INDEX TO DOCKET EPA-R09-OAR-2012- 0021                 (Final with Corrections  -  November 16, 2012) Approval, Disapproval and Promulgation of Air Quality Implementation Plans; Arizona; Regional Haze State and Federal Implementation Plans Index No. Category / Document Title  Document Date regs.gov Document ID A.   EPA Guidance Documents, Policies and Rulemakings

   1.1.  Proposed Rule - Visibility Protection for Federal Class I Areas, 45 FR 34762 1980-05-22 EPA-R09-OAR-2012-0021-0002    1.2.  Final Rule - Visibility Protection for Federal Class I Areas, 45 FR 80084 1980-12-02 EPA-R09-OAR-2012-0021-0002    1.3.  Proposed Rule - Regional Haze Regulations, 62 FR 41138.pdf 1997-07-31  EPA-R09-OAR-2012-0021-0002    1.4.  IWAQM Phase 2 Summary Report And Recommendations For Modeling Long Range Transport Impacts 1998-12 EPA-R09-OAR-2012-0021-0002    1.5.  Final Rule - Regional Haze Regulations, 64 FR 35714 1999-07-01  EPA-R09-OAR-2012-0021-0002    1.6.  Proposed BART Guidelines, 66 FR 38108 2001-06-20 EPA-R09-OAR-2012-0021-0002    1.7.  Guidance for Estimating Natural Visibility Conditions under the Regional Haze Rule 2003-09 EPA-R09-OAR-2012-0021-0002    1.8.  Guidance for Tracking Progress under the Regional Haze Rule 2003-09 EPA-R09-OAR-2012-0021-0002    1.9.  Re-proposed BART Guidelines 2004-05-04 EPA-R09-OAR-2012-0021-0002    1.10.  BART Guidelines Error Correction Memo 2005-06-24 EPA-R09-OAR-2012-0021-0002    1.11.  Final Rule - Regional Haze Regulations and Guidelines for BART Determinations 2005-07-06 EPA-R09-OAR-2012-0021-0002    1.12.  Memo from Joseph W. Paise regarding Regional Haze Regulations and Guidelines for BART 2006-07-19  EPA-R09-OAR-2012-0021-0002    1.13.  Guidance - 110(a)(2)(D) SIPs for the 8-hour Ozone and PM2.5 NAAQS 2006-08-15  EPA-R09-OAR-2012-0021-0002    1.14.  Additional Regional Haze Questions (Guidance) 2006-09-27 EPA-R09-OAR-2012-0021-0002    1.15.  Final Rule - Revision to Regional Haze Regulations, 71 FR 60612 2006-10-13  EPA-R09-OAR-2012-0021-0002    1.16.  Guidance for Setting Reasonable Progress Goals Under the Regional Haze Program 2007-06-01 EPA-R09-OAR-2012-0021-0002    1.17.  Finding of Failure To Submit SIPs Required by the 1999 Regional Haze Rule, 74 FR 2392 2009-01-15  EPA-R09-OAR-2012-0021-0002    1.18.  Proposed Consent Decree, Clean Air Act Citizen Suit, 76 FR 75544 2011-12-02  EPA-R09-OAR-2012-0021-0002    1.19.  Visibility Monitoring Guidance 1999-06-01 EPA-R09-OAR-2012-0021-0002    1.20.  2002 Base Year Emission Inventory SIP Planning 2002-11-18 EPA-R09-OAR-2012-0021-0002    1.21.  Emissions Inventory Guidance for Implementation of Ozone and Particulate Matter NAAQS and Regional Haze Regulations 2005-08-01 EPA-R09-OAR-2012-0021-0002    1.22.  Final Guidance for EPA Rulewriters: Regulatory Flexibility Act 2006-11 EPA-R09-OAR-2012-0021-0002    1.23.  Performance Test Calculation Guidelines 1990-06-06  EPA-R09-OAR-2012-0021-0002    1.24.  Revision to the Guideline on Air Quality Models, 70 FR 68218 2005-11-09  EPA-R09-OAR-2012-0021-0228    1.25.  Methods for Measurement of Filterable PM10 and PM2.5 and Measurement of Condensable PM Emissions From Stationary Sources, 75 FR 80118 2010-12-21 EPA-R09-OAR-2012-0021-0228    1.26.  National Emission Standards for Hazardous Air Pollutants From Coal and Oil-Fired Electric Utility Steam Generating Units and Standards of Performance for Fossil-Fuel-Fired Electric Utility, Industrial-Commercial-Institutional, and Small Industrial-Commercial-Institutional Steam Generating Units (MATS Rule), 77 FR 9304 2012-02-16  EPA-R09-OAR-2012-0021-0228    1.27.  Regional Haze Implementation Plans, Proposed Rule for Nevada, 76 FR 36450 2011-06-22 EPA-R09-OAR-2012-0021-0228    1.28.  Regional Haze Implementation Plans, Proposed Rule for New York, 77 FR 24794 2012-04-25 EPA-R09-OAR-2012-0021-0228    1.29.  Regional Haze Implementation Plans, Proposed Rule for California, 76 FR 13944 2011-03-15 EPA-R09-OAR-2012-0021-0228    1.30.  Regional Haze Implementation Plans, Proposed Rule for Rhode Island, 77 FR 11798 2012-02-28

EPA-R09-OAR-2012-0021-0228    1.31.  Regional Haze Implementation Plans, Proposed Rule for Delaware, 76 FR 27973 2011-05-13

EPA-R09-OAR-2012-0021-0228    1.32.  Regional Haze Implementation Plans, Proposed Rule for Nebraska, 77 FR 12770 2012-03-02 EPA-R09-OAR-2012-0021-0228    1.33.  Regional Haze Implementation Plans, Proposed Rule for Colorado, 77 FR 18052 2012-03-26

EPA-R09-OAR-2012-0021-0228    1.34.  Regional Haze Implementation Plans, Proposed Rule for Oklahoma, 76 FR 16168 2011-12-28 EPA-R09-OAR-2012-0021-0228    1.35.  Regional Haze Implementation Plans, Proposed Rule for Vermont, 77 FR 11914 2012-02-28                                         EPA-R09-OAR-2012-0021-0228    1.36.  Regional Haze Implementation Plans, Proposed Rule for Wisconsin, 77 FR 11928 2012-02-28 EPA-R09-OAR-2012-0021-0228    1.37.  Regional Haze Implementation Plans, Proposed Rule for Kansas, 76 FR 52604 2011-08-23                                         EPA-R09-OAR-2012-0021-0228    1.38.  Regional Haze Implementation Plans, Proposed Rule for Arkansas, 76 FR 64186 2011-10-17 EPA-R09-OAR-2012-0021-0228    1.39.  Regional Haze Implementation Plans, Proposed Rule for Maryland, 77 FR 11827 2012-02-28 EPA-R09-OAR-2012-0021-0228    1.40.  Regional Haze Implementation Plans, Proposed Rule for North Dakota, 76 FR 58570 2011-09-11 EPA-R09-OAR-2012-0021-0228    1.41.  Regional Haze Implementation Plans, Proposed Rule for Illinois, 77 FR 3966 2012-01-26 EPA-R09-OAR-2012-0021-0228    1.42.  Regional Haze Implementation Plans, Proposed Rule for South Dakota 76 FR 76646 2011-12-08 EPA-R09-OAR-2012-0021-0228    1.43.  Regional Haze Implementation Plans, Final Rule for California, 76 FR 34608 2011-06-14 EPA-R09-OAR-2012-0021-0228    1.44.  Regional Haze Implementation Plans, Final Rule for Delaware, 76 FR 42557 2011-07-19 EPA-R09-OAR-2012-0021-0228    1.45.  Regional Haze Implementation Plans, Final Rule for Kansas, 76 FR 80754 2011-12-27                                         EPA-R09-OAR-2012-0021-0228    1.46.  Regional Haze Implementation Plans, Final Rule for New Jersey, 77 FR 19 2012-01-03 EPA-R09-OAR-2012-0021-0228    1.47.  Regional Haze Implementation Plans, Final Rule for District of Columbia, 77 FR 5191   2012-02-02 EPA-R09-OAR-2012-0021-0228    1.48.  Regional Haze Implementation Plans, Final Rule for Arkansas, 77 FR 14603 2012-03-12 EPA-R09-OAR-2012-0021-0228    1.49.  Regional Haze Implementation Plans, Final Rule for Nevada, 77 FR 17334 2012-03-26 EPA-R09-OAR-2012-0021-0228    1.50.  Regional Haze Implementation Plans, Final Rule for South Dakota, 77 FR 24845 2012-04-26 EPA-R09-OAR-2012-0021-0228    1.51.  Regional Haze Implementation Plans, Final Rule for Nebraska, 77 FR 40149 2012-07-06

EPA-R09-OAR-2012-0021-0228    1.52.  Regional Haze Implementation Plans, Final Rule for New York, 77 FR 51915 2012-08-28 EPA-R09-OAR-2012-0021-0228    1.53.  Regional Haze Implementation Plans, Proposed Rule for Virginia 77 FR 3691 2012-01-25 EPA-R09-OAR-2012-0021-0228    1.54.  Regional Haze Implementation Plans, Final Rule for Hawaii, 77 FR 61478 2012-10-09 EPA-R09-OAR-2012-0021-0228    1.55.  Interim Guidance on Considering Environmental Justice During the Development of an Action 2010-07 EPA-R09-OAR-2012-0021-0228

B.  State Plans, Rules, Support Documents, and Correspondence (letters and emails)

   2.1.  Arizona Regional Haze SIP (with appendices) 2011-01 EPA-R09-OAR-2012-0021-0003    2.2.  AEPCO Apache 1 BART Analysis 2007-12 EPA-R09-OAR-2012-0021-0003    2.3.  AEPCO Apache 2 BART Analysis 2007-12 EPA-R09-OAR-2012-0021-0003    2.4.  AEPCO Apache 3 BART Analysis 2007-12 EPA-R09-OAR-2012-0021-0003    2.5.  AEPCO Apache additional BART response 2009-07-08 EPA-R09-OAR-2012-0021-0003    2.6.  APS Cholla 2 BART Analysis 2008-01 EPA-R09-OAR-2012-0021-0003    2.7.  APS Cholla 3 BART Analysis 2008-01 EPA-R09-OAR-2012-0021-0003    2.8.  APS Cholla 4 BART Analysis 2008-01 EPA-R09-OAR-2012-0021-0003    2.9.  Additional APS Cholla BART response 2009-06-18 EPA-R09-OAR-2012-0021-0003    2.10.  SRP Coronado 1 and 2 BART Analysis 2008-02 EPA-R09-OAR-2012-0021-0003    2.11.  SRP Coronado additional BART response 2009-06-25 EPA-R09-OAR-2012-0021-0003    2.12.  Summary of WRAP RMC BART Modeling for Arizona Draft#5  2007-05-25 EPA-R09-OAR-2012-0021-0003    2.13.  WRAP Stationary Sources Joint Forum - Identification of BART-Eligible Sources in the WRAP Region 2005-04-04 EPA-R09-OAR-2012-0021-0003    2.14.  WRAP Stationary Sources Joint Forum  -  Appendix H 2006-09-21 EPA-R09-OAR-2012-0021-0003    2.15.  WRAP RMC BART Exemption Screening Modeling Protocol 2006-09-15 EPA-R09-OAR-2012-0021-0003    2.16.  Original Arizona  Section 309 SIP 2003-12-23 EPA-R09-OAR-2012-0021-0003    2.17.  Arizona Section 309 SIP Revision 2004-12 EPA-R09-OAR-2012-0021-0003    B.18. Direct Final Approval of ADEQ Open Burning Rules, 71 FR 28270 2006-05-14 EPA-R09-OAR-2012-0021-0003    B.19. Arizona  Regional Haze 309 SIP Re-Submittal Letter 2008-12-24 EPA-R09-OAR-2012-0021-0003

C.  EPA Communications with Facilities

   3.1.  Letter from Colleen McKaughan (EPA) to Andrew (AEPCO) 2011-11-17 EPA-R09-OAR-2012-0021-0004    3.2.  Letter from Colleen McKaughan (EPA) to Bevier (SRP) 2011-11-17 EPA-R09-OAR-2012-0021-0004    3.3.  Letter from Colleen McKaughan (EPA) to Bittel (APCC) 2011-11-17 EPA-R09-OAR-2012-0021-0004    3.4.  Letter from Colleen McKaughan (EPA) to Mollenhauer (Catalyst Paper) 2011-11-17 EPA-R09-OAR-2012-0021-0004    3.5.  Letter from Colleen McKaughan (EPA) to Reilly (APS) 2011-11-17 EPA-R09-OAR-2012-0021-0004    3.6.  Letter from Colleen McKaughan (EPA) to Spell (APS) 2011-11-17 EPA-R09-OAR-2012-0021-0004    3.7.  Letter from Colleen McKaughan (EPA) to Verville (Lhoist North America) 2011-11-17 EPA-R09-OAR-2012-0021-0004    3.8.  Letter from Colleen McKaughan (EPA) to Yockey (TEP) 2011-11-17 EPA-R09-OAR-2012-0021-0004    3.9.  Letter from Eric Massey (ADEQ) to Deborah Jordan (EPA) 2011-11-21 EPA-R09-OAR-2012-0021-0004    3.10.  Letter from Arizona Public Service Company (APS) 2011-12-12 EPA-R09-OAR-2012-0021-0004    3.11.  Letter from Sue Kidd (APS) to Francisco Donez (EPA) 2012-02-14 EPA-R09-OAR-2012-0021-0004    3.12.  Letter from Kelly Barr (SRP) to Francisco Donez (EPA) 2012-02-02 EPA-R09-OAR-2012-0021-0004    3.13.   [Reserved]

   3.14.  Summary of EPA meeting with utility companies 2011-12-21 EPA-R09-OAR-2012-0021-0004    3.15.  EPA follow-up to 12/21/2011 utilities meeting 2011-12-29 EPA-R09-OAR-2012-0021-0004    3.16.  Letter from Kelly Barr (SRP) to Deborah Jordan (EPA) 2012-06-29 EPA-R09-OAR-2012-0021-0004    3.17.  Letter from Michelle Freeark (AEPCO) to Deborah Jordan (EPA) 2012-06-26 EPA-R09-OAR-2012-0021-0004    3.18.  2012-08-06 Jordan to Freeark-AEPCO request for information and responses  -  7 files 2012-08-06 EPA-R09-OAR-2012-0021-0019, EPA-R09-OAR-2012-0021-0229    3.19.  Barr SRP to Webb  -  3 files 2012-07-20 EPA-R09-OAR-2012-0021-0029, EPA-R09-OAR-2012-0021-0229    3.20.  Kidd APS to Blumenfeld  -  2 files 2012-07-20 EPA-R09-OAR-2012-0021-0030    3.21.  EPA clarification request to AEPCO  -  2 files 2012-09 EPA-R09-OAR-2012-0021-0031    3.22.  Jordan-Barr SRP Exchange 09-14-2012 EPA-R09-OAR-2012-0021-0032    3.23.  Freeark to McKaughan 2012-09-06 2012-09-06 EPA-R09-OAR-2012-0021-0229    3.24.  Freeark-McKaughan emails re CBI + SNCR 2012-10 2012-10 EPA-R09-OAR-2012-0021-0229    3.25.  Info request to SRP 2012-07-27  -  4 files 2012-07-27 EPA-R09-OAR-2012-0021-0229    C.26. APS SCR cost information 2012-10-15  -  7 files 2012-10-15 EPA-R09-OAR-2012-0021-0233    C.27. McKaughn-Kidd emails re Cholla Unit 1  -  5 files 2012-10 EPA-R09-OAR-2012-0021-0234

D.  EPA Correspondence (other letters and emails)

D-01 AZ Delegation Letter to Lisa Jackson re FIP Comment Period and Hearings  -  also contains 10 response letters dated 2012-07-26 2012-07-19 EPA-R09-OAR-2012-0021-0018 D-02 Emissions conf call memo 2012-08-03 EPA-R09-OAR-2012-0021-0018 D-03 Daryl Seymore_City of Show Low Letter to Lisa Jackson - 2 files 2012-07-19 EPA-R09-OAR-2012-0021-0020 D-04 JR Despain Navajo Cty to Blumenfeld- 2 files 2012-07-19 EPA-R09-OAR-2012-0021-0021 D-05 Willis-Snowflake to Jackson- 2 files 2012-07-19 EPA-R09-OAR-2012-0021-0022 D-06 Henry Darwin ADEQ Letter to Thomas Webb 2012-07-20 EPA-R09-OAR-2012-0021-0023 D-07 Robin Boyd City of Winslow Letter to Lisa Jackson- 2 files 2012-07-20 EPA-R09-OAR-2012-0021-0024 D-08 Jeffers Cattle Co to Jackson- 2 files 2012-07-21 EPA-R09-OAR-2012-0021-0025 D-09 McAnally-Phoenix Chamber to Jackson- 2 files 2012-07-23 EPA-R09-OAR-2012-0021-0026 D-10 Swarthout-NPC to Jackson- 2 files 2012-07-23 EPA-R09-OAR-2012-0021-0027 D-11 Apache Cty to Blumenfeld- 2 files 2012-07-24 EPA-R09-OAR-2012-0021-0028

E.  EPA Contractor Documents

   5.1.  UNC Task 5 Report (AZ-BART-Modeling-Protocol) (Earlier versions of the modeling protocol were received by EPA on March 14, 2012 and June 29, 2012. However, only certain portions of this protocol were relied upon by EPA in the proposed rule signed July 2, 2012. The July 16, 2012 version of the modeling protocol, which included in the docket, incorporates only the material relied upon by EPA for the July 2, 2012 proposal.)  2012-07-16  EPA-R09-OAR-2012-0021-0006    5.2.  UNC Task 8 Report (Apache-Cholla-Coronado BART Analysis Report)_final (An earlier version of the Task 8 Report was received by EPA on June 28, 2012. However, only certain portions of this report were relied upon by EPA in the proposed rule signed July 2, 2012. The July 16, 2012 version of the report, which included in the docket, incorporates only the material relied upon by EPA for the July 2, 2012 proposal.)  2012-07-16  EPA-R09-OAR-2012-0021-0006    5.3.  Jim Staudt CV - EPA-R09-OAR-2012-0021-0203

F.  EPA Final Products

   6.1.  FCPP Technical Support Document 2010-10-06  EPA-R09-OAR-2012-0021-0007    6.2.  Supplemental Cost Analysis  2012-11 EPA-R09-OAR-2012-0021-0204    6.3.  Tangentially-fired coal unit SCR retrofit 2012-11 EPA-R09-OAR-2012-0021-0205    6.4.  Cholla 2001-03 NOx Emission Data (daily) 2012-11 EPA-R09-OAR-2012-0021-0206    6.5.  Cholla 2010-12Q3 NOx Emission Data (monthly) 2012-11 EPA-R09-OAR-2012-0021-0207    6.6.  Coronado 2 2011-12Q3 NOx Emission Data (daily) 2012-11 EPA-R09-OAR-2012-0021-0208    6.7.  CAMD Emission Data 2001-11 (daily) 2012-11 EPA-R09-OAR-2012-0021-0209

G.  Additional Documents Considered for Proposed Rulemaking

   7.1.  Consent Decree Between U.S. and SRP (final as entered) 2008-12-19 EPA-R09-OAR-2012-0021-0008    7.2.  Coronado Title V Permit (final) 2011-12-16 EPA-R09-OAR-2012-0021-0008    7.3.  TSD for Coronado Title V Permit final) 2011-12-16 EPA-R09-OAR-2012-0021-0008    7.4.  Technical Literature: Ultra-Low NOx Control 2007-01-01 EPA-R09-OAR-2012-0021-0008    7.5.  Erickson, Lisauskas, Licata - What's New in SCRs  2006-05-16 EPA-R09-OAR-2012-0021-0008    7.6.  Lani - Nitrogen Oxides Emission Control Options for Coal-Fired EGUs AWMA 2009-05 EPA-R09-OAR-2012-0021-0008    7.7.  AEP Apache Title V TSD 2007-05-24 EPA-R09-OAR-2012-0021-0008    7.8.  AEP Apache Title V Permit 2007-07-09 EPA-R09-OAR-2012-0021-0008    7.9.  Final Title V Permit for Cholla 2012-05-31 EPA-R09-OAR-2012-0021-0008    7.10.  Final Title V TSD for Cholla 2012-05-31 EPA-R09-OAR-2012-0021-0008    7.11.  Cichanowicz - Implementation Schedule for SCR and FGD 2010-10-01 EPA-R09-OAR-2012-0021-0008    7.12.  AZ Corp Commission - Annual Report - Arizona_Electric_Power_Cooperative_Inc 2012-05-14 EPA-R09-OAR-2012-0021-0008    7.13.  ECR memo - Impact of Ammonia in Fly Ash 2010-08-31 EPA-R09-OAR-2012-0021-0008    7.14.  EPRI H2SO4 report 2010-04 EPA-R09-OAR-2012-0021-0008    7.15.  Modeling Files  (Due to the format of some modeling files, they are not available from the electronic docket. These files are available upon request. See the TSD for more information.) - EPA-R09-OAR-2012-0021-0008                                                                           G.16. NGS Revised BART Report 2009-01 EPA-R09-OAR-2012-0021-0008

H.  Notice of Proposed Rulemaking and Technical Support Document

   8.1.  Technical Support Document 2012-07

EPA-R09-OAR-2012-0021-0009    8.2.  Index to Docket EPA-R09-OAR-2012- 0021 Approval, Disapproval and Promulgation of Air Quality Implementation Plans; Arizona; Regional Haze State and Federal Implementation Plans 2012-07

EPA-R09-OAR-2012-0021-0009    8.3.  Approval, Disapproval and Promulgation of Air Quality Implementation Plans; Arizona; Regional Haze State and Federal Implementation Plans (Pre-publication version) 2012-07-02 EPA-R09-OAR-2012-0021-0009    8.4.  Notice of Additional Public Hearings and Extension of Comment Period, 77 FR 45326 2012-07-31 EPA-R09-OAR-2012-0021-0231

I.  Public Comments Received on Proposed Rule and Public Hearing Transcripts

   I-01 7-31-2012 Public Hearing, Phoenix AZ  -  8 files 2012-07-31 EPA-R09-OAR-2012-0021-0033    I-02 8-14-2012 Public Hearing-Holbrook AZ  -  15 files 2012-08-14 EPA-R09-OAR-2012-0021-0034    I-03 Comments received September 17, 2012, from United States Department of the Interior, National Parks Service, Denver CO, from Susan Johnson, DPS, to Thomas Webb, EPA. 2012-09-17 EPA-R09-OAR-2012-0021-0064    I-04 Comments 2012-09-18 Edison Electric Institute (EEI) 	 2012-09-18 EPA-R09-OAR-2012-0021-0061    I-05 Comments from 2012-09-07 Representative Paul Gosar's Public Meeting 2012-09-07 EPA-R09-OAR-2012-0021-0062    I-06 Comment on FR Doc # 2012-17659 - Thomas Armstrong 2012-09-26 EPA-R09-OAR-2012-0021-0035    I-07 Comment on FR Doc # 2012-17659 - Robert Carreira 2012-09-26 EPA-R09-OAR-2012-0021-0036    I-08 Comment on FR Doc # 2012-17659  -  Jonathan Gardner, IBEW 2012-08-30 EPA-R09-OAR-2012-0021-0037    I-09 Comment on FR Doc # 2012- 18545 - Anonymous 2012-09-26 EPA-R09-OAR-2012-0021-0040    I-10 Comment on FR Doc # 2012-18520 - Ralph Score 2012-09-26 EPA-R09-OAR-2012-0021-0038    I-11 Comment on FR Doc # 2012-18520 - Laila Amerman 2012-09-26 EPA-R09-OAR-2012-0021-0039    I-12 Comment on FR Doc # 2012-18520  -  Robert E. Quick, Arizona Mining Association 2012-09-14 EPA-R09-OAR-2012-0021-0041    I-13 Comment on FR Doc # 2012-18520 - Robert E. Quick, Arizona Mining Association  -  with attachments 2012-09-14 EPA-R09-OAR-2012-0021-0042    I-14 Comment on FR Doc # 2012-18520 - CREDO Action mass campaign: 1,955 letters 2012-09-26 EPA-R09-OAR-2012-0021-0043    I-15 Comment on FR Doc # 2012-18520 - Micheal G. Dunn, PacifiCorp 2012-09-17 EPA-R09-OAR-2012-0021-0044    I-16 Comment on FR Doc # 2012-18520 - Christopher Lish 2012-09-18 EPA-R09-OAR-2012-0021-0045    I-17 Comment on FR Doc # 2012-18520 - Anonymous 2012-09-26 EPA-R09-OAR-2012-0021-0046    I-18 Comment on FR Doc # 2012-18520 - T. Ted Cromwell, National Rural Electric Cooperative Association 2012-09-18 EPA-R09-OAR-2012-0021-0047    I-19 Comment on FR Doc # 2012-18520  -  Kelly J. Barr, Salt River Project (SRP) 1 of 2  -  cover letter and comments 2012-09-18 EPA-R09-OAR-2012-0021-0048    I-20 Comment on FR Doc # 2012-18520  -  Kelly J. Barr, Salt River Project (SRP) 2 of 2  -  attachments 2012-09-18 EPA-R09-OAR-2012-0021-0049    I-21 Comment on FR Doc # 2012-18520  -  Mike E. Bowen, New Mexico Mining Association 2012-09-18 EPA-R09-OAR-2012-0021-0050    I-22 Comment on FR Doc # 2012-18520  -  Kevin Rogers, Arizona Farm Bureau 2012-09-18 EPA-R09-OAR-2012-0021-0051    I-23 Comment on FR Doc # 2012-18520  -  Susan Kidd, Arizona Public Service (APS) 2012-09-18 EPA-R09-OAR-2012-0021-0052    I-24 Comment on FR Doc # 2012-18520  -  Earthjustice on behalf of NPCA et al. 2012-09-18 EPA-R09-OAR-2012-0021-0053    I-25 Comment on FR Doc # 2012-18520 - Mark Ourada, American Coalition for Clean Coal Electricity 2012-09-18 EPA-R09-OAR-2012-0021-0054    I-26 Comment on FR Doc # 2012-18520 - Edwin D. Hill, International Brotherhood of Electrical Workers (IBEW) 2012-09-18 EPA-R09-OAR-2012-0021-0055    I-27 Comment on FR Doc # 2012-18520  -  Henry Darwin, Arizona Department of Environmental Quality (ADEQ) 2012-09-18 EPA-R09-OAR-2012-0021-0056    I-28 Comment on FR Doc # 2012-18520 - Henry Darwin, Arizona Department of Environmental Quality (ADEQ)  -  duplicate 2012-09-18 EPA-R09-OAR-2012-0021-0057    I-29 Comment on FR Doc # 2012-18520 - Arizona Utilities Group 2012-09-18 EPA-R09-OAR-2012-0021-0058    I-30 [Not used]

   I-31 Comment on FR Doc # 2012-18520  -  Office of Congressman Jeff Flake 2012-09-18 EPA-R09-OAR-2012-0021-0059    I-32 Comment on FR Doc # 2012-17659  -  James Arndt 2012-08-17 EPA-R09-OAR-2012-0021-0014    I-33 Comment on FR Doc # 2012-17659  -  Sid Abma 2012-07-11 EPA-R09-OAR-2012-0021-0015    I-34 Comment on FR Doc # 2012-17659  -  William Tracey 2012-07-27 EPA-R09-OAR-2012-0021-0016    I-35 Comment on FR Doc # 2012-17659  -  Ed Rogers 2012-08-02 EPA-R09-OAR-2012-0021-0017    I-36 COMMENT letter from EarthJustice to Janet McCabe, June 29, 2012 	 2012-06-29 EPA-R09-OAR-2012-0021-0064    I-37 COMMENT: Email from OConnor to Webb, September 5, 2012 and Donez Email to OConnor, September 7, 2012. 2012-09-05 EPA-R09-OAR-2012-0021-0065    I-38 COMMENT: AZ White Mtns Mass Comment Campaign, August 2012 2012-08 EPA-R09-OAR-2012-0021-0066    I-39 COMMENT: James Arndt, 8-17-2012 2012-08-17 EPA-R09-OAR-2012-0021-0067    I-40 COMMENT via email from Sid Abma to Margo Perez Sullivan July 11, 2012. 2012-07-11 EPA-R09-OAR-2012-0021-0068    I-41 COMMENT via email William Tracey to Margot Perez Sullivan, July 27, 2012. 2012-07-27 EPA-R09-OAR-2012-0021-0069    I-42 COMMENT via email Ed Rogers referring to Cholla power plant and visibility in Winslow, Arizona and other areas sent first to Rory Mays, 8-02-2012, then directed to the correct person, Tom Webb. 2012-08-02 EPA-R09-OAR-2012-0021-0070    I-43 COMMENT via email Therese North to Tom Webb, 8-02-2012. 2012-08-02 EPA-R09-OAR-2012-0021-0071    I-44 COMMENT via email from Richard Low to Jared Blumenfeld, 8-11-2012 2012-08-11 EPA-R09-OAR-2012-0021-0072    I-45 COMMENT via email from Karin and Carole Sitts to Thomas Webb, 8-13-2012. 2012-08-13 EPA-R09-OAR-2012-0021-0073    I-46 COMMENT via email from Melinda Conrad to Thomas Webb, 8-14-2012. 2012-08-14 EPA-R09-OAR-2012-0021-0074    I-47 COMMENT letter from Rep. Jeff Flake to Colleen McKaughan, 8-14-2012. 2012-08-14 EPA-R09-OAR-2012-0021-0075    I-48 COMMENT via email from Randy Murph to Thomas Webb, 8-14-2012. 2012-08-14 EPA-R09-OAR-2012-0021-0076    I-49 COMMENT via email from David Shumway to Thomas Webb, 8-14-2012. 2012-08-14 EPA-R09-OAR-2012-0021-0077    I-50 COMMENT via email from Karlee DeWitt to Thomas Webb, 8-15-2012. 2012-08-15 EPA-R09-OAR-2012-0021-0078    I-51 COMMENT from public hearing: David M. Newlin 2012-08-15 EPA-R09-OAR-2012-0021-0079    I-52 COMMENT from public hearing: Elizabeth Speck, Benson AZ 2012-08-15 EPA-R09-OAR-2012-0021-0080    I-53 COMMENT via email 8-16-2012: Daniel Sawvel, Cochise County AZ 2012-08-16 EPA-R09-OAR-2012-0021-0081    I-54 COMMENT via email 8-16-2012: Jamie Stanford to Thomas Webb, 8-16-12. 2012-08-16 EPA-R09-OAR-2012-0021-0082    I-55 COMMENT via email 8-17-2012: David Santeford. 2012-08-17 EPA-R09-OAR-2012-0021-0083    I-56 COMMENT via email 8-19-2012: Gary Truschke to Thomas Webb. 2012-08-19 EPA-R09-OAR-2012-0021-0084    I-57 COMMENT via email 8-20-2012: Gary Maurer, CEO, Prescott Chamber of Commerce to Thomas Webb. 2012-08-20 EPA-R09-OAR-2012-0021-0085    I-58 COMMENT via email from Emily Regis to Tom Webb August 20, 2012. 2012-08-20 EPA-R09-OAR-2012-0021-0086    I-59 COMMENT via email from Don Berry to Jared Blumenfeld, August 29, 2012. 2012-08-29 EPA-R09-OAR-2012-0021-0087    I-60 COMMENT via email from Nathan Hatch to Tom Webb, August 29, 2012. 2012-08-29 EPA-R09-OAR-2012-0021-0088    I-61 COMMENT via email from Jonathan Gardner to Tom Webb, August 30, 2012. 2012-08-30 EPA-R09-OAR-2012-0021-0089    I-62 COMMENT via email from Tim Miller to Tom Webb, September 4, 2012. 2012-09-04 EPA-R09-OAR-2012-0021-0090    I-63 COMMENT via email from Leigh A. Verley to Tom Webb, September 10, 2012. 2012-09-10 EPA-R09-OAR-2012-0021-0091    I-64 COMMENT via email from Monica Balderrama to Tom Webb, September 11, 2012. 2012-09-11 EPA-R09-OAR-2012-0021-0092    I-65 COMMENT via email from Janice Bernal to Tom Webb, September 11, 2012. 2012-09-11 EPA-R09-OAR-2012-0021-0093    I-66 COMMENT via email from Gail A. Casto to Tom Webb, September 11, 2012. 2012-09-11 EPA-R09-OAR-2012-0021-0094    I-67 COMMENT via email from Bikrham Chaudhary to Tom Webb, September 11, 2012. 2012-09-11 EPA-R09-OAR-2012-0021-0095    I-68 COMMENT via email from Kevin Gin to Tom Webb, September 11, 2012. 2012-09-11 EPA-R09-OAR-2012-0021-0096    I-69 COMMENT via email from Samantha Gooman to Tom Webb, September 11, 2012. 2012-09-11 EPA-R09-OAR-2012-0021-0097    I-70 COMMENT via email from James L. Jones to Tom Webb, September 11, 2012. 2012-09-11 EPA-R09-OAR-2012-0021-0098    I-70 COMMENT via email from Chris Maakestad to Tom Webb, September 11, 2012. 2012-09-11 EPA-R09-OAR-2012-0021-0099    I-71 COMMENT via email from John Shaver to Tom Webb, September 11, 2012. 2012-09-11 EPA-R09-OAR-2012-0021-0100    I-72 COMMENT via email from Cathie Thompson to Tom Webb, September 11, 2012. 2012-09-11 EPA-R09-OAR-2012-0021-0101    I-73 COMMENT via email from Danny Brown to Tom Webb, September 12, 2012. 2012-09-12 EPA-R09-OAR-2012-0021-0102    I-74 COMMENT via email from Lori Fonzi to Tom Webb, September 12, 2012. 2012-09-12 EPA-R09-OAR-2012-0021-0103    I-75 COMMENT via email from Russell McLeod to Tom Webb, September 12, 2012. 2012-09-12 EPA-R09-OAR-2012-0021-0104    I-76 COMMENT via email from Jamie R. Stanford to Tom Webb, September 12, 2012. 2012-09-12 EPA-R09-OAR-2012-0021-0105    I-77 COMMENT via email from Tammy Gehris to Tom Webb, September 13, 2012. 2012-09-13 EPA-R09-OAR-2012-0021-0106    I-78 COMMENT via email from Kirk Gray to Tom Webb, September 13, 2012. 2012-09-13 EPA-R09-OAR-2012-0021-0107    I-79 COMMENT via email from Pat Middlebrook to Tom Webb, September 13, 2012. 2012-09-13 EPA-R09-OAR-2012-0021-0108    I-80 COMMENT via email from Pat David Michael Paul to Tom Webb, September 13, 2012. 2012-09-13 EPA-R09-OAR-2012-0021-0109    I-81 COMMENT via email from Kenneth R Cool III to Tom Webb, September 13, 2012. 2012-09-13 EPA-R09-OAR-2012-0021-0110    I-82 COMMENT via email from Stuart D. Kershner, PhD to Tom Webb, September 14, 2012. 2012-09-14 EPA-R09-OAR-2012-0021-0111    I-83 COMMENT via email from Mark Woods to Tom Webb, September 14, 2012. 2012-09-14 EPA-R09-OAR-2012-0021-0112    I-84 COMMENT via email from Caron Johnson to Tom Webb, September 15, 2012. 2012-09-15 EPA-R09-OAR-2012-0021-0113    I-85 COMMENT via email from Leslie E Thompson to Tom Webb, September 16, 2012. 2012-09-16 EPA-R09-OAR-2012-0021-0114    I-86 COMMENT via email from Robyn Daughenbaugh to Tom Webb, September 17, 2012. 2012-09-17 EPA-R09-OAR-2012-0021-0115    I-87 COMMENT via email from Glen Manygoats to Tom Webb, September 17, 2012. 2012-09-17 EPA-R09-OAR-2012-0021-0116    I-88 COMMENT via email from Kevin Barnes to Tom Webb, September 18, 2012. 2012-09-18 EPA-R09-OAR-2012-0021-0117    I-89 COMMENT via email from Chris Barton to Tom Webb, September 18, 2012. 2012-09-18 EPA-R09-OAR-2012-0021-0118    I-90 COMMENT via email from Lori Fonzi to Tom Webb, September 18, 2012. 2012-09-18 EPA-R09-OAR-2012-0021-0119    I-91 COMMENT via email from Geoff Oldfather to Tom Webb, September 18, 2012. 2012-09-18 EPA-R09-OAR-2012-0021-0120    I-92 COMMENT via email from Vincent Yazzie to Tom Webb, September 18, 2012. 2012-09-18 EPA-R09-OAR-2012-0021-0121    I-93 COMMENT via email from Stephen B. Estitty to Tom Webb, October 3, 2012. 2012-10-03 EPA-R09-OAR-2012-0021-0122    I-94 COMMENT via email from Maureen Creegan to Tom Webb, August 24, 2012. 2012-08-24 EPA-R09-OAR-2012-0021-0123    I-95 COMMENT via email from Gretchen Conger to Tom Webb, August 29, 2012. 2012-08-29 EPA-R09-OAR-2012-0021-0124    I-96 COMMENT via email from Barbara Stockwell to Tom Webb, September 14, 2012. 2012-09-14 EPA-R09-OAR-2012-0021-0125    I-97 COMMENT via email from Michelle Freeark (AEPCO) to Tom Webb, September 18, 2012. 2012-09-18 EPA-R09-OAR-2012-0021-0126    I-98 COMMENT via hardcopy from Dilleen_Kodish_Smith (Earthjustice) Letter to Janet McCabe dated June 29, 2012. 2012-07-29 EPA-R09-OAR-2012-0021-0127    I-99 COMMENT via hardcopy from Lavonda Begay to Jared Blumenfeld July 19, 2012. 2012-07-19 EPA-R09-OAR-2012-0021-0128    I-100 COMMENT via hardcopy from Karl Guzzo to Jared Blumenfeld July 19, 2012. 2012-07-19 EPA-R09-OAR-2012-0021-0129    I-101 COMMENT via hardcopy from Ed Pahl to Jared Blumenfeld July 23, 2012. 2012-07-23 EPA-R09-OAR-2012-0021-0130    I-102 COMMENT via hardcopy from Gary Pierce to Jared Blumenfeld July 23, 2012. 2012-07-23 EPA-R09-OAR-2012-0021-0131    I-103 COMMENT Public Hearing transcript, Benson AZ, August 15, 2012. 2012-08-15 EPA-R09-OAR-2012-0021-0167    I-104 Comment via hardcopy from AZ Rock Products Assoc to Jackson  2012-09 EPA-R09-OAR-2012-0021-0239    I-105 Comment via hardcopy from Benson Unified Sch. Distr #9 2012-10-09 EPA-R09-OAR-2012-0021-0240

J.  Additional Documents Considered for Final Rulemaking

   J-01 Coal Availability Study -- Standing Rock Area, San Juan Basin Northwest New Mexico by Gretchen K. Hoffman and Glen E. Jones, Open-file Report 540, July, 2011. 2011-07 EPA-R09-OAR-2012-0021-0063    J-02 Letter re Potential Force Majeure -- SRP Consent Decree_(41554364)_(2) 2012-08-09 EPA-R09-OAR-2012-0021-0241    J-03 Pierce_Air Response_July 26 2012 2012-07-26 EPA-R09-OAR-2012-0021-0200    J-04 2012-06-26 Kelly J Barr Esq Salt River Letter to Deborah Jordan 2012-06-26 EPA-R09-OAR-2012-0021-0201    J-05 2012-06-29 Michelle R Freeark Arizona's G & T Cooperatives Letter to Deborah Jordan 2012-06-29 EPA-R09-OAR-2012-0021-0201    J-06 Barr_Air Response_July 26 2012 2012-07-26 EPA-R09-OAR-2012-0021-0201    J-07 Burns_Air Response_July 26 2012 2012-07-26 EPA-R09-OAR-2012-0021-0201    J-08 Burns_Air Response_July 26 2012 2012-07-26 EPA-R09-OAR-2012-0021-0201    J-09 Burns_Air Response_July 26 2012 2012-07-26 EPA-R09-OAR-2012-0021-0201    J-10 Clean Air Act, 42 U.S.C. 7401 et seq. 2011 EPA-R09-OAR-2012-0021-0202    J-11 Congressional Review Act (5 U.S.C 801 et seq.) 2011 EPA-R09-OAR-2012-0021-0202    J-12 Executive Order 12866: Regulatory Planning and Review (58 FR 51735) 1993-10-04 EPA-R09-OAR-2012-0021-0202    J-13 Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629) 1994-02-16 EPA-R09-OAR-2012-0021-0202    J-14 Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks (62 FR 19885) 1997-04-23 EPA-R09-OAR-2012-0021-0202    J-15 Executive Order 13132: Federalism (64 FR 43255) 1999-08-10 EPA-R09-OAR-2012-0021-0202    J-16 Executive Order 13175: Consultation and Coordination With Indian Tribal Governments (65 FR 67249) 2000-11-09 EPA-R09-OAR-2012-0021-0202    J-17 Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355) 2001-05-22 EPA-R09-OAR-2012-0021-0202    J-18 Executive Order 13563: Improving Regulation and Regulatory Review (76 FR 3821) 2011-01-21 EPA-R09-OAR-2012-0021-0202    J-19 National Technology Transfer and Advancement Act (15 USC 3701 et seq.) 2011 EPA-R09-OAR-2012-0021-0202    J-20 Paperwork Reduction Act (44 U.S.C. 3501 et seq.) 2011 EPA-R09-OAR-2012-0021-0202    J-21 Regulatory Flexibility Act (5 U.S.C. 601 et seq.) 2011 EPA-R09-OAR-2012-0021-0202    J-22 Unfunded Mandates Reform Act (2 U.S.C. 501 et seq.) 2011 EPA-R09-OAR-2012-0021-0202    J-23 AEPCO Apache Generating Station BART Determination Economic Impacts 11_07_2012 2012-01-07 EPA-R09-OAR-2012-0021-0210    J-24 Apache Station Incremental Cost Assessment Report and spreadsheet  -  2 files 2012-11-12 EPA-R09-OAR-2012-0021-0211    J-25 Haldor-Topsoe SCR Experience List 10-09 2009-10 EPA-R09-OAR-2012-0021-0213    J-26 Hitachi SCR experience list

EPA-R09-OAR-2012-0021-0214    J-27 Ted Kurtides, Lessons Learned from SCR Reactor Retrofit

EPA-R09-OAR-2012-0021-0215    J-28 Institute of Clean Air Companies, SCR White Paper, May 2009 2009-05 EPA-R09-OAR-2012-0021-0216    J-29 Design and Operation of Coal-fired TURBO furnaces for NOx control 1978-11 1978-11 EPA-R09-OAR-2012-0021-0217    J-30 An Overview of Riley Stoker's Burner Development Efforts for NOx Control 1983-04 1983-04 EPA-R09-OAR-2012-0021-0218    J-31 Low NOx Combustion System Solutions for Wall Fired,T-Fired, and Turbo Fired Boilers 2006-08 2006-08 EPA-R09-OAR-2012-0021-0219    J-32 Modeling files explanation and list: ("readme_modeling_files_NFR1") 2012 EPA-R09-OAR-2012-0021-0220    J-33 Revised PM Speciation for Cholla Unit 2: ("2006FinalDryBottomPC_FGD_FFpmSpeciationProfile_Cholla-Unit2-filtPM") (Due to the format of some modeling files, they are not available from the electronic docket. These files are available upon request.) -

   J-34 "CALPUFF Regulatory Update", Roger W. Brode, Presentation at Regional/State/Local Modelers Workshop, June 10 - 12, 2008; http://www.cleanairinfo.com/regionalstatelocalmodelingworkshop/archive/2008/agenda.htm ("BRODE_CA") 2008-06-10 EPA-R09-OAR-2012-0021-0222    J-35 Cholla merged stack impacts ("Cholla_mrg23_visx_table") 2012 EPA-R09-OAR-2012-0021-0223    J-36 Cholla remodeling inputs and outputs ("Cholla_NFR_remodling") 2012 EPA-R09-OAR-2012-0021-0224    J-37 Coronado SCR impacts  ("Coronado_base_p_visx") 2012 EPA-R09-OAR-2012-0021-0225    J-38 Federal Land Managers' Air Quality Related Values Work Group (FLAG) Phase I Report -- Revised (2010), U.S. Forest Service, National Park Service, U.S. Fish And Wildlife Service, October 2010. http://www.nature.nps.gov/air/Pubs/pdf/flag/FLAG_2010.pdf  ("FLAG_2010") 2010-10 EPA-R09-OAR-2012-0021-0226    J-39 Modeling-related citations & documents for AZ FIP NFRM docket ("modeling_docket_list") 2012-11-14 EPA-R09-OAR-2012-0021-0227    J-40 Arizona BART Eligibility TSD  (Supporting Documentation on Emissions Unit Bart Eligibility Analysis) 2006 EPA-R09-OAR-2012-0021-0230    J-41 Memorandum from Jeffrey Cole (RTI International) to Bill Maxwell (EPA) regarding NESHAP MACT Floor Analysis for Coal- and Oil-fired Electric Utility Steam Generating Units for Final Rule"  2011-12-16 EPA-R09-OAR-2012-0021-0230    J-42 EPA, Transport Rule Engineering Feasibility Response to Comments, Docket ID No. EPA‐HQ‐OAR‐2009‐0491‐4529,  2011-07-06 EPA-R09-OAR-2012-0021-0230    J-43 Arizona Department of Transportation, Approved Materials Source List, Fly Ash, Natural Pozzolan, and Lime, Revised  2012-07-10 EPA-R09-OAR-2012-0021-0230    J-44 In re: Upper Blackstone Water Pollution Abatement District, Order Denying Review In Part and Remanding In Part, NPDES Appeal Nos.08-11 to 08-18 & 09-06 2010-05- 28 EPA-R09-OAR-2012-0021-0230    J-45 EPA's Technical Information Document 09, "Methods 201 and 201A in Presence of Water Droplets"  1991-09-09 EPA-R09-OAR-2012-0021-0230    J-46 CEMS Cost Calculation 2012-11 EPA-R09-OAR-2012-0021-0230    J-47 Timeline of all tribal consultations on BART.docx  2012-07-02 EPA-R09-OAR-2012-0021-0230    J-48 History of Arizona State Implementation Plan (SIP) Submittals Under the Regional Haze Rule 2012-11-14 EPA-R09-OAR-2012-0021-0230    J-49 American Corn Growers Ass'n v. EPA, 291 F.3d 1  2002 EPA-R09-OAR-2012-0021-0230    J-50 Center for Energy and Economic Development v. EPA, 398 F.3d 653  2005 EPA-R09-OAR-2012-0021-0230    J-51 Central Arizona Water Conservation Dist. v. EPA, 990 F.2d 1531  1993 EPA-R09-OAR-2012-0021-0230    J-52 Hall v. EPA, 273 F.3d 1146  2001 EPA-R09-OAR-2012-0021-0230    J-53 Luminant Generation Co., L.L.C. v. E.PA, 675 F.3d 917  2012 EPA-R09-OAR-2012-0021-0230    J-54 Montana Sulphur & Chemical Co. v. EPA, 666 F.3d 1174  2012 EPA-R09-OAR-2012-0021-0230    J-55 Texas v. EPA, 690 F.3d 670  2012 EPA-R09-OAR-2012-0021-0230    J-56 Train v. NRDC, 421 U.S. 60  1975 EPA-R09-OAR-2012-0021-0230    J-57 Union Elec. Co. v. EPA, 427 U.S. 246  1976 EPA-R09-OAR-2012-0021-0230    J-58 Utility Air Regulatory Group v. EPA, 471 F.3d 1333  2006 EPA-R09-OAR-2012-0021-0230    J-59 EME Homer City Generation v. EPA, 696 F.3d 7  2012 EPA-R09-OAR-2012-0021-0230    J-60 NPCA v. EPA, Complaint (D.D.C. Case 1:11-cv-01548) 2011-08-29  EPA-R09-OAR-2012-0021-0230    J-61 NPCA v. EPA, Consent Decree (D.D.C. Case 1:11-cv-01548) Dkt # 21 2012-03-30 EPA-R09-OAR-2012-0021-0230    J-62 NPCA v. EPA, D.D.C. Memorandum Opinion and Order (D.D.C. Case 1:11-cv-01548) Dkt # 35 2012-05-25 EPA-R09-OAR-2012-0021-0230    J-63 NPCA v. EPA, Docket (D.D.C. Case 1:11-cv-01548)  2012 EPA-R09-OAR-2012-0021-0230    J-64 Arizona Administrative Code, Title 18, Chapter 2, Air Pollution Control

EPA-R09-OAR-2012-0021-0230    J-65 AEPCO-Small Entity Flexibility 2012-15 2012-11-15 EPA-R09-OAR-2012-0021-0230

K.  Notice of Final Rulemaking and Response to Comments

K.1. Notice of Final Rulemaking (Pre-Publication Version) 2012-11-15

K.2. Final Index to Docket EPA-R09-OAR-2012- 0021 2012-11-15 EPA-R09-OAR-2012-0021-0235 K.3. Final Index to Docket EPA-R09-OAR-2012- 0021 (with corrections) 2012-11-16


                          Incorporation by Reference
                      Docket ID No. EPA-HQ-OAR-2011-0147
                                 May 10, 2012

The contents of the following dockets are hereby incorporated by reference into and are considered to be included in, contained in and to have been placed in Docket EPA-HQ-OAR-2011-0147 (Technical Corrections, Clarifying and Other Amendments Package):

   1) EPA-HQ-OAR-2008-0508 (Greenhouse Gas Mandatory Reporting)
   2) EPA-HQ-OAR-2009-0923 (Oil and Natural Gas Systems)
   3) EPA-HQ-OAR-2009-0924 (Confidential Business Information)
   4) EPA-HQ-OAR-2009-0927 (Additional Sources of Fluorinated Gases)
   5) EPA-HQ-OAR-2010-0109 (Technical Corrections of Certain GHG MRR Provisions)
   6) EPA-HQ-OAR-2010-0929 (Change to the Reporting Date for Inputs to Equations)
   7) EPA-HQ-OAR-2011-0028 (Proposed Confidentiality Determinations for 8 Subparts)
   8) EPA-HQ-OAR-2011-0417 (Mandatory Reporting of Greenhouse Gases: Petroleum and Natural Gas Systems: Revisions to Best Available Monitoring Method Provisions)
   9) EPA-HQ-OAR-2011-0512 (Technical Revisions for Subpart I and W of the Greenhouse Gas Reporting Rule)

Accessing dockets:

Publicly available docket materials are available either electronically through www.regulations.gov or in hard copy at EPA's Docket Center, Public Reading Room, EPA West Building, Room 3334, 1301 Constitution Avenue, NW, Washington, DC 20004.  This Docket Facility 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<PHONE_NUMBER>, and the telephone number for the Air Docket is<PHONE_NUMBER>.


[Federal Register: January 29, 2009 (Volume 74, Number 18)]
[Notices]
[Page 5154]
[DOCID:fr29ja09-35]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2157-167-Washington]

Snohomish County; Public Utility District No. 1; Notice of
Designation of Commission Staff as Non-Decisional

January 22, 2009.
    Commission staff member Bob Easton (Office of Energy Projects, 202-
502-6045<EMAIL_ADDRESS>is designated as ``non-decisional''
staff and assigned to participate in settlement discussions and provide
guidance on the Commission's policies and authorities for the Jackson
Hydroelectric Project in the above-referenced proceeding.
    As ``non-decisional'' staff, Mr. Easton will not participate in an
advisory capacity in the Commission's review of any offer of settlement
or settlement agreement, or deliberations concerning the disposition of
the relicense application in the above-referenced proceeding.
    Different Commission ``advisory staff'' will be assigned to review
any offer of settlement or settlement agreement, and to process the
relicense application, including providing advice to the Commission
with respect to the agreement and the application. Non-decisional staff
and advisory staff are prohibited from communicating with one another
concerning the merits of the settlement and the relicense application.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-1912 Filed 1-28-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 121 (Tuesday, June 24, 2014)]
[Rules and Regulations]
[Pages 35693-35695]
[FR Doc No: 2014-14567]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R10-OAR-2014-0018, FRL-9912-55-Region 10]

Approval and Promulgation of Implementation Plans; Oregon:
Infrastructure Requirements for the 2008 Lead National Ambient Air
Quality Standards

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving the
portion of the December 27, 2013, State Implementation Plan (SIP)
submittal from Oregon relating to the infrastructure requirements of
the Clean Air Act (CAA) for the National Ambient Air Quality Standards
(NAAQS) promulgated for lead (Pb) on October 15, 2008. The CAA requires
that each state, after a new or revised NAAQS is promulgated, review
their SIP to ensure that it meets the infrastructure requirements
necessary to implement the new or revised NAAQS. The EPA finds that the
Oregon SIP meets the CAA infrastructure requirements for the 2008 Pb
NAAQS.

DATES: This final rule is effective on July 24, 2014.

ADDRESSES: The EPA has established a docket for this action under
Docket Identification No. EPA-R10-OAR-2014-0018. All documents in the
docket are listed on the http://www.regulations.gov Web site. Although
listed in the index, some information may not be publicly available,
i.e., Confidential Business Information or other information the
disclosure of which is restricted by statute. Certain other material,
such as copyrighted material, is not placed on the Internet and 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 EPA Region 10, Office of Air,
Waste, and Toxics, AWT-107, 1200 Sixth Avenue, Seattle, Washington
98101. The EPA requests that you contact the person listed in the FOR
FURTHER INFORMATION CONTACT section to schedule your inspection. The
Regional Office's official hours of business are Monday through Friday,
8:30 to 4:30, excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Kristin Hall at:<PHONE_NUMBER>,
<EMAIL_ADDRESS>or the above EPA, Region 10 address.

SUPPLEMENTARY INFORMATION: Throughout this document wherever ``we,''
``us'' or ``our'' is used, it is intended to refer to the EPA.
Information is organized as follows:

Table of Contents

I. Background
II. Final Action
III. Statutory and Executive Order Reviews

I. Background

    Section 110 of the CAA specifies the general requirements for
states to submit SIPs to implement, maintain, and enforce the NAAQS and
the EPA's actions regarding approval of those SIPs. On December 27,
2013, Oregon submitted a SIP revision to the EPA demonstrating that the
SIP meets the infrastructure requirements of the CAA for the 2008 Pb
NAAQS, 2010 nitrogen dioxide NAAQS, and 2010 sulfur dioxide NAAQS. On
April 17, 2014, we proposed approval of the portion of Oregon's
December 27, 2013, submittal relating to the 2008 Pb NAAQS (79 FR
21679). An explanation of the CAA requirements and implementing
regulations that are met by this SIP revision, a detailed explanation
of the revision, and the EPA's reasons for the proposed action were
provided in the notice of proposed rulemaking on April 17, 2014, and
will not be restated here. We note that we intend to address the
remainder of the December 27, 2013, submittal, relating to the
infrastructure requirements of the 2010 nitrogen dioxide NAAQS and 2010
sulfur dioxide NAAQS, in a separate action (79 FR 21679). The public
comment period for our proposed action ended on May 19, 2014, and we
received no comments.

II. Final Action

    The EPA is approving the portion of the December 27, 2013,
submittal from Oregon relating to the infrastructure requirements of
the 2008 Pb NAAQS. Specifically, we are approving the submitted
revision to OAR<PHONE_NUMBER> ``Ambient Air Quality Standard for Lead''
and the addition of OAR<PHONE_NUMBER> ``Applicability.'' We find that
the Oregon SIP meets the following CAA section 110(a)(2) infrastructure
elements for the 2008 Pb NAAQS: (A),

(B), (C), (D)(i)(II), (D)(ii), (E), (F), (G), (H), (J), (K), (L), and
(M).
    As described in detail in our proposal on April 17, 2014 (79 FR
21679), we are not approving the submitted revision to OAR<PHONE_NUMBER>
``State of Oregon Clean Air Act Implementation Plan.'' In addition, we
are taking no action on the submitted revisions to OAR<PHONE_NUMBER>
``General Air Quality Definitions, Table 1--Significant Air Quality
Impact,'' OAR<PHONE_NUMBER> ``Sulfur Dioxide,'' and OAR<PHONE_NUMBER>
``Nitrogen Dioxide'' because these revisions are outside the scope of
the 2008 Pb infrastructure SIP. We intend to address these revisions in
a separate action. This action is being taken under section 110 of the
CAA.

III. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because this action does not involve technical standards; and
does not provide the EPA with the discretionary authority to address,
as appropriate, disproportionate human health or environmental effects,
using practicable and legally permissible methods, under Executive
Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the State, and the EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.
    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. The EPA will submit a report containing this action 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 not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by August 25, 2014. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Lead, Particulate matter, and Reporting and recordkeeping
requirements.

    Authority: 42 U.S.C. 7401 et seq.

    Dated: June 5, 2014.
Dennis J. McLerran,
Regional Administrator, Region 10.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for Part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart MM--Oregon

0
2. In Sec.  52.1970, Table 2 in paragraph (c) is amended by adding in
numerical order entry ``202-0020 Applicability'' and revising entry
``202-0130 Ambient Air Quality Standard for Lead'' under Division 202,
after the table subheading ``Ambient Air Quality Standards'' to read as
follows:

Sec.  52.1970  Identification of plan.

* * * * *
    (c) * * *

                                                 Table 2--EPA Approved Oregon Administrative Rules (OAR)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                State
          State citation                Title/subject      effective date             EPA approval date                         Explanations
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                    CHAPTER 340--DEPARTMENT OF ENVIRONMENTAL QUALITY

                                                                      * * * * * * *
                                              Division 202 Ambient Air Quality Standards and PSD Increments
 >
                                                                      * * * * * * *
                                                              Ambient Air Quality Standards

                                                                      * * * * * * *
202-0020..........................  Applicability........       11/7/2013  6/24/2014, [Insert Federal Register
                                                                            citation].

                                                                      * * * * * * *
202-0130..........................  Ambient Air Quality         11/7/2013  6/24/2014, [Insert Federal Register
                                     Standard for Lead.                     citation].

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

0
3. Section 52.1991 is amended by adding paragraph (c) to read as
follows:

Sec.  52.1991  Section 110(a)(2) infrastructure requirements.

* * * * *
    (c) On December 27, 2013, the Oregon Department of Environmental
Quality submitted a SIP revision to address the requirements of CAA
sections 110(a)(1) and (2) for the 2008 lead NAAQS. The EPA approves
the submittal as meeting the following CAA section 110(a)(2)
infrastructure elements for the 2008 lead NAAQS: (A), (B), (C),
(D)(i)(II), (D)(ii), (E), (F), (G), (H), (J), (K), (L), and (M).

[FR Doc. 2014-14567 Filed 6-23-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: September 25, 2008 (Volume 73, Number 187)]
[Notices]
[Page 55587]
[DOCID:fr25se08-101]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

[Docket Number: OST-95-179 and OST-95-623; [OMB Control :
2105-0537]

Agency Information Collection; Request for Comments; Clearance
and Renewal of a Previously Approved Collection; Disclosure of
Codesharing Arrangements and Long-Term Wet Leases

AGENCY: Office of the Secretary (OST).

ACTION: Notice and request for comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995, Public
Law 104-13 (44 U.S.C. 3501 et seq.) this notice announces that the
Information Collection Request, abstracted below, is being forwarded to
the Office of Management and Budget for renewal and comment. The ICR
describes the nature of the information collection and its expected
cost burden. The Federal Register Notice with a 60-day comment period
soliciting comments on the following collection of information was
published on July 11, 2008 [FR Vol. 73, pages 40008--40010]. No
comments were received.

DATES: Written comments on this notice should be received on or before
October 27, 2008 and submitted to the attention of the DOT/OST Desk
Officer, Office of Information and Regulatory Affairs, Office of
Management and Budget, Docket Library, Room 10102, 725 17th Street,
NW., Washington, DC 20503 with the associated OMB Approval Number 2105-
0537 and Dockets OST-95-179 and OST-95-623.

FOR FURTHER INFORMATION CONTACT: Aleta Best, Office of the Assistant
Secretary for Aviation and International Affairs, Office of the
Secretary, U.S. Department of Transportation, 1200 New Jersey Avenue,
SE., Washington, DC 20590,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Title: Disclosure of Codesharing Arrangements and Long-Term Wet
Leases.
    OMB Control Number: 2105-0537.
    Expiration Date: November 30, 2008.
    Type of Review: Renewal and Approval of a previously approved
collection.
    Respondents: All U.S. air carriers, foreign air carriers, computer
reservations systems (CRSs), and travel agents doing business in the
United States, and the traveling public.
    Number of Respondents: 16,000, excluding travelers.
    Number of Responses: 317,000,000.
    Total Annual Burden: 1,306,366 hours.
    Abstract: U.S. airlines, foreign airlines, and travel agents will
provide oral, written and Internet notification to air travelers
containing pertinent information about codesharing and long-term wet
leases at the time the consumer is considering the purchase of air
transportation and for use during the traveler's journey. This
information is intended to aid the prospective consumer in making a
more informed choice regarding the purchase of air transportation, and
to facilitate travel by reducing the possibility that the traveler will
be misled or confused before and during his or her trip. Since the
purpose of this regulation is to ensure that consumers have complete
information about the air transportation they are considering for
purchase, there are no issues of confidentiality involved.
    Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have a practical
utility; (b) the accuracy of the Department's estimate of burden of the
proposed information collection; (c) ways to enhance the quality,
utility, and clarity of the information collection; (d) ways to
minimize the burden of the collection of information on respondents, by
the use of electronic means, including the use of automated collection
techniques or other forms of information technology.
    All responses to this notice will be summarized and included in the
request for OMB approval. All comments will also become a matter of
public record.

    Issued in Washington, DC on September 18, 2008.
Todd M. Homan,
Director, Office of Aviation Analysis.
[FR Doc. E8-22635 Filed 9-24-08; 8:45 am]

BILLING CODE 4910-9X-P


[Federal Register Volume 85, Number 136 (Wednesday, July 15, 2020)]
[Notices]
[Pages 42868-42871]
[FR Doc No: 2020-15253]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0567]

Notice of Decision Not To Designate Clonorchiasis as an Addition
to the Current List of Tropical Diseases in the Federal Food, Drug, and
Cosmetic Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency), in response
to suggestions submitted to the public docket FDA-2008-N-0567, between
June 20, 2018, and November 21, 2018, has analyzed whether the
foodborne trematode infection clonorchiasis meets the statutory
criteria for designation as a ``tropical disease'' for the purposes of
obtaining a priority review voucher (PRV) under the Federal Food, Drug,
and Cosmetic Act (FD&C Act), namely whether it primarily affects poor
and marginalized populations and whether there is ``no significant
market'' for drugs that prevent or treat clonorchiasis in developed
countries. The Agency has determined at this time that clonorchiasis
does not meet the statutory criteria for addition to the tropical
diseases list under the FD&C Act. Although clonorchiasis
disproportionately affects poor and marginalized populations, it is an
infectious disease for which there is a significant market in developed
nations; therefore, FDA declines to add it to the list of tropical
diseases.

DATES: July 15, 2020.

ADDRESSES: Submit electronic comments on additional diseases suggested
for designation to https://www.regulations.gov. Submit written comments
on additional diseases suggested for designation to the Dockets
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified
with the docket number found in brackets in the heading of this
document.

FOR FURTHER INFORMATION CONTACT: Katherine Schumann, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6242, Silver Spring, MD 20993-0002, 301-
796-1300<EMAIL_ADDRESS>or Stephen Ripley, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Rm. 7301, Silver Spring, MD 20993-0002, 240-402-
7911.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background: Priority Review Voucher Program
II. Decision Not To Designate Clonorchiasis
    A. Clonorchiasis
    B. FDA Determination
III. Process for Requesting Additional Diseases To Be Added to the
List
IV. Paperwork Reduction Act
V. References

I. Background: Priority Review Voucher Program

    Section 524 of the FD&C Act (21 U.S.C. 360n), which was added by
section 1102 of the Food and Drug Administration Amendments Act of 2007
(Pub. L. 110-85), uses a PRV incentive to encourage the development of
new drugs, including biological products, for prevention and treatment
of certain diseases that, in the aggregate, affect millions of people
throughout the world. Further information about the tropical disease
PRV program can be found in the October 6, 2016 (81 FR 69537) guidance
for industry ``Tropical Disease Priority Review Vouchers,'' available
at https://www.fda.gov/media/72569/download. Additions to the statutory
list of tropical diseases by an FDA final order published in the
Federal Register can be accessed at https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/tropical-disease-priority-review-voucher-program.
    On August 20, 2015, FDA published a final order (80 FR 50559)
(August 2015 final order) designating Chagas disease and
neurocysticercosis as additions to the list of tropical diseases under
section 524 of the FD&C Act. The August 2015 final order also set forth
FDA's interpretation of the statutory criteria for designating
additions to the section 524 list of tropical diseases and expands the
list of tropical diseases under section 524(a)(3)(R) of the FD&C Act.
That section, later redesignated as section 524(a)(3)(S) of the FD&C
Act, authorizes FDA to designate by order ``[a]ny other infectious
disease for which there is no significant market in developed nations
and that disproportionately affects poor and marginalized populations''
as a tropical disease for which approved drug applications may be
eligible for a PRV.
    FDA has applied its criteria as set forth in the August 2015 final
order to analyze whether clonorchiasis meets the statutory criteria for
addition to the tropical diseases list. As discussed below, the Agency
has determined that clonorchiasis does not meet the statutory criteria
for designation as a PRV-eligible ``tropical disease'' under section
524 of the FD&C Act; thus, FDA will not add it to the list of tropical
diseases whose applications may be eligible for a priority review
voucher.

II. Decision Not To Designate Clonorchiasis

    FDA has considered all disease suggestions submitted to the public
docket (FDA-2008-N-0567) between June 20, 2018, and November 21, 2018,
as potential additions to the list of tropical diseases under section
524 of the FD&C Act, under the docket review process explained on the
Agency's web page at https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm534162.htm. Based on an
assessment of currently available information, and using the criteria
from its August 2015 final order, FDA has determined that clonorchiasis
will not be designated as a ``tropical disease'' for purposes of the
tropical disease PRV program under section 524 of the FD&C Act.

A. Clonorchiasis

    Clonorchiasis is caused by Clonorchis sinensis, trematodes
(parasitic flatworms), also known as flukes, which are acquired by
humans through the consumption of raw or undercooked fish (Ref. 1). The
natural final hosts of C. sinensis are dogs and other fish-eating
carnivores (Ref. 2). C. sinensis are reported in the Democratic
People's Republic of Korea (North Korea), the Republic of Korea (South
Korea), China, Taiwan, Vietnam, Japan, and the Russian Far East (Ref.
1).
    The final location of adult C. sinensis is the smaller bile ducts
of the liver (Ref. 2). The symptoms of clonorchiasis are related to
inflammation and fibrosis of the tissues adjacent to bile ducts. While
the majority of infected individuals are asymptomatic, patients may
develop cholangitis, intrahepatic calculi, or cholangiohepatitis (Ref.
2). Chronic infection is also associated with the development of
cholangiocarcinoma, a severe and fatal form of bile duct cancer, and C.
sinensis is recognized by the International Agency for Research on
Cancer (IARC) as Group 1, which means that the agent is classified as
carcinogenic to humans (Refs. 3 and 4).
    There is one FDA approved treatment for clonorchiasis,
praziquantel, approved in 1982 and indicated for the treatment of
infections due to all species of schistosoma and infections due to the
liver flukes C. sinensis and Opisthorchis viverrini (Ref. 5).
1. Significant Market in Developed Nations
    FDA was unable to make the determination that no significant market
exists for the treatment or prevention of clonorchiasis in developed
nations, as the most recent data shows significant prevalence of
clonorchiasis in a developed nation. As stated above, clonorchiasis
occurs as a result of infection by C. sinensis, which has been reported
in North Korea, South Korea, China, Taiwan, Vietnam, Japan, and the
Russian Far East. The limited range of C. sinensis means that
individuals are infected only in those countries noted, and infections
in other countries only occur from the movement of infected persons.
North Korea, China, Vietnam, and the Russian Federation (Russia) are
not on the World Bank's list of high-income countries (Ref. 6).
However, South Korea, Japan, and Taiwan are high-income economies,
based on World Bank's list of high-income countries, and therefore are
considered developed countries for purposes of this order (Ref. 6).
    In the developed countries where C. sinensis is found,
clonorchiasis rates are typically low. C. sinensis was endemic in Japan
throughout the 1950s; however, improved hygiene associated with
modernization and industrialization has reduced its incidence in humans
in the country to a negligible level (Ref. 7). Likewise, in Taiwan, C.
sinensis has been nearly eliminated from all but a small number of poor
rural areas (Refs. 8 and 9). However, as of 2008, South Korea had an
estimated 1.4 million people infected with C. sinensis. Based on data
from 1981, the egg-positive proportion of people living near 7 major
rivers was 22 percent among 13,373 examined, varying from 0.6 percent
to 45.5 percent (Ref. 10). The persistence of C. sinensis infection is
thought to be primarily due to difficulties in changing the traditional
habit of eating raw freshwater fish (Refs. 10 and 11). The 2017 South
Korean population was 51.42 million, and using the most recent estimate
of 1.4 million people infected with C. sinensis, the estimated
prevalence of C. sinensis infection in South Korea is over 2 percent of
the population (Ref. 12). This prevalence is higher than 0.1 percent of
the population of South Korea. The 0.1 percent of the population was
discussed in FDA's order of 2015 as a factor for aiding in the
determination of whether a significant market may exist for a disease's
treatment. FDA worked to find a more recent prevalence rate for
clonorchiasis infections in South Korea but was unsuccessful. If more
recent

prevalence information is publicly accessible, please provide this
information to the Dockets Management Staff for Docket No. FDA-2008-N-
0567 (see ADDRESSES) and the Agency will reevaluate our findings.
    There is currently no estimate of the number of individuals with
clonorchiasis in the United States. Of the infections that do occur in
the United States, foodborne trematode infections occur predominantly
in immigrants and travelers from endemic regions (Refs. 13 and 14). For
example, in a retrospective study in one U.S. travel medicine clinic
over 6 years, only 17 cases of Opisthorchis spp. and Clonorchis spp.
were identified through the review of ova and parasite records (Ref.
15). All patients with identified cases were migrants from Laos,
Cambodia, Thailand, Vietnam, the former Soviet Union, and Ecuador (Ref.
15).
    There is evidence that U.S. military personnel were exposed to
Opisthorchis spp. and Clonorchis spp. during their service in the
Vietnam War (Ref. 16). In one study, there was evidence that veterans
were likely previously infected, but patients in the study did not have
evidence of ongoing infection given negative stool exams and negative
imaging studies, and therefore would not have ongoing infections
requiring treatment now (Ref. 16).
    As illustrated above, clonorchiasis occurs rarely in most developed
nations. However, in South Korea, the prevalence was 1.4 million people
infected as of 2008, which may offer an incentive to drive development
of new drug products to treat or prevent clonorchiasis.
2. Clonorchiasis Disproportionately Affects Poor and Marginalized
Populations
    Clonorchiasis disproportionately affects poor and marginalized
populations around the world. As areas where clonorchiasis occurs
develop economically, the epidemiology of clonorchiasis changes, and
fewer cases of clonorchiasis occur. This is supported by data in Japan
and Taiwan where incidences of clonorchiasis have fallen rapidly with
improved hygiene as the countries have developed (Refs. 7 and 8).
    Transmission of foodborne trematodes within countries is typically
restricted to limited areas and reflects behavioral and ecological
patterns that are related to socioeconomic status. This includes
people's food habits, methods of food production and preparation, and
the distribution of intermediate hosts. For example, food can be
contaminated through unhygienic preparation and storage. Furthermore,
the consumption of raw fish and crustaceans is a main risk factor for
contracting these parasites. The parasite's life cycle is closely
linked with water and sanitation. In populations without access to
toilets, or without sewage system infrastructure, unprocessed human and
animal fecal waste may be found near water or used as manure or fish
feed. This can contaminate drinking water and aquatic vegetables,
leading to a continuous cycle of infections.
    Clonorchiasis is included in the World Health Organization (WHO)
List of Neglected Tropical Diseases (Ref. 17). The WHO Foodborne
Disease Burden Epidemiology Reference Group identified clonorchiasis as
an important cause of disability, with an estimated annual incidence of
over 31,620 infections and 5,770 deaths, resulting in global disability
adjusted life years, which is calculated by adding the number of years
of life lost to mortality and the number of years lived with disability
due to morbidity due to the illness, of 522,863 (Ref. 18). Given the
above information, it is reasonable to conclude that clonorchiasis
disproportionately affects poor and marginalized populations.

B. FDA Determination

    In sum, although clonorchiasis disproportionately affects poor and
marginalized populations, it is an infectious disease that fails to
meet the statutory criterion for ``no significant market in developed
nations.'' FDA has determined that, at this time, the available
information does not support a determination that clonorchiasis meets
the statutory criteria in section 524 of the FD&C Act for addition to
the list of tropical diseases.

III. Process for Requesting Additional Diseases To Be Added to the List

    FDA's current determination regarding clonorchiasis does not
preclude interested persons from requesting its consideration in the
future. To facilitate the consideration of future additions to the
list, FDA established a public docket (see https://www.regulations.gov,
Docket No. FDA-2008-N-0567) through which interested persons may submit
requests for additional diseases to be added to the list. Such requests
should be accompanied by information to document that the disease meets
the criteria set forth in section 524(a)(3)(S) of the FD&C Act. FDA
will periodically review these requests, and, when appropriate, expand
the list. For further information, see FDA's Tropical Disease Priority
Review Voucher Program web page at https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/tropical-disease-priority-review-voucher-program.

IV. Paperwork Reduction Act

    This notice reiterates the ``open'' status of the previously
established public docket through which interested persons may submit
requests for additional diseases to be added to the list of tropical
diseases that FDA has found to meet the criteria in section
524(a)(3)(S) of the FD&C Act. Such a request for information is exempt
from Office of Management and Budget review under 5 CFR 1320.3(h)(4) of
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).
Specifically, ``[f]acts or opinions submitted in response to general
solicitations of comments from the public, published in the Federal
Register or other publications, regardless of the form or format
thereof'' are exempt, ``provided that no person is required to supply
specific information pertaining to the commenter, other than that
necessary for self-identification, as a condition of the full
consideration of the comment.''

V. References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. FDA has verified the website addresses, as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.

1. *U.S. Centers for Disease Control and Prevention, 2018,
``Parasites--Clonorchis: Epidemiology & Risk Factors,'' accessed
October 24, 2019, https://www.cdc.gov/parasites/clonorchis/epi.html.
2. *WHO, 2018, ``Fact Sheet on Foodborne Trematodiases,'' accessed
October 23, 2019, https://www.who.int/news-room/fact-sheets/detail/foodborne-trematodiases.
3. *WHO, IARC, 2019, ``IARC Monographs on the Identification of
Carcinogenic Hazards to Humans, Agents Classified by the IARC
Monographs,'' Vols. 1-125, accessed October 23, 2019, https://
monographs.iarc.fr/agents-classified-by-

the-iarc/.
4. *WHO, IARC, 2012, ``IARC Monographs on the Evaluation of
Carcinogenic Risks in Humans, Opisthorchis Viverrini and Clonorchis
Sinensis,'' Vol. 100B, 341-370, accessed October 23, 2019, https://monographs.iarc.fr/wp-content/uploads/2018/06/mono100B-13.pdf.
5. U.S. National Library of Medicine, 2015, ``Label: Biltricide-
Praziquantel Tablet, Film Coated,'' DailyMed.
6. The World Bank, ``World Bank Country and Lending Groups,''
accessed December 12, 2018, https://datahelpdesk.worldbank.org/knowledgebase/articles/906519-world-bank-country-and-lending-groups.
7. Nakamura-Uchiyama, F., K. Hiromatsu, K. Ishiwata, et al., 2003,
``The Current Status of Parasitic Diseases in Japan,'' Internal
Medicine, 42(3):222-236.
8. Lo, T.C., J.H. Chang, H.H. Lee, et al., 2013, ``Risk Factors for
and Prevalence of Clonorchiasis in Miaoli County, Taiwan,''
Southeast Asian Journal of Tropical Medicine and Public Health,
44(6):950-958.
9. Yeh, T.C., P.R. Lin, E.R. Chen, et al., 2001, ``Current Status of
Human Parasitic Infections in Taiwan,'' Journal of Microbiology,
Immunology, and Infection, 34(3):155-160.
10. Seo, B.S., S.H. Lee, S.Y. Cho, et al., 1981, ``An Epidemiologic
Study on Clonorchiasis and Metagonimiasis in Riverside Areas in
Korea,'' Kisaengchunghak Chapchi, 19(2):137-150.
11. Shin, E.H., S.M. Guk, H.J. Kim, et al., 2008, ``Trends in
Parasitic Diseases in the Republic of Korea,'' Trends in
Parasitology, epub ahead of print February 5, 2008, doi: 10.1016/
j.pt.2007.12.003.
12. Statistics Korea, 2018, ``2017 Population and Housing Census,''
accessed October 24, 2019, http://kostat.go.kr/portal/eng/pressReleases/8/7/index.board.
13. Furst, T., U. Duthaler, B. Sripa, et al., 2012, ``Trematode
Infections: Liver and Lung Flukes,'' Infectious Disease Clinics of
North America, 26(2):399-419.
14. Qian, M.-B., Y.-D. Chen, S. Liang, et al., 2012, ``The Global
Epidemiology of Clonorchiasis and its Relation with
Cholangiocarcinoma,'' Infectious Diseases of Poverty, epub ahead of
print October 25, 2012, doi: 10.1186/2049-9957-1-4.
15. Stauffer, W.M., J.S. Sellman, and P.F. Walker, 2004, ``Biliary
Liver Flukes (Opisthorchiasis and Clonorchiasis) in Immigrants in
the United States: Often Subtle and Diagnosed Years After Arrival,''
Journal of Travel Medicine, 11(3):157-159.
16. Psevdos, G., F.M. Ford, and S.T. Hong, 2018, ``Screening US
Vietnam Veterans for Liver Fluke Exposure 5 Decades After the End of
the War,'' Infectious Diseases in Clinical Practice, epub ahead of
print January 16, 2018, doi: 0.1097/IPC.0000000000000611.
17. *WHO, 2018, ``Neglected Tropical Diseases,'' accessed October
24, 2019, https://www.who.int/neglected_diseases/diseases/en/.
18. *WHO, Foodborne Disease Burden Epidemiology Reference Group,
2015, ``WHO Estimates of the Global Burden of Foodborne Diseases
2007-2015,'' accessed October 24, 2019, https://www.who.int/foodsafety/publications/foodborne_disease/fergreport/en/.

    Dated: July 8, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15253 Filed 7-14-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: July 8, 2010 (Volume 75, Number 130)]
[Notices]
[Page 39325]
[DOCID:fr08jy10-148]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

Aviation Proceedings, Agreements Filed the Week Ending June 19,
2010

    The following Agreements were filed with the Department of
Transportation under Sections 412 and 414 of the Federal Aviation Act,
as amended (49 U.S.C. 1382 and 1384) and procedures governing
proceedings to enforce these provisions. Answers may be filed within 21
days after the filing of the application.
    Docket Number DOT-OST-2010-0155.
    Date Filed June 16, 2010.
    Parties Members of the International Air Transport Association.
    Subject Mail Vote 640--Resolution 010y. PTC3 Japan, Korea-South
East Asia. Special Passenger Amending Resolution 010y between Korea
(Rep. of) and Thailand (Memo 1395). Intended effective date: 23 June
2010.

Renee V. Wright,
Program Manager, Docket Operations, Federal Register Liaison.
[FR Doc. 2010-16611 Filed 7-7-10; 8:45 am]
BILLING CODE 4910-62-P