ( i.e., AQI values of 50 and 150). EPA did not propose to change breakpoints at the higher end of the AQI scale (from 200 to 500), which would apply to State contingency plans or the Significant Harm Level (40 CFR 51.16), because the information from
this review does not inform decisions about breakpoints at those higher levels.

With regard to an AQI value of 50, the breakpoint between the good and moderate categories, historically this
value is set at the level of the annual NAAQS, if there is one, or one-half the level of the short-term NAAQS in the absence of an annual NAAQS (63 FR 67823, Dec. 12, 1998). Taking into consideration this practice, EPA proposed to set the AQI value of 50 to be between 25 and 50 ppb SO 2 , 1-hour average; stating that concentrations toward the lower end of this range would be appropriate if the standard was set at the lower end of the range of proposed standard levels, while concentrations toward the higher end of this range would be more appropriate if the standard was set at the higher end of the range of proposed standard levels. EPA solicited comments on this range for an AQI value of 50 and the appropriate basis for selecting an AQI
value of 50.

With regard to an AQI value of 150, the breakpoint between the unhealthy for sensitive groups and unhealthy categories, historically values between the short-term standard and an AQI
value of 500 are set at levels that are approximately equidistant between the AQI values of 100 and 500 unless there is health evidence that suggests a specific level would be appropriate (63 FR 67829, Dec. 12, 1998). For an AQI value of 150, EPA proposed to set the breakpoint within the range from 175 to 200 ppb SO 2 , 1-hour average, since it represents the midpoint between the proposed range for the short-term


### 35587 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

standard and the level of an AQI value of 200 (300 ppb SO 2 , 1-hour average).

EPA received few comments on the proposed breakpoints. Consistent with the level of the short-term primary SO 2 standard promulgated in this rule, EPA is setting the AQI value of 100, the breakpoint between the moderate and unhealthy for sensitive groups category, at 75 ppb, 1-hour average. EPA is setting the AQI value of 50, the breakpoint between the good and moderate categories, at 35 ppb SO 2 , 1-houraverage, which is approximately onehalf the level of the new short-term standard, since the annual SO 2 standard is being revoked. EPA is setting the AQI value of 150, the breakpoint between the unhealthy for sensitive groups and unhealthy categories, at 185 ppb SO 2 , 1- hour average, which represents the approximate midpoint between the level of the new short-term standard (75 ppb

SO 2 , 1-hour average) and the level of an AQI value of 200 (300 ppb SO 2 , 1-hour average).

EPA received comments from several State environmental organizations and organizations of State and local air agencies about forecasting and reporting the AQI for SO 2 . These commenters expressed the view that forecasting hourly SO 2 concentrations would be difficult. One commenter requested that EPA delay the forecasting requirement for one year and other agencies requested that EPA provide assistance in developing a forecast model. Another commenter expressed the view that it is impractical to incorporate SO 2 into its forecasting and public health notification program because SO 2 does not behave like a regional pollutant, and that exceedances may occur with little or no warning and for two hours or less. This commenter requested EPA consider the resources necessary for public communications at the State and local levels, particularly in areas where other air quality exceedances are relatively rare.

EPA recommends and encourages air quality forecasting but it is not required (64 FR 42548; August 4, 1999). We agree that there will be new challenges associated with creating and communicating an SO 2 forecast, and will work with State and local agencies that want to develop an SO 2 forecasting program on issues including, but not limited to, forecasting air quality for short time periods. We plan to work with State and local air agencies to figure out the best way to present this information to the public using the AQI.

With respect to the comment that it is impractical to incorporate SO 2 into a forecasting and public health notification program because SO 2 does not behave like a regional pollutant, this final rule departs from the proposed
rule in that it allows for a combined monitoring and modeling approach. Because of this, the monitoring networkis not required to be wholly sourceoriented in nature. States have flexibility to allow required monitoring sites to serve multiple monitoring objectives including characterizing source impacts, highest concentrations, population exposure, background, and regional transport. Further, EPA expects that much of the existing network will be retained by States to satisfy the minimum monitoring requirements. This means that it is unlikely that AQI reporting and forecasting will be heavily driven by source-oriented monitors. Rather, many of the existing monitors (a majority of which are community-wide monitors) will remain in place, which prevents the need for new geographic regions to be delineated. With respect to concerns expressed about the resources required to report the AQI in areas were exceedances of the standard are very rare, Appendix G to Part 58 specifies that if the index value for a particular pollutant remains below 50 for a season or year, then a State or local agency may exclude the pollutant from the calculation of the AQI.

IX. Statutory and Executive Order

Reviews

A. Executive Order 12866: Regulatory Planning and Review

Under section 3(f)(1) of Executive Order 12866 (58 FR 51735, October 4, 1993), this action is an ‘‘ economically significant regulatory action ’’ because it is likely to have an annual effect on the economy of $100 million or more. Accordingly, 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, EPA prepared a Regulatory Impact Analysis (RIA) of the potential costs and benefits associated with this action. However, the CAA and judicial decisions make clear that the economic and technical feasibility of attaining the national ambient standards cannot be considered in setting or revising NAAQS, although such factors may be considered in the development of State implementation plans to implement the standards. Accordingly, although an RIA has been prepared, the
results of the RIA have not been considered by EPA in developing this
final rule.

When estimating the SO 2 - and PM 2.5 - related human health benefits and compliance costs in Table 2 below, EPA applied methods and assumptions
consistent with the state-of-the-science for human health impact assessment, economics and air quality analysis. EPA applied its best professional judgment in performing this analysis and believes that these estimates provide a reasonable indication of the expected
benefits and costs to the nation of the
selected SO 2 standard and alternatives considered by the Agency. The Regulatory Impacts Analysis (RIA)
available in the docket describes in detail the empirical basis for EPA’s assumptions and characterizes the
various sources of uncertainties affecting the estimates below.

EPA’s 2009 Integrated Science
Assessment for Particulate Matter concluded, based on the scientific literature, that a no-threshold log-linearmodel most adequately portrays the PMmortality concentration-response relationship. Nonetheless, consistent with historical practice and our commitment to characterizing the uncertainty in our benefits estimates, EPA has included a sensitivity analysis
with an assumed threshold in the PMmortality health impact function in the RIA. EPA has included a sensitivity analysis in the RIA to help inform our understanding of the health benefits
which can be achieved at lower air quality concentration levels. While the primary estimate and the sensitivity analysis are not directly comparable, due to differences in population data and use of different analysis years, as well as the difference in the assumption of a threshold in the sensitivity analysis, comparison of the two results provide a rough sense of the proportion of the
health benefits that occur at lower PM 2.5 air quality levels. Using a threshold of

10 μ g/m 3 is an arbitrary choice (EPA could have assumed 6, 8, or 12 μ g/m 3 for the sensitivity analysis). Assuming a
threshold of 10 μ g/m 3 , the sensitivity analysis shows that roughly one-third of the benefits occur at air quality levels
below that threshold. Because the primary estimates reflect EPA’s current methods and data, EPA notes that
caution should be exercised when comparing the results of the primary and sensitivity analyses. EPA appreciates the value of sensitivity analyses in highlighting the uncertainty
in the benefits estimates and will
continue to work to refine these analyses, particularly in those instances in which air quality modeling data are
available.

Table 2 shows the results of the cost and benefits analysis for each standard alternative. As indicated above, implementation of the SO 2 control


### 35588 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

measures identified from
AirControlNET and other sources does
not result in attainment with the all target NAAQS levels in several areas. In these areas, additional unspecified emission reductions might be necessary
to reach some alternative standard levels. The first part of the table, labeled Partial attainment (identified controls), shows only those benefits and costs
from control measures we were able to identify. The second part of the table,
labeled Unidentified Controls, shows only additional benefits and costs resulting from unidentified controls. The third part of the table, labeled Full attainment, shows total benefits and costs resulting from both identified and unidentified controls. It is important to emphasize that we were able to identify control measures for a significant portion of attainment for many of those counties that would not fully attain the target NAAQS level with identified
controls. Note also that in addition to separating full and partial attainment, the table also separates the portion of

benefits associated with reduced SO 2 exposure ( i.e., SO 2 benefits) from the

additional benefits associated with reducing SO 2 emissions, which are precursors to PM 2.5 formation—( i.e., the

PM 2.5 co-benefits). For instance, for the selected standard of 75 ppb, $2.2

million in benefits are associated with

reduced SO 2 exposure while $15 billion to $37 billion are associated with

reduced PM 2.5 exposure.



### T ABLE 

### 2—M ONETIZED 

### B ENEFITS AND 

### C OSTS 

### T O 

### A TTAIN 

### A LTERNATE 

### S TANDARD 

### L EVELS IN 

### 2020

[Millions of 2006$] a

Number of counties

fully controlled Discount

rate (percent) Monetized SO 2 benefits Monetized PM 2.5 co-benefits, c,d Costs Net benefits

**Partial Attainment (identified controls)**

50 ppb .............................. 40 3 b $30,000 to $74,000 ... $2,600 $27,000 to $71,000.

........................ 7 ........................ $28,000 to $67,000 ... ........................ $25,000 to $64,000. 75 ppb .............................. 20 3 b $14,000 to $35,000 ... $960 $13,000 to $34,000.

........................ 7 ........................ $13,000 to $31,000 ... ........................ $12,000 to $30,000. 100 ppb ............................ 6 3 b $6,900 to $17,000 ..... $470 $6,400 to $17,000.

........................ 7 ........................ $6,200 to $15,000 ..... ........................ $5,700 to $15,000.

**Unidentified Controls**

50 ppb .............................. 16 3 b $4,000 to $9,000 ....... $1,800 $2,200 to $7,200.

........................ 7 ........................ $3,000 to $8,000 ....... ........................ $1,200 to $6,200. 75 ppb .............................. 4 3 b $1,000 to $3,000 ....... $500 $500 to $1,500.

........................ 7 ........................ $1,000 to $3,000 ....... ........................ $500 to $2,500. 100 ppb ............................ 3 3 b $500 to $1,000 .......... $260 $240 to $740.

........................ 7 ........................ $500 to $1,000 .......... ........................ $240 to $740.

**Full Attainment**

50 ppb .............................. 56 3 $8.50 $34,000 to $83,000 ... $4,400 $30,000 to $79,000.

........................ 7 ........................ $31,000 to $75,000 ... ........................ $27,000 to $71,000. 75 ppb .............................. 24 3 $2.20 $15,000 to $37,000 ... $1,500 $14,000 to $36,000

........................ 7 ........................ $14,000 to $34,000 ... ........................ $13,000 to $33,000. 100 ppb ............................ 9 3 $0.60 $7,400 to $18,000 ..... $730 $6,700 to $17,000.

........................ 7 ........................ $6,700 to $16,000 ..... ........................ $6,000 to $15,000.

a Estimates have been rounded to two significant figures and therefore summation may not match table estimates.

b The approach used to simulate air quality changes for SO 2 did not provide the data needed to distinguish partial attainment benefits from full attainment benefits from reduced SO 2 exposure. Therefore, a portion of the SO 2 benefits is attributable to the known controls and a portion of the SO 2 benefits are attributable to the unidentified controls. Because all SO 2 -related benefits are short-term effects, the results are identical for all discount rates.

c Benefits are shown as a range from Pope et al. (2002) to Laden et al. (2006). Monetized benefits do not include unquantified benefits, such as other health effects, reduced sulfur deposition, or improvements in visibility.

d These models assume that all fine particles, regardless of their chemical composition, are equally potent in causing premature mortality because there is no clear scientific evidence that would support the development of differential effects estimates by particle type. Reductions in SO 2 emissions from multiple sectors to meet the SO 2 NAAQS would primarily reduce the sulfate fraction of PM 2.5 . Because this rule targets a specific particle precursor ( i.e., SO 2 ), this introduces some uncertainty into the results of the analysis.

B. Paperwork Reduction Act

The information collection requirements in this final rule have been submitted for approval to the Office of Management and Budget (OMB) under the Paperwork Reduction Act, 44 U.S.C.

3501 et seq. The Information Collection Request (ICR) document prepared by EPA for these revisions to part 58 has been assigned EPA ICR number 2370.02.
The information collected under 40 CFR part 53 ( e.g., test results, monitoring records, instruction manual, and other associated information) is needed to

determine whether a candidate method intended for use in determining attainment of the NAAQS in 40 CFR part 50 will meet the design, performance, and/or comparability requirements for designation as a Federal reference method (FRM) or Federal equivalent method (FEM). We do not expect the number of FRM or

FEM determinations to increase over the number that is currently used to

estimate burden associated with SO 2 FRM/FEM determinations provided in the current ICR for 40 CFR part 53 (EPA ICR numbers 2370.01). As such, no change in the burden estimate for 40 CFR part 53 has been made as part of this rulemaking.

The information collected and reported under 40 CFR part 58 is needed to determine compliance with the NAAQS, to characterize air quality and


### 35589 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

associated health impacts, to develop emissions control strategies, and to measure progress for the air pollution program. The amendments would revise the technical requirements for SO 2 monitoring sites, require the siting and operation of additional SO 2 ambient air monitors, and the reporting of the
collected ambient SO 2 monitoring data to EPA’s Air Quality System (AQS). The
ICR is estimated to involve 102 respondents for a total approximate cost of $15,203,762 (total capital, and labor and non-labor operation and maintenance) and a total burden of 207,662 hours. The labor costs
associated with these hours is $11,130,409. Included in the $15,203,762 total are other costs of other non-labor operations and maintenance of $1,104,377 and equipment and contract costs of $2,968,975. In addition
to the costs at the State and local air quality management agencies, there is a burden to EPA for a total of 14,749 hours and $1,060,621. 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 monitors and related activities. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
The OMB control numbers for EPA’s regulations in 40 CFR are listed in 40 CFR part 9.

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 businesses, small organizations, and small governmental jurisdictions.

For purposes of assessing the impacts of this rule on small entities, small entity is defined as: (1) A small business that is a small industrial entity as defined by the Small Business 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 is any not-for-profit enterprise which is independently owned and operated and is not
dominant in its field. After considering the economic impacts of this final rule on small entities, I certify that this action will not have a significant economic impact on
a substantial number of small entities. This final rule will not impose any requirements on small entities. Rather,
this rule establishes national standards
for allowable concentrations of SO 2 in ambient air as required by section 109
of the CAA. American Trucking Ass’ns

v. EPA, 175 F.3d 1027, 1044–45 (DC Cir. 1999) (NAAQS do not have significant impacts upon small entities because NAAQS themselves impose no regulations upon small entities). Similarly, the amendments 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.

D. Unfunded Mandates Reform Act

This action is not subject to the requirements of sections 202 and 205 of
the UMRA. EPA has determined that
this final rule does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and Tribal governments, in the aggregate, or the private sector in any one year. The revisions to the SO 2 NAAQS impose no enforceable duty on any State, local or Tribal governments or the private sector. The expected costs associated with the monitoring requirements are described in EPA’s ICR document, but those costs are not expected to exceed $100 million in the aggregate for any year. Furthermore, as indicated previously, in setting a NAAQS, EPA cannot consider the economic or technological feasibility of attaining ambient air quality standards. Because the CAA prohibits EPA from considering the types of estimates and
assessments described in section 202 when setting the NAAQS, the UMRA does not require EPA to prepare a
written statement under section 202 for
the revisions to the SO 2 NAAQS.

With regard to implementation guidance, the CAA imposes the obligation for States to submit SIPs to implement the SO 2 NAAQS. In this final rule, EPA is merely providing an interpretation of those requirements. However, even if this rule did establish an independent obligation for States to submit SIPs, it is questionable whether an obligation to submit a SIP revision
would constitute a Federal mandate in any case. The obligation for a State to
submit a SIP that arises out of section
110 and section 191 of the CAA is not legally enforceable by a court of law,
and at most is a condition for continued receipt of highway funds. Therefore, it is possible to view an action requiring such a submittal as not creating any enforceable duty within the meaning of U.S.C. 658 for purposes of the UMRA. Even if it did, the duty could be viewed as falling within the exception for a
condition of Federal assistance under

U.S.C. 658.

EPA has determined that this final rule contains no regulatory requirements that might significantly or uniquely affect small governments because it imposes no enforceable duty on any small governments. Therefore, this rule is not subject to the requirements of section 203 of the

UMRA.

E. Executive Order 13132: Federalism

This final rule does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, 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 Federal government and the States regarding the establishment and implementation of air quality improvement programs as codified in the CAA. Under section 109 of the CAA, EPA is mandated to establish NAAQS; however, CAA section 116 preserves the rights of States to establish more stringent requirements if deemed necessary by a State. Furthermore, this rule does not impact CAA section 107
which establishes that the States have primary responsibility for implementation of the NAAQS. Finally, as noted in section E (above) on UMRA, this rule does not impose significant costs on State, local, or Tribal governments or the private sector. Thus, Executive Order 13132 does not apply
to this rule.

F. Executive Order 13175: Consultation
and Coordination With Indian Tribal

Governments

Executive Order 13175, entitled

‘‘ Consultation and Coordination with
Indian Tribal Governments ’’ (65 FR 67249, November 9, 2000), requires 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 final rule does not have Tribal implications, as specified in
Executive Order 13175. It does not have
a substantial direct effect on one or more Indian Tribes, on the relationship between the Federal government and Indian Tribes, or on the distribution of power and responsibilities between the


### 35590 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

Federal government and Tribes. The rule does not alter the relationship between the Federal government and
Tribes as established in the CAA and the TAR. Under section 109 of the CAA, EPA is mandated to establish NAAQS; however, this rule does not infringe existing Tribal authorities to regulate air quality under their own programs or under programs submitted to EPA for approval. Furthermore, this rule does not affect the flexibility afforded to Tribes in seeking to implement CAA programs consistent with the TAR, nor does it impose any new obligation on Tribes to adopt or implement any NAAQS. Finally, as noted in section E (above) on UMRA, this rule does not impose significant costs on Tribal governments. Thus, Executive Order 13175 does not apply to this rule.

G. Executive Order 13045: Protection of
Children From Environmental Health and Safety Risks

This action is subject to Executive Order (62 FR 19885, April 23, 1997) because it is an economically significant regulatory action as defined by Executive Order 12866, and we believe
that the environmental health risk addressed by this action has a disproportionate effect on children. The
final rule will establish uniform national ambient air quality standards
for SO 2 ; these standards are designed to protect public health with an adequate margin of safety, as required by CAA section 109. The protection offered by these standards may be especially important for asthmatics, including asthmatic children, because respiratory effects in asthmatics are among the most sensitive health endpoints for SO 2 exposure. Because asthmatic children are considered a sensitive population, we have evaluated the potential health effects of exposure to SO 2 pollution among asthmatic children. These effects and the size of the population affected are discussed in chapters 3 and 4 of the ISA; chapters 3, 4, 7, 8, 9 of the REA, and sections II.A through II.E of this preamble.

H. Executive Order 13211: Actions That Significantly Affect Energy Supply,
Distribution or Use

This rule is not a ‘‘ significant energy

action ’’ as defined in Executive Order

13211, ‘‘ Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use ’’ (66 FR 28355; May 22, 2001) because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The purpose of this rule is to establish revised NAAQS for SO 2 . The rule does not prescribe specific control strategies by which these ambient standards will be met. Such strategies will be developed by States on a case-by-case basis, and EPA cannot predict whether the control options selected by States will include regulations on energy suppliers, distributors, or users. Thus,
EPA concludes that this rule is not likely to have any adverse energy
effects.

I. National Technology Transfer and
Advancement Act

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104– 113, section 12(d) (15 U.S.C. 27) directs EPA to use voluntary consensus standards in its regulatory activities
unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary 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 EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.

This final rulemaking involves technical standards with regard to ambient monitoring of SO 2 . The use of this voluntary consensus standard would be impractical because the analysis method does not provide for the method detection limits necessary to adequately characterize ambient SO 2 concentrations for the purpose of determining compliance with the final
revisions to the SO 2 NAAQS.

J. 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 their 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.

EPA has determined that this final 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 effects on any population, including any minority or low-income population. The
final rule will establish uniform
national standards for SO 2 in ambient

air.

References
American Lung Association. (2001). Urban air pollution and health inequities: a workshop report. Environ Health Perpect. 109(S3):357–374. American Thoracic Society. (1985).
Guidelines as to what constitutes an adverse respiratory health effect, with special reference to epidemiologic studies of air pollution. Am Rev Respir

Dis. 131:666–668. American Thoracic Society. (2000). What
constitutes an adverse health effect of air pollution? Am J Respir Crit Care Med.

161:665–673. Brode (2010). Representativeness of Ambient Monitoring Data for SO 2 Epidemiological
Studies. Sulfur Dioxide Review Docket. Docket ID No. EPA–HQ–OAR–2007–
0352. Available at http:// www.regulations.gov. EPA. (1982). Air Quality Criteria for
Particulate Matter and Sulfur Oxides. U.S. EPA, Research Triangle Park, NC:
Office of Health and Environmental
Assessment. Available at: http:// cfpub.epa.gov/ncea/cfm/ recordisplay.cfm?deid=46205. EPA. (1986). Second Addendum to Air Quality Criteria for Particulate Matter and Sulfur Oxides (1982): Assessment of Newly Available Health Effects Information. US EPA, Research Triangle Park, NC: Office of Health and
Environmental Assessment. Available at: http://cfpub.epa.gov/ncea/cfm/ recordisplay.cfm?deid=39469. EPA. (1994a). Supplement to the Second Addendum (1986) to Air Quality Criteria
for Particulate Matter and Sulfur Oxides (1982). Research Triangle Park, NC:
Office of Health and Environmental Assessment, Environmental Criteria and
Assessment Office. EPA–600/FP–93/002.
Available at: http://cfpub.epa.gov/ncea/ cfm/recordisplay.cfm?deid=96580. EPA. (1994b). Review of the National Ambient Air Quality Standards for
Sulfur Oxides: Assessment of Scientific and Technical Information, Supplement to the 1986 OAQPS Staff Paper Addendum. Research Triangle Park, NC: Office of Air Quality Planning and
Standards. EPA–452/R–94/013. Sulfur
Dioxide Review Docket. Docket ID No. EPA–HQ–OAR–2007–0352. Available at http://www.regulations.gov. EPA. (2005). Review of the National Ambient Air Quality Standards for Particulate Matter: Policy Assessment of Scientific and Technical Information—OAQPS Staff Paper. Research Triangle Park, NC: Office of Air Quality Planning and
Standards. EPA–452/R–05–005a.
Available at: http://www.epa.gov/ttn/ naaqs/standards/pm/data/ pmstaffpaper

_ 20051221.pdf.


### 35591 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

EPA (2006). Air Quality Criteria for Ozone
and Related Photochemical Oxidants (Final); Available at: http:// www.epa.gov/ttn/naaqs/standards/
ozone/s

_ o3

_ cr

_ cd.html. EPA. (2007a). SO 2 NAAQS Review Plan— Draft. US EPA, Research Triangle Park,
NC: National Center for Environmental
Assessment. Available at http:// www.epa.gov/ttn/naaqs/standards/so2/

s

_ so2

_ cr

_ pd.html. EPA. (2007b). Sulfur Dioxide Health Assessment Plan: Scope and Methods for Exposure and Risk Assessment. US EPA Research Triangle Park, NC: Office of Air Quality Planning and Standards, Research Triangle Park. Available at: http://www.epa.gov/ttn/naaqs/
standards/so2/s

_ so2

_ cr

_ pd.html. EPA (2007c). Review of the National Ambient Air Quality Standards for Pb: Policy
Assessment of Scientific and Technical Information. OAQPS Staff paper. Office of Air Quality Planning and Standards, Research Triangle Park, NC. EPA–452/R–
07–013. Available at: http://www.epa.gov/ttn/naaqs/ standards/pb/data/

20071101

_ pb

_ staff.pd. EPA. (2007d). Review of the National Ambient Air Quality Standards for
Ozone: Assessment of Scientific and Technical Information, OAQPS Staff paper. Office of Air Quality Planning and Standards, Research Triangle Park, NC.
EPA–452/R–07–007a. Available at: http://epa.gov/ttn/naaqs/standards/
ozone/s

_ o3

_ cr

_ sp.html. EPA. (2007e). Review of the National Ambient Air Quality Standards for
Ozone: Ozone Health Risk Assessment
for Selected Urban Areas. Office of Air Quality Planning and Standards, Research Triangle Park, NC. EPA 452/R–
07–009. Available at: http:// www.epa.gov/ttn/naaqs/standards/
ozone/s

_ o3

_ cr

_ td.html. EPA. (2008a). Integrated Science Assessment (ISA) for Sulfur Oxides—Health Criteria (Final Report). EPA/600/R–08/047F.
Available at: http://cfpub.epa.gov/ncea/ cfm/recordisplay.cfm?deid=198843. EPA. (2008b). Integrated Science Assessment (ISA) for Oxides of Nitrogen—Health Criteria (Final Report). EPA/600/R–08/
071 . Available at: http://www.epa.gov/ ttn/naaqs/standards/nox/

s

_ nox

_ cr

_ isi.html. EPA. (2008c). Risk and Exposure Assessment to Support the Review of the NO 2 Primary National Ambient Air Quality Standard. EPA–452/R–08–008a;
Available at: http://www.epa.gov/ttn/ naaqs/standards/nox/s

_ nox

_ cr

_ rea.html. EPA. (2009a). Risk and Exposure Assessment to Support the Review of the SO 2 Primary National Ambient Air Quality Standards- Final Report. EPA–452/R–09– 007; Available at: http:// www.epa.gov/ttn/naaqs/standards/so2/

s

_ so2

_ cr

_ rea.html. EPA. (2009b). Modern SO 2 Instrument Performance Data. Spreadsheet of performance data for existing UVF analyzers. Office of Research and Development. Sulfur Dioxide Review Docket. Docket ID No. EPA–HQ–OAR–
2007–0352. Available at http:// www.regulations.gov. EPA. (2010). Responses to Significant Comments on the 2009 Proposed Rule on the Primary National Ambient Air Quality Standards for Sulfur Dioxide (December 8, 2009; 74 FR 64810) Sulfur
Dioxide Review Docket. Docket ID No. EPA–HQ–OAR–2007–0352. Available at http://www.regulations.gov. Also
available at: http://www.epa.gov/ttn/ naaqs/standards/so2/s

_ so2

_ cr

_ rc.html. Henderson. (2006). Letter to EPA Administrator Stephen Johnson: Clean Air Scientific Advisory Committee’s (CASAC) Peer Review of the Agency’s 2nd Draft Ozone Staff Paper. EPA– CASAC–07–001. October 24, 2006.
Sulfur Dioxide Review Docket. Docket ID No. EPA–HQ–OAR–2007–0352–0044.
Available at http://www.regulations.gov. Henderson. (2008a). Letter to EPA Administrator Stephen Johnson: Clean Air Scientific Advisory Committee’s (CASAC) Peer Review of EPA’s Integrated Science Assessment (ISA) for Sulfur Oxides—Health Criteria (Second External Review Draft, May 2008). EPA– CASAC–08–017 August 8, 2008. Sulfur
Dioxide Review Docket. Available at http://www.regulations.gov. Henderson. (2008b). Letter to EPA Administrator Stephen Johnson: Clean Air Scientific Advisory Committee’s (CASAC) Peer Review of EPA’s Risk and Exposure Assessment to Support the
Review of the SO 2 Primary National Ambient Air Quality Standards (First Draft, July 2008). EPA–CASAC–08–019. August 22, 2008. Sulfur Dioxide Review Docket. Docket ID No. EPA–HQ–OAR–
2007–0352–0034. Available at http:// www.regulations.gov. Ito K. (2007). Characterization of PM 2.5 , gaseous pollutants, and meteorological
interactions in the context of time-series health effects models. J Expos Sci Environ Epidemiol. 17:S45–S60. Jaffe DH, Singer ME, Rimm AA. (2003). Air pollution and emergency department visits for asthma among Ohio medicaid recipients, 1991–1996. Environ Res.

91:21–28. Johns. (2009). Presentation and analysis of controlled human exposure data
described in Table 3–1 of the 2008 Integrated Science Assessment (ISA) for Sulfur Oxides; April 29, 2009. Available

at: http://www.epa.gov/ttn/naaqs/
standards/so2/s

_ so2

_ cr

_ rea.html. Johns and Simmons (2009). Memorandum to the Sulfur Oxides NAAQS Review Docket. Quality Assurance Review of Individual Subject Data Presented in Table 3–1 of the 2008 Integrated Science Assessment (ISA) for Sulfur Oxides. Air Quality Criteria for Sulfur Oxides Docket. Docket ID No. EPA–HQ–ORD–
2006–0260–0036. Available at http:// www.regulations.gov. Linn WS, Avol EL, Peng RC, Shamoo DA,Hackney JD. (1987). Replicated doseresponse study of sulfur dioxide effects in normal, atopic, and asthmatic volunteers. Am Rev Respir Dis.

136:1127–1134. NY DOH. (2006). A Study of Ambient Air
Contaminants and Asthma in New York City. ATSDR Final Report #NTIS PB2006–113523. Albany, NY; New York State Energy Research and Development Authority; New York State Department of Health, for Atlanta, GA; Agency for Toxic Substances and Disease Registry; U.S. Department of Health and Human

Services. Samet JM. (2009). Letter to EPA Administrator Lisa P. Jackson: Clean Air Scientific Advisory Committee’s (CASAC) Review of EPA’s Risk and Exposure Assessment to Support the
Review of the SO 2 Primary National Ambient Air Quality Standards: Second Draft. EPA–CASAC–09–007, May 18,
2009. Sulfur Dioxide Review Docket. Docket ID No. EPA–HQ–OAR–2007–
0352–0035. Available at http:// www.regulations.gov. Schwartz J. (1995). Short term fluctuations in air pollution and hospital admissions of the elderly for respiratory disease.
Thorax. 50:531–538. Thompson R. (2009). Sulfur Dioxide Descriptive Statistics Tables. Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, NC. Sulfur
Dioxide Review Docket. Docket ID No. EPA–HQ–OAR–2007–0352–0036.
Available at http://www.regulations.gov. Thompson R and Stewart MJ. (2009). Air Quality Statistics for Cities Referenced in Key U.S. and Canadian Hospital Admission and Emergency Department Visits for All Respiratory Causes and Asthma. Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, NC. Sulfur Dioxide Review Docket. Docket ID No. EPA–HQ–OAR–2007–
0352–0018. Available at http:// www.regulations.gov. Watkins and Thompson. (2009). SO 2 Network Review and Background; OAQPS; Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, NC. Sulfur Dioxide NAAQS Review Docket. (OAR– 2005–0352). Sulfur Dioxide Review Docket. Docket ID No. EPA–HQ–OAR–
2007–0352–0037. Available at http:// www.regulations.gov. Wilson AM, Wake CP, Kelly T, Salloway JC. (2005). Air pollution, weather, and respiratory emergency room visits in two northern New England cities: An ecological time-series study. Environ

Res. 97:312–321.

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 53

Environmental protection, Administrative practice and procedure, Air pollution control, Intergovernmental


### 35592 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

relations, Reporting and recordkeeping requirements.

40 CFR Part 58

Environmental protection, Administrative practice and procedure, Air pollution control, Intergovernmental relations, Reporting and recordkeeping requirements.

Dated: June 2, 2010.
Lisa P. Jackson,

Administrator.

■ For the reasons stated in the preamble, title 40, chapter I of the Code of Federal Regulations is amended as follows:

**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. Section 50.4 is amended by adding paragraph (e) to read as follows: **§ 50.4 National primary ambient air quality standards for sulfur oxides (sulfur dioxide).** 

* * * * *

(e) The standards set forth in this section will remain applicable to all areas notwithstanding the promulgation
of SO 2 national ambient air quality standards (NAAQS) in § 50.17. The SO 2 NAAQS set forth in this section will no longer apply to an area one year after the effective date of the designation of that area, pursuant to section 107 of the Clean Air Act, for the SO 2 NAAQS set forth in § 50. 17; except that for areas designated nonattainment for the SO 2 NAAQS set forth in this section as of the effective date of § 50. 17, and areas not meeting the requirements of a SIP call with respect to requirements for the SO 2 NAAQS set forth in this section, the SO 2 NAAQS set forth in this section will apply until that area submits, pursuant to section 191 of the Clean Air Act, and EPA approves, an implementation plan providing for attainment of the SO 2 NAAQS set forth in § 50.17. ■ 3. Section 50.14 is amended by revising paragraph (c)(2)(vi) to read as
follows:

**§ 50.14 Treatment of air quality monitoring data influenced by exceptional events.** 

* * * * *

(c) * * * (2) * * * (vi) 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. Table 1 provides the schedule for submission of flags with initial descriptions in AQS and detailed
documentation. These schedules shall apply for those data which will or may influence the initial designation of areas for those NAAQS. EPA anticipates revising Table 1 as necessary to
accommodate revised data submission schedules for new or revised NAAQS.



### T ABLE 

### 1—S CHEDULE OF 

### E XCEPTIONAL 

### E VENT 

### F LAGGING AND 

### D OCUMENTATION 

### S UBMISSION FOR 

### D ATA 

### T O 

### B E 

### U SED IN 

### D ESIGNATIONS 

### D ECISIONS FOR 

### N EW OR 

### R EVISED 

### NAAQS

NAAQS Pollutant/standard/(level)/promulgation date Air quality data collected for calendar year Event flagging & initial description deadline Detailed documentation submission deadline

PM 2.5 /24-Hr Standard (35 μ g/m3) Promulgated October 17, 2006. 2004–2006 October 1, 2007 a .................................... April 15, 2008. a

Ozone/8-Hr Standard (0.075 ppm) Promulgated March 12, 2008. 2005–2007

2008

2009 June 18, 2009 a

....................................... June 18, 2009 a

....................................... 60 days after the end of the calendar

quarter in which the event occurred orFebruary 5, 2010, whichever date occurs first b

. June 18, 2009 a June 18, 2009 1 60 days after the end of the calendar

quarter in which the event occurred orFebruary 5, 2010, whichever date occurs first. b

NO 2 /1-Hour Standard (80–100 PPB, final

level TBD). 2008

2009

2010 July 1, 2010 a

........................................... July 1, 2010 a

........................................... April 1, 2011 a

.......................................... January 22, 2011. a January 22, 2011. a July 1, 2010. a

SO 2 /1-Hour Standard (50–100 PPB,

final level TBD). 2008

2009

2010 October 1, 2010 b

.................................... October 1, 2010 b

.................................... June 1, 2011. b

........................................ June 1, 2011. b June 1, 2011. b June 1, 2011. b 2011 60 days after the end of the calendar quarter in which the event occurred orMarch 31, 2012, whichever date occurs first b

. 60 days after the end of the calendar quarter in which the event occurred orMarch 31, 2012, whichever date occurs first. b

a These dates are unchanged from those published in the original rulemaking, or are being proposed elsewhere and are shown in this table for informational purposes—the Agency is not opening these dates for comment under this rulemaking.

b Indicates change from general schedule in 40 CFR 50.14.

Note: EPA notes that the table of revised

deadlines only applies to data EPA will use to establish the final initial designations for new or revised NAAQS. The general schedule applies for all other purposes, most notably, for data used by EPA for redesignations to attainment.

* * * * *

■ 4. A new 50.17 is added to read as
follows: **§ 50.17 National primary ambient air quality standards for sulfur oxides (sulfur**  **dioxide).**

(a) The level of the national primary 1-hour annual ambient air quality standard for oxides of sulfur is 75 parts per billion (ppb, which is 1 part in 1,000,000,000), measured in the ambient air as sulfur dioxide (SO 2 ).

(b) The 1-hour primary standard is met at an ambient air quality monitoring site when the three-year average of the annual (99th percentile) of the daily maximum 1-hour average concentrations is less than or equal to 75 ppb, as determined in accordance with Appendix T of this part.

(c) The level of the standard shall be measured by a reference method based on Appendix A or A–1 of this part, or by a Federal Equivalent Method (FEM)


### 35593 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

designated in accordance with part 53 of this chapter.

■ 5. Add Appendix A–1 to Part 50 to
read as follows:

Appendix A–1 to Part 50—Reference Measurement Principle and Calibration
Procedure for the Measurement of Sulfur Dioxide in the Atmosphere (Ultraviolet Fluorescence Method)

1.0 Applicability

1.1 This ultraviolet fluorescence (UVF) method provides a measurement of the concentration of sulfur dioxide (SO 2 ) in ambient air for determining compliance with the national primary and secondary ambient air quality standards for sulfur oxides (sulfur dioxide) as specified in § 50.4, § 50.5, and § 50.17 of this chapter. The method is applicable to the measurement of ambient

SO 2 concentrations using continuous (realtime) sampling. Additional quality assurance procedures and guidance are provided in part 58, Appendix A, of this chapter and in
Reference 3.

2.0 Principle

2.1 This reference method is based on automated measurement of the intensity of the characteristic fluorescence released by

SO 2 in an ambient air sample contained in a measurement cell of an analyzer when the air sample is irradiated by ultraviolet (UV) light passed through the cell. The fluorescent light released by the SO 2 is also in the ultraviolet region, but at longer wavelengths than the excitation light. Typically, optimum
instrumental measurement of SO 2 concentrations is obtained with an excitation wavelength in a band between approximately 190 to 230 nm, and measurement of the SO 2 fluorescence in a broad band around 320 nm, but these wavelengths are not necessarily
constraints of this reference method. Generally, the measurement system (analyzer) also requires means to reduce the effects of aromatic hydrocarbon species, and possibly other compounds, in the air sample
to control measurement interferences from these compounds, which may be present in
the ambient air. References 1 and 2 describe
UVF method.

2.2 The measurement system is calibrated by referencing the instrumental fluorescence

measurements to SO 2 standard
concentrations traceable to a National Institute of Standards and Technology (NIST) primary standard for SO 2 ( see Calibration Procedure below).

2.3 An analyzer implementing this measurement principle is shown schematically in Figure 1. Designs should include a measurement cell, a UV light source of appropriate wavelength, a UV detector system with appropriate wave length sensitivity, a pump and flow control system for sampling the ambient air and moving it into the measurement cell, sample air conditioning components as necessary to minimize measurement interferences, suitable control and measurement processing capability, and other apparatus as may be necessary. The analyzer must be designed to provide accurate, repeatable, and continuous
measurements of SO 2 concentrations in ambient air, with measurement performance as specified in Subpart B of Part 53 of this chapter.

2.4 Sampling considerations: The use of a particle filter on the sample inlet line of a

UVF SO 2 analyzer is required to prevent interference, malfunction, or damage due to particles in the sampled air.

3.0 Interferences

3.1 The effects of the principal potential interferences may need to be mitigated to meet the interference equivalent requirements of part 53 of this chapter. Aromatic hydrocarbons such as xylene and naphthalene can fluoresce and act as strong positive interferences. These gases can be removed by using a permeation type scrubber (hydrocarbon ‘‘ kicker ’’ ). Nitrogen oxide (NO) in high concentrations can also fluoresce and cause positive interference. Optical filtering can be employed to improve the rejection of interference from high NO. Ozone can absorb UV light given off by the SO 2 molecule and
cause a measurement offset. This effect can be reduced by minimizing the measurement path length between the area where SO 2 fluorescence occurs and the photomultiplier tube detector ( e.g. <5 cm). A hydrocarbon scrubber, optical filter and appropriate distancing of the measurement path length may be required method components to
reduce interference.

4.0 Calibration Procedure

Atmospheres containing accurately known concentrations of sulfur dioxide are prepared using a compressed gas transfer standard diluted with accurately metered clean air
flow rates.

4.1 Apparatus: Figure 2 shows a typical generic system suitable for diluting a SO 2 gas cylinder concentration standard with clean air through a mixing chamber to produce the
desired calibration concentration standards. A valve may be used to conveniently divert
the SO 2 from the sampling manifold to provide clean zero air at the output manifold for zero adjustment. The system may be made up using common laboratory components, or it may be a commercially manufactured system. In either case, the principle components are as follows:

4.1.1 SO 2 standard gas flow control and measurement devices (or a combined device) capable of regulating and maintaining the standard gas flow rate constant to within ± 2 percent and measuring the gas flow rate
accurate to within ± 2, properly calibrated to
a NIST-traceable standard.

4.1.2 Dilution air flow control and measurement devices (or a combined device) capable of regulating and maintaining the air
flow rate constant to within ± 2 percent and measuring the air flow rate accurate to within

± 2, properly calibrated to a NIST-traceable
standard.

4.1.3 Mixing chamber, of an inert material such as glass and of proper design to provide thorough mixing of pollutant gas
and diluent air streams.

4.1.4 Sampling manifold, constructed of glass, polytetrafluoroethylene (PTFE
Teflon TM ), or other suitably inert material
and of sufficient diameter to insure a minimum pressure drop at the analyzer connection, with a vent designed to insure a minimum over-pressure (relative to ambient air pressure) at the analyzer connection and to prevent ambient air from entering the

manifold.

4.1.5 Standard gas pressure regulator, of

clean stainless steel with a stainless steel diaphragm, suitable for use with a high pressure SO 2 gas cylinder.

4.1.6 Reagents

4.1.6.1 SO 2 gas concentration transfer standard having a certified SO 2 concentration of not less than 10 ppm, in N 2 , traceable to a NIST Standard Reference Material (SRM).

4.1.6.2 Clean zero air, free of

contaminants that could cause a detectable response or a change in sensitivity of the analyzer. Since ultraviolet fluorescence analyzers may be sensitive to aromatic hydrocarbons and O 2 -to-N 2 ratios, it is important that the clean zero air contains less than 0.1 ppm aromatic hydrocarbons and O 2 and N 2 percentages approximately the same as in ambient air. A procedure for generating zero air is given in reference 1.

4.2 Procedure

4.2.1 Obtain a suitable calibration apparatus, such as the one shown schematically in Figure 1, and verify that all materials in contact with the pollutant are of glass, Teflon TM , or other suitably inert material and completely clean.

4.2.2 Purge the SO 2 standard gas lines and pressure regulator to remove any

residual air.

4.2.3 Ensure that there are no leaks in the system and that the flow measuring devices are properly and accurately calibrated under the conditions of use against a reliablevolume or flow rate standard such as a soapbubble meter or a wet-test meter traceable to

a NIST standard. All volumetric flow rates

should be corrected to the same reference temperature and pressure by using the

formula below:



### F F

c m



### = + 

## ( ) 298 15

760 273 15 .

. P

T m

m

Where:

F

c = corrected flow rate (L/min at 25 ° C and 760 mm Hg),

F

m = measured flow rate, (at temperature, T

m and pressure, P

m ),

P

m = measured pressure in mm Hg, (absolute), and

T

m = measured temperature in degrees
Celsius.

4.2.4 Allow the SO 2 analyzer under calibration to sample zero air until a stable response is obtained, then make the proper zero adjustment.

4.2.5 Adjust the airflow to provide an SO 2 concentration of approximately 80 percent of the upper measurement range limit of the

SO 2 instrument and verify that the total air flow of the calibration system exceeds the demand of all analyzers sampling from the output manifold (with the excess vented).

4.2.6 Calculate the actual SO 2 calibration
concentration standard as:


### 35594 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

SO C F

F

p

t 2 

# [ ]

=

Where:

C = the concentration of the SO 2 gas standard

F

p = the flow rate of SO 2 gas standard

F

t = the total air flow rate of pollutant and diluent gases

4.2.7 When the analyzer response has stabilized, adjust the SO 2 span control to obtain the desired response equivalent to the

calculated standard concentration. If substantial adjustment of the span control is needed, it may be necessary to re-check the zero and span adjustments by repeating steps 4.2.4 through 4.2.7 until no further adjustments are needed.

4.2.8 Adjust the flow rate(s) to provide

several other SO 2 calibration concentrations over the analyzer’s measurement range. At least five different concentrations evenly spaced throughout the analyzer’s range are suggested. 4.2.9 Plot the analyzer response (vertical or Y-axis) versus SO 2 concentration (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.

Note: Additional information on calibration and pollutant standards is provided in Section 12 of Reference 3.

5.0 Frequency of Calibration

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 Reference 3, Appendix D: Measurement Quality Objectives and Validation Template for SO 2 (page 9 of 30). The user’s quality control program should 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/operation manuals information and guidance as to
these variables and on other matters of operation, calibration, routine maintenance, and quality control.

6.0 References for SO 2 Method
1. H. Okabe, P. L. Splitstone, and J. J. Ball,

‘‘ Ambient and Source SO 2 Detector Based
on a Fluorescence Method ’’

, Journal of the Air Control Pollution Association, vol. 23, p. 514–516 (1973). 2. F. P. Schwarz, H. Okabe, and J. K. Whittaker, ‘‘ Fluorescence Detection of Sulfur Dioxide in Air at the Parts per Billion Level, ’’ Analytical Chemistry, vol. 46, pp. 1024–1028 (1974).

3. QA Handbook for Air Pollution Measurement Systems—Volume II. Ambient Air Quality Monitoring Programs. U.S. EPA. EPA–454/B–08–003 (2008).

**BILLING CODE 6560–50–P**


### 35595 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

**BILLING CODE 6560–50–C**

■ 6. Appendix A to Part 50 is redesignated as Appendix A–2 to Part

50.

■ 7. Appendix T to Part 50 is added to
read as follows:

Appendix T to Part 50—Interpretation of the Primary National Ambient Air Quality Standards for Oxides of Sulfur (Sulfur Dioxide)

1. General

(a) This appendix explains the data handling conventions and computations necessary for determining when the primary national ambient air quality standards for Oxides of Sulfur as measured by Sulfur Dioxide ( ‘‘ SO 2 NAAQS ’’ ) specified in § 50.17 are met at an ambient air quality monitoring site. Sulfur Dioxide (SO 2 ) is measured in the ambient air by a Federal reference method (FRM) based on appendix A or A–1 to this part or by a Federal equivalent method (FEM) designated in accordance with part 53 of this chapter. Data handling and computation procedures to be used in making comparisons between reported SO 2 concentrations and the levels of the SO 2 NAAQS are specified in the following

sections.

(b) Decisions to exclude, retain, or make adjustments to the data affected by exceptional events, including natural events, are made according to the requirements and process deadlines specified in §§ 50.1, 50.14 and 51.930 of this chapter. (c) The terms used in this appendix are
defined as follows:

Daily maximum 1-hour values for SO 2 refers to the maximum 1-hour SO 2 concentration values measured from midnight to midnight (local standard time) that are used in NAAQS computations.

Design values are the metrics ( i.e., statistics) that are compared to the NAAQS levels to determine compliance, calculated as specified in section 5 of this appendix. The design value for the primary 1-hour NAAQS is the 3-year average of annual 99th percentile daily maximum 1-hour values for a monitoring site (referred to as the ‘‘ 1-hour primary standard design value ’’ ).

99th percentile daily maximum 1-hour
value is the value below which nominally 99 percent of all daily maximum 1-hour concentration values fall, using the ranking and selection method specified in section 5 of this appendix.

Pollutant Occurrence Code (POC) refers to a numerical code (1, 2, 3, etc. ) used to distinguish the data from two or more monitors for the same parameter at a single monitoring site.

Quarter refers to a calendar quarter.

Year refers to a calendar year.

2. Requirements for Data Used for Comparisons With the SO 2 NAAQS and Data Reporting Considerations

(a) All valid FRM/FEM SO 2 hourly data required to be submitted to EPA’s Air Quality System (AQS), or otherwise available to EPA, meeting the requirements of part 58 of this chapter including appendices A, C, and E shall be used in design value calculations. Multi-hour average concentration values collected by wet chemistry methods shall not
be used.

(b) Data from two or more monitors from the same year at the same site reported to
EPA under distinct Pollutant Occurrence Codes shall not be combined in an attempt to meet data completeness requirements. The
Administrator will combine annual 99th percentile daily maximum concentration
values from different monitors in different years, selected as described here, for the purpose of developing a valid 1-hour primary standard design value. If more than one of the monitors meets the completeness requirement for all four quarters of a year, the steps specified in section 5(a) of this appendix shall be applied to the data from the monitor with the highest average of the four quarterly completeness values to derive a valid annual 99th percentile daily
maximum concentration. If no monitor is complete for all four quarters in a year, the steps specified in section 3(c) and 5(a) of this appendix shall be applied to the data from the monitor with the highest average of the four quarterly completeness values in an attempt to derive a valid annual 99th percentile daily maximum concentration. This paragraph does not prohibit a monitoring agency from making a local designation of one physical monitor as the primary monitor for a Pollutant Occurrence Code and substituting the 1-hour data from a second physical monitor whenever a valid
concentration value is not obtained from the primary monitor; if a monitoring agency substitutes data in this manner, each substituted value must be accompanied by an


### 35596 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

AQS qualifier code indicating that
substitution with a value from a second physical monitor has taken place.

(c) Hourly SO 2 measurement data shall be reported to AQS in units of parts per billion (ppb), to at most one place after the decimal, with additional digits to the right being truncated with no further rounding.

3. Comparisons With the 1-Hour Primary

SO 2 NAAQS

(a) The 1-hour primary SO 2 NAAQS is met at an ambient air quality monitoring site when the valid 1-hour primary standard design value is less than or equal to 75 parts per billion (ppb).

(b) An SO 2 1-hour primary standard design value is valid if it encompasses three consecutive calendar years of complete data. A year meets data completeness requirements when all 4 quarters are complete. A quarter is complete when at least 75 percent of the sampling days for each quarter have complete data. A sampling day has complete data if 75 percent of the hourly concentration values, including State-flagged data affected by exceptional events which have been approved for exclusion by the Administrator, are reported.

(c) In the case of one, two, or three years that do not meet the completeness requirements of section 3(b) of this appendix and thus would normally not be useable for the calculation of a valid 3-year 1-hour primary standard design value, the 3-year 1- hour primary standard design value shall
nevertheless be considered valid if one of the following conditions is true.

(i) At least 75 percent of the days in each quarter of each of three consecutive years have at least one reported hourly value, and the design value calculated according to the procedures specified in section 5 is above the level of the primary 1-hour standard.

(ii) (A) A 1-hour primary standard design value that is equal to or below the level of the NAAQS can be validated if the substitution test in section 3(c)(ii)(B) results

in a ‘‘ test design value ’’ that is below the level of the NAAQS. The test substitutes actual

‘‘ high ’’ reported daily maximum 1-hour
values from the same site at about the same time of the year (specifically, in the same calendar quarter) for unknown values that were not successfully measured. Note that the test is merely diagnostic in nature, intended to confirm that there is a very high likelihood that the original design value (the one with less than 75 percent data capture of hours by day and of days by quarter) reflects the true under-NAAQS-level status for that 3- year period; the result of this data substitution test (the ‘‘ test design value ’’ , as defined in section 3(c)(ii)(B)) is not considered the actual design value. For this test, substitution is permitted only if there are at least 200 days across the three matching quarters of the three years under consideration (which is about 75 percent of all possible daily values in those three quarters) for which 75 percent of the hours in the day, including State-flagged data affected by exceptional events which have been approved for exclusion by the Administrator, have reported concentrations. However, maximum 1-hour values from days with less than 75 percent of the hours reported shall also be considered in identifying the high value to be used for
substitution.

(B) The substitution test is as follows: Data substitution will be performed in all quarter periods that have less than 75 percent data capture but at least 50 percent data capture, including State-flagged data affected by exceptional events which have been approved for exclusion by the Administrator; if any quarter has less than 50 percent data capture then this substitution test cannot be used. Identify for each quarter ( e.g., January– March) the highest reported daily maximum1-hour value for that quarter, excluding Stateflagged data affected by exceptional events which have been approved for exclusion by the Administrator, looking across those three months of all three years under consideration. All daily maximum 1-hour values from all days in the quarter period shall be considered when identifying this highest value, including days with less than 75 percent data capture. If after substituting the highest reported daily maximum 1-hour value for a quarter for as much of the missing daily data in the matching deficient quarter(s) as is needed to make them 100 percent complete, the procedure in section 5 yields a recalculated 3-year 1-hour standard

‘‘ test design value ’’ less than or equal to the level of the standard, then the 1-hour primary standard design value is deemed to have passed the diagnostic test and is valid, and
the level of the standard is deemed to have been met in that 3-year period. As noted in section 3(c)(i), in such a case, the 3-year design value based on the data actually reported, not the ‘‘ test design value ’’ , shall be used as the valid design value.

(iii) (A) A 1-hour primary standard design value that is above the level of the NAAQS
can be validated if the substitution test in section 3(c)(iii)(B) results in a ‘‘ test design
value ’’ that is above the level of the NAAQS.
The test substitutes actual ‘‘ low ’’ reported daily maximum 1-hour values from the same site at about the same time of the year (specifically, in the same three months of the calendar) for unknown hourly values that were not successfully measured. Note that the test is merely diagnostic in nature, intended to confirm that there is a very high likelihood that the original design value (the one with less than 75 percent data capture of hours by day and of days by quarter) reflects the true above-NAAQS-level status for that 3- year period; the result of this data substitution test (the ‘‘ test design value ’’ , as defined in section 3(c)(iii)(B)) is not considered the actual design value. For this test, substitution is permitted only if there are a minimum number of available daily data points from which to identify the low quarter-specific daily maximum 1-hour values, specifically if there are at least 200 days across the three matching quarters of the three years under consideration (which is about 75 percent of all possible daily values in those three quarters) for which 75 percent of the hours in the day have reported concentrations. Only days with at least 75 percent of the hours reported shall be considered in identifying the low value to be
used for substitution. (B) The substitution test is as follows: Data substitution will be performed in all quarter periods that have less than 75 percent data capture. Identify for each quarter ( e.g., January–March) the lowest reported daily maximum 1-hour value for that quarter, looking across those three months of all three years under consideration. All daily maximum 1-hour values from all days with at least 75 percent capture in the quarter period shall be considered when identifying this lowest value. If after substituting the lowest reported daily maximum 1-hour value for a quarter for as much of the missing daily data in the matching deficient quarter(s) as is needed to make them 75 percent complete, the procedure in section 5 yields a recalculated 3-year 1-hour standard ‘‘ test design value ’’ above the level of the standard, then the 1-hour primary standard design value is deemed to have passed the diagnostic test and is valid, and the level of
the standard is deemed to have been exceeded in that 3-year period. As noted in section 3(c)(i), in such a case, the 3-year design value based on the data actually reported, not the ‘‘ test design value ’’ , shall be used as the valid design value.

(d) A 1-hour primary standard design value
based on data that do not meet the completeness criteria stated in 3(b) and also do not satisfy section 3(c), may also be considered valid with the approval of, or at the initiative of, the Administrator, who may consider factors such as monitoring site closures/moves, monitoring diligence, the consistency and levels of the valid
concentration measurements that are available, and nearby concentrations in determining whether to use such data.

(e) The procedures for calculating the 1- hour primary standard design values are given in section 5 of this appendix.

4. Rounding Conventions for the 1-Hour Primary SO 2 NAAQS

(a) Hourly SO 2 measurement data shall be reported to AQS in units of parts per billion (ppb), to at most one place after the decimal, with additional digits to the right being truncated with no further rounding.

(b) Daily maximum 1-hour values and therefore the annual 99th percentile of those daily values are not rounded.

(c) The 1-hour primary standard design value is calculated pursuant to section 5 and
then rounded to the nearest whole number or 1 ppb (decimals 0.5 and greater are rounded up to the nearest whole number, and any
decimal lower than 0.5 is rounded down to the nearest whole number).

5. Calculation Procedures for the 1-Hour Primary SO 2 NAAQS

(a) Procedure for identifying annual 99th percentile values. When the data for a particular ambient air quality monitoring site and year meet the data completeness requirements in section 3(b), or if one of the conditions of section 3(c) is met, or if the Administrator exercises the discretionary authority in section 3(d), identification of annual 99th percentile value is accomplished
as follows.

(i) The annual 99th percentile value for a year is the higher of the two values resulting from the following two procedures.


### 35597 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

(1) Procedure 1. For the year, determine the number of days with at least 75 percent of the hourly values reported.

(A) For the year, determine the number of days with at least 75 percent of the hourly values reported including State-flagged data affected by exceptional events which have been approved for exclusion by the
Administrator.

(B) For the year, from only the days with at least 75 percent of the hourly values reported, select from each day the maximum hourly value excluding State-flagged data affected by exceptional events which have been approved for exclusion by the
Administrator.

(C) Sort all these daily maximum hourly values from a particular site and year by descending value. (For example: (x[1], x[2], x[3], * * *, x[n]). In this case, x[1] is the largest number and x[n] is the smallest value.) The 99th percentile is determined from this sorted series of daily values which is ordered from the highest to the lowest number. Using the left column of Table 1, determine the appropriate range ( i.e., row) for the annual number of days with valid data for year y (cn y ). The corresponding ‘‘ n ’’ value in the right column identifies the rank of the annual 99th percentile value in the descending sorted list of daily site values for year y. Thus, P 0.99, y = the nth largest value.

(2) Procedure 2. For the year, determine the number of days with at least one hourly value reported.

(A) For the year, determine the number of days with at least one hourly value reported including State-flagged data affected by exceptional events which have been approved for exclusion by the Administrator.

(B) For the year, from all the days with at least one hourly value reported, select from each day the maximum hourly value excluding State-flagged data affected by exceptional events which have been approved for exclusion by the Administrator.

(C) Sort all these daily maximum values from a particular site and year by descending value. (For example: (x[1], x[2], x[3], * * *, x[n]). In this case, x[1] is the largest number and x[n] is the smallest value.) The 99th percentile is determined from this sorted series of daily values which is ordered from the highest to the lowest number. Using the left column of Table 1, determine the appropriate range ( i.e., row) for the annual number of days with valid data for year y (cn y ). The corresponding ‘‘ n ’’ value in the right column identifies the rank of the annual 99th percentile value in the descending sorted list of daily site values for year y. Thus, P 0.99,y = the nth largest value.

(b) The 1-hour primary standard design value for an ambient air quality monitoring

site is mean of the three annual 99th percentile values, rounded according to the

conventions in section 4.



### T ABLE 

### 1

Annual number of days with valid data

for year ‘‘ y ’’ (cn y ) P 0.99,y is the nth maximum value of the year, where n is the listed number

1–100 ........................ 1

101–200 .................... 2

201–300 .................... 3

301–366 .................... 4

**PART 53–AMBIENT AIR MONITORING**
**REFERENCE AND EQUIVALENT**
**METHODS**

■ 8. The authority citation for part 53
continues to read as follows:

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—[Amended]**

■ 9. Section 53.2 is amended by revising paragraphs (a)(1) and (b) to read as
follows: **§ 53.2 General requirements for a**

**reference method determination.**

* * * * *

(a) Manual methods —(1) Sulfur dioxide (SO 2 ) and Lead. For measuring

SO 2 and lead, appendixes A–2 and G of part 50 of this chapter specify unique manual FRM for measuring those pollutants. Except as provided in § 53.16, other manual methods for lead

will not be considered for a reference method determination under this part.

* * * * *

(b) Automated methods. An automated FRM for measuring SO 2 , CO,

O 3 , or NO 2 must utilize the measurement principle and calibration procedure specified in the appropriate appendix to part 50 of this chapter (appendix A–1 only for SO 2 methods)

and must have been shown in accordance with this part to meet the requirements specified in this subpart A and subpart B of this part.

■ 10. Section 53.8 is amended by revising paragraph (c) to read as follows:

**§ 53.8 Designation of reference and equivalent methods.** 

* * * * *

(c) The Administrator will maintain a current list of methods designated as

FRM or FEM in accordance with this part and will send a copy of the list to any person or group upon request. A copy of the list will be available via the Internet and may be available from other

sources.

■ 11. Table A–1 to Subpart A is revised

to read as follows:



### T ABLE 

### A–1 TO 

### S UBPART 

### A OF 

### P ART 

### 53—S UMMARY OF 

### A PPLICABLE 

### R EQUIREMENTS FOR 

### R EFERENCE AND 

### E QUIVALENT 

### M ETHODS FOR 

### A IR 

### M ONITORING OF 

### C RITERIA 

### P OLLUTANTS

Pollutant Reference or equivalent Manual or automated Applicable part 50 appendix Applicable subparts of part 53

A B C D E F

SO 2 .......... Reference .................... Manual ......................... A–2

Automated ................... A–1 ✓ ✓ Equivalent .................... Manual ......................... A–1 ✓ ✓
Automated ................... A–1 ✓ ✓ ✓
CO ............ Reference .................... Automated ................... C ✓ ✓ Equivalent .................... Manual ......................... C ✓ ✓
Automated ................... C ✓ ✓ ✓
O 3 ............. Reference .................... Automated ................... D ✓ ✓ Equivalent .................... Manual ......................... D ✓ ✓
Automated ................... D ✓ ✓ ✓
NO 2 .......... Reference .................... Automated ................... F ✓ ✓ Equivalent .................... Manual ......................... F ✓ ✓
Automated ................... F ✓ ✓ ✓
Pb ............. Reference .................... Manual ......................... G Equivalent .................... Manual ......................... G ✓ ✓
Automated ................... G ✓ ✓

PM 10 -Pb ... Reference .................... Manual ......................... Q Equivalent .................... Manual ......................... Q ✓ ✓


### 35598 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

T ABLE 

### A–1 TO 

### S UBPART 

### A OF 

### P ART 

### 53—S UMMARY OF 

### A PPLICABLE 

### R EQUIREMENTS FOR 

### R EFERENCE AND 

### E QUIVALENT 

### M ETHODS FOR 

### A IR 

### M ONITORING OF 

### C RITERIA 

### P OLLUTANTS 

### —Continued

Pollutant Reference or equivalent Manual or automated Applicable part 50 appendix Applicable subparts of part 53

A B C D E F

Automated ................... Q ✓ ✓

PM 10 ......... Reference .................... Manual ......................... J ✓ ✓ Equivalent .................... Manual ......................... J ✓ ✓ ✓
Automated ................... J ✓ ✓ ✓

PM 2.5 ........ Reference .................... Manual ......................... L ✓ ✓ Equivalent Class I ....... Manual ......................... L ✓ ✓ ✓ Equivalent Class II ...... Manual ......................... L 1 ✓ ✓ 2 ✓ ✓ 1 2 Equivalent Class III ..... Automated ................... L 1 ✓ ✓ ✓ ✓ 1

PM 10–2.5 .... Reference .................... Manual ......................... L, O ✓ ✓ Equivalent Class I ....... Manual ......................... L, O ✓ ✓ ✓ Equivalent Class II ...... Manual ......................... L, O ✓ ✓ 2 ✓ ✓ 1 2 Equivalent Class III ..... Automated ................... L 1 , O 1 ✓ ✓ ✓ ✓ 1

1. Some requirements may apply, based on the nature of each particular candidate method, as determined by the Administrator. 2. Alternative Class III requirements may be substituted.

**Subpart B—[Amended]**

■ 12. Section 53.20 is amended by revising paragraph (b) and Table B–1 in paragraph (c) to read as follows:

**§ 53.20 General provisions.**

* * * * *

(b) For a candidate method having
more than one selectable measurement range, one range must be that specified in table B–1 (standard range for SO 2 ), and a test analyzer representative of the method must pass the tests required by this subpart while operated in that range. The tests may be repeated for one or more broader ranges ( i.e., ones extending to higher concentrations) than the range specified in table B–1, provided that the range does not extend to concentrations more than four times the upper range limit specified in table B–1. For broader ranges, only the tests for range (calibration), noise at 80% of the upper range limit, and lag, rise and fall time are required to be repeated. The tests may be repeated for one or more narrower ranges (ones extending to lower concentrations) than that specified in table B–1. For SO 2 methods, table B–1 specifies special performance requirements for narrower (lower) ranges. For methods other than SO 2 , only the tests for range (calibration), noise at 0% of the measurement range, and lower detectable limit are required to be repeated. If the tests are conducted or passed only for the specified range (standard range for SO 2 ), any FRM or FEM method determination with respect to the method will be limited to that range. If the tests are passed for both the specified range and one or more broader ranges, any such determination will include the additional range(s) as well as the specified range, provided that the tests required by subpart C of this part (if applicable) are met for the broader range(s). If the tests are passed for both the specified range and one or more narrower ranges, any FRM or FEM
method determination for the method will include the narrower range(s) as well as the specified range. Appropriate
test data shall be submitted for each range sought to be included in a FRM
or FEM method determination under this paragraph (b).

(c) * * *



### T ABLE 

### B–1—P ERFORMANCE 

### S PECIFICATIONS FOR 

### A UTOMATED 

### M ETHODS

Performance parameter Units 1 SO 2
O 3 CO NO 2 Definitions and test procedures Std. range 3 Lower

range 2 3

1. Range ......................................... ppm .............. 0–0 .5 <0 .5 0–0 .5 0–50 0–0 .5 Sec. 53.23(a). 2. Noise .......................................... ppm .............. 0 .001 0 .0005 0 .005 0.5 0 .005 Sec. 53.23(b). 3. Lower detectable limit ................ ppm .............. 0 .002 0 .001 0 .010 1.0 0 .010 Sec. 53.23(c). 4. Interference equivalent Each interferent ....................... ppm .............. ± 0 .005 4 ± 0 .005 ± 0 .02 ± 1.0 ± 0 .02 Sec. 53.23(d). Total, all interferents ................ ppm .............. — — 0 .06 1.5 0 .04 Sec. 53.23(d). 5. Zero drift, 12 and 24 hour .......... ppm .............. ± 0 .004 ± 0 .002 ± 0 .02 ± 1.0 ± 0 .02 Sec. 53.23(e). 6. Span drift, 24 hour 20% of upper range limit ......... Percent ......... — — ± 20 .0 ± 10.0 ± 20 .0 Sec. 53.23(e). 80% of upper range limit ......... Percent ......... ± 3 .0 ± 3 .0 ± 5 .0 ± 2.5 ± 5 .0 Sec. 53.23(e). 7. Lag time ...................................... Minutes ........ 2 2 20 10 20 Sec. 53.23(e).

8. Rise time .................................... Minutes ........ 2 2 15 5 15 Sec. 53.23(e).

9. Fall time ...................................... Minutes ........ 2 2 15 5 15 Sec. 53.23(e).

10. Precision 20% of upper range limit ......... ppm .............. — — 0 .010 0.5 0 .020 Sec. 53.23(e).

Percent ......... 2 2 .................. .................... .................. Sec. 53.23(e). 80% of upper range limit ......... ppm .............. — — 0 .010 0.5 0 .030 Sec. 53.23(e).

Percent ......... 2 2 — — — Sec. 53.23(e).

1. To convert from parts per million (ppm) to μ g/m 3 at 25 ° C and 760 mm Hg, multiply by M/0.02447, where M is the molecular weight of the gas. Percent means percent of the upper range limit.

2. Tests for interference equivalent and lag time do not need to be repeated for any lower SO 2 range provided the test for the standard range shows that the lower range specification is met for each of these test parameters.


### 35599 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

3. For candidate analyzers having automatic or adaptive time constants or smoothing filters, describe their functional nature, and describe and conduct suitable tests to demonstrate their function aspects and verify that performances for calibration, noise, lag, rise, fall times, and precisionare within specifications under all applicable conditions. For candidate analyzers with operator-selectable time constants or smoothing filters, conduct calibration, noise, lag, rise, fall times, and precision tests at the highest and lowest settings that are to be included in the FRM or FEM designation.

4. For nitric oxide interference for the SO 2 UVF method, interference equivalent is ± 0.003 ppm for the lower range.

* * * * *

■ 13. Section 53.21 is amended by revising paragraph (a) to read as follows:

**§ 53.21 Test conditions.**

(a) Set-up and start-up of the test analyzer shall be in strict accordance with the operating instructions specified in the manual referred to in § 53.4(b)(3). Allow adequate warm-up or
stabilization time as indicated in the operating instructions before beginning the tests. The test procedures assume that the test analyzer has an analog measurement signal output that is connected to a suitable strip chart recorder of the servo, null-balance type.
This recorder shall have a chart width of a least 25 centimeters, chart speeds up to 10 cm per hour, a response time of 1 second or less, a deadband of not more than 0.25 percent of full scale, and capability either of reading measurements at least 5 percent below zero or of offsetting the zero by at least 5 percent. If the test analyzer does not have an analog signal output, or if other types of measurement data output are used, an alternative measurement data recording device (or devices) may be used for the tests, provided it is reasonably suited to the nature and purposes of the tests and an analog representation of the analyzer
measurements for each test can be plotted or otherwise generated that is reasonably similar to the analog measurement recordings that would be produced by a conventional chart
recorder.

* * * * *

■ 14. Section 53.22(d) is amended by revising Table B–2 to read as follows:

**§ 53.22 Generation of test atmospheres.**

* * * * *

(d) * * *



### T ABLE 

### B–2—T EST 

### A TMOSPHERES

Test gas Generation Verification

Ammonia .................... Permeation device. Similar to system described in references 1 and 2. Indophenol method, reference 3.

Carbon dioxide ........... Cylinder of zero air or nitrogen containing CO 2 as required to obtain the concentration specified in Table B–3. Use NIST-certified standards whenever possible. If NIST standards are not available, obtain 2 standards from independent sources which agree within 2 percent, or obtain one standard and submit it to an independentlaboratory for analysis, which must agree within 2 percent of the supplier’s nominal analysis. Carbon monoxide ....... Cylinder of zero air or nitrogen containing CO as required to obtain the concentration specified in Table B–3. Use a FRM CO analyzer as described in reference 8.

Ethane ........................ Cylinder of zero air or nitrogen containing ethane as required to obtain the concentration specified in Table B–3. Gas chromatography, ASTM D2820, reference 10. Use NIST-traceable gaseous methane or propane standards
for calibration.Ethylene ..................... Cylinder of pre-purified nitrogen containing ethylene as required to obtain the concentration specified in Table B–3. Do.

Hydrogen chloride ...... Cylinder 1 of pre-purified nitrogen containing approximately100 ppm of gaseous HCL. Dilute with zero air to concentration specified in Table B–3. Collect samples in bubbler containing distilled water and analyze by the mercuric thiocyante method, ASTM (D612), p. 29, reference 4. Hydrogen sulfide ........ Permeation device system described in references 1 and

2. Tentative method of analysis for H 2 S content of the atmosphere, p. 426, reference 5.Methane ..................... Cylinder of zero air containing methane as required to obtain the concentration specified in Table B–3. Gas chromatography ASTM D2820, reference 10. Use
NIST-traceable methane standards for calibration. Naphthalene ............... 1. Permeation device as described in references 1 and 2 .. 2. Cylinder of pre-purified nitrogen containing 100 ppm

naphthalene. Dilute with zero air to concentration specified in Table B–3. Use NIST-certified standards whenever possible. If NIST standards are not available, obtain 2 standards from independent sources which agree within 2 percent, or obtain one standard and submit it to an independentlaboratory for analysis, which must agree within 2 percent of the supplier’s nominal analysis. Nitric oxide ................. Cylinder 1 of pre-purified nitrogen containing approximately100 ppm NO. Dilute with zero air to required concentration. Use NIST-certified standards whenever possible. If NIST standards are not available, obtain 2 standards from independent sources which agree within 2 percent, or obtain one standard and submit it to an independentlaboratory for analysis, which must agree within 2 percent of the supplier’s nominal analysis. Nitrogen dioxide ......... 1. Gas phase titration as described in reference 6 .............2. Permeation device, similar to system described in reference 6. 1. Use an FRM NO 2 analyzer calibrated with a gravimetrically calibrated permeation device.
2. Use an FRM NO 2 analyzer calibrated by gas-phase titration as described in reference 6. Ozone ......................... Calibrated ozone generator as described in reference 9 .... Use an FEM ozone analyzer calibrated as described in
reference 9.

Sulfur dioxide ............. 1. Permeation device as described in references 1 and 2 .. 2. Dynamic dilution of a cylinder containing approximately

100 ppm SO 2 as described in Reference 7. Use an SO 2 FRM or FEM analyzer as described in reference 7.


### 35600 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

T ABLE 

### B–2—T EST 

### A TMOSPHERES 

### —Continued

Test gas Generation Verification

Water .......................... Pass zero air through distilled water at a fixed known temperature between 20 ° and 30 ° C such that the air

stream becomes saturated. Dilute with zero air to concentration specified in Table B–3. Measure relative humidity by means of a dew-point indicator, calibrated electrolytic or piezo electric hygrometer, or wet/dry bulb thermometer.

Xylene ........................ Cylinder of pre-purified nitrogen containing 100 ppm xylene. Dilute with zero air to concentration specified in

Table B–3. Use NIST-certified standards whenever possible. If NIST standards are not available, obtain 2 standards from independent sources which agree within 2 percent, or obtain one standard and submit it to an independentlaboratory for analysis, which must agree within 2 percent of the supplier’s nominal analysis. Zero air ....................... 1. Ambient air purified by appropriate scrubbers or other devices such that it is free of contaminants likely to cause a detectable response on the analyzer. 2. Cylinder of compressed zero air certified by the supplier

or an independent laboratory to be free of contaminants likely to cause a detectable response on the analyzer.

1 Use stainless steel pressure regulator dedicated to the pollutant measured. Reference 1. O’Keefe, A. E., and Ortaman, G. C. ‘‘ Primary Standards for Trace Gas Analysis, ’’ Anal. Chem. 38, 760 (1966). Reference 2. Scaringelli, F. P., A. E. Rosenberg, E., and Bell, J. P., ‘‘ Primary Standards for Trace Gas Analysis. ’’ Anal. Chem. 42, 871 (1970). Reference 3. ‘‘ Tentative Method of Analysis for Ammonia in the Atmosphere (Indophenol Method) ’’

, Health Lab Sciences, vol. 10, No. 2, 115– 118, April 1973.

Reference 4. 1973 Annual Book of ASTM Standards, American Society for Testing and Materials, 1916 Race St., Philadelphia, PA. Reference 5. Methods for Air Sampling and Analysis, Intersociety Committee, 1972, American Public Health Association, 1015. Reference 6. 40 CFR 50 Appendix F, ‘‘ Measurement Principle and Calibration Principle for the Measurement of Nitrogen Dioxide in the Atmosphere (Gas Phase Chemiluminescence). ’’

Reference 7. 40 CFR 50 Appendix A–1, ‘‘ Measurement Principle and Calibration Procedure for the Measurement of Sulfur Dioxide in the Atmosphere (Ultraviolet FIuorscence). ’’

Reference 8. 40 CFR 50 Appendix C, ‘‘ Measurement Principle and Calibration Procedure for the Measurement of Carbon Monoxide in the Atmosphere ’’ (Non-Dispersive Infrared Photometry) ’’

.

Reference 9. 40 CFR 50 Appendix D, ‘‘ Measurement Principle and Calibration Procedure for the Measurement of Ozone in the Atmosphere ’’

. Reference 10. ‘‘ Standard Test Method for C, through C5 Hydrocarbons in the Atmosphere by Gas Chromatography ’’ , D 2820, 1987 Annual Book of Aston Standards, vol 11.03, American Society for Testing and Materials, 1916 Race St., Philadelphia, PA 19103.

■ 15. Section 53.23(d) is amended by revising Table B–3 to read as follows: **§ 53.23 Test procedures.**

* * * * * (d) * * *



### T ABLE 

### B–3—I NTERFERENT 

### T EST 

### C ONCENTRATION



### , 1 

### P ARTS PER 

### M ILLION

Pollutant Analyzer type Hydrochloric acid Ammonia Hydrogen sulfide Sulfur dioxide Nitrogen dioxide Nitric oxide Carbon dioxide Ethylene Ozone Mxylene Water

vapor Carbon

monoxide 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 .............. Spectrophotometricgas phase, including
DOAS. ............ ............ ............ 4 0.14 0.5 ............ ............ ............ 0.5 0.2 .................... ............ ............ ............ ............

O 3 ................ Chemiluminescent ....... ............ ............ 3 0.1 ............ ............ ............ 750 ............ 4 0.08 ............ 3 20,000 ............ ............ ............ ............
O 3 ................ Electrochemical ........... ............ 3 0.1 ............ 0.5 0.5 ............ ............ ............ 4 0.08 ............ .................... ............ ............ ............ ............
O 3 ................ Spectrophotometric-wet chemical (potassium iodide). ............ 3 0.1 ............ 0.5 0.5 3 0.5 ............ ............ 4 0.08 ............ .................... ............ ............ ............ ............

O 3 ................ Spectrophotometricgas phase, including ultraviolet absorption
and DOAS. ............ ............ ............ 0.5 0.5 0.5 ............ ............ 4 0.08 0.02 20,000 ............ ............ ............ ............

CO ............... 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 combustionthermal 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 replacementUV 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 ............ .................... ............ ............ ............ ............

NO 2 ............. Electrochemical ........... 0.2 3 0.1 ............ 0.5 4 0.1 0.5 750 ............ 0.5 ............ 20,000 50 ............ ............ ............
NO 2 ............. Spectrophotometricgas phase. ............ 3 0.1 ............ 0.5 4 0.1 0.5 ............ ............ 0.5 ............ 20,000 50 ............ ............ ............

1. Concentrations of interferent 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.


### 35601 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

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

* * * * *

**Subpart C [Amended]**

■ 16. Section 53.32 is amended by revising paragraph (e)(2) to read as
follows:

**§ 53.32 Test procedures for methods for**
**SO** 2 **, CO, O** 3 **, and NO** 2 **.** * * * * *

(e) * * * (2) For a candidate method having more than one selectable range, one range must be that specified in table B– 1 of subpart B of this part, and a test analyzer representative of the method must pass the tests required by this subpart while operated on that range. The tests may be repeated for one or more broader ranges ( i.e., ones extending to higher concentrations) than the one specified in table B–1 of subpart B of this part, provided that such a range does not extend to concentrations more than four times the upper range limit specified in table B–1 of subpart B of this part and that the test analyzer has passed the tests required by subpart B of this part (if applicable) for the broader range. If the tests required by this subpart are conducted or passed only for the range specified in table B– 1 of subpart B of this part, any equivalent method determination with respect to the method will be limited to that range. If the tests are passed for both the specified range and a broader range (or ranges), any such

determination will include the broader range(s) as well as the specified range. Appropriate test data shall be submitted for each range sought to be included in

such a determination.

* * * * *

■ 17. Table C–1 to Subpart C is revised

to read as follows:



### T ABLE 

### C–1 TO 

### S UBPART 

### C OF 

### P ART 

### 53—T EST 

### C ONCENTRATION 

### R ANGES 

### , N UMBER OF 

### M EASUREMENTS 

### R EQUIRED



### , AND 

### M AXIMUM 

### D ISCREPANCY 

### S PECIFICATIONS

Pollutant Concentration range, parts per million (ppm) Simultaneous measurements required Maximum discrepancy specification, parts per million 1-hour 24-hour

First set Second set First set Second set

Ozone ...................... Low 0.06 to 0.10 ........................................ 5 6 .................... .................... 0.02
Med. 0.15 to 0.25 ...................................... 5 6 .................... .................... 0.03 High 0.35 to 0.46 ....................................... 4 6 .................... .................... 0.04

Total .................................................... 14 18 .................... .................... ........................

....

Carbon monoxide .... Low 7 to 11 ................................................ 5 6 .................... .................... 1.5
Med. 20 to 30 ............................................ 5 6 .................... .................... 2.0 High 25 to 45 ............................................. 4 6 .................... .................... 3.0

Total .................................................... 14 18 .................... .................... ........................

....

Sulfur dioxide ........... Low 0.02 to 0.05 ........................................ 5 6 3 3 0.02
Med. 0.10 to 0.15 ...................................... 5 6 2 3 0.03 High 0.30 to 0.50 ....................................... 4 6 2 2 0.04

Total .................................................... 14 18 7 8 ............................

Nitrogen dioxide ....... Low 0.02 to 0.08 ........................................ .................... .................... 3 3 0.02
Med. 0.10 to 0.20 ...................................... .................... .................... 2 2 0.02 High 0.25 ................................................... .................... .................... 2 2 0.03

Total .................................................... .................... .................... 7 8

.......................... ..

**PART 58—AMBIENT AIR QUALITY**
**SURVEILLANCE**

■ The authority citation for part 58
continues to read as follows:

Authority: 42 U.S.C. 7403, 7410, 7601(a), 7611, and 7619.

**Subpart B [AMENDED]**

■ 19. Section 58.10, is amended by adding paragraph (a)(6) to read as
follows:

**§ 58.10 Annual monitoring network plan and periodic network assessment.** 

* * * * * (a) * * * (6) A plan for establishing SO 2 monitoring sites in accordance with the requirements of appendix D to this part shall be submitted to the EPA Regional Administrator by July 1, 2011 as part of the annual network plan required in paragraph (a) (1). The plan shall provide for all required SO 2 monitoring sites to be operational by January 1, 2013.

* * * * *

■ 20. Section 58.12 is amended by adding paragraph (g) to read as follows:

**§ 58.12 Operating Schedules**

* * * * * (g) For continuous SO 2 analyzers, the maximum 5-minute block average
concentration of the twelve 5-minute
blocks in each hour must be collected except as noted in § 58.12 (a).

* * * * *

■ 21. Section 58.13 is amended by adding paragraph (d) to read as follows:

**§ 58.13 Monitoring network completion.**

* * * * *

(d) The network of SO 2 monitors must be physically established no later than January 1, 2013, and at that time, must be operating under all of the requirements of this part, including the


### 35602 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

requirements of appendices A, C, D, and E to this part.

■ 22. Section 58.16 is amended by adding paragraph (g) to read as follows:

**§ 58.16 Data submittal and archiving requirements.** 

* * * * *

(g) Any State or, where applicable, local agency operating a continuous SO 2 analyzer shall report the maximum 5-

minute SO 2 block average of the twelve 5-minute block averages in each hour, in addition to the hourly SO 2 average.

■ 23. Appendix A to Part 58 is amended as by adding paragraph 2.3.1.6 to read
as follows:

Appendix A to Part 58—Quality Assurance Requirements for SLAMS, SPMs and PSD Air Monitoring

* * * * *

2.3.1.6 Measurement Uncertainty for SO 2

. The goal for acceptable measurement uncertainty for precision is defined as an upper 90 percent confidence limit for the coefficient of variation (CV) of 10 percent and for bias as an upper 95 percent confidence limit for the absolute bias of 10 percent.

* * * * *

■ 24. Appendix D to Part 58 is amended as by revising paragraph 4.4 to read as
follows:

Appendix D to Part 58—Network Design Criteria for Ambient Air Quality Monitoring

* * * * *

4.4 Sulfur Dioxide (SO 2 ) Design Criteria.

4.4.1 General Requirements. (a) State and, where appropriate, local agencies must operate a minimum number of required SO 2 monitoring sites as described below.

4.4.2 Requirement for Monitoring by the Population Weighted Emissions Index. (a) The population weighted emissions index (PWEI) shall be calculated by States for each core based statistical area (CBSA) they
contain or share with another State or States for use in the implementation of or adjustment to the SO 2 monitoring network. The PWEI shall be calculated by multiplying the population of each CBSA, using the most current census data or estimates, and the
total amount of SO 2 in tons per year emitted within the CBSA area, using an aggregate of the most recent county level emissions data available in the National Emissions Inventory for each county in each CBSA. The resulting product shall be divided by one million, providing a PWEI value, the units of which are million persons-tons per year. For any CBSA with a calculated PWEI value equal to or greater than 1,000,000, a minimum of
three SO 2 monitors are required within that CBSA. For any CBSA with a calculated PWEI value equal to or greater than 100,000, but less than 1,000,000, a minimum of two SO 2 monitors are required within that CBSA. For any CBSA with a calculated PWEI value equal to or greater than 5,000, but less than 100,000, a minimum of one SO 2 monitor is required within that CBSA.

(1) The SO 2 monitoring site(s) required as
a result of the calculated PWEI in each CBSA shall satisfy minimum monitoring requirements if the monitor is sited within the boundaries of the parent CBSA and is one of the following site types (as defined in section 1.1.1 of this appendix): population exposure, highest concentration, source impacts, general background, or regional transport. SO 2 monitors at NCore stations may satisfy minimum monitoring requirements if that monitor is located within a CBSA with minimally required monitors under this part. Any monitor that is sited outside of a CBSA with minimum monitoring requirements to assess the highest concentration resulting from the impact of significant sources or source categories existing within that CBSA shall be allowed to count towards minimum monitoring requirements for that CBSA.

4.4.3 Regional Administrator Required Monitoring. (a) The Regional Administrator may require additional SO 2 monitoring
stations above the minimum number of monitors required in 4.4.2 of this part, where the minimum monitoring requirements are not sufficient to meet monitoring objectives. The Regional Administrator may require, at his/her discretion, additional monitors in situations where an area has the potential to have concentrations that may violate or contribute to the violation of the NAAQS, in areas impacted by sources which are not conducive to modeling, or in locations with susceptible and vulnerable populations,
which are not monitored under the minimum monitoring provisions described above. The Regional Administrator and the responsible State or local air monitoring agency shall work together to design and/or maintain the most appropriate SO 2 network to provide sufficient data to meet monitoring objectives.

4.4.4 SO 2 Monitoring Spatial Scales. (a) The appropriate spatial scales for SO 2 SLAMS monitors are the microscale, middle, neighborhood, and urban scales. Monitors sited at the microscale, middle, and neighborhood scales are suitable for determining maximum hourly concentrations
for SO 2. Monitors sited at urban scales are useful for identifying SO 2 transport, trends, and, if sited upwind of local sources, background concentrations.

(1) Microscale —This scale would typify areas in close proximity to SO 2 point and area sources. Emissions from stationary point and area sources, and non-road sources may, under certain plume conditions, result in high ground level concentrations at the microscale. The microscale typically represents an area impacted by the plume with dimensions extending up to approximately 100 meters.

(2) Middle scale —This scale generally represents air quality levels in areas up to several city blocks in size with dimensions on the order of approximately 100 meters to 500 meters. The middle scale may include locations of expected maximum short-term concentrations due to proximity to major SO 2 point, area, and/or non-road sources.

(3) Neighborhood scale —The neighborhood scale would characterize air quality conditions throughout some relatively uniform land use areas with dimensions in the 0.5 to 4.0 kilometer range. Emissions from stationary point and area sources may, under certain plume conditions, result in high SO 2 concentrations at the neighborhood scale. Where a neighborhood site is located away from
immediate SO 2 sources, the site may be useful in representing typical air quality values for a larger residential area, and therefore suitable for population exposure and trends analyses.

(4) Urban scale —Measurements in this
scale would be used to estimate concentrations over large portions of an
urban area with dimensions from 4 to 50
kilometers. Such measurements would be useful for assessing trends in area-wide air quality, and hence, the effectiveness of large scale air pollution control strategies. Urban scale sites may also support other monitoring objectives of the SO 2 monitoring network such as identifying trends, and when monitors are sited upwind of local sources, background concentrations.

4.4.5 NCore Monitoring. (a) SO 2 measurements are included within the NCore multipollutant site requirements as describedin paragraph (3)(b) of this appendix. NCorebased SO 2 measurements are primarily used
to characterize SO 2 trends and assist in understanding SO 2 transport across representative areas in urban or rural locations and are also used for comparison
with the SO 2 NAAQS. SO 2 monitors at NCore
sites that exist in CBSAs with minimum monitoring requirements per section 4.4.2
above shall be allowed to count towards those minimum monitoring requirements.

* * * * *

■ 25. Appendix G to Part 58 is amended as by revising Table 2 to read as follows:

Appendix G to Part 58—Uniform Air Quality Index (AQI) and Daily Reporting

* * * * *


### 35603 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Rules and Regulations

T ABLE 

### 2—B REAKPOINTS FOR THE 

### AQI

These breakpoints Equal these AQI’s

O 3 (ppm)

8-hour O 3 (ppm) 1-hour 1 PM 2.5 ( μ g/m 3 ) PM 10 ( μ g/m 3 ) CO (ppm) SO 2 (ppm) 1-hour NO 2 (ppm) 1-hour AQI Category

0.000–0.059 .. 0.0–15.4 0–54 0.0–4.4 0–0.035 0–0.053 0–50 Good.

0.060–0.075 .. 15.5–40.4 55–154 4.5–9.4 0.036–0.075 0.054–0.100 51–100 Moderate.

0.076–0.095 .. 0.125–0.164 40.5–65.4 155–254 9.5–12.4 0.076–0.185 0.101–0.360 101–150 Unhealthy for Sensitive Groups.

0.096–0.115 .. 0.165–0.204 3 65.5–150.4 255–354 12.5–15.4 4 0.186–0.304 0.361–0.64 151–200 Unhealthy.

0.116–0.374 .. 0.205–0.404 3 150.5–250.4 355–424 15.5–30.4 4 0.305–0.604 0.65–1.24 201–300 Very Unhealthy. ( 2 ) .................. 0.405–0.504 3 250.5–350.4 425–504 30.5–40.4 4 0.605–0.804 1.25–1.64 301–400 ( 2 ) .................. 0.505–0.604 3 350.5–500.4 505–604 40.5–50.4 4 0.805–1.004 1.65–2.04 401–500 Hazardous.

1 Areas are generally required to report the AQI based on 8-hour ozone values. However, there are a small number of areas where an AQI based on 1-hour ozone values would be more precautionary. In these cases, in addition to calculating the 8-hour ozone index value, the 1-hour ozone index value may be calculated, and the maximum of the two values reported.

2 8-hour O 3 values do not define higher AQI values ( ≥ 301). AQI values of 301 or greater are calculated with 1-hour O 3 concentrations.

3 If a different SHL for PM 2.5 is promulgated, these numbers will change accordingly.

4 1-hr SO 2 values do not define higher AQI values ( ≥ 200). AQI values of 200 or greater are calculated with 24-hour SO 2 concentrations.

* * * * *

[FR Doc. 2010–13947 Filed 6–21–10; 8:45 am]

**BILLING CODE 6560–50–P**


## Tuesday,

February 9, 2010



# Part III



# Environmental Protection Agency

40 CFR Parts 50 and 58
Primary National Ambient Air Quality Standards for Nitrogen Dioxide; Final

Rule


### 6474 Federal Register / Vol. 75, No. 26 / Tuesday, February 9, 2010 / Rules and Regulations

**ENVIRONMENTAL PROTECTION**
**AGENCY**

**40 CFR Parts 50 and 58**

**[EPA–HQ–OAR–2006–0922; FRL 9107–9]**

**RIN 2060–AO19**

**Primary National Ambient Air Quality Standards for Nitrogen Dioxide** 

**AGENCY :**  Environmental Protection Agency (EPA).

**ACTION :**  Final rule.

**SUMMARY :**  Based on its review of the air quality criteria for oxides of nitrogen and the primary national ambient air quality standard (NAAQS) for oxides of nitrogen as measured by nitrogen dioxide (NO 2 ), EPA is making revisions to the primary NO 2 NAAQS in order to provide requisite protection of public health. Specifically, EPA is establishing
a new 1-hour standard at a level of 100 ppb, based on the 3-year average of the 98th percentile of the yearly distribution of 1-hour daily maximum concentrations, to supplement the existing annual standard. EPA is also establishing requirements for an NO 2 monitoring network that will include
monitors at locations where maximum

NO 2 concentrations are expected to occur, including within 50 meters of major roadways, as well as monitors
sited to measure the area-wide NO 2 concentrations that occur more broadly

across communities.

**DATES :**  This final rule is effective on April 12, 2010.

**ADDRESSES :**  EPA has established a
docket for this action under Docket ID No. EPA–HQ–OAR–2006–0922. All
documents in the docket are listed on
the http://www.regulations.gov Web site. Although listed in the index, some information is not publicly available,

e.g., confidential business information
or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy form. Publicly available docket
materials are available either electronically through http:// www.regulations.gov or in hard copy at
the Air and Radiation Docket and Information Center, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave., 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 FURTHER INFORMATION CONTACT :**  Dr. Scott Jenkins, Health and Environmental Impacts Division, Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Mail code C504–06, Research Triangle Park, NC 27711; telephone: 919–541– 1167; fax: 919–541–0237; e-mail: jenkins.scott@epa.gov.

**SUPPLEMENTARY INFORMATION :** 

Table of Contents

The following topics are discussed in this preamble: I. Background

A. Summary of Revisions to the NO 2

Primary NAAQS B. Legislative Requirements
C. Related NO 2 Control Programs D. Review of the Air Quality Criteria and

Standards for Oxides of Nitrogen E. Summary of Proposed Revisions to the

NO 2 Primary NAAQS F. Organization and Approach to Final NO 2

Primary NAAQS Decisions
II. Rationale for Final Decisions on the NO 2 Primary Standard
A. Characterization of NO 2 Air Quality
1. Current Patterns of NO 2 Air Quality

2. NO 2 Air Quality and Gradients Around

Roadways
B. Health Effects Information1. Adverse Respiratory Effects and ShortTerm Exposure to NO 2 2. Other Effects With Short-Term Exposure

to NO 2 a. Mortality
b. Cardiovascular Effects 3. Health Effects With Long-Term Exposure

to NO 2 a. Respiratory Morbidity b. Mortality c. Carcinogenic, Cardiovascular, and

Reproductive/Developmental Effects

4. NO 2 -Related Impacts on Public Health C. Human Exposure and Health Risk

Characterization D. Approach for Reviewing the Need To

Retain or Revise the Current Standard E. Adequacy of the Current Standard 1. Rationale for Proposed Decision 2. Comments on the Adequacy of the

Current Standard a. Comments on EPA’s Interpretation of the

Epidemiologic Evidence b. Comments on EPA’s Interpretation of the

Controlled Human Exposure Evidence
c. Comments on EPA’s Characterization of

NO 2 -Associated Exposures and Health
Risks 3. Conclusions on the Adequacy of the

Current Standard
F. Elements of a New Short-Term Standard
1. Indicator a. Rationale for Proposed Decision
b. Comments on Indicator c. Conclusions Regarding Indicator 2. Averaging Time a. Rationale for Proposed Decision b. Comments on Averaging Time c. Conclusions on Averaging Time

3. Form a. Rationale for Proposed Decision
b. CASAC and Public Comments on Form c. Conclusions on Form
4. Level a. Rationale for Proposed Decisions on

Approach and Level
b. Rationale for Alternative Decisions on

Approach and Level c. Comments on Approach and Level i. CASAC Comments on the Approach to

Setting the Standard ii. Public Comments on the Approach To

Setting the Standard
iii. CASAC Comments on Standard Level
iv. Public Comments on Standard Level d. Conclusions on Approach and Standard

Level
G. Annual Standard H. Summary of Final Decisions on the

Primary NO 2 Standard III. Amendments to Ambient Monitoring and Reporting Requirements A. Monitoring Methods
1. Chemiluminescence FRM and

Alternative Methods
2. Allowable FRM and FEMs for

Comparison to the NAAQS a. Proposed Changes to FRM and FEMs

That May Be Compared to the NAAQS
b. Comments
c. Decisions on Allowable FRM and FEMs

for Comparison to the NAAQS B. Network Design 1. Two-Tiered Network Design a. Proposed Two-Tier Network Design
b. Comments c. Conclusions Regarding the Two-Tier

Network Design 2. First Tier (Near-road Monitoring

Component) of the NO 2 Network Design a. Proposed First Tier (Near-road

Monitoring Component) of the Network Design
b. Comments c. Conclusions Regarding the First Tier

(Near-road Monitoring Component) of the Network Design 3. Second Tier (Area-wide Monitoring

Component) of the Network Design a. Proposed Second Tier (Area-wide

Monitoring Component) of the Network Design
b. Commentsc. Conclusions on the Second Tier (Areawide Monitoring Component) of the Network Design 4. Regional Administrator Authority a. Proposed Regional Administrator

Authority
b. Comments c. Conclusions on Regional Administrator

Authority 5. Monitoring Network Implementation a. Proposed Monitoring Network

Implementation Approach
b. Comments c. Conclusions on Monitoring Network

Implementation
6. Near-Road Site Selection a. Proposed Near-Road Site Selection

Criterion
b. Comments
c. Conclusions on Near-Road Site Selection 7. Near-Road Siting Criteria a. Proposed Near-Road Siting Criteria
b. Comments c. Conclusions on Near-Road Siting Criteria
8. Area-wide Monitor Site Selection and

Siting Criteria


### 6475 Federal Register / Vol. 75, No. 26 / Tuesday, February 9, 2010 / Rules and Regulations

1 EPA notes that as the promulgation of a NAAQS is identified in section 307(d)(1) of the Clean Air Act, all of the provisions of this rulemaking are subject to the requirements of section 307(d) of the
Clean Air Act.

2 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 comprising the sensitive group rather than to a single person in such a group. ’’ S. Rep. No. 91–1196, 91st Cong., 2d Sess. 10(1970).

3 EPA is currently conducting a separate review of the secondary NO 2 NAAQS jointly with a review of the secondary SO 2 NAAQS. a. Proposed Area-wide Monitor Site

Selection and Siting Criteria
b. Comments
c. Conclusions on Area-Wide Monitor Site

Selection and Siting Criteria 9. Meteorological Measurements a. Proposed Meteorological Measurements
b. Comments c. Conclusions on Meteorological

Measurements C. Data Reporting 1. Proposed Data Quality Objectives and

Measurement Uncertainty

2. Comments 3. Conclusions on Data Quality Objectives

and Measurement Uncertainty IV. Appendix S—Interpretation of the Primary NAAQS for Oxides of Nitrogen and Revisions to the Exceptional Events
Rule A. Interpretation of the Primary NAAQS

for Oxides of Nitrogen for the Annual Primary Standard 1. Proposed Interpretation of the Annual

Standard 2. Comments on Interpretation of the

Annual Standard 3. Conclusions on Interpretation of the

Annual Standard B. Interpretation of the Primary NAAQS for

Oxides of Nitrogen 1-Hour Primary
Standard 1. Proposed Interpretation of the 1-Hour

Standard 2. Comments on Interpretation of the

1-Hour Standard 3. Conclusions on Interpretation of the

1-Hour Standard C. Exceptional Events Information

Submission Schedule V. Designation of Areas

A. Proposed Process
B. Public Comments C. Final Designations Process VI. Clean Air Act Implementation Requirements
A. Classifications 1. Proposal
2. Public comments
3. Final

B. Attainment Dates 1. Attaining the NAAQS a. Proposal
b. Final 2. Consequences of Failing to Attain by the

Statutory Attainment Date a. Proposal
b. Final C. Section 110(a)(2) NAAQS Infrastructure

Requirements 1. Proposal
2. Final D. Attainment Planning Requirements

1. Nonattainment Area SIPs a. Proposal
b. Public Comments
c. Final
2. New Source Review and Prevention of

Significant Deterioration Requirements a. Proposal
b. Public Comments
c. Final 3. General Conformity a. Proposal 4. Transportation Conformity a. Proposal b. Public Comments
c. Final
VII. Communication of Public Health
Information VIII. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory

Planning and Review B. Paperwork Reduction Act C. Regulatory Flexibility Act
D. Unfunded Mandates Reform Act
E. Executive Order 13132: Federalism
F. Executive Order 13175: Consultation

and Coordination With Indian Tribal

Governments
G. Executive Order 13045: Protection of

Children From Environmental Health & Safety Risks
H. Executive Order 13211: Actions

Concerning Regulations That Significantly Affect Energy Supply,
Distribution or Use I. National Technology Transfer and

Advancement Act J. Executive Order 12898: Federal Actions

To Address Environmental Justice in Minority Populations and Low-Income Populations K. Congressional Review Act
References

I. Background

A. Summary of Revisions to the NO 2 Primary NAAQS

Based on its review of the air quality criteria for oxides of nitrogen and the primary national ambient air quality standard (NAAQS) for oxides of nitrogen as measured by nitrogen dioxide (NO 2 ), EPA is making revisions to the primary NO 2 NAAQS in order to provide requisite protection of public health as appropriate under section 109 of the Clean Air Act (Act or CAA). Specifically, EPA is supplementing the existing annual standard for NO 2 of 53 parts per billion (ppb) by establishing a
new short-term standard based on the 3- year average of the 98th percentile of the yearly distribution of 1-hour daily maximum concentrations. EPA is setting
the level of this new standard at 100 ppb. EPA is making changes in data handling conventions for NO 2 by adding provisions for this new 1-hour primary standard. EPA is also establishing requirements for an NO 2 monitoring network. These new provisions require
monitors at locations where maximum

NO 2 concentrations are expected to occur, including within 50 meters of major roadways, as well as monitors
sited to measure the area-wide NO 2 concentrations that occur more broadly across communities. EPA is making conforming changes to the air quality index (AQI).

B. Legislative Requirements

Two sections of the CAA govern the
establishment and revision of the NAAQS. Section 108 of the Act directs the Administrator to identify and list air pollutants that meet certain criteria, including that the air pollutant ‘‘ in [her] judgment, cause[s] or contribute[s] to air pollution which may reasonably be anticipated to endanger public health
and welfare ’’ and ‘‘ the presence of which
in the ambient air results from
numerous or diverse mobile or stationary sources. ’’ 42 U.S.C. 21 7408(a)(1)(A) & (B). For those air pollutants listed, section 108 requires the Administrator to issue air quality
criteria that ‘‘ accurately reflect the latest scientific knowledge useful 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 ambient air

*** ’’ 42 U.S.C. 7408(2).

Section 109(a) of the Act directs the Administrator to promulgate ‘‘ primary ’’
and ‘‘ secondary ’’ NAAQS for pollutants for which air quality criteria have been issued. 42 U.S.C. 7409(1). 1 Section 109(b)(1) defines a primary standard as

one ‘‘ the attainment and maintenance of which in the judgment of the Administrator, based on [the air quality] criteria and allowing an adequate margin of safety, are requisite to protect the public health. ’’ 2 42 U.S.C. 7409(b)(1). A secondary standard, in

turn, must ‘‘ specify a level of air quality
the attainment and maintenance of which, in the judgment of the Administrator, based on [the air quality] criteria, is requisite to protect the public welfare from any known or anticipated
adverse effects associated with the presence of such pollutant in the
ambient air. ’’ 3 42 U.S.C. 7409(b)(2).

The requirement that primary standards include an adequate margin of safety is intended to address
uncertainties associated with
inconclusive scientific and technical
information available at the time of standard setting. It is also intended to provide a reasonable degree of protection against hazards that research has not yet identified. Lead Industries

Association v. EPA, 647 F.2d 1130, 1154 (DC Cir 1980), cert. denied, 449 U.S.


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4 In this document, the terms ‘‘ oxides of nitrogen ’’
and ‘‘ nitrogen oxides ’’ (NO X ) refer to all forms of oxidized nitrogen (N) compounds, including NO,

NO 2 , and all other oxidized N-containing compounds formed from NO and NO 2 . This follows usage in the Clean Air Act Section 108(c): ‘‘ Such criteria [for oxides of nitrogen] shall include a discussion of nitric and nitrous acids, nitrites, nitrates, nitrosamines, and other carcinogenic and potentially carcinogenic derivatives of oxides of nitrogen. ’’ By contrast, within the air pollution research and control communities, the terms

‘‘ oxides of nitrogen ’’ and ‘‘ nitrogen oxides ’’ are restricted to refer only to the sum of NO and NO 2 , and this sum is commonly abbreviated as NO X . The category label used by this community for the sum of all forms of oxidized nitrogen compounds including those listed in Section 108(c) is NO Y
. 1042 (1980); American Petroleum

Institute v. Costle, 665 F.2d 1176, 1186 (DC Cir. 1981), cert. denied, 455 U.S. 1034 (1982). 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 scientific certainty. Thus, in selecting primary standards that include an adequate margin of safety, the Administrator is seeking not only to prevent pollution
levels that have been demonstrated to be harmful but also to prevent lower pollutant levels that may pose an unacceptable risk of harm, even if the risk is not precisely identified as to nature or degree.

In addressing the requirement for a margin of safety, EPA considers such factors as the nature and severity of the health effects involved, the size of the at-risk population(s), and the kind and degree of the uncertainties that must be addressed. The selection of any particular approach to providing an adequate margin of safety is a policy choice left specifically to the Administrator’s judgment. Lead
Industries Association v. EPA, supra,
647 F.2d at 1161–62.

In setting standards that are

‘‘ requisite ’’ to protect public health and welfare, as provided in section 109(b),
EPA’s task is to establish standards that are neither more nor less stringent than necessary for these purposes. In so doing, EPA may not consider the costs of implementing the standards.
Whitman v. American Trucking Associations, 531 U.S. 457, 471, 475–76 (2001).

Section 109(d)(1) of the Act requires the Administrator to periodically undertake a thorough review of the air quality criteria published under section 108 and the NAAQS and to revise the criteria and standards as may be appropriate. 42 U.S.C. 7409(d)(1). The Act also requires the Administrator to appoint an independent scientific review committee composed of seven members, including at least one member of the National Academy of Sciences, one physician, and one person representing State air pollution control agencies, to review the air quality criteria and NAAQS and to ‘‘ recommend to the Administrator any new * * * standards and revisions of existing criteria and standards as may be appropriate under section 108 and subsection (b) of this section. ’’ 42 U.S.C. 7409(d)(2). This independent review function is performed by the Clean Air Scientific Advisory Committee (CASAC) of EPA’s Science Advisory Board. C. Related NO 2 Control Programs
States are primarily responsible for ensuring attainment and maintenance of ambient air quality standards once EPA
has established them. Under section 110 of the Act, 42 U.S.C. 7410, and related provisions, States are to submit, for EPA approval, State implementation 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 EPA, also administer the prevention of significant deterioration program that covers these pollutants. See 42 U.S.C. 7470–7479. In addition, Federal programs provide for
nationwide reductions in emissions of these and other air pollutants under Title II of the Act, 42 U.S.C. 7521–7574, which involves controls for automobile, truck, bus, motorcycle, nonroad engine and equipment, and aircraft emissions; the new source performance standards under section 111 of the Act, 42 U.S.C. 7411; and the national emission standards for hazardous air pollutants under section 112 of the Act, 42 U.S.C.

7412.

Currently there are no areas in the United States that are designated as
nonattainment of the NO 2 NAAQS. With
the revisions to the NO 2 NAAQS that result from this review, however, some
areas could be classified as nonattainment. Certain States will be required to develop SIPs that identify and implement specific air pollution
control measures to reduce ambient NO 2 concentrations to attain and maintain
the revised NO 2 NAAQS, most likely by requiring air pollution controls on sources that emit oxides of nitrogen (NO X ). 4

While NO X is emitted from a wide variety of source types, the top three categories of sources of NO X emissions are on-road mobile sources, electricity generating units, and non-road mobile sources. EPA anticipates that NO X emissions will decrease substantially over the next 20 years as a result of the ongoing implementation of mobile source emissions standards. In particular, Tier 2 NO X emission standards for light-duty vehicle emissions began phasing into the fleet beginning with model year 2004, in combination with low-sulfur gasoline fuel standards. For heavy-duty engines,

new NO X standards are phasing in between the 2007 and 2010 model years, following the introduction of ultra-low
sulfur diesel fuel. Lower NO X standards for nonroad diesel engines, locomotives, and certain marine engines are becoming effective throughout the nextdecade. In future decades, these lowerNO X vehicles and engines will become an increasingly large fraction of in-use mobile sources, effecting large NO X emission reductions.

D. Review of the Air Quality Criteria and Standards for Oxides of Nitrogen

On April 30, 1971, EPA promulgated identical primary and secondary NAAQS for NO 2 under section 109 of
the Act. The standards were set at 0.053 parts per million (ppm) (53 ppb), annual average (36 FR 8186). EPA completed reviews of the air quality criteria and

NO 2 standards in 1985 and 1996 with decisions to retain the standard (50 FR 25532, June 19, 1985; 61 FR 52852, October 8, 1996).

EPA initiated the current review of the air quality criteria for oxides of nitrogen and the NO 2 primary NAAQS on December 9, 2005 (70 FR 73236) with a general call for information. EPA’s draft Integrated Review Plan for the Primary National Ambient Air Quality Standard for Nitrogen Dioxide (EPA, 2007a) was made available in February, 2007 for public comment and was discussed by the CASAC via a publicly accessible teleconference on May 11, 2007. As noted in that plan, NO X includes multiple gaseous ( e.g., NO 2 , NO) and particulate ( e.g., nitrate) species. Because the health effects associated with particulate species of

NO X have been considered within the
context of the health effects of ambient particles in the Agency’s review of the NAAQS for particulate matter (PM), the current review of the primary NO 2 NAAQS is focused on the gaseous species of NO X and is not intended to address health effects directly associated with particulate species.

The first draft of the Integrated
Science Assessment for Oxides of Nitrogen-Health Criteria (ISA) and the Nitrogen Dioxide Health Assessment Plan: Scope and Methods for Exposure and Risk Assessment (EPA, 2007b) were reviewed by CASAC at a public meeting held on October 24–25, 2007. Based on
comments received from CASAC and the public, EPA developed the second


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5 The ‘‘ form ’’ of a standard defines the air quality statistic that is to be compared to the level of the standard in determining whether an area attains the
standard. draft of the ISA and the first draft of the Risk and Exposure Assessment to Support the Review of the NO 2 Primary National Ambient Air Quality Standard (Risk and Exposure Assessment (REA)). These documents were reviewed by CASAC at a public meeting held on May 1–2, 2008. Based on comments received from CASAC and the public at this meeting, EPA released the final ISA in July of 2008 (EPA, 2008a). In addition,
comments received were considered in developing the second draft of the REA, which was released for public review and comment in two parts. The first part of this document, containing chapters 1–7, 9 and appendices A and C as well as part of appendix B, was released in August 2008. The second part of this document, containing chapter 8 (describing the Atlanta exposure assessment) and a completed appendix B, was released in October of 2008. This document was the subject of CASAC reviews at public meetings on September 9 and 10, 2008 (for the first part) and on October 22, 2008 (for the second part). In preparing the final REA (EPA, 2008b), EPA considered
comments received from the CASAC and the public at those meetings.

In the course of reviewing the second draft REA, CASAC expressed the view that the document would be incomplete without the addition of a policy assessment chapter presenting an integration of evidence-based considerations and risk and exposure
assessment results. CASAC stated that such a chapter would be ‘‘ critical for considering options for the NAAQS for

NO 2 ’’ (Samet, 2008a). In addition, within the period of CASAC’s review of the second draft REA, EPA’s Deputy
Administrator indicated in a letter to the chair of CASAC, addressing earlier CASAC comments on the NAAQS review process, that the risk and exposure assessment will include ‘‘ a broader discussion of the science and how uncertainties may effect decisions
on the standard ’’ and ‘‘ all analyses and approaches for considering the level of the standard under review, including risk assessment and weight of evidence methodologies ’’ (Peacock, 2008, p. 3; September 8, 2008).

Accordingly, the final REA included a new policy assessment chapter. This policy assessment chapter considered
the scientific evidence in the ISA and the exposure and risk characterization results presented in other chapters of the REA as they relate to the adequacy
of the current NO 2 primary NAAQS and potential alternative primary NO 2 standards. In considering the current and potential alternative standards, the policy assessment chapter of the final REA focused on the information that is most pertinent to evaluating the basic elements of national ambient air quality standards: Indicator, averaging time, form, 5 and level. These elements, which together serve to define each standard, must be considered collectively in evaluating the health protection
afforded. CASAC discussed the final version of the REA, with an emphasis on the policy assessment chapter, during a public teleconference held on December 5, 2008. Following that teleconference, CASAC offered
comments and advice on the NO 2 primary NAAQS in a letter to the Administrator (Samet, 2008b).

The schedule for completion of this review is governed by a judicial order resolving a lawsuit filed in September 2005, concerning the timing of the
current review. The order that now governs this review, entered by the court in August 2007 and amended in December 2008, provides that the Administrator will sign, for publication, notices of proposed and final rulemaking concerning the review of the primary NO 2 NAAQS no later than June 26, 2009 and January 22, 2010, respectively. In accordance with this schedule, the Administrator signed a notice of proposed rulemaking on June 26, 2009 (FR 74 34404). This action presents the Administrator’s final decisions on the primary NO 2 standard.

E. Summary of Proposed Revisions to
the NO 2 Primary NAAQS

For the reasons discussed in the preamble of the proposal for the NO 2 primary NAAQS (74 FR 34404), EPA proposed to make revisions to the primary NO 2 NAAQS and to make
related revisions for NO 2 data handling conventions in order to provide requisite protection of public health. EPA also proposed to make corresponding changes to the AQI for

NO 2 . Specifically, EPA proposed to supplement the current annual standard by establishing a new short-term NO 2 standard that would reflect the
maximum allowable NO 2 concentration anywhere in an area. EPA proposed that
this new short-term standard would be based on the 3-year average of the 99th percentile (or 4th highest) of the yearly distribution of 1-hour daily maximum

NO 2 concentrations and solicited comment on using the 3-year average of the 98th percentile (or 7th or 8th highest) of the yearly distribution of 1- hour daily maximum NO 2 concentrations. EPA proposed to set the
level of this new 1-hour standard within the range of 80 to 100 ppb and solicited
comment on standard levels as low as 65 ppb and as high as 150 ppb. EPA proposed to specify the level of the standard to the nearest ppb. EPA also proposed to establish requirements for

an NO 2 monitoring network at locations
where maximum NO 2 concentrations are expected to occur, including monitors within 50 meters of major roadways, as well as area-wide monitors
sited to measure the NO 2 concentrations that can occur more broadly across
communities. EPA also solicited comment on the alternative approach of setting a 1-hour standard that would
reflect the allowable area-wide NO 2 concentration.

F. Organization and Approach to Final

NO 2 Primary NAAQS Decisions
This action presents the
Administrator’s final decisions regarding the need to revise the current

NO 2 primary NAAQS. Revisions to the primary NAAQS for NO 2 , and the rationale supporting those revisions, are
described below in section II. Requirements for the NO 2 ambient monitoring network are described in section III. Related requirements for data completeness, data handling, data reporting, rounding conventions, and exceptional events are described in section IV. Implementation of the
revised NO 2 primary NAAQS is
discussed in sections V and VI. Communication of public health information through the AQI is
discussed in section VII and a discussion of statutory and executive order reviews is provided in section

VIII.

Today’s final decisions are based on a thorough review in the ISA of
scientific information on known and potential human health effects associated with exposure to NO 2 in the
air. These final decisions also take into account: (1) Assessments in the REA of the most policy-relevant information in the ISA as well as quantitative exposure and risk analyses based on that information; (2) CASAC Panel advice and recommendations, as reflected in its
letters to the Administrator and its public discussions of the ISA, the REA, and the notice of proposed rulemaking; (3) public comments received during the development of ISA and REA; and (4) public comments received on the proposed rulemaking.

Some commenters have referred to
and discussed individual scientific analyses on the health effects of NO 2 that were not included in the ISA (EPA, 2008a) ( ‘‘ new studies ’’ ). In considering


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6 It should be noted that the ISA (section 2.4.1)
references a different number of active monitors in
the NO 2 network. The discrepancy between the ISA numbers and the number presented here is due to differing metrics used in pulling data from AQS. The ISA only references SLAMS, NAMS, and PAMS sites with defined monitoring objectives, while Watkins and Thompson (2008) considered all

NO 2 sites reporting data at any point during the year. Based on this approach, Watkins and Thompson (2008) also noted that the size of the

NO 2 monitoring network has remained relatively stable since the early 1980s. and responding to comments for which
such ‘‘ new studies ’’ were cited in support, EPA has provisionally
considered the cited studies in the context of the findings of the ISA.

As in prior NAAQS reviews, EPA is basing its decision in this review on
studies and related information included in the ISA and staff’s policy assessment, which have undergone CASAC and public review. In this NO 2 NAAQS review, staff’s policy assessment was presented in the form of a policy assessment chapter of the REA (EPA, 2008b). The studies assessed in the ISA and REA, and the integration of the scientific evidence presented in them, have undergone extensive critical review by EPA, CASAC, and the public. The rigor of that review makes these studies, and their integrative assessment, the most reliable source of
scientific information on which to base decisions on the NAAQS, decisions that all parties recognize as of great import. NAAQS decisions can have profound impacts on public health and welfare, and NAAQS decisions should be based on studies that have been rigorously assessed in an integrative manner not only by EPA but also by the statutorily mandated independent advisory committee, as well as the public review that accompanies this process. EPA’s provisional consideration of ‘‘ new studies ’’ did not and could not provide that kind of in-depth critical review.

This decision is consistent with EPA’s practice in prior NAAQS reviews and its interpretation of the requirements of the CAA. Since the 1970 amendments, the EPA has taken the view that NAAQS
decisions are to be based on scientific
studies and related information that have been assessed as a part of the pertinent air quality criteria, and has consistently followed this approach. This longstanding interpretation was strengthened by new legislative requirements enacted in 1977, which added section 109(d)(2) of the Act concerning CASAC review of air quality

criteria. See 71 FR 61144, 61148 (October 17, 2006) (final decision on review of PM NAAQS) for a detailed discussion of this issue and EPA’s past practice.

As discussed in EPA’s 1993 decision not to revise the NAAQS for ozone (O 3 ),

‘‘ new studies ’’ may sometimes be of such significance that it is appropriate to delay a decision on revision of a NAAQS and to supplement the pertinent air quality criteria so the studies can be taken into account (58 FR at 13013–13014, March 9, 1993). In the present case, EPA’s provisional
consideration of ‘‘ new studies ’’ concludes that, taken in context, the ‘‘ new ’’ information and findings do not materially change any of the broad scientific conclusions regarding the
health effects of NO 2 made in the air quality criteria. For this reason, reopening the air quality criteria review
would not be warranted even if there
were time to do so under the court order governing the schedule for this rulemaking.

Accordingly, EPA is basing the final
decisions in this review on the studies
and related information included in the

NO 2 air quality criteria that have undergone CASAC and public review.
EPA will consider the ‘‘ new studies ’’ for purposes of decision-making in the next periodic review of the NO 2 NAAQS, which will provide the opportunity to fully assess these studies through a more rigorous review process involving EPA, CASAC, and the public. Further
discussion of these ‘‘ new studies ’’ can be found below, in section II.E, and in the Response to Comments document.

II. Rationale for Final Decisions on the

NO 2 Primary Standard

This section presents the rationale for
the Administrator’s decision to revise the existing NO 2 primary standard by supplementing the current annual
standard with a new 1-hour standard. In developing this rationale, EPA has drawn upon an integrative synthesis of the entire body of evidence on human
health effects associated with the presence of NO 2 in the air. As summarized below in section II.B, this body of evidence addresses a broad range of health endpoints associated with exposure to NO 2 . In considering this entire body of evidence, EPA focuses in particular on those health endpoints for which the ISA finds
associations with NO 2 to be causal or likely causal. This rationale also draws upon the results of quantitative exposure and risk assessments,
summarized below in section II.C.

As discussed below, a substantial
amount of new research has been
conducted since the last review of the

NO 2 NAAQS, with important new information coming from epidemiologic studies in particular. The newly
available research studies evaluated in the ISA have undergone intensive scrutiny through multiple layers of peer review and opportunities for public review and comment. While important uncertainties remain in the qualitative and quantitative characterizations of health effects attributable to exposure to
ambient NO 2 , the review of this
information has been extensive and
deliberate.

The remainder of this section provides background information that informed the Administrator’s decisions on the primary standard and discusses
the rationale for those decisions. Section II.A presents a discussion of NO 2 air quality. Section II.B includes an
overview of the scientific evidence
related to health effects associated with

NO 2 exposure. This overview includes discussion of the health endpoints and at-risk populations considered in the
ISA. Section II.C discusses the approaches taken by EPA to assess exposures and health risks associated
with NO 2 , including a discussion of key
results. Section II.D summarizes the approach that was used in the current
review of the NO 2 NAAQS with regard
to consideration of the scientific evidence and exposure-/risk-based results related to the adequacy of the current standard and potential
alternative standards. Sections II.E–II.G
discuss the Administrator’s decisions regarding the adequacy of the current standard, elements of a new 1-hour standard, and retention of the current annual standard, respectively, taking into consideration public comments on the proposed decisions. Section II.H
summarizes the Administrator’s decisions with regard to the NO 2 primary NAAQS.

A. Characterization of NO 2 Air Quality

1. Current Patterns of NO 2 Air Quality

The size of the State and local NO 2 monitoring network has remained relatively stable since the early 1980s, and currently has approximately 400 monitors reporting data to EPA’s Air Quality System (AQS) database. 6 At present, there are no minimum monitoring requirements for NO 2 in 40 CFR part 58 Appendix D, other than a requirement for EPA Regional Administrator approval before removing any existing monitors, and that any ongoing NO 2 monitoring must have at
least one monitor sited to measure the
maximum concentration of NO 2 in that area (though, as discussed below
monitors in the current network do not measure peak concentrations associated
with on-road mobile sources that can occur near major roadways because the network was not designed for this purpose). EPA removed the specific


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minimum monitoring requirements for

NO 2 of two monitoring sites per area with a population of 1,000,000 or more in the 2006 monitoring rule revisions (71 FR 61236), based on the fact that
there were no NO 2 nonattainment areas at that time, coupled with trends evidence showing an increasing gap between national average NO 2 concentrations and the current annual standard. Additionally, the minimum requirements were removed to provide State, local, and Tribal air monitoring agencies flexibility in meeting higher priority monitoring needs for pollutants
such as O 3 and PM 2.5 , or implementing the new multi-pollutant sites (NCore network) required by the 2006 rule revisions, by allowing them to discontinue lower priority monitoring. There are requirements in 40 CFR part 58 Appendix D for NO 2 monitoring as part of the Photochemical Assessment Monitoring Stations (PAMS) network. However, of the approximately 400 NO 2 monitors currently in operation, only about 10 percent may be due to the PAMS requirements.

An analysis of the approximately 400 monitors comprising the current NO 2 monitoring network (Watkins and Thompson, 2008) indicates that the

current NO 2 network has largely remained unchanged in terms of size and target monitor objective categories since it was introduced in the May 10, 1979 monitoring rule (44 FR 27571).
The review of the current network
found that the assessment of concentrations for general population exposure and maximum concentrations at neighborhood and larger scales were the top objectives. A review of the distribution of listed spatial scales of representation shows that only approximately 3 monitors are described as microscale, representing an area on
the order of several meters to 100 meters, and approximately 23 monitors are described as middle scale, which represents an area on the order of 100 to 500 meters. This low percentage of smaller spatially representative scale
sites within the network of approximately 400 monitoring sites indicates that the majority of monitorshave, in fact, been sited to assess areawide exposures on the neighborhood, urban, and regional scales, as would be expected for a network sited to support
the current annual NO 2 standard and PAMS objectives. The current network does not include monitors placed near major roadways and, therefore, monitors
in the current network do not necessarily measure the maximum
concentrations that can occur on a localized scale near these roadways (as discussed in the next section). It should be noted that the network not only accommodates NAAQS related monitoring but also serves other monitoring objectives, such as support for photochemistry analysis, O 3 modeling and forecasting, and particulate matter precursor tracking.

2. NO 2 Air Quality and Gradients Around Roadways

On-road and non-road mobile sources account for approximately 60% of NO Xemissions (ISA, table 2.2–1) and trafficrelated exposures can dominate personal exposures to NO 2 (ISA section 2.5.4). While driving, personal exposure
concentrations in the cabin of a vehicle could be substantially higher than
ambient concentrations measured nearby (ISA, section 2.5.4). For example, estimates presented in the REA suggest that on/near roadway NO 2 concentrations could be approximately 80% (REA, section 7.3.2) higher on average across locations than concentrations away from roadways and that roadway-associated environments could be responsible for the majority of 1-hour peak NO 2 exposures (REA, Figures 8–17 and 8–18). Because
monitors in the current network are notsited to measure peak roadwayassociated NO 2 concentrations, individuals who spend time on and/or near major roadways could experience

NO 2 concentrations that are considerably higher than indicated by
monitors in the current area-wide NO 2 monitoring network.

Research suggests that the
concentrations of on-road mobile source pollutants such as NO X , carbon monoxide (CO), directly emitted air toxics, and certain size distributions of particulate matter (PM), such as ultrafine PM, typically display peak concentrations on or immediately adjacent to roads (ISA, section 2.5). This situation typically produces a gradient in pollutant concentrations, with concentrations decreasing with increasing distance from the road, and concentrations generally decreasing to near area-wide ambient levels, or typical upwind urban background levels,
within a few hundred meters
downwind. While such a concentration gradient is present on almost all roads, the characteristics of the gradient, including the distance from the road that a mobile source pollutant signature can be differentiated from background concentrations, are heavily dependent on factors such as traffic volumes, local topography, roadside features, meteorology, and photochemical reactivity conditions (Baldauf, et al., 2009; Beckerman et al., 2008; Clements et al., 2008; Hagler et al., 2009; Janssen et al., 2001; Rodes and Holland, 1981; Roorda-Knape et al., 1998; Singer et al., 2004; Zhou and Levy, 2007).

Because NO 2 in the ambient air is due largely to the atmospheric oxidation of
NO emitted from combustion sources (ISA, section 2.2.1), elevated NO 2 concentrations can extend farther away from roadways than the primary pollutants also emitted by on-road mobile sources. More specifically,
review of the technical literature suggests that NO 2 concentrations may return to area-wide or typical urban background concentrations within distances up to 500 meters of roads, though the actual distance will vary with topography, roadside features, meteorology, and photochemical reactivity conditions (Baldauf et al., 2009; Beckerman et al., 2008; Clements et al., 2008; Gilbert et al. 2003; Rodes and Holland, 1981; Singer et al., 2004; Zhou and Levy, 2007). Efforts to quantify the extent and slope of the concentration gradient that may exist from peak near-road concentrations to the typical urban background
concentrations must consider the variability that exists across locations and for a given location over time. As a result, we have identified a range of concentration gradients in the technical literature which indicate that, on average, peak NO 2 concentrations on or immediately adjacent to roads may typically be between 30 and 100 percent greater than concentrations monitored in the same area but farther away from the road (ISA, Section 2.5.4; Beckerman et al., 2008; Gilbert et al., 2003; Rodes and Holland, 1981; Roorda-Knape et al., 1998; Singer et al., 2004). This range of concentration gradients has implications for revising the NO 2 primary standard and for the NO 2 monitoring network (discussed in sections II.F.4 and III).

B. Health Effects Information

In the last review of the NO 2 NAAQS,
the 1993 NO X Air Quality Criteria Document (1993 AQCD) (EPA, 1993) concluded that there were two key health effects of greatest concern at
ambient or near-ambient concentrations
of NO 2 (ISA, section 5.3.1). The first was increased airway responsiveness in
asthmatic individuals after short-term exposures. The second was increased respiratory illness among children associated with longer-term exposures

to NO 2 . Evidence also was found for increased risk of emphysema, but this appeared to be of major concern only with exposures to NO 2 at levels much higher than then current ambient levels (ISA, section 5.3.1). Controlled human


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exposure and animal toxicological studies provided qualitative evidence for airway hyperresponsiveness and lung function changes while epidemiologic studies provided evidence for increased respiratory symptoms with increased indoor NO 2 exposures. Animal toxicological findings of lung host defense system changes with NO 2 exposure provided a biologically-plausible basis for the epidemiologic results. Subpopulations considered potentially more susceptible
to the effects of NO 2 exposure included persons with preexisting respiratory disease, children, and the elderly. The epidemiologic evidence for respiratory health effects was limited, and no studies had considered endpoints such as hospital admissions, emergency department visits, or mortality (ISA, section 5.3.1).

As summarized below and discussed more fully in section II.B of the proposal notice, evidence published since the last review generally has confirmed and
extended the conclusions articulated in the 1993 AQCD (ISA, section 5.3.2). The epidemiologic evidence has grown substantially with the addition of field and panel studies, intervention studies, time-series studies of endpoints such as hospital admissions, and a substantial number of studies evaluating mortality
risk associated with short-term NO 2 exposures. While not as marked as the growth in the epidemiologic literature, a number of recent toxicological and controlled human exposure studies also provide insights into relationships
between NO 2 exposure and health effects. This body of evidence focuses
the current review on NO 2 -related respiratory effects at lower ambient and exposure concentrations than considered in the previous review.

1. Adverse Respiratory Effects and Short-Term Exposure to NO 2

The ISA concluded that the findings of epidemiologic, controlled human exposure, and animal toxicological studies provide evidence that is sufficient to infer a likely causal relationship for respiratory effects following short-term NO 2 exposure (ISA, sections 3.1.7 and 5.3.2.1). The ISA (section 5.4) concluded that the strongest evidence for an association
between NO 2 exposure and adverse
human health effects comes from epidemiologic studies of respiratory symptoms, emergency department visits, and hospital admissions. These studies include panel and field studies,
studies that control for the effects of cooccurring pollutants, and studies
conducted in areas where the whole distribution of ambient 24-hour average NO 2 concentrations was below the current NAAQS level of 53 ppb (annual average). With regard to this evidence,
the ISA concluded that NO 2 epidemiologic studies provide ‘‘ little evidence of any effect threshold ’’ (ISA, section 5.3.2.9, p. 5–15). In studies that have evaluated concentration-response relationships, they appear linear within the observed range of data (ISA, section 5.3.2.9).

Overall, the epidemiologic evidence for respiratory effects has been characterized in the ISA as consistent, in that associations are reported in
studies conducted in numerous locations with a variety of methodological approaches, and coherent, in that the studies report associations with respiratory health outcomes that are logically linked together. In addition, a number of these associations are statistically significant, particularly the more precise effect estimates (ISA, section 5.3.2.1). These epidemiologic studies are supported by evidence from toxicological and controlled human exposure studies, particularly those that evaluated airway hyperresponsiveness in asthmatic individuals (ISA, section 5.4). The ISA concluded that together, the epidemiologic and experimental data sets form a plausible, consistent, and coherent description of a relationship
between NO 2 exposures and an array of adverse respiratory health effects that range from the onset of respiratory symptoms to hospital admissions.

In considering the uncertainties associated with the epidemiologic evidence, the ISA (section 5.4) noted
that it is difficult to determine ‘‘ the
extent to which NO 2 is independently associated with respiratory effects or if

NO 2 is a marker for the effects of another traffic-related pollutant or mix of pollutants. ’’ On-road vehicle exhaust emissions are a widespread source of combustion pollutant mixtures that
include NO X and are an important
contributor to NO 2 levels in near-road locations. Although the presence of other pollutants from vehicle exhaust emissions complicates efforts to quantify specific NO 2 -related health effects, a number of epidemiologic
studies have evaluated associations with

NO 2 in models that also include cooccurring pollutants such as PM, O 3 , CO, and/or SO 2 . The evidence
summarized in the ISA indicates that

NO 2 associations generally remain robust in these multi-pollutant modelsand supports a direct effect of shortterm NO 2 exposure on respiratory morbidity ( see ISA Figures 3.1–7, 3.1– 10, 3.1–11). The plausibility and
coherence of these effects are also supported by epidemiologic studies of
indoor NO 2 as well as experimental ( i.e., toxicological and controlled human exposure) studies that have evaluated host defense and immune system changes, airway inflammation, and airway responsiveness ( see subsequent sections of this proposal and the ISA, section 5.3.2.1). The ISA (section 5.4)
concluded that the robustness of epidemiologic findings to adjustment for co-pollutants, coupled with data from animal and human experimental studies, support a determination that the relationship between NO 2 and respiratory morbidity is likely causal, while still recognizing the relationship
between NO 2 and other traffic related pollutants.

The epidemiologic and experimental studies encompass a number of respiratory-related health endpoints, including emergency department visits and hospitalizations, respiratory symptoms, airway hyperresponsiveness, airway inflammation, and lung function. The findings relevant to these endpoints, which provide the rationale to support the judgment of a likely causal relationship, are described in
more detail in section II.B.1 of the proposal.

2. Other Effects With Short-Term Exposure to NO 2 a. Mortality

The ISA concluded that the epidemiologic evidence is suggestive, but not sufficient, to infer a causal relationship between short-term exposure to NO 2 and all-cause and cardiopulmonary-related mortality (ISA, section 5.3.2.3). Results from several large United States and European multicity studies and a meta-analysis study indicate positive associations
between ambient NO 2 concentrations and the risk of all-cause (nonaccidental) mortality, with effect estimates ranging from 0.5 to 3.6% excess risk in mortality per standardized increment (20 ppb for 24-hour averaging time, 30 ppb for 1- hour averaging time) (ISA, section 3.3.1, Figure 3.3–2, section 5.3.2.3). In general,
the ISA concluded that NO 2 effect estimates were robust to adjustment for co-pollutants. Both cardiovascular and respiratory mortality have been
associated with increased NO 2 concentrations in epidemiologic studies (ISA, Figure 3.3–3); however, similar
associations were observed for other pollutants, including PM and SO 2 . The range of risk estimates for excess mortality is generally smaller than that for other pollutants such as PM. In addition, while NO 2 exposure, alone or in conjunction with other pollutants,


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may contribute to increased mortality, evaluation of the specificity of this
effect is difficult. Clinical studies showing hematologic effects and animal toxicological studies showing biochemical, lung host defense, permeability, and inflammation changes with short-term exposures to NO 2 provide limited evidence of plausible pathways by which risks of mortality may be increased, but no coherent picture is evident at this time (ISA, section 5.3.2.3).

b. Cardiovascular Effects

The ISA concluded that the available
evidence on cardiovascular health effects following short-term exposure to

NO 2 is inadequate to infer the presence or absence of a causal relationship at this time (ISA, section 5.3.2.2). Evidence from epidemiologic studies of heart rate variability, repolarization changes, and cardiac rhythm disorders among heart patients with ischemic cardiac disease are inconsistent (ISA, section 5.3.2.2). In most studies, associations with PM were found to be similar or stronger than
associations with NO 2 . Generally positive associations between ambient

NO 2 concentrations and hospital admissions or emergency department
visits for cardiovascular disease have been reported in single-pollutant models (ISA, section 5.3.2.2); however,
most of these effect estimate values were diminished in multi-pollutant models
that also contained CO and PM indices (ISA, section 5.3.2.2). Mechanistic
evidence of a role for NO 2 in the development of cardiovascular diseases
from studies of biomarkers of inflammation, cell adhesion, coagulation, and thrombosis is lacking (ISA, section 5.3.2.2). Furthermore, the
effects of NO 2 on various hematological parameters in animals are inconsistent and, thus, provide little biological plausibility for effects of NO 2 on the cardiovascular system (ISA, section 5.3.2.2).

3. Health Effects With Long-Term Exposure to NO 2 a. Respiratory Morbidity

The ISA concluded that overall, the epidemiologic and experimental evidence is suggestive, but not sufficient, to infer a causal relationship between long-term NO 2 exposure and respiratory morbidity (ISA, section 5.3.2.4). The available database evaluating the relationship betweenrespiratory illness in children and longterm exposures to NO 2 has increased
since the 1996 review of the NO 2 NAAQS ( see section II.B.3 of the proposal for a more detailed discussion). A number of epidemiologic
studies have examined the effects of long-term exposure to NO 2 and reported positive associations with decrements in lung function and partially irreversible decrements in lung function growth (ISA, section 3.4.1, Figures 3.4–1 and 3.4–2). While animal toxicological studies may provide biological plausibility for the chronic effects of

NO 2 that have been observed in epidemiologic studies (ISA, sections 3.4.5 and 5.3.2.4), the high correlation among traffic-related pollutants in epidemiologic studies makes it difficult to accurately estimate independent effects (ISA, section 5.3.2.4).

b. Mortality

The ISA concluded that the epidemiologic evidence is inadequate to infer the presence or absence of a causal relationship between long-term exposure to NO 2 and mortality (ISA, section 5.3.2.6). In the United States and European cohort studies examining the relationship between long-term exposure to NO 2 and mortality, results have been inconsistent (ISA, section 5.3.2.6). Further, when associations were suggested, they were not specific

to NO 2 but also implicated PM and other traffic indicators. The relatively high correlations reported between NO 2 and PM indices make it difficult to interpret these observed associations at this time (ISA, section 5.3.2.6).

c. Carcinogenic, cardiovascular, and reproductive/developmental effects

The ISA concluded that the available epidemiologic and toxicological evidence is inadequate to infer the presence or absence of a causal relationship for carcinogenic, cardiovascular, and reproductive anddevelopmental effects related to longterm NO 2 exposure (ISA, section 5.3.2.5). Epidemiologic studies conducted in Europe have shown an association between long-term NO 2 exposure and increased incidence of cancer (ISA, section 5.3.2.5). However, the animal toxicological studies have provided no clear evidence that NO 2 acts as a carcinogen (ISA, section 5.3.2.5). The very limited epidemiologic and toxicological evidence do not suggest that long-term exposure to NO 2 has cardiovascular effects (ISA, section 5.3.2.5). The epidemiologic evidence is
not consistent for associations between

NO 2 exposure and fetal growth retardation; however, some evidence is accumulating for effects on preterm delivery (ISA, section 5.3.2.5). Scant animal evidence supports a weak
association between NO 2 exposure and adverse birth outcomes and provides little mechanistic information or biological plausibility for the epidemiologic findings.

4. NO 2 -related Impacts on Public Health

Specific groups within the general population are likely at increased risk for suffering adverse effects from NO 2 exposure. This could occur because they are affected by lower levels of NO 2 than the general population or because they experience a larger health impact than the general population to a given level of exposure (susceptibility) and/or because they are exposed to higher
levels of NO 2 than the general population (vulnerability). The term susceptibility generally encompasses innate ( e.g., genetic or developmental) and/or acquired ( e.g., age or disease)
factors that make individuals more likely to experience effects with exposure to pollutants. The severity of health effects experienced by a susceptible subgroup may be much greater than that experienced by the population at large. Factors that may influence susceptibility to the effects of air pollution include age ( e.g., infants, children, elderly); gender; race/ethnicity; genetic factors; and preexisting disease/condition ( e.g., obesity, diabetes, respiratory disease, asthma, chronic obstructive pulmonary disease (COPD), cardiovascular disease, airway hyperresponsiveness, respiratory infection, adverse birth outcome) (ISA, sections 4.3.1, 4.3.5, and 5.3.2.8). In addition, certain groups may experience relatively high exposure to NO 2 , thus forming a potentially vulnerable population (ISA, section 4.3.6). Factors that may influence susceptibility and vulnerability to air pollution include socioeconomic status (SES), education level, air conditioning use, proximity to roadways, geographic location, level of physical activity, and work environment ( e.g., indoor versus outdoor) (ISA, section 4.3.5). The ISA discussed factors that can confer susceptibility and/or vulnerability to air pollution with most
of the discussion devoted to factors for
which NO 2 -specific evidence exists (ISA, section 4.3). These factors include pre-existing disease ( e.g., asthma), age ( i.e., infants, children, older adults), genetic factors, gender, socioeconomic status, and proximity to roadways ( see section II.B.4 in proposal for more detailed discussion of these factors).

As discussed in more detail in the proposal (section II.B.4), the population potentially affected by NO 2 is large. A considerable fraction of the population resides, works, or attends school near major roadways, and these individuals are likely to have increased exposure to

NO 2 (ISA, section 4.4). Based on data


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7 The most current American Housing Survey ( http://www.census.gov/hhes/www/housing/ahs/
ahs.html ) is from 2007 and lists a higher fraction of housing units within the 300 foot boundary than do prior surveys. According to Table 1A–6 from that report ( http://www.census.gov/hhes/www/ housing/ahs/ahs07/tab1a-6.pdf ), out of 128,203,000 total housing units in the United States, 20,016,000 were reported by the surveyed occupant or landlord as being within 300 feet of a 4-or-more lane highway, railroad, or airport. That constitutes 15.613% of the total housing units in the U.S. Assuming equal distributions, with a current population of 306,330,199, that means that there would be 47.8 million people meeting the 300 foot

criteria. 8 The study by Tolbert et al. (2007) reported positive associations between 1-hour ambient NO 2 concentrations and respiratory-related emergency department visits. The meta-analysis was included in the ISA and reported that short-term exposures

to NO 2 concentrations at or above 100 ppb increased airway responsiveness in most
asthmatics. from the 2003 American Housing Survey, approximately 36 million individuals live within 300 feet (

∼ 90 meters) of a four-lane highway, railroad, or airport (ISA, section 4.4). 7 Furthermore, in California, 2.3% of schools, with a total enrollment of more than 150,000 students were locatedwithin approximately 500 feet of hightraffic roads, with a higher proportion of non-white and economically disadvantaged students attending those schools (ISA, section 4.4). Of this population, asthmatics and members of other susceptible groups discussed above will have even greater risks of experiencing health effects related to

NO 2 exposure. In the United States, approximately 10% of adults and 13% of children (approximately 22.2 million people in 2005) have been diagnosed with asthma, and 6% of adults have been diagnosed with COPD (ISA, section 4.4). The prevalence and severity of asthma is higher among certain ethnic or racial groups such as Puerto Ricans, American Indians, Alaskan Natives, and African Americans (ISA, section 4.4). A higher prevalence of asthma among persons of lower SES
and an excess burden of asthma hospitalizations and mortality in minority and inner-city communities have been observed (ISA, section 4.4). In addition, based on United States census data from 2000, about 72.3 million (26%) of the United States population are under 18 years of age, 18.3 million (7.4%) are under 5 years of age, and 35 million (12%) are 65 years of age or older. Therefore, large portions of the United States population are in age groups that are likely at-risk for health effects associated with exposure to
ambient NO 2 . The size of the potentially at-risk population suggests that exposure to ambient NO 2 could have a significant impact on public health in
the United States.

C. Human Exposure and Health Risk
Characterization

To put judgments about NO 2 - associated health effects into a broader public health context, EPA has drawn upon the results of the quantitative exposure and risk assessments. Judgments reflecting the nature of the evidence and the overall weight of the
evidence are taken into consideration in these quantitative exposure and risk assessments, discussed below. These assessments provide estimates of the
likelihood that asthmatic individuals would experience exposures of potential
concern and estimates of the incidence
of NO 2 -associated respiratory emergency department visits under varying air quality scenarios ( e.g., just meeting the current or alternative standards), as well
as characterizations of the kind and degree of uncertainties inherent in such estimates. As discussed more fully in section II.C of the proposal, this section summarizes the approach taken in the
REA to characterize NO 2 -related exposures and health risks. Goals of the REA included estimating short-term exposures and potential human health risks associated with (1) recent levels of
ambient NO 2 ; (2) NO 2 levels adjusted to simulate just meeting the current standard; and (3) NO 2 levels adjusted to simulate just meeting potential
alternative standards.

For purposes of the quantitative
characterization of NO 2 health risks, the REA determined that it was appropriate to focus on endpoints for which the ISA
concluded that the available evidence is
sufficient to infer either a causal or a likely causal relationship. This was generally consistent with judgments made in other recent NAAQS reviews ( e.g., see EPA, 2005). As noted above in section II.A, the only health effect category for which the evidence was judged in the ISA to be sufficient to infer either a causal or a likely causal relationship is respiratory morbidity following short-term NO 2 exposure. Therefore, for purposes of characterizing
health risks associated with NO 2, the REA focused on respiratory morbidity endpoints that have been associated
with short-term NO 2 exposures.

In evaluating the appropriateness of specific endpoints for use in the NO 2 risk characterization, the REA considered both epidemiologic and controlled human exposure studies. As described in more detail in the proposal (section II.C.1), the characterization of

NO 2 -associated health risks was based on an epidemiology study conducted in Atlanta, Georgia by Tolbert et al. (2007) and a meta-analysis of controlled human exposure studies of NO 2 and airway responsiveness in asthmatics (ISA, Table 3.1–3). 8 As noted above, the purpose of the
assessments described in the REA was to characterize air quality, exposures,
and health risks associated with recent
ambient levels of NO 2 , with NO 2 levels that could be associated with just meeting the current NO 2 NAAQS, and
with NO 2 levels that could be associated with just meeting potential alternative standards. To characterize health risks, the REA employed three approaches. In the first approach, for each air quality scenario, NO 2 concentrations at fixedsite monitors and simulated concentrations on/near roadways were compared to potential health effect
benchmark values derived from the controlled human exposure literature. In the second approach, modeled estimates of exposures in asthmatics were compared to potential health effect benchmarks. In the third approach, concentration-response relationships from an epidemiologic study were used in conjunction with baseline incidence
data and recent or simulated ambient
concentrations to estimate health impacts. An overview of the approaches to characterizing health risks is provided in the proposal (section II.C.2) and each approach, along with its limitations and uncertainties ( see proposal, section II.C.3) has been
described in more detail in the REA (chapters 6 through 9).

Chapters 7–9 of the REA estimated exposures and health risks associated with recent air quality and with air quality, as measured at monitors in the current area-wide network, which had been adjusted to simulate just meeting the current and potential alternative standards. The specific standard levels evaluated, for an area-wide standard based on the 3-year average of the 98th and 99th percentile 1-hour daily

maximum NO 2 concentrations, were 50, 100, 150, and 200 ppb. In interpreting
these results within the context of the
current revisions to the NO 2 primary NAAQS ( see below), we note that
simulation of different standard levels was based on adjusting NO 2 concentrations at available area-wide monitors. Therefore, the standard levels
referred to above reflect the allowable
area-wide NO 2 concentrations, not the
maximum allowable concentrations. As a consequence, the maximum concentrations in an area that just meets
one of these standard levels would be expected to be higher than the standard level. For example, given that near-road


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NO 2 concentrations can be 30% to 100% higher than area-wide concentrations ( see section II.E.2), an area-wide concentration of 50 ppb could correspond to near-road concentrations from 65 to 100 ppb.

Key results of the air quality, exposure, and risk analyses were presented in the policy assessment chapter of the REA and summarized in the proposal (Table 1 in proposal). In considering these results, the policy assessment chapter of the REA
concluded that the risks estimated to be associated with just meeting the current annual standard can be judged important from a public health perspective. The results for specific 1-
hour standard levels estimate that limiting the 98th/99th percentile of the distribution of 1-hour daily maximum

NO 2 concentrations measured at areawide monitors to 50 or 100 ppb could substantially reduce exposures to
ambient NO 2 and associated health risks (compared to just meeting the current standard). In contrast, limiting these
area-wide NO 2 concentrations to 150 or 200 ppb is estimated to result in similar, or in some cases higher, NO 2 -associated exposures and health risks than just meeting the current standard. The pattern of results was similar for standards just meeting either the 98th or the 99th percentile 1-hour daily maximum area-wide standards (REA, Chapters 7, 8, and 9).

D. Approach for Reviewing the Need To
Retain or Revise the Current Standard

EPA notes that the final decision on retaining or revising the current primary

NO 2 standard is a public health policy judgment to be made by the Administrator. This judgment has been informed by a recognition that the
available health effects evidence reflects a continuum consisting of ambient
levels of NO 2 at which scientists generally agree that health effects are likely to occur, through lower levels at which the likelihood and magnitude of the response become increasingly
uncertain. The Administrator’s final decisions draw upon scientific information and analyses related to health effects, population exposures, and risks; judgments about the appropriate response to the range of
uncertainties that are inherent in the scientific evidence and analyses; and
comments received from CASAC and the public.

To evaluate whether the current primary NO 2 standard is requisite or
whether consideration of revisions is appropriate, EPA has used an approach
in this review that was described in the policy assessment chapter of the REA. This approach builds upon those used in reviews of other criteria pollutants, including the most recent reviews of the Pb, O 3 , and PM NAAQS (EPA, 2007c; EPA, 2007d; EPA, 2005), and reflects the body of evidence and information that is currently available. As in other recent reviews, EPA’s considerations included the implications of placing more or less weight or emphasis on different aspects
of the scientific evidence and the exposure/risk-based information, recognizing that the weight to be given
to various elements of the evidence and exposure/risk information is part of the public health policy judgments that the Administrator will make in reaching
decisions on the standard.

A series of general questions framed this approach to considering thescientific evidence and exposure-/riskbased information. First, EPA’s
consideration of the scientific evidence and exposure/risk information with regard to the adequacy of the current standard has been framed by the following questions:

• To what extent does evidence that has
become available since the last review reinforce or call into question evidence for

NO 2 -associated effects that were identified in
the last review?

• To what extent has evidence for different health effects and/or sensitive populations
become available since the last review?

• To what extent have uncertainties
identified in the last review been reduced and/or have new uncertainties emerged?

• To what extent does evidence and exposure-/risk-based information that has
become available since the last review reinforce or call into question any of the
basic elements of the current standard?

To the extent that the available evidence and exposure-/risk-based information suggests it may be appropriate to consider revision of the current standard, EPA considers that evidence and information with regard to its support for consideration of a
standard that is either more or less protective than the current standard. This evaluation has been framed by the following questions:

• Is there evidence that associations, especially causal or likely causal associations, extend to ambient NO 2 concentrations as low as, or lower than, the concentrations that have previously been associated with health effects? If so, what are the important uncertainties associated with
that evidence?

• Are exposures above benchmark levels
and/or health risks estimated to occur in areas that meet the current standard? If so, are the estimated exposures and health risks important from a public health perspective? What are the important uncertainties
associated with the estimated risks? To the extent that there is support for consideration of a revised standard, EPA then considers the specific elements of the standard (indicator, averaging time, form, and level) within the context of the currently available information. In so doing, the Agency has addressed the following questions:

• Does the evidence provide support for considering a different indicator for gaseous

NO X ?

• Does the evidence provide support for considering different averaging times?

• What ranges of levels and forms of alternative standards are supported by the evidence, and what are the associated
uncertainties and limitations?

• To what extent do specific averaging times, levels, and forms of alternative standards reduce the estimated exposures
above benchmark levels and risks attributable

to NO 2 , and what are the uncertainties associated with the estimated exposure and
risk reductions? The questions outlined above have been addressed in the REA, the proposal, and in this final rulemaking. The following sections present the rationale for proposed decisions, discussion of public comments, and the
Administrator’s conclusions on the adequacy of the current standard and potential alternative standards in terms of indicator, averaging time, form, and
level.

E. Adequacy of the Current Standard

This section discusses considerations
related to the decision as to whether the

current NO 2 primary NAAQS is requisite to protect public health with an adequate margin of safety. Specifically, section II.E.1 provides an overview of the rationale supporting the
Administrator’s conclusion in the proposal that the current standard alone does not provide adequate public health protection; section II.E.2 discusses comments received on the adequacy of the current standard; and section II.E.3
discusses the Administrator’s final
decision on whether the current NO 2 primary NAAQS is requisite to protect public health with an adequate margin of safety.

1. Rationale for Proposed Decision

In reaching a conclusion regarding the adequacy of the current NO 2 NAAQS in the proposal (section II.E.5), the
Administrator considered the scientific
evidence assessed in the ISA and the conclusions of the ISA, the exposure and risk information presented in the REA and the conclusions of the policy assessment chapter of the REA, and the views expressed by CASAC. These
considerations are discussed in detail in the proposal (II.E.) and are summarized in this section. In the proposal, the


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Administrator noted the following in considering the adequacy of the current
standard:

• The ISA concluded that the results of epidemiologic and experimental studies form a plausible and coherent data set that supports a relationship
between NO 2 exposures and respiratory endpoints, including respiratory symptoms and respiratory-related hospital admissions and emergency department visits, at ambient concentrations that are present in areas
that meet the current NO 2 NAAQS (ISA, section 5.4).

• The policy assessment chapter of
the REA concluded that risks estimated to be associated with air quality adjusted upward to simulate just meeting the current standard can reasonably be judged important from a public health perspective (REA, section 10.3.3).

• The policy assessment chapter of the REA concluded that exposure- and
risk-based results reinforce the scientific evidence in supporting the conclusion that consideration should be given to revising the current NO 2 NAAQS so as to provide increased public health protection, especially for at-risk groups,
from NO 2 -related adverse health effects associated with short-term, and potential long-term, exposures (REA, section 10.3.3).

• CASAC agreed that the current
annual standard alone is not sufficient to protect public health against the types of exposures that could lead to these health effects. Specifically, in
their letter to the Administrator on the final REA, they stated that ‘‘ CASAC concurs with EPA’s judgment that the current NAAQS does not protect the public’s health and that it should be
revised ’’ (Samet, 2008b).

Based on these considerations (discussed in more detail in the proposal, section II.E), the
Administrator concluded in the proposal that the current NO 2 primary NAAQS is not requisite to protect public health with an adequate margin of safety against adverse respiratory
effects associated with short-term exposures. In considering approaches to revising the current standard, the
Administrator concluded that it is appropriate to consider setting a new
short-term standard in addition to retaining the current annual standard.
The Administrator noted that such a short-term standard could provide increased public health protection, especially for members of at-risk groups,
from effects described in both epidemiologic and controlled human exposure studies to be associated with short-term exposures to NO 2

. 2. Comments on the Adequacy of the
Current Standard

This section discusses comments received from CASAC and public commenters on the proposal that either supported or opposed the Administrator’s proposed decision to
revise the current NO 2 primary NAAQS. Comments on the adequacy of the
current standard that focused on the scientific and/or the exposure/risk basis for the Administrator’s proposed
conclusions are discussed in sections
II.E.2.a-II.E.2.c. Comments on the epidemiologic evidence are considered
in section II.E.2.a. Comments on the controlled human exposure evidence
are considered in section II.E.2.b. Comments on human exposure and
health risk assessments are considered
in section II.E.2.c. To the extent these
comments on the evidence and information are also used to justify
commenters’ conclusions on decisions related to indicator, averaging time, level, or form, they are noted in the appropriate sections below (II.F.1– II.F.4).

In their comments on the proposal (Samet, 2009), CASAC reiterated their support for the need to revise the
current annual NO 2 NAAQS in order to increase public health protection. As noted above, in its letter to the Administrator on the final REA (Samet, 2008b) CASAC stated that it ‘‘ concurs with EPA’s judgment that the current NAAQS does not protect the public’s
health and that it should be revised. ’’ In supporting adoption of a more stringent NAAQS for NO 2 , CASAC considered the
assessment of the scientific evidence presented in the ISA, the results of assessments presented in the REA, and the conclusions of the policy assessment chapter of the REA. As such, CASAC’s rationale for revising the current
standard was consistent with the
Administrator’s rationale as discussed in the proposal.

Many public commenters agreed with CASAC that, based on the available information, the current NO 2 standard is not requisite to protect public health with an adequate margin of safety and
that revisions to the standard are appropriate. Among those calling for
revisions to the standard were environmental groups ( e.g., Clean Air Council (CAC), Earth Justice (EJ), Environmental Defense Fund (EDF),
Natural Resources Defense Council (NRDC), Group Against Smog and Pollution (GASP)); medical/public health organizations ( e.g., American Lung Association (ALA), American Medical Association (AMA), American Thoracic Society (ATS), National Association for the Medical Direction of Respiratory Care (NAMDRC), National
Association of Cardiovascular and Pulmonary Rehabilitation (NACPR), American College of Chest Physicians (ACCP)); a large number of State agencies and organizations ( e.g., National Association of Clean Air Agencies (NACAA), Northeast States for Coordinated Air Use Management (NESCAUM), and State or local agencies in CA, IA, IL, MI, MO, NC, NM, NY, TX, VA, WI); Tribes ( e.g., National Tribal Air Association (NTAA), Fond du Lac Band of Lake Superior Chippewa (Fond du Lac)), and a number of individual
commenters. These commenters
concluded that the current NO 2 standard needs to be revised and that a more stringent standard is needed to protect the health of sensitive population groups. In supporting the need to adopt a more stringent NAAQS
for NO 2 , these commenters often
referenced the conclusions of CASAC
and relied on the evidence and information presented in the proposal. As such, similar to CASAC, the rationale offered by these commenters was consistent with that presented in the proposal to support the Administrator’s proposed decision to
revise the current NO 2 NAAQS.

Some industry commenters ( e.g., Alliance of Automobile Manufacturers (AAM), American Petroleum Institute (API), Interstate Natural Gas Association of America (INGAA), Utility Air Regulatory Group (UARG)) and one State commenter (IN Department of Environmental Management) expressed support for retaining the current annual standard alone. In supporting this view, these commenters generally concluded that the current standard is requisite to protect public health with an adequate margin of safety and that the available evidence is not sufficient to support revision of the standard. For example,
UARG stated that ‘‘ EPA has failed to demonstrate that the present NO 2 NAAQS is no longer at the level requisite to protect public health with an adequate margin of safety. ’’ In addition, INGAA stated that

‘‘ * * * EPA should be compelled to
retain the current standard and defer a
decision on a new short-term standard until the science is more clearly
defined. ’’

In support of their views, these commenters provided specific comments on the epidemiologic and controlled human exposure evidence as discussed below. In responding to these specific comments, we note that the Administrator relied in the proposal on the evidence, information and judgments contained in the ISA and the


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REA (including the policy assessment chapter) as well as on the advice of CASAC. In considering the evidence, information, and judgments of the ISA and the REA, the Agency notes that
these documents have been reviewed extensively by CASAC and have been discussed by CASAC at multiple public meetings ( see section I.D). In their letter to the Administrator regarding the second draft ISA (Henderson, 2008), CASAC noted the following:

Panel members concur with the primary conclusions reached in the ISA with regard
to health risks that are associated with NO 2 exposure. In particular, the Panel agrees with
the conclusion that the current scientific
evidence is ‘‘ sufficient to infer a likely causal relationship between short-term NO 2 exposure and adverse effects on the respiratory system. ’’ The strongest evidence in support of this conclusion comes from epidemiology studies that show generally positive associations between NO 2 and respiratory symptoms, hospitalizations or emergency department visits, as summarized in Figure 5.3.1. ’’

Similarly, in their letter to the Administrator on the final REA (Samet, 2008b), CASAC noted the following:

Overall, CASAC found this version of the REA satisfactory in its approach to moving from the scientific foundation developed in the Integrated Science Assessment (ISA) to setting out evidence-based options for the NAAQS. The REA provides the needed bridge from the evidence presented in the ISA to a characterization of the exposures
and the associated risks with different profiles of exposure. It draws on toxicological and epidemiological evidence and addresses risk to an identified susceptible population, people with asthmatic conditions. EPA has also systematically described uncertainties
associated with the risk assessments. We commend EPA for developing a succinct and thoughtfully developed synthesis in chapter10. This summary chapter represents a longneeded and transparent model for linking a substantial body of scientific evidence to the four elements of the NAAQS.
Therefore, in discussing comments on the interpretation of the scientific evidence and exposure/risk information,
we note that CASAC has endorsed the approaches and conclusions of the ISA and the REA. These approaches and
conclusions are discussed below in more detail, within the context of specific public comments.

a. Comments on EPA’s Interpretation of the Epidemiologic Evidence

Several industry groups ( e.g., API, National Mining Association (NMA), American Chemistry Council (ACC),AAM, Annapolis Center for ScienceBased Public Policy (ACSBPP), Engine Manufacturers Association (EMA), ExxonMobil (Exxon), National Association of Manufacturers (NAM)) commented that, given the presence of numerous co-pollutants in the air, epidemiologic studies do not support
the contention that NO 2 itself is causing
health effects.

While EPA has recognized that multiple factors can contribute to the etiology of respiratory disease and that more than one air pollutant could independently impact respiratory health, we continue to judge, as discussed in the ISA, that the available evidence supports the conclusion that there is an independent effect of NO 2 on respiratory morbidity. In reaching this judgment, we recognize that a major methodological issue affecting NO 2 epidemiologic studies concerns the
evaluation of the extent to which other air pollutants may confound or modify

NO 2 -related effect estimates. The use of multipollutant regression models is the most common approach for controlling potential confounding by co-pollutants in epidemiologic studies. The issues related to confounding and the evidenceof potential confounding by copollutants has been thoroughly reviewed in the ISA ( see Figures 3.1–10 and 3.1–11) and in previous assessments ( e.g., the criteria document for PM) (EPA, 2004). NO 2 risk estimates for respiratory morbidity endpoints, in general, were not sensitive to the inclusion of co-pollutants, including particulate and gaseous pollutants. As observed in Figures 3.1–10 and 3.1–11 in the ISA, relative risks for hospital admissions or emergency department visits are generally unchanged, nor is their interpretation modified, uponinclusion of PM or gaseous copollutants in the models. Similarly,
associations between short-term NO 2 exposure and asthma symptoms aregenerally robust to adjustment for copollutants in multipollutant models, as shown in Figures 3.1–5 and 3.1–7 of the ISA. These results, in conjunction with
the results of a randomized intervention study evaluating respiratory effects of indoor exposure to NO 2 (ISA, section 3.1.4.1), led to the conclusion that the
effect of NO 2 on respiratory health outcomes is robust and independent of
the effects of other ambient copollutants.

In addition, experimental studies
conducted in animals and humans provide support for the plausibility of the associations reported in epidemiologic studies. These controlled human exposure and animal toxicological studies have reported
effects of NO 2 on immune system function, lung host defense, airway inflammation, and airway responsiveness (ISA, section 5.4). These experimental study results support an independent contribution of NO 2 to the respiratory health effects reported in epidemiologic studies (ISA Section 5.4).

In considering the entire body of evidence, including epidemiologic and experimental studies, the ISA (section 5.4, p. 5–16) concluded the following:

Although this [presence of co-pollutants] complicates the efforts to disentangle specific

NO 2 -related health effects, the evidence
summarized in this assessment indicates that

NO 2 associations generally remain robust in multi-pollutant models and supports a direct
effect of short-term NO 2 exposure on respiratory morbidity at ambient concentrations below the current NAAQS. The robustness of epidemiologic findings to adjustment for co-pollutants, coupled with data from animal and human experimental studies, support a determination that the relationship between NO 2 and respiratory morbidity is likely causal, while still recognizing the relationship between NO 2 and other traffic-related pollutants. Comments on specific epidemiologic
studies are discussed below.

The National Association of Manufacturers (NAM) commented that
the final REA relied on an epidemiologic study (Delfino et al. 2002) not critically reviewed in the final ISA. Contrary to NAM’s contention, the study by Delfino et al. (2002) was critically reviewed by EPA staff and pertinent information was extracted from the study. The respiratory health
effects of NO 2 on asthma reported in this study are included in Figure 5.3–1, Table 5.4–1, and Annex Table AX6.3–2
of the ISA. While NAM comments on the narrative discussion of this study in the final ISA, their contention that EPA scientists did not critically analyze the study while preparing the final ISA is incorrect. The inclusion of the study in the figures and tables in this ISA, as well as inclusion in the 2004 PM AQCD, indicate critical analysis of the study that was implemented throughout the review process. The narrative
discussion in the ISA focused on multicity studies (specifically those by
Schwartz et al. 1994, Mortimer et al.
2002 and Schildcrout et al. 2006), which provide substantial epidemiologic evidence for the respiratory health effects of NO 2 on asthma among children.

Additional comments from NAM contend that EPA’s interpretation of three individual epidemiologic studies ( e.g. Krewski et al. 2000; Schildcrout et al. 2006; Mortimer et al. 2002) is inconsistent across different NAAQS
reviews. The NAM comments on all
three studies are discussed below.

NAM stated the following regarding the study by Krewski et al:

In the Final ISA, EPA cites the Krewski, et al. (2000) study as evidence of a significant


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association between NO 2 exposure and mortality. Although EPA acknowledges that exposure to NO 2 was ‘‘ highly correlated ’’ with other pollutants, including PM 2.5 and SO 2 , EPA does not consider the analysis of the respective contributions of single pollutants in the same study that EPA included in its prior Staff Paper for Particulate Matter. In that document, EPA stated: ‘‘ In singlepollutant models, none of the gaseous copollutants was significantly associated with mortality except SO 2

. ’’ If EPA has not altered its scientific views concerning this study as expressed in the PM Staff Paper, it is entirely inappropriate for EPA to suggest that the Krewski, et al. (2000) study provides any
evidence of an association between NO 2 exposure and mortality.

In these comments, NAM fails to recognize that the report from Krewski
et al. (2000) contains a reanalysis of two cohort studies, the Harvard Six Cities and the American Cancer Society (ACS)
studies. The characterization in the NO X ISA of the study by Krewski et al. (2000), referenced by NAM in their comments, refers to the reanalysis of the Harvard Six Cities Study. As stated in
the NO X ISA (p. 3–74):

Krewski et al. (2000) conducted a sensitivity analysis of the Harvard Six Cities study and examined associations between gaseous pollutants ( i.e., O 3 , NO 2 , SO 2 , CO) and mortality. NO 2 showed risk estimates
similar to those for PM 2.5 per ‘‘ low to high ’’ range increment with total (1.15 [95% CI: 1.04, 1.27] per 10-ppb increase), cardiopulmonary (1.17 [95% CI: 1.02, 1.34]), and lung cancer (1.09 [95% CI: 0.76, 1.57]) deaths; however, in this dataset NO 2 was highly correlated with PM 2.5 (r = 0.78), SO 4 2 ¥ (r = 0.78), and SO 2 (r = 0.84).

In contrast, the characterization in the PM Staff Paper (EPA, 2005) of the study by Krewski et al. (2000), referenced by NAM in their comments, refers to the results of the ACS study. Therefore, NAM appears to have confused the
conclusions on the results of the reanalysis of the Harvard Six Cities Study in the NO X ISA with the
conclusions on the results of the reanalysis of the ACS study in the PM Staff Paper.

Further, in considering the reanalysis of the ACS study by Krewski et al. (2000), the NO X ISA observed that ‘‘ NO 2 showed no associations with mortality

outcomes ’’ (ISA, p. 3–74). This
statement is consistent with the interpretation of that reanalysis as discussed in the PM Staff Paper. Thus, there is no inconsistency in the interpretation of the results of the study by Krewski et al. (2000) in the PM Staff Paper (EPA, 2005) and the NO X ISA (EPA, 2008a).

NAM also commented that EPA has relied on a study by Schildcrout et al. (2006) in the NO X ISA but declined to rely on the same study for the previous review of the O 3 NAAQS. NAM made the following comment regarding the study by Schildcrout et al:

Another example of how EPA has reached
different scientific conclusions in the Final ISA than in prior NAAQS documents is provided by the Schildcrout, et al. (2006) study. In the Final ISA, EPA includes an extensive discussion of this study of asthmatic children and the relationship purportedly found in this study between NO 2 and various respiratory symptoms. In contrast, as part of the NAAQS review for ozone, EPA expressly declined to rely on this same study because of specific limitations in the study design. Among the limitations EPA cites were the fact that the Schildcrout, et al. (2006) study included ‘‘ children in which the severity of their asthma was not clearly identified, ’’ and the use of a study population
that was ‘‘ not comparable to other large multi-city studies. ’’ EPA must explain why it
chose to discount the value of the Schildcrout, et al. (2006) study when evaluating the effects of ozone, but has relied on it extensively in the Final ISA for NO 2

. The study by Schildcrout et al. (2006) appeared in the peer-review literature
too late to be considered in the 2006 O 3 AQCD; however, this study was
included in the O 3 Provisional Assessment. The purpose of the
Provisional Assessment was to determine if new literature materially changed any of the broad scientific conclusions regarding the health effects
of O 3 exposure as stated in the 2006 O 3 AQCD. EPA concluded that, taken in context, the ‘‘ new ’’ information and findings did not materially change any
of the broad scientific conclusions regarding the health effects of O 3 exposure made in the O 3 AQCD. Therefore, NAM’s contention that EPA

‘‘ declined ’’ to rely on the Schildcrout study for the O 3 review because of limitations in study design is not

correct.

The observations NAM draws from
the O 3 Provisional Assessment regarding severity of asthma and the study population do not indicate limitations
that resulted in EPA ‘‘ discounting ’’ the study results. Rather, these observations were intended to put the study in perspective for purposes of interpreting
the results within the context of the larger body of O 3 health effects
evidence. These observations were drawn from comments submitted by Dr. Schildcrout regarding the interpretation of the results of his study in the
decision to revise the ozone standards ( see docket ID EPA–HQ–OAR–2005– 0172–6991). The results of this study are being fully considered in the ongoing review of the ozone NAAQS.

Finally, NAM contends that EPA reached differing scientific conclusions on the use of self-reported peak expiratory flow (PEF) depending on regulatory context, particularly in the large multi-city trial by Mortimer et al. (2002). We disagree with this contention. EPA consistently examines clinical measurements of lung function, which include PEF, forced expiratory flow in 1 second (FEV 1 ), forced vital capacity (FVC), maximal midexpiratory flow (MMEF), maximal expiratory flow at 50% (MEF 50 ), maximal expiratory flow at 25% (MEF 25 ), and forced expiratory flow at 25 to 75% of FVC (FEF 25–75 ). Evidence for all of these
clinical measurements is considered before drawing a conclusion related to the association of lung function with a criteria pollutant. In different reviews, there may be more evidence from one of
these clinical measurements than another. In the previous review of the

O 3 NAAQS, EPA identified statistically significant associations between increased ozone levels and morning PEF, which remained significant even when concentrations exceeding 0.08 ppm were excluded from the analysis (Mortimer et al. 2002). EPA considered this evidence, along with evidence of other clinical measurements of changes in lung function, in drawing conclusions on the relationship between ozone and lung function. Using a similar approach to weigh the evidence pertinent to lung function, including studies that produced no statistically significant results for PEF, the NO X ISA (section 3.1.5.3) states:

In summary, epidemiologic studies using data from supervised lung function measurements (spirometry or peak flow meters) report small decrements in lung function (Hoek and Brunekreef, 1994; Linn et al., 1996; Moshammer et al., 2006; Peacock et al., 2003; Schindler et al., 2001). No significant associations were reported in anystudies using unsupervised, selfadministered peak flow [PEF] measurements with portable devices.

The evaluation of the evidence in the

NO X ISA is consistent with the way the evidence from multiple clinical measures of lung function was used in
the review of the O 3 NAAQS.

b. Comments on EPA’s Interpretation of the Controlled Human Exposure
Evidence

A number of industry groups ( e.g., AAM, ACC, API, Dow Chemical Company (Dow), EMA, NAM, UARG) disagreed with EPA’s reliance on a meta-analysis of controlled human exposure studies of airway responsiveness in asthmatics. Based on this meta-analysis (ISA, Table 3.1–3 for results), the ISA concluded that ‘‘ small but significant increases in nonspecific airway hyperresponsiveness were


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9 EPA considers the Goodman study to be a ‘‘ new study ’’ on which, as discussed above in section 1.B, it would not be appropriate to base a standard in the absence of thorough CASAC and public review of the study and its methodology. However, as discussed below, EPA has considered the study in the context of responding to public comments on the proposal and has concluded it does not provide a basis to materially change any of the broad scientific conclusions regarding the health effects of

NO 2 made in the air quality criteria. observed * * * at 0.1 ppm NO 2 for 60- min exposures in asthmatics ’’ (ISA, p. 5– 11). Industry groups raised a number of objections to this analysis and the way
in which it has been used in the current

review.

Several of these industry groups concluded that, in relying on this analysis, EPA has inappropriately relied on a new unpublished meta-analysis that has not been peer-reviewed, was not reviewed by CASAC, and was not conducted in a transparent manner. For example, as part of a Request for
Correction submitted under EPA’s Information Quality Guidelines, NAM
stated that ‘‘ EPA’s substantial reliance on an unpublished assessment
described as a ‘‘ meta-analysis ’’ of the
relation between NO 2 exposure and changes in airway responsiveness violates EPA Guidelines requiring

‘‘ transparency about data and methods. ’’

EPA disagrees with thischaracterization of the updated metaanalysis included in the final ISA. As described in the ISA (p. 3–16), this meta-analysis is based on an earlier analysis by Folinsbee (1992) that has been subject to peer-review, that was published in a scientific journal ( Toxicol Ind Health. 8:1–11, 1992), and that was reviewed by CASAC as part of the previous review of the NO 2 NAAQS (EPA, 1993, Table 15–10). The updates to this earlier analysis did not include substantive changes to the approach. As discussed in the final ISA (p. 3–16), the changes made to the analysis were to remove the results of one allergen study and add results from a non-specific responsiveness study, which focused the meta-analysis on non-specific airway responsiveness, and to discuss results for an additional exposure concentration ( i.e., 100 ppb). The information needed to reproduce this meta-analysis is provided in the ISA (Tables 3.1–2 and 3.1–3, including footnotes).

While the ISA meta-analysis reports findings on airway responsiveness in asthmatics following exposure to 100 ppb NO 2 , a concentration not specifically discussed in the findings of the original report by Folinsbee (1992),
this does not constitute a substantive change to that original analysis. For exposures at rest, four of the studies included in the analysis by Folinsbee evaluated the effects of exposure to 100 ppb NO 2 . In that original meta-analysis, these studies were grouped with another study that evaluated exposures to 140 ppb NO 2 . When analyzed together, exposures to NO 2 concentrations of 100 ppb and 140 ppb (grouped together in the manuscript and described as less than 0.2 ppm) increased airway responsiveness in 65% of resting asthmatics (p < 0.01). Therefore, reporting results at 100 ppb NO 2 in the ISA meta-analysis reflects a change in the way the data are presented and does not reflect a substantive change to the study. This change in presentation allows specific consideration of the potential for exposures to 100 ppb NO 2 to increase airway responsiveness, rather than grouping results at 100 ppb with results at other exposure

concentrations.

In addition, the updated metaanalysis was considered by CASAC during their review of the REA (REA, Table 4–5 reports the results of the updated meta-analysis), which based part of the assessment of NO 2 -associated
health risks on the results of the metaanalysis. In their letter to the Administrator on the final REA (Samet, 2008b), CASAC stated that ‘‘ [t]he
evidence reviewed in the REA indicates
that adverse health effects have been
documented in clinical studies of persons with asthma at 100 ppb ’’ and
that ‘‘ CASAC firmly recommends that the upper end of the range [of standard levels] not exceed 100 ppb, given the findings of the REA. ’’ In addition, in their comments on the proposal, CASAC
reiterated this advice in their statement
that ‘‘ the level of the one-hour NO 2 standard should be within the range of 80–100 ppb and not above 100 ppb. ’’
These statements indicate that CASAC did specifically consider the results of the updated meta-analysis and that they
used those results to inform their recommendations on the range of standard levels supported by the
scientific evidence.

In summary, we note the following:

• The original meta-analysis was published in a peer-reviewed journal and was reviewed by CASAC in the previous review of the NO 2 NAAQS.

• The updated meta-analysis does not include substantive changes to the methodology of this original analysis.

• The changes that were made are clearly described in the ISA.

• CASAC specifically reviewed and considered the ISA meta-analysis in making recommendations regarding the range of standard levels supported by
the science.

Many of these same industry groups
also referred in their comments to a recent meta-analysis of controlled human exposure studies evaluating the airway response in asthmatics following

NO 2 exposure (Goodman et al., 2009). These groups generally recommended that EPA rely on this meta-analysis and on the authors’ conclusions with regard

to NO 2 and airway responsiveness. Specific comments based on the manuscript by Goodman et al., as well as EPA’s responses, are discussed below
in more detail. 9

Industry commenters generally claimed that the meta-analysis by
Goodman et al. supports the conclusion that no adverse effects occur following exposures up to 600 ppb NO 2 . However, Table 4 of the Goodman study reports that 64% (95% Confidence Interval: 58%, 71%) of resting asthmatics exposed to NO 2 experienced an increase in airway responsiveness. Furthermore, Figure 2a of this manuscript reports that for exposures < 0.2 ppm, the fraction affected is 0.61 (95% CI: 0.52, 0.70) while for exposures of 0.2 ppm to < 0.3 ppm, the fraction affected is 0.66 (95% CI: 0.59, 0.74). These findings are consistent with those reported in the meta-analysis by Folinsbee and in the updated meta-analysis that was
included in the final ISA.

Also based on the meta-analysis by
Goodman et al. (2009), several industry
commenters concluded that NO 2 - induced airway hyperresponsiveness is not adverse and, therefore, should not be considered in setting standards. The basis for this comment appears to be the conclusions reached by Goodman et al. that there is no dose-response relationship for NO 2 and that the magnitude of any NO 2 effect on airway responsiveness is too small to be
considered adverse.

Due to differences in study protocols
in the NO 2 -airway response literature (ISA, section 3.1.3), EPA disagrees with the approach taken in the Goodman study to use existing data to attempt to evaluate the presence of a dose-response relationship and to determine the magnitude of the NO 2 response. Examples of differences in the study protocols include the NO 2 exposure method ( i.e., mouthpiece versus chamber), subject activity level ( i.e., rest versus exercise) during NO 2 exposure, choice of airway challenge agent, and physiological endpoint used to quantify airway responses. Goodman et al. (2009) also recognized heterogeneity among studies as a limitation in their analyses.

As a result of these differences, EPAjudged it appropriate in the ISA metaanalysis to assess only the fraction of asthmatics experiencing increased or decreased airway responsiveness


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10 Once EPA determines whether to retain or revise the current standard, the actual air quality levels in various areas of the country are clearly relevant under the NAAQS implementation provisions for the Act, such as the provision for designation of areas based on whether or not they attain the required NAAQS. following NO 2 exposure. We have acknowledged in the REA, the proposal, and in this final rulemaking that there is uncertainty with regard to the magnitude and the clinical-significance

of NO 2 -induced increases in airway responsiveness ( see sections II.C.3 and II.F.4.a in the proposed rulemaking as well as II.F.3 in this final rulemaking). The REA stated the following (p. 302):

[O]ne of the important uncertainties
associated with these [NO 2 -induced airway hyperresponsiveness] results is that, because the meta-analysis evaluated only the direction of the change in airway responsiveness, it is not possible to discern the magnitude of the change from these data. This limitation makes it particularly difficult to quantify the public health implications of

these results.

While we acknowledge this uncertainty, EPA disagrees with the

conclusion that the NO 2 -induced increase in airway responsiveness in asthmatics exposed to NO 2 concentrations up to 600 ppb is not

adverse and should not be considered in setting standards. Specifically, we note

that the ISA concluded that ‘‘ [t]ransient increases in airway responsiveness following NO 2 exposure have the potential to increase symptoms and

worsen asthma control ’’ (ISA, section 5.4). The uncertainty over the adversity of the response reported in controlled human exposure studies does not mean

that the NO 2 -induced increase in airway responsiveness is not adverse. Rather, it means that there is a risk of adversity, especially for asthmatics with more than mild asthma, but that this risk cannot be fully characterized based on existing

studies. The studies of NO 2 and airwayresponsiveness included in the metaanalysis have generally evaluated mild asthmatics, rather than more severely

affected asthmatics who could be more susceptible to the NO 2 -induced increase in airway responsiveness (ISA, section 3.1.3.2). Given that this is the case, and given the large percentage of asthmatics that experienced an NO 2 -induced increase in airway responsiveness in the studies and the large size of the asthmatic population in the United States, the REA concluded that it is appropriate to consider NO 2 -induced airway hyperresponsiveness in characterizing NO 2 -associated health risks (REA, section 10.3.2). As noted above, CASAC endorsed this conclusion

in their letters to the Administrator on the final REA and on the proposal (Samet, 2008b; Samet, 2009). c. Comments on EPA’s Characterization
of NO 2 -Associated Exposures and
Health Risks

Several commenters discussed the analyses of NO 2 -associated exposures and health risks presented in the REA. As in past reviews (EPA 2005, 2007c, 2007d), EPA has estimated allowable
risks associated with the current standard and potential alternative standards to inform judgments on the public health risks that could exist under different standard options. Some industry commenters ( e.g., API, NMA)
concluded that the Administrator should consider modeled exposures and
risks associated with actual NO 2 air quality rather than with NO 2 concentrations adjusted to simulate just meeting the current annual standard or potential alternative 1-hour standards. These commenters pointed out that such simulations require large adjustments to air quality and are highly uncertain and that NAAQS are intended to address actual, rather than highly improbable, risks to health.

We disagree with these commenters that exposure- and risk-related considerations in the NAAQS review should rely only on unadjusted air quality. In considering whether the current standard is requisite to protect public health with an adequate margin of safety, air quality adjustments allow
estimates of NO 2 -related exposures and
health risks that could exist in areas that just meet that standard. That is, these adjustments allow consideration of exposures and risks that would be permissible under the current standard. Therefore, such adjustments are clearly
useful to inform a decision on the issue before EPA ( i.e., the adequacy of the level of public health protection
associated with allowable NO 2 air quality under the standard). Similarly, air quality adjustments to simulate different potential alternative standards provide information on exposures and risks that would be permissible under
these alternatives. 10 As noted above, in
their letter to the Administrator on the final REA (Samet, 2008b), CASAC
concluded that ‘‘ The REA provides the needed bridge from the evidence presented in the ISA to a characterization of the exposures and
the associated risks with different profiles of exposure. ’’

We agree that there are uncertainties inherent in air quality adjustments. These uncertainties are discussed thoroughly in the REA (sections 7.4, 8.12, 9.6, and 10.3.2.1) and in the proposed rule (section II.C.3). For example, the policy assessment chapter of the REA (section 10.3.2.1) noted the following regarding adjustment of NO 2 concentrations:

In order to simulate just meeting the current annual standard and many of the alternative 1-h standards analyzed, an upward adjustment of recent ambient NO 2 concentrations was required. We note that this adjustment does not reflect a judgment
that levels of NO 2 are likely to increase under the current standard or any of the potential
alternative standards under consideration. Rather, these adjustments reflect the fact that the current standard, as well as some of the alternatives under consideration, could allow
for such increases in ambient NO 2 concentrations. In adjusting air quality to simulate just meeting these standards, we have assumed that the overall shape of the
distribution of NO 2 concentrations would not change. While we believe this is a reasonable assumption in the absence of evidence supporting a different distribution and we note that available analyses support this approach (Rizzo, 2008), we recognize this as an important uncertainty. It may be an especially important uncertainty for those scenarios where considerable upward adjustment is required to simulate just meeting one or more of the standards. These air quality adjustments are not meant to imply an expectation that NO 2 concentrations will increase broadly across the United States or in any given area (REA, section 10.3.2.1). Rather, as noted above, they are meant to estimate

NO 2 -related exposures and health risks that would be permitted under the current and potential alternative
standards. Such estimates can inform
decisions on whether the current standard, or particular potential alternative standards, provide the requisite protection of public health.

3. Conclusions Regarding the Adequacy
of the Current Standard

In considering the adequacy of the current standard, the Administrator has
considered the scientific evidence assessed in the ISA, the exposure and risk results presented in the REA, the conclusions of the policy assessment chapter of the REA, and comments from CASAC and the public. These
considerations are described below.

In considering the scientific evidence as it relates to the adequacy of the current standard, the Administrator notes that the epidemiologic evidence has grown substantially since the last
review with the addition of field and panel studies, intervention studies, and
time-series studies of effects such as emergency department visits and hospital admissions associated with


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short-term NO 2 exposures. No epidemiologic studies were available in 1993 assessing relationships between

NO 2 and outcomes such as hospital admissions or emergency department visits. In contrast, dozens of epidemiologic studies on such outcomes, conducted at recent and
current ambient NO 2 concentrations, are now included in this evaluation (ISA, chapter 3).

As an initial consideration with regard to the adequacy of the current standard, the Administrator notes that the evidence relating long-term (weeks to years) NO 2 exposures at current ambient concentrations to adverse health effects was judged in the ISA to
be either ‘‘ suggestive but not sufficient to infer a causal relationship ’’ (respiratory morbidity) or ‘‘ inadequate to infer the presence or absence of a causal relationship ’’ (mortality, cancer, cardiovascular effects, reproductive/ developmental effects) (ISA, sections 5.3.2.4–5.3.2.6). In contrast, the evidence relating short-term (minutes to hours) NO 2 exposures to respiratory morbidity was judged to be ‘‘ sufficient to infer a likely causal relationship ’’ (ISA, section 5.3.2.1). This conclusion was supported primarily by a large body of recent epidemiologic studies that
evaluated associations of short-term

NO 2 concentrations with respiratory symptoms, emergency department visits, and hospital admissions. Given these conclusions from the ISA, the Administrator judges that, at a minimum, consideration of the adequacy of the current annual standard
should take into account the extent to which that standard provides protection against respiratory effects associated
with short-term NO 2 exposures.

In considering the NO 2 epidemiologic studies as they relate to the adequacy of the current standard, the Administrator notes that annual average NO 2 concentrations were below the level of
the current annual NO 2 NAAQS in many of the locations where positive, and often statistically significant, associations with respiratory morbidity endpoints have been reported (ISA, section 5.4). As discussed previously,
the ISA characterized that evidence for respiratory effects as consistent and
coherent. The evidence is consistent in that associations are reported in studies
conducted in numerous locations and with a variety of methodological approaches (ISA, section 5.3.2.1). It is
coherent in the sense that the studies report associations with respiratory health outcomes that are logically linked together (ISA, section 5.3.2.1).
The ISA noted that when the epidemiologic literature is considered as a whole, there are generally positive
associations between NO 2 and respiratory symptoms, hospital admissions, and emergency department
visits. A number of these associations are statistically significant, particularly the more precise effect estimates (ISA, section 5.3.2.1).

As discussed in the proposal (II.E.1) and above, the Administrator acknowledges that the interpretation of
these NO 2 epidemiologic studies is complicated by the fact that on-road vehicle exhaust emissions are a nearly ubiquitous source of combustion pollutant mixtures that include NO 2

. She notes that, in order to provide some perspective on the uncertainty related to the presence of co-pollutants the ISA evaluated epidemiologic studies that employed multi-pollutant models, epidemiologic studies of indoor NO 2 exposure, and experimental studies. Specifically, the ISA noted that a
number of NO 2 epidemiologic studies have attempted to disentangle the
effects of NO 2 from those of cooccurring pollutants by employing multi-pollutant models. When evaluated as a whole, NO 2 effect estimates in these models generally remained robust when co-pollutants were included. Therefore, despite uncertainties associated with separating the effects of NO 2 from those of co-occurring pollutants, the ISA (section 5.4, p. 5–16) concluded that

‘‘ the evidence summarized in this
assessment indicates that NO 2 associations generally remain robust in multi-pollutant models and supports a
direct effect of short-term NO 2 exposure on respiratory morbidity at ambient
concentrations below the current NAAQS. ’’ With regard to indoor studies,
the ISA noted that these studies can test hypotheses related to NO 2 specifically (ISA, section 3.1.4.1). Although confounding by indoor combustion sources is a concern, indoor studies arenot confounded by the same mix of copollutants present in the ambient air or by the contribution of NO 2 to the formation of secondary particles or O 3 (ISA, section 3.1.4.1). The ISA noted that the findings of indoor NO 2 studies
are consistent with those of studies using ambient concentrations from
central site monitors and concluded that indoor studies provide evidence of coherence for respiratory effects (ISA, section 3.1.4.1). With regard to experimental studies, the REA noted that they have the advantage of providing information on health effects that are specifically associated with exposure to NO 2 in the absence of copollutants. The ISA concluded that the

NO 2 epidemiologic literature is supported by (1) evidence from controlled human exposure studies of airway hyperresponsiveness in asthmatics, (2) controlled human exposure and animal toxicological studies of impaired host-defense systems and increased risk of susceptibility to viral and bacterial infection, and (3) controlled human exposure and animal toxicological studies of airway inflammation (ISA, section 5.3.2.1 and 5.4). Given the above consideration of the evidence, particularly the epidemiologic studies reporting NO 2 -associated health effects
in locations that meet the current standard, the Administrator agrees with the conclusion in the policy assessment chapter of the REA that the scientific evidence calls into question the adequacy of the current standard to protect public health.

In addition to the evidence-based considerations described above, the
Administrator has considered the extent to which exposure- and risk-based
information can inform decisions regarding the adequacy of the current
annual NO 2 standard. While she acknowledges the uncertainties associated with adjusting air quality in these analyses, she judges that such analyses are appropriate for
consideration in this review of the NO 2 primary NAAQS. In reaching this
conclusion she notes the considerations discussed above, particularly the endorsement by CASAC of the REA and
its characterization of NO 2 -associated exposures and health risks.

In considering the exposure- and riskbased information with regard to the adequacy of the current annual NO 2 standard to protect the public health,
the Administrator notes the conclusion in the policy assessment chapter of the
REA that risks estimated to be associated with air quality adjusted upward to simulate just meeting the current standard can reasonably be concluded to be important from a public health perspective. In particular, a large percentage (8–9%) of respiratory-related
ED visits in Atlanta could be associated
with short-term NO 2 exposures, most asthmatics in Atlanta could be exposed on multiple days per year to NO 2 concentrations at or above 300 ppb, and
most locations evaluated could experience on-/near-road NO 2 concentrations above 100 ppb on more than half of the days in a given year. Therefore, after considering the results of the exposure and risk analyses presented in the REA the Administrator agrees with the conclusion of the policy assessment chapter of the REA that exposure- and risk-based results
reinforce the scientific evidence in


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supporting the conclusion that consideration should be given to revising the current standard so as to provide increased public health protection, especially for at-risk groups,
from NO 2 -related adverse health effects associated with short-term, and potential long-term, exposures.

In reaching a conclusion on the adequacy of the current standard, the
Administrator has also considered
advice received from CASAC. In their comments on the final REA, CASAC agreed that the primary concern in this review is to protect against health
effects that have been associated with
short-term NO 2 exposures. CASAC also agreed that the current annual standard is not sufficient to protect public health against the types of exposures that could
lead to these health effects. As noted in their letter to the EPA Administrator,

‘‘ CASAC concurs with EPA’s judgment that the current NAAQS does not protect the public’s health and that it
should be revised ’’ (Samet, 2008b).

Based on the considerations discussed above, the Administrator concludes that
the current NO 2 primary NAAQS alone is not requisite to protect public health with an adequate margin of safety. Accordingly, she concludes that the

NO 2 primary standard should be revised in order to provide increased public health protection against respiratory
effects associated with short-term exposures, particularly for susceptible populations such as asthmatics, children, and older adults. In considering approaches to revising the current standard, the Administrator concludes that it is appropriate to consider setting a new short-term standard ( see below). The Administrator
notes that such a short-term standard could provide increased public healthprotection, especially for members of atrisk groups, from effects described in both epidemiologic and controlled human exposure studies to be associated with short-term exposures to

NO 2

. F. Elements of a New Short-Term
Standard

In considering a revised NO 2 primary NAAQS, the Administrator notes the need to protect at-risk individuals from short-term exposures to NO 2 air quality that could cause the types of respiratory morbidity effects reported in epidemiologic studies and the need toprotect at-risk individuals from shortterm exposure to NO 2 concentrations reported in controlled human exposure studies to increase airway responsiveness in asthmatics. The
Administrator’s considerations with regard to her decisions are discussed in the following sections in terms of indicator (II.F.1), averaging time (II.F.2), level (II.F.3), and form (II.F.4).

1. Indicator

a. Rationale for Proposed Decision

In past reviews, EPA has focused on

NO 2 as the most appropriate indicator
for ambient NO X . In making a decision
in the current review on the most appropriate indicator, the Administrator
considered the conclusions of the ISA and the policy assessment chapter of the REA as well as the view expressed by CASAC. The policy assessment chapter of the REA noted that, while the presence of NO X species other than NO 2 has been recognized, no alternative to

NO 2 has been advanced as being a more appropriate surrogate. Controlled human exposure studies and animal toxicology studies assessed in the ISA provide specific evidence for health effects following exposure to NO 2

. Epidemiologic studies also typically report levels of NO 2 though the degree
to which monitored NO 2 reflects actual

NO 2 levels, as opposed to NO 2 plus other gaseous NO X , can vary (REA, section 2.2.3). In addition, because
emissions that lead to the formation of

NO 2 generally also lead to the formation
of other NO X oxidation products, measures leading to reductions in population exposures to NO 2 can generally be expected to lead to reductions in population exposures to other gaseous NO X . Therefore, an NO 2 standard can also be expected to provide some degree of protection against potential health effects that may be independently associated with other gaseous NO X even though such effects are not discernable from currently available studies indexed by NO 2 alone. Given these key points, the policy assessment chapter of the REA concluded that the evidence supports retaining NO 2 as the indicator. Consistent with this conclusion, the
CASAC Panel stated in its letter to the
EPA Administrator that it ‘‘ concurs with
retention of NO 2 as the indicator ’’ (Samet, 2008b). In light of the above considerations, the Administrator proposed to retain NO 2 as the indicator
in the current review.

b. Comments on Indicator

A relatively small number of comments directly addressed the issue
of the indicator for the standard (CASAC, Dow, API, AAM, and the Missouri Department of Natural
Resources Air Pollution Control Program (MODNR)). All of these commenters endorsed the proposal to continue to use NO 2 as the indicator for
ambient NO X
. c. Conclusions on Indicator

Based on the available information discussed above, and consistent with
the views of CASAC and other commenters, the Administrator concludes that it is appropriate to

continue to use NO 2 as the indicator for
a standard that is intended to address effects associated with exposure to NO 2 , alone or in combination with other gaseous NO X . In so doing, the Administrator recognizes that measures leading to reductions in population exposures to NO 2 will also reduce exposures to other nitrogen oxides.

2. Averaging Time

This section discusses considerations related to the averaging time of the NO 2 primary NAAQS. Specifically, this
section summarizes the rationale for the Administrator’s proposed decision regarding averaging time (II.F.2.a; see section II.F.2 of the proposal for more detail), discusses comments related to averaging time (II.F.2.b), and presents
the Administrator’s final conclusions regarding averaging time (II.F.2.c).

a. Rationale for Proposed Decision

In considering the most appropriate averaging time for the NO 2 primary NAAQS, the Administrator noted in the proposal the conclusions and judgments
made in the ISA about available scientific evidence, air quality correlations discussed in the REA, conclusions of the policy assessment chapter of the REA, and CASAC recommendations (section II.F.2 in the proposal). Specifically, she noted the following:

• Experimental studies in humans and animals have reported respiratory effects following NO 2 exposures lasting from less than 1-hour up to several hours. Epidemiologic studies have reported associations between respiratory effects and both 1 hour and
24-hour NO 2 concentrations. Therefore, the experimental evidence provides support for an averaging time of shorter duration than 24 hours ( e.g., 1 hour) while the epidemiologic evidence provides support for both 1-hour and 24-hour averaging times. At a minimum, this suggests that a primary concern with regard to averaging time is the level of protection provided against
1-hour NO 2 concentrations.

• Air quality correlations presented in the policy assessment chapter of the REA illustrated the relatively high degree of variability in the ratios of annual average to short-term NO 2 concentrations (REA, Table 10–2). This


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11 As discussed below, 98th and 99th percentile forms were evaluated in the REA. A 99th percentile form corresponds approximately to the 4th highest 1-hour concentration in a year while a 98th percentile form corresponds approximately to the 7th or 8th highest 1-hour concentration in a year. A 4th highest concentration form has been used previously in the O 3 NAAQS while a 98th percentile form has been used previously in the

PM 2.5 NAAQS. variability suggests that a standard based on annual average NO 2 concentrations would not likely be an effective or efficient approach to focus protection on short-term exposures.

• These air quality correlations (REA, Table 10–1) suggested that a standard based on 1-hour daily maximum NO 2 concentrations could also be effective at protecting against 24-hour NO 2 concentrations.

• The policy assessment chapter of
the REA concluded that the scientific evidence, combined with the air quality correlations, support the appropriateness of a standard based on 1-hour daily maximum NO 2 concentrations to protect against health
effects associated with short-term

exposures.

• CASAC concurred ‘‘ with having a short-term NAAQS primary standard foroxides of nitrogen and using the onehour maximum NO 2 value ’’ (Samet, 2008b).
Based on these considerations, the Administrator proposed to set a new standard based on 1-hour daily

maximum NO 2 concentrations.

b. Comments on averaging time

As discussed above, CASAC endorsed
the establishment of a new standard with a 1-hour averaging time. CASAC stated the following in their comments on the proposal (Samet, 2009):

In reviewing the REA, CASAC supported a
short-term standard for NO 2 and in reviewing the proposal, CASAC supports the proposed one-hour averaging time in EPA’s proposed
rule.
The supporting rationale offered by CASAC in support of a new 1-hour standard was generally the same as that put forward in the final REA and the proposal. Specifically, that rationale
considered the available scientific evidence, which supports a link
between 1-hour NO 2 concentrations and adverse respiratory effects, and air quality information presented in the REA, which suggests that a 1-hour standard can protect against effects
linked to short-term NO 2 exposures while an annual standard would not be an effective or efficient approach to protecting against these effects.

A large number of public commenters
also endorsed the establishment of a new standard with a 1-hour averaging
time. These included a number of State agencies and organizations ( e.g., NACAA, NESCAUM and agencies in CA, IL, NM, TX, VA); environmental, medical, and public health organizations ( e.g., ACCP, ALA, AMA, ATS, CAC, EDF, EJ, GASP, NACPR, NAMDRC, NRDC); and most individual commenters. The supporting rationales offered by these commenters often acknowledged the recommendations of
CASAC and the Administrator’s rationale as discussed in the proposal.

Though many industry commenters recommended not revising the current annual standard (as discussed above in section II.E.2), several of these groups
did conclude that if a short-term standard were to be set, a 1-hour averaging time would be appropriate ( e.g., Colorado Petroleum Association (CPA), Dow, NAM, Petroleum Association of Wyoming (PAW), Utah Petroleum Association (UPA)). As discussed above, industry commenters who disagreed with setting a new 1- hour standard generally based this conclusion on their interpretation of the
scientific evidence and their conclusion that this evidence does not support the
need to revise the current annual standard. These comments, and EPA’s responses, are discussed in more detail above (section II.E) and in the Response
to Comments document.

c. Conclusions on Averaging Time

In considering the most appropriate averaging time for the NO 2 primary NAAQS, the Administrator notes the
available scientific evidence as assessed in the ISA, the air quality analyses presented in the REA, the conclusions of the policy assessment chapter of the REA, CASAC recommendations, and public comments received. These
considerations are described below.

When considering averaging time, the
Administrator notes that the evidence relating short-term (minutes to hours)

NO 2 exposures to respiratory morbidity was judged in the ISA to be ‘‘ sufficient to infer a likely causal relationship ’’ (ISA, section 5.3.2.1) while the evidence relating long-term (weeks to years) NO 2 exposures to adverse health effects was judged to be either ‘‘ suggestive but not sufficient to infer a causal relationship ’’ (respiratory morbidity) or ‘‘ inadequate to infer the presence or absence of a causal relationship ’’ (mortality, cancer, cardiovascular effects, reproductive/ developmental effects) (ISA, sections 5.3.2.4–5.3.2.6). Thus, the Administrator concludes that these judgments most directly support an averaging time that focuses protection on short-term exposures to NO 2

.

As in past reviews of the NO 2 NAAQS, the Administrator notes that it is instructive to evaluate the potential for a standard based on annual average

NO 2 concentrations, as is the current standard, to provide protection against
short-term NO 2 exposures. To this end,
the Administrator notes that Table 10–1 in the REA reported the ratios of shortterm to annual average NO 2 concentrations. Ratios of 1-hour daily maximum concentrations (98th and 99th percentile 11 ) to annual average
concentrations across 14 locations ranged from 2.5 to 8.7 while ratios of 24- hour average concentrations to annual average concentrations ranged from 1.6 to 3.8 ( see Thompson, 2008 for more details). The policy assessment chapter
of the REA concluded that the variability in these ratios across locations, particularly those for 1-hour concentrations, suggested that a standard based on annual average NO 2 concentrations would not likely be an effective or efficient approach to focus protection on short-term NO 2 exposures. For example, in an area with a relatively high ratio ( e.g., 8), the current annual standard (53 ppb) would be expected to allow 1-hour daily maximum NO 2 concentrations of about 400 ppb. In contrast, in an area with a relatively low ratio ( e.g., 3), the current standard would be expected to allow 1-hour daily

maximum NO 2 concentrations of about 150 ppb. Thus, for purposes of protecting against the range of 1-hour

NO 2 exposures, the REA noted that a standard based on annual average concentrations would likely require more control than necessary in some areas and less control than necessary in others, depending on the standard level
selected.

In considering the level of support available for specific short-term averaging times, the Administrator notes that the policy assessment chapter of the
REA considered evidence from both experimental and epidemiologic studies. Controlled human exposure studies and animal toxicological studies provide evidence that NO 2 exposures from less than 1-hour up to 3-hours can result in respiratory effects such as increased airway responsiveness and inflammation (ISA, section 5.3.2.7). Specifically, the ISA concluded that

NO 2 exposures of 100 ppb for 1-hour (or 200 ppb to 300 ppb for 30-min) can result in small but significant increases in nonspecific airway responsiveness (ISA, section 5.3.2.1). In contrast, the epidemiologic literature provides support for short-term averaging times ranging from approximately 1-hour up to 24-hours (ISA, section 5.3.2.7). A


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number of epidemiologic studies have detected positive associations between respiratory morbidity and 1-hour (daily maximum) and/or 24-hour NO 2 concentrations. A few epidemiologic
studies have considered both 1-hour and 24-hour averaging times, allowing comparisons to be made. The ISA reported that such comparisons in studies that evaluate asthma emergency department visits failed to reveal
differences between effect estimates based on a 1-hour averaging time and those based on a 24-hour averaging time (ISA, section 5.3.2.7). Therefore, the ISA concluded that it is not possible, from the available epidemiologic evidence, to
discern whether effects observed areattributable to average daily (or multiday) concentrations (24-hour average) or high, peak exposures (1-hour maximum) (ISA, section 5.3.2.7).

As noted in the policy assessment chapter of the REA, given the above conclusions, the experimental evidence provides support for an averaging time of shorter duration than 24 hours ( e.g., 1–h) while the epidemiologic evidence provides support for both 1-hour and 24-hour averaging times. The Administrator concludes that, at a minimum, this suggests that a primary concern with regard to averaging time is the level of protection provided against
1-hour NO 2 concentrations. However, she also notes that it is important to consider the ability of a 1-hour averaging time to protect against 24- hour average NO 2 concentrations. To this end, the Administrator notes that Table 10–2 in the REA presented correlations between 1-hour daily

maximum NO 2 concentrations and 24- hour average NO 2 concentrations (98th and 99th percentile) across 14 locations ( see Thompson, 2008 for more detail). Typical ratios ranged from 1.5 to 2.0, though one ratio (Las Vegas) was 3.1.
These ratios were far less variable than
those discussed above for annual average concentrations, suggesting that a standard based on 1-hour daily

maximum NO 2 concentrations could also be effective at protecting against 24-
hour NO 2 concentrations. The REA concluded that the scientific evidence, combined with the air quality correlations described above, support the appropriateness of a standard based on 1-hour daily maximum NO 2 concentrations to protect against health
effects associated with short-term

exposures.

Based on these considerations, the
Administrator concludes that a standard with a 1-hour averaging time can effectively limit short-term ( i.e., 1- to 24- hours) exposures that have been linked to adverse respiratory effects. This conclusion is based on the observations
summarized above and in more detail in the proposal, particularly that: (1) The 1-hour averaging time has been directly associated with respiratory effects in both epidemiologic and experimental studies and that (2) results from air quality analyses suggest that a 1-hour standard could also effectively control
24-hour NO 2 concentrations. In addition, the Administrator notes the support provided for a 1-hour averaging time in comments from CASAC, States, environmental groups, and medical/ public health groups. The Administrator notes that arguments offered by some industry groups against setting a 1-hour

NO 2 standard generally focus on commenters’ conclusions regarding
uncertainties in the scientific evidence.
As discussed in more detail above (section II.E.2), the Administrator disagrees with the conclusions of these commenters regarding the appropriate interpretation of the scientific evidence
and associated uncertainties. Given these considerations, the Administrator judges that it is appropriate to set a new

NO 2 standard with a 1-hour averaging

time.

3. Form

This section discusses considerations
related to the form of the 1-hour NO 2 primary NAAQS. Specifically, this
section summarizes the rationale for the Administrator’s proposed decision regarding form (II.F.4.a; see section II.F.3 of the proposal for more detail),
discusses comments related to form (II.F.4.b), and presents the
Administrator’s final conclusions regarding form (II.F.4.c).

a. Rationale For Proposed Decision

When considering alternative forms in the proposal, the Administrator noted the conclusions in the policy assessment chapter of the REA. Specifically, she noted the conclusion that the adequacy of the public health protection provided by the combination
of standard level and form should be the foremost consideration. With regard to this, she noted that concentration-basedforms can better reflect pollutantassociated health risks than forms based on expected exceedances. This is the
case because concentration-based forms give proportionally greater weight to years when pollutant concentrations are
well above the level of the standard than to years when the concentrations are just above the standard, while an expected exceedance form would give the same weight to years with concentrations that just exceed the standard as to years when concentrations greatly exceed the standard. The Administrator also recognized the conclusion in the policy assessment chapter of the REA that it is desirable from a public health perspective to have a form that is reasonably stable and insulated from the impacts of extreme meteorological events. With regard to this, she noted that a form that calls for averaging concentrations over three years would provide greater regulatory stability than a form based on a single year of concentrations. Therefore, consistent
with recent reviews of the O 3 and PM NAAQS, the proposal focused on concentration-based forms averaged over 3 years, as evaluated in the REA.

In considering specific concentrationbased forms, the REA focused on 98th and 99th percentile concentrations averaged over 3 years. This focus on the upper percentiles of the distribution is appropriate given the reliance, in part,

on NO 2 health evidence from experimental studies, which provide information on specific exposure
concentrations that are linked to specific health effects. The REA noted that a 99th percentile form for a 1-hour daily maximum standard would correspond approximately to the 4th highest daily maximum concentration in a year (which is the form of the

current O 3 NAAQS) while a 98th percentile form (which is the form of the
current short-term PM 2.5 NAAQS) would correspond approximately to the 7th or 8th highest daily maximum concentration in a year (REA, Table 10–

4; see Thompson, 2008 for methods).

Consideration in the REA of an appropriate form for a 1-hour standard was based on analyses of standard levels
that reflected the allowable area-wide

NO 2 concentration, not the maximum allowable concentration. Therefore, in their review of the final REA, CASAC did not have the opportunity to comment on the appropriateness of specific forms in conjunction with a
standard level that reflects the
maximum allowable NO 2 concentration anywhere in an area. Given this, when considering alternative forms for the 1-hour standard in the proposal, the Administrator judged that it was appropriate to consider both forms evaluated in the REA ( i.e., 98th and 99th percentiles). Therefore, she proposed to adopt either a 99th percentile or a 4th highest form, averaged over 3 years, and
she solicited comment on both 98th percentile and 7th or 8th highest forms.

b. CASAC and Public Comments on

Form

In their letter to the Administrator,
CASAC discussed the issue of form within the context of the proposed


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12 In addition, the air quality analyses presented
in the REA estimated that on-road NO 2 concentrations are about 80% higher on average than concentrations away from the road (REA, section 7.3.2) and that NO 2 monitors within 20 m

Continued approach of setting a 1-hour standard
level that reflects the maximum
allowable NO 2 concentration anywhere in an area. CASAC recommended that, for such a standard, EPA adopt a form based on the 3-year average of the 98th percentile of the distribution of 1-hour daily maximum NO 2 concentrations. Specifically, they stated the following in their comments on the proposal (Samet, 2009):

The 98th percentile is preferred by CASAC for the form, given the likely instability of measurements at the upper range and the absence of data from the proposed two-tier approach.

As indicated in their letter, CASAC concluded that the potential instability in higher percentile NO 2 concentrations near major roads argues for a 98th, rather than a 99th, percentile form. Several State organizations and agencies ( e.g., NESCAUM and agencies in IN, NC, SD, VA) and industry groups ( e.g., AAM, ACC, API, AirQuality Research and Logistics (AQRL), CPA, Dow, ExxonMobil, IPAMS, PAW, UPA) also recommended a 98th percentile form in order to provide regulatory stability. In contrast, a small number of State and local agencies ( e.g., in MO and TX), several environmental organizations ( e.g., EDF, EJ, GASP, NRDC), and medical/public health organizations ( e.g., ALA, ATS) recommended either a 99th percentile form or a more stringent form ( e.g., no exceedance) to further
limit the occurrence of NO 2 concentrations that exceed the standard
level in locations that attain the
standard.

c. Conclusions On Form

The Administrator recognizes that
there is not a clear health basis for selecting one specific form over another. She also recognizes that the analyses of
different forms in the REA are most directly relevant to a standard that
reflects NO 2 concentrations permitted to occur broadly across a community,
rather than the maximum concentration that can occur anywhere in the area. In contrast, as discussed below (section II.F.4.c), the Administrator has judged it appropriate to set a new 1-hour standard
that reflects the maximum allowable

NO 2 concentration anywhere in an area. In light of this, the Administrator places particular emphasis on the comments received on form from CASAC relating
to a 1-hour standard level that reflects
the maximum allowable NO 2 concentration anywhere in an area. In particular, the Administrator notes that CASAC recommended a 98th percentile form averaged over 3 years for such a standard, given the potential for instability in the higher percentile concentrations around major roadways.

In considering this recommendation, the Administrator recognizes that the public health protection provided by the
1-hour NO 2 standard is based on the approach used to set the standard and the level of the standard ( see below), in conjunction with the form of the
standard. Given that the Administrator is setting a standard that reflects the
maximum allowable NO 2 concentration anywhere in an area, rather than a
standard that reflects the allowable areawide NO 2 concentration, she agrees with CASAC that an appropriate consideration with regard to form is the extent to which specific statistics could
be unstable at locations where

maximum NO 2 concentrations are expected, such as near major roads. When considering alternative forms for the standard, the Administrator notes
that an unstable form could result in areas shifting in and out of attainment, potentially disrupting ongoing air quality planning without achieving public health goals. Given the limited available information on the variability in peak NO 2 concentrations near important sources of NO 2 such as major roadways, and given the
recommendation from CASAC that the potential for instability in the 99th percentile concentration is cause for supporting a 98th percentile form, the Administrator judges it appropriate to set the form based on the 3-year average of the 98th percentile of the annual distribution of 1-hour daily maximum

NO 2 concentrations.

4. Level

As discussed below and in more detail in the proposal (section II.F.4),
the Administrator has considered two different approaches to setting the
1-hour NO 2 primary NAAQS. In the proposal, each of these approaches was linked with a different range of standard levels. Specifically, the Administrator proposed to set a 1-hour standard reflecting the maximum
allowable NO 2 concentration anywhere
in an area and to set the level of such a standard from 80 to 100 ppb. The
Administrator also solicited comment on the alternative approach of setting a
standard that reflects the allowable areawide NO 2 concentration and setting the standard level from 50 to 75 ppb. This
section summarizes the rationale for the Administrator’s proposed approach and range of standard levels (II.F.3.a), describes the alternative approach and range of standard levels (II.F.3.b),
discusses comments related to each approach and range of standard levels (II.F.3.c), and presents the Administrator’s final conclusions regarding the approach and level (II.F.3.d).

a. Rationale For Proposed Decisions on Approach and Level

In assessing the most appropriate approach to setting the 1-hour standard and the most appropriate range of standard levels to propose, the
Administrator considered the broad body of scientific evidence assessed in the ISA, including epidemiologic and controlled human exposure studies, as well as the results of exposure/risk analyses presented in the REA. In light of the body of available evidence and analyses, as described above, the
Administrator concluded in the proposal that it is necessary to provide increased public health protection for at-risk individuals against an array of adverse respiratory health effects linked with short-term ( i.e., 30 minutes to 24 hours) exposures to NO 2 . Such health
effects have been associated withexposure to the distribution of shortterm ambient NO 2 concentrations across an area, including higher short-term ( i.e., peak) exposure concentrations,
such as those that can occur on or near major roadways and near other sources
of NO 2 , as well as the lower short-term exposure concentrations that can occur in areas not near major roadways or
other sources of NO 2 . The Administrator’s proposed decisions on approach and level, as discussed in detail in the proposal (section II.F.4), are
outlined below.

In considering a standard-setting approach, the Administrator was mindful in the proposal that the available evidence and analyses from the ISA and REA support the publichealth importance of roadwayassociated NO 2 exposures. The exposure
assessment described in the REA estimated that roadway-associated exposures account for the majority of exposures to peak NO 2 concentrations (REA, Figures 8–17, 8–18). The ISA concluded (section 4.3.6) that NO 2 concentrations in heavy traffic or on freeways ‘‘ can be twice the residential
outdoor or residential/arterial road
level. ’’ In considering the potential variability in the NO 2 concentration gradient, the proposal noted that available monitoring studies suggest
that NO 2 concentrations could be 30 to 100% higher than those in the same area but away from the road. 12


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of roads measure NO 2 concentrations that are, on average across locations, 40% higher than concentrations measured by monitors at least 100 m from the road (REA, compare Tables 7–11 and 7–13). 13 The 98th percentile concentrations in these study locations ranged from 85 to 94 ppb.

14 For a standard of 100 ppb, area-wide concentrations would be expected to range from approximately 50 ppb (assuming near-road concentrations are 100% higher than area-wide concentrations) to 75 ppb (assuming near-road concentrations are 30% higher than area-wide concentrations). The Administrator also considered that millions of people in the United States live, work, and/or attend school near important sources of NO 2 such as major roadways (ISA, section 4.4), and
that ambient NO 2 concentrations in these locations vary depending on the distance from major roads ( i.e., the closer to a major road, the higher the

NO 2 concentration) (ISA, section 2.5.4). Therefore, these populations, which likely include a disproportionate number of individuals in groups with higher prevalence of asthma and higher hospitalization rates for asthma ( e.g. ethnic or racial minorities and
individuals of low socioeconomic status) (ISA, section 4.4), are likely exposed to NO 2 concentrations that are higher than those occurring away from major roadways.

Given the above considerations, the Administrator proposed an approach to setting the 1-hour NO 2 primary NAAQS whereby the standard would reflect the
maximum allowable NO 2 concentration anywhere in an area. In many locations, this concentration is likely to occur on or near a major roadway. EPA proposed to set the level of the standard such that, when available information regarding the concentration gradient around roads is considered, appropriate public health protection would be provided by limiting the higher short-term peak exposure concentrations expected to occur on and near major roadways, as well as the lower short-term exposure concentrations expected to occur away from those roadways. The Administrator concluded that this approach to setting
the 1-hour NO 2 NAAQS would be expected to protect public health againstexposure to the distribution of shortterm NO 2 concentrations across an area and would provide a relatively high degree of confidence regarding the protection provided against peak exposures to higher NO 2 concentrations,
such as those that can occur around major roadways. The remainder of this section discusses the proposed range of
standard levels.

In considering the appropriate range of levels to propose for a standard that
reflects the maximum allowable NO 2 concentration anywhere in an area, the
Administrator considered the broad body of scientific evidence and exposure/risk information as well as
available information on the relationship between NO 2 concentrations near roads and those away from roads. Specifically, she considered the extent to which a variety of levels would be expected to protect at-risk individuals against increased airway responsiveness, respiratory symptoms, and respiratory-related emergency department visits and hospital admissions.

After considering the scientific evidence and the exposure/risk information ( see sections II.B, II.C, and II.F.4.a.1 through II.F.4.a.3 in the proposal), as well as the available
information on the NO 2 concentration gradient around roadways (section II.A.2 above and in the proposal), the
Administrator concluded that the strongest support is for a standard level at or somewhat below 100 ppb. The Administrator’s rationale in reaching this proposed conclusion is provided
below.

The Administrator noted that a
standard level at or somewhat below 100 ppb in conjunction with the proposed approach would be expected
to limit short-term NO 2 exposures to concentrations that have been reported to increase airway responsiveness in asthmatics ( i.e., at or above 100 ppb). While she acknowledged that exposure

to NO 2 concentrations below 100 ppb could potentially increase airway responsiveness in some asthmatics, the
Administrator also noted uncertainties regarding the magnitude and the clinical significance of the NO 2 -induced increase in airway responsiveness, as discussed in the policy assessment chapter of the REA (section 10.3.2.1,
discussed in section II.F.4.e in the proposal). Given these uncertainties, the
Administrator concluded in the proposal that controlled human exposure studies provide support for limiting exposures at or somewhat below 100 ppb NO 2

.

The Administrator also noted that a
standard level at or somewhat below 100 ppb in conjunction with the proposed approach would be expected to maintain peak area-wide NO 2 concentrations considerably below those measured in locations where key U.S. epidemiologic studies have reported associations with more serious respiratory effects, as indicated by increased emergency department visits and hospital admissions. Specifically, the Administrator noted that 5 key U.S. studies provide evidence for such
associations in locations where the 99th percentile of the distribution of 1-hour daily maximum NO 2 concentrations measured at area-wide monitors ranged from 93 to 112 ppb (Ito et al., 2007; Jaffe et al., 2003; Peel et al., 2005; Tolbert et al., 2007; and a study by the New York State Department of Health, 2006). 13 The Administrator concluded that these studies provide support for a 1-hour standard that limits the 99th percentile of the distribution of 1-hour daily
maximum area-wide NO 2 concentrations to below 90 ppb (corresponds to a 98th percentile concentration of 85 ppb), and that limiting area-wide concentrations to considerably below 90 ppb would be appropriate in order to provide an adequate margin of safety. The Administrator noted that, based on
available information about the NO 2 concentration gradient around roads, a
standard level at or somewhat below 100 ppb set in conjunction with the proposed approach would be expected to accomplish this. Specifically, she noted that given available information regarding NO 2 concentration gradients around roads ( see section II.A.2), a standard level at or below 100 ppb (with either a 99th or 98th percentile form)would be expected to limit peak areawide NO 2 concentrations to approximately 75 ppb or below. 14 Therefore, the Administrator concluded
that a standard level at or somewhat below 100 ppb under the proposed approach would be expected to maintain peak area-wide NO 2 concentrations well below 90 ppb across locations despite the expected variation
in the NO 2 concentration gradient that can exist around roadways in different
locations and over time.

The Administrator also noted that a study by Delfino provides mixed
evidence for effects in a location with area-wide 98th and 99th percentile 1-hour daily maximum NO 2 concentrations of 50 and 53 ppb, respectively. In that study, NO 2 effect estimates were positive, but some reported 95% confidence limits for the odds ratio (OR) that included values less
than 1.00. Given the mixed results of the Delfino study, the Administrator concluded that it may not be necessary
to maintain area-wide NO 2 concentrations at or below 50 ppb to provide protection against the effects reported in epidemiologic studies.

In addition to these evidence-based considerations, the Administrator noted
that a standard level at or somewhat below 100 ppb under the proposed approach would be consistent with the


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15 This conclusion assumes that near-road NO 2 concentrations are 65% higher than area-wide concentrations, reflecting the mid-point in the range
of 30 to 100%. Based on available information suggesting that near-road concentrations can be 30 to 100% higher than area-wide concentrations, a standard level of 80 ppb could limit area-wide concentrations to between 40 and 60 ppb. 16 CASAC members were also part of the CASAC
Panel for the NO 2 NAAQS review (i.e., the Oxides of Nitrogen Primary National Ambient Air Quality Standards Panel). Therefore, references to the
CASAC Panel include both CASAC members and
Panel members. results of the exposure and risk analyses presented in the REA. As discussed in section II.C of the proposal, the results of these analyses provide support for setting a standard that limits 1-hour

area-wide NO 2 concentrations to between 50 and 100 ppb. As described above, a standard level of 100 ppb that

reflects the maximum allowable NO 2 concentration would be expected to

maintain area-wide NO 2 concentrations at or below approximately 75 ppb. Given all of these considerations, the

Administrator concluded in the proposal that a standard level at or somewhat below 100 ppb (with a 99th percentile form), in conjunction with the proposed approach, would be requisite to protect public health with an adequate margin of safety against the array of NO 2 -associated health effects.

In addition to the considerations discussed above, which support setting

a standard level at or somewhat below 100 ppb, the Administrator also

considered the extent to which available evidence could support standard levels below 100 ppb. The Administrator

concluded that the evidence could support setting the standard level below 100 ppb to the extent the following were emphasized:

• The possibility that an NO 2 -induced increase in airway responsiveness could occur in asthmatics following exposures to concentrations below 100 ppb and/or the possibility that such an increase could be clinically significant.

• The mixed results reported in the study by Delfino et al. (2002) of an association between respiratory symptoms and the relatively low

ambient NO 2 concentrations measured in the study area.

Specifically, she noted that a standard level of 80 ppb (99th percentile form), in conjunction with the proposed approach, could limit area-wide NO 2 concentrations to 50 ppb 15 and would be expected to limit exposure

concentrations to below those that have been reported to increase airway responsiveness in asthmatics. For the reasons stated above, the Administrator proposed to set the level of a new 1-hour standard between 80 ppb and 100 ppb. b. Rationale for the Alternative Approach and Range of Levels

As described above, the Administrator proposed to set a 1-hour NO 2 NAAQS reflecting the maximum allowable NO 2 concentration anywhere in an area and
to set the level of such a standard from 80 to 100 ppb. However, prior to the proposal, the approach of setting a
1-hour NO 2 NAAQS that reflects the
maximum allowable NO 2 concentration anywhere in an area had not been discussed by EPA in the REA or considered by CASAC. Rather, the potential alternative standards discussed in the REA, and reviewed by CASAC, reflected allowable area-wide

NO 2 concentrations ( i.e., concentrations that occur broadly across communities).

Given this, the Administrator noted in the proposal that comments received on the approach to setting the 1-hour standard ( i.e., from CASAC and from members of the public) could provide important new information for consideration. Therefore, the
Administrator also solicited comment on the alternative approach of setting a
1-hour NO 2 primary NAAQS that would
reflect the allowable area-wide NO 2 concentration, analogous to the standards evaluated in the REA, and with a level set within the range of 50 to 75 ppb. In discussing this alternative approach with a standard level from 50 to 75 ppb, the Administrator noted the following in the proposal:

• Such a standard would be expected
to maintain area-wide NO 2concentrations below peak 1-hour areawide concentrations measured in locations where key U.S. epidemiologic studies have reported associations with respiratory-related emergency department visits and hospital
admissions.

• Standard levels from the lower end of the range would be expected to limit roadway-associated exposures to NO 2 concentrations that have been reported in controlled human exposure studies to increase airway responsiveness in asthmatics. Specifically, a standard level of 50 ppb under this approach
could limit near-road concentrations to between approximately 65 and 100 ppb, depending on the relationship between
near-road NO 2 concentrations and areawide concentrations.

• This alternative approach would provide relatively more confidence regarding the degree to which a specific
standard level would limit area-wide

NO 2 concentrations and less confidence regarding the degree to which a specific standard level would limit the peak NO 2 concentrations likely to occur near major roadways. c. Comments on Approach and Level

In the proposal, each approach to setting the 1-hour standard, and each range of standard levels, was linked to different requirements for the design of
the NO 2 monitoring network. Specifically, in conjunction with the proposed approach ( i.e., standard
reflects the maximum allowable NO 2 concentration anywhere in an area and the level is set within the range of 80 to 100 ppb), the Administrator proposed to establish a 2-tiered monitoring network
that would include monitors sited to
measure the maximum NO 2 concentrations anywhere in an area, including near major roadways, and
monitors sited to measure maximum
area-wide NO 2 concentrations. In conjunction with the alternative approach ( i.e., standard reflects the
allowable area-wide NO 2 concentration and the level is set within the range of 50 to 75 ppb), the Administrator solicited comment on a monitoringnetwork that would only include areawide NO 2 monitors. Because of these linkages in the proposal, most
commenters combined their comments on the approach to setting a 1-hour
standard and on the standard level with their comments on the monitoring requirements. In this section, we discuss comments from CASAC and public commenters on the approach to setting
a 1-hour standard and on the standard level. Comments on the monitoring
network are also discussed in this section to the extent they indicate a preference for either the proposed or alternative approach to setting the 1- hour standard. More specific comments on monitor placement and network design are discussed below in section III.B.2 and in the Response to Comments document. EPA responses to technical
comments on the scientific evidence and the exposure/response information
are discussed above in section II.E.2 and in the Response to Comments
document. The Administrator’s response to commenters’ views on the approach to setting the 1-hour standard
and on the standard level is embodied
in the discussed in section II.F.4.d.

i. CASAC Comments on the Approach to Setting the Standard

A majority of CASAC and CASAC
Panel members 16 favored the proposed approach of setting a 1-hour standard
that reflects the maximum allowable


### 6496 Federal Register / Vol. 75, No. 26 / Tuesday, February 9, 2010 / Rules and Regulations

NO 2 concentration anywhere in an area and linking such a standard with a 2- tiered monitoring network that would
include both near-road and area-wide monitors, though CASAC did not reach consensus on this approach. Specifically, in their letter to the Administrator (Samet, 2009), CASAC stated the following:

There was a split view on the two approaches among both CASAC and CASAC panel members with a majority of each favoring the Agency’s proposed two-tiered monitoring network because they thought this approach would be more effective in limiting near-roadway exposures that may reach levels in the range at which some individuals with asthma may be adversely affected. Other members acknowledged theneed for research and development of nearroad monitoring data for criteria pollutants in general but favored retention of EPA’s current area-wide monitoring for NO 2 regulatory purposes, due to the lack of epidemiological data based on near-roadway exposure measurements and issues related to implementing a near-road monitoring system
for NO 2

. Thus, the recommendation of the majority of CASAC Panel members was
based on their conclusion that the proposed approach would be more effective than the alternative at limiting near-roadway exposures to NO 2 concentrations that could adversely affect asthmatics. In addition, these CASAC Panel members noted important
uncertainties with the alternative approach. Specifically, they stated the following (Samet, 2009):

Panel members also supported the proposed two-tiered approach because basing regulations on area-wide monitoring alone was problematic. Such an approach would require EPA to embed uncertainties and assumptions about the relationship between area-wide and road-side monitoring into the
area-wide standard.

A minority of CASAC Panel members expressed support for the alternative approach of setting a 1-hour standard
that reflects the allowable area-wide

NO 2 concentration. These CASAC Panel
members concluded that there would be important uncertainties associated with the proposed approach. Specifically, they noted that the key U.S. NO 2epidemiologic studies relied upon areawide NO 2 concentrations. In their view,
the use of area-wide concentrations in these studies introduces uncertainty
into the selection of a standard level for
a standard that reflects the maximum
allowable NO 2 concentration anywhere
in an area and that is linked with a requirement to place monitors near major roads. As a result of this uncertainty, CASAC Panel members who favored the alternative approach
noted that ‘‘ it would be better to set the standard on the same area-wide monitoring basis as employed in the epidemiologic studies upon which it [the standard] now relies ’’ (Samet, 2009).
These CASAC Panel members also strongly supported obtaining monitoring data near major roads, while recognizing
uncertainties associated with identifying appropriate monitoring sites near roads ( see section III.B.2 and the Response to Comments document for more discussion of CASAC’s monitoring comments).

ii. Public Comments on the Approach to Setting the Standard

Consistent with the views expressed by the majority of CASAC members, a
number of commenters concluded that the most appropriate approach would be
to set a 1-hour standard that reflects the
maximum allowable NO 2 concentration anywhere in an area and to couple that standard with a requirement that monitors be placed in locations where maximum concentrations are expected, including near major roads. This view was expressed by some State and local agencies ( e.g., in CA, IA, NY, TX, WA, WI), by a number of environmental organizations ( e.g., CAC, EDF, EJ, GASP, NRDC), by the ALA, and individual
commenters. Several additional medical and public health organizations (ACCP, AMA, ATS, NADRC, NACPR) did not explicitly express a recommendation regarding the approach though these organizations did recommend that, in setting a 1-hour standard, particular attention should be paid to NO X concentrations around major roadways. In support of their recommendation to adopt the proposed approach and to focus monitoring around major roads, these commenters generally concluded that a primary consideration should be
the extent to which the NO 2 NAAQS protects at-risk populations that live and/or attend school near important
sources of NO 2 such as major roads. As such, these comments supported the rationale in the proposal for setting a 1-
hour standard that reflects the
maximum allowable NO 2 concentration anywhere in an area.

A number of State commenters expressed the view that area-wide
monitors should be used for attainment/ non-attainment determinations ( e.g., NACAA, NESCAUM and agencies in IL, IN, MI, MS, NC, NM, SC). One State commenter (NESCAUM) agreed with
EPA concerns about near-road exposures but concluded that it is premature to establish a large near-road monitoring network at this time due to uncertainty regarding the relationship
between near-road and area-wide NO 2 concentrations and the variability in that relationship. NESCAUM
recommended that EPA work with States to establish a targeted monitoring program in select urban areas to gather
data that would inform future modifications to the monitoring network, but that ‘‘ [t]he existing areawide monitoring network should be used to identify initial nonattainment

areas. ’’ Other State commenters also concluded that the most appropriateapproach would be to base nonattainment determinations only on areawide monitors. Based on their monitoring comments, many of these commenters appeared to support setting
a 1-hour standard that reflects the
allowable area-wide NO 2 concentration. State concerns with the proposed approach often included uncertainties associated with identifying and accessing appropriate monitor sites near major roads, as well as concerns related to implementation and cost to States (as discussed further in the Response to Comments document, the Administrator may not consider cost of implementation in decisions on a NAAQS).

One commenter (AAM) concluded that the focus of the proposed approach

on NO 2 concentrations around major roadways is not justified because the REA and the proposal overstate the
extent to which NO 2 concentrations near roads are higher than NO 2 concentrations farther away from the
road. This conclusion is based on an analysis of 42 existing NO 2 monitors in 6 locations. Comparing NO 2 concentrations measured by these monitors, some of which are closer to
roads and others of which are farther from roads, AAM concluded that

‘‘ roadside monitors are not measuring high NO 2 concentrations. ’’

We agree that there is uncertaintyassociated with estimates of roadwayassociated NO 2 concentrations ( see REA, sections 7.4.6 and 8.4.8.3 for detailed discussion of these uncertainties) and in identifying locations where maximum concentrations are expected to occur. However, we note that the Administrator’s conclusions regarding the relationship between NO 2 concentrations near roads and those away from roads rely on multiple lines
of scientific evidence and information. Specifically, the Administrator relied in the proposal on the following in drawing conclusions regarding the
distribution of NO 2 concentrations

across areas:

• Monitoring studies discussed in the ISA and REA that were designed to
characterize the NO 2 concentration gradient around roads, which indicated
that NO 2 concentrations near roads can


### 6497 Federal Register / Vol. 75, No. 26 / Tuesday, February 9, 2010 / Rules and Regulations

17 To measure maximum concentrations, the Administrator proposed monitoring provisions that would require monitors within 50 meters of major roads and to allow the Regional Administrator to require additional monitors in situations where maximum concentrations would be expected to occur in locations other than near major roads ( e.g., due to the influence of multiple smaller roads and/ or stationary sources). be approximately 30 to 100% higher than concentrations away from the road
in the same area.

• Air quality and exposure analyses presented in the REA which estimate that, on average across locations, NO 2 concentrations on roads could be 80% higher than those away from roads and that roadway-associated exposures account for the majority of exposures to

NO 2 concentrations at or above 100 ppb.

In contrast, the existing NO 2 monitoring network, which was the basis for the analysis submitted by AAM, was not designed to characterize the spatial gradients in NO 2 concentrations surrounding roadways. Rather, concentrations of NO 2 measured by existing monitors are likely to reflect
contributions from a combination of mobile and stationary sources, with one or the other dominating depending on the proximity of these sources to the monitors. Therefore, we conclude that the analysis submitted by AAM, which
does not consider other relevant lines of evidence and information, does not appropriately characterize the relationship between NO 2 concentrations near roads and those away from roads. ( See the Response to
Comments document for a more detailed discussion of AAM comments.)

In addition, we note that, although the
Administrator concluded in the proposal that maximum NO 2 concentrations in many areas are likely to occur around major roads, she also recognized that maximum
concentrations can occur elsewhere in an area. For this reason, she proposed to
set a 1-hour NO 2 standard that reflects
the maximum allowable NO 2 concentration anywhere in an area, regardless of where that maximum

concentration occurs. 17 Therefore, the proposed approach to setting the standard would be expected to limit the

maximum NO 2 concentrations anywhere in an area even if in some areas, as is contended by AAM, those

maximum NO 2 concentrations do not
occur near roads.

iii. CASAC Comments on Standard
Level

In commenting on the proposal, CASAC discussed both the proposed range of standard levels ( i.e., 80–100 ppb) and the alternative range of standard levels ( i.e., 50–75 ppb). CASAC did express the consensus conclusion that if the Agency finalizes
a 1-hour standard in accordance with the proposed approach ( i.e., standard
level reflects the maximum allowable

NO 2 concentration anywhere in an area), then it is appropriate to consider the proposed range of standard levels from 80 to 100 ppb. Specifically, the
CASAC letter to the Administrator on the proposal (Samet, 2009) stated the following with regard to the proposed approach:

[T]he level of the one-hour NO 2 standard should be within the range of 80–100 ppb and not above 100 ppb. In its letter of December 2, 2008, CASAC strongly voiced a consensus view that the upper end of the range should not exceed 100 ppb, based on
evidence of risk at that concentration. The lower limit of 80 ppb was viewed as reasonable by CASAC; selection of a value lower than 80 ppb would represent a policy judgment based on uncertainty and the degree of public health protection sought, given the limited health-based evidence at concentrations below 100 ppb.

CASAC also recommended that this level be employed with a 98th percentile form, in order to promote the stability of the standard ( see above for discussion of form).

iv. Public Comments on Standard Level

A number of State and local agencies and organizations expressed support for setting the level of the 1-hour NO 2 standard within the proposed range of 80 to 100 ppb. While some State and local agencies ( e.g., in CA, IA, MI, NY, TX) made this recommendation in conjunction with a recommendation to focus monitoring near major roads and other important sources of NO 2 , a number of State commenters ( e.g., NACAA, NESCAUM and agencies in IL, NC, NM, TX, VA) recommended a standard level from 80 to 100 ppb in conjunction with a recommendation that only area-wide monitors be deployed for purposes of determining
attainment with the standard. Based on these monitoring comments, these State commenters appear to favor an approach where a standard level from 80 to 100 ppb would reflect the
allowable area-wide NO 2 concentration. As discussed above (and in more detail in section III.B.2 and the Response to Comments document), State
commenters often based these
recommendations on uncertainties associated with designing an appropriate national near-road monitoring network.

A number of environmental organizations ( e.g., CAC, EDF, EJ, GASP, NRDC) and medical/public health organizations ( e.g., ACCP, ALA, AMA, ATS, NACPR, NAMDRC) supported setting a standard level below 80 ppb for
a standard that reflects the maximum
allowable NO 2 concentration anywhere in an area. Several of these groups
recommended a standard level of 50 ppb. This recommendation was typically based on the commenters’ interpretation of the epidemiologic and controlled human exposure evidence, as
described below.

Some of these commenters noted that the 98th percentile area-wide NO 2 concentration was below 80 ppb in the location of a single key U.S. epidemiologic study ( i.e., 50 ppb in study by Delfino). Given this,
commenters concluded that the standard level should be set at 50 ppb. Their comments on the monitoring network generally favored a requirement to place monitors near major roads and, therefore, these commenters appeared to favor a standard level as low as 50 ppb
and to recommend that such a standard
level reflect the maximum allowable

NO 2 concentration anywhere in an area. In their comments, the ALA, EDF, EJ, and NRDC stated the following:

Considering the Delfino study alone on EPA’s terms, that is, focusing on the 98th percentile of the 1-hour daily maximum concentrations, EPA reports a concentration of 50 ppb where asthma symptoms were observed. Based primarily on this study, EPA concluded in the REA that it was appropriate to set the lower end of the range at 50 ppb, which corresponded to the lowest-observed effects level of airway hyperresponsiveness in asthmatics. To provide the strongest public health protection, we therefore urge the level of the standard be set at 50 ppb.

In some cases, the same commenters also appeared to recommend setting a standard level below 50 ppb because
mean area-wide NO 2 concentrations reported in locations of key U.S. epidemiologic studies are below this concentration. Specifically, with regard to the key U.S. epidemiologic studies, these commenters ( e.g., ALA, EDF, EJ, NRDC) stated the following:

These studies clearly identify adverse health effects such as emergency room visits and hospital admissions for respiratory causes at concentrations currently occurring
in the United States. Mean concentrations for
all but two of these studies are about or below 50 ppb, suggesting that the standard
must be set below this level to allow for a margin of safety.

The Administrator’s consideration of the Delfino study as it relates to a
decision on standard level is discussed below (section II.F.4.d). Regarding the
recommendation to set the level below 50 ppb based on mean area-wide NO 2 concentrations in epidemiologic study


### 6498 Federal Register / Vol. 75, No. 26 / Tuesday, February 9, 2010 / Rules and Regulations

18 As discussed above, the Administrator has selected the 98th percentile as the form for the new
1-hour NO 2 standard. locations, we note that the Administrator proposed to set a
standard that reflects the maximum
allowable NO 2 concentration anywhere
in an area and to set the form of that standard at the upper end of the distribution of 1-hour daily maximum

NO 2 concentrations. 18 As described in the proposal, such a standard, with a level from the proposed range of 80 to 100 ppb, would be expected to maintain peak area-wide NO 2 concentrations below the peak area-wide
concentrations measured in locations where key U.S. epidemiologic studies have reported associations with respiratory-related emergency department visits and hospital admissions. Because reducing NO X emissions to meet a 98th percentile NO 2 standard should lower the distribution
of NO 2 concentrations, including the mean, a standard that limits the 98th percentile of the distribution of 1-hour daily maximum concentrations would also be expected to limit mean concentrations. Therefore, although we acknowledge that the relationship between peak and mean NO 2 concentrations will likely vary acrosslocations and over time, if peak areawide NO 2 concentrations are maintained below those in key epidemiologic study locations, mean
area-wide NO 2 concentrations would also be expected to be maintained below
the mean area-wide concentrations in those locations ( see ISA, figure 2.4–13 for information on the relationship between peak and mean NO 2 concentrations).

As discussed above (section, II.E.2), a number of industry groups did not support setting a new 1-hour NO 2 standard. However, several of these groups ( e.g., AAM, Dow, NAM, NPRA) also concluded that, if EPA does choose to set a new 1-hour standard, the level
of that standard should be above 100 ppb. As a basis for this recommendation, these groups emphasized uncertainties in the scientific evidence. Specifically, as discussed in more detail above (section II.E.2), these commenters typically concluded that available epidemiologic studies do not support the conclusion
that NO 2 causes reported health effects.
This was based on their assertion that the presence of co-pollutants in the ambient air precludes the identification of a specific NO 2 contribution to reported effects. As a result, these
commenters recommended that a 1-hour
standard should be based on the controlled human exposure evidence and that, in considering that evidence, EPA should rely on the meta-analysis of

NO 2 airway responsiveness studies conducted by Goodman et al., (2009) rather than the meta-analysis included in the final ISA. As described above, they concluded that in relying on the ISA meta-analysis, EPA has inappropriately relied on a new unpublished meta-analysis that has not been peer-reviewed, was not reviewed by CASAC, and was not conducted in a transparent manner. EPA recognizes the
uncertainties in the scientific evidence that are discussed by these industry commenters; however, we strongly disagree with their conclusions regarding the implications of these
uncertainties for decisions on the NO 2 NAAQS. These comments, and EPA’s responses, are discussed in detail above (section II.E.2) and in the Response to
Comments document and are summarized briefly below.

As noted in section II.E.2, we agree that the presence of co-pollutants in the ambient air complicates the interpretation of epidemiologic studies; however, our conclusions regarding causality are based on consideration of the broad body of epidemiologic studies(including those employing multipollutant models) as well as animal toxicological and controlled human exposure studies. The ISA concluded that this body of evidence ‘‘ supports a direct effect of short-term NO 2 exposure on respiratory morbidity at ambient
concentrations below the current NAAQS level ’’ (ISA, p. 5–16). In addition, the ISA (p. 5–15) concluded the following:

[T]he strongest evidence for an association
between NO 2 exposure and adverse human health effects comes from epidemiologic studies of respiratory symptoms and ED visits and hospital admissions. These new findings were based on numerous studies, including panel and field studies, multipollutant studies that control for the effects of other pollutants, and studies
conducted in areas where the whole distribution of ambient 24-h avg NO 2 concentrations was below the current NAAQS level of 0.053 ppm (53 ppb) (annual average).

Given that epidemiologic studies provide the strongest support for an
association between NO 2 and respiratory morbidity, and that a
number of these studies controlled for the presence of other pollutants with multi-pollutant models (in which NO 2 effect estimates remained robust), we disagree that NO 2 epidemiologic studies
should not be used to inform a decision
on the level of the 1-hour NO 2 standard. In addition, we agree that uncertainty exists regarding the extent to which the

NO 2 -induced increase in airway responsiveness is adverse (REA, section 10.3.2.1); however, as discussed in detail above (section II.E.2), we disagree with the conclusion by many industry
commenters that this effect is not adverse in asthmatics following exposures from 100 to 600 ppb NO 2

. Specifically, we do not agree that the approach taken in the study by
Goodman et al. (2009), which was used by many industry commenters to support their conclusions, was appropriate. The authors of the Goodman study used data from existing

NO 2 studies to characterize the doseresponse relationship of NO 2 and airway responsiveness and to calculate the magnitude of the NO 2 effect. Given the protocol differences in existing studies
of NO 2 and airway responsiveness, we do not agree that it is appropriate to base such an analysis on these studies.

The Administrator’s consideration of these uncertainties, within the context of setting a standard level, is discussed
in the next section.

d. Conclusions on Approach and
Standard Level

Having carefully considered the public comments on the appropriate approach and level for a 1-hour NO 2 standard, as discussed above, the
Administrator believes the fundamental
conclusions reached in the ISA and REA remain valid. In considering the approach, the Administrator continues to place primary emphasis on the conclusions of the ISA and the analyses of the REA, both of which focus attention on the importance of roadways in contributing to peak NO 2 exposures, given that roadway-associated exposures can dominate personal exposures to NO 2 . In considering the level at which the 1-hour primary NO 2 standard should be set, the Administrator continues to place primary emphasis on the body of scientific evidence assessed in the ISA, as summarized above in section II.B, while viewing the results of exposure and risk analyses, discussed above in section II.C, as providing information in support of her decision.

With regard to her decision on the approach to setting the 1-hour standard, the Administrator continues to judge it appropriate to provide increased public health protection for at-risk individuals against an array of adverse respiratory
health effects linked with short-term exposures to NO 2, where such health
effects have been associated withexposure to the distribution of shortterm ambient NO 2 concentrations across


### 6499 Federal Register / Vol. 75, No. 26 / Tuesday, February 9, 2010 / Rules and Regulations

19 The most current American Housing Survey (http://www.census.gov/hhes/www/housing/ahs/ ahs.html) is from 2007 and lists a higher fraction of housing units within the 300 foot boundary. According to Table 1A–6 from that report (http:// www.census.gov/hhes/www/housing/ahs/ahs07/ tab1a-6.pdf), out of 128.2 million total housing units in the United States, about 20 million were reported by the surveyed occupant or landlord as being within 300 feet of a 4-or-more lane highway, railroad, or airport. That constitutes 15.6% of the total housing units in the U.S. Assuming equal distributions, with a current population of 306.3 million, that means that there would be 47.8 million people meeting the 300 foot criteria. an area. In protecting public health against exposure to the distribution of
short-term NO 2 concentrations across an area, the Administrator is placing emphasis on providing a relatively high degree of confidence regarding the protection provided against exposures to peak concentrations of NO 2 , such as those that can occur around major roadways. Available evidence and information suggest that roadways account for the majority of exposures to peak NO 2 concentrations and, therefore, are important contributors to NO 2 - associated public health risks. In reaching this conclusion, the Administrator notes the following:

• Mobile sources account for the majority of NO X emissions (ISA, Table 2.2–1).

• The ISA stated that NO 2 concentrations in heavy traffic or on freeways ‘‘ can be twice the residential
outdoor or residential/arterial road level, ’’ that ‘‘ exposure in traffic can dominate personal exposure to NO 2 , ’’
and that ‘‘ NO 2 levels are strongly associated with distance from major roads ( i.e., the closer to a major road, the higher the NO 2 concentration) ’’ (ISA, sections 2.5.4, 4.3.6).

• The exposure assessment presentedin the REA estimated that roadwayassociated exposures account for the majority of exposures to peak NO 2 concentrations (REA, Figures 8–17, 8– 18).

• Monitoring studies suggest that NO 2 concentrations near roads can be considerably higher than those in the same area but away from roads ( e.g., by 30–100%, see section II.A.2).

• In their comments on the approach to setting the 1-hour NO 2 standard, the majority of CASAC Panel members emphasized the importance of setting a standard that limits roadway-associated exposures to NO 2 concentrations that could adversely affect asthmatics. These
CASAC Panel members favored the proposed approach, including its focus
on roads.

In addition, the Administrator notes
that a considerable fraction of the population resides, works, or attends school near major roadways or other
sources of NO 2 and that these populations are likely to have increased exposure to NO 2 (ISA, section 4.4).
Based on data from the 2003 American Housing Survey, approximately 36
million individuals live within 300 feet (

∼ 90 meters) of a four-lane highway, railroad, or airport (ISA, section 4.4). 19 Furthermore, in California, 2.3% of
schools with a total enrollment of more than 150,000 students were locatedwithin approximately 500 feet of hightraffic roads (ISA, section 4.4). Of this population, which likely includes a disproportionate number of individuals in groups with a higher prevalence of asthma and higher hospitalization rates for asthma ( e.g., ethnic or racial
minorities and individuals of low socioeconomic status) (ISA, section 4.4),
asthmatics and members of other susceptible groups ( e.g., children, elderly) will have the greatest risks of experiencing health effects related to

NO 2 exposure. In the United States, approximately 10% of adults and 13% of children have been diagnosed with asthma, and 6% of adults have been diagnosed with COPD (ISA, section 4.4).

In considering the approach to setting the 1-hour standard, the Administrator
also notes that concerns with the proposed approach expressed by the minority of CASAC Panel members included concern with the uncertainty in the relationship between near-road
and area-wide NO 2 concentrations, given that U.S. epidemiologic studies
have been based on concentrations
measured at area-wide monitors. However, as discussed by the majority of CASAC Panel members, a similar uncertainty would be involved in setting a standard with the alternative approach (Samet, 2009). The Administrator agrees with the majority
of CASAC Panel members and concludes that uncertainty in the relationship between near-road and
area-wide NO 2 concentrations should be considered regardless of the approach
selected to set the standard. She recognizes that this uncertainty can and
should be taken into consideration when considering the level of the
standard.

In drawing conclusions on the approach, the Administrator has
considered the extent to which each approach, in conjunction with the ranges of standard levels discussed in the proposal, would be expected to limit
the distribution of NO 2 concentrations across an area and, therefore, would be expected to protect against risks
associated with NO 2 exposures. Specifically, she has considered the extent to which a standard set with each approach would be expected to limit

maximum NO 2 concentrations and areawide NO 2 concentrations.

With regard to expected maximum concentrations, the Administrator notes the following:

• A standard reflecting the maximum
allowable NO 2 concentration anywhere in an area would provide a relatively high degree of confidence regarding the level of protection provided against peak exposures, such as those that can occur on or near major roadways. A standard level from anywhere within the proposed range ( i.e., 80 to 100 ppb) would be expected to limit exposures to

NO 2 concentrations reported to increase airway responsiveness in asthmatics.

• A standard reflecting the allowable
area-wide NO 2 concentration would not provide a high degree of confidence regarding the extent to which maximum

NO 2 concentrations would be limited.

Maximum NO 2 concentrations would be expected to be controlled to varying degrees across locations and over time depending on the NO 2 concentration gradient around roads. Given the expected variability in gradients across locations and over time, most standard levels within the range considered in the proposal with this option ( i.e., 50 to 75 ppb) would not be expected to consistently limit the occurrence of NO 2 concentrations that have been reported to increase airway responsiveness in
asthmatics.

With regard to expected area-wide concentrations, the Administrator notes the following:

• The extent to which a standard reflecting the maximum allowable NO 2 concentration anywhere in an area would be expected to limit area-wide

NO 2 concentrations would vary across locations, e.g., depending on the NO 2 concentration gradient around roads. However, in conjunction with a standard level from anywhere within the proposed range ( i.e., 80–100 ppb), such an approach would be expected to
maintain area-wide NO 2 concentrations
below those measured in locations where key U.S. epidemiologic studies have reported associations between
ambient NO 2 and respiratory-related hospital admissions and emergency department visits (based on available information regarding the NO 2 concentration gradient around roads as discussed below).

• A standard reflecting the maximum
allowable area-wide NO 2 concentration would provide a relatively high degree of certainty regarding the extent to
which area-wide NO 2 concentrations are limited. In conjunction with a standard level from anywhere within the range of


### 6500 Federal Register / Vol. 75, No. 26 / Tuesday, February 9, 2010 / Rules and Regulations

levels discussed in the proposal ( i.e., 50–75 ppb) with this alternative approach, such a standard would be expected to maintain area-wide NO 2 concentrations below those measured in locations where key U.S. epidemiologic studies have reported associations
between ambient NO 2 and respiratoryrelated hospital admissions and emergency department visits.

Given the above considerations, the
Administrator concludes that both approaches, in conjunction with appropriate standard levels, would be expected to maintain area-wide NO 2 concentrations below those measured in locations where key U.S. epidemiologic studies have reported associations
between ambient NO 2 and respiratoryrelated hospital admissions and emergency department visits. In contrast, the Administrator concludes that only a standard reflecting the
maximum allowable NO 2 concentration anywhere in an area, in conjunction with an appropriate standard level, would be expected to consistently limit exposures, across locations and over time, to NO 2 concentrations reported to increase airway responsiveness in asthmatics. After considering the evidence and uncertainties, and the advice of the CASAC Panel, the Administrator judges that the most appropriate approach to setting a 1-hour standard to protect against the
distribution of short-term NO 2 concentrations across an area, including the higher concentrations that can occur
around roads and result in elevated exposure concentrations, is to set a
standard that reflects the maximum
allowable NO 2 concentration anywhere

in an area.

In considering the level of a 1-hour

NO 2 standard that reflects the maximum
allowable NO 2 concentration anywhere in an area, the Administrator notes that there is no bright line clearly directing the choice of level. Rather, the choice of what is appropriate is a public health policy judgment entrusted to the Administrator. This judgment must include consideration of the strengths
and limitations of the evidence and the appropriate inferences to be drawn from the evidence and the exposure and risk assessments. Specifically, the Administrator notes the following:

• Controlled human exposure studies have reported that various NO 2 exposure concentrations increased airway responsiveness in mostly mild asthmatics (section II above and II.B.1.d in proposal). These studies can inform
an evaluation of the risks associated with exposure to specific NO 2 concentrations, regardless of where those exposures occur in an area. Because concentrations evaluated in controlled human exposure studies are at the high end of the distribution of
ambient NO 2 concentrations (ISA, section 5.3.2.1), these studies most directly inform consideration of the risks associated with exposure to peak
short-term NO 2 concentrations.

• Epidemiologic studies (section II.B.1.a and b) conducted in the United States have reported associations
between ambient NO 2 concentrations
measured at area-wide monitors in the
current network and increased respiratory symptoms, emergency department visits, and hospital
admissions. Area-wide monitors in the
urban areas in which these epidemiologic studies were conducted
are not sited in locations where localized peak concentrations are likely to occur. Thus, they do not measure the full range of ambient NO 2 concentrations across the area. Rather,
the area-wide NO 2 concentrations measured by these monitors are used as surrogates for the distribution of
ambient NO 2 concentrations across the area, a distribution that includes NO 2 concentrations both higher than ( e.g., around major roadways) and lower than
the area-wide concentrations measured in study locations. Epidemiologic
studies evaluate whether area-wide NO 2 concentrations are associated with the risk of respiratory morbidity. Available
information on NO 2 concentration gradients around roadways can inform estimates of the relationship between
the area-wide NO 2 concentrations measured in epidemiologic study locations and the higher NO 2 concentrations likely to have occurred around roads in those locations, which
can then inform the decision on the level of a standard reflecting the
maximum allowable NO 2 concentration anywhere in an area.

• The risk and exposure analyses presented in the REA provide information on the potential public health implications of setting standards
that limit area-wide NO 2 concentrations to specific levels. While the Administrator acknowledges the
uncertainties associated with these analyses which, as discussed in the REA, could result in either over- or
underestimates of NO 2 -associated health risks, she judges that these analyses are informative for considering the relative levels of public health protection that could be provided by different
standards.

The Administrator’s consideration of the controlled human exposure evidence, epidemiologic evidence, and exposure/risk information are discussed below specifically with regard to a decision on the level of a standard that
reflects the maximum allowable NO 2 concentration anywhere in an area.

In considering the potential for controlled human exposure studies of

NO 2 and airway responsiveness to inform a decision on standard level, the Administrator notes the following:

• NO 2 -induced increases in airway responsiveness, as reported in controlled human exposure studies, are logically linked to the adverse respiratory effects that have been reported in NO 2 epidemiologic studies.

• The meta-analysis of controlled human exposure data in the ISA reported increased airway responsiveness in a large percentage of asthmatics at rest following exposures at and above 100 ppb NO 2 , the lowest NO 2 concentration for which airway responsiveness data are available in
humans.

• This meta-analysis does not provide any evidence of a threshold below
which effects do not occur. The studies included in the meta-analysis evaluated primarily mild asthmatics while more severely affected individuals could respond to lower concentrations. Therefore, it is possible that exposure to

NO 2 concentrations below 100 ppb could increase airway responsiveness in
some asthmatics.

In considering the evidence, the Administrator recognizes that the NO 2 - induced increases in airway responsiveness reported for exposures

to NO 2 concentrations at or above 100 ppb could be adverse for some asthmatics. However, she also notes that important uncertainties exist with regard to the extent to which NO 2 - induced increases in airway responsiveness are adverse. Specifically, she notes the following with regard to
these uncertainties:

• The magnitude of the NO 2 -induced increase in airway responsiveness, and the extent to which it is adverse, cannotbe quantified from the ISA metaanalysis (REA, section 10.3.2.1).

• The NO 2 -induced increase in airway responsiveness in resting asthmatics was typically not accompanied by increased respiratory symptoms, even following exposures to

NO 2 concentrations well above 100 ppb (ISA, section 3.1.3.3).

• The increase in airway responsiveness that was reported for resting asthmatics was not present in exercising asthmatics (ISA, Table 3.1–3).

Taking into consideration all of the above, the Administrator concludes that existing evidence supports the
conclusion that the NO 2 -induced increase in airway responsiveness at or above 100 ppb presents a risk of adverse


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20 Some of these studies also included susceptible and vulnerable populations ( e.g., children in Peel
et al. (2005); poor and minority populations in Ito et al., 2007). effects for some asthmatics, especially those with more serious ( i.e., more than mild) asthma. The Administrator notes
that the risks associated with increased airway responsiveness cannot be fully characterized by these studies, and thus
she is not able to determine whether the increased airway responsiveness experienced by asthmatics in these
studies is an adverse health effect. However, based on these studies the
Administrator concludes that asthmatics, particularly those suffering from more severe asthma, warrant protection from the risk of adverse
effects associated with the NO 2 -induced increase in airway responsiveness. Therefore, the Administrator concludes that the controlled human exposure evidence supports setting a standard level no higher than 100 ppb to reflect a cautious approach to the uncertainty regarding the adversity of the effect. However, those uncertainties lead her to
also conclude that this evidence does not support setting a standard level lower than 100 ppb.

In considering the more serious health effects reported in NO 2 epidemiologic studies, as they relate to the level of a
standard that reflects the maximum
allowable NO 2 concentration anywhere in an area, the Administrator notes the following:

• A cluster of 5 key U.S. epidemiologic studies (Ito et al., 2007; Jaffe et al., 2003; Peel et al., 2005; Tolbert et al., 2007; and a study by the New York State Department of Health, 2006) provide evidence for associations
between NO 2 and respiratory-related emergency department visits and hospital admissions in locations where 98th percentile 1-hour daily maximum

NO 2 concentrations measured at areawide monitors ranged from 85 to 94 ppb. The Administrator judges it appropriate to place substantial weight on this cluster of key U.S. epidemiologic studies in selecting a standard level, as they are a group of studies that reported positive, and often statistically significant, associations between NO 2 and respiratory morbidity in multiple
cities across the United States. 20

• A single study (Delfino et al., 2002) provides mixed evidence for NO 2 effects ( i.e., respiratory symptoms) in a location with a 98th percentile 1-hour daily

maximum NO 2 concentration, as measured by an area-wide monitor, of 50 ppb. In that study, most of the reported NO 2 effect estimates were positive, but not statistically significant. Given the variability in the NO 2 effect estimates in this study, as well as the
lack of studies in other locations with similarly low NO 2 concentrations, the Administrator judges it appropriate to place limited weight on this study, compared to the cluster of 5 studies as
noted above.

Given these considerations, the
Administrator concludes that the epidemiologic evidence provides strong support for setting a standard that limits the 98th percentile of the distribution of 1-hour daily maximum area-wide NO 2 concentrations to below 85 ppb. This judgment takes into account the determinations in the ISA, based on a much broader body of evidence, that there is a likely causal association between exposure to NO 2 and the types of respiratory morbidity effects reported
in these studies. Given the considerations discussed above, the Administrator judges that it is not necessary, based on existing evidence, to set a standard that maintains peak
area-wide NO 2 concentrations to below 50 ppb.

In considering specific standard levels supported by the epidemiologic evidence, the Administrator notes that a level of 100 ppb, for a standard reflecting the maximum allowable NO 2 concentration anywhere in the area,would be expected to maintain areawide NO 2 concentrations well below 85 ppb, which is the lowest 98th percentile
concentration in the cluster of 5 studies. With regard to this, she specifically notes the following:

• If NO 2 concentrations near roads are 100% higher than concentrations away from roads, a standard level of 100 ppb
would limit area-wide concentrations to approximately 50 ppb.

• If NO 2 concentrations near roads are 30% higher than concentrations away from roads, a standard level of 100 ppb
would limit area-wide concentrations to approximately 75 ppb.

The Administrator has also
considered the NO 2 exposure and risk
information within the context of the
above conclusions on standard level. Specifically, she notes that the results of exposure and risk analyses were interpreted as providing support for limiting area-wide NO 2 concentrations to no higher than 100 ppb. Specifically, these analyses estimated that a standard
that limits area-wide NO 2 concentrations to approximately 100 ppb or below would be expected to result in important reductions in respiratory risks, relative to the level of risk permitted by the current annual standard alone. As discussed above, a standard reflecting the maximum
allowable NO 2 concentration with a level of 100 ppb would be expected to
maintain area-wide NO 2 concentrations to within a range of approximately 50 to 75 ppb. Given this, the Administrator
concludes that a standard level of 100 ppb is consistent with conclusions
based on the NO 2 exposure and risk
information.

Finally, the Administrator notes that a standard level of 100 ppb is consistent
with the consensus recommendation of

CASAC.

Given the above considerations and the comments received on the proposal,
the Administrator determines that the appropriate judgment, based on the entire body of evidence and information available in this review, and the related uncertainties, is a standard level of 100 ppb (for a standard that reflects the
maximum allowable NO 2 concentration anywhere in an area). She concludes that such a standard, with the averaging time and form discussed above, will provide a significant increase in public health protection compared to that provided by the current annual standard alone and would be expected to protect against the respiratory effects that have
been linked with NO 2 exposures in both controlled human exposure and epidemiologic studies. Specifically, she
concludes that such a standard will limit exposures at and above 100 ppb for the vast majority of people, including those in at-risk groups, and
will maintain maximum area-wide NO 2 concentrations well below those in locations where key U.S. epidemiologic studies have reported that ambient NO 2 is associated with clearly adverse respiratory health effects, as indicated by increased hospital admissions and emergency department visits.

In setting the standard level at 100 ppb rather than a lower level, the
Administrator notes that a 1-hour
standard with a level lower than 100 ppb would only result in significant further public health protection if, in fact, there is a continuum of serious, adverse health risks caused by exposure

to NO 2 concentrations below 100 ppb
and/or associated with area-wide NO 2 concentrations well-below those in locations where key U.S. epidemiologic studies have reported associations with respiratory-related emergency department visits and hospital
admissions. Based on the available evidence, the Administrator does not believe that such assumptions are warranted. Taking into account the uncertainties that remain in interpreting
the evidence from available controlled human exposure and epidemiologic studies, the Administrator notes that the likelihood of obtaining benefits to public health with a standard set below


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100 ppb decreases, while the likelihood of requiring reductions in ambient concentrations that go beyond those that are needed to protect public health

increases.

Therefore, the Administrator judges that a standard reflecting the maximum
allowable NO 2 concentration anywhere in an area set at 100 ppb is sufficient to protect public health with an adequate margin of safety, including the health of at-risk populations, from adverse respiratory effects that have been linked to short-term exposures to NO 2 and for which the evidence supports a likely causal relationship with NO 2 exposures. The Administrator does not believe that
a lower standard level is needed to provide this degree of protection. These conclusions by the Administrator appropriately consider the requirement
for a standard that is neither more nor less stringent than necessary for this purpose and recognizes that the CAA does not require that primary standards be set at a zero-risk level or to protect the most sensitive individual, but rather at a level that reduces risk sufficiently so as to protect the public health with an adequate margin of safety.

G. Annual Standard

In the proposal, the Administrator noted that some evidence supports a link between long-term exposures to

NO 2 and adverse respiratory effects and
that CASAC recommended in their comments prior to the proposal that, in addition to setting a new 1-hour standard to increase public health protection, the current annual standard
be retained. CASAC’s recommendation
was based on the scientific evidence
and on their conclusion that a 1-hour standard might not provide adequate protection against exposure to long-term

NO 2 concentrations (Samet, 2008b).

With regard to an annual standard, CASAC and a large number of public commenters ( e.g., NACAA, NESCAUM; agencies from States including CA, IN, MO, NC, NY, SC, TX, VA; Tribal organizations including Fon du Lac and the National Tribal Air Organization; environmental/medical/public health groups including ACCP, ALA, AMA, ATS, CAC, EDF, EJ, GASP, NACPR, NAMDRC, NRDC) agreed with the proposed decision to maintain an annual standard, though their recommendations with regard to the
level of that annual standard differed ( see below).

As noted above, CASAC
recommended ‘‘ retaining the current standard based on the annual average ’’
based on the ‘‘ limited evidence related to potential long-term effects of NO 2 exposure and the lack of strong evidence of no effect ’’ and that ‘‘ the findings of the REA do not provide
assurance that a short-term standard
based on the one-hour maximum will necessarily protect the population from long-term exposures at levels potentially leading to adverse health effects ’’ (Samet, 2008b). A number of State agencies and organizations also recommended maintaining the current level of the annual standard ( i.e., 53 ppb). This recommendation was based on the conclusion that, while someevidence supports a link between longterm NO 2 exposures and adverse respiratory effects, that evidence is not sufficient to support a standard level either higher or lower than the current level. In addition, a number of industry groups ( e.g., AAM, API, Dow, INGAA, UARG) recommended retaining the level of the current annual standard but, as described above, did so within the
context of a recommendation that EPA
should not set a new 1-hour standard.

In contrast, some environmental organizations and medical/public health organizations as well as a small number of States ( e.g., ALA, EDF, EJ, NRDC, and organizations in CA) recommended setting a lower level for the annual standard. These commenters generally supported their recommendation by pointing to the State of California’s annual standard of 30 ppb and to studies where long-term ambient NO 2 concentrations have been associated with adverse respiratory effects such as impairments in lung function growth.

As discussed above (II.B.3), the evidence relating long-term NO 2 exposures to adverse health effects was judged in the ISA to be either

‘‘ suggestive but not sufficient to infer a causal relationship ’’ (respiratory morbidity) or ‘‘ inadequate to infer the presence or absence of a causal relationship ’’ (mortality, cancer, cardiovascular effects, reproductive/ developmental effects) (ISA, sections 5.3.2.4–5.3.2.6). In the case of respiratory morbidity, the ISA (section 5.3.2.4) concluded that ‘‘ The high correlation among traffic-related pollutants made it difficult to accurately estimate the independent effects in these long-term exposure studies. ’’
Given these uncertainties associated with the role of long-term NO 2 exposures in causing the reported effects, the Administrator concluded in the proposal that, consistent with the CASAC recommendation, existing evidence is not sufficient to justify setting an annual standard with either a higher or lower level than the current
standard. Commenters have not submitted any new analyses or information that would change this conclusion. Therefore, the Administrator does not agree with the
commenters who recommended a lower
level for the annual standard.

The Administrator judges that her conclusions in the proposal regarding the annual standard remain appropriate. Specifically, she continues to agree with the conclusion that, though some evidence does support the need to limit long-term exposures to NO 2 , the existing
evidence for adverse health effects following long-term NO 2 exposures does not support either increasing or decreasing the level of the annual standard. In light of this and considering the recommendation from
CASAC to retain the current level of the annual standard, the Administrator judges it appropriate to maintain the level of the annual standard at 53 ppb.

H. Summary of Final Decisions on the Primary NO 2 Standard

For the reasons discussed above, and taking into account information and assessments presented in the ISA and REA, the advice and recommendations of the CASAC, and public comments,
the Administrator has decided to revise the existing primary NO 2 standard. Specifically, the Administrator has
determined that the current annual standard by itself is not requisite to protect public health with an adequate margin of safety. In order to provideprotection for asthmatics and other atrisk populations against an array of adverse respiratory health effects related
to short-term NO 2 exposure, theAdministrator is establishing a shortterm NO 2 standard defined by the 3-year average of the 98th percentile of the yearly distribution of 1-hour daily

maximum NO 2 concentrations. She is setting the level of this standard at 100 ppb, which is to reflect the maximum
allowable NO 2 concentration anywhere in an area. In addition to setting a new 1-hour standard, the Administrator
retains the current annual standard with a level of 53 ppb. The new 1-hour standard, in combination with the annual standard, will provide protection for susceptible groups against adverse respiratory health effects associated with short-term exposures to NO 2 andeffects potentially associated with longterm exposures to NO 2

. III. Amendments to Ambient Monitoring and Reporting Requirements

The EPA is finalizing several changes to the ambient air monitoring, reporting, and network design requirements for the

NO 2 NAAQS. This section discusses the changes we are finalizing which are intended to support the proposed 1-


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21 A list of approved FRM and FEMs is maintained by EPA’s Office of Research and Development, and can be found at: http:// www.epa.gov/ttn/amtic/files/ambient/criteria/ reference-equivalent-methods-list.pdf. hour NAAQS and retention of the current annual NAAQS as discussed in
Section II. Ambient NO 2 monitoring
data are used to determine whether an
area is in violation of the NO 2 NAAQS.
Ambient NO 2 monitoring data are collected by State, local, and Tribal monitoring agencies ( ‘‘ monitoring agencies ’’ ) in accordance with the monitoring requirements contained in 40 CFR parts 50, 53, and 58.

A. Monitoring Methods

We are finalizing the proposed changes regarding the NO 2 Federal Reference Method (FRM) or Federal Equivalent Method (FEM) analyzers. Specifically, we are continuing to use
the NO 2 chemiluminescence FRM and are finalizing the requirement that any

NO 2 FRM or FEM used for making primary NAAQS decisions must be capable of providing hourly averaged concentration data. The following paragraphs provide background and
rationale for the continued use of the
chemiluminescence FRM and the decision to finalize the proposed changes.

1. Chemiluminescence FRM and
Alternative Methods

The current monitoring method in use by most State and local monitoring agencies is the gas-phase chemiluminescence FRM (40 CFR Part 50, Appendix F), which was implemented into the NO 2 monitoring network in the early 1980s. EPA did not propose to discontinue using the chemiluminescence FRM, although we received some comments from industry (Alliance of Automobile Manufacturers, Edison Electric, and the National Petrochemical and Refiners Association) raising concerns about using a method that is subject to known interferences from certain species of oxides of nitrogen known as NO Z . Important components of ambient NO Z include nitrous acid (HNO 2 ), nitric acid (HNO 3 ), and the peroxyacetyl nitrates (PANs).

The issue of concern in public
comments is that the reduction of NO 2 to NO on the MoO X converter substrate
used in chemiluminescence FRMs is not specific to NO 2 ; hence, chemiluminescence method analyzers are subject to varying interferences produced by the presence in the air sample of the NO Z species listed above and others occurring in trace amounts in
ambient air. This interference is often
termed a ‘‘ positive artifact ’’ in the reported NO 2 concentration since the presence of NO Z results in an overestimate in the reported measurement of
the actual ambient NO 2 concentration. This interference by NO Z compounds has long been known and evaluated (Fehsenfeld et al., 1987; Nunnermacker et al., 1998; Parrish and Fehsenfeld, 2000; McClenny et al., 2002; U.S. Environmental Protection Agency, 1993, 2006a). Further, as noted in the ISA (ISA Section 2.3), it appears that interference by NO Z on chemiluminescence FRMs is not more than 10 percent of the reported NO 2 concentration during most or all of the day during winter (cold temperatures), but larger interference ranging up to 70 percent can be found during summer (warm temperatures) in the afternoon at sites away and downwind from strong

emission sources.

The EPA acknowledges that the NO Z interference in the reported NO 2 concentrations collected well
downwind of NO X source areas and in relatively remote areas away from concentrated point, area, or mobile sources is significantly larger than the

NO Z interference in NO 2 measurements taken in urban cores or other areas with
fresh NO X emissions. To meet the primary objective of monitoring

maximum NO 2 concentrations in an area, the EPA is requiring NO 2 monitors to be placed in locations of the expected highest concentrations, not in relatively remote areas away from NO X sources. The required monitors resulting from the network design discussed below in Section III.B will require monitors to be placed near fresh NO X sources or in
areas of dense NO X emissions, where

NO 2 concentrations are expected to be at a maximum, and interference from NO Z species is at a minimum. Therefore, EPA believes that the positive artifact issue, although present, is small, relative to
the actual NO 2 being measured. As a
result EPA believes the
chemiluminescence FRM is suitable for
continued use in the ambient NO 2 monitoring network, as the potential positive bias from NO Z species is not significant enough to discontinue using
the chemiluminescence FRM.

EPA also received support from some industry groups ( e.g. Savannah River Nuclear Solutions, Teledyne API, and the Utility Air Regulatory Groups) and States ( e.g., MODEQ and NCDENR) to further the development of alternative methods in determining NO 2 concentrations. Such alternativemethods include the photolyticchemiluminescence method and cavity ring-down spectroscopy. As a result, EPA will continue working with commercial and industrial vendors, to identify and evaluate such new technologies. These efforts may include field testing instruments and further characterizing methods in a laboratory setting to assess their potential as future reference or equivalent methods, and their role in more directly measuring

NO 2

. 2. Allowable FRM and FEMs for Comparison to the NAAQS

The current CFR language does not prohibit the use of any particular NO 2 FRM or FEM to be used in comparison
to the standard. 21 There are designated wet chemical methods that are only able to report ambient concentration values averaged across multiple hours. With the establishment of a 1-hour NAAQS, any FRM or FEM which is a wet
chemical based method would not be appropriate for use in determining compliance of the 1-hour NAAQS because they are unable to report hourly data. EPA addressed this issue by proposing and finalizing that only those methods capable of providing 1-hour measurements will be comparable to the NAAQS.

a. Proposed Changes to FRM and FEMs That May Be Compared to the NAAQS

EPA proposed that only those FRMs or FEMs that are capable of providing hourly averaged concentration data may be used for comparison to the NAAQS.

b. Comments

EPA received comments from some State and industry groups ( e.g. Missouri, North Carolina, and Air Quality Research and Logistics) supporting the proposed approach to only allowing those FRMs or FEMs that are capable of providing hourly averaged concentration data may be used for comparison to both the annual and 1- hour NAAQS, and did not receive any public comments that objected to the proposed approach.

c. Decisions on Allowable FRM and FEMs for Comparison to the NAAQS

Accordingly, EPA is finalizing the proposed changes to 40 CFR Part 58 Appendix C to allow only data from FRM or FEMs that are capable of providing hourly data to be used for comparison to both the annual and 1- hour NAAQS.

B. Network Design

With the establishment of a 1-hour

NO 2 NAAQS intended to limit exposure to maximum concentrations that may occur anywhere in an area, EPA recognizes that the data from the current

NO 2 network is inadequate to fully assess compliance with the revised


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NAAQS. As a result, EPA is promulgating new NO 2 network design requirements. The following sections provide background, rationale, and details for the final changes to the NO 2 network design requirements.

1. Two-Tiered Network Design

A two-tiered monitoring network is appropriate for the NO 2 NAAQS because one tier (the near-road network) reflects the much higher NO 2 concentrations that occur near-road and the second-tier (area-wide) characterizes
the NO 2 concentrations that occur in a larger area such as neighborhood or urban areas. The ISA (Section 2.5.4 and 4.3.6) stated that NO 2 concentrations in heavy traffic or on freeways ‘‘ can be
twice the residential outdoor or residential/arterial road level, ’’ that

‘‘ exposure in traffic can dominate personal exposure to NO 2 , ’’ and that

‘‘ NO 2 levels are strongly associated with distance from major roads ( i.e., the closer to a major road, the higher the

NO 2 concentration). ’’ The exposure assessment presented in the REA estimated that roadway-associated exposures account for the majority of exposures to peak NO 2 concentrations (REA, Figures 8–17, 8–18). Monitoring studies suggest that NO 2 concentrations near roads can be considerably higher than those in the same area but away from the road ( e.g., by 30–100%, see section II.A.2), where pollutants typically display peak concentrations on or immediately adjacent to roads, producing a gradient in pollutant
concentrations where concentrations decrease with increasing distance from
roads. Since the intent of the revised NAAQS is to limit exposure to peak

NO 2 concentrations that occur anywhere in an area, monitors intended to
measure the maximum allowable NO 2 concentration in an area should include measurements of the peak
concentrations that occur on and near
roads due to on-road mobile sources. The first tier of the network design, which focuses monitoring near highly
trafficked roads in urban areas where peak NO 2 concentrations are likely to occur, is intended to measure maximum concentrations anywhere in an area, particularly those due to on-road mobile sources since roadway-associated exposures account for the majority of exposures to peak NO 2 concentrations.
The basis for the second tier of the network design is to measure the highest area-wide concentrations to characterize the wider area impact of a variety of NO 2 sources on urban populations. Area-wide monitoring of

NO 2 also serves to maintain continuity in collecting data to inform long-term pollutant concentration trends analysis and support ongoing health and
scientific research.

This section discusses the two-tier network design approach compared to the alternative network design which was also presented for comment in conjunction with a solicitation for comment on an alternative NAAQS. The alternative network design concept was based entirely on requiring only
monitors that would be considered areawide, while not requiring any near-roadmonitoring sites. The details of the twotier network design, including how many monitors are required, where they are to be located, and the related siting criteria are discussed in subsequent

sections.

a. Proposed Two-Tier Network Design

EPA proposed a two-tier network design composed of (1) near-road monitors which would be placed in locations of expected maximum 1-hour

NO 2 concentrations near heavily trafficked roads in urban areas and (2)
monitors located to characterize areas with the highest expected NO 2 concentrations at the neighborhood and larger spatial scales (also referred to as

‘‘ area-wide ’’ monitors). As an alternative, and in conjunction with a solicitation for comment on an alternative NAAQS,
EPA solicited comment on a network comprised of only area-wide monitors.

b. Comments

EPA received many comments on the overall two-tier network design, with
those who made statements with a relatively clear position on the issue generally falling into four categories: (1) Those who support the adoption of the proposed two-tier design approach, (2) those who support the adoption of the two-tier concept, but with modifications, (3) those who only supported the adoption of the alternative network design, and (4) those who encourage EPA to commit to
further research of the near-road environment by monitoring near-roads,
but not to use near-road data for regulatory purposes, and therefore support the alternative network design
in which EPA solicited comment on anetwork design composed only of areawide monitors.

Those commenters who generally supported the proposed two-tier network, included CASAC (while there was not a consensus, a majority were in support of the proposed network design), public health organizations ( e.g., AACPR, ACCP, AMA, ATA, and NAMDRC), several State groups ( e.g., the New York City Law Department and the Metropolitan Washington Air Quality Committee), and some industry commenters ( e.g., American Chemistry Council, The Clean Energy Group, and Dow Chemical).

Those commenters who supported the adoption of the two-tier network design concept, but suggested modifications to the actual design included some health and environmental organizations ( e.g., ALA, EDF, EJ, and the NRDC), some States ( e.g., California, the Central Pennsylvania Clean Air Board, Harris County (Texas), Iowa, New York, San Joaquin Air Pollution Control District, Spokane Regional Clean Air Agency (SRCAA), the Texas Commission on Environmental Quality, and Wisconsin), and some industry commenters, including the American Petroleum Institute and the Utility Air Regulatory Group, who are cited by other industry commenters. We believe that although these commenters made suggestions to modify the proposed two-tier network design, they are indicating that it is an acceptable approach. Their comments and suggestions are discussed in greater detail in the following sections.

Those commenters who only supported the adoption of the alternative network design included State and industry groups ( e.g., Indiana Department of Environmental Management, the New York Department of Transportation (NYSDOT), Alliance of Automobile Manufacturers, and the Engine Manufacturers Association). These commenters typically made
comments on the two-tier network design, but did not do so in a way that clearly supported near-road research.

EPA received comments from some States or State organizations ( e.g., National Association of Clean Air Agencies (NACAA), the Northeast States for Coordinated Air Use Management (NESCAUM), and 10 other individual States or State groups) and industry commenters ( e.g., Consumers Energy, Edison Electric, and the National Association of Manufacturers) that encouraged EPA to further research the near-road environment, opposing use of near-road monitoring data for regulatory purposes, and supported the adoption of the alternative network design for regulatory purposes. For example, with regard to implementing the two-tier network design that includes near-road regulatory monitoring, NACAA stated
that ‘‘ * * *a major new network— particularly one that is inherently complicated and untried—should not be
rolled out without the benefit of an effective near-road monitoring research program that can address many of the relevant data questions, and inform the specific siting requirements of the rule. ’’
The NAM stated that ‘‘ conducting such


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a near road [research] monitoring program would allow EPA to collect necessary data that can be used to better understand the health impacts
associated with short term NO 2 exposures. ’’

The EPA notes that the existing
scientific research referenced in the proposal and throughout this final rule
show that there are on- and near-road peaks of NO 2 concentrations, relative to upwind or background levels, which
exist due to on-road mobile source emissions. This research, as a body of evidence, also identifies the multiple local factors that affect how, where, and when peak NO 2 concentrations occur on or near a particular road segment. These factors include traffic volume, fleet mix, roadway design, congestion patterns, terrain, and meteorology. The EPA and States have access to such data typically through Federal, State, and/or local departments of transportation or other government organizations, and, as a result, are in a position to implement a near-roar monitoring network that is
intended to measure maximum expected NO 2 concentrations resulting
from on-road mobile source emissions. Further, EPA notes that near-road monitoring is not a new objective for the ambient air monitoring community as near-road carbon monoxide monitoring has been a part of ongoing, long-term, routine networks for nearly three decades. As a result, there is experience within EPA (both OAR and ORD) and State and local agencies on conducting ambient monitoring near-roads. In addition, EPA intends to develop guidance with input from all
stakeholders to assist with implementation of the monitoring requirements, which is discussed in
section III.B.5. EPA believes that the existing science and research provide a sufficient base of information to require a near-road monitoring network and that the collective experience that exists in the ambient monitoring community will allow for successful implementation of
that network. EPA also believes that through adherence of requirements for near-road site selection and siting
criteria discussed in sections III.B.6 and III.B.7, respectively, that the two-tier network design will provide a network that has a reasonable degree of similarity across the country where the required near-road monitors are targeting the maximum NO 2 concentrations in an area attributable to
on-road mobile sources.

Some industry commenters ( e.g., Engine Manufacturers Association, the South Carolina Chamber of Commerce,
and the South Carolina Manufacturers Alliance) who supported the adoption of the alternative network designsuggested that monitoring in the nearroad environment would not be indicative of exposure for general populations, and that EPA should not
focus on the near-road environment when requiring monitoring. For example, the South Carolina Chamber of
Commerce and the South Carolina
Manufacturers Alliance both state that

‘‘ it appears the proposed monitoring
network will result in a collection of microscale data, which is not at all representative of air quality relevant to population exposure. ’’

The EPA notes that the intent of a near-road monitoring is to support the revised NAAQS by assessing peak NO 2 concentrations that may occur anywhere in an area. EPA recognizes that there is variability in the properties (such as traffic counts, fleet mix, and localized features) among the road segments that may exist in an area, but on the whole, roads are ubiquitous, particularly in urban environments. Consequently, a substantial fraction of the population is potentially exposed to relatively higher
concentrations of NO 2 that can occur in
the near-road environment. The 2007 American Housing Survey ( http:// www.census.gov/hhes/www/housing/
ahs/ahs07/ahs07.html ) estimates that over 20 million housing units are within 300 feet (91 meters) of a 4-lane highway, airport, or railroad. Using the same survey, and considering that the average number of residential occupants in a housing unit is approximately 2.25, it is
estimated that at least 45 million
American citizens live near 4-lane highways, airports, or railroads. Although that survey includes airports and railroads, roads are the most pervasive of the three, indicating that a significant amount of the general population live near roads. Furthermore, the 2008 American Time Use Survey ( http://www.bls.gov/tus/ ) reported that the average U.S. civilian spent over 70 minutes traveling per day. Accordingly, EPA concludes that monitors near major roads will address a component of exposure for a significant portion of the general population that would otherwise not be
addressed.

The majority of State commenters, regardless of their position on the proposed network design, along with some industry commenters, observed that there was a need for funding the monitoring network. These comments urged EPA to provide the resources needed to implement and operate the required monitoring network. EPA notes that it has historically funded part of the cost of the installation and operation of monitors used to satisfy Federal monitoring requirements. EPA understands these concerns, although the CAA requirements from which this final rule derives (CAA sections 110, 310(a) and 319) are not contingent on EPA providing funding to States to assist in meeting monitoring requirements. However, EPA intends to
work with NACAA and the State and local air agencies in identifying
available State and Tribal Air Grant (STAG) funds and consider the increased resource needs that may be needed to plan, implement, and operate
this revised set of minimum requirements.

c. Conclusions Regarding the Two-Tier Network Design

The EPA believes that requiring nearroad monitors in urban areas as part of the network design are necessary to protect against risks associated with exposures to peak concentrations of NO 2 anywhere in an area. The combination
of increased mobile source emissions and increased urban population
densities can lead to increased exposures and associated risks, therefore urban areas are the appropriate areas to concentrate required near-road monitoring efforts. The EPA also recognizes the need to have monitors in neighborhood and larger spatial scale locations away from roads that represent area-wide concentrations. These types of monitors serve multiple important monitoring objectives including comparison to the NAAQS, photochemical pollutant assessment, ozone forecasting, characterization of point and area source impacts, and by providing historical trends data for current and future epidemiological health research. In some situations, when coupled with data from near-road monitors, area-wide monitors may also assist in the determination of spatial
variation of NO 2 concentrations across a given area and provide insight to the gradients that exist between near-road or stationary source oriented
concentrations and area-wide
concentration levels.

After considering the scientific data and the public comments regarding the proposed network design, the
Administrator concludes that a two-tiernetwork design composed of (1) nearroad monitors which would be placed in locations of expected maximum 1-
hour NO 2 concentrations near heavily trafficked roads in urban areas and (2)
monitors located to characterize areas with the maximum expected NO 2 concentrations at the neighborhood and larger spatial scales (also referred to as

‘‘ area-wide ’’ monitors) are needed to implement the 1-hour NO 2 NAAQS and


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22 Of the 24 additional sites, 22 are estimated to be triggered due to a population of 2,500,000 while 2 (Las Vegas, NV and Sacramento, CA) are estimated to be triggered by the presence of one or more road segments with 250,000 AADT since they do not have a population of 2,500,000 people. 23 AASHTO, NESCAUM, and NYDOT did not support the two-tier network design; however they provided suggestions on how the network design might be modified if the EPA were to finalize requirements for near-road monitors. In the case of AASHTO and NYDOT, their suggestions were made with the suggestion that EPA use a separate rulemaking process to require monitors. support the annual NAAQS. The details of this two-tier network design are discussed in the following eight

sections.

2. First Tier (Near-Road Monitoring Component) of the NO 2 Network Design

This section provides background, rationale, and details for the final changes to the first tier of the two-tier

NO 2 network design. In particular, this
section will focus on the thresholds thattrigger monitoring requirements. Nearroad site selection and siting criteria details will be discussed in subsequent

sections.

a. Proposed First Tier (Near-Road Monitoring Component) of the Network Design

EPA proposed that the first tier of the

two-tier NO 2 monitoring network design focus monitors in locations of expected
maximum 1-hour concentrations near major roads in urban areas. As noted in the previous section, the exposure assessment presented in the REA estimated that roadway-associated exposures account for the majority of exposures to peak NO 2 concentrations (REA, Figures 8–17, 8–18). Since the
combination of increased mobile source
emissions and increased urban population densities leads to increased exposures and associated risks, the Administrator judges that urban areas are the appropriate areas in which to concentrate required near-road monitoring efforts. Therefore, weproposed that a minimum of one nearroad NO 2 monitor be required in Core Based Statistical Areas (CBSAs) with a population greater than or equal to 350,000 persons. Based on 2008 Census Bureau statistics, EPA estimated this would result in approximately 143 monitoring sites in as many CBSAs.

We also proposed that a second nearroad monitor be required in CBSAs with a population greater than or equal to 2,500,000 persons, or in any CBSAs with one or more road segments with an Annual Average Daily Traffic (AADT) count greater than or equal to 250,000.
Based on 2008 Census Bureau statistics and data from the 2007 Highway Performance Monitoring System (HPMS) maintained by the U.S. Department of Transportation (DOT) Federal Highway Administration (FHWA), this particular element of the minimum monitoring requirements would have added approximately 24 22 sites to the approximate 143 near-road sites in CBSAs that already would have had one near-road monitor required due to the 350,000 population threshold. Overall, the first tier of the proposed network design was estimated to require
167 near-road sites in 143 CBSAs.

b. Comments

The EPA received comments from some industry and public health organizations ( e.g. Dow Chemical, ATS, and the AMA) supporting the proposed approach to use population thresholds for triggering minimum near-road monitoring requirements. For example, Dow Chemical Company stated that

‘‘ Dow comments that the proposed population thresholds are reasonable for implementation of the new network design and that we don’t see a need to establish a threshold lower than 350,000 people for the lower bound. ’’

The EPA received comments from some States and State groups suggesting that a combination of population and AADT counts or just AADT counts should be used to trigger minimum near-road monitoring requirements. For example, the San Joaquin Air Pollution Control District in California suggested that we modify minimum monitoring requirements so that one near-road NO 2 monitor is required for any CBSA with a population of 350,000 people which also had one or more road segments with AADT counts of 125,000 or more. In another example, Harris County
Public Health and Environmental Services (HCPHES) suggested that

‘‘ * * * rather than specifying population limits for the monitoring, HCPHES supports a metric like the Annual Average Daily Traffic (AADT) as a threshold for requiring a near-road
monitor. An initial focus on an AADT in excess of 250,000 is acceptable as a starting point but EPA should revisit that level and consider lowering it to 100,000 in five years. ’’ AASHTO 23 and

NYDOT 23 suggested that EPA could set a threshold at 140,000 AADT for requiring near-road monitors rather than using population thresholds.

EPA is finalizing the population-only threshold approach to trigger near-road monitoring, as the first step in the process of establishing the first-tier of near-road monitors, and for identifying the appropriate number and locations for siting these monitors. EPA believes that the uncertainty in defining specific national AADT counts is too great to support use in this first step of the alternative approaches suggested by the commenters. EPA notes that, in general, roads with higher AADT counts have relatively higher amounts of mobile source emissions, leading to an increased potential for relatively higher
on-road and roadside NO 2 concentrations. This concept is supported, for example, by Gilbert et al., 2007, who state that the NO 2 concentrations analyzed in their study are significantly associated with traffic counts. In part, these suggestions by
commenters to include AADT counts as part of, or independently as, a threshold for requiring monitors appears to be aimed at increasing the focus of the
near-road network to locations where

NO 2 concentrations are expected to be highest. However these suggestions would also, in effect, reduce the size of the required network compared to the network that EPA had proposed. The differences in fleet mix, roadway design, congestion patterns, terrain, and local meteorology amongst road segments that may have identical AADTs are quite
variable and affect the NO 2 concentrations on and near those segments. The available data and related technical and scientific quantification of what particular AADT count might be expected to contribute to some specific

NO 2 concentration is insufficient to establish a specific, nationally applicable AADT count threshold thatcould be used as part of a populationAADT combination, or a distinct AADT count, to require all near-road monitors. Therefore, EPA chose not to utilize a population-AADT or an AADT-only threshold to trigger all minimally required near-road monitoring because of the lack of a quantitative, nationally applicable relationship between a
certain AADT threshold and an expected NO 2 concentration. Instead, EPA is finalizing the proposed population-only threshold approach to trigger a minimum of one monitor in a CBSA. In larger CBSAs, EPA does require, at a minimum, a second
monitor based on either an AADT count of 250,000 or a population threshold of 2,500,00 or more persons in a CBSA as described more fully below. EPAbelieves this approach for siting nearroad monitoring provides a greater degree of certainty in covering a large segment of the total population (66%, which is explained below) and will provide data on exposure from geographically and spatially diverse areas where a larger number of people


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are likely to be exposed to peak NO 2 concentrations.

Some commenters ( e.g., AASHTO, 23 NESCAUM, 23 NYDEC, NYDOT 23 ) suggested focusing multiple near-road monitors only in relatively larger CBSAs than those which were proposed. For example, NYDEC suggested that EPA require, at minimum, two near-road monitors in any CBSA of 2,500,000 people or more, but not in CBSAs below that population threshold. In their comments, they point out the variety of
near-road environments that exist in the larger CBSAs such as New York City.

EPA notes that the larger CBSAs, such as those with a population of 2,500,000 or more persons, are more likely to have a greater number of major roads across a potentially larger geographic area, and a corresponding increase in potential for exposure in different settings (evidenced in the U.S. Department of Transportation (U.S. DOT) Federal Highway Administration (FHWA)

‘‘ Status of the Nation’s Highways, Bridges, and Transit: 2006 Conditions
and Performance ’’ document which is discussed below). This is the primary reasoning behind the requirement for
two monitors in CBSAs with more than 2,500,000 people. EPA also believes that having multiple monitors in the largest CBSAs will allow better understanding of the differences that may exist
between roads in the same CBSA due to fleet mix, congestion patterns, terrain, or geographic locations. However, EPA
believes that a network with substantially fewer monitors in correspondingly fewer CBSAs, as the commenters suggested, would lead to an insufficient monitoring network lacking a balanced approach needed for a regulatory network intended to support the revised NAAQS on a national basis.

On a related note to those comments that suggested focusing more near-road monitors only in the larger CBSAs, EPA proposed that any CBSAs with one or more road segments with an Annual Average Daily Traffic (AADT) count greater than or equal to 250,000 must have a second monitor if they do not already have two near-road monitors because of the population threshold. Such an AADT-triggered monitor would account for situations where a relatively less populated area has a very highly trafficked road. In this case, EPA notes that because those road segments with 250,000 AADT have been identified by U.S. DOT FHWA ( http:// www.fhwa.dot.gov/policyinformation/ tables/02.cfm ) as being the top 0.03 percent of the most traveled public road segments, that they are the most heavily trafficked roads in the country. Again noting that NO 2 concentrations are significantly associated with traffic counts (Gilbert et al. 2007), these roads segments likely have the greatest potential for high exposures directly
connected to motor vehicle emissions in the entire country. Typically, these very highly trafficked roads are in the largest populated CBSAs, such as those with 2,500,000 people or more, and are somewhat atypical for CBSAs with less than 2,500,000 people. As a result, EPA believes it is appropriate to require a
second monitor in a CBSA that has one or more road segments with 250,000 AADT counts or more if they do not already have two near-road monitors required due their population.

EPA received comments requesting that EPA explain the rationale for the selection of the population thresholds that trigger minimum monitoring requirements and also to reconsider the size of the network. For example, NYDOT suggested that this final rule explain the basis for the 350,000 and 2,500,000 population thresholds that
will establish near-road monitors. In another comment, the Clean Air Council (CAC) questioned the selected population thresholds, noting that they believe that the population thresholds that were proposed were too high. Specifically, CAC stated that ‘‘ at 350,000 persons, numerous metro areas in the
mid-Atlantic and Northeastern States with urban cores and highways running through will likely be exempted from
the new monitors. ’’ The Spokane Regional Clean Air Agency stated that they ‘‘ do not believe it is necessary to require air quality monitoring for NO 2 near major roadways in every metropolitan area. It is our [SRCAA’s]
view that EPA could establish a statistically significant number of air quality monitoring stations near roadways and develop a correlation between traffic density and ambient

NO 2 levels. ’’ Further, the EPA received many State comments suggesting
reductions to the overall size of the near-road network; however the commenters did not provide very specific suggestions on how EPA should accomplish that reduction in size. For example, the Regional Air Pollution Control Agency, which represents a portion of Ohio, stated ‘‘ given the fairly
standard fleet of vehicles on the nation’s major highways, we urge EPA to consider the need for 142 near-roadway monitors. Perhaps a limited number of monitors across the country wouldsuffice to sufficiently characterize nearroadway NO 2 levels. ’’ These State commenters provided various reasons which are discussed throughout this document suggesting that the network be reduced in size, including funding concerns (section III.B.1.b), the perceived need to implement a smaller
near-road research network in lieu of a regulatory network (section III.B.1.b), safety issues (section III.B.7.b), and problems with State implementation plans (section VI. D) and designation issues (section V).

EPA notes that the intent of the first tier of the network design is to support the revised NAAQS in measuring peak

NO 2 exposures in an area by including
a minimum number of monitors resulting in a sufficiently sized national near-road monitoring network that will provide data from a geographically and spatially diverse array of areas, in terms of population, potential fleet mixes, geographic extent, and geographic setting, from across the country. The U.S. Department of Transportation (U.S. DOT) Federal Highway Administration (FHWA) ‘‘ Status of the Nation’s Highways, Bridges, and Transit: 2006
Conditions and Performance ’’ document ( http://www.fhwa.dot.gov/policy/ 2006cpr/es02h.htm ) states that ‘‘ while urban mileage constitutes only 24.9 percent of total (U.S.) mileage, these roads carried 64.1 percent of the 3 trillion vehicles miles (VMT) travelled
in the United States in 2004. ’’ The
document also states that ‘‘ urban interstate highways made up only 0.4 percent of total (U.S.) mileage but carried 15.5 percent of total VMT. ’’
These statements indicate how much
more traffic volume exists on roads in
urban areas versus the more rural areas that have significant amounts mileage of the total public road inventory. The basis for the selection of the proposed CBSA population level of 350,000 to trigger the requirement of one near-road monitor was chosen in an attempt to provide near-road monitoring data from a diverse array of areas, as noted above. However, in response to the significant number of comments discussed above, which in various ways encouraged at
least a reduction of the size of the required near-road network or the implementation of a relatively smaller research network, EPA reconsidered the population threshold that will require
one near-road NO 2 monitor in a CBSA.

EPA reviewed the data, such as population, geographic, and spatial distribution, associated with particular
CBSA areas that would and would not be included in particular CBSA population thresholds. According to the

2008 U.S. Census Bureau estimates ( http://www.census.gov ) there are 143 CBSAs with 350,000 or more persons (including territories) which contain approximately 71% of the total population (excluding territories). These


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CBSAs collectively represent territory in 44 States, the District of Columbia, and Puerto Rico. For comparison, there are 391 CBSAs with 100,000 or more persons, which contain approximately 86% of the total population (excluding territories). These particular CBSAs collectively represent territory in 49 States, the District of Columbia, and Puerto Rico. Further, there are 102 CBSAs with 500,000 or more persons, which contain approximately 66% of the total population (excluding territories). These 102 CBSAs collectively represent territory in 43 States, the District of Columbia, and Puerto Rico. Finally, there are 22 CBSAs with 2,500,000 or more persons, which contain approximately 39% of the total population, collectively representing territory in 19 States, the District of Columbia, and Puerto Rico. In comparison to the CBSA population threshold of 350,000, the 500,000 population threshold has 41 less CBSAs. However, the percentage of the total U.S. population residing in these two sets of CBSAs differs by only approximately 5 percent of the total population ( e.g., 71% in CBSAs of 350,000 or more versus 66% in CBSAs of 500,000 or more persons). Also, when comparing the number of States that have some amount of their territory included in these CBSAs, the difference
between the two sets of CBSAs differs by only 1 State (Alaska).

Further, EPA notes that the REA Air Quality Analysis, (REA, section 7.3.2)
estimated the exceedences of health
benchmark levels across the United States, including explicit consideration of on- or near- roadway exceedances in
17 urban areas associated with CBSA populations ranging from approximately 19,000,000 to 540,000. The analysis
indicated that all 17 of the areas under explicit consideration were estimated to experience NO 2 concentrations on or
near roads that exceeded health
benchmark levels.

c. Conclusions Regarding the First Tier (Near-Road Monitoring Component) of the Network Design

After consideration of public comments, and in light of the information discussed above, the
Administrator has chosen to finalize the CBSA population threshold for requiring a minimum of one near-road monitor in CBSAs with a population of 500,000 or more persons. The Administrator is finalizing the other thresholds that will trigger a second near-road monitor as proposed. Accordingly, one near-road NO 2 monitor is required in CBSAs with a population greater than or equal to 500,000 persons and a second near-road monitor is required in CBSAs with a population greater than or equal to 2,500,000 persons, or in any CBSAs with one or more road segments with an Annual Average Daily Traffic (AADT) count greater than or equal to 250,000.

The Administrator has concluded that using a population threshold of 500,000 to require a minimum of one near-road monitor in a CBSA provides a sufficiently sized, national network of near-road monitors that will provide data from a geographically and spatially diverse set of CBSAs that supports the intent of the revised NAAQS and continues to meet the monitoring objectives of the network. Combined with the forty additional monitors that the Regional Administrators are required to site, discussed below, the monitoring network would cover an additional percentage of the total population.

EPA believes that selecting a lower population threshold, such as 100,000 or, to a lesser degree, 350,000, as discussed in the above examples, would create a much larger network of required near-road monitors but would provide diminished population coverage per monitor, compared to that provided by the 500,000 threshold. EPA notes that if a particular area, such as one with a population less than 500,000 people, might warrant a near-road monitor, the Regional Administrator has the authority to require additional monitors. The Regional Administrators’ authority is discussed in section III.B.4. Further, States have the right to conduct additional monitoring above the minimum requirements on their own
initiative. In the Administrator’s judgment, selecting a higher threshold, such as 2,500,000, as was suggested by some commenters, does not provide a sufficient geographical and spatially diverse near-road network, compared to that provided by the 500,000 threshold. The selection of the 2,500,000 population threshold to trigger a second near-road monitor, as noted earlier in this section, is based on the fact that the larger urban areas in the country are likely to have a greater number of major roads across a potentially larger geographic area, and have a corresponding increase in potential for population exposure to elevated levels in different settings.

Changing the CBSA population threshold 350,000 to 500,000 results in a near-road monitoring network requiring approximately 126 monitors
distributed within 102 CBSAs. Compared to the total number of required near-road monitors that would have resulted from the proposed CBSA population threshold of 350,000 (167 monitors), an estimated 41 fewer monitors are required. EPA has also recognized that susceptible and vulnerable populations, which include asthmatics and disproportionately exposed groups, (as discussed in sections II.B.4 and II.F.4.d) are at particular risk of NO 2 -related health
effects. The Administrator is therefore requiring the Regional Administrators, working in collaboration with States, to site forty monitors in appropriate locations, focusing primarily on protecting such susceptible and
vulnerable communities. This decision
is discussed in detail in section III.B.4.

3. Second Tier (Area-Wide Monitoring Component) of the Network Design

The following paragraphs provide background, rationale, and details for the final changes to the second tier of
the two-tier NO 2 network design. In particular, this section will focus on the threshold that triggers area-wide monitoring requirements. Area-wide site selection and siting criteria details will be discussed in a subsequent section.

a. Proposed Second Tier (Area-Wide Monitoring Component) of the Network Design

As the second tier of the proposed two-tier network design, EPA proposed to require monitors to characterize the expected maximum NO 2 concentrationsat the neighborhood and larger (areawide) spatial scales in an area. This component of the two-tier networkdesign provides information on areawide exposures that may occur due to an individual or a group of point, area, on-road, and/or non-road sources. Further, area-wide sites serve multiple monitoring objectives aside from NAAQS comparison to both the 1-hour and the annual NAAQS, including photochemical pollutant assessment, aiding in ozone forecasting, aiding in particulate matter precursor analysis and particulate matter forecasting. We proposed to require one area-wide monitoring site in each CBSA with a population greater than or equal to1,000,000. We proposed that these areawide sites were to be sited to represent an area of highest concentration at the neighborhood or larger spatial scales. Based on 2008 Census Bureau statistics, there are 52 CBSAs with 1,000,000 people or more, which would result in
an estimated 52 area-wide monitors in as many CBSAs being minimally required. EPA also proposed to allow any current photochemical assessment monitoring station (PAMS) sites that are sited where the highest NO 2 concentrations occur in an urban area


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and represent a neighborhood or urban scale to satisfy the area-wide monitoring requirement.

b. Comments

Most commenters who commented on area-wide monitoring supported the adoption of the alternative area-wide network design and did not specifically comment on the area-wide monitoring component of the proposed two-tier network design. However, EPA did receive comments from public health organizations on area-wide monitoring in the context of the proposed network design. The public health group commenters, including the ALA, EJ, EDF, and the NRDC, stated they ‘‘ oppose the proposed requirement to retain only
52 air monitors to measure area-wide
concentrations of NO 2

. ’’

EPA understands the perceived concern to be that with this provision, EPA is actively reducing the number of required area-wide monitors. Prior to this rulemaking, the Ambient Air Monitoring Regulations, 71 FR 61236 (Oct. 17, 2006) (2006 monitoring rule) removed minimum monitoring requirements for NO 2 , and the rationale for that action is explained in that rule; however, the 2006 Monitoring rule has had a limited impact to date, evidenced by the fact that the size of the NO 2 network has remained relatively steady at around 400 monitors, a majority of which are area-wide monitors, that were operating in 2008 (Watkins and Thompson, 2008). The stability of the

NO 2 network is due in large part to the
fact that area-wide monitors serve multiple monitoring objectives, including photochemical pollutant assessment, pollutant forecasting, and in some cases, support to ongoing health research. However, considering the objective of this two-tier network design, particularly the first tier, of supporting the revised NAAQS to protect against peak NO 2 exposures, some shrinkage in the area-wide network is appropriate and likely. EPA
believes that the actual number of areawide monitors that will operate in the

NO 2 network will be greater than the minimally required 52 sites, but likely
less than the current number. States and Regional Administrators will work together on which area-wide sites may
warrant retention above the minimumrequired if States request existing areawide sites to be shut down or relocated.

c. Conclusions on the Second Tier (Area-Wide Monitoring Component) of the Network Design

Area-wide monitoring sites serve multiple monitoring objectives aside from NAAQS comparison to both the 1- hour and the annual NAAQS, including photochemical pollutant assessment, ozone forecasting, particulate matter precursor analysis and particulate matter forecasting. EPA recognizes that a significant portion of the existing NO 2 monitoring network can be
characterized as area-wide monitors and that these monitoring sites serve multiple monitoring objectives, as noted
above. In order to ensure that a
minimum number of area-wide monitors continue operating into the future, we are finalizing the proposed minimum monitoring requirements forarea-wide monitors, where one areawide monitor is required in any CBSA with 1,000,000 people or more. Since
there were no adverse comments received with regard to allowing PAMS stations that meet siting criteria to satisfy minimum monitoring requirements for area-wide monitors, we are finalizing that allowance as proposed. EPA encourages States to use the upcoming 2010 network assessment process to review existing area-wide

NO 2 sites to help determine what monitors might meet minimum monitoring requirements and whether or not other existing monitors warrant continued operation.

4. Regional Administrator Authority

The following paragraphs provide background, rationale, and details for the final changes to Regional Administrator authority to use discretion in requiring additional NO 2 monitors beyond the minimum network requirements. The proposed ruleestimated that approximately 167 nearroad monitors would be required within CBSAs having populations of 350,000 or more persons. As discussed above in section III.B.2, in response to public comments, particularly from States, EPA is changing the population threshold for siting a minimum of one near-road NO 2 monitor from CBSAs with 350,000 or more persons to CBSAs with 500,000 or more persons. EPA estimates that this change in the population threshold will
result in a reduction in the number of minimally required near-road NO 2 monitors by approximately forty monitors. EPA has also recognized that susceptible and vulnerable populations,
which include asthmatics and disproportionately exposed groups (as discussed in sections II.B.4 and II.F.4.d) are at particular risk of NO 2 -related
health effects. The Administrator is therefore requiring the Regional Administrators, working in collaboration with States, to site these forty monitors in appropriate locations, focusing primarily on protecting susceptible and vulnerable communities. In addition, the Regional Administrators, working with States, may take into account other considerations described below in using their discretion to require additional

monitors.

a. Proposed Regional Administrator Authority

EPA proposed that Regional Administrators have the authority to require monitoring at their discretion in particular instances. First, EPA proposed that the Regional Administrator have discretion to require monitoring above the minimum requirements as necessary to address situations where the required near-road monitors do not represent a location or locations where the expected maximum hourly NO 2 concentrations exist in a CBSA. Second, EPA proposed to allow Regional Administrators the discretion to require additional near-road monitoring sites to address
circumstances where minimum monitoring requirements are not sufficient to meet monitoring objectives, such as where exposures to NO 2 concentrations vary across an area because of varied fleet mixes, congestion patterns, terrain, or geographic areas within a CBSA. And third, EPA proposed that Regional
Administrators have the discretion to require additional area-wide NO 2 monitoring sites above the minimum requirements for area-wide monitors where the minimum requirements are not sufficient to meet monitoring objectives.

b. Comments

EPA received comments from the Center on Race, Poverty and Environment expressing concern that the proposed monitoring provisions fail
to consider ‘‘ disproportionately impacted communities ’’ which include people of color and of lower
socioeconomic status. The commenter argues that this is ‘‘ a gaping hole ’’ in the proposed monitoring system and disproportionately impacts minority and low income populations in rural communities. In addition, the National
Tribal Air Association stated that

‘‘ Indian Tribes and Alaska Natives are highly susceptible to health impacts as
a result of NO 2 exposure ’’ and ‘‘ the prevalence and severity of asthma is higher among certain ethnic or racial groups such as Indian Tribes and Alaska Natives, ’’ which is also discussed in section II.B.4 and the ISA (ISA, section 4.4).

The proposed rule provided the Regional Administrators with the authority to use their discretion and


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consider certain factors to require
monitors above the minimum number in a CBSA. The proposal described one example where a Regional Administrator might require an
additional near-road monitor where ‘‘ a particular community or neighborhood is significantly or uniquely affected by
road emissions. ’’ EPA recognizes that susceptible and vulnerable populations,
which include asthmatics and disproportionately exposed groups, as noted in section II.F.4.d, are at particular risk of NO 2 -related health effects, both because of increased exposure and because these groups have a higher prevalence of asthma and higher hospitalization rates for asthma. As noted above, in conjunction with raising the threshold for requiring one
near-road NO 2 monitor in CBSAs with 500,000 persons or more, EPA is requiring the Regional Administrators, under their discretionary authority, to
work with States to site an additional forty monitors, nationally, focusing primarily on communities where susceptible and vulnerable populations
are located. To address the risks of increased exposure to these populations, the Administrator has determined that it is appropriate and necessary, under this provision, to ensure these additional forty monitors are sited primarily in communities where susceptible and vulnerable populations are exposed to NO 2 concentrations that have the potential to exceed the NAAQS (due to emissions from motor vehicles, point sources, or area sources). As a result of this action, the total number of monitors required through this rulemaking is generally equivalent to the proposed number of minimally required monitors.

EPA received comments from public health groups ( e.g., ALA, Center on Race, Poverty, and the Environment, EDF, EJ, NRDC) and the Swinomish Tribe, who suggested that EPA expand monitoring coverage to address impacts from stationary sources outside of urban areas. For example, ALA, EDF, EJ, and NRDC, stated that ‘‘ EPA should require
States and local offices to review inventory data to identify any potential

NO 2 hotspots outside of those large metropolitan areas. For instance, if a large power plant or any other source is creating elevated NO 2 levels in proximity to homes, schools or other sensitive sites, in an area of less than one million people, EPA should consider requiring a monitor. ’’

EPA recognizes that there are major

NO 2 sources outside of CBSAs that have the potential to contribute to NO 2 concentrations approaching or exceeding the NAAQS. The issue is whether such monitoring should be addressed through a more extensive set of minimum requirements that might include monitoring near all large stationary sources such as airports, seaports, and power plants, which could lead to deploying a large number of
monitors. EPA believes that a more reasonable approach to address monitoring needs related to the diverse set of point, area, and non-road mobile

NO 2 sources, whether inside or outside of CBSAs, is to provide Regional Administrators the authority to require additional monitoring in areas where these impacts could occur. While the proposal did not specifically state that Regional Administrators could require
non-area-wide monitors outside of CBSAs, EPA believes that it is important that Regional Administrators have the authority to require NO 2 monitoring in
locations where NO 2 concentrations may be approaching or exceeding the NAAQS, whether located inside or outside of CBSAs. Therefore, in the final rule, EPA is not limiting the Regional Administrators’ discretionary authority to require NO 2 monitoring only inside CBSAs; instead, the EPA is providing Regional Administrators the authority to
site monitors in locations where NO 2 concentrations may be approaching or exceeding the NAAQS, both inside or
outside of CBSAs.

The EPA also received comments from some State groups ( e.g. the New York Department of Environmental Conservation (NYSDEC), New York Department of Transportation (NYSDOT), and the New York City Law Department) and an industry group (the Council of Industrial Boiler Operators) requesting greater clarification on the way in which Regional Administrators may use their authority to require
additional monitors above the minimum requirements. For example, the Council of Industrial Boiler Operators stated that

‘‘ this [Regional Administrator authority] unreasonably vests an unbounded
amount of discretion in EPA to
determine when ‘‘ minimum monitoring requirements are not sufficient ’’ and which neighborhoods are ‘‘ uniquely affected, ’’ and impose additional monitoring requirements where all applicable monitoring requirements are already met by the State and local

agency. ’’

The authority of Regional Administrators to require additional monitoring above the minimum required is not unique to NO 2 . For example, Regional Administrators have or are proposed to have the authority to use their discretion to require additional Pb monitors (40 CFR Part 58 Appendix D section 4.5), and have the discretion to work with States or local agencies in designing and/or maintaining an appropriate ozone network, per 40 CFR Part 58 Appendix D section 4.1. EPA
believes that while the NO 2 monitoring network is sufficiently sized and focused, a nationally applicable network design may not account for all locations in which potentially high concentrations approaching or exceeding the NAAQS exist. Therefore, EPA believes it is important for Regional Administrators to have the ability to address possible gaps in the minimally required monitoring network, by granting them authority to require monitoring above the minimum requirements.

One case in which the Regional Administrator may exercise discretion in requiring a monitor might be a location or community affected by a stationary source where the required
near-road NO 2 monitor site is not the location of the maximum hourly concentration in a CBSA. For any given CBSA, there is the possibility that the

maximum NO 2 concentrations could be attributed to impacts from one, or a combination of, multiple sources that could include point, area, and non-road
source emissions in addition to on-road mobile source emissions. As a result, the Regional Administrator may choose to require monitoring in such a location. In addition, there is the possibility that a single source or group of sources exists which may contribute to concentrations approaching or exceeding the NAAQS at locations inside or outside CBSAs, including rural communities. In such cases, Regional Administrators, working with States, may require a monitor in these locations. Further, if there are NO 2 sources responsible for producing more widespread impacts on a community or relatively larger area, RegionalAdministrators may require an areawide monitor to assess wider population exposures, or to supportother monitor objectives served by areawide monitors such as photochemical pollutant assessment or pollutant forecasting.

Regional Administrators may also require additional monitoring where a State or local agency is fulfilling its minimum monitoring requirements with an appropriate number of near-road monitors, but an additional location is identified where near-road population exposure exists at concentrations approaching or exceeding the NAAQS. In this case, the exposure may be due to differences in fleet mix, congestion patterns, terrain, or geographic area, relative to any minimally required monitoring site(s) in that area. We note


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that such areas might exist in CBSAs with populations less than 500,000

persons.

EPA recognizes that high
concentrations of NO 2 that approach or exceed the NAAQS could potentially occur in a variety of locations in an area, and we believe that Regional
Administrators should have the discretion to require additional monitoring when a location is identified
based on the factors discussed in the paragraph above. In such situations, State or EPA Regional staff is likely to have identified these locations through data analysis, such as the evaluation of existing ambient data and/or emissions data, or through air quality modeling. Such information may indicate that an
area has NO 2 concentrations that may approach or exceed the NAAQS, and that there is potential for population exposure to those high concentrations.

The Regional Administrator would use this authority in collaboration with State agencies. We expect Regional
Administrators to work with State and local agencies to design and/or maintain the most appropriate NO 2 network to meet the needs of a given area. For all the situations where a Regional Administrator may require additional monitoring, including the forty additional monitors the Regional Administrators are required to site, EPA expects Regional Administrators to work on a case-by-case basis with States. Further, for the forty additional monitors that will focus primarily on protecting susceptible and vulnerable communities, EPA intends to work with States to develop criteria to guide site
selection for those monitors.

c. Conclusions on Regional Administrator Authority

EPA is requiring Regional
Administrators to work with States to site forty NO 2 monitors, above theminimum number required in the twotier network design, focused primarily in susceptible and vulnerable communities exposed to NO 2 concentrations that have the potential to approach or exceed NAAQS. In addition, recognizing that a nationally applicable monitoring network design
will not include all sites with potentially high concentrations due to variations across locations, and in response to public comments, the Administrator is providing Regional
Administrators with the discretion to require additional monitors above the minimum requirements.

Regional Administrators may also use their discretionary authority to require monitoring above the minimum requirements as necessary to address situations inside or outside of CBSAs in which (1) The required near-road monitors do not represent all locations of expected maximum hourly NO 2 concentrations in an area and NO 2 concentrations may be approaching or exceeding the NAAQS in that area; (2) areas that are not required to have a
monitor in accordance with the monitoring requirements and NO 2 concentrations may be approaching or exceeding the NAAQS; or (3) the minimum monitoring requirements for
area-wide monitors are not sufficient to meet monitoring objectives. In all cases in which a Regional Administrator may
consider the need for additional monitoring, EPA expects that Regional
Administrators will work with the State or local agencies to evaluate evidence that suggests an area may warrant additional monitoring. EPA also notes that if additional monitoring should be required, as negotiated between the Regional Administrator and the State, the State will modify the information in its Annual Monitoring Network Plan to include any potential new sites prior to approval by the EPA Regional
Administrator.

5. Monitoring Network Implementation

The following paragraphs provide background, rationale, and details for the final changes to the approach for the monitoring network implementation.

a. Proposed Monitoring Network Implementation Approach

EPA proposed that State and, when appropriate, local air monitoring agencies provide a plan for deploying
monitors in accordance with the proposed network design by July 1, 2011. EPA also proposed that the proposed NO 2 network be physically established no later than January 1,

2013.

b. Comments

Most environmental and public health group commenters suggested that EPA change the implementation date from the proposed January 1, 2013 to a date that would require the minimum required NO 2 network to be deployed sooner than proposed. Most States and State group commenters, along with industry group commenters, recommended that EPA keep the network implementation date as January 1, 2013, or move it later than proposed. Those commenters who suggested moving it later noted that issues with monitoring site identification, site development, and overall lack of experience working in the near-road
environment would make implementation difficult under the proposed implementation deadline.

EPA recognizes the challenges involved with deploying the two-tier network design by the January 1, 2013 date. We recognize the need for additional information and plan to aid State agencies in the network implementation process, particularly by developing guidance in partnership with affected stakeholders, ideally including at a minimum NACAA and the States. EPA agrees with NACAA’s suggestion that the CASAC Ambient Air Monitoring and Methods subcommittee should be consulted as part of developing any guidance developed for near-road monitoring, and has already begun the process by scheduling meetings with them regarding near-road monitoring. Further, EPA believes that
collaboration with the States and State groups in developing guidance will be highly beneficial to the implementation process. This would allow for those States that do have increased experience in near-road monitoring to support the guidance development process and provide a conduit for sharing experiences amongst all stakeholders.

In perspective, EPA believes that the approximate 2 years and 11 months between promulgation of this rulemaking and the mandated January 1, 2013 network implementation date
includes extra time relative to what is traditionally allowed for network implementation following rulemakings. We are also cognizant of the time needed to collect complete data that
would allow data from the two-tier
network to be considered for designations and for use in the next NO 2 NAAQS review data from the 2013, 2014, and 2015 years would provide critical information in the next NAAQS review, intended to occur on a 5-year cycle, and for use in subsequent designations. Even with complete data from 2013, 2014, and 2015 years designations would not occur until 2017, at the earliest.

c. Conclusions on Monitoring Network Implementation

EPA is finalizing the date by which State and, when appropriate, local air monitoring agencies shall establish the required NO 2 monitoring network as January 1, 2013, as was proposed. We
believe that the allotted time for implementation will allow for the development of guidance documentation, particularly allowing
for interactions with CASAC and NACAA/States, and for the processes that will be involved in deploying this network. However, EPA recognizes that the network implementation process,


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particularly for near-road monitors, will include the assessment of road segments in CBSAs to identify locations of maximum expected hourly NO 2 concentrations, identifying and working with other State and local agencies, such as transportation officials, as needed on issues regarding access and safety, and the exchange of information and feedback on potential sites with EPA, prior to any commitment to selecting and presenting new sites in an annual monitoring plan. As a result, based on feedback received through public comments, and to allow for more time to process guidance information, to carry out the deployment processes, and to allow for information exchanges to occur, we are changing the date by which State and, when appropriate, local air monitoring agencies shall provide a plan for deploying monitors in accordance with required network design, including the monitors required under the Regional Administrators’ discretional authority which are to be primarily focused on providing protection to susceptible and vulnerable populations, as discussed in section III.B.4, from July 1, 2011 to July 1, 2012. EPA strongly encourages State and local air agencies to supply as much information as possible on the NO 2 sites they may be considering, including possible site coordinates if available, or have possibly selected, to satisfy the

minimum NO 2 network monitoring requirements in their Annual Monitoring Network Plan submitted July 1, 2011.

6. Near-Road Site Selection

The following paragraphs provide background, rationale, and details for the final changes to the approach and criteria by which required near-road
sites shall be selected.

a. Proposed Near-Road Site Selection

Criterion

EPA proposed that the required nearroad NO 2 monitoring stations shall be selected by ranking all road segments within a CBSA by AADT and then identifying a location or locations adjacent to those highest ranked road segments where maximum hourly NO 2 concentrations are expected to be highest and siting criteria can be met in accordance with that proposed for 40 CFR Part 58 Appendix E (discussed in III.B.7). Where a State or local air monitoring agency identifies multiple acceptable candidate sites where maximum hourly NO 2 concentrations are expected to occur, the monitoring agency should consider taking into account the potential for population exposure in the criteria utilized to select the final site location. Where one CBSA is required to have two near-road NO 2 monitoring stations, we proposed that
the sites shall be differentiated from each other by one or more of the following factors: Fleet mix; congestion patterns; terrain; geographic area within the CBSA; or different route, interstate, or freeway designation.

b. Comments

EPA received many comments from CASAC, public health groups, States and State groups, and industry groups on the proposed process by which
States will select near-road sites. CASAC, along with some health group and State commenters questioned how
States should select a site near the road with the highest ranked AADT possible, noting that EPA did not appear to require States to account for other factors. For example, one CASAC panel member noted that siting monitors based on traffic counts alone might miss
locations where maximum NO 2 concentrations would occur. They proceeded to recommend the use of modeling to assist in the site selection process. In another example, the ALA, EDJ, EJ, and NRDC, stated that ‘‘ Nearroad monitor placement should be determined not only by the highest AADT volumes in a given CBSA, but also by the highest heavy-duty truck
volumes. ’’ NACAA also expressed

concerns on ‘‘ * * * basing monitor locations on the annual average daily traffic (AADT) without regard to vehicle mix or dispersion characteristics

*** ’’

.

EPA does not intend for AADT countsto be the sole basis for choosing a nearroad site. As noted earlier in section III.B.2, there is a general relationship
between AADT and mobile source pollution, where higher traffic counts correspond to higher mobile source
emissions. The use of AADT counts is intended to be a mechanism for focusing on identifying the locations of expected

maximum NO 2 concentrations due to
mobile sources. There are other factors that can influence which road segment in a CBSA may be the actual location
where the maximum NO 2 concentrations could occur. These factors include vehicle fleet mix, roadway design, congestion patterns, terrain, and meteorology. When States identify their top-ranked road segments by AADT, EPA intends for States to
evaluate all of the factors listed above in their site selection process, due to their
influence on where the location of expected maximum NO 2 concentration may occur. As a result of the comments indicating a need for clarification, EPA will specifically list the factors that must be considered by States in their site selection process once a State has identified the most heavily trafficked
roads in a CBSA based on AADT counts. In addition, EPA proposed that States consider these factors when they are required to place two near-road monitors in a CBSA, i.e., CBSAs with a population of 2,500,000 persons or
more. EPA notes that these factors will be used in differentiating the two monitoring sites from each other, providing further characterization of near-road environments in larger urban areas that are more likely to have a greater number of major roads across a potentially larger geographic area, and a corresponding increase in potential for exposure in different settings. Finally, EPA notes that air quality models, which were noted by the CASAC panel
member to be considered for use in near-road site selection, are tools that EPA believes will be useful, and likely used by some States to inform where near-road sites need to be placed.

EPA received comments from some State and industry commenters ( e.g. Iowa, NY DEC, Edison Electric Institute, and Savannah River Nuclear Solutions) who suggested that potential population exposure should be a first-level metric in the near-road monitoring siteselection process, instead of a secondlevel metric as EPA had proposed.

EPA notes that the intent of the revised primary NO 2 NAAQS is to protect against the maximum allowable

NO 2 concentration anywhere in an area,
which includes ambient air on and
around roads. This would limit exposures to peak NO 2 concentrations, including those due to mobile source emissions, across locations (including those locations where population exposure near roads is greatest) in a given CBSA or area, with a relatively high degree of confidence. We also note the agency’s historical practice has been
to site ambient air monitors in locations of maximum concentration, at the appropriate spatial scale. If EPA were to allow population, population density, or another population weighted metric to be a primary factor in the decision on where required near-road NO 2 monitors are to be located, it is possible that the required near-road monitors in a CBSA
would not be located at a site of expected maximum hourly near-road

NO 2 concentration. By monitoring in the location of expected maximum 1-hour concentrations, near-road monitoring sites will likely represent the highest

NO 2 concentrations in an area directly attributable to mobile sources or a group
of sources that includes mobile sources. The proposed rule did permit, and the final rule states, that States are to


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consider population in the site selection process in situations when a State identifies multiple candidate sites where maximum hourly NO 2 concentrations are expected to occur.

EPA received a comment from HCPHES suggesting that required monitoring should take into
consideration the location of other major mobile sources for NO 2 emissions such as airports and seaports. EPA also
received a comment from the South Carolina Department of Health and Environmental Control stating that a
near-road network does not address

‘‘ widespread pollutants from numerous
and diverse sources. ’’

EPA recognizes that there are major

NO 2 sources outside of CBSAs that have the potential to contribute to NO 2 concentrations approaching or exceeding the NAAQS. The issue is whether such monitoring should be addressed through a more extensive set of minimum requirements that might include monitoring near all large stationary sources such as airports, seaports, and power plants, which could lead to deploying a large number of
monitors. EPA believes that a more reasonable approach to address monitoring needs related to the diverse set of point, area, and non-road mobile

NO 2 sources, whether inside or outside of CBSAs, is to provide Regional Administrators the authority to require additional monitoring in areas where these impacts could occur. Providing the Regional Administrators with the discretion to require additional monitors allows them to effectively address such situations, even if that area is satisfying minimum monitoring requirements. This Regional Administrator authority is discussed
above in section III.B.4. EPA also notes that State and local agencies may also
monitor such locations on their own

initiative.

One State commenter, the Wisconsin Department of Natural Resources, requested that the term ‘‘ major road ’’ be defined and also requested clarification
on what ‘‘ top-ranked ’’ means with regard to AADT counts on road segments.
While the term ‘‘ major road ’’ is widely
used in literature and can be found to be defined differently from one scientific study to another, here, EPA is using it in its commonly understood meaning as a road that is relatively heavily trafficked. EPA also does not believe it is appropriate to provide a bright-line definition for ‘‘ top-ranked ’’

. Each CBSA will have a different distribution of total road segments and corresponding AADT counts on thosesegments. Further, since required nearroad monitors are to be sited in locations of expected maximum concentrations, a percentile restriction

on ‘‘ top ranked ’’ roads is unnecessary. The intent of the requirement to rank all road segments by AADT counts and select a site, considering the other local factors noted above, near a ‘‘ top-ranked ’’ road segment is to focus attention on the most heavily trafficked roads, around which there is higher potential for

maximum NO 2 concentrations to occur.

c. Conclusions on Near-Road Site
Selection

We are finalizing the near-road site selection criteria as proposed, and are clarifying that the proposal intended the
selection criteria to include
consideration of localized factors when identifying locations of expected maximum concentrations. As a result, required near-road NO 2 monitoring stations shall be selected by ranking all road segments within a CBSA by AADT and then identifying a location or locations adjacent to those highest ranked road segments, considering fleet mix, roadway design, congestion patterns, terrain, and meteorology, where maximum hourly NO 2 concentrations are expected to occur and siting criteria can be met in
accordance with 40 CFR Part 58 Appendix E. As was noted in section III.B.5 above, EPA will work with States
to assist with the near-road site selection process through the development of guidance material and through information exchanges amongst the air monitoring community.

We are also finalizing the requirement, as proposed, that whenone CBSA is required to have two nearroad NO 2 monitoring stations, the sites
shall be differentiated from each other by one or more of the following factors: fleet mix; congestion patterns; terrain; geographic area within the CBSA; or different route, interstate, or freeway designation, as was proposed.

7. Near-Road Siting Criteria

The following paragraphs provide background, rationale, and details for the final changes to the siting criteria for required near-road monitoring sites.

a. Proposed Near-Road Siting Criteria

EPA proposed that near-road NO 2 monitoring stations must be sited so that
the NO 2 monitor probe is no greater than 50 meters away, horizontally, from the outside nearest edge of the traffic lanes of the target road segment, and
shall have no obstructions in the fetch between the monitor probe and roadway
traffic such as noise barriers or vegetation higher than the monitor probe height. We solicited comment on, but did not propose, having near-road sites located on the predominantly downwind side of the target roadways. EPA proposed that the monitor probe
shall be located within 2 to 7 meters above the ground, as is required for
microscale PM 2.5 and PM 10 sites. We also proposed that monitor probe placement on noise barriers or buildings, where the inlet probe height
is no less than 2 meters and no more than 7 meters above the target road, will be acceptable, so long as the inlet probe is at least 1 meter vertically or horizontally away (in the direction of the target road) from any supporting wall or structure, and the subsequent residence time of the pollutant in the sample line between the inlet probe and the analyzer does not exceed 20
seconds.

b. Comments

EPA received comments from a number of States ( e.g. Michigan, Mississippi, and Tennessee) indicating that the near-road network poses significant safety issues and a related need for increased logistical flexibility for installing a monitoring site. For example, the Mississippi Department of Environmental Quality states that

‘‘ Given the fact that these NO 2 sites will be required to be housed in shelters that are within 50 meters of the road, we believe that these buildings could be large and pose a serious risk to drivers
on the road. ’’

EPA notes that in all instances of field work, safety is a top priority. In this instance of near-road monitoring, we are dealing with the safety of the public driving on roads and the monitoring staff who may operate the near-road monitoring station as well. There are various ways to install near-road sites while ensuring worker and traffic safety, and safety is an important part of the logistical considerations that States should consider when selecting and installing near-road sites. In many cases, State and local monitoring agencies may
be able to work with their State or local transportation officials during the site selection process to deal with access and safety issues. In public comments,
AASHTO recommended that ‘‘ * * * State and local air monitoring agencies be required to coordinate with State and local DOTs for near-road monitoring during the establishment of the monitoring plan. ’’ Although EPA cannot require States to coordinate with other State or local entities, EPA believes that transportation officials would likely be able to assist in finding solutions to ensure safety while working with monitoring agencies in accommodating a new near-road monitoring station. An


### 6514 Federal Register / Vol. 75, No. 26 / Tuesday, February 9, 2010 / Rules and Regulations

24 NESCAUM officially supported the alternative network design; however, they made suggestions regarding the near-road network in the event EPA finalized the proposed two-tier network design. 25 NACAA made a statement containing many concerns about the near-road monitoring component proposal which included a passage regarding the lack of requiring sites to be downwind. They expressed concern in ‘‘ * * * allowing upwind siting of monitors over a wide range of horizontal and vertical distances from the
road * * * ’’

. example of a step that could be taken to alleviate safety concerns might be purposefully placing a monitoring site behind existing barriers like guardrails and fencing, or possibly by installing a short distance of such barriers to protect the site workers, site infrastructure, and nearby traffic. In addition, EPA notes that the 50m distance proposed is wide enough to accommodate a site that would satisfy many setback provisions that exist for private or commercial building permits near roads, and may be
viewed as a confirmation that our proposed siting criteria are safely
attainable.

Some State commenters ( e.g. AASHTO, NYSDOT, and Wisconsin) suggested that the allowable maximum distance a near-road monitoring probe can be from the target road be increased from 50 meters to something wider, such as 200 meters. Conversely, there were some State, environmental, and industry commenters ( e.g. NESCAUM, 24 Group Against Smog and Pollution, and Air Quality Research and Logistics) who suggested that the proposed range was appropriate, or, as suggested by both NESCAUM and the Group Against Smog and Pollution, the allowable distance
should be reduced to as close as 30 or 20 meters to the nearest edge of the traffic lanes of the target road segment, respectively.

EPA believes that increasing the
allowable distance above 50 meterswould compromise the intent of nearroad monitoring. As was noted in the proposal and this document, the ISA (2.5.4 and 4.3.6) and REA (7.3.2) indicate that on-road, mobile source
derived NO 2 exhibits a peak concentration on or very near the source road, and those concentrations decay over a variable but relatively short
distance back to near area-wide or background (upwind of the target road)
concentrations. Literature values indicate that the distance required for

NO 2 concentrations to return to near area-wide or background concentrations away from major roadways can range up to 500 meters, but the peak concentrations are occurring on or very near the source roadway. The behavior
of NO 2 concentrations and the actual
distance over which concentrations return to near area-wide or background levels is variable, and highly dependent on topography, roadside features, meteorology, and the related photochemical reactivity conditions (Baldauf et al., 2008; Beckerman et al., 2007; Clements et al., 2008; Gilbert et al., 2003; Hagler et al., 2009; Rodes and Holland, 1980; Singer et al., 2003; Zhou and Levy, 2007). Therefore, monitor probe placement at increasing distances from a road, such as 200 meters, will correspondingly decrease the potential for sampling maximum concentrations
of NO 2 due to the traffic on the target
road. Baldauf et al. (2009) indicate that monitoring probes would ideally be
situated between 10 and 20 meters from
the nearest traffic lane for near-road pollutant monitoring.

Regarding the comments suggesting required monitor probes be closer than 50 meters, EPA believes the allowable
distance of 50 meters that a near-road

NO 2 probe can be from the target road provides enough flexibility for the logistical issues that can occur on a case-by-case basis, which is inherent in monitoring site placement, while not sacrificing the potential to monitor the peak NO 2 concentrations. However, in light of the information provided here
on how NO 2 peak concentrations can decay over relatively short distances away from roads, EPA strongly encourages States to place near-road sites, or at least monitor probes, as close as safely possible to target roads to increase the probability of measuring the peak NO 2 concentrations that occur in the near-road environment, again noting that Baldauf et al. (2009) indicate that monitor probes would ideally be
situated between 10 and 20 meters from
the nearest traffic lane for near-road pollutant monitoring.

EPA also proposed that required nearroad NO 2 monitor probes shall have no
obstructions in the fetch between the monitor probe and roadway traffic such as noise barriers or vegetation higher than the monitor probe height. EPA expects that when a State makes a measurement in determining whether

an NO 2 inlet probe is no greater than 50 meters away, horizontally, from the outside nearest edge of the traffic lanes of the target road segment, that the measurement would likely represent a path to the monitor probe that is normal to the target road. However, EPA notes that the monitor probe will likely be influenced by various parts of the target road segment that are at a relative angle compared to the normal transect
between the road and the monitor probe. EPA is not adjusting the wording of this requirement, but does intend for
States to consider more than one linear pathway between the target road and the monitor probe being clear of obstructions when considering
candidate site locations.

EPA received comments on the solicitation for comment on requiring near-road monitoring sites to be placed on the downwind side of the target road where the commenters ( e.g. NACAA, 25 NESCAUM, and the Clean Air Council) encouraged such a requirement. Conversely, other commenters ( e.g., Air Quality and Logistics and NYSDEC suggested that such a requirement may be overly restrictive and not necessary. For example, NYSDEC stated that ‘‘ It is important to avoid making the monitor siting criteria too restrictive. It is very likely that in some CBSAs, finding
suitable locations near the busiest road segments will not be possible. It is also important to remember that the NO 2 monitoring instrumentation provides data continuously. Sites located downwind of sources will likely be impacted more frequently than the sites located upwind particularly when the
sites are more than 50 meters from the source, and are preferred, but either side
of the road will be downwind some of the time. Many of the highest NO 2 concentrations are also likely to occur during inversion periods and during calm meteorological conditions when the upwind-downwind designations have little meaning. ’’

EPA noted in its proposal that
research literature indicates that in certain cases, mobile source derived pollutant concentrations, including

NO 2 , can be detected upwind of roads, above background levels, due to a phenomenon called upwind meandering. Kalthoff et al. (2007)
indicates that mobile source derived pollutants can meander upwind on the order of tens of meters, mainly due to vehicle induced turbulence. Further,
Beckerman et al. (2008) note that nearroad pollutant concentrations on the predominantly upwind side of their study sites dropped off to near background levels within the first 50 meters, but were above background in this short and variable upwind range, which could be due, at least in part, to
vehicle induced turbulence. This upwind meandering characteristic of pollutants in the near-road environment provides an additional basis for locating
near-road sites within 50 meters of target road segments, but also reduces
the absolute need to be downwind of the road. EPA believes that very few, if any, near-road sites would be able to be situated in a location that was always downwind. For example, a hypothetical


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site may have winds routinely out of
several different cardinal directions throughout the year, without one being a dominant direction. As a result, given variable meteorology, for some period of a year, a given near-road site may not be downwind of the target road, no matter
which side of the road it is on. Therefore, EPA is not finalizing a requirement that near-road sites must be climatologically downwind of the target road segment because of the additional limitations this introduces to finding potential site candidates in exchange for what may be a small increase in the opportunity to monitor peak NO 2 concentrations. However, EPA encourages States to place monitors in the climatologically downwind direction whenever possible, in an attempt to measure the peak NO 2 concentrations more often than not. One way States may identify where the predominantly downwind location might be for candidate sites could be to use portable meteorological devices to characterize meteorological tendencies, in addition to evaluating other available meteorological data sources.

EPA proposed that required near-road

NO 2 monitor probes be located within 2 to 7 meters above the ground, as is required for microscale PM 2.5 and PM 10 sites. EPA also proposed that monitor probe placement on noise barriers or buildings, where the inlet probe height
is no less than 2 meters and no more than 7 meters above the target road, will be acceptable, so long as the inlet probe is at least 1 meter vertically or horizontally away (in the direction of the target road) from any supporting
wall or structure. NESCAUM
commented that ‘‘ EPA needs to reconcile near-roadway NO 2 probe height requirements with the existing micro-scale near-roadway CO probe height requirement of 2.5 to 3.5 meters above prevailing terrain. NESCAUM supports using this existing height for all near-roadway pollution monitors, as it minimizes probe height effects on measurements, and allows for proper measurement of collocated particle number concentration (which requires a very short inlet, i.e., on the order of inches) and CO. ’’ NYSDEC commented
that ‘‘ The height requirement may not be practical for road segments in dense urban areas where existing buildings heights may exceed 7 meters. The requirement to maintain a 1 meter clearance from a supporting wall or structure may not be adequate for taller
walls often found in urban areas. These walls can create down washing and street canyon effects which will make the resulting data less representative of nearby areas and will make interpretation of the resulting data difficult. However, there will need to be consistency between similar site settings. ’’ Finally, EPA received comments from some health groups ( e.g., ALA, EJ, EDF, and NRDC) who
commented that ‘‘ the lower end of the proposed height of 2 to 7 meters appears to capture the highest NO 2 concentrations, and more accurately represents human exposure at the breathing zone. ’’

In the proposal, EPA noted that nearroad monitoring sites will be adjacent to a variety of road types, where some target roads will be on an even plane with the monitoring station, while others may be cut roads ( i.e., below the plane of the monitoring station) or fill and open elevated roads ( i.e., where the road plane is above the monitoring station). EPA recognizes that consistency across sites with regard to probe height is desirable, and consistency with microscale, urban canyon CO sites might also be desirable. However, as was noted in the earlier
discussion on ‘‘ downwind ’’ site placements, it is important to avoid making the monitor siting criteria too restrictive. An allowable range between 2 and 7 meters provides more flexibility in site installation, which EPA considers important because of the variety of siting situations each State may have to deal with for each individual site. While EPA agrees that a tighter allowable range such as 2.5 to 3.5
meters would reduce site to site variability and keep probes nearer the microscale siting requirements of CO, the wider range of 2 to 7 meters still provides an adequate amount of site to site consistency. EPA may also address this issue through forthcoming guidance, where an increased consistency for probe heights in similar situations such as urban canyons may be a site implementation goal, within the required 2 to 7 meter probe height range. Further, EPA believes that although certain situations, as noted by NYSDEC, may exist where the 1 meter clearance from walls or structures may be problematic near taller buildings or walls, this requirement is consistent
with similar such clearance requirements for microscale CO sites in
similar such situations that exist in urban canyons.

In the proposed rule, EPA proposed in the siting criteria language that the subsequent residence time of the pollutant in the sample line between the inlet probe and the analyzer cannot
exceed 20 seconds. EPA received comments from Air Quality Research and Logistics regarding guidelines for maximum allowable inlet length and sample residence time, where they
stated that ‘‘ * * * the fast photodynamic O 3 -NO X equilibrium may occur in darkened sample lines at
residence times of 10–20 seconds (Butcher et al. 1971; Ridley et al. 1988; Parrish et al. 1990). EPA should correct this apparent error by specifying much lower maximum residence times ( e.g., 1–2 seconds) or accounting for this effect by reporting ‘corrected’ values in error by no more than the allowed rounding convention ( e.g., ± 1 ppb). ’’

EPA notes that in 40 CFR Part 58 Appendix E, paragraph (9)(c), states that sample probes for reactive gas analyzers, particularly NO Y monitors, at NCore monitoring sites must have a sample
residence time less than 20 seconds.
EPA believes this rule is also appropriate for NO 2 monitors, particularly if a monitor inlet manifold is extended away from the main monitoring shelter. EPA does agree that shorter sample residence time in the inlet manifold is desirable. Although we do not believe it appropriate to require
residence times on the order of 1 to 2 seconds, and do not believe correcting values is appropriate (which was not a concept which was proposed), we do encourage States to use best practices in selecting non-reactive manifold materials, and to install sampling
manifolds in an efficient manner that minimizes sample residence time. While EPA proposed this concept in the preamble to the proposed rule, we did not include it in the proposed regulatory text. The final rule includes regulatory text on this subject at 40 CFR Part 58 Appendix E, paragraph (9)(c).

c. Conclusions on Near-Road Siting

Criteria

We are finalizing the near-road NO 2 monitor siting criteria, as proposed, where (1) required near-road NO 2 monitor probes shall be as near as practicable to the outside nearest edge of the traffic lanes of the target road segment; but shall not be located at a distance greater than 50 meters, in the horizontal, from the outside nearest edge of the traffic lanes of the target road segment, (2) required near-road

NO 2 monitor probes shall have an unobstructed air flow, where no obstacles exist at or above the height of the monitor probe, between the monitor probe and the outside nearest edge of the traffic lanes of the target road segment, (3) required near-road NO 2 monitors are required to have sampler
inlets between 2 and 7 meters above ground level, and (4) residence time of

NO 2 in the sample line between the


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inlet probe and the analyzer does not
exceed 20 seconds.

8. Area-Wide Monitor Site Selection and Siting Criteria

The following paragraphs provide background, rationale, and details for the final changes to the site selection and monitor siting criteria for required area-wide monitoring sites.

a. Proposed Area-Wide Monitor Site Selection and Siting Criteria

EPA proposed that sites required as part of the second tier of the NO 2 monitoring network design, known as the area-wide monitoring component, be sited to characterize the highest expected NO 2 concentrations at the neighborhood and larger (area-wide) spatial scales in a CBSA.

b. Comments

While most commenters who supported area-wide monitoring did so with regard to the adoption of the alternative area-wide network design rather than as part of the proposed approach, only a few commented on the actual sites and siting criteria. The DowChemical Company suggested that areawide sites should be located at least 1,000 meters away from any major roads
or intersections to ensure that the
concentration of NO 2 measured is representative of an area-wide concentration instead of peak near-road

concentrations.

EPA notes that in order for an NO 2 monitoring site to be classified as a neighborhood (or larger) spatial scale site, it must meet the roadway set-back requirements in Table E–1 of 40 CFR Part 58 Appendix E. EPA believes that this existing set-back table is appropriate to use to ensure that any

NO 2 site that may be intended as an area-wide site will be sufficiently distanced from any major road. For example, an NO 2 monitoring site may be considered neighborhood scale if it is 10 or more meters from the edge of the nearest traffic lane of a road with 10,000
or less AADT counts.

c. Conclusions on Area-Wide Monitor Site Selection and Siting Criteria

We are finalizing the requirement that any sites required as part of the second
tier of the NO 2 monitoring network design, known as the area-wide monitoring component, be sited to characterize the highest expected NO 2 concentrations at the neighborhood and larger (area-wide) spatial scales in a

CBSA. 9. Meteorological Measurements
The following paragraphs provide background, rationale, and details for the final changes to the requirement of meteorological monitoring at near-road monitoring sites.

a. Proposed Meteorological

Measurements

In further support of characterizing the peak NO 2 concentrations occurring in the near-road environment, EPA proposed to require three-dimensional anemometry, providing wind vector
data in the horizontal and vertical planes, along with temperature and relative humidity measurements, at all required near-road monitoring sites.

b. Comments

EPA received comments from the South Carolina Department of Health
and Environmental Control commented that the recording of air turbulence data at near-road monitoring stations should be encouraged but not required. Other States ( e.g., Alaska, North Carolina, and Wisconsin) provided comments that did not support the proposed meteorological measurement requirements, noting issues with costs, problems siting the probe nearer to structures and to the ground than is typically done, and that the averaging period required to better understand turbulence (through anemometry data) in the near-road environment requires a much higher frequency than what is typically reported.

EPA is removing the proposed requirements that would have required meteorological monitoring at near-road

NO 2 monitoring stations. However, EPA strongly encourages States to do some meteorological monitoring to better
characterize the conditions under which they are acquiring NO 2 data. The nearroad microscale environment is complex, and understanding the turbulent dispersion that may be affecting NO 2 measurements, along with having a basic understanding of from
which direction the measured NO 2 concentrations are coming from, which are very informative in the effort to fully understand the data being collected. At a minimum, basic anemometry data would be useful in identifying whether the site is upwind, downwind, or otherwise oriented, relative to the target
road.

c. Conclusions on Meteorological

Measurements

We are not finalizing the proposal to require three-dimensional anemometry, providing wind vector data in the horizontal and vertical planes, along with temperature and relative humidity measurements, at all required near-road monitoring sites.

C. Data Reporting

The following paragraphs provide background, rationale, and details for the final changes to the data reporting requirements, data quality objectives, and measurement uncertainty.

1. Proposed Data Quality Objectives and Measurement Uncertainty

In the proposal, EPA noted that State and local monitoring agencies are required to report hourly NO, NO 2 , and

NO X data to AQS within 90 days of the end of each calendar quarter. We also noted that many agencies also voluntarily report their pre-validated data on an hourly basis to EPA’s real time AIRNow data system, where the data may be used by air quality forecasters to assist in ozone forecasting. We believe these data reporting procedures are appropriate to support the revised primary NO 2 NAAQS.

EPA proposed to develop data quality objectives (DQOs) for the proposed NO 2 network. We proposed a goal for acceptable measurement uncertainty for

NO 2 methods to be defined for precision as an upper 90 percent confidence limit for the coefficient of variation (CV) of 15 percent and for bias as an upper 95 percent confidence limit for the absolute bias of 15 percent.

2. Comments

EPA received comments from the State of Missouri, supporting the proposed DQOs and goals for measurement uncertainty, and from North Carolina, suggesting that measurement uncertainty goals match those of the NCore multi-pollutant
network.

EPA agrees that it is desirable to have measurement uncertainty goals that match that of other pollutants. EPA originally proposed the goals for precision and bias under consideration that there may be a need to account for potential increased uncertainty in 1-
hour near-road NO 2 data. However, we agree with the suggestion from the State of North Carolina, and are changing the goals for acceptable measurement uncertainty for NO 2 methods to be defined for precision as an upper 90 percent confidence limit for the coefficient of variation (CV) of 10 percent and for bias as an upper 95 percent confidence limit for the absolute bias of 15 percent. These goals match the existing goals for NO 2 and are
consistent with historical measurement uncertainty goals.


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3. Conclusions on Data Quality Objectives and Measurement Uncertainty

We are finalizing the approach to develop data quality objectives, and are changing the proposed goal for measurement uncertainty, where the goals for acceptable measurement uncertainty for NO 2 methods to be defined for precision as an upper 90 percent confidence limit for the coefficient of variation (CV) of 10 percent and for bias as an upper 95 percent confidence limit for the absolute bias of 15 percent.

IV. Appendix S—Interpretation of the Primary NAAQS for Oxides of Nitrogen and Revisions to the Exceptional Events
Rule

The EPA proposed to add Appendix S, Interpretation of the Primary National Ambient Air Quality Standards for Oxides of Nitrogen, to 40 CFR part 50 in order to provide data handling procedures for the proposed NO 2 1-hour primary standard and for the existing

NO 2 annual primary standard. The proposed Appendix S detailed the computations necessary for determining when the proposed 1-hour and existing annual primary NO 2 NAAQS are met. The proposed Appendix S also addressed data reporting, data completeness considerations, and rounding conventions.

Two versions of Appendix S were proposed. The first applied to a 1-hour primary standard based on the annual 4th high value form, while the second applied to a 1-hour primary standard based on the 99th percentile daily value
form.

The final version of Appendix S is printed at the end of this notice and applies to an annual primary standard and a 1-hour primary standard based on the 98th percentile daily value form.Appendix S is based on the nearroadway approach to the setting the
level of the 1-hour standard and to siting monitors. As such, these versions place no geographical restrictions on which monitoring sites’ concentration data can and will be compared to the 1- hour standard when making
nonattainment determinations and other findings related to attainment or
violation of the standard.

The EPA is amending and moving the provisions of 40 CFR 50.11 related to data completeness for the existing annual primary standard to the new Appendix S, and adding provisions for the proposed 1-hour primary standard. Substantively, the data handling procedures for the annual primary standard in Appendix S are the same as the existing provisions in 40 CFR 50.11 for that standard, except for an addition of a cross-reference to the Exceptional Events Rule, the addition of
Administrator discretion to consider otherwise incomplete data complete, and the addition of a provision addressing the possibility of there being multiple NO 2 monitors at one site. The procedures for the 1-hour primary standard are entirely new.

The EPA is also making NO 2 -specific changes to the deadlines, in 40 CFR 50.14, by which States must flag ambient air data that they believe have been affected by exceptional events and submit initial descriptions of those events, and the deadlines by which
States must submit detailed justifications to support the exclusion of
that data from EPA determinations of
attainment or nonattainment with the NAAQS. The deadlines now contained in 40 CFR 50.14 are generic, and are not always appropriate for NO 2 given the anticipated schedule for the designations of areas under the final

NO 2 NAAQS.

The purpose of a data interpretation appendix in general is to provide the practical details on how to make a comparison between multi-day and possibly multi-monitor ambient air
concentration data and the level of the NAAQS, so that determinations of compliance and violation are as objective as possible. Data interpretation guidelines also provide criteria for determining whether there are sufficient data to make a NAAQS level comparison at all. The regulatory language for the pre-existing annual

NO 2 NAAQS, originally adopted in 1977, contained data interpretation instructions only for the issue of data completeness. This situation contrasts with the situations for ozone, PM 2.5 , PM 10 , and most recently Pb for which there are detailed data interpretation appendices in 40 CFR part 50 addressing more issues that can arise in comparing monitoring data to the NAAQS.

A. Interpretation of the Primary NAAQS for Oxides of Nitrogen for the Annual Primary Standard

The purpose of a data interpretation
rule for the NO 2 NAAQS is to give effect to the form, level, averaging time, and indicator specified in the regulatory text at 40 CFR 50.11, anticipating and resolving in advance various future situations that could occur. Appendix S provides common definitions and requirements that apply to both the annual and the 1-hour primary
standards for NO 2 . The common requirements concern how ambient data are to be reported, what ambient data are to be considered (including the issue of which of multiple monitors’ data sets
will be used when more than one monitor has operated at a site), and the applicability of the Exceptional Events Rule to the primary NO 2 NAAQS.

The proposed Appendix S also addressed several issues in ways which are specific to the individual primary

NO 2 standards, as described below.

1. Proposed Interpretation of the Annual
Standard

The proposed data interpretation provisions for the annual standard are consistent with the pre-existing instructions included along with the
statement of the level and form of the
standard in 40 CFR 50.11. These are the following: (1) At least 75% of the hours in the year must have reported concentration data. (2) The available hourly data are arithmetically averaged, and then rounded (not truncated) to whole parts per billion. (3) The design value is this rounded annual average concentration. (4) The design value is compared with the level of the annual primary standard (expressed in parts per billion).

In the proposal, EPA noted that it would be possible to introduce additional steps for the annual primary standard which in principle could make the design value a more reliable indicator of actual annual average
concentration in cases where some monitoring data have been lost. For example, averaging within a calendar quarter first and then averaging across quarters could help compensate for uneven data capture across the year. For some aspects of the data interpretation procedures for some other pollutants, the current data interpretation appendices do contain such additional steps. The proposed provisions for the proposed 1-hour NO 2 standard also incorporated some such features.

2. Comments on Interpretation of the
Annual Standard

We received four comments, all from State agencies, on data interpretation for
the annual NO 2 standard. Of the four commenters, two recommended the use of a weighted annual mean to appropriately implement the annual primary standard. Two other
commenters asserted that there is no strong seasonality in NO 2 concentrations, and that therefore there is no need to use a weighted annual mean or to require data completeness quarter-by-quarter.


### 6518 Federal Register / Vol. 75, No. 26 / Tuesday, February 9, 2010 / Rules and Regulations

3. Conclusions on Interpretation of the
Annual Standard

Upon investigating the issue of NO 2 seasonality using data from AQS as part of considering the comments, we have
found that there are notable variations in quarterly mean NO 2 concentrations. It is therefore quite possible that an unweighted annual mean calculated without a quarter-by-quarter data completeness requirement might not represent the true annual mean as well as a weighted annual mean calculated with a quarter-by-quarter completeness requirement. However, the current practice of requiring 75% completeness of all of the hours in the year and calculating the annual mean without weighting has been retained in the final rule, because of its simplicity and
because we believe it will not interfere with effective implementation of the annual NAAQS. No area presently is
nonattainment for or comes close to violating the annual standard. Therefore, the choice between the two approaches can only have a practical effect, if any, on whether at some time
in the future an area is determined to be newly violating the annual standard. If a monitor has a complete and valid design value below the standard using the unweighted mean approach (with only an annual data completeness requirement) but the design value would be considered incomplete and invalid under a hypothetical weighted mean approach (with a quarterly completeness requirement), the monitor
would in either case be considered not to be violating and its data would not be
the basis for a nonattainment designation. If a monitor has a design value above the standard using the unweighted annual mean approach but is incomplete with respect to a hypothetical quarterly completeness requirement, then the two approaches would have different implications for
the determination of a violation. A quarterly completeness requirement would make a finding of violation impossible, unless the Administrator chose to treat the data as if complete under another provision of the final rule. The unweighted annual mean approach would allow but not force a finding of violation, because the
Administrator will have discretion to make any such findings because there will be no mandatory round of designations for the annual standard given that the annual standard has not
been revised in this review. The
Administrator will be able to consider the representativeness of the unweighted annual mean when deciding whether to make a discretionary nonattainment redesignation. Given that the annual standard requires only one year of monitoring data for the calculation of a design value, little time will be lost if
the Administrator chooses to work with a State to obtain a new design value based on more complete and/or seasonally balanced monitoring data.

B. Interpretation of the Primary NAAQS for Oxides of Nitrogen 1-Hour Primary
Standard

1. Proposed Interpretation of the 1-Hour
Standard

With regard to data completeness for the 1-hour primary standard with a 4th highest daily value form, the proposed Appendix followed past EPA practice for other NAAQS pollutants by requiring that in general at least 75% of the monitoring data that should have resulted from following the planned monitoring schedule in a period must be available for the key air quality statistic from that period to be considered valid. For the 1-hour primary NO 2 NAAQS, the key air quality statistics are the daily
maximum 1-hour concentrations in three successive years. It is important that sampling within a day encompass the period when concentrations are likely to be highest and that all seasons of the year are well represented. Hence, the 75% requirement was proposed to be applied at the daily and quarterly
levels.

Recognizing that there may be years with incomplete data, the proposed text provided that a design value derived from incomplete data would
nevertheless be considered valid in
either of two situations.

First, if the design value calculated from at least four days of monitoring observations in each of these years exceeds the level of the 1-hour primary standard, it would be valid. This situation could arise if monitoring was intermittent but high NO 2 levels were measured on enough hours and days for the mean of the three annual 4th high
values to exceed the standard. In this situation, more complete monitoring could not possibly have indicated that the standard was actually met.

Second, we proposed a diagnostic
data substitution test which was intended to identify those cases with incomplete data in which it nevertheless is very likely, if not virtually certain, that the daily 1-hour design value would have been observed to be below the level of the NAAQS if monitoring data had been minimally complete.

It should be noted that one possible outcome of applying the proposed substitution test is that a year with incomplete data may nevertheless be determined to not have a valid design value and thus to be unusable in making 1-hour primary NAAQS compliance determinations for that 3-year period.

Also, we proposed that the Administrator have general discretion touse incomplete data based on casespecific factors, either at the request of
a State or at her own initiative. Similar provisions exist already for some other NAAQS.

The second version of the proposed Appendix S contained proposed interpretation procedures for a 1-hour primary standard based on the 99th percentile daily value form. The 4th high daily value form and the 99th percentile daily value form would yield the same design value in a situation in which every hour and day of the year has reported monitoring data, since the 99th percentile of 365 daily values is the 4th highest value. However, the two forms diverge if data completeness is 82% or less, because in that case the 99th percentile value is the 3rd highest (or higher) value, to compensate for the lack of monitoring data on days when
concentrations could also have been high.

Logically, provisions to address possible data incompleteness under the 99th percentile daily value form should
be somewhat different from those for the 4th highest form. With a 4th highest form, incompleteness should not invalidate a design value that exceeds the standard, for reasons explained above. With the 99th percentile form, however, a design value exceeding the standard stemming from incomplete data should not automatically be considered valid, because concentrations on the unmonitored days could have been relatively low, such that the actual 99th percentile value for the year could have been lower, and the design value could have been below the standard. The second proposed version of Appendix S accordingly had somewhat different provisions for dealing with data incompleteness. One
difference was the addition of another diagnostic test based on data substitution, which in some cases can validate a design value based on incomplete data that exceeds the
standard.

The second version of the proposed Appendix S provided a table for determining which day’s maximum 1-
hour concentration will be used as the 99th percentile concentration for the year. The proposed table is similar to
one used now for the 24-hour PM 2.5 NAAQS, which is based on a 98th percentile form, but adjusted to reflect


### 6519 Federal Register / Vol. 75, No. 26 / Tuesday, February 9, 2010 / Rules and Regulations

a 99th percentile form for the 1-hour primary NO 2 standard. The proposed Appendix S also provided instructions for rounding (not truncating) the average of three annual 99th percentile hourly concentrations before comparison to the level of the primary NAAQS.

2. Comments on Interpretation of the 1-
Hour Standard

Three commenters expressed the view that the 75% completion per quarter requirement should apply with respect
to the 1-hour standard. A fourth
commenter recommended that the requirement be increased to 82%. Another person commented that the requirement of 75% of the hours in a day is too stringent. The commenter noted that it would be inappropriate not to count the day if the maximum
concentration observed in the hours measured is sufficiently high to make a difference with regard to compliance with the NAAQS. A comment was
received that the substitution test should not be included, on the grounds
that nonattainment should not be declared without irrefutable proof. This
commenter also said that the same completeness requirement as used for
nonattainment should be used for
attainment. We received one comment that the computation of design values where multiple monitors are present at a site should be averaged and not taken from a designated primary monitor.

3. Conclusions on Interpretation of the
1-Hour Standard

Consistent with the Administrator’s decision to adopt a 98th percentile form for the 1-hour NAAQS, the final version of Appendix S is based on that form.
Table 1 has been revised from the version that was proposed, so that it
results in the selection of the 98th percentile value rather than the 99th percentile value.

We agree with the three comments expressing the view that the requirement for 75% data completeness per quarter should apply with respect to
the 1-hour standard. A fourth comment recommended that the requirement be increased to 82%. We believe 82% is too stringent because of the number of
monitors that would not achieve such a requirement and we believe that 75% captures the season. We agree that an incomplete day should be counted if the
maximum concentration observed in the hours measured is sufficiently high to make a difference with regard to compliance with the NAAQS, and we
have accounted for that in section 3.2.c.i by validating the design value if it is above the level of the primary 1-hour standard when at least 75 percent of the days in each quarter have at least one reported hourly value. We agree that
substitution should not be used for the
establishment of attainment/
nonattainment. The commenter who remarked on this issue appears not to have understood that the specific proposed substitution tests have essentially zero probability of making a clean area fail the NAAQS, or vice versa, because the substituted values are chosen to be conservative against such
an outcome. As noted in section 3.2(c)(i), when substitution is used, the 3-year design value based on the data actually reported, not the ‘‘ test design
value ’’ , shall be used as the valid design
value.

In the course of considering the above comment regarding data substitution
tests to be used in cases of data incompleteness, EPA has realized that
there could be some cases of data incompleteness in which the proposed procedure for calculating the 1-hour design value might result in an in appropriately low design value. As proposed, only days with measurements for at least 75% of the hours in the day would be considered in any way when identifying the 99th percentile value (99th for purposes of the adopted NAAQS). However, there could be individual hours in other, incompletely monitored days that had measured concentrations higher than the identified 98th percentile value from the complete days. It would be inappropriate not to consider those hours and days in some way. However, if all days with at least one hourly concentration were used to identify the 99th percentile value without any regard to their incompleteness, this could also result in a design value that is biased low because the extra days
could increase the number of ‘‘ annual number of days with valid data ’’ enough
to affect which row of Table 1 of Appendix S is used. It could, for example, result in the 8th highest ranked daily maximum concentration being identified as the 98th percentile value (based on Table 1 of Appendix S) rather than a higher ranked concentration; this would also be inappropriate because days which were not monitored intensively enough to give a reasonable likelihood of catching the maximum hourly concentration would in effect be treated as if they had such a likelihood. For example, 50 days with only one hourly measurement during a time of day with lower
concentrations would ‘‘ earn ’’ the State the right to drop one notch lower in the ranking of days when identifying the 98th percentile day, inappropriately. The final version of Appendix S solves this problem by providing that two procedures be used to identifying the 98th percentile value, the first based only on days with 75% data completeness and the second based on all days with at least one hourly measurement. The final design value is the higher of the two values that result from these two procedures.

With regard to situations with multiple monitors operating at one site, we think as discussed in the proposal, that designation of a primary monitor is preferable to averaging the data from multiple monitors based on administrative simplicity and transparency for the public, and is unbiased with respect to compliance outcome provided the State is able to make the designation only before any
data has been collected.

Finally, as proposed, the final version of Appendix S has a cross reference to the Exceptional Events Rule (40 CFR 50.14) with regard to the exclusion of data affected by exceptional events. In addition, the specific steps for including such data in completeness calculations while excluding such data from actual design value calculations is clarified in Appendix S.

C. Exceptional Events Information
Submission Schedule

The Exceptional Events Rule at 40 CFR 50.14 contains generic deadlines for a State to submit to EPA specified information about exceptional events and associated air pollutant
concentration data. A State must initially notify EPA that data has been affected by an event by July 1 of the year after the data are collected; this is done by flagging the data in AQS and providing an initial event description. The State must also, after notice and opportunity for public comment, submit a demonstration to justify any claim within 3 years after the quarter in which the data were collected. However, if a regulatory decision based on the data (for example, a designation action) is anticipated, the schedule to flag data in AQS and submit complete
documentation to EPA for review is foreshortened, and all information must
be submitted to EPA no later than one year before the decision is to be made.

These generic deadlines are suitable for the period after initial designations have been made under a NAAQS, when the decision that may depend on data exclusion is a redesignation from
attainment to nonattainment or from nonattainment to attainment. However, these deadlines present problems with respect to initial designations under a newly revised NAAQS. One problem is


### 6520 Federal Register / Vol. 75, No. 26 / Tuesday, February 9, 2010 / Rules and Regulations

that some of the deadlines, especially the deadlines for flagging some relevant data, may have already passed by the time the revised NAAQS is promulgated. Until the level and form of the NAAQS have been promulgated a
State does not know whether the criteria for excluding data (which are tied to the level and form of the NAAQS) were met on a given day. The only way a State could guard against this possibility is to flag all data that could possibly be eligible for exclusion under a future NAAQS. This could result in flagging far more data than will eventually be eligible for exclusion. EPA believes this
is an inefficient use of State and EPA resources, and is potentially confusing and misleading to the public and regulated entities. Another problem is that it may not be feasible for information on some exceptional events that may affect final designations to be
collected and submitted to EPA at least one year in advance of the final designation decision. This could have the unintended consequence of EPA designating an area nonattainment as a
result of uncontrollable natural or other qualified exceptional events.

When Section 50.14 was revised in March 2007, EPA was mindful that designations were needed under the recently revised PM 2.5 NAAQS, so exceptions to the generic deadline were
included for PM 2.5 . The EPA was also
mindful that similar issues would arise for subsequent new or revised NAAQS. The Exceptional Events Rule at section 50.14(c)(2)(v) 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 data for initial designation of areas for those NAAQS. ’’

EPA proposed revised exceptional event data flagging and documentation deadlines in FR 34404 [ Federal Register /Vol. 74, No. 134/Wednesday, July 15, 2009/Proposed Rules] and invited comments from the public. The Agency received no comments related to the revised proposed schedule for NO 2 exceptional event data flagging and
documentation deadlines.

For the specific case of NO 2 , EPA anticipates that initial designations under the revised NAAQS may be made by January 22, 2012 based on air quality data from the years 2008–2010. ( See
Section VI below for more detailed discussion of the designation schedule and what data EPA intends to use.) If final designations are made by January 22, 2012, all events to be considered during the designations process must be flagged and fully documented by States one year prior to designations, by January 22, 2011. This date also
coincides with the Clean Air Act
deadline for Governors to submit to EPA their recommendations for designating
all areas of their States.

The final rule text at the end of this notice shows the changes that will apply if a revised NO 2 NAAQS is promulgated by January 22, 2010, and designations are made two years after promulgation of a NO 2 NAAQS revision.

Table 1 below summarizes the data flagging and documentation deadlines corresponding to the two year designation schedule discussed in this section. If the promulgation date for a
revised NO 2 NAAQS occurs on a different date than January 22, 2010,
EPA will revise the final NO 2 exceptional event flagging and
documentation submission deadlines accordingly to provide States with reasonably adequate opportunity to review, identify, and document exceptional events that may affect an area designation under a revised NAAQS.



### T ABLE 

### 1—S CHEDULE FOR 

### E XCEPTIONAL 

### E VENT 

### F LAGGING AND 

### D OCUMENTATION 

### S UBMISSION FOR 

### D ATA 

### T O 

### B E 

### U SED IN 

### D ESIGNATIONS 

### D ECISIONS FOR 

### N EW OR 

### R EVISED 

### NAAQS

NAAQS pollutant/standard/(level)/promulgation date Air quality data collected for calendar year Event flagging & initial description deadline Detailed documentation submission deadline

NO 2 /1-Hour Standard (100 PPB) .............................. 2008 July 1, 2010 a ............................................................ January 22, 2011. 2009 July 1, 2010 .............................................................. January 22, 2011. 2010 April 1, 2011 a ............................................................ July 1, 2011. a

a Indicates change from general schedule in 40 CFR 50.14. **Note:** EPA notes that the table of revised deadlines only applies to data EPA will use to establish the final initial designations for new or revised NAAQS. The general schedule applies for all other purposes, most notably, for data used by EPA for redesignations to atta inment.

V. Designation of Areas

A. Proposed Process

The CAA requires EPA and the States to take steps to ensure that the new or revised NAAQS are met following promulgation. The first step is to identify areas of the country that do not meet the new or revised NAAQS. Section 107(d)(1) provides that, ‘‘ By such date as the Administrator may reasonably require, but not later than 1 year after promulgation of a new or revised NAAQS 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 should be designated as nonattainment, attainment, or unclassifiable for the new NAAQS. 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. ’’

No later than 120 days prior to promulgating designations, EPA is required to notify States of any intended modifications to their designations as EPA may deem necessary. States then have an opportunity to comment on
EPA’s tentative decision. Whether or not a State provides a recommendation, the EPA must promulgate the designation that it deems appropriate.

Accordingly, Governors must submit
their initial NO 2 designation
recommendations to EPA no later than January 2011. If the Administrator intends to modify any State’s recommendation, the EPA will notify the Governor no later than 120 days prior to designations in January 2012.
States that believe the Administrator’s modification is inappropriate will have an opportunity to demonstrate why they
believe their recommendation is more appropriate before designations are
finalized.

B. Public Comments

Several industry commenters requested that EPA slow the timeline for implementing a near-roadway monitoring network and designating roadway areas because they believe EPA lacks significant information about the implementation and performance of a national, near-roadway monitoring
network. Two commenters also requested that if a near-roadway monitoring network is deployed, that 1-
hour NO 2 standards be made more


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26 Since EPA is retaining the annual standard without revision, the discussion in this section relates to implementation of the proposed 1-hour standard, rather than the annual standard. lenient until the next review period so
that more information will be available about near-roadway NO 2 concentrations before a stringent standard is selected.

A response to commenters’ requests that EPA slow the monitoring implementation schedule and the request that EPA make the 1-hour NO 2 standard more lenient until the next review period are addressed in sections III.B.5 and II.F.4.D, respectively.

Section 110(d)(1)(B) requires the EPA to designate areas no later than 2 years following promulgation of a new or revised NAAQS ( i.e., by January 2012). While the CAA provides the Agency an additional third year from promulgation of a NAAQS to complete designations in
the event that there is insufficient information to make NAAQS compliance determinations, we anticipate that delaying designations for an additional year would not result in significant new data to inform the initial designations. A near-roadway monitoring network is not expected to be fully deployed until January 2013 therefore, EPA must proceed with initial designations using air quality data from the existing NO 2 monitoring network.
Because none of the current NO 2monitors are sited to measure nearroadway ambient air, we expect that most areas in the country with current

NO 2 monitors will not violate the new

NO 2 NAAQS. In the event that a current

NO 2 monitor indicates a violation of the revised standards, EPA intends to designate such areas ‘‘ nonattainment ’’ no later than 2 years following promulgation of the revised standards. We intend to designate the rest of the country as ‘‘ unclassifiable ’’ for the
revised NO 2 NAAQS until sufficient airquality data is collected from a nearroadway monitoring network. Once the near-roadway network is fully deployed and 3 years of air quality data are available, the EPA has authority under the CAA to redesignate areas as appropriate from ‘‘ unclassifiable ’’ to

‘‘ attainment ’’ or ‘‘ nonattainment. ’’ We anticipate that sufficient data to conduct designations would be available after

2015.

A number of commenters, largely from industry groups, focused on the concern that a near-roadway monitoring network would lead to regional nonattainment on the basis of high NO 2 concentrations found near roadways. These commenters requested that any
future nonattainment areas be limited to the area directly surrounding roadways
found to have above-standard NO 2 concentrations.

The CAA requires that any area that does not meet a NAAQS or that contributes to a violation in a nearby area that does not meet the NAAQS be designated ‘‘ nonattainment. ’’ States and
EPA will need to determine which
sources and activities contribute to a NAAQS violation in each area. Depending on the circumstances in each area this may include sources and activities in areas beyond the area directly surrounding a major roadway.
EPA intends to issue nonattainment area boundary guidance after additional information is gathered on the probable contributors to violating near-roadway

NO 2 monitors.

C. Final Designations Process

The EPA intends to promulgate initial

NO 2 designations by January 2012 (2 years after promulgation of the revised NAAQS). Along with today’s action EPA is also promulgating new monitoring rules that focus on roadways. As noted in section III, States must site required NO 2 near-roadway monitors and have them operational by January 1, 2013. States will need an additional 3 years thereafter to collect air quality data in order to determine compliance with the revised NAAQS. This means that a full set of air quality
data from the new network will not be
available until after 2015. Since we anticipate that data from the new network will not be available prior to the CAA designation deadlines discussed above, the EPA intends to complete initial NO 2 designations by January 2012 using the 3 most recent years of quality-assured air quality data from the current monitoring network, which would be for the years 2008– 2010. The EPA will designate as

‘‘ nonattainment ’’ any areas with NO 2 monitors recording violations of the
revised NO 2 NAAQS. We intend to designate all other areas of the country

as ‘‘ unclassifiable ’’ to indicate that there
is insufficient data to determine whether or not they are attaining the
revised NO 2 NAAQS.

Once the NO 2 monitors are positioned in locations meeting the near-roadway siting requirements and monitoring data become available, the Agency has authority under section 107(d)(3) of the CAA to redesignate areas as appropriate
from ‘‘ unclassifiable ’’ to ‘‘ attainment ’’ or

‘‘ nonattainment. ’’ The EPA intends to issue guidance on the factors that States should consider when determining
nonattainment boundaries after additional information is gathered on the probable contributors to violating near-roadway NO 2 monitors.

VI. Clean Air Act Implementation Requirements

This section of the preamble discusses the Clean Air Act (CAA) requirements that States and emissions sources must address when implementing new or
revised NO 2 NAAQS based on the
structure outlined in the CAA and existing rules. 26 EPA may provide additional guidance in the future, as necessary, to assist States and emissions sources to comply with the CAA requirements for implementing new or
revised NO 2 NAAQS.

The CAA assigns important roles to EPA, States, and, in specified circumstances, Tribal governments to achieve the NAAQS. States have the primary responsibility for developing and implementing State Implementation Plans (SIPs) that contain State measures necessary to achieve the air quality standards in each area. EPA provides assistance to States by providing technical tools, assistance, and guidance, including information on the potential control measures that may help areas meet the standards.

States are primarily responsible for ensuring attainment and maintenance of ambient air quality standards once they have been established by EPA. Under section 110 of the CAA, 42 U.S.C. 7410, and related provisions, States are required to submit, for EPA approval, SIPs that provide for the attainment and maintenance of such standards through control programs directed at sources of

NO 2 emissions. If a State fails to adopt and implement the required SIPs by the time periods provided in the CAA, the EPA has responsibility under the CAA to adopt a Federal Implementation Plan (FIP) to assure that areas attain the NAAQS in an expeditious manner.

The States, in conjunction with EPA, also administer the prevention of significant deterioration (PSD) program
for NO 2 and nonattainment new source review (NSR). See sections 160–169 of the CAA. In addition, Federal programs provide for nationwide reductions in
emissions of NO 2 and other air pollutants under Title II of the Act, 42 U.S.C. 7521–7574, which involves controls for automobiles, trucks, buses, motorcycles, nonroad engines, and aircraft emissions; the new source performance standards (NSPS) for stationary sources under section 111 of the CAA, 42 U.S.C. 7411.

CAA Section 301(d) authorizes EPA to treat eligible Indian Tribes in the same manner as States (TAS) under the CAA and requires EPA to promulgate regulations specifying the provisions of
the statute for which such treatment is appropriate. EPA has promulgated these


### 6522 Federal Register / Vol. 75, No. 26 / Tuesday, February 9, 2010 / Rules and Regulations

regulations—known as the Tribal Authority Rule or TAR—at 40 CFR Part

49. See 63 FR 7254 (February 12, 1998). The TAR establishes the process for Indian Tribes to seek TAS eligibility and
sets forth the CAA functions for which TAS will be available. Under the TAR, eligible Tribes may seek approval for all CAA and regulatory purposes other than
a small number of functions enumerated at section 49.4. Implementation plans
under section 110 are included within the scope of CAA functions for which eligible Tribes may obtain approval. Section 110(o) also specifically describes Tribal roles in submitting implementation plans. Eligible Indian Tribes may thus submit implementation plans covering their reservations and other areas under their jurisdiction.

Under the CAA and TAR, Tribes are not, however, required to apply for TAS or implement any CAA program. In promulgating the TAR EPA explicitly determined that it was not appropriate to treat Tribes similarly to States for purposes of, among other things, specific plan submittal andimplementation deadlines for NAAQSrelated requirements. 40 CFR 49.4(a). In addition, where Tribes do seek approval of CAA programs, including section 110 implementation plans, the TAR provides flexibility and allows them to submit partial program elements, so long as such elements are reasonably
severable— i.e., ‘‘ not integrally related to program elements that are not included in the plan submittal, and are consistent with applicable statutory and regulatory requirements. ’’ 40 CFR 49.7.

To date, very few Tribes have sought TAS for purposes of section 110 implementation plans. However, some Tribes may be interested in pursuing such plans to implement today’s proposed standard. As noted above, such Tribes may seek approval of partial, reasonably severable plan elements, or they may seek to implement all relevant components of an air quality program for purposes of meeting the requirements of the Act. In several sections of this preamble, EPA
describes the various roles and requirements States will address in implementing today’s proposed
standard. Such references to States are generally intended to include eligible
Indian Tribes to the extent consistent with the flexibility provided to Tribes
under the TAR. Where Tribes do not
seek TAS for section 110 implementation plans, EPA will promulgate Federal implementation plans as ‘‘ necessary or appropriate to protect air quality. ’’ 40 CFR 49.11(a). EPA also notes that some Tribes operate air quality monitoring networks in their areas. For such monitors to be used to measure attainment with this primary NAAQS for NO 2 , the criteria and procedures identified in this rule would apply.

A. Classifications

1. Proposal

Section 172(a)(1)(A) of the CAA authorizes EPA to classify areas designated as nonattainment for the purpose of applying an attainment date pursuant to section 172(a)(2), or for other reasons. In determining the appropriate classification, EPA may consider such factors as the severity of the nonattainment problem and the availability and feasibility of pollution control measures ( see section 172(a)(1)(A) of the CAA). The EPA may classify NO 2 nonattainment areas, but is not required to do so. The primary
reason to establish classifications is to
set different deadlines for each class of nonattainment area to complete the planning process and to provide for different attainment dates based upon the severity of the nonattainment problem for the affected area. However, the CAA separately establishes specific planning and attainment deadlines for certain pollutants including NO 2 in
sections 191 and 192: 18 months from nonattainment designation for the submittal of an attainment plan, and as expeditiously as possible, but no later than 5 years from nonattainment designation for areas to attain the standard. In the proposal, EPA stated its
belief that classifications are unnecessary in light of these relatively
short deadlines.

2. Public Comments

One commenter stated that they disagree with EPA’s decision not to impose non-attainment classifications
on areas with measured near-road NO 2 concentrations in excess of the new NO 2 standard, and urged EPA to provide a graduated non-attainment classification system for the new standard. According to the commenter, ‘‘ a classificationsystem defining higher levels of nonattainment with increasingly stringent requirements at those levels is one that allows for finer calibration of air quality regulatory response defined at the
Federal level. ’’

As stated in the proposed rule, Section 192(a), of part D, of the CAA specifically provides an attainment date for areas designated as nonattainment
for the NO 2 NAAQS. Therefore, EPA has legal authority to classify NO 2 nonattainment areas, but the 5-year
attainment date addressed under section 192(a) cannot be extended pursuant to section 172(a)(2)(D). Based on this limitation, EPA proposed not to
establish classifications within the 5- year interval for attaining any new or
revised NO 2 NAAQS. It is also EPA’s belief that given the short deadlines that States have to develop and submit SIP’s
and for areas to achieve emissions
reductions in order to attain the standard within the 5 year attainment period, a graduated classifications system would not be appropriate. Therefore, EPA is using it’s discretion
under the CAA not to establish
classifications.

3. Final

EPA is not making any changes to the
discussion on classifications in the proposed rule. Therefore, there will be
no classifications for the revised NO 2 NAAQS.

B. Attainment Dates

The maximum deadline by which an area is required to attain the NO 2 NAAQS is determined from the effective date of the nonattainment designation
for the affected area. For areas designated nonattainment for the
revised NO 2 NAAQS, SIPs must provide for attainment of the NAAQS as expeditiously as practicable, but no later than 5 years from the date of the nonattainment designation for the area ( see section 192(a) of the CAA). The
EPA will determine whether an area has
demonstrated attainment of the NO 2 NAAQS by evaluating air quality monitoring data consistent with the form of the NAAQS for NO 2 if revised, which will be codified at 40 CFR part 50, Appendix F.

1. Attaining the NAAQS

a. Proposal

In order for an area to be redesignated as attainment, the State must comply with the five requirements as provided under section 107(d)(3)(E) of the CAA. This section requires that:

—EPA must have determined that the

area has met the NO 2 NAAQS; —EPA has fully approved the State’s

implementation plan; —The improvement in air quality in the

affected area is due to permanent and enforceable reductions in emissions; —EPA has fully approved a

maintenance plan for the area; and —The State(s) containing the area have

met all applicable requirements under section 110 and part D.

b. Final

EPA did not receive any comments on this aspect of the proposed rule and is not making any changes to the


### 6523 Federal Register / Vol. 75, No. 26 / Tuesday, February 9, 2010 / Rules and Regulations

27 Two elements identified in section 110(a)(2) are not listed below because, as EPA interprets the CAA, SIPs incorporating any necessary local
nonattainment area controls would not be due within 3 years, but rather are due at the time the nonattainment area planning requirements are due. These elements are: (1) Emission limits and other control measures, section 110(a)(2)(A), and (2) Provisions for meeting part D, section 110(a)(2)(I), which requires areas designated as nonattainment to meet the applicable nonattainment planning requirements of part D, title I of the CAA. discussion on attaining the NAAQS in the proposed rule.

2. Consequences of Failing To Attain by the Statutory Attainment Date

a. Proposal

Any NO 2 nonattainment area that fails to attain by its statutory attainment date would be subject to the requirements of sections 179(c) and (d) of the CAA. EPA is required to make a finding of failure
to attain no later than 6 months after the specified attainment date and publish a
notice in the Federal Register. The State would be required to submit an implementation plan revision, no later than one year following the effective
date of the Federal Register notice making the determination of the area’s failure to attain, which demonstrates
that the standard will be attained as expeditiously as practicable, but no later than 5 years from the effective date of EPA’s finding that the area failed to attain. In addition, section 179(d)(2) provides that the SIP revision must include any specific additional measures as may be reasonably prescribed by EPA, including ‘‘ all measures that can be feasibly implemented in the area in light of technological achievability, costs, andany nonair quality and other air qualityrelated health and environmental impacts. ’’

b. Final

EPA did not receive any comments on this aspect of the proposed rule and is not making any changes to the discussion on consequences of failing to attain by the statutory attainment date in the proposed rule.

C. Section 110(a)(2) NAAQS Infrastructure Requirements

1. Proposal

Section 110(a)(2) of the CAA requires all States to develop and maintain a solid air quality management infrastructure, including enforceable emission limitations, an ambient monitoring program, an enforcement program, air quality modeling, and adequate personnel, resources, and legal authority. Section 110(a)(2)(D) also requires State plans to prohibit
emissions from within the State which contribute significantly to

nonattainment or maintenance areas in any other State, or which interfere with programs under part C to prevent significant deterioration of air quality or to achieve reasonable progress toward the national visibility goal for Federal class I areas (national parks and wilderness areas). Under section 110(a)(1) and (2) of the CAA, all States are required to submit
SIPs to EPA which demonstrate that basic program elements have been addressed within 3 years of the promulgation of any new or revised NAAQS. Subsections (A) through (M) of section 110(a)(2) listed below, set forth the elements that a State’s program must
contain in the SIP. 27 The list of section 110(a)(2) NAAQS implementation requirements are the following:

• Ambient air quality monitoring/ data system: Section 110(a)(2)(B) requires SIPs to provide for setting up and operating ambient air quality monitors, collecting and analyzing data and making these data available to EPA upon request.

• Program for enforcement of control measures: Section 110(a)(2)(C) requires SIPs to include a program providing for enforcement of measures and regulation and permitting of new/modified

sources.

• Interstate transport: Section 110(a)(2)(D) requires SIPs to include provisions prohibiting any source or other type of emissions activity in the State from contributing significantly to
nonattainment in another State or from interfering with measures required to prevent significant deterioration of air quality or to protect visibility.

• Adequate resources: Section 110(a)(2)(E) requires States to provide assurances of adequate funding, personnel and legal authority for implementation of their SIPs.

• Stationary source monitoring system: Section 110(a)(2)(F) requires States to establish a system to monitor emissions from stationary sources and to submit periodic emissions reports to

EPA.

• Emergency power: Section 110(a)(2)(G) requires States to include contingency plans, and adequate authority to implement them, for emergency episodes in their SIPs.

• Provisions for SIP revision due to NAAQS changes or findings of inadequacies: Section 110(a)(2)(H) requires States to provide for revisions of their SIPs in response to changes in the NAAQS, availability of improved methods for attaining the NAAQS, or in response to an EPA finding that the SIP is inadequate.

• Consultation with local and Federal government officials: Section 110(a)(2)(J) requires States to meet applicable local and Federal government consultation requirements when developing SIP and reviewing preconstruction permits.

• Public notification of NAAQS
exceedances: Section 110(a)(2)(J) requires States to adopt measures to notify the public of instances or areas in which a NAAQS is exceeded.

• PSD and visibility protection: Section 110(a)(2)(J) also requires States to adopt emissions limitations, and such other measures, as may be necessary to prevent significant deterioration of air quality in attainment areas and protect visibility in Federal Class I areas in accordance with the requirements of CAA Title I, part C.

• Air quality modeling/data: Section 110(a)(2)(K) requires that SIPs provide for performing air quality modeling for predicting effects on air quality of emissions of any NAAQS pollutant and submission of data to EPA upon request.

• Permitting fees: Section 110(a)(2)(L) requires the SIP to include requirements for each major stationary source to pay permitting fees to cover the cost of reviewing, approving, implementing and enforcing a permit.

• Consultation and participation by affected local government: Section 110(a)(2)(M) requires States to provide for consultation and participation by local political subdivisions affected by
the SIP.

2. Final

EPA did not receive any comments on this aspect of the proposed rule and is not making any changes to the discussion on section 110(a)(2) NAAQS infrastructure requirements in the proposed rule.

D. Attainment Planning Requirements

1. Nonattainment Area SIPs
a. Proposal

Any State containing an area designated as nonattainment with respect to the NO 2 NAAQS must develop for submission a SIP meeting the requirements of part D, Title I, of the CAA, providing for attainment by the applicable statutory attainment date ( see sections 191(a) and 192(a) of the CAA). As indicated in section 191(a) all components of the NO 2 part D SIP must
be submitted within 18 months of the effective date of an area’s designation as

nonattainment.

Section 172 of the CAA includes general requirements for all designated nonattainment areas. Section 172(c)(1)


### 6524 Federal Register / Vol. 75, No. 26 / Tuesday, February 9, 2010 / Rules and Regulations

28 The terms ‘‘ major ’’ and ‘‘ minor ’’ define the size of a stationary source, for applicability purposes, in terms of an annual emissions rate (tons per year, tpy) for a pollutant. Generally, a minor source is any source that is not ‘‘ major. ’’ ‘‘ Major ’’ is defined by the applicable regulations—PSD or

nonattainment NSR. requires that each nonattainment area plan ‘‘ provide for the implementation of all reasonably available control measures (RACM) as expeditiously as practicable (including such reductions in emissions from existing sources in the area as may be obtained through the adoption, at a minimum, of Reasonably Available Control Technology (RACT)), and shall provide for attainment of the national primary ambient air quality
standards. ’’ States are required to implement RACM and RACT in order to

attain ‘‘ as expeditiously as practicable ’’

.

Section 172(c) requires States with
nonattainment areas to submit a SIP for
these areas which contains an
attainment demonstration that shows
that the affected area will attain the standard by the applicable statutory
attainment date. The State must also
show that the area will attain the standards as expeditiously as practicable, and it must include an analysis of whether implementation of reasonably available measures will
advance the attainment date for the area.

Part D SIPs must also provide for reasonable further progress (RFP) ( see section 172(c)(2) of the CAA). The CAA
defines RFP as ‘‘ such annual
incremental reductions in emissions of the relevant air pollution as are required by part D, or may reasonably be required by the Administrator for the purpose of ensuring attainment of the applicable NAAQS by the applicable attainment
date. ’’ ( See section 171 of the CAA.) Historically, for some pollutants, RFP has been met by showing annual
incremental emission reductions sufficient to maintain generally linear progress toward attainment by the applicable attainment date.

All NO 2 nonattainment area SIPs must include contingency measures which must be implemented in the event that
an area fails to meet RFP or fails to attain the standards by its attainment date. ( See section 172(c)(9).) These contingency measures must be fully adopted rules or control measures that take effect without further action by the
State or the Administrator. The EPA interprets this requirement to mean that the contingency measures must be implemented with only minimal further action by the State or the affected sources with no additional rulemaking actions such as public hearings or legislative review.

Emission inventories are also critical for the efforts of State, local, and Federal agencies to attain and maintain the NAAQS that EPA has established for criteria pollutants including NO 2

. Section 191(a) in conjunction with section 172(c) requires that areas designated as nonattainment for NO 2 submit an emission inventory to EPA no later than 18 months after designation as
nonattainment. In the case of NO 2 , sections 191(a) and 172(c) also require that States submit periodic emission
inventories for nonattainment areas. The periodic inventory must include
emissions of NO 2 for point, nonpoint, mobile (on-road and non-road), and area

sources.

b. Public Comments

Several commenters indicated that EPA should take steps to ensure that States actually require mobile source
emissions reductions in order to attain
the NO 2 NAAQS as opposed to controlling point sources. Another
commenter went further and stated that States be required to control on-road emissions as opposed to emissions from stationary sources and in particular
EGUs. This commenter also indicated that EPA should delay nonattainment designations until States had a cost effective means of reducing on-road
emissions of NO 2

.

EPA cannot require States to develop a SIP that only addresses one type of source, in this case on-road mobile sources. States may select appropriate control measures to attain the NAAQS and EPA must approve them if they otherwise meet all applicable requirements of the Act. See CAA 116. EPA expects that States will evaluate a range of control measures that will
reduce NO 2 emissions within the time
allowed to attain the standard. This
would include the emissions reductions
attributable to Federal controls on onroad and non-road mobile sources, and controls that they have put in place to
reduce NO X emissions in order to attain the 8-hour ozone NAAQS and/or the

PM 2.5 NAAQS. If these existing controls
are not sufficient for an area to reach
attainment with the NO 2 NAAQS, EPA would expect the State to implement
additional control measures that would bring the area into attainment by the deadline. For a designation based on data from a near roadway monitor EPA would expect the States to give primary consideration to controlling emissions from on-road sources; however, it is likely that other types of sources
contribute to the concentrations that are measured at a near roadway monitor and a State may decide to implement controls on these other contributing

sources.

The Clean Air Act requires that EPA finalize designations within two years after a NAAQS is revised unless the available air quality data is insufficient to make designations by that time. In that case, EPA must finalize designations within three years after the NAAQS is revised. As discussed elsewhere in today’s final rule, EPA
believes that it has sufficient data to make designations within two years and that most areas will be designated as unclassifiable at that time. Taking the additional year provided by the CAA
would not allow additional data from the new near roadway monitors to be factored into the designations process in any event. Therefore, it is EPA’s intention to designate areas within two years as required by the Act. EPA intends to redesignate areas once it has sufficient data from the new monitoring network to designate areas as clearly attaining or not attaining the standard.

c. Final

The EPA is not making any changes
to the discussion on nonattainment area SIPs in the proposed rule.

2. New Source Review and Prevention of Significant Deterioration Requirements
a. Proposal

The Prevention of Significant Deterioration (PSD) and nonattainment New Source Review (NSR) programs contained in parts C and D of Title I of the CAA govern preconstruction review of any new or modified major stationary sources of air pollutants regulated under the CAA as well as any precursors to the formation of that pollutant when identified for regulation by the
Administrator. 28 The EPA rules addressing these programs can be found at 40 CFR 51.165, 51.166, 52.21, 52.24, and part 51, appendix S. States which have areas designated as nonattainment
for the NO 2 NAAQS must submit, as a part of the SIP due 18 months after an area is designated as nonattainment, provisions requiring permits for the construction and operation of new or modified stationary sources anywhere
in the nonattainment area. SIPs that address the PSD requirements related to
attainment areas are due no later than 3 years after the promulgation of a revised NAAQS for NO 2

.

The NSR program is composed of three different permit programs:

• Prevention of Significant Deterioration (PSD).

• Nonattainment NSR (NA NSR).

• Minor NSR. The PSD program applies when a major source, that is located in an area that is designated as attainment or


### 6525 Federal Register / Vol. 75, No. 26 / Tuesday, February 9, 2010 / Rules and Regulations

29 In addition, the PSD program applies to noncriteria pollutants subject to regulation under the Act, except those pollutants regulated under section 112 and pollutants subject to regulation only under section 211(o). 30 Criteria pollutants are those pollutants for which EPA has established a NAAQS under section
109 of the CAA. unclassifiable for any criteria pollutant, is constructed, or undergoes a major
modification. 29 The nonattainment NSR program applies on a pollutant-specific basis when a major source constructs or modifies in an area that is designated as nonattainment for that pollutant. The minor source NSR program addresses both major and minor sources which undergo construction or modification activities that do not qualify as major, and it applies, as necessary to assure attainment, regardless of the designation
of the area in which a source is located.

The PSD requirements include but are not limited to the following:

• Installation of Best Available Control Technology (BACT);

• Air quality monitoring and modeling analyses to ensure that a project’s emissions will not cause or contribute to a violation of any NAAQS or maximum allowable pollutant increase (PSD increment);

• Notification of Federal Land Manager of nearby Class I areas; and

• Public comment on permit. Nonattainment NSR requirements
include but are not limited to:

• Installation of Lowest Achievable Emissions Rate (LAER) control technology;

• Offsetting new emissions with creditable emissions reductions;

• A certification that all major sources owned and operated in the State by the same owner are in compliance with all applicable requirements under the CAA;

• An alternative siting analysis demonstrating that the benefits of a proposed source significantly outweigh
the environmental and social costs imposed as a result of its location, construction, or modification; and

• Public comment on the permit. Minor NSR programs must meet the statutory requirements in section 110(a)(2)(C) of the CAA which requires

‘‘ * * * regulation of the modification and construction of any stationary source * * * as necessary to assure that the [NAAQS] are achieved. ’’ Areas which are newly designated as
nonattainment for the NO 2 NAAQS as a result of any changes made to the NAAQS will be required to adopt a nonattainment NSR program to address major sources of NO 2 where the program does not currently exist for the NO 2 NAAQS and may need to amend their minor source program as well. Prior to adoption of the SIP revision addressing major source nonattainment NSR for NO 2 nonattainment areas, the requirements of 40 CFR part 51, appendix S may apply.

b. Public Comments

One commenter claimed that EPA’s setting of a more stringent standard, i.e., short-term NO 2 NAAQS, could have important implications for NSR and PSD and title V permits. Another
commenter indicated that the promulgation of a new 1-hr NO 2 shortterm standard could create the need for
a short-term PSD increment. Another
commenter stated that a 1-hr NO 2 Significant Impact Level (SIL) should be developed.

The EPA acknowledges that a decision to promulgate a new short-term

NO 2 NAAQS will clearly have implications for the air permitting process. The full extent of how a new
short-term NO 2 NAAAQS will affect the NSR process will need to be carefully evaluated. First, major new and modified sources applying for NSR/PSD permits will initially be required to demonstrate that their proposed
emissions increases of NO X will not
cause or contribute to a violation of
either the annual or 1-hour NO 2 NAAQS
and the annual PSD increment. In addition, we believe that section 166 of
the CAA authorizes us to consider the need to promulgate a new 1-hour increment. Historically, EPA has developed increments for each applicable averaging period for which a NAAQS has been promulgated. However, increments for a particular pollutant do not necessarily need to match the averaging periods that have been established for NAAQS for the same pollutant. Environmental Defense Fund, Inc. v. EPA, 898 F.2d 183, 189– 190 (DC Cir. 1990) ( ‘‘ * * * the ‘goals and purposes’ of the PSD program, set forth in 160, are not identical to the
criteria on which the ambient standards
are based. ’’ ) Thus, we would need to
evaluate the need for a new 1-hour NO 2 increment in association with the goals and purposes of the statutory PSD program requirements.

We also believe that there may be a need to revise the screening tools currently used under the NSR/PSD program for completing NO 2 analyses. These screening tools include the significant impact levels (SILs), as mentioned by one commenter, but also include the significant emissions rate
for emissions of NO X and the significant monitoring concentration (SMC) for

NO 2 . EPA intends to evaluate the need for possible changes or additions to each of these important screening tools for

NO X /NO 2 due to the addition of a
1-hour NO 2 NAAQS. If changes or additions are deemed necessary, EPA will propose any such changes for public notice and comment in a separate

action.

c. Final

The EPA is not making any changes to the discussion concerning the requirements for NSR and PSD as stated in the proposed rule.

3. General Conformity

a. Proposal

Section 176(c) of the CAA, as amended (42 U.S.C. 7401 et seq. ), requires that all Federal actions conform to an applicable implementation plan developed pursuant to section 110 and part D of the CAA. The EPA rules, developed under the authority of section 176(c) of the CAA, prescribe the criteria and procedures for demonstrating and assuring conformity
of Federal actions to a SIP. Each Federal agency must determine that any actions covered by the general conformity rule conform to the applicable SIP before the
action is taken. The criteria and procedures for conformity apply only in
nonattainment areas and those areas redesignated attainment since 1990 ( ‘‘ maintenance areas ’’ ) with respect to the criteria pollutants under the CAA: 30 carbon monoxide (CO), lead (Pb), nitrogen dioxide (NO 2 ), ozone (O 3 ), particulate matter (PM 2.5 and PM 10 ), and sulfur dioxide (SO 2 ). The general conformity rules apply one year following the effective date of designations for any new or revised NAAQS.

The general conformity determination examines the impacts of direct and
indirect emissions related to Federal actions. The general conformity rule provides several options to satisfy air quality criteria, such as modeling or offsets, and requires the Federal action to also meet any applicable SIP requirements and emissions milestones. The general conformity rule also requires that notices of draft and final general conformity determinations be provided directly to air quality regulatory agencies and to the public by publication in a local newspaper.

b. Final

EPA did not receive any comments on this aspect of the proposed rule and is not making any changes to the discussion concerning general conformity stated in the proposed rule.


### 6526 Federal Register / Vol. 75, No. 26 / Tuesday, February 9, 2010 / Rules and Regulations

4. Transportation Conformity

a. Proposal

Transportation conformity is required under CAA section 176(c) (42 U.S.C. 7506(c)) to ensure that transportation plans, transportation improvement programs (TIPs) and Federally supported highway and transit projects will not cause new air quality violations, worsen existing violations, or delay timely attainment of the relevant NAAQS or interim reductions and milestones. Transportation conformity applies to areas that are designated
nonattainment and maintenance for transportation-related criteria pollutants: Carbon monoxide (CO), ozone (O 3 ), nitrogen dioxide (NO 2 ), and particulate matter (PM 2.5 and PM 10 ). Transportation conformity for a revised

NO 2 NAAQS does not apply until one year after the effective date of a nonattainment designation. ( See CAA section 176(c)(6) and 40 CFR 93.102(d)).

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 to the SIP. The EPA is not making changes to the Transportation Conformity rule in this rulemaking. However, in the future,
EPA will review the need to conduct a rulemaking to establish any new or revised transportation conformity tests that would apply under a revision to the

NO 2 NAAQS for transportation plans, TIPs, and applicable highway and transit projects.

b. Public Comments

Several commenters stated that transportation conformity could stop the funding of highway and transit projects

in NO 2 nonattainment areas. These
commenters stated that if an area fails to demonstrate conformity, it enters a conformity lapse and only certain types of projects can be funded during a lapse.
The commenters further stated that the

NO 2 NAAQS will require more areas to determine conformity for the first time. The commenters also expressed concern
that the NO 2 NAAQS proposal did not
contain sufficient information to
understand to what extent revisions to the NAAQS, and the NO 2 monitoring requirements, will result in transportation conformity requirements for individual transportation projects such as the need for a hot-spot analysis.
The commenters further stated that hotspot analyses could result in needless delays for transportation improvement projects.

With regard to the comment that more
areas will have to demonstrate conformity for the first time due to the revisions to the NO 2 NAAQS, given that today’s final rule is requiring that near roadway monitoring be carried out in urban areas with populations greater than 350K, EPA believes that most areas with such populations that would be designated nonattainment for NO 2 are already designated nonattainment or
maintenance for one or more of the other transportation-related criteria pollutants (ozone, PM 2.5 , PM 10 and carbon monoxide). As such, these areas would have experience in making transportation conformity
determinations. If areas with no conformity experience are designated
nonattainment for the NO 2 NAAQS,
EPA and U.S. DOT would be available to assist areas in implementing the transportation conformity requirements.

The commenter expressed concern that transportation conformity could stop highway and transit funding because areas could experience a conformity lapse and in such cases only certain types of projects could be funded. A conformity lapse occurs
when an area misses a deadline for a required conformity determination. A

new nonattainment area must demonstrate conformity within one year after the effective date of its designation. For any areas designated nonattainment
for the revised NO 2 NAAQS in early2012, they would have to determine conformity within one year of the effective date of that designation which would be in early-2013. If that date was missed, a lapse would occur and only projects exempt from conformity such as safety projects, transportation control measures in an approved SIP for the area and projects or project phases that were approved by U.S. DOT before the lapse began can proceed during the lapse. EPA’s experience in implementing the 1997 ozone and PM 2.5 NAAQS shows that nearly all areas make their initial conformity determinations within the one-year grace period. Areas can also lapse if they fail to determine conformity by an applicable deadline such as determining conformity within two years after motor vehicle emissions budgets are found adequate. However, areas that miss one of these conformity deadlines have a one-year grace period before the lapse goes into effect. During the grace period,
the area can continue to advance projects from the transportation plan and transportation improvement program. EPA’s experience is that areas generally are able to make a conformity
determination before the end of the grace period.

The commenter expressed concern
that the NO 2 NAAQS proposal did not contain sufficient detail concerning possible project-level requirements for transportation projects and that any requirements for hot-spot analyses could needlessly delay transportation projects. As EPA indicated in the NPRM, EPA is considering whether to revise the transportation conformity rule to establish requirements that would apply to transportation plans, transportation improvement programs and/or transportation projects in NO 2 nonattainment and maintenance areas. If EPA concludes that the conformity rule must be revised in light of the final

NO 2 NAAQS, we will conduct notice and comment rulemaking to accomplish
the revisions. At that time interested parties will have the opportunity to comment on any transportation conformity NPRM. This is the same
course of action that EPA has taken with respect to revising the transportation conformity rule for the ozone and PM 2.5 NAAQS.

With regard to the commenter’s assertion that a requirement for hot-spot analyses for individual projects would needlessly delay transportation projects, EPA disagrees. First, CAA section 176(c)(1)(B) requires that transportation projects not cause new violations or make existing violations worse, or delay timely attainment or cause an interim milestone to be missed. EPA would only impose a hot-spot requirement for projects in NO 2 nonattainment and maintenance areas if they are necessary to comply with CAA conformity requirements and therefore are needed to protect public health by reducing exposures to unhealthy levels of NO 2 that could be created by the implementation of a proposed highway or transit project. The public would be exposed to unhealthy levels of NO 2 if a highway or transit project caused a new
violation of the NO 2 NAAQS, made an existing violation worse, or delayed timely attainment or delayed achieving an interim emissions milestone. If any delay in the project did occur, it would
not be viewed as needless as it occurred for the important purpose of protecting the exposed public’s health. Second,EPA does not agree that requiring a hotspot analysis would needlessly delay projects in NO 2 nonattainment areas. Such hot-spot analyses, if they are eventually required, generally would be done as part of the NEPA process, which these projects are already subject to; therefore, conducting an NO 2 hotspot analysis would not be introducing a new step to a project’s approval process, but rather would add one additional analysis which must be completed as part of an existing project approval process.


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c. Final

EPA is not making any changes to the discussion concerning transportation conformity as stated in the proposed
rule.

VII. Communication of Public Health
Information

Information on the public health implications of ambient concentrations of criteria pollutants is currently made available primarily through EPA’s Air Quality Index (AQI) program. This section describes the conforming changes that were proposed, major comments received on these changes, EPA’s responses to these comments and final decisions on the AQI breakpoints. Recognizing the importance of revising the AQI in a timely manner to be consistent with any revisions to the NAAQS, EPA proposed conforming changes to the AQI in connection with
the final decision on the NO 2 NAAQS if revisions to the primary standard were promulgated. Conforming changes would include setting the 100 level of the AQI at the same level as the revised primary NO 2 NAAQS and also setting the other AQI breakpoints at the lower end of the AQI scale ( i.e., AQI values of 50 and 150). EPA did not propose to change breakpoints at the higher end of the AQI scale (from 200 to 500), which would apply to State contingency plans or the Significant Harm Level (40 CFR 51.16), because the information from
this review does not inform decisions about breakpoints at those higher levels.

With regard to an AQI value of 50, the breakpoint between the good and moderate categories, EPA proposed to
set this value to be between 0.040 and 0.053 ppm NO 2 , 1-hour average. EPA proposed that the figure towards the lower end of this range would be appropriate if the standard is set towards the lower end of the proposed range for the standard ( e.g. 80 ppb), while figures towards the higher end of the range would be more appropriate for standards set at the higher end of the range for the standard ( e.g., 100 ppb). EPA noted that historically this value is set at the level of the annual NAAQS, if there is one, or one-half the level of the short-term NAAQS in the absence of an annual NAAQS, and solicited comments on this range for an AQI of 50 and the appropriate basis for selecting an AQI of 50 within this range.

With regard to an AQI value of 150, the breakpoint between the unhealthy for sensitive groups and unhealthy categories, the range of 0.360 to 0.370 ppm NO 2 , 1-hour average, represents the midpoint between the proposed range
for the short-term standard and the level of an AQI value of 200 (0.64 ppm NO 2 , 1-hour average). Therefore, EPA proposed to set the AQI value of 150 to be between 0.360 and 0.370 ppm NO 2 , 1-hour average.

EPA received comments from several State environmental agencies and organizations of State and local agencies that generally expressed the view that the AQI was designed to provide the public with information about regional air quality and therefore it should be based on community-wide monitors.
These commenters went on to state that using near-road NO 2 monitors for the AQI would present problems because they would not represent regional NO 2 concentrations and it would be difficult to communicate this type of information to the public using the AQI. Some expressed concern that NO 2 measured at near-roadway monitors could be the critical pollutant and could drive the AQI even though it may not represent air quality across the area. Other agencies expressed concern that there is currently no way to forecast ambient

NO 2 levels near roadways. One State agency commented that the AQI is intended to represent air quality where people live, work and play.

EPA agrees with commenters that the AQI should represent regional air quality, and that measurements that apply to a limited area should not be used to characterize air quality across the region. Community-wide NO 2 monitors should be used to characterize air quality across the region. However, the AQI reporting requirements encourage, but do not require, the reporting of index values of sub-areas of an MSA. We agree with the commenter that stated the view that the AQI is intended to represent air quality where people live, work and play. To the extent that near-roadway monitoring occurs in areas where people live, work or play, EPA encourages reporting of the AQI for that specific sub-area of the MSA (64 FR 42548, August 4, 1999). We also agree that it may be difficult to communicate this type of information and we plan to work with State and local air agencies to figure out the best way to present this information to the public using the AQI. Air quality forecasting is recommended but not required (64 FR 42548, August 4, 1999). EPA will work with State agencies that want to develop a forecasting program.

With regard to the proposed breakpoints, EPA received few
comments. The National Association of Clean Air Agencies commented that it would be confusing to the public to have an AQI value of 50 set below the
level of the annual NO 2 standard. We agree with this comment, and therefore have decided that it is appropriate to set the AQI value of 50, the breakpoint between the good and moderate ranges,
set at the numerical level of the annual standard, 53 ppb NO 2 , 1-hour average. The AQI value of 100, the breakpoint between the moderate and unhealthy for sensitive groups category, is set at 100 ppb, 1-hour average, the level of the primary NO 2 NAAQS. EPA is setting an AQI value of 150, the breakpoint between the unhealthy for sensitive groups and unhealthy categories, at 0.360 ppm NO 2 , 1-hour average.

VIII. Statutory and Executive Order

Reviews

A. Executive Order 12866: Regulatory Planning and Review

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is a

‘‘ significant regulatory action ’’ because it
was deemed to ‘‘ raise novel legal or policy issues. ’’ Accordingly, EPA
submitted this action to the Office of Management and Budget (OMB) for
review under Executive Order 12866 and any changes made in response to
OMB recommendations have been
documented in the docket for this action. In addition, EPA prepared a Regulatory Impact Analysis (RIA) of the potential costs and benefits associated with this action. However, the CAA and judicial decisions make clear that the economic and technical feasibility of attaining ambient standards are not to be considered in setting or revising NAAQS, although such factors may be considered in the development of State plans to implement the standards. Accordingly, although an RIA has been prepared, the results of the RIA have not been considered in developing this final
rule.

B. Paperwork Reduction Act

The information collection requirements in this final rule have been submitted for approval to the Office of Management and Budget (OMB) under the Paperwork Reduction Act, 44 U.S.C.

3501 et seq. The information collection requirements are not enforceable until OMB approves them.

The Information Collection Request (ICR) document prepared by EPA for these revisions to part 58 has been assigned EPA ICR number 2358.02.

The information collected under 40 CFR part 53 ( e.g., test results, monitoring records, instruction manual, and other associated information) is
needed to determine whether a
candidate method intended for use in determining attainment of the National Ambient Air Quality Standards (NAAQS) in 40 CFR part 50 will meet


### 6528 Federal Register / Vol. 75, No. 26 / Tuesday, February 9, 2010 / Rules and Regulations

the design, performance, and/or comparability requirements for designation as a Federal reference method (FRM) or Federal equivalent method (FEM). We do not expect the
number of FRM or FEM determinations
to increase over the number that is currently used to estimate burden
associated with NO 2 FRM/FEM determinations provided in the current ICR for 40 CFR part 53 (EPA ICR numbers 2358.01). As such, no change in the burden estimate for 40 CFR part 53 has been made as part of this rulemaking.

The information collected and reported under 40 CFR part 58 is needed to determine compliance with the NAAQS, to characterize air quality and associated health impacts, to develop emissions control strategies, and to measure progress for the air pollution program. The amendments would revise the technical requirements for NO 2 monitoring sites, require the siting and operation of additional NO 2 ambient air monitors, and the reporting of the
collected ambient NO 2 monitoring data to EPA’s Air Quality System (AQS). The annual average reporting burden for the collection under 40 CFR part 58 (averaged over the first 3 years of this ICR) is $3,261,007. 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 monitors and related

activities.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB
control number. The OMB control numbers for EPA’s regulations in 40 CFR are listed in 40 CFR part 9.

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 businesses, small organizations, and small governmental jurisdictions.

For purposes of assessing the impacts of this rule on small entities, small entity is defined as: (1) A small business that is a small industrial entity as defined by the Small Business 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 is any not-for-profit enterprise which is independently owned and operated and is not
dominant in its field.

After considering the economic impacts of this final rule on small entities, I certify that this action will not have a significant economic impact on
a substantial number of small entities. This final rule will not impose any requirements on small entities. Rather,
this rule establishes national standards
for allowable concentrations of NO 2 in ambient air as required by section 109
of the CAA. American Trucking Ass’ns

v. EPA, 175 F.3d 1027, 1044–45 (DC cir. 1999) (NAAQS do not have significant impacts upon small entities because NAAQS themselves impose no regulations upon small entities). Similarly, the amendments 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.

D. Unfunded Mandates Reform Act

This rule does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and Tribal governments, in the aggregate, or the private sector in any one year. The revisions to the NO 2 NAAQS impose no enforceable duty on any State, local or Tribal governments or the private sector. The expected costs associated with the monitoring requirements are described in EPA’s ICR document, but those costs are not expected to exceed $100 million in the aggregate for any year. Furthermore, as indicated previously, in setting a NAAQS EPA cannot consider the economic or technological feasibility of attaining ambient air quality standards. Because the Clean Air Act prohibits EPA from considering the types of
estimates and assessments described in section 202 when setting the NAAQS, the UMRA does not require EPA to prepare a written statement under
section 202 for the revisions to the NO 2 NAAQS. Thus, this rule is not subject to the requirements of sections 202 or 205
of UMRA.

With regard to implementation guidance, the CAA imposes the obligation for States to submit SIPs to implement the NO 2 NAAQS. In this final rule, EPA is merely providing an interpretation of those requirements. However, even if this rule did establish an independent obligation for States to submit SIPs, it is questionable whether an obligation to submit a SIP revision would constitute a Federal mandate in any case. The obligation for a State to
submit a SIP that arises out of section
110 and section 191 of the CAA is not legally enforceable by a court of law,
and at most is a condition for continued receipt of highway funds. Therefore, it is possible to view an action requiring such a submittal as not creating any enforceable duty within the meaning of 2 U.S.C. 658 for purposes of the UMRA. Even if it did, the duty could be viewed as falling within the exception for a
condition of Federal assistance under

2 U.S.C. 658.

This rule is also not subject to the requirements of section 203 of UMRA because it contains no regulatory requirements that might significantly or uniquely affect small governments because it imposes no enforceable duty on any small governments.

E. Executive Order 13132: Federalism

This action does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, 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 Federal government and the States regarding the establishment and implementation of air quality improvement programs as codified in the CAA. Under section 109 of the CAA, EPA is mandated to establish NAAQS; however, CAA section 116 preserves the rights of States to establish more stringent requirements if deemed necessary by a State. Furthermore, this rule does not impact CAA section 107
which establishes that the States have primary responsibility for implementation of the NAAQS. Finally, as noted in section E (above) on UMRA, this rule does not impose significant costs on State, local, or Tribal governments or the private sector. Thus, Executive Order 13132 does not apply
to this rule.

F. Executive Order 13175: Consultation
and Coordination With Indian Tribal

Governments

This action does not have Tribal implications, as specified in Executive Order 13175 (65 FR 67249, November 9, 2000). It does not have a substantial
direct effect on one or more Indian Tribes, on the relationship between the Federal government and Indian Tribes, or on the distribution of power and responsibilities between the Federal government and Tribes. The rule does not alter the relationship between the


### 6529 Federal Register / Vol. 75, No. 26 / Tuesday, February 9, 2010 / Rules and Regulations

Federal government and Tribes as
established in the CAA and the TAR. Under section 109 of the CAA, EPA is mandated to establish NAAQS; however, this rule does not infringe existing Tribal authorities to regulate air quality under their own programs or under programs submitted to EPA for approval. Furthermore, this rule does not affect the flexibility afforded to Tribes in seeking to implement CAA programs consistent with the TAR, nor does it impose any new obligation on Tribes to adopt or implement any NAAQS. Finally, as noted in section E (above) on UMRA, this rule does not impose significant costs on Tribal governments. Thus, Executive Order 13175 does not apply to this action.

G. Executive Order 13045: Protection of
Children From Environmental Health Risks and Safety Risks

This action is subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it is an economically significant regulatory action as defined by Executive Order 12866, and EPA
believes that the environmental health or safety risk addressed by this action has a disproportionate effect on
children. The final rule will establish uniform national ambient air quality
standards for NO 2 ; these standards are designed to protect public health with an adequate margin of safety, as required by CAA section 109. The protection offered by these standards may be especially important for asthmatics, including asthmatic children, because respiratory effects in asthmatics are among the most sensitive health endpoints for NO 2 exposure. Because asthmatic children are considered a sensitive population, we have evaluated the potential health effects of exposure to NO 2 pollution among asthmatic children. These effects and the size of the population affected are discussed in chapters 3 and 4 of the ISA; chapters 3, 4, and 8 of the REA, and sections II.A through II.E of this preamble.

H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution or Use

This action is not a ‘‘ significant energy

action ’’ as defined in Executive Order

13211, ‘‘ Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use ’’ (66 FR 28355 (May 22, 2001)) because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The purpose of this rule is to establish revised NAAQS for NO 2 . The rule does not prescribe specific control strategies by which these ambient standards will be met. Such strategies will be developed by States on a case-by-case basis, and EPA cannot predict whether the control options selected by States will include regulations on energy suppliers, distributors, or users. Thus,
EPA concludes that this rule is not likely to have any adverse energy
effects.

I. National Technology Transfer and
Advancement Act

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104– 113, section 12(d) (15 U.S.C. 27 2 note) directs EPA to use voluntary consensus standards in its regulatory activities
unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary 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 EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.

This final rulemaking involves
technical standards. Therefore the Agency conducted a search to identify potential applicable voluntary consensus standards. However, we identified no such standards, and none were brought to our attention in comments. Therefore, EPA has decided
to use the technical standard described in Section III.A of the preamble.

J. 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 their 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.

EPA has determined that this final 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 effects on any population, including any minority or low-income population. The
final rule will establish uniform
national standards for NO 2 in ambient

air.

K. Congressional Review Act

The Congressional Review Act, 5

U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General
of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in
the Federal Register . A Major rule cannot take effect until 60 days after it is published in the Federal Register

. This action is a ‘‘ major rule ’’ as defined by 5 U.S.C. 804(2). This rule will be effective on April 12, 2010.

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Recommendations Concerning EPA’s Proposed Rule for the Revision of the National Ambient Air Quality Standards (NAAQS) for Nitrogen Dioxide. ’’ EPA– CASAC–09–014, September 9. Schildcrout, JS, Sheppard L, Lumley T,

Slaughter JC, Koenig JQ, Shapiro GG. (2006). Ambient air pollution and asthma exacerbations in children: an eight-city analysis. Am J Epidemiol. 164:505–517. Schindler, C, Ku  ̈ nzli N, Bongard JP, Leuenberger P, Karrer W, Rapp R, Monn C, Ackermann-Liebrich U. (2001). Short-term variation in air pollution and in average lung function among never-smokers. Am. J. Respir. Crit. Care Med. 163: 356–361. Schwartz, J, Dockery DW, Neas LM, Wypij D,

Ware JH, Spengler JD, Koutrakis P, Speizer FE, Ferris BG, Jr. (1994). Acute effects of summer air pollution on respiratory symptom reporting in children. Am J Respir Crit Care Med. 150:1234–1242. Singer, B, Hodgson A, Hotchi T, Kim J.

(2004). Passive measurement of nitrogen oxides to assess traffic-related pollutant exposure for the East Bay Children’s Respiratory Health Study. Atmos Environ.

38:393–403. Thompson, R. (2008). Nitrogen Dioxide (NO 2 )

Descriptive Statistics Tables. Memo to the

NO 2 NAAQS docket. Available at http:// www.epa.gov/ttn/naaqs/standards/nox/

s

_ nox

_ cr

_ rea.html

. Tolbert, PE, Klein M, Peel JL, Sarnat SE,

Sarnat JA. (2007). Multipollutant modeling issues in a study of ambient air quality and emergency department visits in Atlanta. J. Exposure Sci. Environ. Epidemiol. 17(Suppl. 2s): S29–S35. Watkins, N. and Thompson, R. (2008). NO X

Network Review and Background. Memo to
the NO 2 NAAQS docket. Zhou, Y and Levy JI. (2007). Factors

influencing the spatial extent of mobilesource air pollution impacts: a metaanalysis. BMC Public Health. 7:89.
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 58

Environmental protection, Administrative practice and procedure, Air pollution control, Intergovernmental relations, Reporting and recordkeeping requirements.

Dated: January 22, 2010.
Lisa P. Jackson,

Administrator.

■ For the reasons stated in the preamble, title 40, chapter I of the Code of Federal Regulations is amended as follows:

**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. Section 50.11 is revised to read as
follows:

**§ 50.11 National primary and secondary ambient air quality standards for oxides of**  **nitrogen (with nitrogen dioxide as the indicator).** 

(a) The level of the national primary annual ambient air quality standard for oxides of nitrogen is 53 parts per billion (ppb, which is 1 part in 1,000,000,000), annual average concentration, measured in the ambient air as nitrogen dioxide.

(b) The level of the national primary 1-hour ambient air quality standard for oxides of nitrogen is 100 ppb, 1-hour average concentration, measured in the ambient air as nitrogen dioxide.

(c) The level of the national secondary ambient air quality standard for nitrogen dioxide is 0.053 parts per million (100 micrograms per cubic meter), annual
arithmetic mean concentration. (d) The levels of the standards shall be measured by:

(1) A reference method based on appendix F to this part; or

(2) By a Federal equivalent method (FEM) designated in accordance with part 53 of this chapter.

(e) The annual primary standard is met when the annual average concentration in a calendar year is less than or equal to 53 ppb, as determined in accordance with Appendix S of this part for the annual standard.

(f) The 1-hour primary standard is met when the three-year average of the annual 98th percentile of the daily maximum 1-hour average concentration is less than or equal to 100 ppb, as
determined in accordance with Appendix S of this part for the 1-hour
standard.

(g) The secondary standard is attained
when the annual arithmetic mean concentration in a calendar year is less than or equal to 0.053 ppm, rounded to three decimal places (fractional parts equal to or greater than 0.0005 ppm must be rounded up). To demonstrate attainment, an annual mean must be based upon hourly data that are at least 75 percent complete or upon data
derived from manual methods that are at least 75 percent complete for the scheduled sampling days in each calendar quarter.

■ 3. Section 50.14 is amended by adding an entry to the end of table in paragraph (c)(2)(vi) to read as follows:

**§ 50.14 Treatment of air quality monitoring data influenced by exceptional events.** 

* * * * *

(c) * * * (2) * * * (vi) * * *



### T ABLE 

### 1—S CHEDULE FOR 

### E XCEPTIONAL 

### E VENT 

### F LAGGING AND 

### D OCUMENTATION 

### S UBMISSION FOR 

### D ATA 

### T O 

### B E 

### U SED IN 

### D ESIGNATIONS 

### D ECISIONS FOR 

### N EW OR 

### R EVISED 

### NAAQS

NAAQS pollutant/ standard/

(level)/ promulgation date Air quality data collected for calendar

year Event flagging & initial description

deadline Detailed documentation

submission

deadline

*******
NO 2 /1-Hour Standard (100 PPB) .............................. 2008 July 1, 2010 a ............................................................. January 22, 2011. 2009 July 1, 2010 ............................................................... January 22, 2011. 2010 April 1, 2011 a ............................................................ July 1, 2011 a

.

a Indicates change from general schedule in 40 CFR 50.14. Note: EPA notes that the table of revised deadlines only applies to data EPA will use to establish the final initial designations for new or revised NAAQS. The general schedule applies for all other purposes, most notably, for data used by EPA for redesignations to atta inment.


### 6532 Federal Register / Vol. 75, No. 26 / Tuesday, February 9, 2010 / Rules and Regulations

* * * * *

■ 4. Appendix S to Part 50 is added to
read as follows:

Appendix S to Part 50—Interpretation of the Primary National Ambient Air Quality Standards for Oxides of Nitrogen (Nitrogen Dioxide)

1. General

(a) This appendix explains the data handling conventions and computations necessary for determining when the primary national ambient air quality standards for oxides of nitrogen as measured by nitrogen dioxide ( ‘‘ NO 2 NAAQS ’’ ) specified in 50.11 are met. Nitrogen dioxide (NO 2 ) is measured in the ambient air by a Federal reference method (FRM) based on appendix F to this part or by a Federal equivalent method (FEM) designated in accordance with part 53 of this chapter. Data handling and computation procedures to be used in making comparisons between reported NO 2 concentrations and the levels of the NO 2 NAAQS are specified in the following

sections.

(b) Whether to exclude, retain, or make adjustments to the data affected by exceptional events, including natural events, is determined by the requirements and process deadlines specified in 50.1, 50.14 and 51.930 of this chapter.

(c) The terms used in this appendix are
defined as follows:

Annual mean refers to the annual average
of all of the 1-hour concentration values as defined in section 5.1 of this appendix.

Daily maximum 1-hour values for NO 2 refers to the maximum 1-hour NO 2 concentration values measured from midnight to midnight (local standard time) that are used in NAAQS computations.

Design values are the metrics ( i.e.

, statistics) that are compared to the NAAQS levels to determine compliance, calculated as specified in section 5 of this appendix. The design values for the primary NAAQS are:

(1) The annual mean value for a monitoring site for one year (referred to as the ‘‘ annual primary standard design value ’’ ).

(2) The 3-year average of annual 98th percentile daily maximum 1-hour values for a monitoring site (referred to as the ‘‘ 1-hour primary standard design value ’’ ).

98th percentile daily maximum 1-hour
value is the value below which nominally 98 percent of all daily maximum 1-hour concentration values fall, using the ranking and selection method specified in section 5.2 of this appendix.

Quarter refers to a calendar quarter.

Year refers to a calendar year.

2. Requirements for Data Used for Comparisons With the NO 2 NAAQS and Data Reporting Considerations

(a) All valid FRM/FEM NO 2 hourly data required to be submitted to EPA’s Air Quality System (AQS), or otherwise available to EPA, meeting the requirements of part 58 of this chapter including appendices A, C, and E shall be used in design value calculations. Multi-hour average concentration values collected by wet chemistry methods shall not
be used. (b) When two or more NO 2 monitors are operated at a site, the State may in advance designate one of them as the primary
monitor. If the State has not made this designation, the Administrator will make the designation, either in advance or retrospectively. Design values will be developed using only the data from the primary monitor, if this results in a valid design value. If data from the primary monitor do not allow the development of a valid design value, data solely from the other monitor(s) will be used in turn to develop a valid design value, if this results in a valid design value. If there are three or more monitors, the order for such comparison of the other monitors will be determined by the Administrator. The Administrator may
combine data from different monitors in different years for the purpose of developing a valid 1-hour primary standard design value, if a valid design value cannot be developed solely with the data from a single monitor. However, data from two or more monitors in the same year at the same site will not be combined in an attempt to meet data completeness requirements, except if one monitor has physically replaced another instrument permanently, in which case the
two instruments will be considered to be the same monitor, or if the State has switched the designation of the primary monitor from one instrument to another during the year.

(c) Hourly NO 2 measurement data shall be reported to AQS in units of parts per billion (ppb), to at most one place after the decimal, with additional digits to the right being truncated with no further rounding.

3. Comparisons With the NO 2 NAAQS

3.1 The Annual Primary NO 2 NAAQS
(a) The annual primary NO 2 NAAQS is met at a site when the valid annual primary standard design value is less than or equal to 53 parts per billion (ppb).

(b) An annual primary standard design value is valid when at least 75 percent of the hours in the year are reported.

(c) An annual primary standard design
value based on data that do not meet the completeness criteria stated in section 3.1(b) may also be considered valid with the approval of, or at the initiative of, the Administrator, who may consider factors such as monitoring site closures/moves, monitoring diligence, the consistency and
levels of the valid concentration measurements that are available, and nearby concentrations in determining whether to use
such data.

(d) The procedures for calculating the annual primary standard design values are given in section 5.1 of this appendix.

3.2 The 1-hour Primary NO 2 NAAQS
(a) The 1-hour primary NO 2 NAAQS is met at a site when the valid 1-hour primary standard design value is less than or equal to 100 parts per billion (ppb).

(b) An NO 2 1-hour primary standard design value is valid if it encompasses three consecutive calendar years of complete data. A year meets data completeness requirements when all 4 quarters are complete. A quarter is complete when at least 75 percent of the sampling days for each quarter have complete data. A sampling day has complete data if 75 percent of the hourly concentration values, including State-flagged data affected by exceptional events which have been approved for exclusion by the Administrator, are reported.

(c) In the case of one, two, or three years that do not meet the completeness requirements of section 3.2(b) of this appendix and thus would normally not be useable for the calculation of a valid 3-year 1-hour primary standard design value, the 3- year 1-hour primary standard design value
shall nevertheless be considered valid if one of the following conditions is true.

(i) At least 75 percent of the days in each quarter of each of three consecutive years have at least one reported hourly value, and the design value calculated according to the procedures specified in section 5.2 is above the level of the primary 1-hour standard.

(ii)(A) A 1-hour primary standard design value that is below the level of the NAAQS
can be validated if the substitution test in section 3.2(c)(ii)(B) results in a ‘‘ test design
value ’’ that is below the level of the NAAQS.
The test substitutes actual ‘‘ high ’’ reported daily maximum 1-hour values from the same site at about the same time of the year (specifically, in the same calendar quarter)
for unknown values that were not successfully measured. Note that the test is merely diagnostic in nature, intended to confirm that there is a very high likelihood that the original design value (the one with less than 75 percent data capture of hours by day and of days by quarter) reflects the true under-NAAQS-level status for that 3-year period; the result of this data substitution test (the ‘‘ test design value ’’ , as defined in section 3.2(c)(ii)(B)) is not considered the actual design value. For this test, substitution is permitted only if there are at least 200 days across the three matching quarters of the three years under consideration (which is about 75 percent of all possible daily values in those three quarters) for which 75 percentof the hours in the day, including Stateflagged data affected by exceptional events which have been approved for exclusion by the Administrator, have reported concentrations. However, maximum 1-hour values from days with less than 75 percent of the hours reported shall also be considered in identifying the high value to be used for
substitution.

(B) The substitution test is as follows: Data substitution will be performed in all quarter periods that have less than 75 percent data capture but at least 50 percent data capture, including State-flagged data affected by exceptional events which have been approved for exclusion by the Administrator; if any quarter has less than 50 percent data capture then this substitution test cannot be used. Identify for each quarter ( e.g., January– March) the highest reported daily maximum1-hour value for that quarter, excluding Stateflagged data affected by exceptional events which have been approved for exclusion by the Administrator, looking across those three months of all three years under consideration. All daily maximum 1-hour values from all days in the quarter period shall be considered when identifying this highest value, including days with less than


### 6533 Federal Register / Vol. 75, No. 26 / Tuesday, February 9, 2010 / Rules and Regulations

75 percent data capture. If after substituting the highest non-excluded reported daily maximum 1-hour value for a quarter for as much of the missing daily data in the matching deficient quarter(s) as is needed to make them 100 percent complete, the procedure in section 5.2 yields a recalculated 3-year 1-hour standard ‘‘ test design value ’’ below the level of the standard, then the 1- hour primary standard design value is deemed to have passed the diagnostic test and is valid, and the level of the standard is deemed to have been met in that 3-year period. As noted in section 3.2(c)(i), in such a case, the 3-year design value based on the data actually reported, not the ‘‘ test design
value ’’ , shall be used as the valid design
value.

(iii)(A) A 1-hour primary standard design value that is above the level of the NAAQS
can be validated if the substitution test in section 3.2(c)(iii)(B) results in a ‘‘ test design
value ’’ that is above the level of the NAAQS.
The test substitutes actual ‘‘ low ’’ reported daily maximum 1-hour values from the same site at about the same time of the year (specifically, in the same three months of the calendar) for unknown values that were not successfully measured. Note that the test is merely diagnostic in nature, intended to confirm that there is a very high likelihood that the original design value (the one with less than 75 percent data capture of hours by day and of days by quarter) reflects the true above-NAAQS-level status for that 3-year period; the result of this data substitution test (the ‘‘ test design value ’’ , as defined in section 3.2(c)(iii)(B)) is not considered the actual design value. For this test, substitution is permitted only if there are a minimum number of available daily data points from which to identify the low quarter-specific daily maximum 1-hour values, specifically if there are at least 200 days across the three matching quarters of the three years under consideration (which is about 75 percent of all possible daily values in those three quarters) for which 75 percent of the hours in the day have reported concentrations. Only days with at least 75 percent of the hours reported shall be considered in identifying the low value to be used for
substitution.

(B) The substitution test is as follows: Data substitution will be performed in all quarter periods that have less than 75 percent data capture. Identify for each quarter ( e.g., January-March) the lowest reported daily maximum 1-hour value for that quarter, looking across those three months of all three years under consideration. All daily maximum 1-hour values from all days with at least 75 percent capture in the quarter period shall be considered when identifying this lowest value. If after substituting the lowest reported daily maximum 1-hour value for a quarter for as much of the missing daily data in the matching deficient quarter(s) as is needed to make them 75 percent complete, the procedure in section 5.2 yields a recalculated 3-year 1-hour standard ‘‘ test design value ’’ above the level of the standard, then the 1-hour primary standard design value is deemed to have passed the diagnostic test and is valid, and the level of
the standard is deemed to have been exceeded in that 3-year period. As noted in section 3.2(c)(i), in such a case, the 3-year design value based on the data actually reported, not the ‘‘ test design value ’’ , shall be used as the valid design value.

(d) A 1-hour primary standard design value
based on data that do not meet the completeness criteria stated in 3.2(b) and also do not satisfy section 3.2(c), may also be considered valid with the approval of, or at the initiative of, the Administrator, who may consider factors such as monitoring site closures/moves, monitoring diligence, the consistency and levels of the valid
concentration measurements that are available, and nearby concentrations in determining whether to use such data.

(e) The procedures for calculating the 1- hour primary standard design values are given in section 5.2 of this appendix.

4. Rounding Conventions

4.1 Rounding Conventions for the Annual Primary NO 2 NAAQS

(a) Hourly NO 2 measurement data shall be reported to AQS in units of parts per billion (ppb), to at most one place after the decimal, with additional digits to the right being truncated with no further rounding.

(b) The annual primary standard design value is calculated pursuant to section 5.1
and then rounded to the nearest whole number or 1 ppb (decimals 0.5 and greater are rounded up to the nearest whole number, and any decimal lower than 0.5 is rounded down to the nearest whole number).

4.2 Rounding Conventions for the 1-hour Primary NO 2 NAAQS
(a) Hourly NO 2 measurement data shall be reported to AQS in units of parts per billion (ppb), to at most one place after the decimal, with additional digits to the right being truncated with no further rounding.

(b) Daily maximum 1-hour values are not
rounded.

(c) The 1-hour primary standard design value is calculated pursuant to section 5.2
and then rounded to the nearest whole number or 1 ppb (decimals 0.5 and greater are rounded up to the nearest whole number, and any decimal lower than 0.5 is rounded down to the nearest whole number).

5. Calculation Procedures for the Primary

NO 2 NAAQS

5.1 Procedures for the Annual Primary NO 2 NAAQS

(a) When the data for a site and year meet the data completeness requirements in section 3.1(b) of this appendix, or if the Administrator exercises the discretionary authority in section 3.1(c), the annual mean is simply the arithmetic average of all of the reported 1-hour values.

(b) The annual primary standard design
value for a site is the valid annual mean rounded according to the conventions in

section 4.1.

5.2 Calculation Procedures for the 1-hour Primary NO 2 NAAQS

(a) Procedure for identifying annual 98th percentile values. When the data for a particular site and year meet the data completeness requirements in section 3.2(b), or if one of the conditions of section 3.2(c) is met, or if the Administrator exercises the discretionary authority in section 3.2(d), identification of annual 98th percentile value is accomplished as follows.

(i) The annual 98th percentile value for a year is the higher of the two values resulting from the following two procedures.

(1) Procedure 1. (A) For the year, determine the number of days with at least 75 percent of the hourly values reported including State-flagged data affected by exceptional events which have been approved for exclusion by the

Administrator.

(B) For the year, from only the days with at least 75 percent of the hourly values reported, select from each day the maximum hourly value excluding State-flagged data affected by exceptional events which have been approved for exclusion by the

Administrator.

(C) Sort all these daily maximum hourly values from a particular site and year by descending value. (For example: (x[1], x[2], x[3], * * *, x[n]). In this case, x[1] is the largest number and x[n] is the smallest value.) The 98th percentile is determined from this sorted series of daily values which is ordered from the highest to the lowest number. Using the left column of Table 1, determine the appropriate range ( i.e., row) for the annual number of days with valid data for year y (cn y ) as determined from step (A). The corresponding ‘‘ n ’’ value in the right

column identifies the rank of the annual 98th percentile value in the descending sorted list of daily site values for year y. Thus, P 0.98, y = the nth largest value.

(2) Procedure 2. (A) For the year, determine the number of days with at least one hourly value reported including State-flagged data affected by exceptional events which have been approved for exclusion by the Administrator.

(B) For the year, from all the days with at least one hourly value reported, select from each day the maximum hourly value excluding State-flagged data affected by exceptional events which have been approved for exclusion by the Administrator.

(C) Sort all these daily maximum values from a particular site and year by descending value. (For example: (x[1], x[2], x[3], * * *, x[n]). In this case, x[1] is the largest number and x[n] is the smallest value.) The 98th percentile is determined from this sorted series of daily values which is ordered from the highest to the lowest number. Using the left column of Table 1, determine the appropriate range ( i.e., row) for the annual number of days with valid data for year y (cn y ) as determined from step (A). The corresponding ‘‘ n ’’ value in the right column

identifies the rank of the annual 98th percentile value in the descending sorted list of daily site values for year y. Thus, P 0.98, y = the nth largest value.

(b) The 1-hour primary standard design

value for a site is mean of the three annual 98th percentile values, rounded according to

the conventions in section 4.


### 6534 Federal Register / Vol. 75, No. 26 / Tuesday, February 9, 2010 / Rules and Regulations

T ABLE 

### 1

Annual number

of days with valid data for

year ‘‘ y ’’ (cn y ) P 0.98, y is the nth maximum value of the year, where n

is the listed

number

1–50 1

51–100 2

101–150 3

151–200 4

201–250. 5

251–300 6

301–350 7

351–366 8

**PART 58—AMBIENT AIR QUALITY**
**SURVEILLANCE**

■ 5. The authority citation for part 58
continues to read as follows:

Authority: 42 U.S.C. 7403, 7410, 7601(a), 7611, and 7619.

**Subpart A—[Amended]**

■ 6. Section 58.1, is amended by adding
the definitions for ‘‘ AADT ’’ and ‘‘ Nearroad NO 2 Monitor ’’ in alphabetical order
to read as follows:

**§ 58.1 Definitions**

* * * * *

AADT means the annual average daily
traffic.

* * *
Near-road NO 2 Monitor means any NO 2 monitor meeting the specifications in 4.3.2 of Appendix D and paragraphs 2, 4(d), 6.1, and 6.4 of Appendix E of this part.

* * * * *

**Subpart B [Amended]**

■ 7. Section 58.10, is amended by adding paragraphs (a)(5) and (b)(12) to
read as follows:

**§ 58.10 Annual monitoring network plan and periodic network assessment.** 

(a) * * * (5) A plan for establishing NO 2 monitoring sites in accordance with the requirements of appendix D to this part
shall be submitted to the Administrator by July 1, 2012. The plan shall provide for all required monitoring stations to be operational by January 1, 2013.

* * * * *

(b) * * * (12) The identification of required

NO 2 monitors as either near-road or
area-wide sites in accordance with Appendix D, Section 4.3 of this part.

* * * * *

■ 8. Section 58.13 is amended by adding paragraph (c) to read as follows: **§ 58.13 Monitoring network completion.**

* * * * *

(c) The network of NO 2 monitors must be physically established no later than January 1, 2013, and at that time, must be operating under all of the requirements of this part, including the requirements of appendices A, C, D, and E to this part.

■ 9. Section 58.16 is amended by revising paragraph (a) to read as follows:

**§ 58.16 Data submittal and archiving requirements.** 

* * * * *

(a) The State, or where appropriate, local agency, shall report to the Administrator, via AQS all ambient air quality data and associated quality
assurance data for SO 2 ; CO; O 3 ; NO 2 ; NO; NO Y ; NO X ; Pb–TSP mass concentration; Pb–PM 10 mass concentration; PM 10 mass concentration;

PM 2.5 mass concentration; for filterbased PM 2.5 FRM/FEM the field blank mass, sampler-generated average daily temperature, and sampler-generated average daily pressure; chemically speciated PM 2.5 mass concentration data; PM 10–2.5 mass concentration; chemically speciated PM 10–2.5 mass concentration data; meteorological data from NCore and PAMS sites; average daily temperature and average daily pressure for Pb sites if not already reported from sampler generated records; and metadata records and information specified by the AQS Data Coding Manual ( http://www.epa.gov/ ttn/airs/airsaqs/manuals/manuals.htm ). The State, or where appropriate, local agency, may report site specific meteorological measurements generated by onsite equipment (meteorological instruments, or sampler generated) or measurements from the nearest airport reporting ambient pressure and temperature. Such air quality data and information must be submitted directly to the AQS via electronic transmission on the specified quarterly schedule described in paragraph (b) of this

section.

* * * * *

■ 10. Appendix A to Part 58 is amended by adding paragraph 2.3.1.5 to read as
follows:

Appendix A to Part 58—Quality Assurance Requirements for SLAMS, SPMs and PSD Air Monitoring

* * * * *

2.3.1.5 Measurement Uncertainty for

NO 2 . The goal for acceptable measurement uncertainty is defined for precision as an upper 90 percent confidence limit for the coefficient of variation (CV) of 15 percent and for bias as an upper 95 percent confidence limit for the absolute bias of 15 percent.

* * * * *

■ 11. Appendix C to Part 58 is amended by adding paragraph 2.1.1 to read as
follows:

Appendix C to Part 58—Ambient Air Quality Monitoring Methodology

* * * * *

2.1.1 Any NO 2 FRM or FEM used for making primary NAAQS decisions must be capable of providing hourly averaged
concentration data.

* * * * *

■ 12. Appendix D to Part 58 is amended by revising paragraph 4.3 to read as
follows:

Appendix D to Part 58—Network Design Criteria for Ambient Air Quality Monitoring

* * * * *

4.3 Nitrogen Dioxide (NO 2 ) Design Criteria
4.3.1 General Requirements

(a) State and, where appropriate, local agencies must operate a minimum number of required NO 2 monitoring sites as described
below.
4.3.2 Requirement for Near-road NO 2 Monitors

(a) Within the NO 2 network, there must be
one microscale near-road NO 2 monitoring station in each CBSA with a population of 500,000 or more persons to monitor a location of expected maximum hourly concentrations sited near a major road with high AADT counts as specified in paragraph 4.3.2(a)(1) of this appendix. An additional
near-road NO 2 monitoring station is required for any CBSA with a population of 2,500,000 persons or more, or in any CBSA with a population of 500,000 or more persons that has one or more roadway segments with 250,000 or greater AADT counts to monitor a second location of expected maximum hourly concentrations. CBSA populations
shall be based on the latest available census figures.

(1) The near-road NO 2 monitoring stations shall be selected by ranking all road segments within a CBSA by AADT and then identifying a location or locations adjacent to those highest ranked road segments, considering fleet mix, roadway design, congestion patterns, terrain, and meteorology, where maximum hourly NO 2 concentrations are expected to occur and siting criteria can be met in accordance with appendix E of this part. Where a State or local air monitoring agency identifies multiple acceptable candidate sites where maximum hourly NO 2 concentrations are expected to occur, the monitoring agency shall consider the potential for population exposure in the criteria utilized to select the
final site location. Where one CBSA is required to have two near-road NO 2 monitoring stations, the sites shall be differentiated from each other by one or more of the following factors: fleet mix; congestion patterns; terrain; geographic area within the


### 6535 Federal Register / Vol. 75, No. 26 / Tuesday, February 9, 2010 / Rules and Regulations

CBSA; or different route, interstate, or freeway designation.

(b) Measurements at required near-road

NO 2 monitor sites utilizing
chemiluminescence FRMs must include at a minimum: NO, NO 2 , and NO X
. 4.3.3 Requirement for Area-wide NO 2 Monitoring

(a) Within the NO 2 network, there must be one monitoring station in each CBSA with a population of 1,000,000 or more persons to monitor a location of expected highest NO 2 concentrations representing the neighborhood or larger spatial scales. PAMS sites collecting NO 2 data that are situated in an area of expected high NO 2 concentrations at the neighborhood or larger spatial scale may be used to satisfy this minimum monitoring requirement when the NO 2 monitor is operated year round. Emission inventories and meteorological analysis should be used to identify the appropriate locations within a CBSA for locating required
area-wide NO 2 monitoring stations. CBSA populations shall be based on the latest available census figures.
4.3.4 Regional Administrator Required Monitoring

(a) The Regional Administrators, in collaboration with States, must require a minimum of forty additional NO 2 monitoring stations nationwide in any area, inside or outside of CBSAs, above the minimum monitoring requirements, with a primary focus on siting these monitors in locations to protect susceptible and vulnerable populations. The Regional Administrators, working with States, may also consider additional factors described in paragraph (b) below to require monitors beyond the minimum network requirement.

(b) The Regional Administrators may require monitors to be sited inside or outside
of CBSAs in which:

(i) The required near-road monitors do not represent all locations of expected maximum hourly NO 2 concentrations in an area and

NO 2 concentrations may be approaching or exceeding the NAAQS in that area;

(ii) Areas that are not required to have a monitor in accordance with the monitoring requirements and NO 2 concentrations may be approaching or exceeding the NAAQS; or

(iii) The minimum monitoring requirements for area-wide monitors are not sufficient to meet monitoring objectives.

(c) The Regional Administrator and the responsible State or local air monitoring agency should work together to design and/ or maintain the most appropriate NO 2 network to address the data needs for an area, and include all monitors under this provision in the annual monitoring network plan.

4.3.5 NO 2 Monitoring Spatial Scales

(a) The most important spatial scale for
near-road NO 2 monitoring stations to effectively characterize the maximum expected hourly NO 2 concentration due to mobile source emissions on major roadways is the microscale. The most important spatial scales for other monitoring stations characterizing maximum expected hourly

NO 2 concentrations are the microscale and middle scale. The most important spatial scale for area-wide monitoring of high NO 2 concentrations is the neighborhood scale.

(1) Microscale —This scale represents areas in close proximity to major roadways or point and area sources. Emissions from roadways result in high ground level NO 2 concentrations at the microscale, where concentration gradients generally exhibit a marked decrease with increasing downwind distance from major roads. As noted in appendix E of this part, near-road NO 2 monitoring stations are required to be within 50 meters of target road segments in order to measure expected peak concentrations. Emissions from stationary point and area sources, and non-road sources may, under certain plume conditions, result in high ground level concentrations at the microscale. The microscale typically represents an area impacted by the plume with dimensions extending up to approximately 100 meters.

(2) Middle scale —This scale generally represents air quality levels in areas up to several city blocks in size with dimensions on the order of approximately 100 meters to 500 meters. The middle scale may include locations of expected maximum hourly concentrations due to proximity to major

NO 2 point, area, and/or non-road sources.

(3) Neighborhood scale —The neighborhood scale represents air quality conditions throughout some relatively
uniform land use areas with dimensions in the 0.5 to 4.0 kilometer range. Emissions from stationary point and area sources may, under certain plume conditions, result in high NO 2 concentrations at the neighborhood scale. Where a neighborhood site is located away from immediate NO 2 sources, the site may be useful in representing typical air quality values for a larger residential area, and therefore suitable for population exposure and trends analyses.

(4) Urban scale —Measurements in this
scale would be used to estimate concentrations over large portions of an
urban area with dimensions from 4 to 50
kilometers. Such measurements would be useful for assessing trends in area-wide air quality, and hence, the effectiveness of large scale air pollution control strategies. Urban scale sites may also support other monitoring objectives of the NO 2 monitoring network identified in paragraph 4.3.4 above.

4.3.6 NO y Monitoring

(a) NO/NO y measurements are included within the NCore multi-pollutant site requirements and the PAMS program. These
NO/NO y measurements will produce
conservative estimates for NO 2 that can be used to ensure tracking continued compliance with the NO 2 NAAQS. NO/NO y monitors are used at these sites because it is important to collect data on total reactive nitrogen species for understanding O 3 photochemistry.

* * * * *

■ 13. Appendix E to Part 58 is amended
as follows:

■ a. By revising paragraphs 2, and 6.1.

■ b. By adding paragraphs 4(d) and 6.4.

■ c. By revising paragraphs 9(c), 11 and
Table E–4. Appendix E to Part 58—Probe and Monitoring Path Siting Criteria for Ambient Air Quality Monitoring

* * * * *

2. Horizontal and Vertical Placement

The probe or at least 80 percent of the monitoring path must be located between 2 and 15 meters above ground level for all ozone and sulfur dioxide monitoring sites, and for neighborhood or larger spatial scale Pb, PM 10 , PM 10–2.5 , PM 2.5 , NO 2 and carbon
monoxide sites. Middle scale PM 10–2.5 sites are required to have sampler inlets between 2 and 7 meters above ground level. Microscale Pb, PM 10 , PM 10–2.5 and PM 2.5 sites are required to have sampler inlets between 2 and 7 meters above ground level.
Microscale near-road NO 2 monitoring sites are required to have sampler inlets between 2 and 7 meters above ground level. The inlet probes for microscale carbon monoxide monitors that are being used to measure concentrations near roadways must be 3 ± 1 ⁄ 2 meters above ground level. The probe or at least 90 percent of the monitoring path must be at least 1 meter vertically or horizontally away from any supporting structure, walls, parapets, penthouses, etc., and away from dusty or dirty areas. If the probe or a significant portion of the monitoring path is located near the side of a building or wall,
then it should be located on the windward side of the building relative to the prevailing wind direction during the season of highest concentration potential for the pollutant being measured.

* * * * *

4. * * *

(d) For near-road NO 2 monitoring stations, the monitor probe shall have an unobstructed air flow, where no obstacles exist at or above the height of the monitor probe, between the monitor probe and the outside nearest edge of the traffic lanes of the target road segment.

* * * * *

6. * * *

6.1 Spacing for Ozone Probes and Monitoring Paths

In siting an O 3 analyzer, it is important to
minimize destructive interferences form sources of NO, since NO readily reacts with

O 3 . Table E–1 of this appendix provides the required minimum separation distances between a roadway and a probe or, where applicable, at least 90 percent of a monitoring path for various ranges of daily roadway traffic. A sampling site having a point analyzer probe located closer to a roadway than allowed by the Table E–1 requirements
should be classified as microscale or middle scale, rather than neighborhood or urban scale, since the measurements from such a site would more closely represent the middle scale. If an open path analyzer is used at a site, the monitoring path(s) must not cross over a roadway with an average daily traffic count of 10,000 vehicles per day or more. For those situations where a monitoring path crosses a roadway with fewer than 10,000 vehicles per day, monitoring agencies must consider the entire segment of the monitoring


### 6536 Federal Register / Vol. 75, No. 26 / Tuesday, February 9, 2010 / Rules and Regulations

path in the area of potential atmospheric
interference from automobile emissions. Therefore, this calculation must include the length of the monitoring path over the roadway plus any segments of the monitoring path that lie in the area between the roadway and minimum separation distance, as
determined from the Table E–1 of this appendix. The sum of these distances must not be greater than 10 percent of the total monitoring path length.

* * * * *

6.4 Spacing for Nitrogen Dioxide (NO 2 ) Probes and Monitoring Paths

(a) In siting near-road NO 2 monitors as required in paragraph 4.3.2 of appendix D of this part, the monitor probe shall be as near as practicable to the outside nearest edge of the traffic lanes of the target road segment; but shall not be located at a distance greater than 50 meters, in the horizontal, from the outside nearest edge of the traffic lanes of the target road segment.

(b) In siting NO 2 monitors for neighborhood and larger scale monitoring, it is important to minimize near-road influences. Table E–1 of this appendix provides the required minimum separation distances between a roadway and a probe or, where applicable, at least 90 percent of a monitoring path for various ranges of daily roadway traffic. A sampling site having a point analyzer probe located closer to a roadway than allowed by the Table E–1 requirements should be classified as
microscale or middle scale rather than neighborhood or urban scale. If an open path analyzer is used at a site, the monitoring path(s) must not cross over a roadway with an average daily traffic count of 10,000 vehicles per day or more. For those situations where a monitoring path crosses a roadway with fewer than 10,000 vehicles per day, monitoring agencies must consider the entire segment of the monitoring path in the area of potential atmospheric interference form automobile emissions. Therefore, this calculation must include the length of the monitoring path over the roadway plus any segments of the monitoring path that lie in the area between the roadway and minimum separation distance, as determined form the Table E–1 of this appendix. The sum of these distances must not be greater than 10 percent of the total monitoring path length.

* * * * *

9. * * *

(c) No matter how nonreactive the sampling probe material is initially, after a period of use reactive particulate matter is deposited on the probe walls. Therefore, the time it takes the gas to transfer from the probe inlet to the sampling device is also critical. Ozone in the presence of nitrogen oxide (NO) will show significant losses even in the most inert probe material when the
residence time exceeds 20 seconds. 26 Other
studies 27 28 indicate that a 10 second or less residence time is easily achievable. Therefore, sampling probes for reactive gas
monitors at NCore and at NO 2 sites must have a sample residence time less than 20
seconds.

* * * * *

11. Summary

Table E–4 of this appendix presents a summary of the general requirements for probe and monitoring path siting criteria with respect to distances and heights. It is apparent from Table E–4 that different elevation distances above the ground are shown for the various pollutants. The discussion in this appendix for each of the pollutants describes reasons for elevating the monitor, probe, or monitoring path. The differences in the specified range of heights
are based on the vertical concentration gradients. For CO and near-road NO 2 monitors, the gradients in the vertical direction are very large for the microscale, so a small range of heights are used. The upper limit of 15 meters is specified for the consistency between pollutants and to allow the use of a single manifold or monitoring path for monitoring more than one pollutant.



### T ABLE 

### E–4 OF 

### A PPENDIX 

### E TO 

### P ART 

### 58. S UMMARY OF 

### P ROBE AND 

### M ONITORING 

### P ATH 

### S ITING 

### C RITERIA

Pollutant Scale (maximum monitoring path length, meters) Height from ground to probe, inlet or 80% of

monitoring path 1 Horizontal and vertical distance from supporting structures 2 to probe, inlet or 90%

of monitoring path 1 (meters) Distance from trees to probe, inlet or 90%

of monitoring path 1 (meters) Distance from roadways to probe, inlet or monitoring path 1 (meters)

SO 2 3,4,5,6 ..................... Middle (300 m) NeighborhoodUrban, and Regional (1 km). 2–15 .......................... >1 .............................. >10 ............................ N/A

CO 4,5,7 ........................ Micro, middle (300 m), Neighborhood (1 km). 3 1 ⁄ 2 : 2–15 .................. >1 .............................. >10 ............................ 2–10; see Table E–2 of this appendix formiddle and neighborhood scales.
O 3 3,4,5 ......................... Middle (300 m) Neighborhood,Urban, and Regional (1 km). 2–15 .......................... >1 .............................. >10 ............................ See Table E–1 of this appendix for all

scales.

NO 2 3,4,5 ...................... Micro (Near-road [50– 300]). 2–7 (micro); ............... >1 .............................. >10 ............................ ≤ 50 meters for nearroad microscale. Middle (300m) ........... 2–15 (all other scales). ................................... ...................................

Neighborhood, Urban,

and Regional (1 km). ................................... ................................... ................................... See Table E–1 of this appendix for all

other scales Ozone precursors (for

PAMS) 345

. Neighborhood and Urban (1 km). 2–15 .......................... >1 .............................. >10 ............................ See Table E–4 of this appendix for all

scales. PM, Pb 3,4,5,6,8 ............. Micro: Middle, Neighborhood, Urban and Regional. 2–7 (micro); 2–7 (middle PM 10–2.5 ); 2–15 (all other scales). >2 (all scales, horizontal distance only). >10 (all scales) ......... 2–10 (micro); see Figure E–1 of this appendix for all other

scales.

N/A—Not applicable.

1 Monitoring path for open path analyzers is applicable only to middle or neighborhood scale CO monitoring, middle, neighborhood, urban, and regional scale NO 2 monitoring, and all applicable scales for monitoring SO 2 ,O 3 , and O 3 precursors.

2 When probe is located on a rooftop, this separation distance is in reference to walls, parapets, or penthouses located on roof.

3 Should be >20 meters from the dripline of tree(s) and must be 10 meters from the dripline when the tree(s) act as an obstructio n.

4 Distance from sampler, probe, or 90% of monitoring path to obstacle, such as a building, must be at least twice the height the obstacle protrudes above the sampler, probe, or monitoring path. Sites not meeting this criterion may be classified as middle scale ( see text).

5 Must have unrestricted airflow 270 degrees around the probe or sampler; 180 degrees if the probe is on the side of a building or a wall.


### 6537 Federal Register / Vol. 75, No. 26 / Tuesday, February 9, 2010 / Rules and Regulations

6 The probe, sampler, or monitoring path should be away from minor sources, such as furnace or incineration flues. The separation distance is dependent on the height of the minor source’s emission point (such as a flue), the type of fuel or waste burned, and the quality of the fuel (sulfur, ash, or lead content). This criterion is designed to avoid undue influences from minor sources.

7 For microscale CO monitoring sites, the probe must be >10 meters from a street intersection and preferably at a midblock locati on.

8 Collocated monitors must be within 4 meters of each other and at least 2 meters apart for flow rates greater than 200 liters/min or at least 1 meter apart for samplers having flow rates less than 200 liters/min to preclude airflow interference.

* * * * *

14. Appendix G to Part 58 is amended as by revising paragraph 9 and Table 2
to read as follows:

Appendix G to Part 58—Uniform Air Quality Index (AQI) and Daily Reporting

* * * * *

9. How Does the AQI Relate to Air Pollution
Levels?

For each pollutant, the AQI transforms
ambient concentrations to a scale from 0 to 500. The AQI is keyed as appropriate to the national ambient air quality standards (NAAQS) for each pollutant. In most cases,
the index value of 100 is associated with the numerical level of the short-term ( i.e., averaging time of 24-hours or less) standard for each pollutant. The index value of 50 is associated with one of the following: the
numerical level of the annual standard for a pollutant, if there is one; one-half the level of the short-term standard for the pollutant; or the level at which it is appropriate to begin to provide guidance on cautionary language. Higher categories of the index are based on increasingly serious health effects that affect increasing proportions of the population. An index value is calculated each day for each pollutant (as described in section 12 of this appendix), unless that pollutant is specifically excluded ( see section 8 of this appendix). The pollutant with the highest index value for the day is the ‘‘ critical ’’ pollutant, and must be included in the daily AQI report. As a result, the AQI for any given day is equal to the index value of the critical pollutant for that day. For the purposes of reporting the AQI, the indexes for PM 10 and

PM 2.5 are to be considered separately.

* * * * *



### T ABLE 

### 2—B REAKPOINTS FOR THE 

### AQI

These breakpoints Equal these AQIs

O 3 (ppm)

8-hour O 3 (ppm) 1-hour 1 PM 2.5 ( μ g/m 3 ) PM 10 ( μ g/m 3 ) CO (ppm) SO 2 (ppm) NO 2 (ppm) 1-hour AQI Category

0.000–0.059 ..................... 0.0–15.4 0–54 0.0–4.4 0.000–0.034 0–0.053 0–50 Good.

0.060–0.075 ..................... 15.5–40.4 55–154 4.5–9.4 0.035–0.144 0.054–0.100 51–100 Moderate.0.076–0.095 0.125–0.164 40.5–65.4 155–254 9.5–12.4 0.145–0.224 0.101–0.360 101–150 Unhealthy for Sensitive Groups.

0.096–0.115 0.165–0.204 3 65.5–150.4 255–354 12.5–15.4 0.225–0.304 0.361–0.64 151–200 Unhealthy.

0.116–0.374 0.205–0.404 3 150.5–250.4 355–424 15.5–30.4 0.305–0.604 0.65–1.24 201–300 Very Unhealthy. ( 2 ) 0.405–0.504 3 250.5–350.4 425–504 30.5–40.4 0.605–0.804 1.25–1.64 301–400 Hazardous. ( 2 ) 0.505–0.604 3 350.5–500.4 505–604 40.5–50.4 0.805–1.004 1.65–2.04 401–500 Hazardous.

1 Areas are generally required to report the AQI based on 8-hour ozone values. However, there are a small number of areas where an AQI based on 1-hour ozone values would be more precautionary. In these cases, in addition to calculating the 8-hour ozone index value, the 1-hour ozone index value may be calculated, and the maximum of the two values reported.

2 8-hours O 3 values do not define higher AQI values ( ≥ 301). AQI values of 301 or greater are calculated with 1-hour O 3 concentrations.

3 If a different SHL for PM 2.5 is promulgated, these numbers will change accordingly.

[FR Doc. 2010–1990 Filed 2–8–10; 8:45 am]

**BILLING CODE 6560–50–P**


## VII-1

CHAPTER VII

The following documentation of filing and notifi cation is incorporated as part of this hearing record and is maintained on file:

1. DENR 101 Internal Approval Form.

2. Submission for Notice Form and material submitted to the Office of Administrative Hearings.

3. The public notice as it appears in The North Carolina Register Volume 25, Issue 19, pages 2224-2225

.

4. Letters to newspapers requesting th at the public notice be published.

5. Affidavits of Publication from newspaper.

6. Memorandum transmitting hearing noti ce and proposal to regional offices for public inspection.

7. Memorandum transmitting hearing noti ce and proposal to local programs.

8. Letter notifying EPA of hearing.

9. Submission of Filing Forms and material filed with Office of Administrative Hearings.

10. Letter transmitting hearing record to EPA.