Recommendations Concerning the Proposed Rule for the Revision of the

National Ambient Air Quality Standards (NAAQS) for NO2.''
EPA-CASAC-08-016, July 18.
Ito, K, Thurston, GD, Silverman, RA. (2007). Characterization of
PM2.5, gaseous pollutants, and meteorological interactions in the
context of time-series health effects models. J. of Expos. Science
and Environ. Epidemiology. 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.
Janssen, NAH., van Vliet PHN, Asrts F, Harssema H, Brunekreef B.
(2001). Assessment of exposure to traffic related air pollution of
children attending schools near motorways. Atmos. Environ. 35:3875-
3884.
Kalthoff, N, Baumer D, Corsmeier U, Kohler M, Vogel B. (2005).
Vehicle-induced turbulence near a motorway, Atmospheric Environment
39:5737-5749.
Kim, S-Y, O'Neill M, Lee J-T, Cho Y, Kim J, and Kim H. (2007). Air
pollution, socioeconomic position, and emergency hospital visits for
asthma in Seoul, Korea. Int. Arch. Occup. Environ. Health 80:701-
710.
Linn, WS, Szlachcic Y, Gong H, Kinney PL, Berhane KT. (2000). Air
pollution and daily hospital admissions in metropolitan Los Angeles.
Environ. Health Perspect. 108:427-434.
McClenny, WA, Williams EJ, Cohen RC, Stutz J. (2002). Preparing to
measure the effects of the NOX SIP Call--methods for ambient air
monitoring of NO, NO2, NOY, and individual NOZ species.
J. Air Waste Manage. Assoc. 52:542-562.
McCurdy, TR. (1994). Analysis of high 1 hour NO2 values
and associated annual averages using 1988-1992 data. Office of Air
Quality Planning and Standards, Research Triangle Park, NC.
Available in Docket A-93-06.
Mortimer, KM, Neas LM, Dockery DW, Redline S, Tager IB. (2002). The
effect of air pollution on inner-city children with asthma. Eur
Respir J. 19:699-705.
National Heart, Lung, and Blood Institute (NHLBI). (2007) Expert
panel report 3: guidelines for the diagnosis and management of
asthma. Bethesda, MD: U.S. Department of Health and Human Services,
National Institutes of Health, National Asthma Education and
Prevention Program; NIH Publication No. 07-4051.
New York Department of Health. (2006). A study of ambient air
contaminants and asthma in New York City, Final Report Part B: Air
contaminants and emergency department visits for asthma in the Bronx
and Manhattan. Prepared for: The U.S. Department of Health and Human
Services, Agency for Toxic Substance and Disease Registry.
Nunnermacker, LJ, Imre D, Daum PH, Kleinman L, Lee YN, Lee JH,
Springston SR, Newman L, Weinstein-Lloyd J, Luke WT, Banta R,
Alvarez R, Senff C, Sillman S, Holdren M, Keigley GW, Zhou X.
(1998). Characterization of the Nashville urban plume on July 3 and
July 18, 1995. J. Geophys. Res. [Atmos.] 103:28,129-28,148.
Oftedal, B, Brunekreef B, Nystad W, Madsen C, Walker SE, Nafstad P.
(2008). Residential outdoor air pollution and lung function in
schoolchildren. Epidemiology 19:129-137.
Ostro, B, Lipsett M, Mann J, Braxton-Owens H, White M. (2001). Air
pollution and exacerbation of asthma in African-American children in
Los Angeles. Epidemiology 12:200-208.
Parrish, DD, Fehsenfeld FC. (2000). Methods for gas-phase
measurements of ozone, ozone precursors and aerosol precursors.
Atmos. Environ. 34:1921-1957.
Peacock, M. (2008). Letter to CASAC chair Rogene Henderson.
September 8.
Peacock, M. (2006). Letter to EPA Assistant Administrator Dr. George
Gray: ``Process for Reviewing National Ambient Air Quality
Standards.'' December 7.
Peel, JL, Tolbert PE, Klein M, Metzger KB, Flanders WD, Knox T,
Mulholland JA, Ryan PB, Frumkin H. (2005). Ambient air pollution and
respiratory emergency department visits. Epidemiology. 16:164-174.
Pilotto, LS, Douglas RM, Attewell RG, Wilson SR (1997) Respiratory
effects associated with indoor nitrogen dioxide exposure in
children. Int. J. Epidemiol. 26: 788-796.
Pilotto, LS, Nitschke M, Smith BJ, Pisaniello D, Ruffin RE, McElroy
HJ, Martin J, Hiller JE. (2004). Randomized controlled trial of
unflued gas heater replacement on respiratory health of asthmatic
schoolchildren. Int J Epidemiol. 33:208-214.
Rizzo (2008). Investigation of how distributions of hourly nitrogen
dioxide concentrations have changed over time in six cities.
Nitrogen Dioxide NAAQS Review Docket (EPA-HQ-OAR-2006-
0922). Available at http://www.epa.gov/ttn/naaqs/
standards/nox/s_nox_cr_rea.html.
Rodes, CE and Holland DM. (1981). Variations of NO, NO2,
and O3 concentrations downwind of a Los Angeles Freeway.
Atmos. Environ. 15:243-250.
Roorda-Knape, MC, Janssen NAH, De Hartog JJ, Van Vliet PHN, Harssema
H, Brunekreef B. (1998). Air pollution from traffic in city
districts near major motorways. Atmos. Environ. 32:1921-1930.
Rojas-Martinez, R, Perez-Padilla R, Olaiz-Fernandez G, Mendoza-
Alvarado L, Moreno-Macias H, Fortoul T, McDonnell W, Loomis D,
Romieu I. (2007a) Lung function growth in children with long-term
exposure to air pollutants in Mexico City. Am. J. Respir. Crit. Care
Med. 176:377-384.
Rojas-Martinez, R, Perez-Padilla R, Olaiz-Fernandez G, Mendoza-
Alvarado L, Moreno-Macias H, Fortoul T, McDonnell W, Loomis D,
Romieu I. (2007b) Lung function growth in children with long-term
exposure to air pollutants in Mexico City. Online data supplement.
Available: http://ajrccm.atsjournals.org/cgi/data/176/4/377/DC1/1 [3
October, 2007].
Ryerson, TB, Williams EJ, Fehsenfeld FC. (2000). An efficient
photolysis system for fast-response NO2 measurements. J.
Geophys. Res. [Atmos.] 105:26,447-26,461.
Samet, J. (2008a). 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
NO2 Primary National Ambient Air Quality Standard: Second
Draft.'' EPA-CASAC-08-021, September 24.
Samet, J. (2008b). Letter to EPA Administrator Stephen Johnson:
``Clean Air Scientific Advisory Committee's (CASAC) Review Comments
on EPA's Risk and Exposure Assessment to Support the Review of the
NO2 Primary National Ambient Air Quality Standard.'' EPA-
CASAC-09-003, December 16.
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.
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.
Stout, JW, Visness CM, Enright P, Lamm, C, Shapiro G, Gan, VN, Adams
K, Mitchell HE. (2006). Classification of asthma severity in
children. Arch Pediatr Adolesc Med. 160:844-850.
Strand, V, Rak S, Svartengren M, Bylin G. (1997). Nitrogen dioxide
exposure enhances asthmatic reaction to inhaled allergen in subjects
with asthma. Am J Respir Crit Care Med. 155:881-887.
Strand, V, Svartengren M, Rak S, Barck C, Bylin G. (1998). Repeated
exposure to an ambient level of NO2 enhances asthmatic
response to nonsymptomatic allergen dose. Eur Respir J. 12:6-12.
Thompson, R. (2008). Nitrogen Dioxide (NO2) Descriptive
Statistics Tables. Memo to the NO2 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.
Venkatram, A, Isakov V, Thoma E, Baldauf RW. (2007). Analysis of air
quality data near roadways using a dispersion model. Atmos. Environ.
41:9481-9497.
Watkins, N. and Thompson, R. (2008). NOX Network Review
and Background. Memo to the NO2 NAAQS docket.

Wolff, GT. (1995). Letter to EPA Administrator Carol Browner:
``CASAC Review of the Staff Paper for the Review of the National
Ambient Air Quality Standards for Nitrogen Dioxide: Assessment of
Scientific and Technical Information.'' EPA-SAB-CASAC-LTR-95-004,
August 22.
Zhou, Y and Levy JI. (2007). Factors influencing the spatial extent
of mobile source air pollution impacts: a meta-analysis. 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: June 26, 2009.
Lisa P. Jackson,
Administrator.

    For the reasons stated in the preamble, title 40, chapter I of the
Code of Federal Regulations is proposed to be amended as follows:

PART 50--NATIONAL PRIMARY AMBIENT AIR QUALITY STANDARDS

    1. The authority citation for part 50 continues to read as follows:

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

Subpart A--General Provisions

    2. Section 50.11 is revised to read as follows:

Sec.  50.11  National primary and secondary ambient air quality
standards for oxides of nitrogen (nitrogen dioxide).

    (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 (80-100) 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 (99th percentile)(fourth highest) of the daily maximum 1-
hour average concentration is less than or equal to (80-100) 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 revising paragraph (c)(2)(vi) to
read as follows:

Sec.  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 and the schedule 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.

 Table 1--to Paragraph (c)(2)(vi): Schedule for Exceptional Event Flagging and Documentation Submission for Data
                          To Be Used in Designations Decisions for New or Revised NAAQS
----------------------------------------------------------------------------------------------------------------
                                      Air quality data
 NAAQS pollutant/standard/(level)/     collected for      Event flagging & initial      Detailed documentation
         promulgation date             calendar year        description deadline         submission deadline
----------------------------------------------------------------------------------------------------------------
PM2.5/24-Hr Standard (35[mu]g/m\3\)          2004-2006  October 1, 2007 \a\........  April 15, 2008. \a\
 Promulgated October 17, 2006.
Ozone/8-Hr Standard (0.075 ppm)              2005-2007  June 18, 2009 \b\..........  June 18, 2009.\b\
 Promulgated March 12, 2008.
                                                  2008  June 18, 2009 \b\..........  June 18, 2009.\b\
                                                  2009  60 Days after the end of     60 Days after the end of
                                                         the calendar quarter in      the calendar quarter in
                                                         which the event occurred     which the event occurred
                                                         or February 5, 2010,         or February 5, 2010,
                                                         whichever date occurs        whichever date occurs
                                                         first. \b\                   first.\b\
NO2/1-Hour Standard (80-100 ppb,                  2008  July 1, 2010 \b\...........  January 22, 2011.
 final level TBD).
                                                  2009  July 1, 2010...............  January 22, 2011.
                                                  2010  April 1, 2011 \b\..........  July 1, 2011.\b\
----------------------------------------------------------------------------------------------------------------
\a\ These dates are unchanged from those published in the original rulemaking, and are shown in this table for
  informational purposes.
\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. Appendix S is added to read as follows:

Option 1 for Appendix S to Part 50:

Appendix S to Part 50--Interpretation of the Primary National Ambient
Air Quality Standards for Oxides of Nitrogen (Nitrogen Dioxide) (1-Hour
Primary Standard Based on the 4th Highest Daily Maximum Value Form)

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 (``NO2 NAAQS'') specified in Sec.  50.11
are met. Nitrogen dioxide (NO2) 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 NO2 concentrations and the levels of the
NO2 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
Sec. Sec.  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 NO2 refers to the
maximum 1-hour NO2 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 4th highest daily maximum 1-
hour values for a monitoring site (referred to as the ``1-hour
primary standard design value'').
    Annual 4th highest daily maximum 1-hour value refers to the 4th
highest daily 1-hour maximum value at a site in a particular year.
    Quarter refers to a calendar quarter.
    Year refers to a calendar year.

2. Requirements for Data Used for Comparisons With the NO2
NAAQS and Data Reporting Considerations

    (a) All valid FRM/FEM NO2 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 NO2 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 in advance, 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 NO2 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 NO2 NAAQS

3.1 The Annual Primary NO2 NAAQS

    (a) The annual primary NO2 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 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 NO2 NAAQS

    (a) The 1-hour primary NO2 NAAQS is met at a site
when the valid 1-hour primary standard design value is less than or
equal to [80-100] parts per billion (ppb).
    (b) An NO2 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 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
either of the following conditions is true.
    (i) If there are at least four days in each of the 3 years that
have at least one reported hourly value, and the resulting 3-year 1-
hour primary standard design value exceeds the 1-hour primary NAAQS.
In this situation, more complete data capture could not possibly
have resulted in a design value below the 1-hour primary NAAQS.
    (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 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 percent of the hours in the day 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; 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 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 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 5.2 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.
    (d) A 1-hour primary standard design value based on data that do
not meet the completeness criteria stated in section 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 NO2
NAAQS

    (a) Hourly NO2 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 NO2
NAAQS

    (a) Hourly NO2 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, including the annual 4th
highest of those daily 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 NO2 NAAQS

5.1 Calculation Procedures for the Annual Primary NO2
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 NO2
NAAQS

    (a) 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), calculation
of the 4th highest daily 1-hour maximum is accomplished as follows.
    (i) For each year, select from each day the highest hourly
value. All daily maximum 1-hour values from all days in the quarter
period shall be considered at this step, including days with less
than 75 percent data capture.
    (ii) For each year, order these daily values and take the 4th
highest.
    (iii) The 1-hour primary standard design value for a site is
mean of the three annual 4th highest values, rounded according to
the conventions in section 4.2.

Option 2 for Appendix S to Part 50:

Appendix S to Part 50--Interpretation of the Primary National Ambient
Air Quality Standards for Oxides of Nitrogen (Nitrogen Dioxide) (1-Hour
Primary Standard Based on the 99th Percentile Form)

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 (``NO2 NAAQS'') specified in Sec.  50.11
are met. Nitrogen dioxide (NO2) 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 NO2 concentrations and the levels of the
NO2 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
Sec. Sec.  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 NO2 refers to the
maximum 1-hour NO2 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 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 5.2 of this appendix.
    Quarter refers to a calendar quarter.
    Year refers to a calendar year.

2. Requirements for Data Used for Comparisons With the NO2
NAAQS and Data Reporting Considerations

    (a) All valid FRM/FEM NO2 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 NO2 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 NO2 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 NO2 NAAQS

3.1 The Annual Primary NO2 NAAQS

    (a) The annual primary NO2 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 NO2 NAAQS

    (a) The 1-hour primary NO2 NAAQS is met at a site
when the valid 1-hour primary standard design value is less than or
equal to [80-100] parts per billion (ppb).
    (b) An NO2 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 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 percent of the hours in the day 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; 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 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 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 5.2 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 NO2
NAAQS

    (a) Hourly NO2 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 NO2
NAAQS

    (a) Hourly NO2 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 4th
highest of those daily 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 NO2 NAAQS

5.1 Procedures for the Annual Primary NO2 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 NO2
NAAQS

    (a) Procedure for identifying annual 99th 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 99th percentile values will be based on the
number of days with at least 75 percent of the hourly values
reported.
    (i) For the year, from only the days with at least 75 percent of
the hourly values reported, select from each day the highest hourly
value.
    (ii) Sort all the valid daily 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 (cny). 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, P0.99, y= the nth largest value.

                     Table 1--to Section 5.2(a)(ii)
------------------------------------------------------------------------
                                                         P0.99, y is the
                                                           nth maximum
 Annual number of days with valid data for year ``y''     value of the
                         (cny)                          year, where n is
                                                           the listed
                                                             number
------------------------------------------------------------------------
1-100.................................................                 1
101-200...............................................                 2
201-300...............................................                 3
301-366...............................................                 4
------------------------------------------------------------------------

    (b) The 1-hour primary standard design value for a site is mean
of the three annual 4th highest values, rounded according to the
conventions in section 4.2.

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 definitions for ``AADP'' and
``Near-road NO2 Monitor'' in alphabetical order to read as
follows:

Sec.  58.1  Definitions.

* * * * *
    AADT means the annual average daily traffic.
* * * * *
    Near-road NO2 Monitor means any NO2 monitor
meeting the specifications in 4.3.2 of Appendix D and paragraphs 2,
4(b), 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:

Sec.  58.10   Annual monitoring network plan and periodic network
assessment.

    (a) * * *
    (5) A plan for establishing NO2 monitoring sites in
accordance with the requirements of appendix D to this part shall be
submitted to the Administrator by July 1, 2011. The plan shall provide
for all required stations to be operational by January 1, 2013.
* * * * *
    (b) * * *
    (12) The identification of required NO2 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:

Sec.  58.13  Monitoring network completion.

* * * * *
    (c) The network of NO2 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, E, and G to this part.
    9. Section 58.16 is amended by revising paragraph (a) to read as
follows:

Sec.  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 SO2; CO; O3;
NO2; NO; NOY; NOX; Pb-TSP mass
concentration; Pb-PM10 mass concentration; PM10
mass concentration; PM2.5 mass concentration; for filter-
based PM2.5FRM/FEM the field blank mass, sampler-generated
average daily temperature, and sampler-generated average daily
pressure; chemically speciated PM2.5 mass concentration
data; PM10-2.5 mass concentration; chemically speciated
PM10-2.5 mass concentration data; meteorological data from
NCore, PAMS, and near-road NO2 monitoring 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 as by adding section <IP_ADDRESS>
to read as follows:

Appendix A to Part 58--Quality Assurance Requirements for SLAMS, SPMs
and PSD Air Monitoring

* * * * *
    <IP_ADDRESS> Measurement Uncertainty for NO2. 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 as by adding section 2.1.1 to
read as follows:

Appendix C to Part 58--Ambient Air Quality Monitoring Methodology

* * * * *
    2.1.1 Any NO2 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 section 4.3 to
read as follows:

Appendix D to Part 58--Network Design Criteria for Ambient Air Quality
Monitoring

* * * * *

4.3 Nitrogen Dioxide (NO2) Design Criteria

    4.3.1 General Requirements. (a) State and, where appropriate,
local agencies must operate a minimum number of required
NO2 monitoring sites as described below.
    4.3.2 Requirement for Near-road NO2 Monitors. (a)
Within the NO2 network, there must be one microscale
near-road NO2 monitoring station in each CBSA with a
population of 350,000 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
NO2 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 350,000 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 NO2 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 NO2 concentrations are
expected to be highest 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 NO2 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
NO2 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.
    (b) Measurements at required near-road NO2 monitor
sites must include at a minimum: NO, NO2, NOX,
wind vector data in the horizontal and vertical planes, ambient
temperature, and ambient relative humidity.
    4.3.3 Requirement for Area-wide NO2 Monitoring. (a)
Within the NO2 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 NO2
concentrations representing the neighborhood or larger spatial
scales. PAMS sites collecting NO2 data that are situated
in an area of expected high NO2 concentrations at the
neighborhood or larger spatial scale may be used to satisfy this
minimum monitoring requirement when the NO2 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 NO2 monitoring
stations. CBSA populations shall be based on the latest available
census figures.
    4.3.4 Regional Administrator Required Monitoring. (a) The
Regional Administrator may require additional NO2
monitoring stations above the minimum requirements to monitor in
locations away from roads, or sites that do not meet near-road
NO2 monitor siting criteria noted in appendix E of this
part, where required near-road monitors do not represent a location
or locations where the expected maximum hourly NO2
concentrations exist in a CBSA. The Regional Administrator may also
require additional near-road NO2 monitoring stations
above the minimum required in situations where the minimum
monitoring requirements are not sufficient to meet monitoring
objectives, and may consider additional locations of expected high
NO2 concentrations and the variety of exposure potential
due to increased variety in amount or types of fleet mix, congestion
patterns, terrain, or geographic areas within a CBSA. The Regional
Administrator and the responsible State or local air monitoring
agency should work together to design and/or maintain the most
appropriate NO2 network to service the variety of data
needs for an area.
    (b) The Regional Administrator may require additional
NO2 monitoring stations for area-wide NO2
monitors at the neighborhood and larger spatial scales above the
minimum monitoring requirements where the minimum monitoring
requirements are not sufficient to meet monitoring objectives for an
area, such as supporting photochemical pollutant assessment, air
quality forecasting, PM precursor analysis, and characterizing
impacts of NO2 sources on certain communities. The
Regional Administrator and the responsible State or local air
monitoring agency should work together to design and/or maintain the
most appropriate NO2 network to service the variety of
data needs for an area.
    4.3.5 NO2 Monitoring Spatial Scales. (a) The most
important spatial scale for near-road NO2 monitoring
stations to effectively characterize the maximum expected hourly
NO2 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
NO2 concentrations are the microscale and middle scale.
The most important spatial scale for area-wide monitoring of high
NO2 concentrations is the neighborhood scale.
    (1) Microscale--This scale would typify areas in close proximity
to major roadways or point and area sources. Emissions from roadways
result in high ground level NO2 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 NO2
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 NO2 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 NO2
concentrations at the neighborhood scale. Where a neighborhood site
is located away from immediate NO2 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
NO2 monitoring network identified in paragraph 4.3.4
above.
    4.3.6 NOy Monitoring. (a) NO/NOy
measurements are included within the NCore multipollutant site
requirements and the PAMS program. These NO/NOy
measurements will produce conservative estimates for NO2
that can be used to ensure tracking continued compliance with the
NO2 NAAQS. NO/NOy monitors are used at these
sites because it is important to collect data on total reactive
nitrogen species for understanding O3 photochemistry.
* * * * *
    13. Section Appendix E to part 58 is amended as follows:
    a. By revising section 2.
    b. By adding paragraph (d) to section 4.
    c. By revising section 6.1.
    d. By adding section 6.4.
    e. By revising section 11 including 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, PM10, PM10-2.5,
PM2.5, NO2 and carbon monoxide sites. Middle
scale PM10-2.5 sites are required to have sampler inlets
between 2 and 7 meters above ground level. Microscale Pb,
PM10, PM10-2.5 and PM2.5 sites are
required to have sampler inlets between 2 and 7 meters above ground
level. Microscale near-road NO2 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. Spacing From Obstructions

* * * * *
    (d) For near-road NO2 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
O3 analyzer, it is important to minimize destructive
interferences form sources of NO, since NO readily reacts with
O3. 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 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 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 (NO2) Probes and
Monitoring Paths (a) In siting near-road NO2 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 NO2 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 from Table E-1 of this appendix. The sum of
these distances must not be greater than 10 percent of the total
monitoring path length.
* * * * *

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 NO2 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.

                                Table E-4 of Appendix E to Part 58--Summary of Probe and Monitoring Path Siting Criteria
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Horizontal and
                                                                                vertical distance
                                                               Height from ground      from supporting     Distance from trees   Distance from roadways
            Pollutant              Scale (maximum monitoring   to probe, inlet or     structures \2\ to    to probe, inlet or      to probe, inlet or
                                      path length, meters)      80% of monitoring    probe, inlet or 90%    90% of monitoring      monitoring path \1\
                                                                    path \1\         of monitoring path     path \1\ (meters)           (meters)
                                                                                \1\ (meters)
--------------------------------------------------------------------------------------------------------------------------------------------------------
SO2 3, 4, 5, 6...................  Middle (300 m)             2-15................  > 1.................  > 10................  N/A.
                                    Neighborhood Urban, and
                                    Regional (1 km).
CO 4, 5, 7.......................  Micro, middle (300 m)      3\1/2\: 2-15........  > 1.................  > 10................  2-10; see Table E-2 of
                                    Neighborhood (1 km).                                                                         this appendix for
                                                                                middle and neighborhood
                                                                                scales.
O3 3, 4, 5.......................  Middle (300 m)             2-15................  > 1.................  > 10................  See Table E-1 of this
                                    Neighborhood, Urban, and                                                                     appendix for all
                                    Regional (1 km).                                                                             scales.
NO2 \3,4,5\......................  Micro (Near-road [50-      2-7 (micro).........  > 1.................  > 10................  <= 50 meters for near-
                                    300]).                                                                                road microscale.
                                   Middle (300m)............  2-15 (all other
                                                               scales).
                                   Neighborhood, Urban, and                                                                     See Table E-1 of this
                                    Regional (1 km).                                                                             appendix for all other
                                                                                scales.
Ozone precursors (for PAMS) 3, 4,  Neighborhood and Urban (1  2-15................  > 1.................  > 10................  See Table E-4 of this
 5.                                 km).                                                                                appendix for all
                                                                                scales.
PM,Pb 3, 4, 5, 6, 8..............  Micro: Middle,             2-7 (micro); 2-7      > 2 (all scales,      > 10 (all scales)...  2-10 (micro); see Figure
                                    Neighborhood, Urban and    (middle PM10	2.5);    horizontal distance                         E-1 of this appendix
                                    Regional.                  2-15 (all other       only).                                      for all other scales.
                                                               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 NO2 monitoring, and all applicable scales for monitoring SO2,O3, and O3 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 obstruction.

\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.
\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 location.
\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 by revising section 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 PM10 and
PM2.5 are to be considered separately.
* * * * *

                                                            Table 2--Breakpoints for the AQI
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                 These breakpoints                                                            Equal these AQI's
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                      PM2.5        PM10
           O3 (ppm) 8-hour            O3 (ppm) 1-    ([mu]g/      ([mu]g/    CO (ppm)    SO2 (ppm)    NO2 (ppm) 1-       AQI             Category
                                        hour\1\       m\3\)        m\3\)                                  hour
--------------------------------------------------------------------------------------------------------------------------------------------------------
0.000-0.059.........................  ...........     0.0-15.4        0-54     0.0-4.4  0.000-0.034  0-(0.040-0.053        0-50  Good.
                                          .......                                                                 )
0.060-0.075.........................  ...........    15.5-40.4      55-154     4.5-9.4  0.035-0.144  (0.041-0.054)-      51-100  Moderate.
                                          .......                                                     (0.080-0.100)
0.076-0.095.........................  0.125-0.164    40.5-65.4     155-254    9.5-12.4  0.145-0.224  (0.081-0.101)-     101-150  Unhealthy for Sensitive
                                                                                (0.360-0.370)               Groups.
0.096-0.115.........................  0.165-0.204      3 65.5-     255-354   12.5-15.4  0.225-0.304  (0.361-0.371)-     151-200  Unhealthy.
                                                         150.4                                                 0.64
0.116-0.374.........................  0.205-0.404     3 150.5-     355-424   15.5-30.4  0.305-0.604       0.65-1.24     201-300  Very Unhealthy.
                                                         250.4
(\2\)...............................  0.405-0.504     3 250.5-     425-504   30.5-40.4  0.605-0.804       1.25-1.64     301-400  Hazardous.
                                                         350.4
(\2\)...............................  0.505-0.604     3 350.5-     505-604   40.5-50.4  0.805-1.004       1.65-2.04     401-500  Hazardous.
                                                         500.4
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 O3 values do not define higher AQI values (>=301). AQI values of 301 or greater are calculated with 1-hour O3 concentrations.
\3\ If a different SHL for PM2.5 is promulgated, these numbers will change accordingly.

 [FR Doc. E9-15944 Filed 7-14-09; 8:45 am]

BILLING CODE 6560-50-P


1 03 23 05 BOARD OF SCIENTIFIC COUNSELORS COMPUTATIONAL TOXICOLOGY SUBCOMMITTEE DRAFT AGENDA April 25 26, 2005 U. S. EPA Research Triangle Park ( RTP) Campus EPA Main Building ( Room C111A) 109 T. W. Alexander Drive Research Triangle Park, NC 27711 Monday, April 25, 2005 10: 00 a. m.  10: 30 a. m. Registration 10: 30 a. m.  10: 45 a. m. Welcome and Introductions Dr. George Daston, Subcommittee Chair  DFO Remarks Lori Kowalski, ORD 10: 45 a. m.   11: 00 a. m. Acting AA/ ORD Remarks Mr. Tim Oppelt 11: 00 a. m.  12: 15 p. m. Background and Direction of ORD's Dr. Robert Kavlock, National Center for Computational Director, NCCT/ Dr. Jerry Toxicology ( NCCT) Blancato, Deputy Director, NCCT 12: 15 p. m.  1: 15 p. m. Lunch*

1: 15 p. m.   2: 15 p. m. Summary of FY04 ORD Computational Dr. Robert Kavlock, Toxicology Activities Director, NCCT 2: 15 p. m.   2: 45 p. m. Discussion Comp Tox Subcommittee 2: 45 p. m.   3: 45 p. m. Research Theme I: Information Dr. Ann Richard, NCCT Technology 3: 45 p. m. 4: 15 p. m. Break*

4: 15 p. m.   5: 15 p. m. Research Theme II: Prioritization Dr. Robert Kavlock, Director, NCCT/ Dr. James Rabinowitz,, NCCT 5: 15 p. m.   5: 30 p. m. Recap Day's Activities Dr. George Daston, Subcommittee Chair 5: 30 p. m. Adjourn 2 Tuesday, April 26, 2005 8: 30 a. m.  9: 30 a. m. Research Theme III: Biological Models Dr. Hugh Barton, NCCT / Dr. Woodrow Setzer, NCCT/ Dr. Michael Zager, NCCT/ UNC Dr. Jerry Blancato, Deputy Director, NCCT 9: 30 a. m.   10: 30 a. m. Research Theme IV: Cumulative Dr. Elaine Cohen Hubal,/ Risk Dr. Woodrow Setzer, NCCT 10: 30 a. m.   10: 45 a. m. Public Comment 10: 45 a. m.   11: 00 a. m. Break*

11: 00 a. m   12: 00 p. m. Discussion Comp Tox Subcommittee  Highlights from posters  General 12: 00 p. m.   12: 30 p. m. Future Business Dr. George Daston,  Action Items Subcommittee Chair  Letter Report  Next Meeting 12: 30 p. m Adjourn * Note that posters covering ORD Comp Tox Center research will be available in the meeting room and/ or adjacent space and can be viewed during meeting breaks.


[Federal Register Volume 82, Number 49 (Wednesday, March 15, 2017)]
[Notices]
[Pages 13817-13819]
[FR Doc No: 2017-05095]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0041]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Safety Assurance Case

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection associated with
safety assurance cases.

DATES: Submit either electronic or written comments on the collection
of information by May 15, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or

confidential business information, such as a manufacturing process.
Please note that if you include your name, contact information, or
other information that identifies you in the body of your comments,
that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-N-0041 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Safety Assurance Case.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) The accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) Ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) Ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Safety Assurance Case--OMB Control Number 0910-0766--Extension

    In January 2011, the Food and Drug Administration (FDA) announced
its intention to evaluate the use of assurance cases as part of our
Plan of Action to strengthen the 510(k) program following the
publication of the draft guidance on infusion pumps (April 26, 2010, 75
FR 21632). The initial test assurance case focused on infusion pumps
because the Infusion Pump Improvement Initiative was also exploring the
use of assurance cases as a means of improving premarket review. The
infusion pump assurance case beta testing included infusion pump
devices classified under 21 CFR 880.5725.
    The assurance case consists of a structured argument, supported by
a body of valid scientific evidence that provides an organized and
comprehensible case that the infusion pump is comparably safe for its
intended use within its environment of use. The argument should be
commensurate with the potential risk posed by the infusion pump, the
complexity of the infusion pump, and the familiarity with the
identified risks and mitigation measures.
    Assurance cases are dependent on individual product specifications,
hazards, design, and documentation. For this reason, assurance cases
are considered to be device-specific, meaning any newly developed
device would have its own unique assurance case. If the manufacturer
submits a 510(k) for modifications to a legally marketed infusion pump
for which no assurance case exists, FDA recommends that manufacturers
develop and submit a case for their infusion pump.
    Following the completion of the assurance case beta testing, FDA
has written an Infusion Pump Total Life Cycle final guidance with
recommendations for how manufacturers of infusion pumps should submit
an assurance case with their premarket notification (510(k))
submissions. The guidance recommends that an assurance case demonstrate
mitigation of infusion pump related hazardous situations through
analysis of operational, environmental, electrical, hardware, software,
mechanical, biological, chemical, and use hazards, as appropriate.
    FDA is requesting extension of approval for the information
collection requirements contained within an

assurance case. The assurance case requires the device sponsor to
explicitly describe how and why their device meets FDA regulatory
requirements, as they relate to safety.
    The respondents to this collection of information are infusion pump
manufacturers subject to FDA's laws and regulations.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                              Activity                                  Number of      responses  per    Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Assurance Case Report..............................................              31                1               31              112            3,472
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA's estimate of 31 respondents is based on the number of
manufacturers of infusion pumps listed in FDA's Registration and
Listing database (FURLS). The estimated average burden per response,
112 hours, is based on FDA's expectation of the amount of information
that will be contained in the report, on public comment received
regarding the burden, on consultation with stakeholders/industry, and
on FDA's experience in the creation of an assurance case argument
structures for use in the guidance. Our estimate also reflects that
some information used to support the assurance case, such as activities
conducted under existing design controls, is already covered in another
information collection request (OMB control number 0910-0073) and is
therefore not included in the burden estimate in this information
collection request. The respondents to this collection of information
are infusion pump manufacturers.

    Dated: March 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05095 Filed 3-14-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 56 (Monday, March 23, 2020)]
[Rules and Regulations]
[Pages 16243-16245]
[FR Doc No: 2020-05870]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 31301; Amdt. No. 3895]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This rule establishes, amends, suspends, or removes Standard
Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums
and Obstacle Departure Procedures (ODPs) for operations at certain
airports. These regulatory actions are needed because of the adoption
of new or revised criteria, or because of changes occurring in the
National Airspace System, such as the commissioning of new navigational
facilities, adding new obstacles, or changing air traffic requirements.
These changes are designed to provide safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective March 23, 2020. The compliance date for
each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of March 23, 2020.

ADDRESSES: Availability of matters incorporated by reference in the
amendment is as follows:

For Examination

    1. U.S. Department of Transportation, Docket Ops-M30, 1200 New
Jersey Avenue SE, West Bldg., Ground Floor, Washington, DC 20590-0001.
    2. The FAA Air Traffic Organization Service Area in which the
affected airport is located;
    3. The office of Aeronautical Navigation Products, 6500 South
MacArthur Blvd., Oklahoma City, OK 73169 or,
    4. The National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html .

Availability

    All SIAPs and Takeoff Minimums and ODPs are available online free
of charge. Visit the National Flight Data Center at nfdc.faa.gov to
register. Additionally, individual SIAP and Takeoff Minimums and ODP
copies may be obtained from the FAA Air Traffic Organization Service
Area in which the affected airport is located.

FOR FURTHER INFORMATION CONTACT: Thomas J. Nichols, Flight Procedures
and Airspace Group, Flight Technologies and Procedures Division, Flight
Standards Service, Federal Aviation Administration. Mailing Address:
FAA Mike Monroney Aeronautical Center, Flight Procedures and Airspace
Group, 6500 South MacArthur Blvd., Registry Bldg. 29, Room 104,
Oklahoma City, OK 73169. Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends Title 14 of the Code of
Federal Regulations, Part 97 (14 CFR part 97), by establishing,
amending, suspending, or removes SIAPS, Takeoff Minimums and/or ODPS.
The complete regulatory description of each SIAP and its associated
Takeoff Minimums or ODP for an identified airport is listed on FAA form
documents which are incorporated by reference in this amendment under 5
U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAA
forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when
required by an entry on 8260-15A.
    The large number of SIAPs, Takeoff Minimums and ODPs,their complex
nature, and the need for a special format make publication in the
Federal Register expensive and impractical.

Further, airmen do not use the regulatory text of the SIAPs, Takeoff
Minimums or ODPs, but instead refer to their graphic depiction on
charts printed by publishers of aeronautical materials. Thus, the
advantages of incorporation by reference are realized and publication
of the complete description of each SIAP, Takeoff Minimums and ODP
listed on FAA form documents is unnecessary. This amendment provides
the affected CFR sections and specifies the types of SIAPs, Takeoff
Minimums and ODPs with their applicable effective dates. This amendment
also identifies the airport and its location, the procedure, and the
amendment number.

Availability and Summary of Material Incorporated by Reference

    The material incorporated by reference is publicly available as
listed in the ADDRESSES section.
    The material incorporated by reference describes SIAPS, Takeoff
Minimums and/or ODPS as identified in the amendatory language for part
97 of this final rule.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP, Takeoff Minimums and ODP as Amended in the
transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments
may have been issued previously by the FAA in a Flight Data Center
(FDC) Notice to Airmen (NOTAM) as an emergency action of immediate
flight safety relating directly to published aeronautical charts.
    The circumstances that created the need for some SIAP and Takeoff
Minimums and ODP amendments may require making them effective in less
than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an
effective date at least 30 days after publication is provided.
    Further, the SIAPs and Takeoff Minimums and ODPs contained in this
amendment are based on the criteria contained in the U.S. Standard for
Terminal Instrument Procedures (TERPS). In developing these SIAPs and
Takeoff Minimums and ODPs, the TERPS criteria were applied to the
conditions existing or anticipated at the affected airports. Because of
the close and immediate relationship between these SIAPs, Takeoff
Minimums and ODPs, and safety in air commerce, I find that notice and
public procedure under 5 U.S.C. 553(b) are impracticable and contrary
to the public interest and, where applicable, under 5 U.S.C 553(d),
good cause exists for making some SIAPs effective in less than 30 days.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) is not a ``significant regulatory action'' under
Executive Order 12866;(2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26,1979); and
(3)does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97

    Air Traffic Control, Airports, Incorporation by reference,
Navigation (Air).

    Issued in Washington, DC, on March 6, 2020.
Rick Domingo,
Executive Director, Flight Standards Service.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me, Title 14,
Code of Federal Regulations, Part 97 (14 CFR part 97) is amended by
establishing, amending, suspending, or removing Standard Instrument
Approach Procedures and/or Takeoff Minimums and Obstacle Departure
Procedures effective at 0901 UTC on the dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority: 49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114,
40120, 44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:

Effective 23 April 2020

Laurel, MS, Hesler-Noble Field, VOR-A, Amdt 6
Lebanon, NH, Lebanon Muni, RNAV (GPS) RWY 18, Amdt 1
Hudson, NY, Columbia County, NDB-A, Amdt 4B, CANCELLED
New Castle, PA, New Castle Muni, NDB RWY 23, Amdt 3C, CANCELLED
Viroqua, WI, Viroqua Muni, Takeoff Minimums and Obstacle DP, Amdt 2

Effective 21 May 2020

Marianna, AR, Marianna/Lee County-Steve Edwards Field, RNAV (GPS)
RWY 36, Amdt 1B
West Memphis, AR, West Memphis Muni, ILS OR LOC RWY 17, Amdt 5B
Fort Huachuca Sierra Vista, AZ, Sierra Vista Muni-Libby AAF, TACAN
RWY 8, Amdt 1B
Fort Huachuca Sierra Vista, AZ, Sierra Vista Muni-Libby AAF, TACAN
RWY 26, Amdt 1B
Chico, CA, Chico Muni, Takeoff Minimums and Obstacle DP, Amdt 7
Modesto, CA, Modesto City-Co-Harry Sham Fld, ILS OR LOC RWY 28R,
Amdt 15
Modesto, CA, Modesto City-Co-Harry Sham Fld, RNAV (GPS) RWY 28R,
Amdt 1
Modesto, CA, Modesto City-Co-Harry Sham Fld, VOR RWY 28R, Amdt 1
Paso Robles, CA, Paso Robles Muni, PASO ROBLES ONE, Graphic DP
Paso Robles, CA, Paso Robles Muni, Takeoff Minimums and Obstacle DP,
Amdt 2
Sacramento, CA, Sacramento Intl, Takeoff Minimums and Obstacle DP,
Amdt 1A
Live Oak, FL, Suwannee County, RNAV (GPS) RWY 25, Orig-C
Perry, FL, Perry-Foley, Takeoff Minimums and Obstacle DP, Amdt 1B
Clarion, IA, Clarion Muni, NDB RWY 14, Amdt 4A, CANCELLED
Council Bluffs, IA, Council Bluffs Muni, ILS OR LOC RWY 36, Amdt 1B
Independence, IA, James H Connell Fld at Independence Muni, RNAV
(GPS) RWY 18, Amdt 1A
Independence, IA, James H Connell Fld at Independence Muni, RNAV
(GPS) RWY 36, Amdt 1A
Independence, IA, James H Connell Fld at Independence Muni, Takeoff
Minimums and Obstacle DP, Amdt 5A
Mapleton, IA, James G Whiting Memorial Field, RNAV (GPS) RWY 20,
Orig-C
Sheldon, IA, Sheldon Rgnl, RNAV (GPS) RWY 33, Amdt 1D
Spencer, IA, Spencer Muni, RNAV (GPS) RWY 12, Orig-A
Urbana, IL, Frasca Field, VOR-A, Amdt 11B
Harper, KS, Harper Muni, RNAV (GPS)-A, Orig
Harper, KS, Harper Muni, VOR OR GPS-B, Amdt 1B, CANCELLED
Independence, KS, Independence Muni, ILS OR LOC RWY 35, Amdt 2A
Independence, KS, Independence Muni, VOR-A, Amdt 3A
Kingman, KS, Kingman Airport--Clyde Cessna Field, Takeoff Minimums
and Obstacle DP, Orig-B
Harlan, KY, Tucker-Guthrie Memorial, RNAV (GPS)-A, Amdt 1
Shreveport, LA, Shreveport Downtown, Takeoff Minimums and Obstacle
DP, Amdt 4
Baltimore, MD, Baltimore/Washington Intl Thurgood Marshall, Takeoff
Minimums and Obstacle DP, Amdt 10A
Augusta, ME, Augusta State, RNAV (GPS)-B, Orig-C, CANCELLED
Augusta, ME, Augusta State, Takeoff Minimums and Obstacle DP, Amdt 4
Battle Creek, MI, W K Kellogg, NDB RWY 23R, Amdt 19A, CANCELLED
Austin, MN, Austin Muni, RNAV (GPS) RWY 35, Amdt 2A
Mahnomen, MN, Mahnomen County, RNAV (GPS) RWY 17, Amdt 1A
Mahnomen, MN, Mahnomen County, RNAV (GPS) RWY 35, Amdt 1A

Pine River, MN, Pine River Rgnl, NDB RWY 34, Amdt 2A
Staples, MN, Staples Muni, NDB RWY 14, Amdt 3C
Tarkio, MO, Gould Peterson Muni, Takeoff Minimums and Obstacle DP,
Amdt 1
Trenton, MO, Trenton Muni, NDB RWY 18, Amdt 7D, CANCELLED
Trenton, MO, Trenton Muni, NDB RWY 36, Amdt 10B, CANCELLED
Tioga, ND, Tioga Muni, RNAV (GPS) RWY 12, Orig-B
Toledo, OH, Toledo Executive, Takeoff Minimums and Obstacle DP, Amdt
3
Gregory, SD, Gregory Muni--Flynn Fld, RNAV (GPS) RWY 13, Orig-C
Pierre, SD, Pierre Rgnl, ILS OR LOC RWY 31, Amdt 13
Gilmer, TX, Fox Stephens Field-Gilmer Muni, VOR/DME-A, Amdt 1A,
CANCELLED
Houston, TX, William P Hobby, Takeoff Minimums and Obstacle DP, Amdt
7
Mount Pleasant, TX, Mount Pleasant Rgnl, VOR/DME-A, Orig-A,
CANCELLED
Sulphur Springs, TX, Sulphur Springs Muni, RNAV (GPS) RWY 1, Amdt 1C
Terrell, TX, Terrell Muni, NDB RWY 17, Amdt 4, CANCELLED
Ogden, UT, Ogden-Hinckley, ILS OR LOC RWY 3, Amdt 5A
Newport News, VA, Newport News/Williamsburg Intl, ILS OR LOC RWY 7,
Amdt 35
Marshfield, WI, Marshfield Muni, SDF RWY 34, Amdt 7, CANCELLED

[FR Doc. 2020-05870 Filed 3-20-20; 8:45 am]
 BILLING CODE 4910-13-P